On November 28, 2022 Presage Biosciences, a biotechnology company whose mission is understanding the complexity of drug response in the tumor microenvironment, reported completion of a first-of-its-kind Phase 0 clinical study utilizing its CIVO (Comparative In Vivo Oncology) multiplexed microdosing technology (Press release, Presage Biosciences, NOV 28, 2022, View Source [SID1234624523]). Presage evaluated an investigational immuno-oncology agent, subasumstat, alone and in combination with other immuno-oncology agents. The spatial biology and mechanistic insights generated from this fully-enrolled Phase 0 study not only provided additional target validation in patient tumors, but also delivered unique drug combination and pharmacodynamic biomarker data with the potential to inform further clinical development of the investigational therapy.
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"This pioneering collaboration has delivered important translational data early in the clinical development process to help elucidate the modulation of the tumor microenvironment by an investigational agent through detailed visualization and molecular profiling in patients with head and neck cancer," said Christopher Arendt, Head of Oncology Cell Therapy and Therapeutic Area Unit at Takeda.
"Execution of this first-of-its-kind trial (NCT04065555) required innovation on multiple fronts: Development of novel technology, training and coordination of clinical trial sites; establishment of a novel regulatory path with the U.S. Food and Drug Administration, and exploration of a new dimension in spatial biology – pairing drug-exposure with molecular profiling technology," said Rich Klinghoffer, PhD, Presage CEO. "These achievements enabled us to successfully execute on a truly cutting-edge study and I am proud of the Presage Team’s accomplishment."
The Presage platform was developed to interrogate the highly complex tumor microenvironment that is unique to each individual patient, and to better understand the potential therapeutic response to treatment with investigational cancer agents. Accurate ex vivo modeling of tumors has proven difficult, and represents a fundamental challenge to early drug development. Under the conventional drug development paradigm, evidence of biological activity of a drug is typically not known until later stages of clinical development, and only after investment of significant time, resources, and cost. With a mission to address this fundamental issue, Presage Biosciences operates as a translational oncology research organization that is uniquely capable of providing spatial biology insights to help advance novel treatments for cancer patients.
"Patients have unmet needs and require more options to reduce cancer burden, improve survival, and enhance their quality of life and Presage will continue to interrogate the tumor microenvironment and work towards furthering the precision and efficiency of cancer drug development," said Klinghoffer.
Preliminary findings from the PBI-TAK-01 study were highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting and additional spatial biology data was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting. Presage has ongoing collaborations with Takeda and Merck for Phase 0 trials with CIVO.
About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of deep spatial biology insights. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.