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Recursion Announces FDA Clearance of Investigational New Drug Application for REC-1245, a Potential First-In-Class RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma

  • First program to combine Recursion’s end–to–end suite of AI–enabled active learning modules, resulting in target identification to IND enabling studies in under 18 months
  • Plan to initiate dosing of Phase 1/2 in Q4 2024 to evaluate REC–1245 in a biomarker enriched patient population, including patients with solid tumors and lymphoma

SALT LAKE CITY, Oct. 02, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC–1245, a new chemical entity for the treatment of biomarker–enriched solid tumors and lymphoma.

Chris Gibson, Ph.D., Co–founder and CEO of Recursion said, “REC–1245 is a prime example of using an expansive AI–enabled platform for drug discovery. After exploring many predicted biological and chemical relationships across our maps of biology, we identified RMB39 as a novel target that looks functionally similar to the well–known but hard to drug target CDK12. We also identified and optimized small molecules that target RBM39 without directly impacting CDK12 or CDK13 using these same AI–enabled maps. In under 18 months, leveraging some of our newer chemistry tools, Recursion rapidly progressed REC–1245 from novel target biology to preclinical drug candidate, more than twice the speed of industry average.”

Recursion identified the novel regulatory role of RBM39 associated with CDK12 using its maps of biology and first reported this relationship in early 2023 at Download Day, Recursion’s R&D and investor event. Recursion believes the modulation of RBM39 may be associated with a therapeutic effect in certain biomarker–enriched solid tumors and lymphoma. Additionally, Recursion estimates that the initially addressable population for this potential therapeutic to be >100,000 patients in the US and EU5. REC–1245 is a potent and selective RBM39 degrader with a potential first–in–class profile. Preclinical data support that RBM39 degradation induces splicing defects which downregulate DNA Damage Response (DDR) networks and cell cycle checkpoints.

“RBM39 degraders may offer a promising therapeutic approach for patients with solid tumors, particularly those with limited treatment options,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer at Recursion. “Recursion’s platform was among the first to rapidly uncover the therapeutic potential of RBM39 degradation, a finding now validated by independent research. This mechanism provides new opportunities for targeting tumors, which are often resistant to conventional treatments. By advancing this research, we aim to deliver a critical option for patients facing significant unmet needs, ultimately improving their prognosis and quality of life.”

The Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential monotherapy efficacy of REC–1245, and is expected to initiate in Q4 2024.

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
[email protected]

Investor Contact
[email protected]

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC–1245; timing of and plans to initiate dosing of Phase 1 clinical trial of REC–1245; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10–K and Quarterly Reports on Form 10–Q. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9249970)

Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome

MNV–201 is a mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria

In pre–clinical studies, MNV–201 demonstrated improved engraftment and bone marrow reconstitution potential of patient derived hematopoietic stem cells

In vitro data also demonstrated improved ability to differentiate to erythroid cells, supporting potential for improvement in biomarkers of anemia

HAIFA, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd, a clinical stage biopharmaceutical company advancing mitochondrial cell therapies for primary and secondary mitochondrial diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MNV–201, an autologous hematopoietic stem cell product augmented with allogeneic mitochondria. The IND supports the initiation of a Phase Ib dose exploration clinical trial of MNV–201 in patients with Low Risk Myelodysplastic Syndrome (MDS).

Anemia is a common and serious symptom in patients with low–risk myelodysplastic syndrome (LR–MDS), affecting almost 90% of cases and is often the primary characteristic of the disease. Anemia in MDS can have a negative impact on quality of life and may correlate with decreased progression–free survival and overall survival. 

“The FDA’s clearance of our IND marks an important achievement for Minovia, allowing us to clinically evaluate our allogeneic mitochondrial cell therapy approach and proceed with the Phase Ib clinical program for this first–in–class allogeneic mitochondrial therapy for low risk MDS patients,” said Natalie Yivgi Ohana, PhD, CEO of Minovia. “We are pleased to have safely dosed two MDS patients enrolled in an ongoing study under the Israeli Ministry of Health. We look forward to treating additional patients under this IND, as well as to learning about the potential of MAT to improve anemia in this patient population.”

The Phase Ib clinical trial is an open–label, dose exploration study to evaluate the safety and efficacy of MNV–201 in subjects with low risk MDS. This trial will continue our campaign to evaluate dose exploration and safety of single or repeat dosing of MNV–201. The trial will also enable assessment of efficacy in improving anemia and durability of response. The study is expected to enroll at least three patients each in the low, medium and high dose cohorts, and up to a total of 15 patients in total. For more information visit clinicaltrials.gov.

About MNV–201
MNV–201 is an autologous hematopoietic stem cell product enriched with allogeneic mitochondria. MNV–201 aims to restore mitochondrial function in low risk MDS patient hematopoietic stem cells, resulting in improved differentiation to erythroid lineage with the potential to improve anemia. Preclinical research suggests the potential for safe dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for MNV–201 therapy.

