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Astellas and Poseida Therapeutics Enter Into Research Collaboration and License Agreement to Develop Novel Allogeneic Cell Therapies in Oncology

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Astellas Pharma Inc. and Poseida Therapeutics, Inc. have entered into a research collaboration and license agreement to develop novel allogeneic CAR-T cell therapies in oncology. The partnership will leverage Poseida's proprietary allogeneic CAR-T platform and Xyphos' ACCELTM technology to create innovative convertibleCAR® programs targeting solid tumors. Under the agreement, Xyphos will reimburse Poseida for research costs and be responsible for product development and commercialization. Poseida will receive an upfront payment of US $50 million, with potential milestone and contingency payments totaling up to US $550 million, along with tiered royalties. The collaboration aims to address unmet medical needs in oncology and expand Astellas' portfolio with cutting-edge CAR-T cell therapies.

Astellas Pharma Inc. e Poseida Therapeutics, Inc. hanno stipulato una collaborazione di ricerca e un accordo di licenza per sviluppare nuove terapie con cellule CAR-T allogene in oncologia. La partnership sfrutterà la piattaforma allogenica CAR-T di Poseida e la tecnologia ACCELTM di Xyphos per creare programmi innovativi convertibleCAR® mirati ai tumori solidi. Secondo l'accordo, Xyphos rimborserà a Poseida i costi di ricerca e sarà responsabile dello sviluppo e della commercializzazione del prodotto. Poseida riceverà un pagamento anticipato di 50 milioni di dollari USA, con pagamenti potenziali per milestone e contingenti che possono arrivare fino a 550 milioni di dollari USA, oltre a royalty scalari. La collaborazione mira a rispondere alle esigenze mediche non soddisfatte in oncologia e ad ampliare il portafoglio di Astellas con terapie CAR-T all'avanguardia.
Astellas Pharma Inc. y Poseida Therapeutics, Inc. han establecido una colaboración de investigación y un acuerdo de licencia para desarrollar nuevas terapias de células CAR-T alogénicas en oncología. La asociación aprovechará la plataforma CAR-T alogénica de Poseida y la tecnología ACCELTM de Xyphos para crear programas convertibleCAR® innovadores que se dirigirán a tumores sólidos. Según el acuerdo, Xyphos reembolsará los costos de investigación a Poseida y será responsable del desarrollo y comercialización del producto. Poseida recibirá un pago inicial de 50 millones de dólares estadounidenses, con pagos potenciales por hitos y contingencias que pueden totalizar hasta 550 millones de dólares estadounidenses, además de regalías escalonadas. La colaboración busca abordar necesidades médicas no cubiertas en oncología y expandir la cartera de Astellas con terapias de células CAR-T de vanguardia.
Astellas Pharma Inc.와 Poseida Therapeutics, Inc.는 종양학 분야에서 새로운 동종 CAR-T 세포 치료제를 개발하기 위한 연구 협력 및 라이센스 계약을 체결했습니다. 이 파트너십은 Poseida의 독점적 동종 CAR-T 플랫폼과 Xyphos의 ACCELTM 기술을 활용하여 고형 종양을 대상으로 하는 혁신적인 convertibleCAR® 프로그램을 만들 것입니다. 계약에 따라 Xyphos는 Poseida에 연구 비용을 환급하고 제품 개발 및 상용화를 담당하게 됩니다. Poseida는 선급금으로 5천만 달러를 받게 되며, 가능한 이정표 및 조건부 지불로 최대 5억 5천만 달러를 받을 수 있으며, 단계적으로 로열티를 받게 됩니다. 이 협력은 종양학에서 충족되지 않은 의료 필요를 해결하고 최첨단 CAR-T 세포 치료법으로 Astellas의 포트폴리오를 확장할 것을 목표로 합니다.
Astellas Pharma Inc. et Poseida Therapeutics, Inc. ont conclu une collaboration de recherche et un accord de licence pour développer de nouvelles thérapies allogéniques de cellules CAR-T en oncologie. Le partenariat exploitera la plateforme CAR-T allogénique propriétaire de Poseida et la technologie ACCELTM de Xyphos pour créer des programmes innovants de convertibleCAR® ciblant les tumeurs solides. Selon l'accord, Xyphos remboursera à Poseida les coûts de recherche et sera responsable du développement et de la commercialisation du produit. Poseida recevra un paiement initial de 50 millions de dollars américains, avec des paiements éventuels basés sur des étapes clés pouvant atteindre jusqu'à 550 millions de dollars américains, ainsi que des royalties échelonnées. La collaboration vise à répondre aux besoins médicaux non satisfaits en oncologie et à enrichir le portefeuille d'Astellas avec des thérapies de cellules CAR-T de pointe.
Astellas Pharma Inc. und Poseida Therapeutics, Inc. haben eine Forschungskooperation und Lizenzvereinbarung abgeschlossen, um neue allogene CAR-T-Zelltherapien in der Onkologie zu entwickeln. Die Partnerschaft wird Poseidas proprietäre allogene CAR-T-Plattform und Xyphos' ACCELTM-Technologie nutzen, um innovative convertibleCAR® Programme für solide Tumoren zu entwickeln. Laut Vereinbarung wird Xyphos die Forschungskosten von Poseida erstatten und für die Produktentwicklung und Vermarktung verantwortlich sein. Poseida erhält eine Vorauszahlung von 50 Millionen US-Dollar, mit möglichen Meilenstein- und Eventualzahlungen, die sich auf bis zu 550 Millionen US-Dollar belaufen können, sowie gestaffelte Lizenzgebühren. Die Zusammenarbeit zielt darauf ab, ungedeckte medizinische Bedürfnisse in der Onkologie zu adressieren und Astellas' Portfolio mit bahnbrechenden CAR-T-Zelltherapien zu erweitern.
Positive
  • The collaboration between Astellas Pharma Inc. and Poseida Therapeutics, Inc. to develop novel allogeneic CAR-T cell therapies in oncology showcases a commitment to advancing cancer treatments and addressing unmet medical needs.

