Biothera expands relationship with Merck, enters collaboration for combination cancer immunotherapy trials in multiple indications
Biothera’s Imprime PGG and Merck’s anti-PD-1 inhibitor Keytruda (pembrolizumab) to be evaluated in combination for patients with either advanced melanoma or metastatic triple negative breast cancer.
Biothera Pharmaceuticals has announced a collaboration with Merck (MSD), 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 tumour targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies.
Under this new collaboration, a Phase II 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 Ib/II 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.
Barry Labinger, CEO of Biothera, stated: “Combination therapies with breakthrough medicines such as Keytruda are potentially the next major advance in the treatment of cancer. We believe that Imprime PGG is uniquely suited to complement immune checkpoint inhibitor therapy and meaningfully enhance patient outcomes. The trial will assess safety and efficacy, as well as provide biomarker and pharmacodynamic data that will inform the design of potential Phase 3 pivotal studies.”
Eric Rubin, Vice President and Therapeutic Area Head, Oncology Early-stage Development, Merck Research Laboratories, commented, “As a leading innovator in the field of immuno-oncology, Merck is dedicated to advancing breakthrough science by continuing to identify novel combinations with potential to improve the care for people with cancer. We are pleased to expand our partnership with Biothera as we explore the potential for combining Keytruda with their lead candidate.”
Related News
-
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. -
News CPHI Podcast Series: Why we need to consider women in clinical trials
The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. -
News US FDA does not approve MDMA therapy for PTSD, requests more data
The MDMA-based therapeutic developed by Lykos Therapeutics, a California-based Public Benefit Corporation (PBC), has been reviewed and unapproved by the US FDA. The regulator has requested additional phase III trial data for further safety and efficacy... -
News Novartis and Viatris latest facing lawsuit over HeLa cell misuse
Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. -
News Sanofi invests billions into Frankfurt insulin production site
French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production. -
News Novel oral Type 1 diabetes drug gains US FDA IND designation
A University of Alabama at Birmingham startup has gained FDA clearance for Investigational New Drug clinical trials for an oral Type 1 diabetes drug, a milestone for diabetes treatment. -
News A Day in the Life of a Vice President in R&D & Engineering
In the Day in the Life of Series, we've already had the chance to get to know a range of people in various roles in the pharma industry. In the latest interview we get a glimpse into the R&D side of things from Jennifer Sorrells, Vice Presiden...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance