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InflaRx Doses First Patient in Multicenter Phase II Clinical Trial in Cutaneous Squamous Cell Carcinoma with Vilobelimab
Proof-of-concept trial will evaluate vilobelimab alone and in combination with pembrolizumab JENA, Germany, June 08, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V.
About this update from Inflarx N.v.
[{"type":"text","content":"Proof-of-concept trial will evaluate vilobelimab alone and in combination with pembrolizumab JENA, Germany, June 08, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the enrollment of the first patient in an open-label, multicenter Phase II clinical study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). The Phase II clinical trial is expected to enroll approximately 70 patients at sites in Europe, the U.S. and elsewhere. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm. Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx, said: “We are pleased to initiate the first clinical trial to evaluate vilobelimab in cancer. Scientific data suggest C5a involvement in tumor formation and progression, as well as in immunosuppression. Additionally, there is pre-clinical evidence of synergies between PD-1 and C5a/C5aR inhibitors in inducing anti-tumor responses. Based on this, we believe that vilobelimab has the potential alone and in combination with the PD-1 checkpoint inhibitor pembrolizumab to treat the advanced stages of this potentially deadly skin cancer.” The C5a/C5aR pathway has been implied as a potential driver for tumorigenesis, metastases and avoidance of immune cell destruction, particularly in the context of cSCC. Several independent pre-clinical studies showed that the combination of a C5a or C5aR pathway inhibitor with inhibition of the PD-1/PD-L1 axis leads to an antitumoral effect, which was stronger than inhibition of one of the axes alone. This provides a pre-clinical rationale for the combined blockade of PD-1 and C5a to restore antitumor immune responses and to inhibit tumor cell growth. About cutaneous squamous cell carcinoma (cSCC) cSCC is the second most common form of skin cancer and, if caught early, it is generally ...