InflaRx Provides Update on Vilobelimab (IFX-1) Development
- Multiple data readouts expected in 2021
- Phase II trial in patients with cutaneous squamous cell carcinoma expected to start in the first half of 2021
JENA, Germany, Jan. 11, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today provided an update on the ongoing development of vilobelimab (IFX-1), a first-in-class anti-C5a antibody.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “Despite the challenges of COVID-19, we made strong development progress with vilobelimab in 2020. We also are happy to be able to do our part in fighting the ongoing pandemic as we evaluate vilobelimab in patients with severe COVID-19, who as we all know are in desperate need of safe and effective treatments. Looking to the year ahead, we expect to have several important data readouts. We are also excited that we will soon start our first trial in oncology, an important new indication for vilobelimab.”
The Company today announced plans to start an open label, multicenter Phase II 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).
cSCC is the second most common nonmelanoma skin cancer/keratinocyte carcinoma and represents 20% to 50% of all skin cancers. Although the majority of cSCCs are successfully excised surgically, a subset has features associated with a higher likelihood of recurrence, metastasis, and death.
The non-comparative two-stage Phase II trial is expected to start in the first half of 2021 and will be a multi-national study, including sites in Europe, the US and elsewhere. The study investigates two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess the antitumor activity and safety of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.
Hidradenitis Suppurativa (HS)
The Company has been assessing different strategies to progress the clinical development of vilobelimab for HS in the United States. InflaRx plans to submit a Special Protocol Assessment (SPA) to the Food & Drug Administration (FDA) for the Phase III trial in Hidradenitis Suppurativa in the first quarter of 2021. Details on the Phase III design will be provided once an agreement has been reached with the FDA.