Partnering News: Gilead, Merck & Co., Sanofi & MoreBy
A roundup of bio/pharmaceutical partnering news from: Gilead/Merck & Co.; Sanofi/Exscientia; Bayer/Mammoth Biosciences; Novartis/BeiGene; Novartis/Alnylam; BioNTech/Crescendo Biologics; AstraZeneca/Neurimmune; Lilly/Entos;Pfizer/Acuitas Therapeutics; Bristol-Myers Squibb/Evotec; Regeneron/Ultragenyx; and Eisai/Roivant.
Gilead, Merck & Co. in Pact for Oncology Drug Combo
Gilead Sciences and Merck & Co. have entered into two clinical trial collaboration and supply agreements to evaluate the combination of Gilead’s Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate for treating metastatic triple-negative breast cancer, and Merck’s Keytruda (pembrolizumab), an anti-programmed death-1 antibody for treating cancer, as a first-line treatment for metastatic non-small cell lung cancer (NSCLC).
As part of the collaboration, Merck will sponsor a global Phase III clinical trial of Trodelvy in combination with Keytruda for patients with metastatic NSCLC. Additionally, the companies recently established an agreement whereby Gilead will sponsor a Phase II signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC.
Everest Medicines, a New York-based bio/pharmaceutical company, will also participate in the global Phase III study in Asia through its existing collaboration agreement with Gilead.
Source: Gilead Sciences
Sanofi, Exscientia in $5.3-Bn AI-Driven Small-Molecule Drug Pact
Sanofi and Exscientia, an Oxford, UK-based artificial intelligence (AI)-based drug development company, have entered into a research collaboration and license agreement to develop up to 15 small molecule candidates across oncology and immunology, in a deal worth up to $5.3 billion ($100 million upfront and up to $5.2 billion in milestones).
The companies have been working together since 2016. In 2019, Sanofi in-licensed Exscientia’s bispecific small-molecule candidate capable of targeting two distinct targets in inflammation and immunology.
Under the agreement, Exscientia will receive an upfront cash payment of $100 million from Sanofi and will be eligible to receive future research, translational, clinical development, regulatory and commercial milestone payments of up to approximately $5.2 billion in aggregate, if all milestones for all programs are achieved. In the case that Sanofi commercializes a therapeutic from the collaboration, Exscientia will also be eligible to receive tiered royalties on product sales ranging from high-single-digits to mid-teens and an option for clinical co-investment to increase the royalty rate up to 21% on net sales of co-funded products.
Bayer, Mammoth Biosciences in $1.04-Bn CRISPR Pact
Bayer and Mammoth Biosciences, a San Francisco-based developer of a CRISPR-based disease detection platform, have entered into a pact, worth up to $1.04 billion ($40 million upfront and up to $1 billion in milestone payments), to develop in vivo gene-editing therapies using Mammoth’s CRISPR systems.
The companies will start their collaboration with a focus on liver-targeted diseases. Additionally, Bayer gains access to this gene-editing technology, which offers the potential of advanced in vivo applicability due to the ultra-compact size of these CRISPR systems.
Under the agreement, Mammoth Biosciences will receive an upfront payment of $40 million and is eligible to receive target option exercise fees as well as potential future payments of more than $1 billion upon successful achievement of certain research, development, and commercial milestones across five preselected in-vivo indications with a first focus on liver-targeted diseases. In addition, Bayer will pay research funding and tiered royalties up to low double-digit percentage of net sales. The companies are also exploring work on ex-vivo projects on a nonexclusive basis.
Novartis, BeiGene in $1-Bn Deal for Cancer Therapy
Last month (December 2021), Novartis and BeiGene, a Beijing-based bio/pharmaceutical company, have signed a $1-billion collaboration and license agreement for ociperlimab (BGB-A1217), a late-stage TIGIT inhibitor, expanding the company’s research and development activities in immuno-oncology.
Under terms of the agreement, Novartis will make an upfront payment to BeiGene of $300 million. A fee of up to $700 million would be paid to BeiGene if the option is exercised before late 2023. Upon exercise of the option, Novartis would obtain the development and commercialization rights to ociperlimab in the US, Canada, Mexico, the European Union, UK, Norway, Iceland, Liechtenstein, Switzerland, Russia and Japan. BeiGene agrees to provide 50% of the co-detailing efforts in the US following approval and will retain the rights to ociperlimab in China and all other countries.
Novartis, Alnylam in Liver-Disease Therapy Pact
Novartis and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based bio/pharmaceutical company focused on RNA interference (RNAi) therapeutics, have agreed to collaborate on the discovery and development of an siRNA-based targeted therapy to restore functional liver cells in patients with end-stage liver disease.
The agreement will use Alnylam’s siRNA technology to inhibit a target discovered at the Novartis Institutes for BioMedical Research. The collaboration aims to develop liver-targeted therapies as a potential alternative to transplantation for patients experiencing liver failure.
During the exclusive three-year research collaboration, Alnylam will develop and test potential siRNAs using target-specific assays developed by Novartis. Once a lead candidate is identified, further development and clinical research will be conducted by Novartis.
