Gilead and Tubulis Enter Into Exclusive Option and License Agreement to Develop ADC Candidate for Select Solid Tumor Target
Gilead Sciences (GILD) and Tubulis have entered into an exclusive option and license agreement to develop an antibody-drug conjugate (ADC) for solid tumors. The collaboration leverages Tubulis' Tubutecan and Alco5 platforms to create a Topoisomerase I inhibitor-based ADC candidate. Gilead will pay $20 million upfront and a potential $30 million option exercise fee. Additional development and commercialization milestones could reach $415 million, plus mid-single to low double-digit royalties. Tubulis will lead early-stage R&D, while Gilead will handle development and commercialization if they exercise their option.
Gilead Sciences (GILD) e Tubulis hanno stipulato un accordo esclusivo di opzione e licenza per sviluppare un coniugato anticorpo-farmaco (ADC) per tumori solidi. La collaborazione sfrutta le piattaforme Tubutecan e Alco5 di Tubulis per creare un candidato ADC basato su un inibitore della Topoisomerasi I. Gilead pagherà 20 milioni di dollari in anticipo e una potenziale commissione di esercizio dell'opzione di 30 milioni di dollari. Ulteriori traguardi nello sviluppo e nella commercializzazione potrebbero raggiungere 415 milioni di dollari, oltre a royalties che vanno dal medio singolo a basse cifre a due cifre. Tubulis guiderà la ricerca e sviluppo nelle fasi iniziali, mentre Gilead gestirà lo sviluppo e la commercializzazione se eserciteranno la loro opzione.
Gilead Sciences (GILD) y Tubulis han firmado un acuerdo exclusivo de opción y licencia para desarrollar un conjugado de anticuerpo-fármaco (ADC) para tumores sólidos. La colaboración aprovecha las plataformas Tubutecan y Alco5 de Tubulis para crear un candidato a ADC basado en un inhibidor de la Topoisomerasa I. Gilead pagará 20 millones de dólares por adelantado y una posible comisión de ejercicio de opción de 30 millones de dólares. Los hitos adicionales de desarrollo y comercialización podrían alcanzar 415 millones de dólares, además de regalías que oscilan entre un solo dígito medio y un bajo dígito doble. Tubulis liderará la I+D en las etapas iniciales, mientras que Gilead se encargará del desarrollo y la comercialización si ejercen su opción.
길리어드 사이언스(GILD)와 튜불리스가 고형 종양을 위한 항체-약물 접합체(ADC)를 개발하기 위한 독점 옵션 및 라이센스 계약을 체결했습니다. 이 협력은 튜불리스를 위한 Tubutecan 및 Alco5 플랫폼을 활용하여 Topoisomerase I 억제제 기반의 ADC 후보를 생성합니다. 길리어드는 선불로 2천만 달러를 지불할 것입니다 그리고 3천만 달러의 옵션 행사 수수료가 발생할 수 있습니다. 추가 개발 및 상업화 이정표는 4억 1천5백만 달러에 이를 수 있으며, 중간 단일에서 낮은 두 자릿수 로열티가 포함됩니다. 튜불리스는 초기 연구 개발을 이끌고, 길리어드는 그들이 옵션을 행사할 경우 개발과 상업화를 처리할 것입니다.
Gilead Sciences (GILD) et Tubulis ont conclu un accord exclusif d'option et de licence pour développer un conjugé anticorps-médicament (ADC) destiné aux tumeurs solides. La collaboration s'appuie sur les plateformes Tubutecan et Alco5 de Tubulis pour créer un candidat ADC basé sur un inhibiteur de la topoisomérase I. Gilead paiera 20 millions de dollars à l'avance et une potentielle frais d'exercice d'option de 30 millions de dollars. Des étapes supplémentaires de développement et de commercialisation pourraient atteindre 415 millions de dollars, plus des redevances au taux qui varie du simple chiffre médian à un faible chiffre double. Tubulis dirigera la recherche et le développement au stade précoce, tandis que Gilead s'occupera du développement et de la commercialisation s'ils exercent leur option.