About Minovia Therapeutics
Minovia Therapeutics Ltd. is a clinical stage biotechnology company advancing mitochondrial cell therapies for primary–genetic and age–related mitochondrial diseases. Minovia's clinical stage product candidate, MNV–201, is composed of mobilized peripheral blood, autologous CD34+ cells enriched with allogeneic, cryopreserved placental derived mitochondria, produced by Minovia's proprietary Mitochondrial Augmentation Technology (MAT). The enrichment of hematopoietic stem cells with healthy and functional mitochondria aims to restore stem cells function of patients suffering mitochondrial dysfunction, caused both by mtDNA mutations or deletions in pediatric patients suffering from primary mitochondrial diseases, or in adults with age–related bone marrow failure disorders. MNV–201 is currently in clinical studies for pediatric patients with single–large scale mtDNA deletion syndromes (Pearson Syndrome and Kearn Sayre Syndrome) with four patients successfully dosed; and in Low Risk Myelodysplastic Syndrome. For more information, please visit www.minoviatx.com or follow the Company LinkedIn.

About Low Risk Myelodysplastic Syndrome

Myelodysplastic syndromes (MDS) are a group of bone marrow failures that occur when the blood–forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types. Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias or progression to acute myeloid leukemia (AML). MDS is generally a disease that develops with aging; the median age at diagnosis of MDS is ~70 years.

Mitochondrial Dysfunction in MDS: Scientific literature shows a correlation between mitochondrial dysfunction and MDS progression. It is known that ineffective hematopoiesis in MDS results from increased susceptibility of clonal myeloid progenitors to apoptosis. This may be triggered by intrinsic factors, such as mitochondrial polarization due to iron retention in ringed sideroblasts. A subset of MDS patients present with sideroblastic anemia, a phenotype common in Pearson Syndrome patients and which implicates mitochondrial dysfunction of HSPCs as part of the pathology of MDS.

Contact Information: Natalie Yivgi Ohana, Co–Founder and CEO

Phone: +972–74–7039954

Email: [email protected]


GLOBENEWSWIRE (Distribution ID 9237236)

Entera Bio and OPKO Health Provide Update on PK/PD Results of Oral Oxyntomodulin (GLP-1/Glucagon) Peptide Tablet Candidate for Obesity and Metabolic Disorders

JERUSALEM and MIAMI, Sept. 25, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and OPKO Health, Inc. (NASDAQ: OPK) (OPKO) announced today topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long–acting oxyntomodulin (OXM) analog developed by OPKO and Entera’s proprietary N–Tab™ technology. The program is focused on developing the first oral dual agonist GLP–1/glucagon peptide as a potential once–daily treatment for patients with obesity, metabolic and fibrotic disorders. OXM is a naturally occurring peptide hormone found in the small intestine that acts to suppress appetite and induce weight loss.

Entera and OPKO have completed in vivo proof–of–concept PK/PD studies in rodent and pig models. The studies’ objectives were met with oral OXM exhibiting significant systemic exposure following a single dose in both models. Furthermore, a favorable PK profile and bioavailability were shown with oral OXM. In the pig model, oral OXM achieved high plasma concentrations with prolonged systemic exposure, which is consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog.

To assess the pharmacologic effect of oral OXM, a glucose tolerance test was performed in rats. Oral OXM showed a statistically significant reduction in plasma glucose levels post–glucose administration compared with placebo. Entera and OPKO plan to present these data at an upcoming clinical conference.

“We are very pleased with the progress we are making in our collaboration with OPKO. These bioavailability and pharmacological data support continuing toward IND–enabling efforts for the program,” said Miranda Toledano, Entera Chief Executive Officer.

OPKO previously reported that weekly injections of pegylated OXM demonstrated significant weight loss and reduction in HbA1, triglyceride and cholesterol levels in 113 obese and diabetic patients in a Phase 2B study. The OXM agonist peptide has since been modified to maintain its long–acting profile while increasing its potential potency. Currently, there are no approved OXM agonists available, and those in development by others are small molecules or require subcutaneous injections.

About Entera Bio

Entera is a clinical–stage company focused on developing oral peptide or 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 a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. 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. Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH (1–34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP–1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare 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.

About OPKO Health

OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry–leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com.

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 and OPKO’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 or OPKO 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 our product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera and OPKO’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 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 and OPKO’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 and OPKO’s most recent Annual Report on Form 10–K filed with the SEC, as well as the companies’ 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 and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and Entera and OPKO undertake 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 9236250)

Zenas BioPharma Announces Closing of Full Exercise of Underwriters’ Option to Purchase Additional Shares in Initial Public Offering

WALTHAM, Mass., Sept. 19, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas”), (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 that the underwriters of its previously announced upsized initial public offering of 13,235,294 shares of its common stock, which closed on September 16, 2024, exercised in full their option to purchase an additional 1,985,294 shares at the initial public offering price of $17.00 per share. After giving effect to the full exercise of the underwriters’ option to purchase additional shares, which closed on September 19, 2024, Zenas sold 15,220,588 shares in its initial public offering, resulting in gross proceeds of approximately $258.7 million. All of the shares were sold by Zenas. Zenas’ shares began trading on the Nasdaq Global Select Market on September 13, 2024 under the ticker symbol “ZBIO”.

