A roundup of news from Merck & Co., Daiichi Sankyo, EMA and Vir Biotechnology. Highlights below.  

* Merck & Co., Daiichi Sankyo Expand ADC Pact
* European Medicines Agency Supports Pilot Study for Establishing an African Medicines Agency 
* Vir Biotechnology To Acquire Select T-Cell Assets from Sanofi; Cutting Its Workforce 

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Merck & Co., Daiichi Sankyo Expand ADC Pact 
Merck & Co. and Daiichi Sankyo have expanded their existing $22-billion global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates (ADCs) by Daiichi to include Merck’s MK-6070, an investigantional drug for treating small-cell lung cancer (SCLC) and neuroendocrine tumors.  

MK-6070 is a T-cell engager targeting DLL3, an inhibitory canonical Notch ligand that is expressed at high levels in SCLC and is currently being evaluated in a Phase I/II clinical trial. The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan, one of the ADCs in their existing ADC pact, in certain patients with SCLC as well as other potential combinations. The US Food and Drug Administration (FDA) granted orphan drug designation to MK-6070 for the treatment of SCLC in March 2022. Merck obtained MK-6070 through its $680-million acquisition of Harpoon Therapeutics, a South San Francisco, California-based bio/pharmaceutical company, in March (March 2024).  

Merck and Daiichi’s  formed their ADC pact in October 2023 for $22 billion, wich included the global licensing and commercialization for three ADC candidates from Daiichi Sanyko:  ifinatamab deruxtecan, patritumab deruxtecan, and raludotatug deruxtecan. Under that deal, Merck agreed to pay Daiichi Sankyo a $4-billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months (as reported in October 2023), and potential additional payments of up to $16.5 billion contingent upon the achievement of future sales milestones, for a total potential consideration of up to $22 billion. The new deals adds an upfront payment of $170 million to Merck from Daiichi for the development of MK-6070. 

Under the expanded agreement, the companies will jointly develop and commercialize MK-6070 worldwide, except in Japan, where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070. 

Under the agreement, Merck will receive an upfront cash payment of $170 million and has also satisfied a contingent obligation from the original collaboration agreement. The companies will share R&D and commercialization expenses as well as profits worldwide, except for Japan where Merck retains exclusive rights and Daiichi Sankyo receives a royalty based on sales. R&D expenses related to MK-6070 in combination with ifinatamab deruxtecan will be shared in a manner consistent with the original agreement for ifinatamab deruxtecan. Merck will generally record sales for MK-6070 worldwide. 

Source: Merck & Co. 

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European Medicines Agency Supports Pilot Study for Establishing an African Medicines Agency 
The European Medicines Agency (EMA) has awarded a grant to the African Medicines Regulatory Harmonization (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to test procedures for the joint continental evaluation of medicines in Africa. 

AUDA-NEPAD has been working on harmonization activities for a decade, paving the way for the creation of the African Medicines Agency (AMA). The launch of the continental pilot is one of these activities that aim to validate procedures and processes ahead of the establishment of the AMA. The pilot, which is co-funded with the Bill & Melinda Gates Foundation, will run for a year. 

During the pilot, the AMRH Evaluation of Medicinal Products Technical Committee will evaluate the quality, safety, and efficacy of priority medicinal products with the support of the continental Good Manufacturing Practices Technical Committee. The learnings from the evaluations will help to develop continental processes and procedures, facilitate national authorizations of recommended medicines, and strengthen information sharing and reliance. 

Source: European Medicines Agency 

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Vir Biotechnology To Acquire Select T-Cell Assets from Sanofi; Cutting Its Workforce 
Vir Biotechnology, a San Francisco, California-based clinical-stage bio/pharmaceutical company, has signed an exclusive worldwide license agreement with Sanofi for multiple clinical-stage T-cell engagers (TCEs) and exclusive use of Sanofi’s protease-cleavable masking platform for oncology and infectious diseases. Sanofi had gained those assets through its acquisition of Amunix Pharmaceuticals, a South San Francisco, California-based immuno-oncology company in 2022, in a $1.2-billion deal ($1 billion upfront and $225 million in potential milestones).  

The clinical-stage assets include: SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules through the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues. The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index  and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs. 

The license agreement is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino (HSR) Act Antitrust Improvements Act of 1976, as amended (HSR). 

Separately, Vir Biotechnology has initiated a restructuring of its workforce and trimming of its portfolio. This includes phasing out programs in influenza, COVID-19, and the company’s T cell-based viral vector platform, as well as a workforce reduction of approximately 25% or approximately 140 employees. The company expects to end 2024 with approximately 435 employees, a decrease of approximately 200 from its peak headcount in the second quarter of 2023. This includes the Sanofi employees who are expected to join Vir following receipt of HSR clearance. 

Source: Vir Biotechnology (Sanofi) and Vir Biotechnology (restructuring)