On April 14, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27 (Press release, Surface Oncology, APR 14, 2022, View Source [SID1234612214]). The trials include a randomized Phase 2 clinical study evaluating SRF388 in combination with Roche’s atezolizumab and bevacizumab in patients with treatment-naïve hepatocellular carcinoma (HCC) and a Phase 2 monotherapy study in patients with previously-treated non-small-cell lung cancer (NSCLC).
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"While important progress has been made in recent years, unfortunately the prognosis for the majority of patients with hepatocellular carcinoma and previously-treated non-small cell lung cancer remains very poor," said Alison O’Neill, M.D., chief medical officer. "We have generated strong translational and early clinical data supporting a role for IL-27 blockade in these diseases, and we are pleased to be able to evaluate SRF388’s potential to improve patient outcomes in these indications."
Randomized Phase 2 Study in Patients with Treatment-Naive Unresectable or Metastatic Hepatocellular Carcinoma in Clinical Collaboration with Roche
The blinded, randomized Phase 2 study is enrolling approximately 100 patients with treatment-naïve unresectable or metastatic HCC. Patients are randomized to receive either SRF388 or a placebo in combination with atezolizumab and bevacizumab. The study will evaluate the ability of SRF388 to improve progression-free survival in combination with atezolizumab and bevacizumab compared to placebo plus atezolizumab and bevacizumab. Key secondary endpoints will include the safety, overall response rates and duration of response of the combinations. Due to the blinded nature of the study, Surface does not expect to have detailed clinical data prior to study conclusion but anticipates a futility analysis in early 2023 and final data in the first half of 2024.
Single-Arm Phase 2 Study in Patients with Non-Small-Cell Lung Cancer
The single-arm, Phase 2 study is enrolling up to 40 patients with NSCLC who have previously received treatment with one or more lines of therapy, including PD-1 blockade-based regimens or targeted therapies in disease cases with driver mutations. The primary endpoint will be overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) with an anticipated data readout in 2023.
About SRF388
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver, kidney and lung cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immunosuppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping to identify patients most likely to respond to SRF388. In November 2020, Surface announced that SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.