Servier and Black Diamond Therapeutics Announce Global Licensing Agreement for BDTX-4933, A Targeted Oncology Therapy
Servier and Black Diamond Therapeutics (BDTX) have entered into a global licensing agreement for BDTX-4933, a Phase 1 targeted oncology therapy. The deal includes a $70 million upfront payment to Black Diamond, with potential additional payments of up to $710 million in development and commercial milestones, plus tiered royalties.
BDTX-4933 is designed as a potential best-in-class treatment targeting both RAS mutations and RAF alterations in solid tumors, including non-small cell lung cancer (NSCLC). The drug is currently in Phase 1 development, evaluating safety, tolerability, and antitumor activity in patients with recurrent advanced/metastatic cancers harboring BRAF, CRAF, or NRAS mutations.
Under the agreement, Servier will lead global development activities and commercialization of BDTX-4933 across multiple indications.
Servier e Black Diamond Therapeutics (BDTX) hanno stipulato un accordo di licenza globale per BDTX-4933, una terapia oncologica mirata in fase 1. L'accordo prevede un pagamento iniziale di 70 milioni di dollari a Black Diamond, con ulteriori pagamenti potenziali fino a 710 milioni di dollari legati a traguardi di sviluppo e commercializzazione, oltre a royalties scaglionate.
BDTX-4933 è progettato come un potenziale trattamento di punta mirato sia alle mutazioni RAS che alle alterazioni RAF nei tumori solidi, inclusa la carcinoma polmonare non a piccole cellule (NSCLC). Il farmaco è attualmente in fase 1 di sviluppo, valutando sicurezza, tollerabilità e attività antitumorale in pazienti con tumori avanzati/metastatici ricorrenti che presentano mutazioni BRAF, CRAF o NRAS.
In base all'accordo, Servier guiderà le attività di sviluppo globale e commercializzazione di BDTX-4933 in diverse indicazioni.
Servier y Black Diamond Therapeutics (BDTX) han firmado un acuerdo de licencia global para BDTX-4933, una terapia oncológica dirigida en fase 1. El acuerdo incluye un pago inicial de 70 millones de dólares a Black Diamond, con pagos adicionales potenciales de hasta 710 millones de dólares en hitos de desarrollo y comercialización, además de regalías escalonadas.
BDTX-4933 está diseñado como un tratamiento potencial de primera clase que apunta tanto a las mutaciones RAS como a las alteraciones RAF en tumores sólidos, incluyendo el cáncer de pulmón no microcítico (NSCLC). El fármaco se encuentra actualmente en desarrollo de fase 1, evaluando la seguridad, la tolerabilidad y la actividad antitumoral en pacientes con cánceres avanzados/metastásicos recurrentes que presentan mutaciones BRAF, CRAF o NRAS.
Según el acuerdo, Servier liderará las actividades de desarrollo global y comercialización de BDTX-4933 en múltiples indicaciones.
Servier와 Black Diamond Therapeutics (BDTX)는 BDTX-4933에 대한 글로벌 라이선스 계약을 체결했습니다. 이는 1상 표적 종양학 치료제입니다. 이 계약에는 Black Diamond에 대한 7000만 달러의 선불 지급이 포함되며, 개발 및 상업적 이정표에 따라 최대 7억 1000만 달러의 추가 지급과 단계별 로열티가 포함됩니다.
BDTX-4933은 고형 종양, 특히 비소세포 폐암(NSCLC)에서 RAS 변이와 RAF 변이를 모두 표적으로 하는 잠재적인 최상의 치료제로 설계되었습니다. 이 약물은 현재 1상 개발 중으로, BRAF, CRAF 또는 NRAS 변이를 가진 재발성 고급/전이성 암 환자에서 안전성, 내약성 및 항종양 활성을 평가하고 있습니다.
계약에 따라 Servier는 여러 적응증에 걸쳐 BDTX-4933의 글로벌 개발 활동 및 상업화를 주도할 것입니다.