BioNTech, Crescendo s in $790-M Immunotherapy Pact
BioNTech and Crescendo Biologics, a clinical-stage immuno-oncology company developing targeted T-cell enhancing therapeutics, have entered into multi-target discovery collaboration to develop immunotherapies for cancer and other diseases, in a deal worth up to $790 million ($40 million upfront and up to $750 in milestone payments).
The collaboration uses BioNTech’s multimodal immunotherapy expertise with Crescendo’s transgenic Humabody VH platform to develop immunotherapies, including mRNA-based antibodies and engineered cell therapies against targets selected by BioNTech.
The initial term of the discovery collaboration is three years. Under the agreement, Crescendo will receive $40 million upfront, including a cash payment and an equity investment from BioNTech, as well as research funding for the period of the collaboration. BioNTech will be responsible for global development and hold exclusive global commercialization rights on any products arising from the collaboration. Crescendo will be eligible to receive development, regulatory and commercial milestones up to a total of more than $750 million, in addition to tiered royalties on global net sales.
AstraZeneca, Neurimmune in $760-M Cardio Drug Pact
Alexion, AstraZeneca’s Rare Disease Group, has entered into a $760-million global collaboration and license agreement with Neurimmune, a Zurich, Switzerland-based bio/pharmaceutical company, for NI006, an investigational human monoclonal antibody, currently in Phase Ib development for transthyretin amyloid cardiomyopathy, a fatal condition from progressive heart failure.
Under the agreement, Alexion will be granted an exclusive global license to develop, manufacture, and commercialize NI006. Alexion will pay Neurimmune an upfront payment of $30 million with the potential for additional contingent milestone payments of up to $730 million upon achievement of certain development, regulatory, and commercial milestones as well as low-to-mid teen royalties on net sales of any approved medicine resulting from the collaboration.
Neurimmune will continue to be responsible for completion of the current Phase Ib clinical trial on behalf of Alexion, and Alexion will pay certain trial costs. Alexion will be responsible for further clinical development, manufacturing and commercialization. The transaction is expected to close following satisfaction of customary closing conditions and regulatory clearances.
Lilly, Entos in Neurology Therapy Research Pact
Eli Lilly and Company has entered into a research collaboration with Entos Pharmaceuticals, a company developing nucleic acid-based therapies, to use Entos’ Fusogenix nucleic acid delivery technology to research, develop, and commercialize nucleic acid products targeting the central and peripheral nervous system.
Under the collaboration, Lilly and Entos have agreed to multiple programs focused on the development of proteo-lipid vehicles (PLVs) for delivery of therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems. Entos will be responsible for the generation, development, and optimization of PLVs using its Fusogenix platform technology.
Lilly will be responsible for selecting PLVs for clinical development and commercialization. Entos will receive an initial payment of $50 million, which includes an equity investment in Entos. For each of the programs under the collaboration, Entos is also eligible to receive up to $400 million in potential developmental and commercial milestone payments, as well as royalties upon the successful commercialization of products.
Pfizer, Acuitas in Lipid Nanoparticle Delivery Pact
Pfizer and Acuitas Therapeutics, a Canadian company developing lipid nanoparticle (LNP) delivery systems for messenger RNA (mRNA)-based therapeutics, have entered into a development and option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas’ LNP technology for up to 10 targets for vaccine or therapeutic development.
Acuitas’ LNP technology is used in Comirnaty, Pfizer’s/BioNTech’s COVID-19 vaccine.
Regeneron, Ultragenyx in $93-M Commercialization Pact
Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, and Ultragenyx Pharmaceutical, a bio/pharmaceutical company developing drugs for rare and ultra-rare genetic diseases, have entered into a pact to clinically develop, commercialize, and distribute Evkeeza (evinacumab), a monoclonal antibody for hypercholesterolemia (HoFH), in countries outside of the US, in a deal worth up to $93 million ($30 million upfront and up to $63 million milestones).
Regeneron will receive a $30-million upfront payment and is eligible to receive up to $63 million in additional potential regulatory and sales milestones. Ultragenyx will receive the rights to develop, commercialize, and distribute the medicine in countries outside of the US and make payments to Regeneron based on net sales. Ultragenyx will share in certain costs for global trials led by Regeneron and also have the right to continue to clinically develop Evkeeza in countries outside of the US for HoFH and other potential indications.
BMS, Evotec Expand Neuroscience Pact
Bristol-Myers Squibb (BMS) and Evotec, a Hamburg, Germany-based drug-discovery and development company, have expanded their neurodegeneration collaboration to include a new targeted protein degradation approach. The focus will be on selected targets that are relevant to a range of neurodegenerative conditions. Evotec receives payments totaling $15 million from BMS.
Eisai, Roivant in Pact for Anticancer Agent
Eisai has entered into a license agreement with Roivant Sciences, a New York-based bio/pharmaceutical and healthcare technology company, for the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent, H3B-8800, an orally available small-molecule modulator of splicing factor 3B subunit 1.
Under the agreement, Eisai will receive a contractual upfront payment, development, and regulatory milestone payments for H3B-8800, and will also receive a certain amount of royalties on sales revenue of H3B-8800 after the launch.