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NEWS: Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra Therapeutics
Tue, April 18, 2023 at 7:30 AM EDT
In this article: COEP
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Proposed transaction would provide Coeptis with two clinical stage assets leveraging NK cell therapies in relapsed or refractory acute myeloid leukemia (AML) and hospitalized respiratory infections, as well as preclinical programs for hematologic and solid tumors
Clinical data from AML Clinical Trial Expected during 2H 2023
WEXFORD, Pa. , April 18, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced it has entered into a binding term sheet with Deverra Therapeutics, Inc. ("Deverra Therapeutics") pursuant to which it has obtained an exclusive right, until August 31, 2023, to negotiate towards the acquisition or license of assets from Deverra Therapeutics related to its proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages. Deverra Therapeutics is currently advancing clinical programs investigating these technologies in relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with respiratory viral infections.
The transaction, if finalized, would provide Coeptis with, among other assets, exclusive rights to two FDA approved Investigational New Drug (IND) applications and two Phase 1 clinical trials (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections. In addition, Coeptis would gain access to a highly scalable allogeneic cellular immunotherapy platform that is being developed to generate and deliver off-the-shelf (no HLA matching), cost effective, on demand cell therapies to a broad patient population. Deverra expects phase I clinical trial data from its AML study to be complete during 2H 2023.
Additionally, subject to the successful negotiation and completion of any proposed transaction, Deverra Therapeutics' current Scientific Founder, Chief Scientific Officer and EVP, Research & Development, Colleen Delaney, MD, would be expected to assume the position of Chief Scientific and Medical Officer at Coeptis Therapeutics. Dr. Delaney is a world-renowned expert in cell and gene therapy research with more than 20 years' experience in the translation of scientific discovery to clinical practice, including all aspects of cell therapy product development.
"This transaction would greatly expand Coeptis' technology portfolio by incorporation of a cutting-edge allogeneic cell therapy platform with extensive safety and clinical data and align itself with leading experts in the field of cell and gene therapy," said Dave Mehalick, President and CEO of Coeptis Therapeutics. Mr. Mehalick continued, "The addition of these clinical and pre-clinical immune effector cell programs would significantly diversify our R&D capabilities and bring a clinical pipeline with multiple novel approaches to combination cellular immunotherapy approaches, not yet achieved by others. Importantly, the substantial capabilities of the allogeneic cell therapy platform would open new pathways for Coeptis to consider expanding its cell-based therapies beyond autologous CAR T. We are excited about the possibility of exploring the application of both the SNAP-CAR and GEAR technologies to allogeneic, off-the-shelf immune effector cells. The NK and macrophage (MAC) immune effector cell generation from Deverra's platform combined with Coeptis' target specific CARs has the potential to result in development of allogeneic NK and MAC cell therapies."
Dr. Delaney stated: "Deverra's allogeneic cell therapy platform has been in use clinically since 2006, and we have generated significant clinical and safety data since that time. This platform has been shown to provide extreme flexibility and optionality in the generation and modification of multiple distinct immune effector cell types from a single platform. We are excited about the prospect of bringing together our established allogeneic cell platform with the novel targets and technologies from Coeptis to generate first-in-class allogeneic cell therapies to treat a wide range of life-threatening disorders in a cost effective and clinically accessible way."
The proposed transaction is subject to confirmatory due diligence, negotiation and execution of definitive documentation based on agreed terms and other closing conditions, including third party approvals, as well as a right of first refusal in place that a third party possesses and will have a right to exercise. There can be no assurance that the parties will reach a definitive agreement related to the proposed acquisition or license of assets or that, even if any such agreement is reached, any such transaction will be successfully consummated.
About Coeptis Therapeutics Holdings, Inc.
Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh (SNAP-CAR), and the GEAR™ cell therapy and companion diagnostic platforms, which Coeptis is developing with VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis' business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer. The Company is headquartered in Wexford, PA. For more information on Coeptis visit https://coeptistx.com/.
