Partnering News: BioNTech, Kyowa Kirin, Sanofi & More 

A roundup of bio/pharmaceutical partnering news from BioNTech/Autolus Therapeutics, Kyowa Kirin/Bridge Bioscience, Sanofi/Graviton Bioscience, Merck & Co./Vector Institute, Rigel Pharmaceuticals/Blueprint Medicines and Pfizer/American Cancer Society.  

* BioNTech, Autolus Therapeutics in $250-M CAR T Therapy Pact 
* Kyowa Kirin, Bridge Bio in $100-M Pact for Rare Disease Skeletal Drug 
* Sanofi Takes Stake in Bio/Pharma Company Graviton Bioscience  
* Merck & Co., Vector Institute In AI Healthcare Pact 
* Rigel Pharma To Acquire Cancer Drug From Blueprint Medicines 
* Pfizer, American Cancer Society Partner for Cancer Patient Care

BioNTech, Autolus Therapeutics in $250-M CAR T Therapy Pact 
BioNTech, a Mainz, Germany-based bio/pharmaceutical company, and Autolus Therapeutics, a London-based bio/pharmaceutical company, have entered a strategic collaboration to advance both companies’ autologous CAR-T programs, in a deal worth up to $250 million ($50 million upfront and a $200-million equity stake in Autolus by BioNTech). In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement. 

BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement. BioNTech will have the right to appoint a director to the Board of Autolus. 

Under the  license and option agreement, BioNTech will make a cash payment of $50 million and is granted the following as outlined below.  

BioNTech is eligible to receive an up to mid-single digit royalties on net sales of obe-cel, Autolus’ lead CAR-T therapy for treating adult acute lymphoblastic leukemia. Autolus will retain full rights to and control of the development and commercialization of obe-cel.  

BioNTech has the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the UK, and commercial supply infrastructure for the development of BioNTech’s BNT211, BioNTech’s most advanced cell-therapy development program, in additional CLDN6+ tumor types. BioNTech says it plans to have 10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024, including its fully owned CLDN6 CAR-T program BNT211 in relapsed or refractory germ-cell tumors. 

Autolus will lead the development and commercialization of Autolus’ Auto1/2  for treating acute lymphoblastic leukemia, and Autolus’ Auto6NG, a solid-tumor CAR-T therapy, in any oncology indication, with BioNTech having an option to support certain development activities and co-commercialize both candidates in certain territories. If BioNTech exercises an option, it will receive a profit share with respect to the exercised product candidate worldwide while Autolus will be eligible to receive an option exercise fee, milestone payments, and co-funding of development expenses. 

In addition, Autolus granted BioNTech an exclusive license to develop and commercialize therapeutics incorporating certain of Autolus’ proprietary binders along with options to license binders and cell-programming technology for use in BioNTech’s in vivo cell-therapy development programs and investigational antibody-drug conjugates. If BioNTech exercises an option, Autolus will be eligible to receive exercise fees and milestones payments, with low-single digit royalties on net sales of the licensed products. 

Source: BioNTech 

Kyowa Kirin, Bridge Bio in $100-M Pact for Rare Disease Skeletal Drug 
BridgeBio Pharma, a Palo Alto, California-based bio/pharmaceutical company, and Kyowa Kirin, a Tokyo-based bio/pharmaceutical company, have entered an agreement under which BridgeBio’s affiliate, QED Therapeutics, grants Kyowa Kirin an exclusive license in Japan to develop and commercialize infigratinib, a skeletal disease drug, in a deal worth $100 million. 

Under the agreement, Kyowa Kirin will obtain a license to develop and commercialize infigratinib for achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan. In exchange, BridgeBio will receive an upfront payment of $100 million as well as royalties up to the high-twenties percent on sales of infigratinib in Japan, with the potential for additional milestone-based payments. Infigratinib is an oral small molecule designed to inhibit FGFR3 (fibroblast growth factor receptor) and thus target FGFR3-driven skeletal dysplasias at their source, including achondroplasia and hypochondroplasia. 

Source: Kyowa Kirin 

Sanofi Takes Stake in Bio/Pharma Company Graviton Bioscience 
Sanofi has taken an undisclosed equity stake in Graviton Bioscience, a clinical-stage bio/pharmaceutical company.  

Graviton is developing therapeutics for central nervous system, autoimmune, fibrotic, and other serious diseases where ROCK2 and its other therapeutic compounds play a role in pathology. ROCK2 is an effector of the small GTPase Rho and belongs to the AGC family of kinases. Graviton’s first drug candidate, GV101, is in clinical studies, with additional assets advancing through the preclinical pipeline.  

Under the agreement, in return for its equity stake, Sanofi receives a right of first negotiation to license compounds across various indications, including immunological and metabolic syndrome indications.  

Graviton is headed by its CEO and founder, Dr. Samuel Waksal, the founder and former Chairman and CEO of Kadmon Pharmaceuticals, which Sanofi acquired in 2021 for $1.9 billion.  

Source: Graviton Bioscience 

Merck & Co., Vector Institute In AI Healthcare Pact 
Merck & Co. and the Vector Institute, a Toronto, Canada-based AI research organization, have entered into a multi-year agreement to advance AI in healthcare.   

This agreement will allow Merck Canada, Merck & Co.’s Canadian arm, to gain access to Vector’s research capabilities in AI. Merck Canada will have the opportunity to tap into Vector Institute’s network of AI researchers, engineers, and start-ups.  

Source: The Vector Institute     

Rigel Pharma To Acquire Cancer Drug From Blueprint Medicines in $117.5-M Deal 
Rigel Pharmaceuticals, a South San Francisco, California-based bio/pharmaceutical company, has agreed to acquire the US rights to Gavreto (pralsetinib), an anti-cancer drug, from Blueprint Medicines, a Cambridge, Massachusetts-based bio/pharmaceutical company, in a deal worth up to $117.5 million ($15 million upfront and $102.5 million in milestone payments).  

Gavreto is a once-daily, small-molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions. It is approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 

Gavreto is also approved for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 

Under the agreement, Blueprint will receive $15 million, $10 million of which is payable upon first commercial sale by Rigel and an additional $5 million of which is payable on the first anniversary of the closing date, subject to certain conditions. Blueprint is also eligible to receive up to $97.5 million in future commercial milestone payments and up to $5 million in future regulatory milestone payments, in addition to tiered royalties ranging from 10% to 30%. Patents that have issued or are expected to issue covering Gavreto will have statutory expiration dates between 2036 and 2041. Rigel expects to complete the transition of the asset and start recognizing product sales in the third quarter of 2024.  

Source: Rigel Pharmaceuticals 

Pfizer, American Cancer Society Partner for Cancer Patient Care 
Pfizer and the American Cancer Society (ACS) have announced the launch of a three-year, $15-million initiative to bridge the gap in cancer-care disparities.  

Through $15 million in funding from Pfizer, the initiative aims to improve health outcomes in medically underrepresented communities across the US by enhancing awareness of and access to cancer screenings, clinical trial opportunities, and patient support and comprehensive navigation. The program will initially focus on breast and prostate cancer in medically underserved communities, with the potential to expand to additional cancer types.  

ACS plans to engage additional partners to extend the reach of the programmatic activities to more individuals and deepen the tangible impact in select communities. 

Source: Pfizer