Servier et Black Diamond Therapeutics (BDTX) ont conclu un accord de licence mondial pour BDTX-4933, une thérapie oncologique ciblée de phase 1. L'accord comprend un paiement initial de 70 millions de dollars à Black Diamond, avec des paiements supplémentaires potentiels pouvant atteindre 710 millions de dollars en fonction des jalons de développement et de commercialisation, ainsi que des redevances échelonnées.
BDTX-4933 est conçu comme un traitement potentiel de référence ciblant à la fois les mutations RAS et les altérations RAF dans les tumeurs solides, y compris le cancer du poumon non à petites cellules (NSCLC). Le médicament est actuellement en développement de phase 1, évaluant la sécurité, la tolérance et l'activité antitumorale chez des patients atteints de cancers avancés/récidivants métastatiques portant des mutations BRAF, CRAF ou NRAS.
En vertu de l'accord, Servier dirigera les activités de développement mondial et la commercialisation de BDTX-4933 dans plusieurs indications.
Servier und Black Diamond Therapeutics (BDTX) haben eine globale Lizenzvereinbarung für BDTX-4933 getroffen, eine Phase-1-gezielte Onkologie-Therapie. Der Deal beinhaltet eine Vorauszahlung von 70 Millionen Dollar an Black Diamond, mit potenziellen zusätzlichen Zahlungen von bis zu 710 Millionen Dollar in Entwicklungs- und kommerziellen Meilensteinen sowie gestaffelten Lizenzgebühren.
BDTX-4933 ist als potenzielle erstklassige Behandlung konzipiert, die sowohl RAS-Mutationen als auch RAF-Änderungen in soliden Tumoren, einschließlich nicht-kleinzelligem Lungenkrebs (NSCLC), anspricht. Das Medikament befindet sich derzeit in der Phase-1-Entwicklung, in der Sicherheit, Verträglichkeit und antitumorale Aktivität bei Patienten mit rezidivierenden fortgeschrittenen/metastatischen Krebserkrankungen, die BRAF-, CRAF- oder NRAS-Mutationen aufweisen, bewertet werden.
Im Rahmen der Vereinbarung wird Servier die globalen Entwicklungsaktivitäten und die Vermarktung von BDTX-4933 in mehreren Indikationen leiten.
- Significant upfront payment of $70 million strengthens BDTX's cash position
- Potential for substantial additional revenue through $710 million in milestone payments
- Partnership with global pharmaceutical company enhances development and commercialization capabilities
- Ongoing royalty stream potential from global sales
- BDTX-4933 is still in early Phase 1 development with uncertain clinical outcomes
- Development and commercialization control transferred to Servier
Insights
The licensing agreement between Servier and Black Diamond Therapeutics represents a transformative financial event for BDTX. The
The potential
For a clinical-stage company with a
This partnership transforms Black Diamond's risk profile by providing capital strength, development support, and commercial validation while refocusing the company on their remaining pipeline candidates. The market cap to transaction value ratio makes this deal particularly noteworthy, as it suggests potential undervaluation of BDTX's remaining pipeline assets.
This licensing agreement centers on BDTX-4933, a potentially significant advancement in precision oncology targeting the critical RAS/RAF signaling pathway. RAS and RAF mutations drive approximately
Black Diamond's MasterKey approach represents an innovative strategy in oncology drug development. Rather than targeting just a single mutation, their platform aims to inhibit families of oncogenic mutations simultaneously. This could potentially address a major challenge in precision medicine—the heterogeneity of cancer mutations within and between patients.
BDTX-4933's mechanism targeting both RAS mutations and RAF alterations positions it uniquely in the competitive landscape. Most existing approved therapies target either specific BRAF mutations (like vemurafenib) or have activity against the broader RAS family. A drug effectively targeting both pathways could demonstrate wider clinical utility and potentially overcome some resistance mechanisms.
