First Patient With Squamous Cell Carcinoma Dosed in Phase 2 Trial for Vilobelimab


The first patient was enrolled and dosed in InflaRx’s phase 2 trial of vilobelimab for the treatment of cutaneous squamous cell carcinoma.

It was announced in early June that InflaRx officially dosed its first patient in the phase 2 clinical trial evaluating vilobelimab for the treartment of PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC).

Vilobelimab is a first-in-class – meaning a new mechanism of action for a treatment – monoclonal anti-human complement factor C5a antibody. It blocks activity of C5a, a protein fragment in cancer. It has also proven to be able to control inflammatory response-driven tissue and organ damage.

“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,” said Dr. Korinna Pilz, the global head of clinical research and development at InflaRx, in a release.

The trial expects to enroll 70 patients across multiple countries, examining vilobelimab alone and vilobelimab in combination with Keytruda (pembrolizumab). Researchers aim to assess the safety and antitumor activity of vilobelimab alone, while determining the maximum tolerated/recommended dose, safety and antitumor activity in the group receiving vilobelimab and Keytruda.

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