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EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY Accepted for Oral Presentation at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases

JERUSALEM , Feb. 19, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of oral peptide and protein replacement therapies in tablet form, today announced that the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO–IOF–ESCEO) Scientific Programme Committee has accepted both submitted abstracts related to EB613 for presentation at the WCO–IOF–ESCEO congress. The congress will take place at the Roma Convention Center, Rome, Italy from April 10 to April 13, 2025.

EB613 is being developed as the first once–daily oral anabolic (bone forming) PTH(1–34) tablet treatment to support earlier osteoanabolic intervention, for high–risk post–menopausal women with osteoporosis. In a Placebo–controlled Phase 2 study, 6 months of EB613 treatment demonstrated fast onset of action and robust increases in BMD at all skeletal sites. Further, EB613 induced increases in bone formation (P1NP) and suppression of bone resorption (CTX).

“EFFECTS OF EB613 TABLETS [ORAL PTH(1–34)] ON TRABECULAR AND CORTICAL BONE USING 3D–DXA: POST–HOC RESULTS FROM PHASE 2 STUDY” will be presented as an Oral Presentation Friday April 11 at 10:00 GMT in the Auditorium A.

“EB613 TABLET TREATMENT [ORAL PTH(1–34)] – DOES PK DRIVE BONE MODELING VERSUS BONE REMODELING?” will be presented as a Poster Presentation Friday April 11th – Sunday April 13th 2025.

“We thank our distinguished authors and are looking forward to sharing further mechanistic insights on EB613 with the thousands of top researchers and healthcare professionals who attend WCO–IOF–ESCEO,” said Miranda Toledano, Chief Executive Officer of Entera.

It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and approximately 1 in 5 adults will die within the year following a hip fracture. Post menopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.

EB613 is intended to provide an anabolic ‘boost’ to strengthen skeletal microarchitecture and induce rapid BMD gains, followed by consolidation with an antiresorptive agent. “Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most patients with high–risk osteoporosis requiring an anabolic intervention. Our EB613 program is being developed to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of patients to adequately manage their bone health with a simple once daily tablet treatment,” Said Toledano.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9360860)

Zenas BioPharma Announces Key 2024 Accomplishments and 2025 Business Objectives to Support the Global Development and Commercialization of Therapies for Autoimmune Diseases

– Advancing Phase 2 and Phase 3 trials of obexelimab, a unique CD–19 x FcγRIIb inhibitor of B cell function–

–Topline results from Phase 2 Trial in Relapsing Multiple Sclerosis (MoonStone) expected in third quarter 2025–

–Topline results from pivotal Phase 3 Trial in Immunoglobulin G4–Related Disease (INDIGO) expected year–end 2025–

– Enrollment of Phase 2 Trial in Systemic Lupus Erythematosus (SunStone) expected to be completed in 2025–

– Out–licensed greater–China anti–IGF–1R Thyroid Eye Disease programs to Zai Lab –

WALTHAM, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical–stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year–end 2024.

“Based upon the progress achieved across all of our corporate goals and objectives during 2024, we enter 2025 with an opportunity to achieve major value–driving milestones with the anticipated results from our ongoing obexelimab Phase 2 and Phase 3 clinical trials,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “We are extremely proud of the accomplishments of our dedicated team as we enter the year well–financed and able to focus on execution, and achievement of our key objectives for the year.”

The Company enters 2025 well–capitalized to deliver its key milestones with approximately $350 million in cash, cash equivalents, and short–term investments as of December 31, 2024, 1 which is expected to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026.

2024 Accomplishments and Recent Achievements

During 2024, the Company achieved the following objectives and announced a recent business development transaction:

  • Completed enrollment of the Phase 3 INDIGO trial, a global Phase 3 registration–directed, randomized, double–blind placebo–controlled trial of obexelimab in patients with Immunoglobulin–G4 Related Disease (IgG4–RD), the largest clinical trial ever conducted in this patient population.
  • Initiated the Phase 2 MoonStone trial, a Phase 2, multicenter, randomized, double–blind, placebo–controlled trial, to evaluate the efficacy and safety of obexelimab in patients with Relapsing Multiple Sclerosis (RMS).
  • Initiated the Phase 2 SunStone trial, a Phase 2, multicenter, randomized, double–blind, placebo–controlled trial, to evaluate the efficacy and safety of obexelimab to reduce disease activity in patients with Systemic Lupus Erythematosus (SLE).
  • Provided initial data from the Phase 2 SApHiAre trial, a global, multicenter, open–label safety and dose confirmation run–in period (SRP) to evaluate the safety and activity of obexelimab in patients with warm Autoimmune Hemolytic Anemia (wAIHA). Obexelimab achieved clinical proof–of–mechanism by increasing hemoglobin levels and red blood cells, and decreasing LDH and total bilirubin levels. Obexelimab was well tolerated in the SRP.
  • Completed an upsized Series C and initial public offering, raising approximately $458.7 million in aggregate gross proceeds to fund its planned activities for obexelimab and the Company’s growth strategy.
  • Bolstered its leadership team with the appointments of Chief Commercial Officer, Orlando Oliveira, and Chief Legal Officer, Jeff Held.
  • Out–licensed ZB005, a human IgG4 monoclonal antibody designed to bind only to the active form of C1s, for which Zenas held the development and commercialization rights in China, Hong Kong, Macau and Taiwan (Greater China) through an exclusive license with Dianthus.
  • The Company recently out–licensed regional rights to its thyroid eye disease programs, including ZB001, an insulin–like growth factor–1 receptor (anti–IGF–1R) monoclonal antibody, to Zai Lab (Zai).  Zenas received an upfront fee and is eligible to receive milestone payments and royalties in the future, as consideration for an exclusive sublicense to Zai to develop and commercialize ZB001 and related programs in Greater China.

Anticipated 2025 Clinical Milestones for Obexelimab

Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self–administered, subcutaneous once–weekly injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in five completed clinical trials in a total of 198 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases.

During 2025, the Company expects to achieve the following key clinical milestones:

  • Report the 12–week primary endpoint results in the third quarter of 2025 from the Phase 2 MoonStone trial in patients with RMS.

The role of B cells in the pathogenesis of multiple sclerosis including RMS has been demonstrated through the successful clinical development, approval and clinical use of anti–CD20 B cell targeting therapies of other companies, including OCREVUS® (ocrelizumab) and KESIMPTA® (ofatumumab), which selectively deplete CD20–expressing B cells. The Company believes obexelimab’s unique mechanism of action to potently inhibit but not deplete a broader B cell lineage than CD20, nonclinical data, and a subcutaneous injection regimen, supports its potential for the treatment of RMS.