About Deverra Therapeutics
Deverra Therapeutics is a privately held clinical stage biotechnology company dedicated to the development of allogeneic, off-the-shelf (no matching required) cellular immunotherapies for on-demand treatment of patients with cancer and infectious diseases. Deverra is the only company with a proprietary and clinically proven stem cell expansion technology that also serves as starting material for generation of multiple fully functional immune effector cells that can also be engineered to be potent killers of cancer cells. Deverra was a pioneer developing universal non-HLA matched allogeneic and off-the-shelf cell therapies that have been utilized in multiple clinical trials with no safety concerns.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of our management made in connection therewith contain or may contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events or performance, and underlying assumptions, and other statements that are other than statements of historical facts. When we use words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, we are making forward-looking statements. Forward-looking statements are not a guarantee of future performance and involve significant risks and uncertainties that may cause the actual results to differ materially and perhaps substantially from our expectations discussed in the forward-looking statements. Factors that may cause such differences include but are not limited to: (1) the inability to maintain the listing of the Company's securities on the Nasdaq Global Market; (2) the risk that, if the Deverra transaction closes it will disrupt current plans and operations of the Company; (3) the inability to recognize the anticipated benefits of the proposed transaction, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth economically and hire and retain key employees; (4) the risks that the Company's products in development or the targeted Deverra assets fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (5) costs related to integrating the assets and pursuing the contemplated asset development paths; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (8) the impact of the global COVID-19 pandemic on any of the foregoing risks and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission (the "SEC"). The foregoing list of factors is not exclusive. All forward-looking statements are subject to significant uncertainties and risks including, but not limited, to those risks contained or to be contained in reports and other filings filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings made or to be made with the SEC, which are available for review at www.sec.gov. We undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations, or rules.
CONTACTS
Coeptis Therapeutics, Inc.
Andy Galy, Sr. VP of Communications
andy.galy@coeptistx.com
Tiberend Strategic Advisors, Inc.
Investors
Jon Nugent
jnugent@tiberend.com
Media
David Schemelia
dschemelia@tiberend.com
Cision
Cision
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ProfitScout
2 years ago
Coeptis Therapeutics Secures Exclusive Rights to Negotiate to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial Immuno-Oncology Treatment Strategies
March 29, 2023 (PR Newswire)
Potential acquisition of VyGen-Bio would strengthen Coeptis' oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform and companion diagnostic technologies
Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced it has obtained the exclusive right to negotiate towards the acquisition of VyGen-Bio, Inc. or its assets. Coeptis intends to immediately commence its due diligence review of VyGen-Bio's assets, including its IP and knowhow related to rights to GEAR™ cell therapy and companion diagnostic platforms, and, depending on the results of its due diligence analysis, turn to negotiation of definitive deal documents. VyGen-Bio's product candidates and platforms were discovered by scientists at the world-renowned Karolinska Institutet in Stockholm, Sweden, including Dr. Arnika Wagner, who is expected to play a key collaborative development role for Coeptis as the Company builds its capabilities to develop treatments for cancer and gains technologies to develop additional cell and gene therapies.
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This transaction, if finalized, would expand upon Coeptis' collaboration with VyGen-Bio, which is currently focused on CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers with an initial focus on multiple myeloma, and CD38-Diagnostic, an in vitro diagnostic tool being developed to help identify cancer patients who may be appropriate candidates for anti-CD38 mAb therapy.
In the event a transaction is consummated, Coeptis would then be in a position to advance the development of various GEAR-engineered cells, including NK cells, T cells, and hematopoietic stem cells, and to pursue development of GEAR-engineered cells for use in combination with mAbs that target a potentially wide range of receptor targets. Additional development options that would be explored could include therapeutic modalities where the antigen-specificity of mAbs is used, such as CAR-T and bispecific antibodies for the treatment of a broad range of hematologic malignancies and solid tumors.
"We believe that the acquisition of VyGen-Bio's GEAR Platform would represent a significant inflection point in the growth of Coeptis and our strategy to be a leader in the development of 'next generation' cell therapy technologies for cancer and other diseases," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Our vision for GEAR is bold and ambitious, as we believe this novel cell engineering approach protects the integrity, fitness and function of the cell while importantly shielding it from destruction by co-administered mAbs. We believe the GEAR platform offers the potential to not only improve existing cancer therapies, but further expand the use of existing therapies in new indications."
