Partnering News: AbbVie, Sanofi, BioNTech & More
A roundup of bio/pharmaceutical partnering news from AbbVie/Sosei, Sanofi/Innovent, and BioNTech/Genmab.
AbbVie, Sosei in $1.2-Bn Small-Molecule Neuroscience Drug Pact
AbbVie and Sosei Heptares, a Tokyo-based bio/pharmaceutical company, have entered a drug- discovery collaboration and option-to-license agreement to discover, develop, and commercialize small molecules that modulate G protein-coupled receptor (GPCR) targets associated with neurological disease, in a deal worth up to $1.2 billion ($40 million upfront and up to $1.2 billion in milestone payments).
Under the agreement, Sosei will conduct and fund R&D activities through the completion of investigational new drug-enabling studies. AbbVie has the option to license up to three programs at this stage and will have responsibility for clinical, regulatory and commercial development thereafter.
Sosei receives an upfront payment of $40 million on signing and is eligible to receive up to $40 million in near-term research milestone payments expected over the next three years (as reported on August 1, 2022), as well as further potential option, development and commercial milestones totaling up to $1.2 billion, plus tiered royalties on global sales.
The new agreement expands the companies’ ongoing collaboration signed between the companies in June 2020, which is focused on inflammatory and autoimmune diseases.
Source: Sosei Group
Sanofi, Innovent in $455-M Cancer-Drug Pact in China
Sanofi and Innovent Biologics, a Suzhou, China-based bio/pharmaceutical company, have formed a partnership to develop and commercialize in China two of Sanofi’s clinical-stage oncology drug candidates in combination with Innovent’s sintilimab, a checkpoint inhibitor for treating cancer, in a deal worth up to EUR 440 million ($455 million) (a EUR 300-million [$309-million] equity stake by Sanofi in Innovent and up to EUR 80 million ($82 million) in milestone payments to Sanofi and up to EUR 60 million ($62 million) in milestone payments to Innovent).
Under the agreement, Innovent will be responsible for developing and eventually commercializing in China Sanofi’s Phase III drug candidate, SAR408701 (tusamitamab ravtansine), an antibody drug conjugate (ADC), and Sanofi’s Phase II drug candidate, SAR444245, in combination with Innovent’s sintilimab in multiple oncology-based indications.
Sanofi’s SAR408701 (tusamitamab ravtansine) is an ADC targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is expressed in non-small cell lung cancer (NSCLC), gastric cancer, and other cancers. It is currently in a global Phase III study for the second-line treatment of NSCLC and in global Phase II studies in additional indications, including first-line NSCLC, gastric cancers, and other solid tumors.
Under the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to EUR 80 million ($82 million) in development milestone payment and royalties on the net sales of the product in China upon approval.
Sanofi’s SAR444245 is currently in global Phase II studies for treating skin cancers, gastrointestinal cancer, NSCLC/mesothelioma, head and neck tumors, and lymphoma.
Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole marketing authorization holder for both assets and will be fully responsible for SAR444245’s commercialization. Innovent will be entitled to receive up to EUR 60 million ($62 million) in development milestone payments and royalties on the net sales of the product in China upon approval.
In addition to the companies’ collaboration and license agreement, Sanofi is making an initial strategic equity investment in Innovent of EUR 300 million ($309 million). Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for EUR 300 million ($309 million).
Innovent’s sintilimab, marketed as TYVYT in China, was jointly developed by Innovent and Eli Lilly and Company. Innovent is conducting more than 20 clinical studies of sintilimab in various cancer indications. In China, sintilimab is approved for six indications, including relapsed or refractory classic Hodgkin’s lymphoma, non-squamous NSCLC, squamous NSCLC, hepatocellular carcinoma, esophageal squamous cell carcinoma, and gastric or gastroesophageal junction adenocarcinoma.
BioNTech, Genmab Expand Cancer Immunotherapy Pact
BioNTech, a Mainz, Germany-based bio/pharmaceutical company and Genmab, a Copenhagen, Denmark-based bio/pharmaceutical company, have expanded their global strategic collaboration to develop and commercialize cancer immunotherapies to include development of monospecific antibodies.
Since 2015, the companies have been working on the joint development of bispecific cancer antibodies. Under the expansion, BioNTech and Genmab will jointly work to research, develop, and commercialize monospecific antibody candidates for various cancer indications. The first monospecific antibody candidate, GEN1053/BNT313, is expected to enter clinical trials by the end of 2022. Under the agreement, the companies will equally share the development costs and potential future profit deriving from GEN1053/BNT313.
The companies currently have two jointly developed investigational medicines in clinical testing as part of their earlier collaboration: GEN1046/BNT311, in Phase I/II clinical trials, for treating advanced solid tumors and in a Phase II study for treating non-small cell lung cancer and GEN1042/BNT312, in Phase I/II trials, for treating metastatic or locally advanced solid tumors.