Orphan Drug Designation & FDA INTERACT Meeting
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or the "Company")
BiVictriX Announces FDA Orphan Drug Designation and completion of FDA INTERACT meeting for BVX001 in the treatment of Acute Myeloid Leukaemia
§ FDA guidance aligns with ongoing development plans and Orphan Drug Designation provides financial incentives and greater potential market exclusivity for BVX001
Alderley Park, 17 April 2024 - BiVictriX Therapeutics plc (AIM: BVX), a biotechnology company developing novel, next-generation bispecific Antibody Drug Conjugates (bxADCs) which are designed to offer substantially improved cancer cell selectivity, announces that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of Acute Myeloid Leukaemia (AML) to the Company's lead asset BVX001, a novel twin antigen (CD33/CD7) targeting bxADC. The Company also today announces the completion of an Initial Targeted Engagement for Regulatory Advice (INTERACT) meeting with the FDA Center for Drug Evaluation and Research (CDER), to obtain guidance on questions relating to BVX001's pharmacology, toxicology and chemistry, manufacturing and controls (CMC) in preparation for filing an investigational new drug (IND) application.
Tiffany Thorn, BiVictriX's Founder and CEO commented: "The ODD grant for our lead asset BVX001 represents important US regulatory progress for BiVictriX, highlighting the significant unmet need for novel therapies targeting AML and providing us with greater market exclusivity potential. The INTERACT forum gave us clear and timely guidance from the FDA on BVX001, and we consider the feedback to be very positive. With strong alignment between our future development plans and the comments from the FDA reviewers, it is an exciting time for the Company. We continue to advance our preclinical data package for BVX001, with plans to submit a pre-IND application, and to present further efficacy and safety data at a key Haematology Conference in the second half of 2024."
Dr Michael Kauffman, BiVictriX's Chairman commented: "Early engagement with the FDA for novel therapeutic approaches is key, and I am delighted with our progress to date. Our ability to qualify for an INTERACT meeting underscores the novel and compelling approach we are taking with our scientific platform to develop truly differentiated therapies in areas of high unmet need, as demonstrated by our ODD. I am confident that BVX001 has unique and novel attributes that will support its advancement to the clinic. This timely FDA guidance and ODD will expedite BVX001's development, as we look to work closely with the FDA and other regulatory agencies."
FDA Orphan Drug Designation provides orphan status to therapies intended for the prevention, diagnosis or treatment of diseases affecting less than 200,000 people in the US. Sponsors of therapies granted Orphan Drug Designation are entitled to certain financial incentives, including tax credits for qualified clinical trials, prescription drug user fee exemptions and potential seven-year marketing exclusivity upon FDA approval.
INTERACT is the first point of FDA interaction for companies undertaking an Investigational New Drug application to study First-in-Human products, potentially leading to market authorisation via a Biologics License Application (BLA). Over two thirds of INTERACT meeting requests are rejected[1].
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About BiVictriX Therapeutics plc
BiVictriX is a UK-based drug discovery and development company which is focused on leveraging clinical experience to develop a new class of highly selective, next generation cancer therapeutics which exhibit superior potency, whilst significantly reducing treatment-related toxicities.
The Company utilises a first-in-class approach to generate a proprietary pipeline of Bi-Cygni® Antibody Drug Conjugate therapeutics which are designed to selectively target cancer-specific antigen pairs, or "Bi-Cygni® fingerprints", on tumour cells, which are largely absent from healthy cells.
BiVictriX has established a growing proprietary library of cancer-specific Bi-Cygni® fingerprints, which enable the Company to target a diverse array of different cancer types. The Company utilises these novel Bi-Cygni® fingerprints, together with the Company's novel Antibody Drug Conjugate therapeutic design, to develop more effective and safer therapeutics to target cancers that are expected to constitute orphan indications and areas of high unmet medical need.
Find out more about BiVictriX online at www.bivictrix.com
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