On September 9, 2020 Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its Comparative In Vivo Oncology (CIVO) intratumoral microdosing platform, reported a new research collaboration with Takeda Pharmaceutical Company Limited (Takeda) that will utilize CIVO to evaluate multiple investigational oncology agents and combinations in Phase 0 trials (Press release, Presage Biosciences, SEP 9, 2020, https://www.prnewswire.com/news-releases/presage-announces-new-multi-project-collaboration-with-takeda-for-phase-0-studies-of-novel-cancer-agents-with-civo-technology-301126141.html [SID1234612195]).
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The agreement includes evaluation of a specified new investigational agent, as well as options for additional future projects over the next several years. All projects will involve the use of CIVO to evaluate patients’ unique responses to microdoses of cancer drugs. The agreement includes undisclosed upfront and milestone payments to Presage.
"Takeda’s partnership with Presage has yielded valuable learnings across our early immuno-oncology pipeline and this expansion of our collaboration represents a natural evolution of our fruitful efforts," said Chris Arendt, Head, Oncology Therapeutic Area Unit at Takeda. "The ability to gain critical mechanistic insights earlier in the development process is invaluable in clinical translation and can ultimately help us to accelerate advancing innovative oncology medicines to patients who may benefit."
"We are pleased to enter into this new, expanded alliance with Takeda – our longstanding collaborator with a deep oncology pipeline – that will further the company’s investigational efforts to rapidly advance anticancer agents and combinations with the most potential," said Rich Klinghoffer, PhD, Presage CEO. "For far too long, early cancer drug development has been reliant on laboratory models of cancer that serve as poor proxies of human tumors. It’s time to change that paradigm and employ platforms like CIVO to safely and more accurately evaluate novel therapies in cancer patients."
Research recently published in Clinical Cancer Research highlights the feasibility and safety of CIVO to evaluate multiple antitumor agents simultaneously in patients with solid tumors. (K. Gundle et al, Clinical Cancer Research, April 2020, Doi: 10.1158/1078-0432). These data support how multidrug assessments with CIVO may help define specific responses within the intact native tumor microenvironment providing better understanding of drug activity as well as potential mechanisms of tumor resistance. "Patients need and deserve the best cancer treatments. As described in our recent peer reviewed publication, the use of CIVO can bridge the gap between preclinical and clinical research, providing a frontline drug development tool to identify the most promising anti-cancer therapies that can truly impact human health," said Klinghoffer.
Takeda has previously partnered with Presage on preclinical mechanism of action and combination studies, including work highlighted by both companies at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting and an ongoing Phase 0 trial. Presage also has ongoing collaborations with Celgene and BMS for Phase 0 trials with CIVO.
About CIVO and Phase 0 Trials
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables intratumoral microdosing and analysis of multiple cancer agents. Phase 0 trials, or Exploratory Investigational New Drug studies, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. Presage is advancing the use of CIVO in Phase 0 trials in order to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. A recently completed clinical trial demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.