Unloxcyt (cosibelimab-ipdl) / Sun Pharma - LARVOL DELTA

FDA approves label update for UNLOXCYT (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC) (PRNewswire) - "The updated label now incorporates long-term follow-up data from the pivotal CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC), which showed patients receiving UNLOXCYT experienced durable clinical responses."

FDA event • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Arsen Osipov | Trial completion date: Dec 2027 ➔ Feb 2027 | Initiation date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2027 ➔ Feb 2027

Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Immunotherapy in Advanced Cutaneous Squamous Cell Carcinoma: A Retrospective Study of 59 Patients in a Monographic Center (EADV 2025) - "In cases where surgery or radiotherapy is not feasible as curative treatment, immune checkpoint inhibitors, such as anti-PD-1 agents (Cemiplimab, Nivolumab, Pembrolizumab) and anti-PD-L1 agents (Cosibelimab), are the main therapeutic option. Immunotherapy is a safe and effective treatment option for a broad range of patients with advanced cSCC. Our study conducted in routine clinical practice provides valuable insights into treatment response and supports further research into predictive biomarkers and patient stratification strategies."

IO biomarker • Metastases • Retrospective data • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years. (PubMed, J Am Acad Dermatol) - "Cosibelimab demonstrated robust and durable ORRs with increasing CR rates in advanced CSCC and low rates of severe immune-related adverse events."

Journal • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • PD-L1

Fortress Biotech Announces Closing of Sale of Subsidiary Checkpoint Therapeutics (The Manila Times) - "Fortress Biotech, Inc...today announced that its subsidiary, Checkpoint Therapeutics, Inc...has been acquired by Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, 'Sun Pharma')....We are thrilled that our Fortress-founded subsidiary, Checkpoint, closed an exciting deal with Sun Pharma that expedites patient access to FDA approved UNLOXCYT (cosibelimab-ipdl) through their established global commercial organization. This transaction is also another successful milestone for Fortress, as we will receive approximately $28 million shortly after closing and are eligible for a 2.5% royalty on net sales of UNLOXCYT, and up to an additional $4.8 million if the contingent value right (CVR) is achieved."

M&A • Skin Cancer • Squamous Cell Skin Cancer

A Comprehensive Narrative Review of the Challenges Surrounding Cutaneous SCC. (PubMed, Dermatol Ther (Heidelb)) - "While surgical excision is indicated for high-risk invasive cSCC, other treatments may include adjuvant radiation therapy (ART) and systemic therapies such as immune checkpoint inhibitors (cemiplimab, pembrolizumab, and cosibelimab) and epidermal growth factor receptor (EGFR) inhibitors (cetuximab). Despite advancements, inconsistent application of ART and biopsy limitations persist, highlighting the need for a standardized, evidence-based approach to cSCC management. This review highlights the challenges surrounding cSCC and the potential value of molecular tools to improve outcomes for patients with high-risk cSCC."

IO biomarker • Journal • Review • Genetic Disorders • Head and Neck Cancer • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Sun Pharma Completes its Acquisition of Checkpoint Therapeutics (Sun Pharma) - "Sun Pharmaceutical Industries Limited...announced the successful completion of its acquisition of Checkpoint Therapeutics, Inc. ('Checkpoint'), an immunotherapy and targeted oncology company. As part of the acquisition, Sun Pharma acquires UNLOXCYT, the first and only FDAapproved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma...Sun Pharma has acquired all outstanding shares of Checkpoint at a price of $4.10 per share in cash, without interest, plus one non-tradable contingent value right (CVR) per share representing the right to receive up to an additional $0.70 in cash, without interest, if certain specified milestones are met, as set out in the terms and conditions of the contingent value rights agreement. "

M&A • Squamous Cell Carcinoma

Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Arsen Osipov

New P1 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

PD-L1 Inhibitor Cosibelimab for Cutaneous Squamous Cell Carcinoma: Comprehensive Evaluation of Efficacy, Mechanism, and Clinical Trial Insights. (PubMed, Biomedicines) - "In this review, we evaluate the therapeutic potential of cosibelimab by analyzing its mechanism of action, clinical trial data, and its role compared to other PD-1/PD-L1 inhibitors, such as pembrolizumab and cemiplimab. Given its efficacy and safety, cosibelimab holds promise not only as a monotherapy but also for future exploration in combination regimens and broader oncologic indications. Future trials are required to validate its long-term outcomes, including overall survival, and to explore its use in combination therapies and neoadjuvant/adjuvant settings."

Journal • Review • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Cosibelimab. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

Cosibelimab: First Approval. (PubMed, Drugs) - "In contrast to other anti-PD-L1 antibodies, cosibelimab can induce antibody-dependent cell mediated cytotoxicity as it includes a functional Fc domain. This article summarizes the milestones in the development of cosibelimab leading to this first approval for this indication."