  • Following an initial screening period, patients in the MoonStone trial are being randomized 2:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for a 12–week treatment period.
  • The primary objective of this double–blinded portion of the trial will be to assess the change from baseline in the cumulative number of gadolinium (Gd) enhancing lesions identified on T1–weighted magnetic resonance imaging (MRI).
  • Upon completion of the 12–week period, patients will enter an open–label period where patients on placebo will receive obexelimab treatment for at least three months, and patients initially randomized to obexelimab will continue treatment.
  • Important secondary endpoints during this open–label period include using standardized assessments, novel 3D imaging and biomarkers, including serum neurofilament light chain (NfL), to evaluate the impact of obexelimab on disease progression.

More information on the Phase 2 MoonStone trial (NCT06564311) is available at clinicaltrials.gov

  • Report topline results year–end 2025 from the Phase 3 INDIGO trial in patients with IgG4–RD.

IgG4–RD is a chronic fibro–inflammatory disease that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs, and kidneys. Patients with IgG4–RD may present with a single organ involved but more frequently present with multiple organ involvement. As the disease progresses and patients experience new or worsening symptoms (i.e., flares), lesions develop in additional organs and the cellular inflammation characterizing early disease moves toward a more fibrotic stage, which can lead to major irreversible tissue damage and ultimately organ failure. We estimate that the currently diagnosed population of IgG4–RD patients in the U.S. is approximately 20,000, with comparable prevalence rates globally.

Despite the growing recognition of IgG4–RD and advances in the understanding of its pathophysiology, there are no approved therapies for the treatment of this disease and there remains high unmet medical need. The current standard of care is treatment with glucocorticoids (GCs). Although GCs are initially effective, treatment with GCs can often result in various complications and co–morbidities. Most patients can relapse within 12 months of discontinuing GC treatment, and maintenance therapy with GCs has not been shown to prevent recurrence of disease.

The pathogenesis of IgG4–RD suggests that B cell–targeted therapies may provide therapeutic benefit. Although not approved by any regulatory authorities to treat IgG4–RD, certain B cell depleting agents (e.g., rituximab) are occasionally administered to patients with IgG4–RD. However, B cell depleting agents are often associated with infections, including serious opportunistic infections, and can compromise a patient’s ability to mount a response to vaccinations.

The reported evidence for the role of B cells in the pathogenesis of IgG4–RD, the observed effects of B cell targeting agents in previous trials in IgG4–RD, the data from our Phase 2 IgG4–RD trials with obexelimab, and its unique, non–depleting mechanism and once–weekly, subcutaneous injection regimen support its development in patients with IgG4–RD.

  • INDIGO is the largest clinical trial conducted in patients living with IgG4–RD and is designed to evaluate the safety and efficacy of obexelimab in approximately 190 patients with active IgG4–RD and being conducted at approximately 100 sites in 20 countries.
  • Following an initial screening period, patients were randomized 1:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for 52 weeks, followed by an opportunity for eligible patients to continue in an open–label extension period where all patients will receive treatment with obexelimab.
  • The primary efficacy endpoint of INDIGO is the time to first IgG4–RD flare, as determined per protocol by the investigator and the adjudication committee.
  • Secondary endpoints include annualized flare rate, the proportion of patients achieving complete remission, and use and quantity of rescue medication, including GCs.

More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov

  • Complete enrollment in 2025 in the Phase 2 SunStone trial in patients with SLE and report topline results in the first half of 2026.

The crucial role of B cells in SLE pathogenesis is well recognized, from producing autoantibodies to abnormal regulation of immune responses. Moreover, SLE is an autoimmune disease characterized by B cell dysfunction, the production of autoantibodies toward cellular and nuclear components, and multiorgan damage caused by immune complex deposition and inflammation within affected tissues. Current treatments are limited in number and modestly effective. Obexelimab has demonstrated clinical activity in a prior Phase 2 double–blind, randomized trial demonstrating proof–of–concept in the overall trial population and increased response in patients who maintained higher systemic exposure to obexelimab, and also in biomarker–defined subpopulations. Coupled with the safety data obtained to date, we believe these data provide support for the development of obexelimab in patients with SLE.

  • Patients with active SLE determined at screening by the investigator and adjudication committee are randomized 1:1 to obexelimab 250 mg or placebo administered as a subcutaneous injection every seven days for 24 weeks.
  • The 250 mg once–weekly subcutaneous injection dose has been selected to maximize the potential for clinical activity as higher systemic exposure (Ctrough) correlated with greater clinical activity in the prior Phase 2 trial in SLE.
  • The primary endpoint is the percentage of responders, defined by BILAG–based Composite Lupus Assessment, with a reduction of SLE disease activity at week 24.
  • Biomarker analysis is planned to be conducted in all patients, including baseline RNA expression profiles to immunophenotype patients and evaluation of their differential responses to treatment.

More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov

About Zenas BioPharma, Inc.

Zenas is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self–administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn.

Forward looking statements

This press release contains “forward–looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward–looking statements. In some cases, forward–looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward–looking statements contain these words. Forward–looking statements include, but are not limited to, statements concerning Zenas’s plans, objectives, expectations and intentions; the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO trial topline results, the 12–week primary endpoint data for the MoonStone trial and the anticipated timing of completing enrollment and reporting topline results for the SunStone trial; its growth strategy; the Company’s preliminary unaudited cash, cash equivalents and short–term investments as of December 31, 2024; and cash runway guidance. The forward–looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward–looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third–party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10–Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward–looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward–looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward–looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward–looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward–looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward–looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.

Investor Contact:

Matthew Osborne

Investor Relations and Corporate Communications
[email protected]

Media Contact:

Argot Partners
[email protected]

1 This amount is preliminary and unaudited and is subject to completion of the Company’s financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2024.


GLOBENEWSWIRE (Distribution ID 9353140)

BioAro launches AI-Driven PanOmiQ with Ultrafast Whole Genome Sequencing Analysis Technology

CALGARY, Alberta, Feb. 03, 2025 (GLOBE NEWSWIRE) — BioAro, a global leader in precision health and genomics, will unveil its groundbreaking AI–powered PanOmiQ platform at the prestigious Precision Medicine World Conference (PMWC) in Silicon Valley. This Whole Genome Sequencing (WGS) solution achieves unparalleled efficiency, reducing analysis time to under two hours and generating Variant Call Format (VCF) files in under five minutes. This historic milestone in medical and computing science redefines the landscape of precision medicine and AI–driven genomic analysis.

