Surface Oncology Announces FDA Clearance of SRF617 and SRF388 INDs to Initiate Phase 1 Clinical Trials
Company focuses efforts and resources on advancing SRF617 and SRF388; Implements strategic restructuring
Initial clinical updates for SRF617 and SRF388 expected by the end of 2020
Extends current cash runway into 2022
CAMBRIDGE, Mass., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) applications for its antibody candidates, SRF617 (targeting CD39) and SRF388 (targeting IL-27), and the Company is executing on plans to initiate clinical trials to advance both programs.
“Since Surface’s founding approximately five years ago, we have brought four novel, internally developed programs to the IND stage,” said Jeff Goater, chief executive officer. “The entire team is very proud of this impressive accomplishment. As we strive to have a positive impact on the treatment of people who are diagnosed with cancer, we have decided it is in the best interest of our overall mission to focus our resources on the SRF617 and SRF388 programs. Restructuring was a difficult decision because of the effect it has on our dedicated and talented people. I am extremely grateful for the efforts of our employees and their tremendous contributions to Surface’s rapid progress and strong culture. We are committed to supporting all of our employees during this transition.”
The active INDs for both SRF617 and SRF388 enable Surface Oncology to initiate phase 1 clinical trials for each product candidate. The Company anticipates providing initial clinical updates for both SRF617 and SRF388 by the end of 2020.
-- SRF617 is a fully human anti-CD39 antibody designed to promote anti-tumor immunity through a dual mechanism of reducing immunosuppressive adenosine and driving the extracellular accumulation of immunostimulatory ATP within the tumor microenvironment. Due to this dual mechanism, Surface Oncology believes CD39 is the most promising therapeutic target on the adenosine axis, a notable immunosuppressive pathway. The Company’s phase 1/1b trial will evaluate SRF617 in patients with advanced solid tumors both as a monotherapy and in combination with other cancer therapies. -- SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this highly immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, the Company has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.
The Company also remains encouraged by the promise and progress of its wholly-owned, earlier-stage programs, SRF813 (targeting CD112R) and a regulatory T cell program, and will seek to partner these programs.
The strategic restructuring will reduce the Company’s workforce by approximately 35%. With these steps to focus resources, Surface Oncology’s current cash and cash equivalents are now projected to fund the Company into 2022. Anticipated milestones under the NZV930 (targeting CD73) collaboration with Novartis and additional capital potentially available under the K2 HealthVentures debt financing, in aggregate, would extend Surface Oncology’s cash runway into the second half of 2022.
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 lead programs targeting CD39 (SRF617) and IL-27 (SRF388), a clinical-stage collaboration with Novartis targeting CD73 (NZV930); and two preclinical programs, each focused primarily on activating either natural killer or regulatory T cells. Surface’s novel 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, SRF813 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 Company’s anticipated cash needs, 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 SRF813, will not be successfully developed or commercialized, and the risks related to Surface Oncology’s dependence on third parties in connection with its manufacturing, clinical trials and preclinical studies. 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, 2018, which is available on the Security 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.
Contacts:InvestorsPete Rahmer email@example.com 415-515-9763
Media Tom Donovan firstname.lastname@example.org 857-559-3397