Cambridge, MA (Press Release) – 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 to the com­pany’s lead inves­ti­ga­tional can­di­date SRF231 for the treat­ment of patients with multiple myeloma. SRF231 is a fully human anti­body that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells which prevents them from being engulfed and elim­i­nated by macrophages.

“While the poten­tial appli­ca­tions for SRF231 in on­col­ogy are quite broad, we are particularly excited about the oppor­tu­ni­ty to provide benefit to patients with multiple myeloma. We have already dem­onstrated the ability of our anti­body to in­­crease phagocytosis of myeloma cells and to shrink tumors in pre­clin­i­cal models,” said Rob Ross, M.D., chief medical officer of Surface Oncology. “Receiving orphan desig­na­tion for SRF231 rep­re­sents an important mile­stone as we con­tinue to progress the pro­gram in the clinic in multiple myeloma and other cancer types.”

The FDA’s Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the treat­ment of rare diseases or con­di­tions that affect fewer than 200,000 people in the United States. The desig­na­tion provides certain benefits to the drug developer in­­clud­ing the poten­tial for seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clin­i­cal trials.

SRF231 is cur­rently being eval­u­ated in a multi-center, open-label Phase I trial to assess safety and tolerability in multiple ascending doses with the goal of estab­lish­ing a recommended dose for further study. Following the dose escalation phase, the com­pany intends to eval­u­ate the safety and efficacy of SRF231 in a targeted set of solid and hema­to­logic malig­nan­cies.

About SRF231

SRF231 is a fully human mono­clonal anti­body thera­peutic targeting CD47, a protein over­ex­pressed on many cancer cells which prevents them from being engulfed and elim­i­nated by macro­phage medi­ated phago­cytosis. SRF231 pre­clin­i­cal results presented at the 2016 Society for Immuno­therapy of Cancer (SITC) and the American Society of Hematology (ASH) meetings dem­onstrated that SRF231 has potent anti-tumor activity pre­clin­i­cally in several dif­fer­en­t tumor models and in com­bi­na­tion with existing cancer modalities. Importantly, pre­clin­i­cal studies also showed that SRF231 does not induce hemag­gluti­na­tion, an important poten­tial safety advantage.

About Surface Oncology

Surface Oncology is an immuno-oncology com­pany devel­op­ing next-generation anti­body ther­a­pies focused on the tumor microenvironment with lead pro­grams targeting CD47, CD73, CD39 and IL-27. 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. The com­pany has a pipe­line of seven novel immuno­therapies and a strategic col­lab­o­ra­tion with Novartis focused on up to three next-generation cancer immuno­therapies. For more in­­for­ma­tion, please visit www.surfaceoncology.com.

Source: Surface Oncology, Inc.