This innovation represents a transformative leap in global healthcare, combining speed, accuracy, and affordability to make precision medicine more accessible than ever before. “PanOmiQ isn’t just a technological advancement–it’s a game–changer for global healthcare,” says Dr. Anmol S. Kapoor, Chairman and CEO at BioAro. “By cutting genome analysis time from days to hours, we’re making precision medicine available to everyone, not just the privileged few. This innovation allows clinicians to act on real–time genetic insights, shifting medicine from reactive treatments to proactive, preventative care. This is how we extend human longevity and make personalized health a universal reality.”

BioAro’s commitment to innovation is evident in its continuous pursuit of cutting–edge AI–driven solutions that enhance diagnostic accuracy and expand accessibility to genomic medicine. By integrating AI into genomic analysis, PanOmiQ effectively eliminates the bottlenecks of traditional sequencing methods, which have historically been time–consuming and cost prohibitive. This breakthrough enables researchers, healthcare providers, and institutions to expedite precision diagnostics, optimize treatment plans, and significantly reduce the burden on healthcare infrastructure.

Dr. Raja B. Singh, Chief Scientific Officer at BioAro, will showcase PanOmiQ at PMWC, highlighting its ability to democratize precision health through AI–driven genomic technology. By eliminating the high costs and complexity of traditional Whole Genome Sequencing (WGS), PanOmiQ makes advanced genomics accessible to hospitals, researchers, and underserved communities worldwide. This innovation paves the way for new possibilities in cancer research, rare disease diagnostics, and infectious disease monitoring, reinforcing the critical role of AI in shaping the future of healthcare.

One of PanOmiQ’s most remarkable achievements is its proficiency in variant calling. In August 2024, PanOmiQ achieved a 100% match in variant calling during proficiency testing conducted by the College of American Pathologists (CAP), solidifying its position as one of the most accurate genomic platforms available. This level of precision ensures that clinicians and researchers can trust the insights derived from genomic data, leading to better patient care and groundbreaking discoveries.

“We’re not just making genomics faster; we’re making it smarter and more precise,” says Dr. Raja B. Singh. “AI–driven accuracy at this scale ensures that patients receive the most reliable genetic insights, leading to better diagnostics, targeted treatments, and groundbreaking discoveries in fields like cancer research and rare genetic diseases. This is the future of precision medicine.”

The unveiling of PanOmiQ at PMWC Silicon Valley marks a transformative moment in healthcare innovation. By harnessing AI–driven genomic analysis, PanOmiQ enables faster, personalized treatments, reduces healthcare costs, and expands access to precision medicine in underserved regions. From advancing cancer research and rare disease treatments to monitoring infectious diseases in real–time, this groundbreaking platform empowers clinicians and researchers to deliver proactive, preventative care, ultimately improving patient outcomes and extending human longevity.

Healthcare providers worldwide face significant challenges in delivering timely and accurate diagnoses, particularly in regions with limited access to advanced medical technologies. PanOmiQ bridges this gap by providing an efficient, scalable, and cost–effective genomic analysis solution. This advancement is particularly crucial in oncology, where rapid genome sequencing can inform personalized treatment strategies and improve survival rates. Similarly, in the study of rare genetic diseases, PanOmiQ’s capabilities accelerate diagnosis and enable early intervention, transforming patient lives.

PanOmiQ is more than just a Whole Genome Sequencing (WGS) platform–it is the World’s Fastest Multi–Genomic Platform. Its advanced AI–powered analytics extends to Whole Exome Sequencing and microbiome analysis, covering skin, oral, gut, and vaginal microbiomes in real–time. This comprehensive approach to genomics allows researchers and healthcare professionals to gain deeper insights into the interplay between genetics and microbiomes, further advancing the field of precision health.

By integrating microbiome analysis, PanOmiQ enhances the understanding of how microbial ecosystems influence human health. This is particularly relevant in personalized nutrition, immunotherapy, and chronic disease management, where microbiome composition plays a critical role. The ability to conduct real–time microbiome assessments allows clinicians to tailor interventions with unprecedented accuracy, optimizing patient care on an individual level.

“The ability to analyze an entire genome at the population level in under two hours is a historic leap in medical science,” Dr. Kapoor concludes. “We’re not just decoding DNA faster; we’re rewriting the future of healthcare.”

By accelerating genomic analysis and expanding access to precision medicine, PanOmiQ is poised to transform the global healthcare landscape. The implications of this innovation are profound, ranging from improved disease prevention strategies to personalized treatment plans tailored to each patient’s unique genetic profile. As BioAro continues to drive innovation, the company remains steadfast in its mission to make precision health a reality for all.

About BioAro

BioAro is a pioneering precision health and genomics company headquartered in Calgary, Alberta. Specializing in Whole Genome Sequencing, Whole Exome Sequencing, CF–DNA testing, Epigenetics such as Telomere, Methylation, Gene Expression Analysis, Cancer Sequencing, Pharmacogenomics, Microbiome Testing, and AI–Powered Bioinformatics, BioAro is at the forefront of AI–driven healthcare innovation. Through its cutting–edge genomic, longevity, and precision health solutions such as BioELR, Biongevity, The BioSport, and BioGut Clinic, BioAro is transforming patient outcomes, accelerating medical research, and shaping the future of personalized medicine.

Media Contact

Email: [email protected]

Phone: 587–721–2222

Website: www.PanOmiQ.com

Photos accompanying this announcement are available at

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GLOBENEWSWIRE (Distribution ID 9351417)

شركة BioAro تطلق تقنية تحليل تسلسل الجينوم الكامل فائقة السرعة PanOmiQ المدعومة بالذكاء الاصطناعي

كالجاري، ألبرتا،, Feb. 03, 2025 (GLOBE NEWSWIRE) —

ستكشف شركة BioAro، الرائدة عالميًا في مجال الصحة الدقيقة وعلم الجينوم، عن منصتها المبتكرة PanOmiQ المدعومة بالذكاء الاصطناعي في المؤتمر العالمي المرموق للطب الدقيق (PMWC) في منطقة وادي السيليكون، ويحقق هذا الحل الخاص بتحليل تسلسل الجينوم الكامل (WGS) كفاءة لا مثيل لها، حيث يقلل وقت التحليل إلى أقل من ساعتين ويُولِد ملفات بتنسيق الاتصال المتغير (VCF) في أقل من خمس دقائق، وبذلك يُعيد هذا الإنجاز التاريخي في علوم الطب والحوسبة ترسيخ مكانة الطب الدقيق وتحليل الجينوم المدعوم بالذكاء الاصطناعي.

