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  Title	Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT(TM) (cosibelimab-ipdl)
  ID	5072257
  External ID	7389707394
  Author	Unknown
  Published Date	Dec. 13, 2024, 5:18 p.m.
  Summary	WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™
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  URL	https://stockhouse.com/news/press-releases/2024/12/13/checkpoint-therapeutics-announces-fda-approval-of-unloxcyt-tm-xa0-cosibelimab
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• Content Details

  Content ID	3050585
  Key	d11faa38-bd08-4393-a4df-6152eb1b05bf
  Content	WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (“PD-L1”) blocking antibody to receive FDA marketing approval for this indication. The recommended commercial dosage of UNLOXCYT is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks. “Today's FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (“PD-1”), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (“ADCC”), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC.” “cSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis. cSCC remains a disease with a significant need for more effective and tolerable treatment options, particularly for patients with concomitant hematological malignancies, solid organ transplant recipients, or a history of autoimmune disorders,” stated Emily Ruiz, M.D., M.P.H., Academic Director of the Mohs and Dermatologic Surgery Center at Brigham and Women's Hospital, Director of the High-Risk Skin Cancer Clinic at Dana Farber Cancer Center, and Associate Professor of Dermatology at Harvard Medical School. “UNLOXCYT is the first FDA-approved PD-L1–blocking antibody to demonstrate clinically meaningful objective response rates with durable responses in advanced cSCC. With its dual mechanisms of action and compelling safety profile, this promising drug will provide U.S. oncologists with an important new immunotherapy option for the treatment of cSCC.” FDA approval for UNLOXCYT was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee, from Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with advanced solid tumor cancers, including cSCC. “We are excited about the approval of UNLOXCYT and are currently developing a commercial launch plan. We want to thank the patients, physicians, nurses, and clinical coordinators for their support and participation in our clinical program, and the FDA for their collaboration throughout this process,” concluded Mr. Oliviero. 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 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this 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. The immune-suppressed population in particular represents a challenging target in the treatment of advanced cSCC, as patients present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment. About UNLOXCYT™ (cosibelimab-ipdl) UNLOXCYT is a human immunoglobulin G1 (“IgG1”) monoclonal antibody that binds PD-L1 and blocks the interaction between PD-L1 and its T cell receptors, PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. UNLOXCYT has also been shown to induce ADCC. INDICATION and IMPORANT SAFETY INFORMATION INDICATION UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-Mediated Pneumonitis Immune-Mediated Colitis Immune-Mediated Hepatitis Immune-Mediated Endocrinopathies Adrenal Insufficiency Hypophysitis Thyroid Disorders Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis Immune-Mediated Nephritis with Renal Dysfunction Immune-Mediated Dermatologic Adverse Reactions Other Immune-Mediated Adverse Reactions Infusion-Related Reactions Complications of Allogeneic HSCT Embryo-Fetal Toxicity Common Adverse Reactions The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. Please see full Prescribing Information About Checkpoint Therapeutics Checkpoint Therapeutics, Inc. (“Checkpoint”) is a commercial-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint has received approval from the U.S. FDA for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Additionally, Checkpoint is evaluating its lead investigational small-molecule, targeted anti-cancer agent, olafertinib (formerly 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 www.checkpointtx.com Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding expectations for the timing and commercial launch and availability of UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation; the commercial potential of UNLOXCYT; and anticipated healthcare professional and patient acceptance and use of UNLOXCYT for the FDA-approved indication. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following: our ability to establish and maintain a commercial infrastructure or to partner or license UNLOXCYT to a third-party with a commercial infrastructure; our, or our partner or licensee's, ability to successfully launch, market and sell UNLOXCYT or future products, if approved; failure to obtain and maintain requisite regulatory approvals; the potential for variation from our projections and estimates about the potential market for UNLOXCYT; the risk that UNLOXCYT will not be commercially successful; our ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); potential regulatory challenges to our plans to seek marketing approval for UNLOXCYT in additional geographies, outside of the U.S.; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company Contact: Jaclyn Jaffe Checkpoint Therapeutics, Inc. ir@checkpointtx.com Investor Relations Contact: Sandya von der Weid Associate Director, LifeSci Advisors, LLC svonderweid@lifesciadvisors.com Media Relations Contact: Katie Kennedy Gregory FCA checkpoint@gregoryfca.com
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  Publisher URL	https://stockhouse.com
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