BURLINGAME -
Soquelitinib demonstrated durable anti-tumor activity, evidenced by progression free survival, duration of response and overall survival rates that exceed current standard of care therapies for patients with relapsed PTCL. The data continues to support the advancement of soquelitinib into a Phase 3 registrational clinical trial in PTCL.
'We have continued to enroll patients in the soquelitinib Phase 1/1b clinical trial to further confirm the eligibility requirements and design for our planned Phase 3 clinical trial,' said
New Soquelitinib Interim Data from the Phase 1/1b Clinical Trial
Updated interim data as of
For the eligible patient population, objective responses (complete response, CR plus partial response, PR) were seen in 7 of 21 patients with disease control (CR, PR and stable disease) in 12 of 21 patients. The stable disease group included 5 patients who achieved tumor reductions that did not meet the criteria for a PR, with two of these patients continuing on therapy.
For the eligible patient population, the median duration of response (DOR) for the seven patients with objective response by Lugano criteria was 14.5+ months (ranged from 6.9-25.2 months); three of these patients continued on therapy.
A total of five patients in the eligible patient population remained on therapy, including one patient with a CR at 21+ months, two patients with a PR at 3+ and 8+ months, and 2 with stable disease at 3+ and 5+ months.
One additional eligible patient, not shown here, was treated at a higher dose and achieved a PR. While in PR, this patient went on to receive a bone marrow transplant and achieved a CR, which has continued as of the data cutoff without any further therapy for 2+ years.
For the ineligible patient population, no objective responses were seen in 11 evaluable patients.
About
About Soquelitinib
Soquelitinib (formerly known as CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib's mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company's product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of solid tumors and hematological cancers; the Company's ability and its partners' ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company's Phase 1/1b clinical trial of soquelitinib and the timing of and the Company's ability to launch clinical trials including the potential registrational Phase 3 clinical trial for soquelitinib. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as 'believe,' 'expect,' 'anticipate,' 'intend,' 'plan,' 'estimate,' 'seek,' 'will,' 'may' or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the three months ended
Contact:
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Email: llea@corvuspharma.com
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