يشكل هذا الابتكار تحولاً جذريًا في مجال الرعاية الصحية العالمية، حيث يجمع بين السرعة والدقة والتكلفة الميسورة، مما يجعل الطب الدقيق في متناول الجميع أكثر من أي وقتٍ مضى. يقول الدكتور Anmol S. Kapoor، رئيس مجلس الإدارة والرئيس التنفيذي لشركة BioAro: “إن تقنية PanOmiQ ليست مجرد تقدم تكنولوجي فحسب، بل إنها تغيير جذري في مجال الرعاية الصحية العالمية”. “ومن خلال تقليص مدة تحليل الجينوم من أيام إلى ساعات، فإننا نجعل الطب الدقيق متاحًا للجميع، وليس فقط لطبقة الأثرياء، فتُمكِن هذه الابتكارات الأطباء السَريريين من اتخاذ قرارات مبنية على رؤى وتحليلات جينية فورية، مما يحوّل الطب من العلاجات التفاعلية إلى رعاية استباقية ووقائية، وبهذا يُمكننا إطالة عُمْر الإنسان وجعل صحته الشخصية واقعًا عالميًا.”

يظهر التزام شركة BioAro بالابتكار من خلال سعيها المستمر لتقديم حلول متطوّرة مدعومة بالذكاء الاصطناعي، والتي من شأنها أن تعزز دقة التشخيص وتُيسر إمكانية الوصول إلى الطب الجيني. وتذلل تقنية PanOmiQ بفعاليةٍ العوائق التي كانت تعترض طرق التسلسل التقليدية، والتي كانت عادةً ما تستغرق وقتًا طويلاً وتتكبد تكاليف باهظة، وذلك من خلال دمج الذكاء الاصطناعي في تحليل الجينوم. يُمكِّن هذا الإنجاز الباحثين ومقدمي الرعاية الصحية والمؤسسات من تسريع التشخيص الدقيق وتحسين خطط العلاج وتقليل العبء على البنية التحتية للرعاية الصحية بشكل كبير.

سيعرض الدكتور Raja B. Singh، كبير المسؤولين العلميين في شركة BioAro، تقنية PanOmiQ في المؤتمر العالمي للطب الدقيق (PMWC)، مُسلطًا الضوء على قدرتها على تمكين الوصول إلى الصحة الدقيقة من خلال تكنولوجيا الجينوم المدعومة بالذكاء الاصطناعي. تجعل تقنية PanOmiQ علم الجينوم المُتقدم متاحًا للمستشفيات والباحثين والمجتمعات المحرومة في جميع أنحاء العالم، وذلك من خلال القضاء على التكاليف الباهظة وتعقيدات تحليل تسلسل الجينوم الكامل (WGS) التقليدي، ويفتح هذا الابتكار آفاقًا جديدة في أبحاث السرطان وتشخيص الأمراض النادرة ومراقبة الأمراض المُعْدية، مما يعزز الدور الفعّال للذكاء الاصطناعي في تشكيل مستقبل الرعاية الصحية.

ومن بين أبرز إنجازات تقنية PanOmiQ، كفاءتها العالية في اكتشاف المتغيرات الجينية. وفي أغسطس 2024، حققت تنقية PanOmiQ تطابقًا بنسبة 100% في اكتشاف المتغيرات الجينية خلال اختبار الكفاءة الذي أجرته الكلية الأمريكية لأطباء علم الأمراض (CAP)، مما يعزز مكانتها كإحدى أكثر منصات الجينوم المتاحة دقةً. يضمن هذا المستوى من الدقة أن يثق الأطباء والباحثون في النتائج المستمدة من البيانات الجينية، مما يسهم في تحسين رعاية المرضى وتحقيق اكتشافات رائدة.

يقول الدكتور Raja B. Singh: “نحن لا نجعل التحليلات الجينية أسرع فحسب؛ بل نجعلها أكثر ذكاءً ودقة، وتضمن الدقة المدعومة بالذكاء الاصطناعي في هذا النطاق حصول المرضى على تحليلات ونتائج جينية أكثر موثوقية، مما يؤدي إلى تشخيصات أفضل وعلاجات أكثر دقةً واكتشافات رائدة في مجالات مثل أبحاث السرطان والأمراض الوراثية النادرة، لذلك، تُعَد هذه التقنية مستقبل الطب الدقيق.”

إن إطلاق تقنية PanOmiQ في المؤتمر العالمي للطب الدقيق (PMWC) في منطقة وادي السيليكون يُعَد لحظةً فارقةً في مجال ابتكارات الرعاية الصحية. وبفضل الاستفادة من التحليل الجينومي القائم على الذكاء الاصطناعي، تُمكِن تقنية PanOmiQ من توفير علاجات أسرع وأكثر تخصيصًا وتقلل من تكاليف الرعاية الصحية وتُوسِع نطاق الوصول إلى الطب الدقيق في المناطق المحرومة. تساعد هذه المنصة الرائدة الأطباء والباحثين على تقديم رعاية استباقية ووقائية، بدءًا من تطوير أبحاث السرطان وعلاجات الأمراض النادرة وصولًا إلى مراقبة الأمراض المُعْدية في الوقت الفعلي، مما يساهم في تحسين نتائج المرضى وإطالة العُمْر البشري.

يواجه مقدمو الرعاية الصحية في جميع أنحاء العالم تحديات كبيرة في تقديم تشخيصات دقيقة وفي الوقت المناسب، لا سيما في المناطق ذات الوصول المحدود إلى التقنيات الطبية المتقدمة. وتسدّ تقنية PanOmiQ هذه الفجوة من خلال تقديم حل تحليل جيني فعّال وقابل للتطوير ومنخفض التكلفة. يُعَد هذا التطوُّر إنجازًا مهمًا للغاية في مجال الأورام، حيث يمكن للتسلسل السريع للجينوم أن يساهم في وضع استراتيجيات علاجية مخصصة لكل مريض وبالتالي تحسين معدلات البقاء على قيد الحياة. وعلى نحوٍ مماثل، في دراسة الأمراض الوراثية النادرة، تسهم إمكانات تقنية PanOmiQ في تسريع التشخيص وتمكين التدخل المبكر، مما يُحدِث تحولاً في حياة المرضى.

