Checkpoint Therapeutics Stock Rises After Positive Topline Results from the Registration-Enabling Trial
Jan 25, 2022 By MarketDepth
Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) shares jumped more than 13% Tuesday after the clinical-stage immunotherapy and targeted oncology company announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous cell carcinoma (“cSCC”).
“Most people don’t realize that cutaneous squamous cell carcinoma is the second most common form of skin cancer. While treatable with surgery when caught early, cSCC patients diagnosed with advanced disease that has recurred or metastasized have traditionally faced a poor prognosis and often suffer from painful physical discomfort. These impressive results demonstrate that cosibelimab, a novel PD-L1 antibody with a unique two-fold mechanism of action, has the potential to offer physicians a new treatment option that provides compelling efficacy, complemented by a favorable tolerability profile, for patients living with this devastating disease.”Professor Philip Clingan, Medical Oncologist at Southern Medical Day Care Centre in Australia and co-principal investigator of the trial
The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate (“ORR”) of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 (“RECIST 1.1”) criteria. The median duration of response (“DOR”) had not yet been reached at the data cut-off point (76% of responses are ongoing). Safety data across 201 patients with advanced cancers enrolled and treated in all cohorts of the ongoing study remain consistent with those previously reported, with the majority of treatment-emergent adverse events reported as Grade 1 or 2 in severity. Based on these results, Checkpoint intends to submit a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration for cosibelimab later this year, to be followed by a marketing authorization application (“MAA”) submission in Europe and additional potential submissions in markets worldwide.
“Upon approval, we intend to position cosibelimab at a lower price point than currently available PD-(L)1 therapies, which we hope will lead to meaningful market share in the U.S. and international markets around the world. We also believe the safety and efficacy profile of cosibelimab could make cosibelimab an attractive agent for use in combination regimens, potentially with drug candidates within our current portfolio, additional molecules we may in-license, and synergistic molecules through potential collaborations, particularly those that can take advantage of the two-fold mechanism of action of cosibelimab.”Mr. Oliviero