  • The partnership aims to leverage Poseida's proprietary allogeneic CAR-T platform and Xyphos' ACCELTM technology to develop innovative convertibleCAR® programs targeting solid tumors, demonstrating a focus on cutting-edge research and technology.

  • Under the agreement, Xyphos will cover research costs, oversee product development, and handle future commercialization, highlighting a collaborative effort to bring new therapies to market.

  • As part of the collaboration, Poseida will receive an upfront payment of US $50 million, with the potential for milestone and contingency payments totaling up to US $550 million, as well as tiered royalties, showcasing the economic value of Poseida's technologies.

Negative
  • While the collaboration between Astellas Pharma Inc. and Poseida Therapeutics, Inc. shows promise in advancing cancer treatments, there may be risks involved in the development and commercialization of innovative convertibleCAR® programs, with potential challenges in clinical trials, regulatory approvals, and market acceptance.

  • The financial commitments involved in the agreement, including upfront, milestone, and royalty payments, could impact the financial outlook of both companies, potentially leading to increased expenses or dilution for shareholders.

- Leverages Poseida's proprietary allogeneic CAR-T platform to develop innovative convertibleCAR® programs targeting solid tumors -

TOKYO and SAN DIEGO, May 1, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Poseida Therapeutics, Inc. (NASDAQ: PSTX, President and CEO: Kristin Yarema, "Poseida") today announced that Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and Poseida have entered into a research collaboration and license agreement to develop novel convertibleCAR® programs by combining the innovative cell therapy platforms from each of the companies.

Poseida is advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. In oncology, its pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors that address patient populations with high unmet medical need. Xyphos utilizes a novel and proprietary ACCELTM technology*1 platform that uses its convertibleCAR® (convertible Chimeric Antigen Receptor)*1 in combination with proprietary MicAbodies*1 to target tumor cells.

Under the terms of the agreement, the companies plan to combine Poseida's proprietary allogeneic CAR-T platform with Xyphos' ACCELTM technology to create one Poseida-developed CAR-T construct to form the basis of two convertibleCAR® product candidates targeting solid tumors. Xyphos will reimburse Poseida for costs incurred as part of the research agreement and will be responsible for the development and future commercialization of products generated from the collaboration. Poseida will receive US $50 million upfront plus potential development and sales milestones and contingency payments of up to US $550 million in total. Additionally, Poseida is eligible for up to low double digit tiered royalties as a percentage of net sales.

Kristin Yarema, Ph.D., President and CEO of Poseida
"We are excited to expand our relationship with Astellas, where we share a vision that cutting edge, off the shelf cell therapies can address significant unmet needs of patients with solid tumor malignancies. Today's agreement further reinforces the economic value of Poseida's highly differentiated non-viral technologies and enables development in areas beyond our core pipeline focus. It also highlights Poseida's role as the partner of choice in allogeneic CAR-T."

