BioNTech shares slip as FDA places partial clinical hold on lung cancer study

Investing.com -- BioNTech (NASDAQ:BNTX ) shares fell Friday after the company said it had been informed by partner OncoC4 that FDA placed partial clinical hold on Phase 3 study of BNT316/ONC-392 (gotistobart) in non-small cell lung cancer.

The move comes “due to varying results between the squamous and non-squamous NSCLC patient populations,” BioNTech said in an announcement

The company’s shares fell more than 1.5%.

The PRESERVE-003 trial is a two-stage, open-label, randomized study designed to assess the efficacy and safety of the antibody candidate BNT316/ONC-392 as a single-agent therapy for patients with metastatic NSCLC who have previously progressed on PD-(L)1-inhibitor treatments.

According to BioNTech, an independent data monitoring committee recently identified potential variances in the trial data between different NSCLC patient populations.

Following this discovery, OncoC4 and BioNTech have voluntarily paused the enrollment of new patients into the trial and have reported the observed variances to the FDA for further review and guidance.

Despite the partial clinical hold, patients who are already participating in the trial will continue to receive their treatment as planned.

“Trials evaluating BNT316/ONC-392 in other indications remain unaffected,” the company said.

BioNTech reported earlier this year that its quarterly losses had quadrupled as the company banks on a strategy shift towards new cancer treatments after a sharp drop-off in sales of its COVID-19 vaccine.

The biotech firm reported a reaching 807.8 million euros ($885 million) in the second quarter, up from 190.4 million euros a year earlier. It also saw a 23% drop in revenue to 128.7 million euros, driven primarily by declining sales of its COVID-19 vaccine, developed in partnership with Pfizer (NYSE:PFE ).

Source: Investing.com