Date: 2016-08-24
Type of information: Clinical research agreement
Compound: Imprime PGG and Keytruda® (pembrolizumab)
Company: Merck&Co (USA - NJ) Biothera Pharmaceuticals (USA - MN)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research collaboration
Action mechanism: îmmunotherapy product/monoclonal antibody/immune checkpoint inhibitor/ß glucane. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. MK-3475 is currently being studied in three clinical trials for advanced melanoma including a Phase III trial of MK-3475 versus ipilimumab in ipilimumab-naïve advanced melanoma patients (PN 006). Enrollment is complete in the advanced melanoma cohorts in the company’s Phase IB trial (PN 001) and the Phase II trial (PN 002) comparing two doses of MK-3475 versus chemotherapy in patients with advanced melanoma who have progressed after prior therapy. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. In April 2013, MK-3475 has received a Breakthrough Therapy designation for advanced melanoma from the FDA. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway. Imprime PGG is a yeast-derived pharmaceutical-grade soluble 1,3/1,6 ?-glucan. it is being developed for the treatment of cancer in conjunction with tumor targeting and immunomodulatory antibodies. Imprime has shown promising results in multiple Phase 2 clinical trials in non-small cell lung cancer (NSCLC) and chronic lymphocytic leukemia (CLL) with additional studies ongoing.
Disease:
Details: * On August 24, 2016, Biothera Pharmaceuticals announced a collaboration with Merck&Co to expand the companies’ ongoing clinical program evaluating Keytruda® (pembrolizumab), Merck’s anti-PD-1 inhibitor, in combination with Biothera’s Imprime PGG, a Pathogen Associated Molecular Patterning molecule, or PAMP. Imprime PGG acts as an immunological “ignition switch” enlisting the innate immune system to enhance the therapeutic efficacy of tumor targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. Under this new collaboration, a Phase 2 clinical trial is anticipated to enroll up to 95 patients who have either advanced melanoma no longer responding to initial treatment with a checkpoint inhibitor therapy or TNBC whose disease has progressed following treatment with one or more lines of therapy for metastatic disease. Biothera will be the sponsor of the study, which is planned to begin in the fourth quarter of 2016. Merck will provide clinical supplies of Keytruda® for the planned studies. Other terms of the collaboration were not disclosed. Biothera previously announced an agreement in December 2015 for Merck to supply Keytruda® for a Phase 1b/2 clinical study testing combination therapy with Imprime PGG in NSCLC patients. The Big Ten Cancer Research Consortium will conduct the multi-center trial, which is expected to commence this fall.
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