لا تُعَد تقنية PanOmiQ مجرد منصة لتسلسل الجينوم الكامل (WGS) فحسب – إنها أسرع منصة تقدم نتائج تحليلات جينية متعددة في العالم. وتمتد تحليلاتها المتقدمة المدعومة بالذكاء الاصطناعي لتشمل التسلسل الكامل للإكسوم وتحليل الميكروبيوم، بما في ذلك ميكروبيومات الجلد والفم والأمعاء والمهبل بشكل فوري. يتيح هذا النهج الشامل في علم الجينوم للباحثين ومُقدمي الرعاية الصحية التوصل إلى رؤى أعمق حول التفاعل بين الجينات والميكروبيومات، مما يعزز التقدم في مجال الصحة الدقيقة.

ومن خلال دمج تحليل الميكروبيوم، تُحسِّن تقنية PanOmiQ الفهم حول كيفية تأثير الأنظمة البيئية الميكروبية على صحة الإنسان. ويحظى هذا الأمر بأهمية خاصة في التغذية الشخصية والعلاج المناعي وإدارة الأمراض المزمنة، حيث يؤدّي تكوين الميكروبيوم دورًا حيويًا في هذا المجال. تُمكِن القدرة على إجراء تقييمات الميكروبيوم الفورية الأطباء السَريريين من تخصيص التدخلات بدقة غير مسبوقة، مما يحسن رعاية المرضى على المستوى الفردي.

واختتم الدكتور Kapoor حديثه قائلاً: “إن القدرة على تحليل جينوم كامل على مستوى السكان في أقل من ساعتين هي قفزة تاريخية في قطاع العلوم الطبية. فنحن لا نحلل الحمض النووي بشكل أسرع فحسب، بل نعيد كتابة مستقبل الرعاية الصحية.”

تستعد PanOmiQ لتحويل المشهد في قطاع الرعاية الصحية العالمي من خلال سرعة إنجاز التحليلات الجينية وتوسيع نطاق الوصول إلى الطب الدقيق. تتعدد النتائج المترتبة على هذا الابتكار بشكل كبير، بدءًا من تحسين استراتيجيات الوقاية من الأمراض إلى خطط العلاج الشخصية المُصَممة خصيصًا لتناسب السمات الجينية الفريدة لكل مريض. وبينما تواصل BioAro دفع عجلة الابتكار، تظل الشركة متمسكةً بمهمتها لجعل الصحة الدقيقة واقعًا متاحًا للجميع.

نبذة عن شركة BioAro

BioAro هي شركة رائدة في مجال الصحة الدقيقة وعلوم الجينوم، ويقع مقرها الرئيسي في كالجاري، ألبرتا. تتخصص شركة BioAro في تحليلات تسلسل الجينوم الكامل وتسلسل الإكسوم الكامل وتحليل الحمض النووي الخالي من الخلايا وعلم ما فوق الجينات مثل التيلومير والمِثْيَلَة وتحليل تعبير الجينات وتسلسل أورام السرطان وعلم الصيدلة الجيني واختبار الميكروبيومات وعلم المعلومات الحيوية القائم على الذكاء الاصطناعي، مما يجعلها في طليعة الشركات المبتكرة في قطاع الرعاية الصحية المدعومة بالذكاء الاصطناعي. تعمل BioAro على تحسين نتائج المرضى وتسريع مدة إنجاز الأبحاث الطبية وإعادة تشكيل مستقبل الطب الشخصي، وذلك من خلال حلولها المتطورة في علم الجينوم وإطالة العُمْر البشري والصحة الدقيقة مثل BioELR وBiongevity وThe BioSport وBioGut Clinic.

جهة الاتصال الإعلامية

البريد الإلكتروني: [email protected]

الهاتف: 2222–721–587

الموقع الإلكتروني: www.PanOmiQ.com

الصور المرفقة بهذا البيان الصحفي متوفرة على الرابط التالي

https://www.globenewswire.com/NewsRoom/AttachmentNg/0457de01–fb5f–4a9f–a6af–64296a22e37d
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GLOBENEWSWIRE (Distribution ID 9351536)

Zenas BioPharma to Present at the Guggenheim SMID Cap Biotech Conference

WALTHAM, Mass., Jan. 28, 2025 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical–stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology–based therapies, today announced management’s fireside chat presentation at the Guggenheim SMID Cap Biotech Conference on Wednesday, February 5, 2025, at 3:00 p.m. ET.

A live webcast and archived replay of the Company’s presentation can be accessed under “Events and Presentations” in the Investor & Media Relations section of the Zenas BioPharma website.

About Zenas BioPharma, Inc.

Zenas is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative immunology–based therapies for patients in need. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self–administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.

Investor Contact:

Matthew Osborne

Investor Relations and Corporate Communications
[email protected]

Media Contact:
Argot Partners

[email protected]


GLOBENEWSWIRE (Distribution ID 9348330)

Entera Bio to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference

JERUSALEM, Jan. 27, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, announced that it will participate and be available for investor meetings at the Oppenheimer 35th Annual Healthcare Life Sciences Conference being held February 11 – 12, 2025 in a virtual format.

The presentation scheduled for Tuesday, February 11th at 12:40–1:10 PM ET in Track 1 will feature a business overview and update by Miranda Toledano, the Company’s Chief Executive Officer.

About Entera Bio

Entera is a clinical–stage company focused on developing tablet treatments of peptide and small protein replacement therapies for significant unmet medical needs where an oral form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose–ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary (BMD) endpoints. These outcomes have been published in the Journal for Bone and Mineral Research in April 2024, followed by an independent editorial in June 2024. Entera is preparing to initiate a Phase 3 registrational study for EB613 in H2 2025 pursuant to FDA’s expected qualification of a quantitative treat–to–target BMD endpoint (FNIH–SABRE). The EB612 program is being developed as the first oral PTH (1–34) tablet peptide replacement therapy for hypoparathyroidism. In partnership with OPKO Health (Nasdaq: “OPK”), Entera is also developing the first oral oxyntomodulin, a dual targeted GLP–1/glucagon peptide tablet for the treatment of obesity, fibrotic and metabolic disorders; and the first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare gastrointestinal inflammatory or malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9347915)

Brains Bioceutical Expande Oferta de Canabinóides Líder do Setor com D9-THC e CBN, Abrindo Novas Fronteiras para o Desenvolvimento de Medicamentos

VANCOUVER, British Columbia, Dec. 18, 2024 (GLOBE NEWSWIRE) — A Brains Bioceutical Corp. (Brains Bio), líder global em Ingredientes Farmacêuticos Ativos (APIs) de canabinóides naturais e compatíveis com GMP, anuncia a expansão da sua oferta líder do setor. O Canabinol (CBN) está disponível como um API certificado pela EU–GMP, o D9–tetra–hidrocanabinol (THC) está em uma forma cristalina sólida, passando por um trabalho aprimorado de otimização da estabilidade e a validação final está sendo realizada com o Canabigerol (CBG).

