On November 16, 2022 Greywolf Therapeutics, a biotechnology company focused on generating entirely novel anti-tumour immune responses through targeted cancer neoantigen creation, reported it has entered into a clinical supply agreement with Regeneron for their PD-1 inhibitor Libtayo (cemiplimab) (Press release, Grey Wolf Therapeutics, NOV 16, 2022, View Source [SID1234650154]). The agreement relates to Greywolf’s planned Phase 1/2 clinical trial evaluating the safety, tolerability and efficacy of their lead development candidate GRWD5769 (an investigational first-in-class ERAP1 inhibitor), including in combination with Libtayo, in a range of solid tumour types. The study is expected to begin in the first half of 2023.
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In both the GRWD5769 monotherapy and GRWD5769/Libtayo combination modules of the trial, a particular focus will be on patients with virally associated solid tumours, such as head and neck squamous cell carcinoma, cervical cancer, and hepatocellular carcinoma as Greywolf’s analysis of patient data suggests these could be particularly sensitive to GRWD5769.
"GRWD5769 is a first-in-class ERAP1 inhibitor, designed to upregulate the generation of novel neoantigens, and mobilise an entirely novel T cell response against tumours, and in so doing overcome the challenges of T cell exhaustion. Based on this unique mechanism, we believe this compound holds great promise as a monotherapy, and we’re excited to evaluate our approach in the clinic where there is a particularly strong rationale for observing striking effects in patients with virally associated cancers." said Peter Joyce, Ph.D., chief executive officer of Greywolf Therapeutics. "At the same time, we believe that this innovative approach to attacking cancer also has great potential to synergistically improve outcomes when used in rational combination with other anti-cancer agents, particularly immune checkpoint inhibitors. As such, we are looking forward to the opportunity to assess GRWD5769 in combination with Regeneron’s Libtayo. Their continued investment in immuno-oncology innovation is clearly aligned with our first in class approach to cancer immunotherapy and we are delighted to be working with them as we progress into the clinic".