Unloxcyt (cosibelimab-ipdl) / Checkpoint Therapeutics - LARVOL DELTA

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)."

Video

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

Checkpoint Therapeutics Announces $14 Million Registered Direct Offering Priced At-the-Market (GlobeNewswire) - "Checkpoint Therapeutics, Inc...today announced that it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 7,756,233 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.805 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market...H.C. Wainwright & Co. is acting as exclusive placement agent for the offering....The closing of the offering is expected to occur on or about January 31, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $14 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the planned resubmission of its Biologics License Application ('BLA') for cosibelimab."

Financing • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer (GlobeNewswire) - "Checkpoint Therapeutics...announced that the U.S. Food and Drug Administration ('FDA') has issued a complete response letter ('CRL') for the cosibelimab biologic license application ('BLA') for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma ('cSCC') who are not candidates for curative surgery or radiation. The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab....'We believe we can address the feedback in a resubmission to enable marketing approval in 2024'..."

FDA event • Non-melanoma Skin Cancer • Squamous Cell Skin Cancer

Checkpoint Therapeutics Strengthens Intellectual Property Protection for Cosibelimab with New U.S. Patent Issuance (GlobeNewswire) - "Checkpoint Therapeutics, Inc...today announced that the U.S. Patent and Trademark Office ('USPTO') has issued a new patent (U.S. Patent No. 11,834,505) covering a method of treating various cancers, including cutaneous squamous cell carcinoma ('cSCC'), through the administration of cosibelimab....The USPTO previously issued a composition of matter patent (U.S. Patent No. 10,590,199), specifically covering cosibelimab, or a fragment thereof. Together, these patents protect Checkpoint’s differentiated and potential best-in-class anti-PD-L1 antibody, cosibelimab, in the U.S. through at least May 2038, not including any potential patent term extension under the Hatch-Waxman Act."

Patent • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Fortress Biotech Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights (Fortress Biotech Press Release) - "We are also anticipating the PDUFA goal date of January 3, 2024, for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ('cSCC'); We also expect to continue to advance our early-to-mid-clinical-stage candidates, some of which may begin pivotal trials during the next twelve to eighteen months, including: MB-106 – CD20-targeted CAR-T cell therapy for hematologic malignancies; MB-109 – IL13Rα2-targeted CAR-T cell therapy combined with HSV-1 oncolytic virus for recurrent glioblastoma and high-grade astrocytomas"

New trial • PDUFA date • Anaplastic Astrocytoma • Glioblastoma • Hematological Malignancies • Squamous Cell Skin Cancer

Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. (PubMed, J Immunother Cancer) - P1 | "Cosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile."

Journal • Metastases • Fatigue • Hematological Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Checkpoint Therapeutics Announces Publication of Cosibelimab Pivotal Trial Results in the Journal for ImmunoTherapy of Cancer (GlobeNewswire) - P1 | N=500 | NCT03212404 | Sponsor: Checkpoint Therapeutics, Inc. | "Checkpoint Therapeutics, Inc...announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma ('cSCC'), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer....As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results. Median duration of response was not yet reached."

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

Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma (J Immunother Cancer) - P1 | N=500 | NCT03212404 | Sponsor: Checkpoint Therapeutics, Inc. | "Objective response was observed in 37 of 78 participants (47.4% (95% CI: 36.0% to 59.1%)), with median follow-up of 15.4 months (range: 0.4 to 40.5) as of data cut-off. Median DOR was not reached (range: 1.4+ to 34.1+ months), with response ongoing in 73.0% of participants. Common treatment-emergent AEs (≥15%) were fatigue (26.9%), rash (16.7%), and anemia (15.4%)....Cosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile."

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

Checkpoint Therapeutics Announces Exercise of Warrants for $11.13 Million in Gross Proceeds (GlobeNewswire) - "Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including the manufacturing of cosibelimab and certain pre-commercial activities in anticipation of potential approval and commercial launch."

Commercial • Oncology