Grant of MK Cell Patent & Licencing Update

Roquefort Therapeutics (LSE:ROQ), the Main Market listed biotech company focused on developing first in class medicines in the high value and high growth immunology and oncology markets, confirms that the European Patent Office has granted the patent for its Mesodermal Killer ("MK") cell therapy, across 39 counties including the UK and EU[i].

Novel Cellular Immunology / Oncology Medicine

Mesodermal Killer cells are a novel therapeutic cell type developed from the pioneering work of Roquefort Therapeutics' non-executive director, Nobel Laureate, Professor Sir Martin Evans. MK cells display a novel immunophenotype[ii] and thus represent a new class of cell, which is confirmed by the granting of this patent.

The Company's MK cells form an off-the-shelf (allogenic) cellular medicine, which underpins a promising new form of immunotherapy. MK cells have been shown to have both a direct effect and to recruit and activate Natural Killer ("NK") cells[iii] immune response in immunology and oncology indications. Cell based immunotherapy is an attractive new niche highlighted by the recent successful US$167 million NASDAQ IPO of Artiva Biotherapeutics[iv] and the licensing deals of Dragonfly Therapeutics and Fate Therapeutics (NASDAQ: FATE), with both immunology and oncology indications.

The granted European Patent Organization patent is valid in 39 countries across Europe and provides protection for both the composition of matter of the MK cell type and for a population of NK cells primed (activated) by the MK cells. This affords Roquefort Therapeutics protection for a portfolio of multiple novel medicines comprising of the MK cells alone, MK + NK cells or primed NK cells.

Pre-Clinical Development

Since Roquefort Therapeutics acquired the MK cell programme as part of the Oncogeni acquisition in 2021, the Company has tested the MK cells in combination with NK cells. MK cells were shown to activate Natural Killer cells and this activation produced up to a two-fold increase in cytotoxicity compared to treatment with NK cells alone. The data, whilst early stage, indicates how the MK cell programme can be used to activate Natural Killer cells in the high value difficult to treat immunology and oncology disease areas.

The Company plans to complete in vivo studies to demonstrate MK activation of NK cells in high value immunology and / or cancer indications in preparation for a key value inflection point of initiating a clinical study.

Out-Licencing Update

As announced on 23 May 2024, Roquefort Therapeutics signed a term sheet for the out-licensing of its Midkine antibody portfolio to PDC FZ-LLC ("PDC"), a leading MEA pharmaceutical research and development organisation. The Company continues to work with PDC to progress this transaction to completion.

In addition, Roquefort Therapeutics is actively pursuing an out-licensing deal with Big Pharma for its STAT-6 siRNA programme. As part of this initiative the Company is carrying out additional in vitro experiments in an immunology setting - with the results expected shortly. The Company believes that positive immunology results will enhance the Company's existing positive oncology results and therefore strengthen the programme's attractiveness to potential licensees. The Company will update the market as this process progresses.

Roquefort Therapeutics CEO Ajan Reginald commented:

"The granting of this European patent for MK cell therapy highlights both the security of our foundational IP in confirming the novelty of the MK cells and the commercial potential of MK cells in immunology and oncology markets. These markets are highly attractive to both Big Pharma and to sophisticated Biotech investors, recently highlighted by Artiva's oversubscribed IPO in July 2024.

Roquefort Therapeutics has the potential to build a similar immunotherapy franchise having already established the ability to manufacture the allogenic (off-the-shelf) MK cells and to incorporate and prime NK cells in a scalable manufacturing process. The MK cells generate a significant activation of NK cells which may augment the efficacy of NK cells, which is the critical attribute in immunology and oncology indications. The strategic implication of the granting of the MK cell patent is that this creates a significant franchise opportunity in immunology for the Company.

We have had a busy summer meeting with PDC to work on progressing our licensing deal, as well as advancing the STAT-6 siRNA programme in immunology for Big Pharma partners interested in a potential licence or sale.

With both the MK cell therapy and the STAT-6 siRNA being in the attractive immunology market, and the out- licensing deals we are working on closing in Q4, we believe the next few months have the potential to be transformational for Roquefort Therapeutics."