Morgan Stanley, Jefferies, Citigroup, and Guggenheim Securities acted as joint book–running managers for the offering.

Registration statements relating to the shares sold in the offering have been filed with the U.S. Securities and Exchange Commission (“SEC”) and became effective on September 12, 2024. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; and from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821–7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

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.

Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
[email protected]

Media Contact:
Argot Partners
[email protected]


GLOBENEWSWIRE (Distribution ID 9233662)

Zenas BioPharma Announces Pricing of Upsized Initial Public Offering

WALTHAM, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas”), (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 the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. All of the shares are being offered by Zenas. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $225.0 million. Zenas’ common stock is expected to begin trading on the Nasdaq Global Select Market on September 13, 2024 under the ticker symbol “ZBIO”. The offering is expected to close on September 16, 2024, subject to the satisfaction of customary closing conditions. In addition, Zenas has granted the underwriters a 30–day option to purchase up to an additional 1,985,294 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

Morgan Stanley, Jefferies, Citigroup, and Guggenheim Securities are acting as joint book–running managers for the offering.

Registration statements relating to the shares being sold in the offering have been filed with the U.S. Securities and Exchange Commission (“SEC”) and became effective on September 12, 2024. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; and from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821–7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

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.

Forward–Looking Statements

This press release contains forward–looking statements. Investors are cautioned not to place undue reliance on these forward–looking statements, including statements about the completion, timing and size of the initial public offering and the commencement of trading on the Nasdaq Global Select Market. Each forward–looking statement is subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the initial public offering discussed above will be completed on the terms described or at all. Completion of the proposed initial public offering and the terms thereof are subject to numerous factors, many of which are beyond the control of Zenas, including, without limitation, market conditions, failure of customary closing conditions and the factors discussed in the “Risk Factors” section of the prospectus that forms a part of the registration statement, in the form last filed with the SEC. These forward–looking statements speak only as of the date of this press release and Zenas undertakes no obligation to publicly update or revise any forward–looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
[email protected]

Media Contact:
Argot Partners
[email protected]


GLOBENEWSWIRE (Distribution ID 9230259)

“لايفيرا أوميكس” تعيّن خبير الجينوم الكريّع رئيساً للقسم الطبي والجينومي

  • لايفيرا أوميكس تستهدف تعزيز مكانة المملكة عالمياً في مجال الجينوم البشري متعدد الجينات.
  • لايفيرا، المملوكة بالكامل لصندوق الاستثمارات العامة، توسع نطاق عملياتها في لايفيرا أوميكس، وتستثمر في بناء فريق عالمي من الخبراء السعوديين والعالميين.

الرياض، المملكة العربية السعودية, Sept. 10, 2024 (GLOBE NEWSWIRE) —  أعلنت شركة لايفيرا أوميكس، المشروع المشترك الذي أُطلق في يناير 2024، تعيين الخبير العالمي والباحث السعودي في مجال علم الوراثة الجزيئي، البروفيسور فوزان سامي الكريّع، رئيساً للقسم الطبي والجينومي و اللذي سينضم لمجلس إدارة لايفيرا أوميكس ، ليساهم بخبرته الممتدة لأكثر من 17 عاماً في تحقيق أهداف الشركة الرامية لتطوير حلول مبتكرة في مجال الطب الجينومي.

برز الكريّع، الرئيس السابق لمركز الجينوميات الانتقالية بمستشفى الملك فيصل التخصصي ومركز الأبحاث في الرياض، والأستاذ الحالي لعلم الوراثة البشرية في جامعة الفيصل، كرائد في مجال الطب الجينومي، حيث ساهم بأكثر من 590 بحثاً علمياً نُشرت في مجلات عالمية مرموقة، وكمُتحدث رئيسي في المؤتمرات العلمية الدولية حول الطب الجيني والرعاية الصحية الدقيقة.

نال الكريّع عدة جوائز مرموقة من بينها جائزة وليام كنج بويز لطب الوراثة من معهد هارفارد للطب الشخصي في بوسطن، وجائزة الملك سلمان لأبحاث الإعاقة (فرع العلوم الصحية والطبية)، وجائزة ”كرت ستيرن” من الجمعية الأمريكية للوراثة البشرية، كأول فائز يحصل عليها من خارج الولايات المتحدة الأمريكية. و كما فاز بجائزة الكويت (فرع العلوم الطبية الأساسية), و جائزة الشيخ حمدان بن راشد آل مكتوم للعلوم الطبية.

حصل البروفيسور الكريّع –على شهادة البورد من جامعة هارفارد بالاضاقة إلى العديد من شهادات البورد المهنية، وحقق إنجازاتٍ بارزةً في مجال الوراثة البشرية، شملت اكتشاف الوظائف الفسيولوجية والتركيبية لمئات الجينات، ما ساعد في تشخيص العديد من الاعتلالات الوراثية، فضلاً عن أهمية اكتشافاته في تكريس مفهوم العلاقة الوثيقة بين الجينات وصحة الإنسان.

