NAYA Biosciences and ONK Therapeutics have forged a collaborative research alliance to assess a combination therapy that incorporates NAYA’s FLEX-NK bispecific antibodies and ONK’s finely engineered natural killer (NK) cells.

The focus of the partnership lies in investigating the synergy between NAYA’s GPC3-targeted NY-303 FLEX-NK bispecific antibody and ONK’s ONKT105 – an allogeneic NK cell therapy characterised by a double knock-out (KO) of CISH + TGFβR2, along with a knock-in (KI) of sIL-15.

NAYA CEO Dr Daniel Teper said: “We are impressed with the data ONK has generated using its differentiated editing of NK cells, which may further enhance the efficacy of our FLEX-NK bispecific antibodies.

“The future development of this combination therapy alongside our monotherapy clinical trials will help expand patient options and narrow the gap towards improving the long-term survival of patients with hepatocellular carcinoma.”

ONK CEO Chris Nowers said: “The opportunity to partner with NAYA to evaluate the activity of our optimally gene-edited, non-CAR directed, allogeneic NK cell therapies in combination with its exciting FLEX-NK bispecific antibodies offers an opportunity to further improve response rates and durability of NK cell therapy.

“We believe this therapeutic combination represents a broadly applicable and versatile approach to treat patients with cancer and autoimmune diseases, where additional treatment options are needed.”

In 2024, NAYA Biosciences and ONK Therapeutics are set to evaluate multiple combination therapies in preclinical cancer models, with plans to progress to clinical trials thereafter.

Their joint research and development teams will collaboratively assess the potential of ONK’s gene-edited NK cell therapy, ONKT105, in combination with NAYA’s NY-303 bispecific antibody.

The goal is to identify the most promising candidate for potential clinical development, with both companies sharing the costs associated with manufacturing and preclinical assessments.

NAYA’s FLEX-NK bispecific antibodies are constructed using a proprietary tetravalent, multifunctional format featuring a flexible linker, enabling simultaneous binding to different antigens on one or multiple cells.

These antibodies redirect and activate Natural Killer (NK) cells, leveraging NKP46 activating receptors to induce killing activity against tumour targets. NKp46, exhibiting sustained expression in the tumour microenvironment, plays a crucial role in NK-cell lysis for both autologous and allogeneic cells.

The NY-303 bispecific antibody from NAYA specifically targets GPC3 for the treatment of hepatocellular carcinoma (HCC) and other solid tumours. Notably, it has demonstrated enhanced inhibition of tumour growth when combined with NK cells, as evidenced in presentations at prominent conferences like the American Association for Cancer Research (AACR) and the Society for Immunotherapy of Cancer (SITC).

ONK Therapeutics employs an innovative gene-editing strategy to engineer NK cell therapies tailored for specific indications and purposes, whether used alone (CAR NK) or in combination with monoclonal antibodies or NK cell engager therapies.

All of ONK’s allogeneic NK cell therapy candidates feature a foundational CISH KO gene edit, enhancing metabolic properties and in vivo persistence. ONK holds exclusive worldwide rights to CISH KO in NK cells, irrespective of the source.

Additional gene edits, such as the knockout (KO) of immunosuppressive checkpoints like TGFβR2, along with gene knock-ins (KIs) like sIL-15, are incorporated to further fortify NK cell therapies for maximal activity within the tumour microenvironment.