Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab

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Waltham, Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ:  CKPT), a clinical-stage immunotherapy and targeted oncology company, today 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”).  

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. 

“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,” commented Professor Philip  Clingan, Medical Oncologist at Southern Medical Day Care Centre in Australia and co-principal  investigator of the trial. “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.” 

James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, “We are thrilled  to report these topline results from our pivotal trial of cosibelimab in metastatic cutaneous  squamous cell carcinoma. We believe the strong ORR result is attributable to cosibelimab’s  differentiated, two-fold mechanism of action of engaging both T-cells and natural killer cells,  while also demonstrating a potential favorable safety profile through its binding to PD-L1, 

reported in literature as associated with lower rates of severe or worse adverse events as  compared to PD-1 therapy. We extend our sincere thanks to the patients, caregivers,  investigators and their site staff for their dedication to this trial, particularly during these  challenging times globally. We look forward to a detailed presentation of the data at an  upcoming medical meeting.” 

Mr. Oliviero continued, “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.” 

Additionally, Checkpoint continues to enroll a registration-enabling cohort of patients with  locally advanced cSCC, anticipating this potential second indication could be included in the  planned initial BLA submission, as well as the global, randomized Phase 3 (CONTERNO) trial of  cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line  treatment of patients with non-squamous non-small cell lung cancer. 

Conference Call Information 

Checkpoint will host a conference call today, Tuesday, January 25, 2022, at 8:30 AM ET to  discuss the topline results. In order to participate in the conference call, please dial 1-877-269- 7756 (U.S.), 1-201-689-7817 (outside of the U.S.).  

A live webcast of this conference call will be available on the IR Calendar page under News &  Events, located within the Investors section of Checkpoint’s website,, and an audio recording of the  conference call will also be available for replay for a period of approximately 30 days following the call. 

About Cutaneous Squamous Cell Carcinoma 

Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in  the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to  curative resection, approximately 40,000 cases will become advanced and an estimated 15,000  people will die from their disease. In addition to being a life-threatening disease, cSCC causes  significant functional morbidities and cosmetic deformities based on tumors commonly arising  in the head and neck region and invading blood vessels, nerves and vital organs such as the eye  or ear. 

About Cosibelimab 

Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1  (“PD-L1”) and blocks the PD-L1 interaction with the programmed death receptor-1 (“PD-1”) and  B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the 

interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive  effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab  is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through  sustained >99% target tumor occupancy to reactivate an antitumor immune response and the  additional benefit of a functional Fc domain capable of inducing antibody-dependent cell mediated cytotoxicity (“ADCC”) for potential enhanced efficacy in certain tumor types. 

About Checkpoint Therapeutics 

Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted  oncology company focused on the acquisition, development and commercialization of novel  treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody  product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the  Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial  in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including  cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma intended to  support one or more applications for marketing approval. In addition, Checkpoint is evaluating  its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal  growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR  mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and  was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit

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