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Nasdaq: COEP Profile

OUR NEW PROFILE IS:   (NASDAQ: COEP)

Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra Therapeutics

Coeptis Therapeutics Secures Exclusive Rights to Negotiate to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial Immuno-Oncology Treatment Strategies

Coeptis Therapeutics Enters into Exclusive Option Agreement with University of Pittsburgh for Rights to CAR-T Technologies Designed to Target Multiple Cancer Indications, Including Hematologic and Solid Tumors


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Hello Everyone,

We have another profile that we want to put on your radar for tomorrow’s session.

We have had some recent biotech companies that we have profiled go on to make significant moves in 2023.

This is a company that has seen activity pick up pretty significantly over the past 3 sessions with no recent news to speak of.

Pull up COEP immediately.

This one almost doubled from late April to mid May on fairly light interest.

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.

MAJOR CATALYSTS

👉Potential acquisition of VyGen-Bio would strengthen their oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform

👉Focused on SNAP-CAR T Cells, a Platform Technology Being Developed to be Combined with Tagged, Tumor-Specific Antibodies to Potentially Target Many Different Tumor      Types.

👉Exclusive Rights to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial Immuno-Oncology Treatment Strategies.

👉SNAP-CAR Technology Highlighted in Peer-Reviewed Article in Translational Medicine Journal.

👉Research Agreement with the University of Pittsburgh to Expand Pre-Clinical Development of SNAP-CAR T Cells Targeting HER2-Positive Cancers.

👉Collaboration with IQVIA, a Global Contract Research Organization, to Identify Target Indications and Initiate IND-Enabling Activities.

👉CAR T Cell Therapy Market is Expected to Reach $20.56 Billion by 2029 from $1.96 Billion in 2021.

Coeptis Therapeutics, Inc. has entered into an exclusive license agreement with the University of Pittsburgh for certain intellectual property rights to technologies developed within research laboratories at the University of Pittsburgh. Chimeric antigen receptors (CARs) are artificial T cell receptors that re-target T cells to specifically recognize and kill tumor cells. The licensing agreement involves a CAR T cell therapy platform called “SNAP CAR” designed to be a universal therapeutic in the treatment of various types of cancer. The SNAP-CAR T cell therapy is currently in preclinical development. $COEP NASDAQ

Through the company’s subsidiary, Coeptis Pharmaceuticals, they have entered into co-development agreements with VyGen-Bio, led by its team of leading medical researchers at the Karolinska Institutet (KI) based in Stockholm, Sweden, to jointly develop novel natural killer cell-based therapeutics and related diagnostics with an initial focus on the urgent need to improve treatments for cancers that over-express the CD38 protein (CD38+).

COEP‘s Scientific Collaboration

Coeptis is collaborating with researchers from the University of Pittsburgh and contracted a prominent Clinical Research Organization (CRO) to begin developing the SNAP-CAR T cell therapy with the goal to pursue clinical trials. Coeptis has been assigned the worldwide development and commercialization rights to the licensed technology in the field of human treatment of cancer with antibody or antibody fragments using SNAP-CAR T cell technology.

VyGen-Bio is a discovery-stage, cell-based immunotherapy company focused on the development of transformational technology platforms: GEAR-NK, modified natural killer cell-based therapeutics (NK cells), optimized to be co-administered with targeted antibodies; and, GEAR Diagnostic, a companion diagnostic being developed to select patient populations most likely to benefit from targeted antibody therapies.

CAR T And SNAP-CAR Strategy

The Importance Of CAR T Cell Therapy – Chimeric antigen receptor (CAR) therapy is a new treatment for cancer in which a patient’s T cells (a type of immune cell) are genetically engineered to recognize cancer cells to target and destroy them. Cells are extracted from the patient and then genetically engineered to make the CAR and are re-introduced back into the patient. Currently approved CAR T therapies are revolutionizing the treatment of many blood cancers including B cell leukemias and lymphomas by targeting specific proteins found on these cancers, and there is hope in treating additional cancers including solid tumors by having them recognize new targets.

What is SNAP-CAR And How Does It Target Certain Cancers? – Coeptis has licensed a CAR T cell therapy platform called “SNAP-CAR” to be a universal therapeutic. The SNAP-CAR technology is in preclinical development at the University of Pittsburgh. Instead of directly binding to a target on the tumor cell, the CAR T cells are co-administered with one or more antibody adaptors that bind to the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent bond. A covalent bond is the highest affinity bond possible, thus this binding is expected to translate to highly potent therapeutic activity.

SNAP-CAR, A Highly Programmable Therapeutic Platform –Pre-clinical studies in mice have demonstrated that by targeting tumors via antibody adaptor molecules, the SNAP-CAR therapy provides a highly programmable therapeutic platform that may present several potential advantages over standard CAR T treatments.

Immunotherapy Challenges

Reducing potential toxicity: The therapeutic activity of the SNAP-CAR T cells can be controlled by the antibody dose, which we envision would allow clinicians to potentially mitigate toxicity from over-activity. We also envision that the immune response against cancer may also be boosted in patients with additional doses of the tagged tumor-specific antibody.

The Goal

Lowering the chance for cancer relapse: Relapse from CAR T cell therapy which often results from the loss or down-regulation of the targeted protein on the cancer, can potentially be avoided by combining SNAP-CAR T cells with antibodies targeting multiple antigens at once.

