MD Anderson Resumes Phase Ib Clinical Trial of Investigational Cancer Therapy

MD Anderson Resumes Phase Ib Clinical Trial of Investigational Cancer Therapy

MD Anderson Cancer Center (“MDACC”) has resumed its investigator-initiated trial of an early stage pancreatic cancer therapy called SOR-C13 developed by a clinical-stage company called Sorcimed. In February, Sorcimed announced that MDACC completed the first cohort of the dose escalation phase of the trial, which centered on late-stage pancreatic cancer patients, evidencing the investigational product was safe and well-tolerated and excluded any drug-related adverse events. COVID-19 causes a temporary suspension but now the trail has been reactivated.

The Investigational Drug: SOR-C13

SOR-C13 is a novel, short, synthetic peptide developed from the C-terminal region of soricidin, a proprietary 54 amino acid peptide, discovered by Soricimed Biopharma found in the saliva of the Northern Short-tailed Shrew. The experimental drug binds with high affinity and selectivity—and disrupts the function of –TRPV6, a calcium channel over-expressed in solid tumor cancers. TRPV6 plays a central role in biochemical cascade that results in the upregulation of an array of pro-cancerous genes. TRPV6 is considered to be an important target of novel anticancer therapy.  SOR-C13 is the first highly specific TRPV6 inhibitor to be identified and to be taken into clinical.

The Study

This phase Ib study has been designed for the study team to investigate the side effects and best dose of SOR-C13 in treating patients with solid tumors that have spread to other places in the body (advanced) and does not respond to treatment. Drugs used in chemotherapy, such as SOR-C13, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Now this b stage of the phase I will look to refine dosing and further explore safety as well as review more closely the efficacy of SOR-C13. It of course capitalizes on the momentum of the Phase I results thus far. In this study conventional RECIST tumor assessment will be augmented with Image Analysis Group’s advancement imaging, machine learning and radiomics, which will measure tumor microenvironment characteristics to more accurately predict treatment effects. The therapy showed promising results in preclinical animal studies.

Principal Investigator Comments

Dr. Siqing Fu, a member of the Department of Investigational Cancer Therapeutics at MDACC and the study’s Principal Investigator, commented, “We are looking forward to gathering additional SOR-C13 safety data, followed by early efficacy data in the planned expansion cohort.”

The Company

Soricimed Biopharma Inc is a privately-held, science-based company focused on the development and commercialization of applications originally derived from its unique and proprietary family of peptides found in the paralytic venom of the northern short-tailed shrew. Product development is ongoing for three distinct verticals: as targeted drug candidates for the treatment of solid-tumor cancers; an environmentally responsible pesticide for the agriculture and aquaculture sectors; and as novel active ingredients in skin-care products for the cosmetic industry.

The Oncology IP

Soricimed’s oncology vertical focuses on targeted drug candidates for the treatment of solid-tumor cancers. Soricimed’s lead drug candidate, SOR-C13, has been shown to be safe and well tolerated, with indications of efficacy in a Phase 1 human clinical trial. A follow-on Phase 1b Investigator Initiated Trial (“IIT”) in late-stage cancer is currently underway. SOR-C13 has been granted orphan drug status for the treatment of pancreatic and ovarian cancers by the U.S. Food and Drug Administration. In addition, a portfolio of targeted Peptide-drug Conjugates (“PDCs”) is in late pre-clinical development at this time.

Lead Research/Investigator

Dr. Siqing Fu, MD, PhD, Department of Investigational Cancer Therapeutics at MDACC

Call to Action:  To date the company has raised capital from strategic investors but is looking for additional funding sources.