وفي هذا الصدد، علّق الدكتور إبراهيم الجفالي، رئيس مجلس إدارة شركة لايفيرا، قائلاً: “نحن سعداء بانضمام البروفيسور الكريّع إلى فريق العمل في لايفيرا أوميكس، وستكون الخبرات العلمية والعملية المتراكمة لديه أداة أساسية لمساعدة الشركة في تحقيق رسالتها الساعية لتعزيز مقدرات المملكة في قطاع الأدوية الحيوية وتمكين الاستراتيجية الوطنية للتقنية الحيوية“.

نبذة عن لايفيرا

لايفيرا، المملوكة بالكامل لصندوق الاستثمارات العامة، هي شركة متخصصة في إجراء التعاقدات المتعلقة بتطوير وتصنيع المنتجات الدوائية الحيوية (CDMO)، تم إطلاقها في عام 2023 ومقرها الرياض. تتمثل رسالة الشركة في تعزيز مقدرات المملكة في قطاع الأدوية الحيوية وتمكين الإستراتيجية الوطنية للتقنية الحيوية، في حين يكمن هدفها في تسويق وتطوير وصناعة العلاجات المتقدمة وغيرها من الأدوية واللقاحات الأساسية. في يناير 2023 أتمت لايفيرا الاستثمار في حصة الأغلبية بمصنع سعودي بيو المتخصص في تصنيع الأدوية البيولوجية في الرياض. وتعمل الشركة حالياً على تطوير هذا المصنع ليكون جاهزاً للتشغيل في عام 2026 وفق المعايير العالمية لتصنيع الأدوية بنظام التعاقد، ومن بينها الإنسولين وغيرها من الأدوية البيولوجية للشركات الدوائية العالمية الرائدة التي تخدم السوق السعودي والإقليمي. وتعمل لايفيرا على تطوير مقدرات تصنيع بيولوجية إضافية، عبر شركتها الفرعية لايفيرا أوميكس، وتمكن عملاءها من تطوير وتسويق العلاجات المتقدمة.

نبذة عن لايفيرا أوميكس

تأسست لايفيرا أوميكس، التابعة لشركة لايفيرا، في يناير 2024 لتطوير السعة المختبرية متعددة الجينوميات –الجافة والرطبة– على نطاق واسع وفق أعلى المعايير العالمية، وللمساعدة في تمكين أهداف الجينوم في الإستراتيجية الوطنية للتقنية الحيوية في المملكة. وتتعاون لايفيرا أوميكس مع العملاء لتلبية احتياجاتهم السريرية وصحة السكان والأبحاث والتطوير، وتهدف إلى تعزيز سرعة ودقة التشخيصات السريرية عبر أنظمة الرعاية الصحية في المملكة، وتمكين الطب الدقيق للأمراض النادرة والمتكررة، من خلال الحلول المبتكرة القائمة على البيانات، والاستفادة من الخبرة الرائدة في مجال التشخيص والشراكات.

[email protected]

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GLOBENEWSWIRE (Distribution ID 9228307)

Lifera Omics Appoints Prof. Fowzan Alkuraya, a Renowned Genomics Expert as Chief Medical and Genomic Officer

  • Lifera, a biopharma company wholly owned by the Public Investment Fund (PIF), launched in 2023, is scaling up its subsidiary Lifera Omics and developing a team of leading Saudi and global talent to fulfil its mission
     
  • Lifera Omics aims to elevate Saudi Arabia’s role in multiomics globally

RIYADH, Saudi Arabia, Sept. 10, 2024 (GLOBE NEWSWIRE) — Lifera Omics, a subsidiary of Lifera that was launched in January 2024, announced the appointment of renowned Saudi human geneticist, Prof. Fowzan Sami Alkuraya, as its Chief Medical and Genomics Officer, who will be also added to the Board of Lifera Omics. Prof. Alkuraya’s deep experience in human genomics built over 17 years will contribute significantly in enabling Lifera Omics’ objectives.

Prof. Alkuraya, a former Chairman of Translational Genomics at King Faisal Specialist Hospital and Research Centre in Riyadh and current Professor of Human Genetics at Alfaisal University, has significantly contributed to the field of genomics, through over 590 scientific publications in prestigious international journals and as a frequent speaker at international scientific conferences on genomic medicine and precision health.

Prof. Alkuraya garnered numerous prestigious awards, including the William King Wilson Prize in Genetics from Harvard Medical School, the King Salman Award for Disability Research, and the Curt Stern Award from the American Society of Human Genetics – the first non–US based recipient of this honor. He also won Kwiat Prize for Basic Medical Science Subject Area and Sheikh Hamdan Bin Rashid Al Maktoum Award for Medical Sciences.

Prof. Alkuraya was granted his post graduate board certification from Harvard University, in addition to several other board certifications. His contributions to human genetics have been instrumental in elucidating the physiological and structural roles of hundreds of genes, resulting in the diagnosis of many genetic disorders. His discoveries have significantly advanced the understanding of the intricate relationship between human genes and health.

