The US Food and Drug Administration (FDA) has put a temporary stop to a clinical trial involving an experimental cancer drug licensed by German biotechnology company BioNTech SE from Chinese biotech firm MediLink Therapeutics Ltd (via Bloomberg).
This decision, announced on Monday, is due to safety concerns surrounding the drug, known as BNT326/YL202.
A photo taken on March 27, 2021 shows the logo on the facade of the new manufacturing site of German company BioNTech for the production of the Covid-19 vaccine in Marburg, central Germany. Photo by THOMAS LOHNES/AFP via Getty Images
FDA Delays Breast and Lung Cancer Drug Trials
The drug in question, BNT326/YL202, is an antibody-drug conjugate (ADC), a type of targeted cancer therapy designed to deliver treatment directly to cancer cells, potentially minimizing damage to healthy cells.
The trial was set to enroll 80 patients with non-small cell lung cancer (NSCLC) and breast cancer, specifically targeting those whose cancer had advanced or spread despite previous treatments.
The first-in-human Phase 1 clinical trial is being conducted in both China and the United States. It was scheduled to deliver results by the end of this year, but the FDA's recent action has delayed this timeline.
Why the FDA Intervened
The FDA's intervention came after concerns were raised about the safety of BNT326/YL202 at higher doses. According to BioNTech, the FDA believes that "the compound may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries."
This prompted the FDA to place a partial clinical hold on the trial, which means new patient enrollment in the US has been paused.
The halted study was originally being run by MediLink and targeted particularly sick individuals whose standard treatments had failed. This trial is part of a growing trend where European companies, like BioNTech, license assets from Chinese counterparts to expand their treatment pipelines.
BioNTech, in particular, agreed to pay MediLink over $1 billion for global rights to its ADC.
In response to the FDA's concerns, MediLink has paused the enrollment of new patients in the US. The company is now working to fulfill the FDA's requirements, which include sharing detailed pharmacological data and updating safety findings from ongoing studies.
The FDA has specifically requested more information on severe adverse events (grade 5) observed in two studies.
For BioNTech, which gained global recognition for its COVID-19 vaccine developed in partnership with Pfizer, this development comes as part of its strategic shift towards cancer drug development.
With declining sales of its COVID-19 vaccine, Reuters tells us that BioNTech is investing in expanding its pipeline to include novel cancer treatments like BNT326/YL202.
BioNTech's American Depositary Receipts (ADRs) were reported to be little changed before market opening, although they have dropped almost 13% this year. The company's future in this area now hinges on addressing the FDA's safety concerns and successfully resuming the trial.