Essas novas adições complementam o portfólio atual da Brains Bio, com o CBD API sendo usado em mais de 30 estudos clínicos e pré–clínicos, incluindo um Estudo de Fase III de Epilepsia Refratária concluído – enviado à Marketing Authorisation – e um Estudo de Fase II de Transtorno de Uso de Opioides. Com distribuição global imediata de amostras, a Brains Bio abre novos caminhos para pesquisa clínica, desenvolvimento de produtos e inovação terapêutica.

A Próxima Onda das Terapias à Base de Canabinóides
O portfólio expandido da Brains Bio é um exemplo da dedicação da empresa com o desenvolvimento de canabinóides para pesquisa e desenvolvimento farmacêutico. As ofertas incluem produtos formulados e APIs compatíveis com os requisitos de monografia da Ph. Eur. e da ICH Q7, criados para apoiar programas clínicos aprovados por regulamentações visando necessidades médicas críticas não atendidas. Essas APIs, com aplicações potenciais em uma ampla gama de usos terapêuticos, incluindo distúrbios neurológicos, dor crônica e condições inflamatórias, estão prontas para impulsionar avanços clínicos inovadores.

Ampliação das Histórias de Sucesso Existentes
A indústria farmacêutica já testemunhou a integração bem–sucedida de medicamentos à base de canabinóides. Vários medicamentos aprovados pela FDA e pela EMA têm demonstrado benefícios clínicos significativos, incluindo:

  • Epidiolex (CBD): Uma solução oral para o tratamento de crises epilépticas associadas às síndromes de Lennox–Gastaut e Dravet (aprovado pela FDA/ EMA).
  • Marinol & Syndros (Dronabinol): Formulações para náuseas e vômitos induzidos por quimioterapia e anorexia relacionada à AIDS (aprovado pela FDA/EMA).
  • Sativex (CBD/THC): Um tratamento para espasticidade na EM e outras condições neurológicas (aprovado pela EMA).

Esses sucessos destacam o potencial terapêutico das terapias à base de canabinóides e sua crescente aceitação pela comunidade médica, com a Brains Bio permanecendo dedicada ao avanço da compreensão científica dos canabinóides.

“Um marco para a indústria farmacêutica”
“A introdução de CBN API, D9 THC e CBG de alta qualidade é um marco para a Brains Bio e para toda a indústria farmacêutica”, disse Ricky Brar, CEO e presidente da Brains Bioceutical Corp. “Esses produtos capacitam pesquisadores e desenvolvedores de medicamentos a ultrapassar os limites da ciência de canabinóides, acelerando a entrega de terapias transformadoras para pacientes em todo o mundo. Essa conquista é mais um exemplo do nosso compromisso inabalável de fornecer APIs que atendam aos mais altos padrões de segurança, qualidade e consistência.”

Um Mercado Pronto para Crescer
O Relatório Global de Pesquisa de Mercado Farmacêutico Derivado de Canabinóides 2024 projeta um aumento significativo, de US $ 884,3 milhões em 2021 para US $ 4,87 bilhões até 2034 (CAGR de 13,4%). Este aumento indica o aumento do reconhecimento da eficácia das terapias com canabinóides na abordagem de uma ampla gama de condições médicas.

O portfólio de APIs da Brains Bio representa a próxima fronteira, fornecendo aos inovadores farmacêuticos um ingrediente robusto e em conformidade para acelerar o desenvolvimento de tratamentos à base de canabinóides aprovados pela regulamentação.

Solicitação de Amostras e Consultas
As APIs THC e CBN da Brains Bioceutical Corp. já estão disponíveis para distribuição de amostras. Para mais informações, as empresas farmacêuticas e organizações de pesquisa podem contatar a empresa em [email protected].

Sobre a Brains Bioceutical Corp.
A Brains Bioceutical Corp. é líder global no desenvolvimento e fabricação de APIs de canabinóides naturais para a indústria farmacêutica. Seu foco no avanço da pesquisa com canabinóides se traduz em soluções inovadoras que atendem às necessidades médicas críticas não atendidas, transformando o futuro da medicina.

[email protected]
BRAINSBIO.COM
1–855–927–2476

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Brains Bioceutical weitet das branchenführende Cannabinoid-Angebot auf D9-THC und CBN aus, um neue Grenzen in der Wirkstoffentwicklung zu erschließen

VANCOUVER, British Columbia, Dec. 18, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (Brains Bio), ein weltweit führendes Unternehmen für natürliche GMP–konforme cannabinoide Pharmawirkstoffe (API), gibt die Erweiterung seines branchenführenden Angebots bekannt. Cannabinol (CBN) ist als EU–GMP–zertifizierter API erhältlich. D9–Tetrahydrocannabinol (THC) hat eine feste kristalline Form, wird auf eine erhöhte Stabilität hin optimiert und einer abschließenden Validierung als Cannabigerol (CBG) unterzogen.

Diese neuen Ergänzungen komplettieren das aktuelle Sortiment von Brains Bio, da der CBD API derzeit in über 30 klinischen und vorklinischen Studien verwendet wird, darunter eine abgeschlossene Phase–III–Studie zu refraktärer Epilepsie (eingereicht für die Marktzulassung) und eine Phase–II–Studie zum Missbrauch opioider Wirkstoffe. Durch die sofortige globale Bereitstellung von Produktproben eröffnet Brains Bio neue Wege für die klinische Forschung, Produktentwicklung und therapeutische Innovation.

Die nächste Generation von Cannabinoid–basierten Therapien
Das erweiterte Sortiment von Brains Bio trägt dem Engagement des Unternehmens für die Cannabinoid–Entwicklung im Bereich von Arzneimittelforschung und –entwicklung Rechnung. Das Angebot umfasst formulierte Produkte und API konform zu den Anforderungen von Ph. Eur. Monograph und ICH Q7, und ist darauf ausgelegt, regulatorisch zulassungsfähige klinische Programme für wichtige ungedeckte medizinische Bedarfe zu unterstützen. Diese API mit potenziellen Anwendungsmöglichkeiten für ein breites therapeutisches Spektrum einschließlich neurologischer Erkrankungen, chronischer Schmerzen und entzündlicher Erkrankungen sollen wegweisende klinische Fortschritte auf den Weg bringen.