“We are delighted to welcome such a trusted and respected leader to the Lifera Omics Executive Leadership team,” said Dr. Ibrahim Juffali, Chairman of Lifera. “Dr. Fowzan’s deep clinical and scientific expertise will be instrumental in helping Lifera achieve its mission to improve Saudi Arabia’s biopharma resilience and to enable the National Biotech Strategy.”

About Lifera

Lifera is a biopharma contract and development manufacturing organization (CDMO) wholly owned by the Public Investment Fund (PIF), launched in 2023 based in Riyadh, Saudi Arabia. Lifera’s mission is to improve Saudi Arabia’s biopharma resilience and enable the National Biotech Strategy. Lifera’s goal is to commercialize, develop and manufacture advanced therapeutics and other life–saving and essential medicines and vaccines. In January 2023, Lifera completed a majority stake investment in SaudiBio, a brownfield biologics drug product manufacturing plant in Riyadh. Lifera is currently upgrading this plant to be commissioned in 2026 to global standards to contract manufacture insulins, biosimilars and other biologics for leading global pharmaceutical companies serving the KSA and regional markets. Lifera is in the process of developing additional biomanufacturing capacity and through its subsidiary Lifera Omics, further enables Lifera’s customers to develop and commercialize advanced therapeutics.

About Lifera Omics

Lifera Omics, a subsidiary of Lifera, was established in January 2024 to develop at–scale multiomic dry and wet lab capacity to the highest global standards and to help enable the genomics goals of Saudi Arabia’s National Biotech Strategy. Lifera Omics partners with customers to serve their clinical, population health and R&D needs. Lifera Omics aims to enhance the speed and accuracy of clinical diagnoses across health systems in Saudi Arabia, and to enable precision medicine for rare and common diseases through innovative, data–driven solutions, leveraging industry–leading diagnostic expertise and partnerships.

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GLOBENEWSWIRE (Distribution ID 9228307)

Recursion Announces Phase 2 Data of REC-994, a First-in-Disease Investigational Treatment for Symptomatic Cerebral Cavernous Malformation (CCM), has Met its Primary Endpoint of Safety and Tolerability

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced top–line results of the SYCAMORE trial, a 12–month Phase 2 randomized double–blind, placebo–controlled, safety, tolerability and exploratory efficacy study for REC–994 in symptomatic CCM patients.

REC–994 met its primary endpoint of safety and tolerability, demonstrating a similar profile across placebo and both 200mg and 400mg dosage–arms with regard to the frequency and severity of adverse events after 12 months of treatment. Magnetic resonance imaging–based secondary efficacy endpoints showed a trend towards reduced lesion volume and hemosiderin ring size in patients at the highest dose (400mg) as compared to placebo. Time–dependent improvement in these trends at the 400mg dose was also observed in this signal–finding study. Improvements in either patient or physician–reported outcomes were not yet seen at the 12 month time point. A meeting with the FDA is anticipated as soon as practical to discuss plans for an additional clinical study. Recursion plans to present data from this trial at a forthcoming medical conference and intends to submit these data for publication in a peer reviewed scientific journal.

“These studies are making significant strides in the development of therapeutics for CCM. The data from this readout is an impressive start and will provide a valuable contribution to the existing CCM literature and strongly supports the need for a future study, with a longer duration and a larger patient cohort,” said Dr. Jan–Karl Burkhardt, MD, Division Head, Cerebrovascular Surgery, University of Pennsylvania and Principal Investigator of the study. Connie Lee, Psy.D., founder and CEO of the Alliance to Cure Cavernous Malformation added: “I speak for the patients who have participated in the trial and those who have been cheering from the sidelines while waiting for news. This promising start is a critical step forward and will bring hope to thousands of families who currently have no options but brain or spinal cord surgery. The Alliance to Cure Cavernous Malformation looks forward to partnering with Recursion as they move to the next stage of the REC–994 program.”

“We are encouraged by the recent data from our signal–finding Phase 2 study in CCM, where the trial successfully met its primary safety endpoint and became the first investigational therapy to demonstrate safety alongside some promising trends in exploratory efficacy endpoints. These results provide critical insights that will inform our next study design, including exploring study duration, higher doses, and a larger cohort of patients,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer of Recursion. “This is the first of several key clinical readouts for the company and represents an early proof–of–platform milestone for our constantly evolving Recursion OS, as we build upon our success in drug discovery with expertise and execution in mid–phase development. We are deeply grateful to the patients and investigators, and we are committed to advancing potential transformational therapies for CCM and beyond.”

