Checkpoint Therapeutics is taking a second shot at approval for its anti-PD-L1 candidate after the FDA rejected its first submission around seven months ago due to issues at a third-party manufacturer.
The Waltham, MA-based biotech said Tuesday it resubmitted its BLA for cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The drug is intended for patients who are not eligible for curative surgery or radiation, according to a company release.
Checkpoint also entered a direct offering and private placement on Tuesday with an eye to raising $12 million. The fundraise comes after the company reached alignment with the FDA just last week on a resubmission strategy for cosibelimab.
The drugmaker originally filed for approval for the antibody drug last year with the agency setting a PDUFA date in January 2024. But in December, Checkpoint received a complete response letter detailing problems at a contract manufacturing organization. Checkpoint said at the time that the CRL did not highlight any other issues.
In its registrational test, cosibelimab achieved a 47.4% overall response rate at a median follow-up of 15.4 months, according to data unveiled in 2022. At the time, Checkpoint said it could offer a 20% to 30% discount on the usual $150,000 price tag for other drugs with the same mechanism.
There are three PD-L1s approved for some form of squamous cell carcinoma — Regeneron’s Libtayo, Merck’s Keytruda and Bristol Myers Squibb’s Opdivo.