Surface Oncology Announces FDA Clearance of IND Application for GSK4381562, a Novel Antibody Targeting PVRIG

Rhea-AI Summary

Surface Oncology (Nasdaq: SURF) announced the FDA's approval of its IND application for GSK4381562, a fully human IgG1 antibody targeting PVRIG, allowing it to enter a Phase 1 clinical trial. The company will receive a $30 million milestone payment upon the first patient being treated and is eligible for an additional $700 million in future milestone payments, as well as tiered royalties on global net sales. GSK4381562 aims to enhance NK and T cell activation within the tumor microenvironment, representing a promising therapeutic advancement.

Positive

• FDA clearance for IND application of GSK4381562 enables Phase 1 trial.
• Surface to receive $30 million milestone payment upon first patient treatment.
• Potential for additional $700 million in milestone payments and tiered royalties.

Negative

• None.

Surface to receive $30 million milestone payment upon first patient treated in the Phase 1 study

CAMBRIDGE, Mass., Dec. 01, 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 cleared the Investigational New Drug Application (IND) for GSK4381562 (formerly SRF813) to proceed into a first-in-human clinical trial. GSK4381562 is a fully human IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells.

In December 2020, Surface announced it had entered into an agreement in which GSK exclusively licensed worldwide development and commercial rights to GSK4381562. Surface will receive a $30 million milestone payment in conjunction with the initiation of the first Phase 1 study for GSK4381562 and is eligible to receive an additional $700 million in future milestone payments, as well as be eligible to receive tiered royalties on global net sales.

“GSK4381562 is a differentiated anti-PVRIG antibody and represents a new therapeutic approach designed to enhance NK and T cell activation in the tumor microenvironment,” said Rob Ross, M.D., chief executive officer. “We are pleased to have reached this milestone with our partners at GSK and look forward to continued advancement of this promising program in the clinic.”

About GSK4381562:

GSK4381562 is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells. GSK4381562 binds to a distinct epitope on PVRIG and blocks the interaction of PVRIG with CD112, its binding partner that is overexpressed on tumor cells. Preclinically, GSK4381562 promotes the activation of both NK cells and T cells, with the potential to elicit a strong anti-tumor response and promote immunological memory.

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 depleting tumor 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 (GSK4381562; 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 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.

Contacts:

Investors
Laurence Watts
Gilmartin Group
619-916-7620
laurence@gilmartinir.com

or

Stephen Jasper
Gilmartin Group
858-525-2047
stephen@gilmartinir.com

Media
Chris Railey
Ten Bridge Communications
chris@tenbridgecommunications.com
617-834-0936

FAQ

What is the significance of the FDA's approval for Surface Oncology's GSK4381562?

The FDA's approval allows Surface Oncology to start Phase 1 clinical trials for GSK4381562, marking a crucial step in its development.

How much milestone payment will Surface Oncology receive from GSK?

Surface Oncology will receive a $30 million milestone payment upon the treatment of the first patient in the Phase 1 study.

What additional financial prospects does Surface Oncology have related to GSK4381562?

In addition to the initial $30 million, Surface is eligible for up to $700 million in future milestone payments and tiered royalties on global net sales.