Background on Cerebral Cavernous Malformation (CCM)

CCM is a neurovascular condition that impacts approximately 360,000 symptomatic individuals in the US and EU5. The disease is often underdiagnosed and potentially affects over 1 million patients worldwide. CCM manifests as vascular malformations of the spinal cord and brain characterized by abnormally enlarged capillary cavities without intervening brain parenchyma. Patients with CCM lesions are at substantial risk for seizures, headaches, progressive neurological deficits, and potentially fatal hemorrhagic stroke. Currently, only non–pharmacologic treatments including microsurgical resection and stereotactic radiosurgery are available options for this high unmet need patient population. However, surgical resection or stereotactic radiosurgery is not always feasible because of location and may not be curative.

About REC–994

REC–994 is an orally bioavailable, superoxide scavenger small molecule under development for the treatment of symptomatic CCM. The potential of REC–994 in CCM was demonstrated using the earliest version of what would become the foundational technology underlying the Recursion OS. Subsequently, REC–994 demonstrated preclinical activity in models for CCM and tolerability and suitability for chronic dosing in Phase 1 single ascending dose escalation (SAD) and multiple ascending dose escalation (MAD) trials in healthy volunteers directed and executed by Recursion. Recursion has sought and received Orphan Drug Designation for REC–994 in symptomatic CCM in the US and Europe.

About the Trial

Our Phase 2 SYCAMORE clinical trial is a randomized, double–blind, placebo–controlled study of two doses of REC–994 in participants with CCM. The primary endpoint of the study is safety and tolerability. Secondary efficacy endpoints include MRI–based endpoints, clinician and patient reported outcomes, as well as selected biomarkers. This trial was fully enrolled in June 2023 with 62 participants, and 80% of participants who completed 12 months of treatment have entered the long–term extension study. This signal–finding study was not powered to demonstrate statistical significance.

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
[email protected]

Investor Contact
[email protected]

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding Recursion’s anticipated meeting with the FDA; Recursion’s plans to present SYCAMORE trial data at a medical conference and submit the data for publication; the clinical relevance of the SYCAMORE trial data and obtaining additional confirmatory data; promising trends in REC–994 efficacy endpoints; advancing potential transformational therapies for CCM and beyond; subsequent REC–994 studies and their results and advancing Recursion’s REC–994 program further; the size of the potential CCM patient population; Recursion OS and other technologies potential and advancement of the future of medicine; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10–K, our subsequent Quarterly Reports on Form 10–Q, and our Current Reports on Form 8–K. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9223929)

Brains Bioceutical s’apprête à obtenir l’une des premières certifications CEP pour le cannabidiol au monde auprès de la Direction européenne de la qualité du médicament et soins de santé

SANDWICH, Royaume–Uni, 23 août 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) a franchi une étape décisive en soumettant l’une des premières demandes de CEP (Certification de conformité) au monde pour sa substance pharmaceutique active (API) à base de cannabidiol (CBD) à la Direction européenne de la qualité du médicament et soins de santé (EDQM). Cette démarche historique démontre que le CBD de BBC répond aux normes les plus strictes de l’industrie en matière de cannabinoïdes de qualité pharmaceutique.

La CEP confirme que le CBD de BBC répond aux normes de la Pharmacopée européenne (Ph. Eur.), une reconnaissance cruciale pour les fabricants de produits pharmaceutiques en Europe, au Canada, en Australie, au Japon et aux États–Unis. Cette certification facilite les processus réglementaires et garantit une qualité, une uniformité et une sécurité élevées sur les marchés mondiaux.

Parmi les autres avantages de la CEP, citons :

  • Faciliter et simplifier les interactions entre les régulateurs et l’industrie, en veillant à ce que les substances utilisées dans la production pharmaceutique répondent aux normes de la Pharmacopée européenne et soient conformes à la législation européenne pertinente.
  • Faciliter la gestion des médicaments expérimentaux pour les produits médicinaux.
  • Compléter et rapprocher les monographies de la Pharmacopée européenne et les exigences des dossiers réglementaires pour les médicaments.
  • Faire le lien entre les autorités sanitaires et l’industrie, en améliorant la communication et la coopération.

Ricky Brar, PDG et président de Brains Bioceutical Corp. a souligné l’importance de cette certification dans la stratégie à long terme de l’entreprise. « L’obtention d’une CEP pour notre substance pharmaceutique active à base de cannabidiol est une étape cruciale dans notre stratégie pour devenir le leader du marché mondial des cannabinoïdes. Elle renforce notre engagement en faveur de la qualité et de l’innovation et permet à Brains Bio d’établir une nouvelle norme pour l’industrie. Il ne s’agit pas seulement de répondre aux exigences réglementaires, mais de les dépasser et d’établir une nouvelle référence en matière de produits cannabinoïdes de qualité pharmaceutique. »

Dean Billington, directeur de l’exploitation de Brains Bioceutical Corp. a ajouté : « Notre demande auprès de l’EDQM témoigne du travail acharné et du dévouement de notre équipe. La CEP nous offrira un avantage concurrentiel significatif, en garantissant que notre IPA de cannabidiol sera reconnu comme un ingrédient de premier ordre pour l’usage pharmaceutique. Nous sommes fiers d’être des pionniers dans ce secteur qui évolue rapidement et de rechercher l’excellence dans tous les aspects de nos activités. »

La demande mondiale de produits pharmaceutiques à base de cannabinoïdes reste soutenue, comme en témoigne Epidiolex, dont Jazz Pharmaceuticals prévoit qu’il générera un chiffre d’affaires d’environ 1,4 milliard de dollars en 2024 [1]. Cela reflète une croissance et une demande continues pour des produits pharmaceutiques à base de cannabinoïdes de haute qualité.

