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Gear-NK (CD38)

GEAR-NK (CD38)

Our science stems from the premise that certain cancer therapies for CD38+ tumors can be enhanced to minimize off-target effects while harnessing the therapeutic impact of NK cells. CD38 is a multifunctional transmembrane glycoprotein that is abnormally overexpressed in a variety of tumor types and is associated with cancer progression.1

Immunotherapies, specifically anti-CD38 monoclonal antibodies (mAbs) target the CD38+ cancer cells, but also kill other important innate immune effector cells such as CD38+NK cells that recognize and destroy cancer cells, or virus-infected cells.

1 Dwivedi S, Rendón-Huerta EP, Ortiz-Navarrete V, Montaño LF. CD38 and Regulation of the Immune Response Cells in Cancer. J Oncol. 2021;2021:6630295. Published 2021 Feb 27.

HOW DOES CD38 PLAY AN IMPORTANT ROLE IN TARGETING CERTAIN CANCERS?

CD38 is a protein receptor overexpressed on certain cancers including hematological malignancies and solid tumors.  With the development of anti-CD38 monoclonal antibody therapies (mAbs) designed to bind to CD38 antigen to generate immune-mediated killing, survival outcomes for CD38+ cancers have significantly improved.  However, despite the potential benefit of anti-CD38 mAbs, cancers such as multiple myeloma are still considered to be incurable.

 

Gear-NK (CD38) Strategy

Animations herein are provided as visual aids to help articulate hypothesized proof-of-concept in a general manner and do not depict precise scientific mechanisms-of-action.

IMMUNOTHERAPY CHALLENGES

Various immunotherapies for CD38+ tumors are designed to find and kill cells that express the CD38 antigen; therefore, CD38+ NK cells are likely to become collateral damage and with their eradication, the overall anti-tumor response is suboptimal.

THE GOAL

To protect CD38+ Natural Killer (NK) cells so that functional disease-targeting NK cells will not be eradicated, enabling their co-existence with CD38 targeting therapies, and thus allowing for complementary tumor killing and immune surveillance.

A novel COMBINATORIAL APpROACH

Modified NK cells that are co-administered with select monoclonal antibodies and/or other CD38 targeting immunotherapies are in pre-clinical development to enhance and maximize tumor kill via combinatorial approaches otherwise not possible.

current Anti-CD38 pathway

Anti-CD38 mAbs (Infused antibodies from current cancer treatments) bind to CD38 proteins and kill both CD38+ Cancer cells and our body’s Natural Killer Cells.

 

Animations herein are provided as visual aids to help articulate hypothesized proof-of-concept in a general manner and do not depict precise scientific mechanisms-of-action.

pathway with Gear-nk (cd38) cell therapy

CD38-GEAR-NK are modified, NK cells that can avoid being ablated by therapies designed to target the CD38 antigen, thus enabling the combination of passive immunity with innate active immunity to more efficiently target and eradicate CD38+ malignancies.

Animations herein are provided as visual aids to help articulate hypothesized proof-of-concept in a general manner and do not depict precise scientific mechanisms-of-action.

Coeptis and VyGen-Bio, Inc. have entered into a series of Agreements to co-develop certain pre-clinical therapeutic and diagnostic product candidates with a focus on the discovery-stage development of a platform technology referred to as Gene-Edited Antibody Resistant (“GEAR”) cell therapy products. The CD38-GEAR-NK product candidate is under development as a potential cell-based cancer therapeutic to be co-administered with other CD38 targeting immunotherapies including monoclonal antibodies (“mAbs”), The GEAR Technology Platform is being developed by VyGen-Bio to modify Natural Killer cell-based therapies (NK cells) targeting cancers in combination with mAbs and potentially to modify Hematopoietic Stems Cells (HSCs) in combination with mAbs to improve bone marrow transplant outcomes in the treatment of a broad range of hematological malignancies. This pre-clinical co-development platform  is comprised of unproven early development product candidates with proof-of-concept studies ongoing and with IP protection strategies at preliminary stages, and as such, these programs and related assets are subject to all of the risks associated with early-stage biotech drug and diagnostic development.

Gear
Diagnostics

Expanding on the GEAR-NK technology, a CD38-based diagnostic is being developed as an in vitro screening tool to assist in pre-determining which cancer patients are most likely to benefit from targeted mAb therapies, either as monotherapy or in combination with GEAR-NK as a companion diagnostic. The GEAR Diagnostic platform is being designed to enhance optimal patient selection, which is a global priority for healthcare systems seeking significant cost-savings through the delivery of predictable therapeutic solutions, while also potentially protecting patients from being unnecessarily subjected to less effective therapies.

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