Bestehende Erfolgsgeschichten als Ausgangsbasis
Die Arzneimittelindustrie kann bereits auf die erfolgreiche Integration von Cannabinoid–basierten Medikamenten zurückblicken. Mehrere durch die FDA und EMA zugelassenen Medikamente zeigen einen erheblichen klinischen Nutzen, darunter:

  • Epidiolex (CBD): Eine Lösung zum Einnehmen für die Behandlung epileptischer Anfälle im Zusammenhang mit dem Lennox–Gastaut–Syndrom und Dravet–Syndrom (zugelassen durch die FDA/EMA).
  • Marinol & Syndros (Dronabinol): Formulierungen gegen Übelkeit und Erbrechen, die durch eine Chemotherapie ausgelöst wurden, sowie bei Anorexie in Verbindung mit AIDS (zugelassen durch die FDA/EMA).
  • Sativex (CBD/THC): Eine Behandlung für spastische Anfälle bei MS und anderen neurologischen Erkrankungen (zugelassen durch die EMA).

Diese Erfolge untermauern das therapeutische Potenzial von Cannabinoid–basierten Therapien und ihre wachsende Akzeptanz in der medizinischen Community, und Brains Bio engagiert sich auch weiterhin dafür, das wissenschaftliche Verständnis von Cannabinoiden voranzubringen.

„Ein Meilenstein für die Arzneimittelindustrie“
„Die Einführung von qualitativ hochwertigem CBN API, D9 THC und CBG ist ein wegweisender Augenblick für Brains Bio und für die gesamte Arzneimittelindustrie“, so Ricky Brar, CEO und Chairperson von Brains Bioceutical Corp. „Diese Produkte ermöglichen es der Forschung und Wirkstoffentwicklung die Grenzen der Cannabinoid–Wissenschaft zu erweitern und die Bereitstellung revolutionärer Therapien für Patientinnen und Patienten auf der ganzen Welt zu beschleunigen. Dieser Erfolg spiegelt unser unerschütterliches Engagement für die Herstellung von API wider, die den höchsten Standards in puncto Sicherheit, Qualität und Konsistenz entsprechen.“

Ein auf Wachstum ausgelegter Markt
Der Global Cannabinoid Derived Pharmaceutical Market Research Report 2024 (Marktforschungsbericht 2024 für weltweite Cannabinoid–abgeleitete Arzneimittel) prognostiziert einen erheblichen Anstieg von 884,3 Millionen USD im Jahr 2021 auf 4,87 Milliarden USD bis zum Jahr 2034 (CAGR von 13,4 %). Dieser steile Anstieg spiegelt das erhöhte Bewusstsein für die Wirksamkeit cannabinoider Therapien in der Bekämpfung zahlreicher medizinischer Erkrankungen wider.

Das API–Sortiment von Brains Bio markiert den nächsten Meilenstein, da Innovatoren in der Arzneimittelindustrie einen zuverlässigen und konformen Wirkstoff für die Weiterentwicklung regulatorisch zugelassener Cannabinoid–basierter Behandlungen erhalten.

Anforderung von Produktproben und Anfragen
Die THC– und CBN–API von Brains Bioceutical Corp. sind jetzt als Produktprobe erhältlich. Arzneimittefirmen und Forschungsorganisationen erreichen das Unternehmen bezüglich Anfragen oder weiterer Informationen über [email protected].

Über Brains Bioceutical Corp.
Brains Bioceutical Corp. ist ein weltweit führendes Unternehmen in der Entwicklung und Herstellung natürlicher cannabinoider API für die Arzneimittelindustrie. Im Fokus der Cannabinoid–Forschung steht die Übertragung auf innovative Lösungen für wichtige medizinische Anforderungen, um eine neue Zukunft der Medizin einzuläuten.

[email protected]
BRAINSBIO.COM
1–855–927–2476

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GLOBENEWSWIRE (Distribution ID 9321095)

Brains Bioceutical élargit son offre de cannabinoïdes leaders sur le marché avec le D9-THC et le CBN, et ouvre ainsi de nouvelles possibilités en matière de développement de médicaments

VANCOUVER, Colombie–Britannique, 18 déc. 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (Brains Bio), leader mondial dans la fabrication d’ingrédients pharmaceutiques actifs (IPA) à base de cannabinoïdes naturels et conformes aux BPF, annonce élargir sa gamme de produits leaders sur le marché. Le cannabinol (CBN) est disponible en tant qu’IPA certifié BPF au sein de l’UE. Le D9–tétrahydrocannabinol (THC) est une structure cristalline solide, et des travaux visant à optimiser la stabilité du cannabigérol (CBG) et à effectuer les dernières étapes en vue de sa validation sont en cours.

Ces nouveaux ajouts viennent compléter le portefeuille actuel de Brains Bio. Le CBD est un IPA utilisé dans le cadre de plus de 30 études cliniques et précliniques, y compris une étude de phase III portant sur l’épilepsie réfractaire ayant débouché sur une demande de mise sur le marché, et une étude de phase II portant sur les troubles liés à l’usage d’opiacés. Par le biais d’une distribution immédiate d’échantillons à l’échelle mondiale, Brains Bio ouvre de nouvelles voies pour la recherche clinique, le développement de produits et l’innovation thérapeutique.

La nouvelle vague de traitements à base de cannabinoïdes dévoilée
Le portefeuille élargi de Brains Bio reflète la détermination de la société à développer des cannabinoïdes pour la recherche et le développement pharmaceutique. Parmi sa gamme de produits, on peut citer des produits formulés et des IPA conformes à la Pharmacopée européenne (Ph. Eur.) et aux exigences de l’ICH Q7, conçues pour soutenir les programmes cliniques approuvés par les organismes de réglementation et ciblant des besoins médicaux fondamentaux non satisfaits. Ces IPA, avec des applications potentielles pour une large gamme d’usages thérapeutiques, notamment concernant les troubles neurologiques, les douleurs chroniques et les maladies inflammatoires, sont en passe d’entraîner des progrès cliniques révolutionnaires.

S’appuyer sur les réussites antérieures
L’industrie pharmaceutique a déjà assisté à l’intégration réussie de médicaments à base de cannabinoïdes. Plusieurs médicaments autorisés par la FDA et l’EMA démontrent des bénéfices cliniques significatifs, notamment :

  • Epidiolex (CBD) : solution buvable destinée à traiter les crises d’épilepsie associées aux syndromes de Lennox–Gastaut et de Dravet (autorisé par la FDA/l’EMA).
  • Marinol et Syndros (Dronabinol) : formulations pour les nausées et vomissements induits par la chimiothérapie et l’anorexie liée au SIDA (autorisés par la FDA/l’EMA).
  • Sativex (CBD/THC) : traitement contre la spasticité liée à la SEP et à d’autres maladies neurologiques (autorisé par l’EMA).

