Partnering News: J&J, BMS, Takeda, Astellas, GSK & More 

A roundup of bio/pharmaceutical partnering news from J&J/Nanobiotix, Bristol-Myers Squibb/Prothena, Takeda/F-Star Therapeutics, BeiGene/DualityBio, Astellas/4D Molecular Therapeutics, and GSK/Elsie Biotechnologies. 

* J&J, Nanobiotix in $2.7-Bn Licensing Pact for Radiopharmaceuticals 
* BMS in $2.2-Bn Pact for Global Rights to Prothena’s Alzheimer’s Drug Candidate 
* Takeda, F-Star Therapeutics in $1-Bn Immunotherapy Pact 
* BeiGene, Duality Bio in $1.3-Bn ADC Pact 
* Astellas, 4D Molecular Therapeutics in $963-M Pact for Rare Disease Ophthalmic Gene Therapies 
* GSK, Elsie Biotechnologies in Oligo Research Pact 

J&J, Nanobiotix in $2.7-Bn Licensing Pact for Radiopharmaceuticals 
Johnson & Johnson (J&J) and Nanobiotix, a Paris-based bio/pharmaceutical company, have signed a global licensing, co-development, and commercialization agreement for NBTXR3, a radioenhancer to improve anti-cancer radiopharmaceuticals, in a deal worth up to $2.7 billion ($30 million upfront and $2.7 billion in milestone payments). 

NBTXR3 is currently being evaluated in several studies across solid tumor indications, including a Phase III study evaluating NBTXR3 for treating locally advanced head and neck cancer. NBTXR3 is also being evaluated as a potential systemic agent in combination with anti-PD-1 immune checkpoint inhibitors for metastatic cancers. 

Under the agreement, Nanobiotix will grant J&J a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, excepting territories previously licensed to Nanobiotix’s partner, LianBio, a Shanghai, China-based bio/pharmaceutical company.  

Under its agreement with J&J, Nanobiotix will receive near-term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million and in-kind regulatory and development support valued at up to $30 million that J&J may provide at its sole discretion. Nanobiotix will maintain operational control of all ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply. J&J will be fully responsible for an initial Phase II study evaluating NBTXR3 for treating patients with Stage 3 lung cancer and will have the right to assume control of studies currently led by Nanobiotix. 

Nanobiotix is eligible for success-based payments of up to $1.8 billion, in the aggregate, relating to potential development, regulatory, and sales milestones. Moreover, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by J&J at its sole discretion, and of up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen. 

Source: Nanobiotix 

BMS in $2.2-Bn Pact for Global Rights to Prothena’s Alzheimer’s Drug Candidate 
Bristol Myers Squibb (BMS) has exercised an option with Prothena Corporation, a Dublin, Ireland-based clinical bio/pharmaceutical company, to obtain the exclusive worldwide commercial rights for PRX005, Prothena’s Alzheimer drug candidate, in a deal worth up to $2.2 billion ($55 million upfront and $2.2 billion in milestone payments). The companies had previously formed a neuroscience R&D collaboration. 

PRX005, in Phase I development, is an anti-tau antibody to address the buildup of tau proteins in the brain, which are considered a potential cause of Alzheimer’s disease. The drug targets an area within the microtubule binding region of tau for the potential treatment of Alzheimer’s disease. 

Under the agreement, Prothena is eligible to receive up to an additional $160 million for US rights, up to $110 million for global rights, and up to $1.7 billion for regulatory and commercial milestone payments for a total of up to $2.2 billion, which also includes amounts received to date (as of July 10, 2023). BMS will be responsible for development, manufacturing, and commercialization going forward 

Source: Prothena 

Takeda, F-Star Therapeutics in $1-Bn Immuno-oncology Pact 
Takeda and F-star Therapeutics, a London-based bio/pharmaceutical company, have entered into a strategic discovery collaboration and license agreement for the research and development of immunotherapies for cancer, in a deal worth up to $1 billion. 

Under the agreement, F-star and Takeda will jointly research and develop domains against undisclosed immuno-oncology targets using F-star’ proprietary research platform, Fcab. Takeda will receive a worldwide, exclusive royalty-bearing license to research, develop, and commercialize antibodies incorporating Fcab domains arising from the collaboration, and F-star will retain the right to research, develop, and commercialize antibodies incorporating certain other Fcab domains. 

F-star will receive an undisclosed upfront payment as well as research funding for the period of the collaboration. F-star is also eligible to receive potential future development and commercialization milestone payments of up to approximately $1 billion if all milestones across multiple programs are reached during the term of the agreement, plus royalties on potential annual net sales of any commercial product resulting from the license. 