Journal • Review • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Sun Pharma to Acquire Checkpoint Therapeutics (PRNewswire) - "Sun Pharmaceutical Industries Limited...and Checkpoint Therapeutics...announced that they have entered into an agreement by which Sun Pharma will acquire Checkpoint, an immunotherapy and targeted oncology company....Will add UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to Sun Pharma's global onco-derm franchise....Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right (CVR) entitling the stockholder to receive up to an additional $0.70 in cash, without interest....The transaction is expected to be completed in the second calendar quarter of 2025."

M&A • Oncology • Solid Tumor • Squamous Cell Skin Cancer

Cosibelimab (Unloxcyt) for cutaneous squamous cell carcinoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=272 | Active, not recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=500 ➔ 272 | Trial completion date: Dec 2024 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT (cosibelimab-ipdl) (GlobeNewswire) - "Checkpoint Therapeutics...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....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)..."

FDA approval • Squamous Cell Skin Cancer

Cosibelimab Shows Promising Efficacy and Safety in Cutaneous CSCC (Cancer Network) - "According to Jason J. Luke, MD...results from a phase 1 CK-301-101 trial (NCT03212404) seem to support the use of cosibelimab (Unloxcyt) in the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)."

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Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results in Advanced Cutaneous Squamous Cell Carcinoma Presented at ESMO Congress 2024 (Fortress Biotech Press Release) - P1 | N=500 | NCT03212404 | Sponsor: Checkpoint Therapeutics, Inc. | "Checkpoint Therapeutics, Inc...announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ('PD-L1') antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ('cSCC') during the European Society for Medical Oncology ('ESMO') Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17, 2024....ORRs of 54.8% and 50.0% achieved in locally advanced and metastatic cSCC, with median follow-up durations of 24.1 and 29.3 months, respectively. Results demonstrate a deepening of response over time, with complete response rates of 25.8% and 12.8% in locally advanced and metastatic cSCC, respectively."

P1 data • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Cosibelimab in advanced cutaneous squamous cell carcinoma (CSCC): Longer-term efficacy and safety results from pivotal study (ESMO 2024) - P1 | "Cosibelimab demonstrates robust objective response and complete response rates in advanced CSCC, with manageable safety and notable low rates of overall and severe immune-related AEs."

Clinical • Metastases • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

CONTERNO: Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab (CK-301) in First Line Metastatic Non-squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=25 | Terminated | Sponsor: Checkpoint Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma (GlobeNewswire) - "Checkpoint Therapeutics...announced that the U.S. Food and Drug Administration ('FDA') has accepted for review Checkpoint’s resubmission of its Biologics License Application ('BLA') for cosibelimab, its anti-programmed death ligand-1 ('PD-L1') antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma ('cSCC') who are not candidates for curative surgery or curative radiation. The resubmission has been accepted as a complete response to the FDA’s December 2023 complete response letter ('CRL') and the FDA has set a Prescription Drug User Fee Act ('PDUFA') goal date of December 28, 2024."

FDA filing • PDUFA • Skin Cancer • Squamous Cell Skin Cancer

GC Cell and Checkpoint Therapeutics Advance Collaborative Cancer Research (GlobeNewswire) - "GC Cell...and Checkpoint Therapeutics...have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint’s anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer ('CIK') T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction....The anticipated synergy between cosibelimab’s antibody-dependent cellular cytotoxicity ('ADCC') mechanism of action and Immuncell-LC’s robust autologous CIK T cell response is supported by extensive research. This combination is expected to leverage immune system components more effectively in targeting and eliminating cancer cells."

Licensing / partnership • Oncology

Checkpoint Therapeutics Announces Biologics License Application Resubmission for Cosibelimab (GlobeNewswire) - "Checkpoint Therapeutics, Inc...announced it has completed the resubmission of its Biologics License Application ('BLA') to the U.S. Food and Drug Administration ('FDA') for cosibelimab, its anti-programmed death ligand-1 ('PD-L1') antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ('cSCC') who are not candidates for curative surgery or curative radiation....The BLA resubmission is supported by the results of Checkpoint’s studies in selected recurrent or metastatic cancers, including pivotal cohorts in metastatic and locally advanced cSCC."

FDA filing • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Checkpoint Therapeutics Announces Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission (Fortress Biotech Press Release) - "Checkpoint Therapeutics, Inc...announced it has reached alignment with the Food and Drug Administration ('FDA') on its biologics license application ('BLA') resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ('cSCC') who are not candidates for curative surgery or curative radiation."

FDA filing • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Checkpoint Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Updates (GlobeNewswire) - "In December 2023, the FDA issued a CRL for the cosibelimab BLA....Checkpoint intends to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year."

BLA • Squamous Cell Skin Cancer

Checkpoint Therapeutics Reports Full-Year 2023 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "...'We continue to work closely with our third-party contract manufacturing organization to expeditiously resolve the deficiencies noted in the complete response letter ('CRL') we received last December, and are targeting a Biologics License Application ('BLA') resubmission for cosibelimab by mid-year to potentially obtain marketing approval before the end of 2024'."

BLA • Non-melanoma Skin Cancer • Squamous Cell Skin Cancer