Randomized Phase 2 clinical study evaluating SRF388 in first-line hepatocellular carcinoma in clinical collaboration with Roche
Single-arm Phase 2 clinical study evaluating SRF388 as a monotherapy in patients with previously-treated non-small-cell lung cancer
“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
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.
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.
About Surface Oncology
Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its pipeline includes two wholly-owned clinical-stage programs targeting CD39 (SRF617) and IL-27 (SRF388), as well as a preclinical program focused on selectively depleting regulatory T cells in the tumor microenvironment via targeting CCR8 (SRF114). In addition, Surface has two partnerships with major pharmaceutical companies: a collaboration with Novartis targeting CD73 (NZV930; Phase 1) and a collaboration with GlaxoSmithKline targeting PVRIG (GSK4381562, formerly SRF813; Phase 1). Surface’s novel, investigational cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. For more information, please visit www.surfaceoncology.com.
Cautionary Note Regarding Forward-Looking Statements:
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388, SRF617, SRF114 and its other product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Surface Oncology’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Surface Oncology’s product candidates, including SRF388, SRF617 and SRF114, will not be successfully developed or commercialized, the risks related to Surface Oncology’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies, and the potential impact of COVID-19 on Surface Oncology’s clinical and preclinical development timelines and results of operations. Additional risks and uncertainties that could affect Surface Oncology’s future results are included in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2021, available on the Securities and Exchange Commission’s website at www.sec.gov and Surface Oncology’s website at www.surfaceoncology.com. Additional information on potential risks will be made available in other filings that Surface Oncology makes from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements contained in this press release are based on assumptions that Surface Oncology believes to be reasonable as of this date. Except as required by law, Surface Oncology assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
Source: Surface Oncology, Inc.