On December 18, 2018 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported updates related to its product pipeline, notably the significant reduction of the investment in and scope of its SRF231 program, the planned filing of two Investigational New Drug applications (INDs) in 2019 and extension of its cash runway (Press release, Surface Oncology, DEC 18, 2018, View Source [SID1234532130]).
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"A disciplined approach to both drug development and portfolio prioritization is central to our mission to develop truly innovative immunotherapies to help those affected by cancer," said Jeff Goater, chief executive officer of Surface Oncology. "The decision to significantly reduce the scope of our SRF231 program was driven by initial data from our ongoing phase 1 trial, the CD47 competitive landscape, as well as the continued emergence and prioritization of our CD39 and IL-27 programs."
The company is conducting a multi-center, open-label phase 1 trial of SRF231 designed to assess safety and tolerability in multiple ascending doses. To date, 18 patients have been treated with SRF231 on an every-three-week schedule. During the dose escalation portion of the phase 1, two hematologic dose-limiting toxicities (DLTs) were seen at a lower dose (12 mg/kg) than anticipated and resolved without long-term toxicity. Surface will explore additional dose administration schedules but will not open expansion cohorts in the phase 1 study.
"While the early biological activity observed in the clinic with SRF231 potentially represents novel biology, specifically a lack of hemagglutination and differential effects on white blood cells, it does not meet our standard for pursuing additional clinical expansions at this time," said Rob Ross, M.D., chief medical officer of Surface Oncology. "In the coming months we will focus on identifying a potential dose and schedule, while exploring key insights about SRF231."
This outlined activity may support business development opportunities for SRF231. The company anticipates presenting additional SRF231 data in the second half of 2019.
Surface believes the reprioritization of its programs will extend the company’s projected cash runway through 2021 based upon its current operating plan, which includes advancing its next two preclinical programs SRF617 and SRF388 into clinical studies and through initial clinical data. Phase 1 clinical work for the company’s Novartis-partnered CD73 program, NZV930, is ongoing. Based on the reallocation of capital, the company now anticipates that the SRF388 program will accelerate and be ready for IND filing before the end of 2019. Cash and cash equivalents at year end 2018 is projected to be approximately $160 million.