Source: F-star Therapeutics 

BeiGene, DualityBio in $1.3-Bn ADC Pact 
BeiGene, a Beijing-based bio/pharmaceutical company, and DualityBio, a Shanghai-based bio/pharmaceutical company developing antibody drug conjugates (ADCs), have entered an agreement under which BeiGene will acquire an exclusive option for a global clinical and commercial license from DualityBio for an investigational, preclinical ADC for treating  select solid tumors, in a deal worth up to $1.3 billion. 

Under the agreement, DualityBio will receive an upfront payment and will be eligible for a payment contingent upon BeiGene exercising its option and additional payments based upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.3 billion, in addition to tiered royalties. Upon exercising its option, BeiGene will hold global clinical, manufacturing, and commercial rights while DualityBio will perform all research activities through investigational new drug (IND)-enabling studies and support future IND filings by BeiGene. 

The pending deal is the latest for BeiGene, which is also commercializing a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera and is partnered on new product development with other companies, including Novartis, Mirati Therapeutics, Seagen, and Zymeworks.   

BeiGene and Novartis signed a $2.2-billion licensing agreement in 2021 for BeiGene’s anti-cancer drug, tislelizumab, in North America, Europe, and Japan. The companies later announced in 2021 an option, collaboration and license agreement in December 2021 for BeiGene’s anti-cancer drug, ociperlimab. In 2020, Amgen and BeiGene formed a $2.8-billion drug-development and commercialization pact, which included an equity investment by Amgen in BeiGene. Amgen later invested an additional $421 million in BeiGene.  

Source: BeiGene 

Astellas, 4D Molecular Therapeutics in $963-M Pact for Rare Disease Ophthalmic Gene Therapies 
Astellas Pharma and 4D Molecular Therapeutics (4DMT), an Emeryville, California-based bio/pharmaceutical company developing gene therapies, have signed a license agreement for rare disease ophthalmic gene therapies, in a deal worth up to $963 million ($20 million upfront and $942.5 million in milestone payments). 

Under the agreement, Astellas gains rights to use 4DMT’s intravitreal retinotropic R100 vector, an eye disease viral vector, for one genetic target implicated in rare monogenic ophthalmic disease(s), with options to add up to two additional targets implicated in rare monogenic ophthalmic diseases after paying additional option exercise fees. 

R100 is an adeno-associated virus (AAV) vector designed for intravitreal delivery. It has the ability to penetrate the internal limiting membrane barrier and to transduce the entire retina, resulting in transgene expression within retinal cells, according to information from Astellas. All three 4DMT’s clinical-stage ophthalmic product candidates use the R100 vector, including 4D-150 for treating wet age-related macular degeneration and diabetic macular edema. 

Under the agreement, 4DMT will provide its R100 vector technology to Astellas to deliver Astellas’ genetic payloads for treating rare monogenic diseases. Astellas will conduct all subsequent research, development, manufacturing, and commercialization activities. 4DMT will receive $20 million upfront, and potential future option fees and milestones of up to $942.5 million, including potential near-term development milestones of $15 million for the initial target. In addition, 4DMT is entitled to receive mid-single digit to double-digit, sub-teen royalties on net sales of all licensed products. 

Source: Astellas 

GSK, Elsie Biotechnologies in Oligo Research Pact 
GSK and Elsie Biotechnologies, a San Diego, California-based bio/pharmaceutical company, have entered a research collaboration agreement to advance the discovery and development of Elsie’s oligonucleotide discovery platform with the aim of finding oligonucleotides.  

The collaboration combines GSK’s expertise in DNA-encoded library technologies with Elsie’s drug-discovery platform. The companies will begin an initial research period where GSK and Elsie will explore the platform’s capabilities. Throughout the research term, GSK may exercise an option to a non-exclusive license from Elsie for the discovery platform and P(V) chemistry technologies to employ in GSK’s own oligonucleotide drug-discovery research. 

Elsie’s discovery platform is a throughput process that allows for the complete evaluation of oligonucleotide chemical space. Elsie also applies P(V) chemistry technologies to synthesize oligonucleotide therapeutics.  

Under the agreement, Elsie will receive an upfront collaboration payment from GSK to conduct initial research activities. Upon exercising the option during the research term, GSK would be obligated to make further payments, including licensing fees, development, and commercial milestones. 

Source: Elsie Biotechnologies