BVX.L Regulatory News (BVX)

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BIVICTRIX THERAPEUTICS PLC

("BiVictriX" or the "Company")

US Patent Granted Providing Broad Protection for BVX001

Alderley Park, 23 August 2023 - BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a differentiated approach to develop next-generation cancer therapies with substantially improved cancer cell selectivity and anti-cancer activity, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent providing broad protection for the Company's lead asset, BVX001.

The claims granted within this patent (patent number US11,732,040), which belongs to the wider patent family "Therapy" currently being prosecuted in eight territories worldwide, provides ultimate broad protection for the lead therapeutic asset, BVX001, at the antigen level.

The claims granted in the United States provide broad protection for an antibody-based therapeutic attached to a cell-killing payload, such as an alternative Antibody Drug Conjugate ("ADC") therapy or any akin therapeutic, which binds to the Company's Bi-Cygni® twin antigen fingerprint comprising CD7 x CD33, for use in treating of a CD7+CD33+ haematological malignancy. The coverage extends beyond the Company's lead indication of Acute Myeloid Leukaemia ("AML"), providing protection across any haematological cancer type which may be positive for CD7 and CD33. This is true irrespective of the therapeutic format employed, including use of alternative antibody sequences, alternative antibody formats and/or alternative cell killing payloads, which often represent routes taken by third parties to develop a competitive therapeutic. Taken together, these granted claims represent a very broad and commercially favourable position for BiVictriX.

Further to the US patent issue, which follows the issuance of a Notice of Allowance from the USPTO, announced in July 2023, BiVictriX confirms receipt of an additional Notice of Allowance from the Japanese Patent Office. The notice relates to the Japanese patent (publication number JP2021504469) which also forms part of the wider patent family, "Therapy". It is anticipated that this patent will be granted in Japan in the coming weeks, providing further protection for BVX001 at the broadest level. BiVictriX is currently seeking approval for this patent family in an additional six jurisdictions worldwide, with further patent grants expected in the forthcoming months.

Tiffany Thorn, CEO of BiVictriX commented: "I am excited to announce that our first patent has been granted in the United States. This patent relates to our broadest patent family, providing robust protection for BVX001 at the antigen level, across multiple cancer types, and acts as a key milestone for the Company demonstrating the breadth of patent protection we can achieve with the Bi-Cygni® approach. This patent grant is expected to be the first of many as we continue to prosecute the wider patent family in seven further jurisdictions worldwide, creating a robust patent protected portfolio.

Barbara Fleck, European Patent Attorney and Partner at Appleyard Leads IP LLP commented: "I am very pleased to see that the USPTO has issued BiVictriX's patent with broad claims to methods for treating a CD7+CD33+ haematological malignancy by administering a cell inhibiting agent linked to a cytotoxin that bispecifically binds to CD33 and CD7. Obtaining such broad claims in the antibody space is challenging and this not only validates BiVictriX's Bi-Cygni® ADC technology for the treatment of AML, but also provides the Company with broad US patent coverage in a competitive space."

ENDS

About BiVictriX Therapeutics plc

BiVictriX (AIM: BVX) is an emerging biotechnology company leveraging clinical experience and its proprietary discovery engine to advance a new class of highly cancer-selective, next-generation precision cancer therapies in one of the fastest-growing markets in oncology. BiVictriX's first-in-class Bi-Cygni® Antibody Drug Conjugates ("ADCs") combine superior efficacy with substantially improved cancer-selectivity and safety to provide opportunities for prolonged dosing and greater efficacy in the clinic. The Company is advancing its pipeline to deliver the future of cancer care across a broad range of haematological and solid cancer indications in areas of high unmet medical need.

Find out more at www.bivictrix.com and connect with us on LinkedIn and Twitter @BiVictriX.