La procédure d’examen de l’EDQM, qui a débuté le 8 août 2024, durera environ 115 jours ouvrables. L’obtention d’une CEP confirmera que le CBD de Brains Bio répond aux exigences rigoureuses de la Ph. Eur.

Cette demande de CEP souligne la détermination sans faille de Brains Bio à établir de nouvelles normes pour l’industrie des cannabinoïdes. Elle vient s’ajouter aux licences de BPF et de substances contrôlées de l’UE dont dispose Brains Bio. En alignant son IPA CBD sur les critères rigoureux de la Pharmacopée européenne, Brains Bio participe non seulement au marché, mais façonne aussi activement son avenir.

Dans le cadre de notre partenariat stratégique, Brains Bioceutical et DSM–Firmenich ont uni leurs forces pour mettre à profit leur expertise combinée dans la recherche et le développement des cannabinoïdes. En collaboration avec Brains Bioceutical, fabricant de cannabinoïdes de qualité pharmaceutique, DSM–Firmenich offre une plateforme d’innovation de bout en bout conçue pour accompagner les premières étapes du développement de médicaments à base de cannabinoïdes et optimiser le potentiel des formulations à base de CBD. Cette plateforme offre une expertise de pointe en matière de formulation, un réseau mondial de spécialistes de la réglementation et des compétences en matière d’études précliniques et cliniques. L’entreprise est également en mesure de fournir des solutions personnalisées en fonction du domaine thérapeutique et de l’objectif de délivrance du médicament. Pour en savoir plus sur la façon dont la plateforme d’innovation des cannabinoïdes de DSM–Firmenich contribue à améliorer la santé des patients, visitez le site : www.dsm.com/cannabinoid–actives.

À propos de Brains Bioceutical Corp.

Brains Bioceutical est le leader des solutions de santé et de bien–être à base de plantes naturelles, fondées sur l’expérience clinique et la recherche scientifique.

Brains Bio est un fabricant de premier plan de substances pharmaceutiques actives (IPA) naturelles et pures de la plus haute qualité. Grâce à un ensemble unique de licences et de certifications, Brains Bio est stratégiquement positionné pour tirer parti de l’environnement réglementaire complexe, en garantissant son avantage en tant que pionnier et en termes de qualité des produits. Brains Bio a des activités diversifiées dans les secteurs pharmaceutiques, médicaux et nutraceutiques au sein du marché des cannabinoïdes, qui connaît une croissance rapide, ce qui lui confère une proposition de valeur forte et unique.

[1] https://investor.jazzpharma.com/investors

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


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical steht kurz vor Erhalt einer der weltweit ersten CEP-Zertifizierungen für Cannabidiol vom Europäischen Direktorat für die Qualität von Arzneimitteln und Gesundheitsfürsorge

SANDWICH, Vereinigtes Königreich, Aug. 23, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) hat einen bahnbrechenden Meilenstein erreicht, indem es einen der weltweit ersten CEP–Anträge (Eignungszertifikat) für seinen pharmazeutischen Wirkstoff Cannabidiol (CBD) beim Europäischen Direktorat für die Qualität von Arzneimitteln und Gesundheitsfürsorge (EDQM) eingereicht hat. Diese bahnbrechende Leistung zeigt, dass das CBD von BBC den höchsten Branchenstandard für Cannabinoidprodukte in pharmazeutischer Qualität erfüllt.

Die CEP–Zertifizierung bestätigt, dass das CBD von BBC den Standards des Europäischen Arzneibuchs (Ph. Eur.) entspricht, eine wichtige Bestätigung für Pharmahersteller in Europa, Kanada, Australien, Japan und den USA. Diese Zertifizierung vereinfacht die regulatorischen Prozesse und gewährleistet eine hohe Qualität, Konsistenz und Sicherheit für globale Märkte.

Zu den weiteren Vorteilen des CEP gehören:

  • Erleichterung und Vereinfachung der Interaktion zwischen Regulierungsbehörden und der Industrie, um sicherzustellen, dass die in der pharmazeutischen Produktion verwendeten Substanzen den Standards des Europäischen Arzneibuchs und den einschlägigen EU–Rechtsvorschriften entsprechen.
  • Erleichterung der Verwaltung von Prüfpräparaten für Arzneimittel.
  • Ergänzung und Brücke zwischen den Monografien des Europäischen Arzneibuchs und den Anforderungen an das Zulassungsdossier für Arzneimittel.
  • Bindeglied zwischen Gesundheitsbehörden und Industrie und Verbesserung der Kommunikation und Zusammenarbeit.

