On October 4, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported details about its plan to initiate a randomized Phase 2 clinical study evaluating SRF388, a potential first-in-class antibody against IL-27, in combination with Roche’s atezolizumab and bevacizumab, in patients with treatment-naïve hepatocellular carcinoma (HCC) (Press release, Surface Oncology, OCT 4, 2021, View Source [SID1234590735]). Initiation-enabling activities are underway, and the Company expects to dose the first patient in early 2022.
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"We are delighted to announce this new study of SRF388 in HCC, which offers the potential for increased clinical benefit to patients and broadens Surface’s clinical program for our potential first-in-class IL-27 antibody," said Alison O’Neill, M.D., chief medical officer. "We believe there is strong scientific rationale for targeting the immunosuppressive cytokine IL-27 as a first-line treatment for this patient population, especially in conjunction with PD-1 and VEG-F blockade, which has proven clinical efficacy in extending survival and progression-free survival (PFS) based on the IMBrave150 study versus sorafenib. We believe that our randomized Phase 2 approach is well suited to provide robust data for these patients."
The blinded, randomized Phase 2 study is expected to enroll approximately 100 first-line patients with unresectable or metastatic HCC. Patients will be randomized to receive either SRF388 or a placebo in combination with atezolizumab and bevacizumab. The study will primarily evaluate investigator-assessed PFS of SRF388 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab. Secondary endpoints from the trial will include safety, overall response rates and duration of response. Because this is a blinded study, Surface does not expect to have detailed clinical data prior to study conclusion, but does anticipate a futility analysis in early 2023 and final data in the first half of 2024.
Initial data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting earlier this year showed SRF388 was well tolerated at all doses tested, set the recommended Phase 2 dose at 10 mg/kg every four weeks and demonstrated evidence of monotherapy activity.
Financial Outlook:
Surface has expanded its existing debt facility with K2 HealthVentures, increasing the capacity to $50M. Based upon its current operating plan, including the SRF388 first-line HCC randomized Phase 2 clinical study, which includes the extended debt facility, Surface maintains a projected cash runway through 2023.