ONK Therapeutics and NAYA Biosciences Announce Research Partnership to Advance Combination Therapy of Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies and FLEX-NK™ Bispecific Antibodies

  • ONK Therapeutics and NAYA Biosciences to assess proof-of-concept and establish activity and feasibility of the combination of ONK’s optimally engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK™ bispecific antibodies for the treatment of cancer
  • Partnership may be expanded to joint clinical development following successful completion of the initial research
  • Combination therapy expected to improve response rate and address significant unmet medical need in hepatocellular carcinoma (HCC)

Galway, Ireland and San Diego, Ca., Aventura, Fla. and Sarasota, Fla., Dec 6, 2023 – ONK Therapeutics (“ONK”), an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf natural killer (NK) cell therapies, and NAYA Biosciences Inc. (“NAYA”), a company dedicated to increasing patient access to breakthrough treatments in fertility, oncology, and regenerative medicine today announced that they have entered into a research partnership to evaluate combination therapy consisting of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK™ bispecific antibodies.

Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.

“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,” commented NAYA’s CEO Dr. Daniel Teper. “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’s CEO Chris Nowers added, “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.”

ONK and NAYA plan to assess several combination therapies in preclinical cancer models in 2024 prior to subsequently exploring initiating clinical trials. The companies’ R&D teams will collaboratively evaluate ONK’s optimally gene-edited NK cell therapy, ONKT105, with NAYA’s NY-303 bispecific antibody before selecting the best candidates for potential clinical development. Both companies will share the costs of manufacturing and preclinical assessments.

ONK Therapeutics employs an innovative gene editing strategy to engineer NK cell therapies that are fit for purpose and optimally engineered, depending on the indication and intent for use alone (CAR NK), or in combination with targeting monoclonal antibody or NK cell engager therapies. All of ONK’s allogeneic NK cell therapy products candidates include the foundational CISH KO gene edit, to allow for enhanced metabolic properties and improved in vivo persistence. ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells. Additional gene edits, such as the KO of immunosuppressive checkpoints such as TGFβR2, as well as gene knock-ins (KIs), such as sIL-15, are included to further armor the NK cell therapies for maximal activity within the tumor microenvironment.

NAYA’s FLEX-NK bispecific antibodies are built on a proprietary tetravalent, multifunctional format with flexible linker, facilitating simultaneous binding to different antigens on one or multiple cells. They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKp46 activating receptors. NKp46 mediates NK-cell lysis in both autologous and allogeneic cells and shows sustained expression on NK cells in the tumor microenvironment. NY-303 targets GPC3 for the treatment of HCC and other solid tumors and has demonstrated enhanced tumor growth inhibition when combined with NK cells in data presented at leading conferences including the American Association for Cancer Research (AACR) and the Society for Immunotherapy of Cancer (SITC).

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About ONK Therapeutics – www.onktherapeutics.com

ONK Therapeutics is an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf, natural killer (NK) cell therapies. With a growing pre-clinical pipeline targeting both hematological malignancies and solid tumors, ONK is advancing multiple cell therapy candidates towards the clinic, including its two lead programs, ONKT105, a highly functional, multi gene edited NK cell therapy for use either alone or in combination with monoclonal antibodies or NK cell engagers, and ONKT102, an optimized affinity CD38 CAR-NK product, intended for the treatment of patients with relapsed/refractory multiple myeloma. Read about the pipeline here.

The company’s optimally engineered NK cell therapy platform utilizes a suite of proprietary gene edits and cell modification strategies to optimize NK cell metabolic health, persistence and anti-tumor effect of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. These include CISH knockout (KO); the expression of high affinity, membrane bound, TNF-related apoptosis-inducing ligand variants (TRAILv) targeting DR5 or DR4; and the deletion of inhibitory receptors, including extracellular proteins for example CD96, and Siglec-7. Read about the platform here.

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About NAYA Biosciences

NAYA Biosciences is building a group of agile, disruptive, high-growth companies dedicated to increasing patient access to life-transforming treatments in oncology, fertility, and regenerative medicine.  NAYA’s capabilities in biology, cell and gene therapy, and artificial intelligence (AI) provide a synergistic platform for the accelerated clinical development and commercialization of these breakthrough treatments.

NAYA Oncology aims to achieve clinical proof-of-concept for its two bispecific antibodies acquired from Cytovia Therapeutics, with the goal of advancing towards breakthrough outcomes for Hepatocellular Carcinoma and Multiple Myeloma patients. Clinical trials are expected to start in 2024.

NAYA Fertility aims to increase accessibility to advanced fertility care through a growing network of INVO-owned and affiliated clinics and the commercialization of INVO’s unique FDA-cleared INVOcell® device.

NAYA Regenerative Medicine is evaluating the acquisition of clinic-stage assets aiming to restore biological function in patients with damaged tissues and organs.

On October 22, 2023, NAYA and INVO announced a merger agreement, which is expected to close in Q1 2024.  For additional details, see Inline XBRL Viewer (sec.gov).

For more information, please visit www.nayabiosciences.com.

 

Media enquiries

ONK Therapeutics – International:
Sue Charles (Charles Consultants)
+44 7968 726585
sue@charles-consultants.com

ONK Therapeutics – Ireland:

Ray Gordon (Gordon MRM)
+353 87 2417373
ray@gordonmrm.ie

NAYA Biosciences:
Anna Baran-Djokovic
305-615-9162
anna@nayabiosciences.com

INVO Bioscience:
Steve Shum
978-878-9505
sshum@invobio.com

INVO Investor Contact:
Robert Blum (Lytham Partners, LLC)
602-889-9700
INVO@lythampartners.com