On February 1, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported new data from an ongoing preclinical study of its investigational small molecule T-cell signaling pathway inhibitor (Press release, Corvus Pharmaceuticals, FEB 1, 2018, View Source;p=RssLanding&cat=news&id=2329771 [SID1234523681]).
Results showed that this orally-administered drug demonstrated safety and activity in companion dogs diagnosed with T-cell lymphoma. The data will be presented at the 10TH Annual T-Cell Lymphoma Forum in La Jolla, Calif., by Ryan Wilcox, M.D., Ph.D., assistant professor at the University of Michigan Comprehensive Cancer Center and an expert in peripheral and cutaneous T-cell lymphomas (PTCLs and CTCLs). The presentation is based on a study being led by Douglas Thamm, V.M.D., professor and director of clinical research at Flint Animal Cancer Center at Colorado State University.
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"We are very encouraged by the preliminary activity observed with our novel T-cell signaling pathway inhibitor in canine spontaneous T-cell lymphomas," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "Canine lymphomas, including T-cell malignancies, have cellular and clinical features very similar to human T-cell lymphomas, which are difficult to treat and for which new and improved therapies are desperately needed. Based on the results of this proof-of-concept study to date, we plan to continue enrolling animals in the study, and anticipate advancing the compound into a human clinical trial in approximately a year."
In the reported preclinical study, two dogs have been treated with Corvus’ T-cell signaling pathway inhibitor — one with PTCL and one with CTCL. Results showed evidence of antitumor activity in both animals. A complete response was achieved in the PTCL animal after 28 days of daily dosing, and a partial response was achieved in the CTCL animal within 14 days of the initiation of treatment. The compound was well tolerated in both dogs with no clinical signs or laboratory findings of toxicity.
"At Corvus, small molecule inhibitors of lymphocyte signaling is an area of expertise, and several of the key developers of ibrutinib are researchers here," said Joseph J. Buggy, Ph.D., co-founder and head of research at Corvus. "Similar to the mechanism of action of ibrutinib, our inhibitors are designed to selectively target important signaling pathways that we believe could drive the growth and survival of malignant lymphoma cells. This T-cell signaling pathway inhibitor is just one of multiple product opportunities in our R&D pipeline that target important immune cells and are designed to act on well-defined, very specific and crucial targets."
ABOUT CORVUS’ NOVEL T-CELL SIGNALING PATHWAY INHIBITOR
T-cell signaling is involved in T-cell activation, proliferation and differentiation, and plays a role in the replication and growth of various T-cell malignancies. Corvus’ novel T-cell signaling pathway inhibitor was designed to bind selectively to T-cells. It is orally bioavailable and has been shown to achieve cellular occupancy of the target in vivo in various animal models. It has been evaluated in preclinical safety studies.
The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell cancers — similar to the role of Bruton’s tyrosine kinase (BTK) in B-cells. BTK is now an established target for treating various B-cell lymphomas, and two BTK inhibitors, ibrutinib and aclarabrutinib, have been approved by the U.S. Food and Drug Administration for lymphoma indications. Proof-of-concept was demonstrated with ibrutinib in early preclinical studies in spontaneous canine B-cell lymphoma prior to initiation of human clinical trials.
ABOUT T-CELL LYMPHOMAS
Human T-cell lymphomas are a heterogenous group of difficult-to-treat malignancies. They include peripheral T-cell lymphomas (PTCLs), cutaneous T-cell lymphomas (CTCLs), anaplastic large cell lymphomas, acute lymphocytic lymphoma (ALL), angioimmunoblastic T-cell lymphoma (AITL) and others.
According to the Leukemia and Lymphoma Society, PTCLs comprise a diverse group of aggressive diseases. They generally affect people older than 60 years, although they can occur anytime during adulthood. Common signs and symptoms include fatigue, a painless swelling in the neck, armpit or groin (due to an enlarged lymph node), night sweats, rash and weight loss. Median survival is about two years. Current treatment for PTCLs includes chemotherapy, but most patients relapse.
CTCLs originate in the skin, with advanced stages defined by involvement of lymph nodes, peripheral blood and internal organs. CTCLs are treated with chemotherapy as well as topical therapies, including radiation to the skin.