AGOURA HILLS, Calif. & KENILWORTH, N.J.—A2 Biotherapeutics disclosed today that the company has entered into an agreement with Merck & Co., known as MSD outside the US and Canada. With this collaboration, A2 will continue research and preclinical development of its undisclosed Tmod cell therapy; both companies will co-fund A2’s clinical development and allogeneic manufacturing activities through Phase 1.
“This transaction extends our cash runway on the heels of our successful $71.5M Series B in October,” noted Scott Foraker, president and CEO of A2 Biotherapeutics. “It also brings Merck’s immunotherapy and other expertise for the Tmod candidate especially in the later stages of development, manufacturing and commercialization, and enables A2 to build allogeneic product development and manufacturing capabilities.”
Merck plans to assist with preclinical development; the company also has the option to exclusively develop, manufacture, and commercialize the candidate following Phase 1. Under the agreement A2 will receive an upfront payment, and will be eligible for opt-in and milestone payments, as well as royalties on sales of any approved product. A2 will also receive from Merck an equity investment, and reimbursement of certain expenses. Merck additionally has the option to designate a new Tmod program, with increased economic terms.
A2’s Tmod engineered T cells are said to combine an activating mechanism to kill tumor cells with a blocking mechanism that protects normal cells from harm by exploiting the loss of genetic material in tumors. These cells have the potential to make existing targets safer and more effective by protecting normal cells as they deliver a more therapeutically effective dose to kill tumor cells.
“In vitro studies have provided compelling evidence supporting the view that Tmod-based cell therapy can distinguish tumor cells from normal cells, across multiple tumor targets. We hope that the combined efforts of Merck Research Laboratories and A2 Biotherapeutics will enable the application of this ingenious approach to improve the treatment of patients suffering from refractory solid tumors,” added Dr. Roger M. Perlmutter, president of Merck Research Laboratories.
This isn’t the only noteworthy news out of Merck today — the company has reported a supply agreement with the U.S. government to support the development, manufacture, and initial distribution of an investigational biological COVID-19 therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the FDA.
In September 2020, OncoImmune reported topline findings from an interim efficacy analysis of the SAC-COVID Phase 3 study evaluating MK-7110 for the treatment of patients with severe and critical COVID-19. An interim analysis of data from 203 participants indicated that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60 percent higher probability of improvement in clinical status, compared to placebo. The patients’ risk of death or respiratory failure was reduced by more than 50 percent. The study is currently ongoing.
“Building upon the promising clinical findings to date for MK-7110, Merck is pleased to be collaborating with the US government to advance the manufacture and distribution of this candidate for patients with serious COVID-19 disease,” Perlmutter stated.
Under the agreement, Merck will receive up to approximately $356 million for manufacturing and supply of approximately 60,000-100,000 doses of MK-7110 to the US government through June 30, 2021. This approach, part of the government’s Operation Warp Speed goals, is intended to expedite delivery of MK-7110 to the American people as quickly as possible, following potential EUA or FDA approval. Merck also plans to invest in expanding its manufacturing capacity, in order to quickly supply MK-7110.