In July, for Checkpoint Therapeutics, it was all about complete response rates adding momentum for its promising skin cancer candidate. Five months later however, it’s a complete response letter (CRL) that has flipped the script on cosibelimab.
On Monday, Checkpoint said that the United States regulator had rejected cosibelimab because of findings during an inspection of a facility of its third-party contract manufacturer.
The Waltham, Massachusetts-based biotech added that the FDA did not identify any issues with the “approvability of cosibelimab,” citing no clinical data, safety or labeling concerns.
“We believe we can address the feedback in a resubmission to enable marketing approval in 2024,” James Oliviero, Checkpoint’s CEO, said in a release. “We are committed to working closely with our third-party manufacturer and the FDA on our resubmission in order to make cosibelimab available.”
Arriving late as a PD-1/PD-L1 inhibitor, cosibelimab has posted strong data indicating its fitness for approval. In July, Checkpoint presented long-term results of two phase 3 trials that showed “substantial increases” in the number of patients with both locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC) who had experienced a complete response of their tumors.
The data added more fuel to Checkpoint’s biologic license application for approval of cosibelimab as a first-line treatment for cSCC in patients who are not eligible for surgery or radiation, which the company submitted in January of this year.
But with the CRL, Checkpoint’s share price plummeted on Monday from $3.27 to $1.54, with a rebound to $1.98 by Tuesday morning.
The CRL puts Checkpoint in a precarious spot. In its third-quarter earnings presentation, the company reported cash and equivalents of just $1.8 million.
Checkpoint was established in 2014 and a year later licensed cosibelimab from the Dana-Farber Cancer Institute. The company has hoped to bring cosibelimab as a lower-priced alternative to Merck’s dominant PD-1 Keytruda.