Resiquimod

Surge Therapeutics just dosed the final patient in a phase 1 trial of its breast cancer candidate, which is meant to be given during tumor-removal surgery. From left to right: Surge founder and CEO Michael Goldberg, Ph.D.; Freya Schnabel, M.D., director of breast surgery at NYU; Acacia Sharma, research project manager at NYU; and Shane Roberts, field clinical manager at Surge.\n For all of the groundbreaking advancements in cancer treatment over the last decades, the first step for tackling almost all solid tumors is still surgery. If the cancer comes back, medicines like immunotherapies can then be given systemically to eradicate the tumor’s remnants. For Surge Therapeutics, this separation of surgery and medicine makes no sense.Feb. 10, Surge dosed the final patient in its phase 1 trial of SRG-514, a breast cancer candidate that, like the rest of the biotech’s pipeline, is meant to be injected directly into the tumor site by the surgeon during an operation. The company now plans to bring the candidate into a pivotal phase 3 study this summer, founder and CEO Michael Goldberg, Ph.D., told Fierce Biotech.Surge was founded on a seemingly simple premise—giving patients anticancer medicine at the same time their cancer is surgically removed—but it’s one that has the potential to be transformative, Goldberg said.“The surgeon goes in, he cuts out the tumor, and then sutures up the patient and sends them home,” he said. “That doesn\'t make a lot of sense to me, to leave that space empty when we could be filling it with medicine.”It didn’t make a lot of sense to Goldberg’s mentor, acclaimed scientist and biotech entrepreneur Robert Langer, either. Langer, an MIT professor perhaps best known for cofounding mRNA giant Moderna, is now chair of Surge’s scientific advisory board.“To me, it’s a natural thing,” Langer told Fierce. Goldberg has pioneered methods to give immunotherapy locally, he said, and Surge has “incredible safety data so far.” SRG-514 is a unique formulation of an anti-inflammatory drug called ketorolac, which is usually given to patients after surgery has wrapped up. By instead targeting the med to where the patient’s tumor actually is in their body, Surge hopes to fully eradicate any lingering cancer cells and prevent deadly recurrence of the disease.Surge’s other programs, STM-416 and STM-416p, look to do something similar with antitumor drug resiquimod in bladder cancer and prostate cancer. Both are set to enter phase 2 studies this year, Goldberg said.The Massachusetts-based biotech’s approach builds on Langer’s long history of innovation in drug delivery. Langer and another former student previously cofounded Taris Biomedical to advance a silicone-based system that can be inserted into the bladder to continuously release anticancer medicine. Johnson & Johnson acquired that company in 2019, and the bladder cancer candidate was approved in 2025 as Inlexzo.Should Surge succeed in its mission, the potential impact could be enormous.“There are 9 million cancer patients each year who undergo surgical tumor resection,” Goldberg explained. “Approximately 40% of them will recur within five years, and 90% of cancer-related mortality is owing to recurrence or metastasis.”To Goldberg, that makes cancer recurrence the “single biggest unmet need in oncology,” he said.Beyond the numbers, Goldberg also has a personal connection to Surge’s mission. He has lost multiple friends to cancer that came back after surgery, he told Fierce.“The mission that we have is to create a world where nobody grieves the loss of a loved one to preventable postsurgical cancer recurrence,” Goldberg said.Langer’s confidence in Surge’s approach is bolstered by his close relationship with his former student Goldberg. For the biotech veteran, it’s important to support the next generation of industry leaders alongside backing big science breakthroughs.“I want to see as many good things that will help the world as possible,” Langer told Fierce. Alongside “transformative science,” he wants to “train great people and make sure that as much of that great science gets out to the world as possible.”This desire also explains Langer’s recent cofounding of Soufflé Therapeutics, a mysterious RNA startup that arose in October 2025 with $200 million and multiple Big Pharma partnerships in the oven. Langer’s daughter Susan is founding president and chief business officer of the venture, and his former student Amir Nashat is CEO.When it comes to launching new biotechs like Soufflé and Surge, Langer and Goldberg both recognize that things are different now—especially for vaccine companies like Moderna. But both also believe that, ultimately, science and meritocracy will prevail.“If you have great ideas, if you have outstanding data, there will be a path to success,” Goldberg said.Over Langer’s close to 50 years in biotech, the industry has “gone up and down, up and down, up and down,” he said. But the overall trajectory has been up, and at the end of the day, “science will win.”