"If we are able to successfully consummate an acquisition transaction, we plan to initially focus on advancing the first GEAR candidate, CD38-GEAR-NK, to the clinic for the treatment of multiple myeloma and to concurrently engage in business development activities to expand the GEAR Platform into new cell therapy products via potential co-development and/or licensing partnerships," Mehalick added.
GEAR was discovered by scientists at the Karolinska Institutet (KI), including Evren Alici M.D., Ph.D., Hans-Gustaf Ljunggren M.D., Ph.D., and Arnika Kathleen Wagner Ph.D. Drs. Alici, Ljunggren, and Wagner are founding members of VyGen-Bio and will continue to contribute in the development of the technology platforms as members of Coeptis' Scientific Advisory Board. Drs. Ljunggren and Alici are managing directors of NextGenNK, an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden's innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine.
"GEAR-NK cells, and ultimately all GEAR-engineered cells, are being designed to potentially decrease side-effects associated with certain mAb therapies and potentially reduce or eliminate the 'on-target-off-tumor' effect. As a Coeptis' SAB member, I look forward to collaborating in the development of these technologies, which may have widespread applicability in cancer and beyond," stated GEAR co-inventor, Dr. Wagner.
About Coeptis Therapeutics Holdings, Inc.
Coeptis TherapeuticsHoldings, Inc.,together with its subsidiariesincludingCoeptis Therapeutics, Inc.and Coeptis Pharmaceuticals, Inc.,(collectively"Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh (SNAP-CAR),and a cell therapy technology (CD38-GEAR-NK) and an in vitro diagnostic (CD38-Diagnostic) targeting CD38-related cancers,whichCoeptis is developing with VyGen-Bio and leading medical researchers at theKarolinska Institutet. Coeptis' business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer. The Company is headquartered inWexford, PA. For more information on Coeptis visithttps://coeptistx.com/.
About VyGen-Bio™, Inc.
VyGen-Bio is a discovery-stage, cell-based immunotherapy company focused on the development of potentially transformational technology platforms. GEAR-NK is a modified NK cell-based therapeutic being designed to be co-administered with targeted antibodies. The Company is also developing companion diagnostics designed to potentially identify patient populations that may be most likely to benefit from targeted antibody therapies. Headquartered in Tampa, Florida on the campus of the H. Lee Moffitt Cancer Center, VyGen-Bio is a majority-owned subsidiary of Vycellix, Inc. (www.Vycellix.com). The Company's platforms were discovered by scientists at Karolinska Institutet (KI), Stockholm, Sweden that collaborate with VyGen-Bio. Additionally, VyGen-Bio is a Partner in "NextGenNK", an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden's innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of our management made in connection therewith contain or may contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events or performance, and underlying assumptions, and other statements that are other than statements of historical facts. When we use words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, we are making forward-looking statements. Forward-looking statements are not a guarantee of future performance and involve significant risks and uncertainties that may cause the actual results to differ materially and perhaps substantially from our expectations discussed in the forward-looking statements. Factors that may cause such differences include but are not limited to: (1) the inability to maintain the listing of the Company's securities on the Nasdaq Global Market following the business combination; (2) the risk that the business combination disrupts current plans and operations of Company as a result of the consummation of the business combination; (3) the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth economically and hire and retain key employees; (4) the risks that the Company's products in development fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (5) costs related to the business combination; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (8) the impact of the global COVID-19 pandemic on any of the foregoing risks and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission (the "SEC"). The foregoing list of factors is not exclusive. All forward-looking statements are subject to significant uncertainties and risks including, but not limited, to those risks contained or to be contained in reports and other filings filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings made or to be made with the SEC, which are available for review atwww.sec.gov. We undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations, or rules.
CONTACTS
Coeptis Therapeutics, Inc.Andy Galy, Sr. VP of Communicationsandy.galy@coeptistx.com
Tiberend Strategic Advisors, Inc.InvestorsJon Nugentjnugent@tiberend.com
MediaDavid Schemeliadschemelia@tiberend.com
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SOURCE Coeptis Therapeutics
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