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Coeptis Therapeutics Secures Worldwide Development and Commercialization Rights to Next-Generation GEAR™ Cell Therapy Platform Strengthening its High-Impact Precision Immuno-Oncology Pipeline

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Coeptis Therapeutics (NASDAQ: COEP) has secured exclusive worldwide rights to develop and commercialize the GEAR™ (Gene Edited Antibody Resistant) Cell Therapy Platform, expanding from its previous co-development rights. The company has formed GEAR Therapeutics, a majority-owned subsidiary, to advance GEAR-modified natural killer cells (GEAR-NK) into human trials.

The GEAR-NK technology represents a novel cancer treatment approach, allowing modified NK cells to be used alongside monoclonal antibodies (mAbs) without being neutralized - a common limitation in current treatments. The platform also shows potential for modifying hematopoietic stem cells to improve bone marrow transplant outcomes in hematological malignancies.

The technology was licensed from VyGen-Bio, Inc., with research origins at Sweden's Karolinska Institutet. According to Dr. Evren Alici, COEP Scientific Advisory Board member, pre-clinical proof-of-concept data suggests GEAR-NK could reduce NK cell fratricide while improving clinical benefits in treatments like CD38 mAbs for multiple myeloma.

Coeptis Therapeutics (NASDAQ: COEP) ha ottenuto diritti esclusivi a livello mondiale per sviluppare e commercializzare la piattaforma di terapia cellulare GEAR™ (Gene Edited Antibody Resistant), ampliando i diritti di co-sviluppo precedentemente acquisiti. L'azienda ha creato GEAR Therapeutics, una sussidiaria a maggioranza controllata, per portare le cellule natural killer modificate GEAR (GEAR-NK) in sperimentazioni umane.

La tecnologia GEAR-NK rappresenta un nuovo approccio al trattamento del cancro, consentendo l'uso di cellule NK modificate insieme a anticorpi monoclonali (mAbs) senza essere neutralizzate, una limitazione comune nei trattamenti attuali. La piattaforma mostra anche potenziale per modificare le cellule staminali ematopoietiche per migliorare i risultati dei trapianti di midollo osseo nelle neoplasie ematologiche.

La tecnologia è stata concessa in licenza da VyGen-Bio, Inc., con origini di ricerca presso il Karolinska Institutet in Svezia. Secondo il Dr. Evren Alici, membro del Consiglio Scientifico di COEP, i dati preclinici di prova di concetto suggeriscono che GEAR-NK potrebbe ridurre la fratricidio delle cellule NK migliorando i benefici clinici in trattamenti come gli mAbs CD38 per il mieloma multiplo.

Coeptis Therapeutics (NASDAQ: COEP) ha obtenido derechos exclusivos a nivel mundial para desarrollar y comercializar la plataforma de terapia celular GEAR™ (Gene Edited Antibody Resistant), ampliando los derechos de co-desarrollo que tenía anteriormente. La compañía ha formado GEAR Therapeutics, una subsidiaria mayoritaria, para avanzar las células natural killer modificadas GEAR (GEAR-NK) a ensayos clínicos humanos.

La tecnología GEAR-NK representa un enfoque innovador para el tratamiento del cáncer, permitiendo que las células NK modificadas se utilicen junto con anticuerpos monoclonales (mAbs) sin ser neutralizadas, una limitación común en los tratamientos actuales. La plataforma también muestra potencial para modificar células madre hematopoyéticas para mejorar los resultados de los trasplantes de médula ósea en malignidades hematológicas.

La tecnología fue licenciada de VyGen-Bio, Inc., con orígenes de investigación en el Karolinska Institutet de Suecia. Según el Dr. Evren Alici, miembro del Consejo Asesor Científico de COEP, los datos preclínicos de prueba de concepto sugieren que GEAR-NK podría reducir la fratricida de células NK mientras mejora los beneficios clínicos en tratamientos como los mAbs CD38 para el mieloma múltiple.

Coeptis Therapeutics (NASDAQ: COEP)는 GEAR™ (Gene Edited Antibody Resistant) 세포 치료 플랫폼을 개발하고 상업화할 수 있는 전 세계 독점 권리를 확보하여 이전의 공동 개발 권리를 확장했습니다. 이 회사는 GEAR 수정 자연 살해 세포(GEAR-NK)를 인간 임상 시험으로 진전시키기 위해 대다수 소유 자회사인 GEAR Therapeutics를 설립했습니다.