While still in Phase 1, the fact that dose expansion cohorts are already planned suggests encouraging initial safety data. The focus on multiple tumor types, especially non-small cell lung cancer, indicates confidence in the drug's mechanism across different cancer contexts. Servier's substantial investment validates the scientific approach, though clinical results will ultimately determine whether BDTX-4933 truly achieves the "best-in-class" potential described.
- The partnership underscores Servier’s commitment to developing targeted therapies that address unmet medical needs in oncology
- Servier will develop and commercialize BDTX-4933, a Phase 1 asset with best-in-class potential targeting both RAS mutations and RAF alterations, in solid tumors, including non-small cell lung cancer
- Black Diamond will receive an upfront payment of
$70 million and up to$710 million in development and commercial sales milestone payments
plus royalties
SURESNES, France and CAMBRIDGE, Mass., March 19, 2025 (GLOBE NEWSWIRE) -- Servier, an independent global pharmaceutical group governed by a non-profit foundation, and Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors. Under this global agreement, Servier will develop and commercialize BDTX-4933, a small molecule designed by Black Diamond Therapeutics to address unmet medical needs in RAF/RAS-mutant solid tumors.
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said Claude Bertrand, Executive Vice-President of R&D at Servier. “We look forward to accelerating the development of this therapy as a potential best-in-class treatment for cancer patients.”
“This agreement supports our mission to advance oral cancer therapies designed to give patients the opportunity for longer, healthier, and more active lives,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Servier’s commitment to innovation and deep expertise in oncology make it an ideal partner for Black Diamond as we work to develop breakthrough cancer treatments.”
Under the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including non-small cell lung cancer (NSCLC), with potential applications in other solid tumors. Black Diamond Therapeutics will receive an upfront payment of
Currently in Phase 1 development, BDTX-4933 is uniquely designed to target RAS and RAF alterations in solid tumors. The dose escalation and expansion cohort first-in-human study aims at evaluating safety and tolerability, the preliminary recommended Phase 2 dose, and antitumor activity of BDTX-4933 in adults with recurrent advanced/metastatic cancers harboring BRAF, CRAF, or NRAS mutations.
Servier Contact
For Media: presse@servier.com
Black Diamond Therapeutics Contacts
For Investors: investors@bdtx.com
For Media: media@bdtx.com
About Servier
Servier is a global pharmaceutical group governed by a non-profit Foundation that aspires to make a meaningful social impact for patients and for a sustainable world. The Group’s unique governance model preserves its independence while prioritizing long-term innovation for patients by reinvesting
As a world leader in cardiometabolism and venous diseases, Servier brings transformative innovation in chronic diseases thanks to its holistic approach, making patient adherence a global priority. With the ambition of becoming a leading player in the field of rare cancers, Servier deeply invest in oncology and devotes close to
Headquartered in France, Servier medicines are available in close to 140 countries. In 2023/2024, the Group which employs over 22,000 people worldwide, achieved sales revenue of
More information on: servier.com. Follow us on social media: LinkedIn, Facebook, Twitter, Instagram
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing a Phase 2 NSCLC trial of BDTX-1535, a brain-penetrant fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR-mutant NSCLC and glioblastoma.
For more information, please visit www.blackdiamondtherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the partnership with Servier and the intended and potential benefits thereof, including the receipt of potential milestone and royalty payments from commercial product sales, along with tiered royalties based on global net sales, if any; Servier’s ability to develop and commercialize BDTX-4933, including the ongoing Phase 1 clinical trial of BDTX-4933; and the potential of BDTX-4933 to address the unmet medical need for patients with RAF/RAS-mutant solid tumors, including NSCLC. Any forward-looking statements in this press release are based on Black Diamond’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in Black Diamond’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Black Diamond undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
FAQ
What is the value of the licensing deal between Servier and Black Diamond Therapeutics (BDTX)?
What type of cancer does BDTX-4933 target?
What is the current development stage of BDTX-4933?
Who will be responsible for developing and commercializing BDTX-4933?