A Novel Approach

Targeting new cancers: SNAP-CAR T cells are a platform technology that is being developed to be co-administered with tagged, tumor-specific antibodies to potentially target many different tumor types, including hematological malignancies and solid tumors.

GEAR-NK (CD38) Strategy

GEAR-NK (CD38) – The company’s 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.

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.

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.

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.

Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra Therapeutics

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. $COEP Opening Bell

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 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.

Coeptis Therapeutics Secures Exclusive Rights to Negotiate to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial Immuno-Oncology Treatment Strategies

Potential acquisition of VyGen-Bio would strengthen Coeptis’ oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform and companion diagnostic technologies

WEXFORD, Pa., March 29, 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 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.

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 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.

NEWS

MANAGEMENT

LEADERSHIP TEAM

Management has demonstrated a track record of acquiring and developing novel therapies.

Dave Mehalick

Dave Mehalick

Chairman, President and Chief Executive Officer

Mr. Mehalick is a successful executive with a career spanning over 30 years across a variety of industries including life sciences, technology, financial services, military contracting, entertainment, and consumer products. His career has allowed him deep immersion into all facets of executive management notably mergers and acquisitions, corporate finance, C- Suite management, product development and licensing, partnerships, product commercialization, and corporate communications. Mr. Mehalick has assisted and managed several organizations towards successful investor monetization across all aspects of company evolution resulting in billions of dollars in transactions and financings. Currently, Mr. Mehalick is our Chairman, Chief Executive Officer and President, and one of our co-founders. He has been involved in several companies in a variety of positions and functions prior to Coeptis spanning many different industries. Mr. Mehalick began his career in the financial services industry in the wealth management area before transitioning to investment banking in the early 2000’s. He held positions of Vice President and Senior Vice President at multiple firms notably First Union Capital Markets, Gruntal and Co. and Ferris Baker Watts. He then began working earnestly with companies to assist them in all aspects of growth. He was a founding partner in American Defense Systems, a military contractor designing lightweight antiballistic armor and hardening systems for transportation and solid structures. After procuring several military contracts, the company grew revenues to a point that they became public on the AMEX stock exchange. Throughout his career Mr. Mehalick was involved in numerous similar situations either in a management or consultant role to allow strong returns for shareholders via acquisitions or public strategies.

Brian Cogley

Brian Cogley

Chief Financial Officer

Brian Cogley is a senior-level financial executive with 15 years of experience in corporate finance and accounting across a variety of industries, including life sciences, pharmaceuticals, financial services, and manufacturing. Prior to joining Coeptis Therapeutics, Mr. Cogley was a Senior Manager in the Accounting Advisory practice at CFGI, LLC., where he served pharmaceutical and financial services clients in technical accounting implementations and execution. In this role, he led financial operations for client companies and successfully executed various financial projects while performing multiple interim management roles. Formerly, Mr. Cogley worked as the Vice President of Finance & Accounting at NexTier Bank, after holding previous roles as Global Cash Manager, Senior Accountant, Financial Analyst and Senior Audit Associate across the finance industry, including at KPMG, a “Big 4” accounting firm. In Mr. Cogley’s varied career experience, he developed expertise in financial planning, reporting and variance analysis, as well as in asset and liability management, handling cash, investments, derivatives and debt portfolios for efficient use of company funds. A forward-thinker with problem-solving skills and enthusiasm, Mr. Cogley’s leadership of teams has resulted in innovative thinking and tangible results. Mr. Cogley holds a bachelor’s degree in accounting and a Master of Business Administration with a concentration in finance from Duquesne University.

Christine Sheehy

Christine Sheehy

VP of Compliance and Corporate Secretary

Christine Sheehy is a pharmaceutical business leader with over 25 years of experience, including globally commercializing drug products and working in development of targeted therapeutics including cell and gene therapies. Ms. Sheehy was Senior Vice-President of Operations for Kadmon Pharmaceuticals, leading the global supply chain, distribution, and IT organizations. She was a founding employee of start-up pharmaceutical company Three Rivers Pharmaceuticals, which was acquired by Kadmon Pharmaceuticals in 2010. During that time, she launched branded and generic products in the U.S., leading the operational business. Globally, Ms. Sheehy has executed international supply and distribution partnerships in Europe and Asia. Prior to Three Rivers Pharmaceuticals, Ms. Sheehy held various roles ranging from business and finance consulting to financial management. Strategically minded, with a strong ability to understand all aspects of the business, her leadership skills have been developed by working substantially in start-ups and early-stage companies. Additionally, over the past 15 years Ms. Sheehy has held board of director and advisory positions for multiple industry organizations, and she holds a bachelor’s degree in accounting from Penn State University.­­­­

Dan Yerace

Dan Yerace

Director and Vice President of Operations

Dan Yerace is a co-founder of Coeptis Pharmaceuticals and serves as the Vice President of Operations. Mr. Yerace has over ten years of experience in the pharmaceutical industry and is a key strategist responsible for supply chain management, business development, portfolio management, and corporate strategy. Mr. Yerace has broad operational experience and has held leadership positions in procurement, global supply chain management, operations, and business development for small private firms and fortune 500 multi-national corporations. Prior to joining Coeptis, Mr. Yerace served as Senior Director of Global Supply Chain and Commercial Business Development for Kadmon Pharmaceuticals. Mr. Yerace holds a bachelor’s degree in economics, and a masters of business administration from Waynesburg University.

Sincerely,

MICROCAPDAILY

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