Ces réussites mettent en évidence le potentiel thérapeutique des traitements à base de cannabinoïdes et leur acceptation croissante au sein de la communauté médicale. Brains Bio continue à se consacrer à faire progresser les connaissances scientifiques sur les cannabinoïdes.

« Une étape clé pour l’industrie pharmaceutique »
« L’introduction de CBN, un IPA de haute qualité, du D9 THC et du CBG constitue un moment historique pour Brains Bio et pour l’industrie pharmaceutique dans son ensemble, » a déclaré Ricky Brar, PDG et président de Brains Bioceutical Corp. « Ces produits permettent aux chercheurs et aux développeurs de médicaments de repousser les limites de la science autour des cannabinoïdes, et de fournir ainsi plus rapidement des traitements révolutionnaires pour les patients du monde entier. Cette prouesse reflète notre engagement inébranlable à fournir des IPA qui répondent aux normes les plus strictes en matière de sécurité, de qualité et de régularité. »

Un marché appelé à se développer
Le Global Cannabinoid Derived Pharmaceutical Market Research Report (Rapport d’étude de marché mondial sur les produits pharmaceutiques dérivés des cannabinoïdes) de 2024 prévoit une augmentation significative du marché, qui devrait passer de 884,3 millions de dollars en 2021 à 4,87 milliards de dollars d’ici 2034 (TCAC de 13,4 %). Cette augmentation reflète la reconnaissance croissante de l’efficacité des thérapies à base de cannabinoïdes dans le traitement de très nombreuses maladies.

Le portefeuille d’IPA de Brains Bio représente l’avenir, et offre aux pionniers de l’industrie pharmaceutique un ingrédient solide et conforme pour accélérer le développement de traitements à base de cannabinoïdes autorisés en vertu des réglementations.

Demandes d’échantillons et de renseignements
Des échantillons des IPA de Brains Bioceutical Corp., le THC et le CBN, peuvent être distribués dès à présent. Pour toute demande de renseignements et d’informations complémentaires, les laboratoires pharmaceutiques et les organismes de recherche peuvent contacter la société à l’adresse [email protected].

À propos de Brains Bioceutical Corp.
Brains Bioceutical Corp. est un leader mondial dans le développement et la fabrication d’IPA à base de cannabinoïdes naturels pour l’industrie pharmaceutique. La société s’emploie à faire avancer les recherches sur les cannabinoïdes, ce qui se traduit par des solutions innovantes qui répondent à des besoins médicaux fondamentaux non satisfaits, dans l’optique de révolutionner l’avenir de la médecine.

[email protected]
BRAINSBIO.COM
1–855–927–2476

Une photo accompagnant cette communication est disponible à l’adresse https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9321095)

Brains Bioceutical Expands Industry-Leading Cannabinoid Offering with D9-THC and CBN, Unveiling New Frontiers for Drug Development

VANCOUVER, British Columbia, Dec. 16, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (Brains Bio), a global leader in natural, GMP–compliant cannabinoid Active Pharmaceutical Ingredients (APIs), announces the expansion of its industry–leading offering. Cannabinol (CBN) is available as an EU–GMP certified API, D9–Tetrahydrocanabinol (THC) is in a solid crystalline form, undergoing enhanced stability optimization work and final validation work is being undertaken on Cannabigerol (CBG).

These new additions complement Brains Bio's current portfolio, with the CBD API being used in over 30 clinical and pre–clinical studies, including a completed Phase III Refractory Epilepsy Study – submitted for Marketing Authorisation – and a Phase II Opioid Use Disorder Study. With immediate global sample distribution, Brains Bio unlocks new avenues for clinical research, product development, and therapeutic innovation.

Unveiling the Next Wave of Cannabinoid–Based Therapies
Brains Bio's expanded portfolio reflects the company's dedication to the development of cannabinoids for pharmaceutical research and development. Their offerings include formulated products and APIs compliant with the Ph. Eur. Monograph and ICH Q7 requirements, designed to support regulatory–approvable clinical programs targeting critical unmet medical needs. These APIs, with potential applications for a wide range of therapeutic uses, including neurological disorders, chronic pain, and inflammatory conditions, are poised to drive groundbreaking clinical advancements.

Building on Existing Success Stories
The pharmaceutical industry has already witnessed the successful integration of cannabinoid–based medications. Several FDA– and EMA–approved drugs showcase significant clinical benefits, including:

  • Epidiolex (CBD): An oral solution for treating epileptic seizures associated with Lennox–Gastaut and Dravet syndromes (FDA/ EMA–approved).
  • Marinol & Syndros (Dronabinol): Formulations for chemotherapy–induced nausea and vomiting, and AIDS–related anorexia (FDA/EMA–approved).
  • Sativex (CBD/THC): A treatment for spasticity in MS and other neurological conditions (EMA–approved).

These successes highlight the therapeutic potential of cannabinoid–based therapies and their growing acceptance within the medical community. with Brains Bio remaining dedicated to advancing the scientific understanding of cannabinoids.

“A Milestone for the Pharmaceutical Industry”
“The introduction of high–quality CBN API, D9 THC and CBG is a landmark moment for Brains Bio, and for the entire pharmaceutical industry,” said Ricky Brar, CEO and Chairperson of Brains Bioceutical Corp. “These products empower researchers and drug developers to push the boundaries of cannabinoid science, accelerating the delivery of transformative therapies to patients worldwide. This achievement reflects our unwavering commitment to providing APIs that meet the highest standards of safety, quality, and consistency.”

A Market Poised for Growth
The Global Cannabinoid Derived Pharmaceutical Market Research Report 2024 projects a significant rise, from $884.3 million in 2021 to $4.87 billion by 2034 (CAGR of 13.4%). This surge reflects the increasing recognition of cannabinoid therapies' effectiveness in addressing a wide range of medical conditions.

Brains Bio's API portfolio represents the next frontier, providing pharmaceutical innovators with a robust and compliant ingredient to expedite the development of regulatory–approved cannabinoid–based treatments.

Requesting Samples and Inquiries
Brains Bioceutical Corp.'s THC and CBN API are now available for sample distribution. For inquiries and further information, pharmaceutical companies and research organizations can contact the company at [email protected].

About Brains Bioceutical Corp.
Brains Bioceutical Corp. is a global leader in developing and manufacturing natural cannabinoid APIs for the pharmaceutical industry. Their focus on advancing cannabinoid research translates into innovative solutions that address critical unmet medical needs, transforming the future of medicine.

[email protected]
BRAINSBIO.COM
1–855–927–2476

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


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