Biotech company Halozyme Therapeutics is laying off more than half its staff and pivoting its focus following the failure of its lead Phase III trial program.
The San Diego-based company said Monday that the Phase III HALO-301 trial of the drug PEGPH20 in first-line metastatic pancreatic cancer failed to improve overall survival. And the failure was a major one. With a p value of 0.9692, the results did not even approach statistical significance – the threshold for that is a value of 0.05 or less – and a hazard ratio of 1 meant patients in the study arm were no more likely to survive than those in the control arm. In response, the company said it would discontinue all clinical development of PEGPH20.
“Based on the preclinical and Phase II data, we believed a targeted approach with a differentiated mechanism of action had a strong chance to make a breakthrough in this incredibly challenging cancer,” Halozyme CEO Helen Torley said Monday morning on a conference call with investment bank analysts to discuss the results.
Patients were randomized to receive PEGPH20 with Celgene’s Abraxane (nab-paclitaxel) and gemcitabine or Abraxane with gemcitabine alone. Patients in the study arm showed a median overall survival of 11.2 months, compared with 11.5 months in the control arm.
Still, the response from shareholders was more muted. Shares of the company fell 3.5 percent on the Nasdaq before rising 6.6 percent and then settling at approximately the same level as their Friday closing price.
Indeed, the company is responding with a rapid restructuring. On the analyst call, Torley said it would lay off 55 percent of its workforce – about 160 employees – and shift its focus to its drug delivery technology program. The program, ENHANZE, is based on a recombinant enzyme that allows for large volumes to be delivered in a single injection, thereby allowing certain drugs like biologics that are normally administered intravenously to instead be administered subcutaneously.
An example of a product using ENHANZE is the subcutaneous formulation of Johnson & Johnson’s Darzalex (daratumumab), for which the company submitted an application for Food and Drug Administration approval for the blood cancer multiple myeloma in June. The intravenous formulation of the drug was originally approved in 2015. Data presented at the American Society of Clinical Oncology’s annual meeting in June showed it to be non-inferior to the intravenous version.
Photo: MarsBars, Getty Images