GEAR-NK 기술은 수정된 NK 세포를 단일클론 항체(mAbs)와 함께 사용하면서도 중화되지 않도록 하는 혁신적인 암 치료 접근 방식을 나타냅니다. 이는 현재 치료에서 흔히 발생하는 제한 사항입니다. 이 플랫폼은 또한 혈액 종양에서 골수 이식 결과를 개선하기 위해 조혈모세포를 수정할 수 있는 잠재력을 보여줍니다.

이 기술은 스웨덴의 카롤린스카 연구소에서 연구된 내용을 바탕으로 VyGen-Bio, Inc.로부터 라이선스를 받았습니다. COEP 과학 자문 위원회 위원인 Evren Alici 박사에 따르면, 전임상 개념 증명 데이터는 GEAR-NK가 NK 세포의 형제살해를 줄이고 다발성 골수종에 대한 CD38 mAbs와 같은 치료에서 임상적 이점을 개선할 수 있음을 시사합니다.

Coeptis Therapeutics (NASDAQ: COEP) a obtenu des droits exclusifs mondiaux pour développer et commercialiser la plateforme de thérapie cellulaire GEAR™ (Gene Edited Antibody Resistant), élargissant ainsi ses droits de co-développement précédents. L'entreprise a créé GEAR Therapeutics, une filiale majoritaire, pour faire avancer les cellules tueuses naturelles modifiées GEAR (GEAR-NK) vers des essais cliniques humains.

La technologie GEAR-NK représente une approche novatrice du traitement du cancer, permettant l'utilisation de cellules NK modifiées aux côtés d'anticorps monoclonaux (mAbs) sans être neutralisées, une limitation courante dans les traitements actuels. La plateforme montre également un potentiel pour modifier les cellules souches hématopoïétiques afin d'améliorer les résultats des greffes de moelle osseuse dans les malignités hématologiques.

La technologie a été licenciée par VyGen-Bio, Inc., avec des origines de recherche au Karolinska Institutet en Suède. Selon le Dr Evren Alici, membre du Conseil consultatif scientifique de COEP, les données précliniques de preuve de concept suggèrent que GEAR-NK pourrait réduire la fratricide des cellules NK tout en améliorant les bénéfices cliniques dans des traitements comme les mAbs CD38 pour le myélome multiple.

Coeptis Therapeutics (NASDAQ: COEP) hat sich exklusive weltweite Rechte zur Entwicklung und Vermarktung der GEAR™ (Gene Edited Antibody Resistant) Zelltherapieplattform gesichert und die zuvor bestehenden Co-Entwicklungsrechte ausgeweitet. Das Unternehmen hat GEAR Therapeutics gegründet, eine mehrheitlich im Besitz befindliche Tochtergesellschaft, um GEAR-modifizierte natürliche Killerzellen (GEAR-NK) in klinische Studien zu bringen.

Die GEAR-NK-Technologie stellt einen neuartigen Ansatz zur Krebsbehandlung dar, da sie die Verwendung modifizierter NK-Zellen zusammen mit monoklonalen Antikörpern (mAbs) ermöglicht, ohne dass diese neutralisiert werden - eine häufige Einschränkung bei aktuellen Behandlungen. Die Plattform zeigt auch Potenzial zur Modifikation von hämatopoetischen Stammzellen, um die Ergebnisse von Knochenmarktransplantationen bei hämatologischen Malignitäten zu verbessern.

Die Technologie wurde von VyGen-Bio, Inc. lizenziert, mit Forschungsursprüngen am Karolinska Institutet in Schweden. Laut Dr. Evren Alici, Mitglied des wissenschaftlichen Beratungsgremiums von COEP, deuten präklinische Machbarkeitsdaten darauf hin, dass GEAR-NK die Fratricide von NK-Zellen reduzieren und die klinischen Vorteile in Behandlungen wie CD38 mAbs für das multiple Myelom verbessern könnte.

