German pharma powerhouse Merck KGaA is continuing its R&D deal hot streak, signaling an increased ambition to offload commercially promising assets. The company is ringing in the new year with an over $120 million transaction that will grant the rights to its IL-12-targeting cancer drug, M9241, to clinical-stage immunotherapy company PDS Biotech.
For its part, PDS is forking over an upfront payment of $5 million in addition to a potential $116 million — the bulk of which is dependent on the meeting of certain commercial milestones.
In striking this deal, the two companies are building on a track record of solid business agreements in their history. They have been striving to develop a triple-combo immunotherapy for the treatment of HPV-associated malignancies, and the solution is presently in a phase I/II trial. That study incorporates what is now known as M9241 as well as M7824 and PDS0101 from — you guessed it — PDS. A recently released recruitment report cited 51 patients enrolled out of the 56 expected. Completion is anticipated in the early days of 2024, putting it six months behind schedule.
PDS announced that it has an upcoming meeting on the books with the FDA concerning a registrational trial of the triple combo. M9241 has a deeper history prior to the triple combo test, as it was also pitted against solid tumors in a phase I trial led by the National Cancer Institute. Another phase I/II trial in which the aforementioned institute and the National Institutes of Health are testing the med as a supplement to chemotherapy is ongoing.