Seattle-based biotech Alpine Immune Sciences Inc. (Nasdaq: ALPN) has halted enrollment for clinical trials with its drug aimed at cancer, ALPN-202, after a second patient death.
The drug, also called davoceticept, was undergoing early clinical trials both as a stand-alone treatment and in combination with Merck's Keytruda, or pembrolizumab. Alpine announced Monday it was stopping enrollment for both trials after a patient in the Keytruda combination trial died of cardiogenic shock, which is when the "heart cannot pump enough blood and oxygen to the brain and other vital organs," according to the National Institutes of Health. The company said the Keytruda combination trial had previously been on a partial clinical hold when a different patient died of cardiogenic shock.
Alpine referred inquiries to the press release and didn't comment on whether the company was shutting down ALPN-202 altogether or if the company would start new trials down the road.
According to the release, the most recent patient who died had metastatic colorectal cancer previously treated with a colectomy and chemotherapies. The patient had received a single dose each of ALPN-202 and Keytruda. Alpine is assessing all ALPN-202 clinical trial participants, according to the company.
Alpine said it will now mostly focus on developing ALPN-303, which targets autoimmune and inflammatory diseases, and ALPN-101, which also targets inflammatory diseases. Alpine in 2020 signed a $60 million licensing agreement with Chicago-based AbbVie for ALPN-101, and the deal included an extra $805 million if the drug hit certain milestones.
“Patient safety remains our highest priority,” Alpine CEO Mitchell Gold said in the release. “We will continue to work with the U.S. Food and Drug Administration, Merck, the study safety monitoring committee and the study investigators to further understand this important safety issue. Davoceticept has shown encouraging signs of clinical activity, and it is unfortunate we have not yet been able to identify a safe dose regimen for the combination with pembrolizumab."
Alpine was founded in 2015 and went public in 2017 through a merger with Nivalis Therapeutics, a Boulder, Colorado-based pharmaceutical company that was focused on cystic fibrosis. Alpine, an immunotherapy company focused on protein engineering, raised $100 million through an underwritten public offering in September. In September 2021, Alpine raised about $91 million through a private placement, a way companies can raise money by selling shares to select investors.