Positive
  • Secured exclusive worldwide rights to GEAR platform, expanding from co-development rights
  • Pre-clinical proof-of-concept data shows promising results for GEAR-NK technology
  • Technology has potential applications in multiple cancer types and treatment modalities
  • Formation of majority-owned subsidiary GEAR Therapeutics to advance clinical development
Negative
  • Technology still in pre-clinical stage, requiring significant development before commercialization
  • No human trial data available yet to prove efficacy

Insights

Coeptis' acquisition of exclusive worldwide rights to the GEAR platform marks a substantial upgrade from their previous co-development position. This technology addresses a significant limitation in current cancer immunotherapies by creating antibody-resistant natural killer (NK) cells that can be administered alongside targeted monoclonal antibodies without being neutralized by them - a problem known as "fratricide" that has hampered combination approaches.

The GEAR-NK platform's mechanism is scientifically sound - by engineering NK cells to resist antibody-mediated depletion while preserving their cancer-killing functions, it potentially enhances the efficacy of existing therapies like CD38-targeting antibodies used in multiple myeloma. The creation of a dedicated subsidiary (GEAR Therapeutics) indicates a structured approach to development.

The technology's validation from researchers at Karolinska Institutet, home to the Nobel Assembly, adds significant credibility. While still pre-clinical, this platform could potentially address multiple hematologic malignancies with applications extending to solid tumors and modified hematopoietic stem cells for improving bone marrow transplants.

The main technical challenge ahead will be translating these modifications into clinically effective therapies that maintain safety profiles while demonstrating improved outcomes compared to existing standards of care. The path from promising preclinical data to successful human studies remains the critical next step.

For a microcap biotech with $35.5 million market capitalization, securing exclusive worldwide commercialization rights to this platform significantly enhances Coeptis' intellectual property portfolio and potential future revenue streams. This transaction transforms their position from participant to controlling owner in what appears to be a promising oncology technology.

The formation of GEAR Therapeutics as a majority-owned subsidiary creates a focused vehicle for development while potentially opening doors for targeted investment or partnership opportunities specific to this technology. This structure also provides flexibility for future financing or partial monetization while maintaining strategic control.

While the announcement lacks disclosure of financial terms or capital requirements for advancing to human trials, the expanded rights create multiple potential value-driving catalysts as the platform progresses. The technology's versatility across multiple cancer indications and potential therapeutic approaches (NK cells, hematopoietic stem cells) expands the addressable market opportunity substantially.

The association with Sweden's Karolinska Institutet adds institutional credibility that could be valuable for attracting development partners. For investors, this represents a meaningful expansion of Coeptis' technological foundations and commercial potential, though balanced against the standard risks of early-stage oncology development where human proof-of-concept data remains to be generated.

COEP forms GEAR Therapeutics, as a majority-owned subsidiary, to advance GEAR-modified natural killer (NK) cells into first-in-human studies for broad range of cancers and other therapeutic modalities.

WEXFORD, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- COEPTIS, Inc. (Nasdaq: COEP) ("the Company" or "Coeptis"), a pioneering technology firm at the forefront of innovative biotechnology solutions today announced it has successfully licensed exclusive worldwide development and commercialization rights to the GEAR™ (Gene Edited Antibody Resistant) Cell Therapy Platform, representing a first-in-class approach to modifying potent cancer-targeting immune cells to optimize the likelihood of deep remission in patients with hematologic malignancies and other cancers. Coeptis had previously held limited co-development rights to GEAR. As part of this exclusive GEAR license agreement with VyGen-Bio, Inc., Coeptis has formed a new majority-owned subsidiary, GEAR Therapeutics, Inc., with the mission to advance GEAR-based cell therapy towards human proof-of-concept studies to initially evaluate GEAR-modified natural killer cells (GEAR-NK) for the treatment of a broad range of cancers and other therapeutic modalities.

How Is GEAR-NK Expected to Enhance Current Blood Cancer Treatments?
Gene-Edited Antibody Resistant NK cells (GEAR-NK) are being developed as novel cancer strategy to allow for modified NK cells to be co-administered with targeted monoclonal antibodies (“mAbs”), which in the absence of the GEAR-NK would otherwise be neutralized/eradicated by mAb therapy due to a common receptor shared by both malignant cells and NK cells. GEAR-NK represents a combination cancer therapy with the potential for significantly improved outcomes for patients. The GEAR platform also holds the potential 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.