Ricky Brar, CEO und Vorstandsvorsitzender von Brains Bioceutical Corp., betonte die Bedeutung dieser Zertifizierung für die langfristige Strategie des Unternehmens. „Die Erlangung einer CEP–Zertifizierung für unseren aktiven pharmazeutischen Cannabidiol–Wirkstoff ist ein entscheidender Schritt auf unserem Weg, den globalen Cannabinoid–Markt anzuführen. Dies bestärkt uns in unserem Engagement für Qualität und Innovation und positioniert Brains Bio als Maßstab für die Branche. Hier geht es nicht nur darum, die gesetzlichen Anforderungen zu erfüllen – es geht darum, sie zu übertreffen und einen neuen Maßstab dafür zu setzen, wie Cannabinoidprodukte in pharmazeutischer Qualität aussehen sollten.“

Dean Billington, Chief Operating Officer von Brains Bioceutical Corp., fügte hinzu: „Unsere Einreichung beim EDQM ist ein Zeugnis für die harte Arbeit und das Engagement unseres Teams. Die CEP–Zertifizierung wird einen erheblichen Wettbewerbsvorteil bieten und sicherstellen, dass unser Cannabidiol–Wirkstoff als erstklassiger Inhaltsstoff für pharmazeutische Zwecke anerkannt wird. Wir sind stolz darauf, in dieser sich schnell entwickelnden Branche an vorderster Front zu stehen und in allen Aspekten unserer Geschäftstätigkeit Spitzenleistungen zu erbringen.“

Die weltweite Nachfrage nach Arzneimitteln auf Cannabinoidbasis ist nach wie vor hoch, wie das Beispiel Epidiolex zeigt, mit dem Jazz Pharmaceuticals im Jahr 2024 voraussichtlich einen Umsatz von etwa 1,4 Mrd. USD erzielen wird [1]. Dies spiegelt das anhaltende Wachstum und die Nachfrage nach hochwertigen pharmazeutischen Cannabinoidprodukten wider.

Der am 8. August 2024 eingeleitete Überprüfungsprozess des EDQM wird etwa 115 Arbeitstage dauern. Die erfolgreiche Erteilung einer CEP–Zertifizierung bestätigt, dass das CBD von Brains Bio die strengen Anforderungen des Ph. Eur. erfüllt.

Diese Bemühungen um die Zulassung von Cannabidiol unterstreichen das unerschütterliche Engagement von Brains Bio, neue Standards für die Cannabinoid–Branche zu setzen. Dies baut auf den EU–GMP– und den Lizenzen für kontrollierte Substanzen von Brains Bio auf. Durch die Anpassung seines CBD–Wirkstoffs an die strengen Kriterien des Europäischen Arzneibuchs nimmt Brains Bio nicht nur am Markt teil, sondern gestaltet dessen Zukunft aktiv mit.

Im Rahmen unserer strategischen Partnerschaft haben sich Brains Bioceutical und DSM–Firmenich zusammengeschlossen, um ihr gemeinsames Know–how in der Cannabinoid–Forschung und –Entwicklung zu nutzen. Zusammen mit Brains Bioceutical – einem Hersteller hochwertiger Cannabinoide in pharmazeutischer Qualität – bietet DSM–Firmenich eine umfassende Innovationsplattform an, die darauf ausgelegt ist, die Entwicklung von Cannabinoid–Arzneimitteln in der Anfangsphase zu unterstützen und das Potenzial von CBD–basierten Formulierungen auszuschöpfen. Zu den Kompetenzen des Unternehmens gehören modernste Formulierungskenntnisse, ein globales Netzwerk von Zulassungsspezialisten sowie die Durchführung präklinischer und klinischer Studien. Das Unternehmen ist auch in der Lage, maßgeschneiderte Lösungen je nach Therapiebereich und Ziel der Arzneimittelabgabe anzubieten. Weitere Informationen darüber, wie die Cannabinoid–Innovationsplattform von DSM–Firmenich zur Verbesserung der Gesundheit von Patienten beiträgt, finden Sie unter: www.dsm.com/cannabinoid–actives.

Über die Brains Bioceutical Corp.

Brains Bioceutical ist der führende Pionier im Bereich der Entwicklung von evidenzbasierten und wissenschaftlich fundierten natürlichen, pflanzlichen Gesundheits– und Wellnesslösungen.

Brains Bio ist ein führender Hersteller von natürlichen und reinen pharmazeutischen Wirkstoffen (APIs) höchster Qualität. Mit einem einzigartigen Paket an Lizenzen und Registrierungen ist Brains Bio strategisch positioniert, um das komplexe regulatorische Umfeld zu nutzen und sich seinen Vorsprung als Vorreiter und in der Produktqualität zu sichern. Brains Bio ist diversifiziert über die pharmazeutischen, medizinischen, und nutrazeutischen Sektoren innerhalb des schnell wachsenden Cannabinoidmarktes, was zu einem starken und einzigartigen Wertversprechen führt.

[1] https://investor.jazzpharma.com/investors

Ein Foto zu dieser Mitteilung ist verfügbar unter https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


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