Surface Oncology’s SRF617 Receives Orphan Drug Designation from FDA for Treatment of Pancreatic Cancer

Rhea-AI Summary

Surface Oncology (Nasdaq: SURF) announced that the FDA has granted Orphan Drug Designation for its therapeutic candidate SRF617, aimed at treating pancreatic cancer. This designation is significant as it highlights the urgent need for new immunotherapies in this area. SRF617, currently in Phase 1/1b studies, uses a dual mechanism to enhance anti-tumor immunity by inhibiting CD39. With this designation, Surface Oncology is eligible for various incentives such as tax credits and marketing exclusivity, potentially benefiting its clinical development efforts.

Positive

• FDA granted Orphan Drug Designation for SRF617, enhancing its market potential.
• SRF617 is designed to promote anti-tumor immunity, addressing a critical need in pancreatic cancer treatment.

Negative

• None.

CAMBRIDGE, Mass., March 30, 2021 (GLOBE NEWSWIRE) -- Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for one of the company’s lead therapeutic candidates, SRF617, for the treatment of patients with pancreatic cancer.

“We are pleased to receive this important designation from the FDA, which supports our conviction that new immunotherapies for pancreatic cancer are urgently needed,” said Alison O’Neill, M.D., senior vice president, clinical development at Surface Oncology. “We are very encouraged by our clinical progress to date with SRF617, a highly innovative therapy with the potential to promote anti-tumor immunity in patients with cancer. SRF617 is in Phase 1/1b studies across a variety of solid tumors, including combination studies with gemcitabine and abraxane in patients with pancreatic cancer.”

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.

About SRF617:

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39 which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.

About Surface Oncology:

Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its proprietary pipeline includes two wholly owned clinical-stage programs targeting CD39 (SRF617) and IL-27 (SRF388), as well as a preclinical program focused on depleting regulatory T cells 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 (SRF813; preclinical). 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, 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, 2020 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:

Investors
Matt Lane
matt@gilmartinir.com
617-901-7698

Media
Gina Nugent
gina@tenbridgecommunications.com
617-460-3579

FAQ

What is the significance of the FDA granting Orphan Drug Designation to Surface Oncology's SRF617?

The Orphan Drug Designation for SRF617 enhances its market potential, providing benefits like tax credits and marketing exclusivity.

What stage is the SRF617 therapy currently in?

SRF617 is currently in Phase 1/1b clinical studies for treating pancreatic cancer.

What does SRF617 target in pancreatic cancer treatment?

SRF617 targets CD39 to enhance anti-tumor immunity by reducing immunosuppressive adenosine and increasing ATP levels.

How does the Orphan Drug Designation affect Surface Oncology?

It offers benefits such as partial tax credits for clinical trial costs and seven years of marketing exclusivity.

What potential advantages does SRF617 offer over existing treatments?

SRF617 has a dual mechanism of action that could improve anti-tumor responses compared to current therapies.