According to COEP Scientific Advisory Board member, Evren Alici, M.D., Ph.D., “GEAR-based immunotherapy represents a differentiated approach to potentially optimize and enhance current antibody-based cancer therapy, such as CD38 mAbs for the treatment of multiple myeloma. By leveraging specific sites, we aim to enable GEAR-modified immune cells, NK cells in this instance, to be co-administered in combination with antibodies in a manner that largely avoids undesired ‘on target/off tumor effects’ on a plethora of combination or retargeting therapies. The encouraging pre-clinical proof-of-concept data lead us to believe a GEAR-NK strategy holds the potential to advantageously eliminate or reduce the risk of NK cell fratricide while improving clinical benefit.” Dr. Alici serves as head of the cell & gene therapy group at Sweden’s renowned Karolinska Institutet.

Dave Mehalick, CEO of COEPTIS, expressed excitement, saying, “This expanded ownership of the GEAR technology is a major achievement for COEPTIS. The market potential of GEAR is extensive and is driven by therapeutic need. GEAR, integrated into our allogeneic cellular immunotherapy platform, has the potential to provide a beneficial, cost-effective therapeutic option available to all patients in need.”

About VyGen-Bio, Inc.
With operations in Florida, USA and Stockholm, Sweden, VyGen-Bio is a majority-owned subsidiary of Vycellix, Inc (www.Vycellix.com). The Company’s platforms were discovered by research scientists based at the Cell & Gene Therapy Group at Karolinska Institutet (KI), Sweden. Additionally, VyGen-Bio is a member-partner in “NextGenNK”, the 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. Website: www.VyGen-Bio.com

About COEPTIS, Inc.
COEPTIS, Inc., together with its subsidiaries Coeptis Pharmaceuticals, Inc., GEAR Therapeutics, Inc., SNAP Biosciences, Inc., and Coeptis Technologies (collectively "Coeptis"), is a biopharmaceutical and technology company. The biopharmaceutical divisions focus on developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases. Coeptis aims to advance treatment paradigms and improve patient outcomes through its cutting-edge research and development efforts.

The Company's therapeutic portfolio is underscored by assets licensed from Deverra Therapeutics, which include an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage, unmodified natural killer cell therapy technology. COEPTIS is also developing a universal, multi-antigen CAR technology licensed from the University of Pittsburgh (SNAP-CAR), alongside GEAR cell therapy and companion diagnostic platforms in collaboration with VyGen-Bio and distinguished medical researchers at the Karolinska Institute.

Building on its core competencies, COEPTIS has recently established a Technology Division, which focuses on enhancing operational capabilities through advanced technologies. This division features AI-powered marketing software and robotic process automation tools acquired from NexGenAI Solutions Group, designed to optimize business processes and improve overall efficiency.

Headquartered in Wexford, PA, COEPTIS is dedicated to advancing its mission within the regulatory framework set forth by the FDA, ensuring that all activities align with the highest standards of compliance and patient care. For more information on COEPTIS, visit https://coeptistx.com

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 Capital Market; (2) the inability to recognize the anticipated benefits of the Deverra licensed assets, 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; (3) the risks that the Company's products in development or the newly-licensed assets fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (4) costs related to ongoing asset development including the Deverra licensed assets and pursuing the contemplated asset development paths; (5) changes in applicable laws or regulations; (6) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (7) 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
IR@coeptistx.com


FAQ

What is the significance of Coeptis (COEP) acquiring worldwide rights to the GEAR platform?

COEP has expanded from co-development rights to exclusive worldwide development and commercialization rights for GEAR technology, enabling broader development of cancer treatments through their new subsidiary GEAR Therapeutics.

How does the GEAR-NK cell therapy technology work in cancer treatment?

GEAR-NK allows modified natural killer cells to be used alongside monoclonal antibodies without being neutralized, potentially improving cancer treatment outcomes by avoiding 'on target/off tumor effects'.

What cancers will COEP's GEAR-NK cell therapy target?

GEAR-NK is being developed for a broad range of cancers, with initial focus on hematologic malignancies, including multiple myeloma where it can be combined with CD38 monoclonal antibodies.

What are the potential applications of COEP's GEAR platform beyond NK cells?

The GEAR platform can potentially modify hematopoietic stem cells (HSCs) to improve bone marrow transplant outcomes in various blood cancers.
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