Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, has announced top-line results from its Phase 1 multi-center, open-label, dose escalation study of first-in-class peptide SOR-C13 in subjects with advanced solid tumor cancers.
The primary goal of the study was to assess safety and tolerability of SOR-C13 in subjects with advanced carcinomas commonly known to express the TRPV6 channel and who had failed all previous anti-cancer treatments. SOR-C13 is the first drug candidate targeting TRPV6 to enter human clinical trials. In this study, SOR-C13 was found to be safe and well tolerated by subjects. Additionally, SOR-C13 demonstrated potential activity with 54% of subjects achieving stable disease as defined by the clinical protocol while on treatment.
In the Phase 1 trial, SOR-C13 was administered intravenously with 4 ascending doses over two 21-day cycles of treatment. There were no reported serious adverse events directly related to SOR-C13. Fatigue, low albumin, or anemia was reported in 30% of subjects during treatment. In all but one case, these events were assessed as unrelated or unlikely related to SOR-C13.The only safety event related to SOR-C13 infusion was a transient, short-lived reduction of serum calcium. This reduction was not associated with any symptoms at any SOR-C13 dose.
Additionally, this safety study provided the opportunity to measure potential anti-cancer efficacy of SOR-C13. Anti-tumor activity was observed across a wide variety of tumor types. Twelve of 22 evaluable subjects (54.5%) had stable disease after 2 cycles. The duration of response ranged from 4 to 7.5 cycles. One subject is still on treatment and in stable disease after 17 cycles (12 months). Two patients with advanced pancreatic cancer showed tumor size reduction of 7% and 27% after two treatment cycles with correlated changes in levels of CA 19-9, a validated pancreatic cancer biomarker.
"These data are promising, because they demonstrate a very good safety and tolerability profile for SOR-C13 at doses associated with activity against a spectrum of advanced solid-tumor cancers", stated Paul Gunn, President and CEO at Soricimed.
"We expect to receive the full results of this study later this calendar quarter, including additional data from laboratory safety tests, pharmacokinetic modeling, and biomarkers of SOR-C13 activity and mechanism of action, along with further analysis of efficacy measurements", commented Dr. Toney Ilenchuk, Soricimed's Chief Development Officer, "With the full results of this study in hand, we will determine the next steps in the clinical development of SOR-C13, possibly including Phase 1/2 studies in specific cancer types to incorporate a recommended Phase II dose. We plan to report the full results and analysis of the Phase 1 study at an international cancer conference later this year."
About the Phase 1 Trial: The Phase 1 trial was a multicenter, open-label, dose escalation study designed to assess safety and tolerability of SOR-C13 in up to 30 subjects with advanced solid tumor cancers. In addition to assessing the safety, tolerability and pharmacokinetics of SOR-C13 the trial was also designed to look at additional secondary endpoints including efficacy (clinically meaningful response) and to collect data on biomarkers that may be used in the future as indicators of potential efficacy. Study subjects who achieved a clinically meaningful response to 2 cycles of treatment in the trial, including disease stabilization, were offered additional SOR-C13 cycles after cycle 2 at the same dose level. Subjects were enrolled into the trial at 2 sites in Canada (Juravinski Cancer Centre and London Health Sciences Centre) and at the University of Texas MD Anderson Cancer Center.
About SOR-C13: SOR-C13 is a first-in-class peptide in development for the treatment of cancer. SOR-C13 binds with high selectivity and affinity to TRPV6, a calcium channel that is highly elevated in carcinomas including prostate, breast, lung and ovary and is correlated with poor outcomes. TRPV6-mediated Ca2+ entry is responsible for maintaining a high tumour proliferation rate, as well as increasing tumour cell survival and fortifying mechanisms that withstand cell destruction. By binding to this channel, SOR-C13 starves cancer cells of calcium that is needed for cell growth and division. As demonstrated in animal models, the result is an inhibition of tumor growth. Due to the high specificity of SOR-C13 for its target and its unique mechanism of action this drug candidate may result in fewer and less severe side effects compared to standard cancer chemotherapy. SOR-C13 is the first drug candidate targeting TRPV6 to have entered clinical development anywhere in the world.
SOR-C13 was discovered almost accidentally. Work that started at Mount Allison University led to the discovery and development of a novel mammalian paralytic peptide, now called soricidin, originally discovered in Northern Short-Tailed Shrew venom. The peptide has two major properties - that being the ability to paralyze by stopping nerve transmission and of greater, immediate interest, the ability to works as a calcium channel inhibitor, which is the mechanism of action behind SOC-C13.