First Interim Results of CLASSICAL-Lung Phase 1b/2 Study Demonstrate Up To 90 Percent Disease Control Rate and Increase in Immune Cells and Decrease in Immunosupressive Cells in Response to Combination Therapy with Pepinemab (VX15/2503) and Avelumab
ROCHESTER, N.Y., April 09, 2019 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and Huntington’s disease today summarizes key data on the company’s anti-SEMA4D technology that were presented at the 2019 Annual Meeting of the American Association for Cancer Research (AACR).
- The company presented interim data for its Phase 1b/2 CLASSICAL-Lung study of its pepinemab antibody in combination with avelumab (Merck KGaA, Darmstadt, Germany) in NSCLC, which demonstrated a disease control rate (DCR) of 75 percent for all dose escalation subjects, while those who remained on therapy for two months or more showed a 90 percent disease control rate (excludes subjects who were deceased or had rapidly progressing tumors shortly following enrollment). While this is a small sample and comparison across clinical trials are imperfect, single agent avelumab had previously shown 50 percent DCR in a similar NSCLC population. Treatment with the combination therapy was deemed well tolerated at all dose levels.
- Initial results of a separate Window-of-Opportunity study in various solid tumors (CRC, melanoma, and HNSCC) being performed at the Winship Cancer Institute of Emory University showed that pepinemab increased infiltration of CD8+ cytotoxic T-cells and reduced regulatory T cells (Treg) and myeloid derived suppressor cells (MDSC), a balanced response that increases tumoricidal and reduces immunosuppressive activity in the tumor. The company believes that this is important supporting clinical data previously reported only in animal tumor models.
- Patient recruitment in the phase 2 CLASSICAL-Lung study continues with the goal of enrolling an additional 50 patients in two cohorts: 22 patients who are immunotherapy naïve and 28 patients whose tumors progressed during or following prior immunotherapy.
- The company plans to present additional updates of all ongoing oncology clinical trials at ASCO 2019 in early June and anticipates topline data for the CLASSICAL–Lung clinical trial in Q4 2019.
- The posters may be accessed on the Investor Relations page of the Vaccinex website (www.vaccinex.com) or directly via the links below:
About Vaccinex, Inc.
Vaccinex, Inc. is a clinical-stage immunotherapy company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including cancer, neurodegenerative diseases, and autoimmune disorders, with currently active clinical trials in Non-Small Cell Lung Cancer and Huntington’s disease. Vaccinex is based in Rochester, New York.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “potential,” “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Forward-looking statements may involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab (VX15/2503), and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in our prospectus for our initial public offering dated August 9, 2018, filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended.
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