Melanoma Advanced Melanoma Metastatic Melanoma Unresectable Melanoma
The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. Why Should I Register and Submit Results?ĬMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma.“The unique combination of a differentiated Toll-like receptor 9 with other antibody-based oncology agents may result in increased clinical benefit and provide new treatment options for patients in need. “As we continue to advance and expand our research efforts in immuno-oncology, the acquisition of Checkmate will add a promising new modality to Regeneron’s toolkit of potential approaches for difficult-to-treat cancers,” Leonard Schleifer, Regeneron’s president and CEO, said in a prepared statement. Regeneron views the Checkmate drug as complementary to its own oncology assets. Two have reached mid-stage testing: odronextamab, which is in development for B-cell non-Hodgkin lymphoma, and REGN548, which is a potential multiple myeloma therapy. The Regeneron oncology pipeline is comprised mainly of antibody drugs.
#Checkmate pharmaceuticals skin
Libtayo has approvals in lung and skin cancers. Vidutolimod could complement Libtayo, offering a treatment option to patients whose cancer does not respond to that Regeneron drug. Regeneron’s presence in cancer is through Libtayo, a PD-1 inhibitor marketed under a partnership with Sanofi. The company also has data from tests of vidutolimod as a monotherapy in patients whose tumors had progressed despite treatment with an immunotherapy that blocks PD-1, a protein on immune cells that keeps them from recognizing cancer cells.
#Checkmate pharmaceuticals trial
Checkmate has said it believes success in this trial could support the submission of an application seeking FDA approval. The drug is currently in a Phase 2 melanoma study evaluating the therapy in combination with Opdivo, a checkpoint inhibitor from Bristol Myers Squibb. Other companies taking this approach include TriSalus Life Sciences, Idera Pharmaceuticals, and Bolt Biotherapeutics.Ĭheckmate aimed to use vidutolimod as a way to establish its approach as a way to potentially treat a wide range of solid tumors.
Checkmate has competition in the chase for cancer therapies that activate Toll-like receptors. Given as an injection into the tumor, vidutolimod is intended to direct T cells to attack the injected tumor as well as other tumors throughout the body. The drug activates TRL9 with a nucleotide that’s delivered in a virus-like particle. The company’s lone drug candidate, vidutolimod, is designed to stimulate Toll-like receptor 9 (TLR9), a receptor expressed in immune cells. Tarrytown, New York-based Regeneron and Cambridge, Massachusetts-based Checkmate expect to close the transaction in the middle of this year.Ĭheckmate is developing therapies that activate the innate immune system, the body’s first-line defense against pathogens. Shares of the Checkmate jumped to nearly that level after the deal was announced Tuesday, well above Monday’s $2.43 closing price but still shy of the $15 per share IPO price in 2020. According to terms of the deal, Regeneron will pay $10.50 cash for each Checkmate share.
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