CMO Baccinex Manufactures Clinical Batches for OSE Pharma

OSE Pharma SA, an immuno-oncology company developing a T-specific immunotherapy for late-stage cancer patients, has taken further steps in its pharmaceutical development by successfully manufacturing its lead product Tedopi in compliance with good manufacturing practices (GMP) at a dedicated facility, certified both in Europe and the U.S. This announcement comes a few weeks after several European regulatory authorities issued a positive opinion so that OSE Pharma may initiate its pivotal phase 3 clinical trial of Tedopi in patients with advanced non-small cell lung cancer (NSCLC).

The initial clinical batches of Tedopi were manufactured by Baccinex, a company that specializes in manufacturing development batches for clinical trials as well as commercial batches. These sterile products will be administered by subcutaneous injection during the phase 3 clinical trial of Tedopi in NSCLC.

“We are very pleased with the collaboration we started a few months ago with Baccinex to manufacture the clinical batches of neo-epitopes that are used in the composition of Tedopi,” said Jean-Pascal Conduzorgues, pharmaceutical director and qualifed person at OSE Pharma. “This global manufacturing company, based in Switzerland, is GMP-certified to produce batches of sterile products. We worked closely with Baccinex teams to achieve the manufacturing stage and relied on the experience they’ve acquired working with peptides to manufacture the products that will be used in our clinical trial. We’re particularly grateful for their responsiveness in finalizing these GMP batches, following the positive opinion we recently received from 7 European agencies to start our trial.”