Adam Pearson, Chief Strategy Officer (CStO) of Astellas
"At Astellas, we have a strong commitment to developing novel treatments for patients with cancer and have positioned Immuno-Oncology as a Primary Focus of our R&D strategy*2. By leveraging our extensive expertise, experience in cancer biology and unique technologies, we are focused on reinvigorating the immune system's ability to discover, disarm and destroy cancers in more patients. By combining the ACCELTM platform with Poseida's elegant and cutting-edge genetic editing platforms, we believe the collaboration will bring synergies between the two companies' breakthrough research and will ultimately lead to expansion of Astellas' portfolio and to delivery of innovative CAR-T cell therapies to cancer patients."

In August 2023, Astellas and Poseida announced a strategic investment by Astellas to support Poseida's commitment to redefining cancer cell therapy.

*1 ACCELTM technology and convertibleCAR®: ACCELTM technology is based on a synthetic biology approach that utilizes the binding of an engineered protein ligand to an orthogonal engineered receptor which forms the extracellular domain of a convertible CAR (chimeric antigen receptor). The convertibleCAR® is targeted to tumor cells with a tumor-associated antigen-specific engineered antibody-like molecule (MicAbody) containing the engineered ligand. For more information, please visit http://www.xyphosinc.com

*2: Astellas has established a Focus Area Approach for its research and development strategy. For more information, please visit our website at Areas of Interest | Astellas Pharma Inc.

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.

About Xyphos Biosciences, Inc., an Astellas Company
Xyphos Biosciences, Inc., located at South San Francisco, Calif., is a wholly owned subsidiary of Astellas featuring ACCELTM technology, a CAR (chimeric antigen receptor) technology platform for immune cell therapies. Xyphos Biosciences was launched in 2017, and the Company was acquired by Astellas Pharma in December of 2019. For more information about the company, please visit www.xyphosinc.com.

About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell therapies and genetic medicines with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for both solid tumors and hematologic cancers as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed a global strategic collaboration with Roche to unlock the promise of cell therapies for patients with hematologic malignancies. Learn more at www.poseida.com and connect with Poseida on X and LinkedIn.

Cautionary Notes (Astellas)
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

Forward-Looking Statements (Poseida)
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. Such forward-looking statements include statements regarding, among other things, the upfront payment and other potential fees, reimbursements, milestone, and royalty payments and research development activities under the collaboration agreement, the potential benefits of Poseida's relationship with Astellas and Xyphos; the quotes from Dr. Yarema and Mr. Pearson; the potential capabilities and benefits of Poseida's technology platforms and product candidates; and Poseida's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the fact that the collaboration agreement may be terminated early; the fact that Poseida will have limited control over the efforts and resources that Astellas or Xyphos devote to advancing development programs under the collaboration agreement, and Poseida may not receive the potential fees and payments under the collaboration agreement or fully realize the benefits of the collaboration; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-and-poseida-therapeutics-enter-into-research-collaboration-and-license-agreement-to-develop-novel-allogeneic-cell-therapies-in-oncology-302133127.html

SOURCE Poseida Therapeutics, Inc.

FAQ

What is the collaboration between Astellas Pharma Inc. and Poseida Therapeutics, Inc. about?

The collaboration aims to develop novel allogeneic CAR-T cell therapies in oncology.

What technology will be used in the collaboration?

The partnership will leverage Poseida's proprietary allogeneic CAR-T platform and Xyphos' ACCELTM technology to create convertibleCAR® programs targeting solid tumors.

What is the upfront payment Poseida will receive under the agreement?

Poseida will receive a US $50 million upfront payment as part of the collaboration.

What are the potential payments Poseida may receive from the collaboration?

Poseida is eligible for potential milestone and contingency payments totaling up to US $550 million, along with tiered royalties based on net sales.

Poseida Therapeutics, Inc.

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poseida therapeutics, inc. is currently developing car-t and gene therapy products for cancer and orphan diseases. spinout of transposagen biopharmaceuticals early this year, poseida is also collaborating with j&j’s janssen to develop allogeneic car-t therapies against cancer. poseida boasts best-in-class genome engineering capabilities for effectively silencing target genes or inserting therapeutic genes and/or technologies. proprietary tools include piggybac™ dna modification system, nextgen™ crispr, xtn™ talen and footprint-free™ gene editing system, which are clean (synthetic and virus-free) and can be surgically precise. poseida aims to shuttle the first car-t and gene therapy product candidates into phase i clinical trials in early 2016. poseida is now hiring and searching for ambitious and motivated scientists desiring a fast-paced work environment with diverse research opportunities in the field of cellular and gene therapy.