Final patient dosed in Phase 1 study of SRG-514 in breast cancer patients undergoing breast-conserving surgery; registrational trial design being finalized with input from FDA A dditional intraoperative immunotherapy programs in bladder and prostate cancer advancing toward Phase 2 trials in 2026 CAMBRIDGE, Mass.--(BUSINESS WIRE)-- #biotech -- SURGE Therapeutics (SURGE), a clinical-stage oncology company pioneering intraoperative immunotherapy, today announced the final patient has been dosed in its Phase 1 clinical trial of SRG-514, an investigational therapy for breast cancer patients undergoing surgery. The treatment was generally well tolerated in the Phase 1 dose-escalation study, and there were no treatment-related dose-limiting toxicities or treatment-related serious adverse events to date. Based on the data generated to date and discussions with the FDA, the company is preparing to advance SRG-514 directly into a registrational trial. SRG-514 is designed to deliver immunotherapy intraoperatively, directly into the resection cavity during the time of tumor removal. The therapy aims to reprogram the local inflammatory response from immunosuppressive to immunostimulatory, with the goal of generating a durable, systemic anti-tumor immune response when tumor burden is at its lowest. “Intraoperative immunotherapy represents a fundamentally different approach to treating cancer,” said Michael Goldberg, Ph.D., CEO & Founder, SURGE Therapeutics. “With SRG-514, we are targeting primary drivers of cancer mortality – post-surgical recurrence and metastasis – by improving how, when, and where immunotherapy is delivered. We are encouraged by the data generated to date and by the broader potential of our programs to serve as pipelines-in-a-product.” “One of the most persistent challenges in oncology is that microscopic disease can remain even after successful tumor removal and later drive cancer recurrence, both locally and distally,” said Robert Langer, Sc.D., Institute Professor at MIT and Chair of SURGE’s Scientific Advisory Board. “Applying established principles of drug delivery in the intraoperative setting creates a powerful opportunity to influence immune responses where and when intervention may have the greatest impact.” SRG-514 is a novel thermosensitive formulation of ketorolac, a non-steroidal anti-inflammatory drug commonly used perioperatively. By intervening during surgery, the therapy is designed to provide extended, localized release directly at the tumor resection site and may counteract surgery-induced immune suppression, a biological process that can promote recurrence and metastasis. Post-surgical recurrence remains one of the most significant unmet needs in oncology, as 90% of cancer-related deaths are driven by local recurrence and metastasis. Each year, approximately 9 million cancer patients worldwide undergo surgical tumor resection, yet an estimated 40% of patients experience disease recurrence within five years. While surgery triggers acute inflammation, standard post-operative therapies are typically not administered until several weeks after surgery, allowing residual cancer cells time to develop strategies to evade immune surveillance. SURGE’s proprietary SURGERx™ platform uses an injectable, biodegradable hydrogel optimized for intraoperative administration to deliver a drug in a highly concentrated manner. The company expects to initiate a registrational trial of SRG-514 in triple-negative breast cancer this year, with potential expansion into additional breast cancer and solid tumor indications. In parallel, the company is advancing two additional intraoperative immunotherapy programs – STM-416 and STM-416p, utilizing the TLR7/8 agonist resiquimod, in bladder cancer and prostate cancer, respectively. Both programs are expected to enter Phase 2 clinical trials this year. These programs highlight SURGE’s mission to transform surgery from a purely physical intervention into a therapeutic modality to deliver localized immunotherapy to potentially improve patient outcomes. About SURGE Therapeutics SURGE Therapeutics is a clinical-stage oncology company developing intraoperative immunotherapies designed to eliminate minimal residual disease at the time of cancer surgery. Through its proprietary SURGERx™ platform, the company delivers immunotherapy directly to the resection cavity with the intention of preventing post-surgical recurrence and drive durable antitumor immunity across solid tumors. For more information, visit . Contacts Media Contact Kimberly Ha KKH Advisors 917-291-5744 kimberly.ha@kkhadvisors.com