Gilead Sciences (GILD) und Tubulis haben eine exklusive Options- und Lizenzvereinbarung zur Entwicklung eines Antikörper-Arzneimittel-Konjugats (ADC) für solide Tumoren getroffen. Die Zusammenarbeit nutzt die Tubutecan- und Alco5-Plattformen von Tubulis, um einen ADC-Kandidaten auf Basis eines Topoisomerase-I-Inhibitors zu schaffen. Gilead wird 20 Millionen Dollar im Voraus zahlen und eine mögliche Optionsausübung gebühr von 30 Millionen Dollar. Weitere Entwicklungs- und Vermarktungsmeilensteine könnten bis zu 415 Millionen Dollar erreichen, zuzüglich Lizenzgebühren im mittleren einstelligen bis niedrigen zweistelligen Bereich. Tubulis wird die frühe Forschung und Entwicklung leiten, während Gilead die Entwicklung und Kommerzialisierung übernimmt, wenn sie ihre Option ausüben.
- Strategic expansion into ADC technology through partnership with minimal initial investment ($20M upfront)
- Access to proprietary Tubutecan and Alco5 platforms for solid tumor treatment
- Risk-mitigated deal structure with option to license after early development
- Expected reduction in 2024 GAAP and non-GAAP EPS by $0.01
- Substantial future payment obligations if option exercised ($445M + royalties)
Insights
This strategic collaboration represents a calculated move into the high-growth ADC market. The deal structure is financially prudent with
The ADC market is experiencing rapid growth, with analysts projecting it to reach
The collaboration targets a significant unmet need in solid tumors using Tubulis' Tubutecan and Alco5 platforms. Their focus on Topoisomerase I inhibitor-based ADCs with enhanced stability and reduced off-target toxicity addresses key challenges in current ADC therapeutics. This approach could potentially overcome the limitations of existing ADCs, particularly regarding the therapeutic window and durability of response.
The technology combination looks promising - Tubulis' expertise in ADC design paired with Gilead's development capabilities could accelerate the path to clinic. The emphasis on superior biophysical properties suggests potential for best-in-class efficacy.
– Single-Asset Focused Collaboration, License, and Option Agreement Combines Tubulis’ Differentiated ADC Platform Technologies with Gilead’s Oncology Research and Development Expertise –
– Agreement Provides Gilead with Exclusive Option to License the Resulting ADC Program for Further Development –
Through this agreement, Gilead will gain access to Tubulis’ proprietary Tubutecan and Alco5 platforms. The companies will collaborate to select the best technology to utilize, with Tubulis leading discovery and development efforts to design a Topoisomerase I inhibitor-based ADC candidate with superior biophysical properties and stability to address current treatment challenges such as durability and off-target toxicity.
“As we expand our oncology portfolio to address the greatest gaps in care, accessing novel technologies is critical to advancing our pipeline,” said Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences. “With Gilead’s ongoing focus on innovating with next-generation therapies and combinations, we are excited to partner with Tubulis to explore a range of solutions that may help increase the therapeutic value of the ADC modality.”
“Gilead has established a long track record of developing drugs that provide a significant step-up in therapeutic value, making them a great collaborator for leveraging our technology platforms, in line with our vision of fundamentally changing the ADC landscape,” said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. “Tubulis remains primarily focused on driving value through our own clinical development programs while selectively building partnerships with leaders in the industry.”
Terms of the Agreement
Under the terms of the agreement, Tubulis will receive an upfront payment of
Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Tubulis is expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in
About Tubulis
Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. Our first NaPi2b-targeting program, TUB-040, is being evaluated in the clinic in ovarian and non-small cell lung cancer. The second candidate from our growing pipeline, TUB-030, targeting 5T4, is set to follow imminently. We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead’s earnings; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving programs developed pursuant to the collaboration; the ability of the parties to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all for the investigational programs developed pursuant to the collaboration, and the risk that any such approvals may be subject to significant limitations on use; the possibility that the parties may make a strategic decision to discontinue development of any of the investigational programs developed pursuant to the collaboration, and therefore these programs may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The Tubulis name and logo are trademarks of Tubulis.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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Tubulis Info
Dominik Schumacher, CEO & Co-Founder
Phone: + 49 (0) 175 800 5594
Email: contact@tubulis.com
Media Requests for Tubulis
Trophic Communications
Stephanie May, PhD
Phone: +49 (0) 171 185 56 82
Email: tubulis@trophic.eu
Gilead Info
Jessica Smith, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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