Spexis provides business update and announces financial results for the first half of 2023 - Seite 2

The company has worldwide rights to ColiFin ex-Europe and is preparing a Phase 3 program in CF patients which includes the COPILOT safety and tolerability trial, and the COPA efficacy trial. COPILOT is expected to initiate prior to the end of 2023.

Capital commitments from SPRIM Global Investments (SGI) and additional institutional investors totaling USD $7.5 million to-date will enable the near-term initiation of COPILOT. The company’s clinical trial partnership with SGI, which includes debt facilities, is expected to provide Spexis with up to half of the Phase 3 clinical development costs of ColiFin. Future milestones are contingent on securing additional capital and/or partnering agreements.

Balixafortide:

Today Spexis announced plans to pursue the clinical development of balixafortide, the Company’s potent and selective macrocyclic CXCR4 inhibitor, in PDAC, an aggressive form of pancreatic cancer with a poor survival rate. Balixafortide has been well-studied in clinical trials and has demonstrated a promising safety profile both as a monotherapy as well as in combination with other therapies. PDAC has been traditionally resistant to immunotherapy due to a combination of tumor microenvironment features unique to PDAC, but recent preclinical studies have shown the successful modulation of these factors using anti-CXCR4 antibodies, anti-programmed cell death protein 1 antibodies (anti-PD-1) and focal adhesion kinase inhibitors (FAKi). The combination of anti-CXCR4 antibodies, anti-PD-1 antibodies and FAKi led to a significantly decreased metastatic rates in a well-validated PDAC murine liver metastasis model. These results were subsequently validated substituting anti-CXCR4 antibodies for balixafortide. The synergistic effects of targeting PDAC with this regimen represents a unique opportunity for balixafortide to address the significant unmet need that has persisted in the fight against pancreatic cancer.

PDAC accounts for more than 90% of pancreatic cancer diagnoses, and its poor survival rate is due to limited treatment options and the absence of an early diagnosis in many patients. The average 5-year survival rate is less than 10%, and pancreatic cancer represents an increasing and worrying proportion of cancer deaths. In 2023, the American Cancer Society projects over 50,000 patients will die of pancreatic cancer in the United States, the third-leading cause of cancer deaths. Despite a growing patient population, treatment options have remained limited, increasing the demand for novel therapeutics and approaches.