REG - BiVictriX Therapcts. - Orphan Drug Designation & FDA INTERACT Meeting

Bivictrix TherapeuticsAnnouncement

17/04/2024 07:01

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RNS Number : 8798K  BiVictriX Therapeutics PLC  17 April 2024

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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 .

 

 ENDS

 For more information, please contact:

BiVictriX Therapeutics plc
 Tiffany Thorn, Chief Executive Officer

 Michael Kauffman, Non-Executive Chairman                            Email: info@bivictrix.com (mailto:info@bivictrix.com)

 SP Angel Corporate Finance LLP (NOMAD and Broker)                     Tel: +44 (0) 20 3470 0470
 David Hignell, Caroline Rowe, Kasia Brzozowska (Corporate Finance)

 Vadim Alexandre, Rob Rees (Sales and Broking)

 Panmure Gordon (UK) Limited (Joint Broker)                            Tel: +44 (0) 20 7886 2500
 Rupert Dearden/Freddy Crossley/Emma Earl

 ICR Consilium
 Mary-Jane Elliott, Namrata Taak,                                    Tel: +44 (0) 20 3709 5700

 Max Bennett, Emmalee Hoppe                                          Email: Bivictrix@consilium-comms.com (mailto:Bivictrix@consilium-comms.com)

 

 

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
(http://www.bivictrix.com/)

 

 

 

 1 
https://www.parexel.com/application/files/resources/assets/what-to-know-about-fda-interact-meetings.pdf
(https://www.parexel.com/application/files/resources/assets/what-to-know-about-fda-interact-meetings.pdf)

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