On March 9, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that it has enrolled 36 subjects in the open-label, Phase 1b/2 KEYNOTE-B84 study (NCT04815720) to evaluate first line therapy of pepinemab in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (Press release, Vaccinex, MAR 9, 2023, View Source [SID1234628378]). Based on this milestone, the Company expects to conduct a planned interim analysis and disclose the results in mid-2023.
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"Reaching the midpoint of enrollment in the KEYNOTE-B84 study is an important milestone for Vaccinex because it triggers a planned interim analysis of our collaboration with Merck Sharp & Dohme in head and neck cancer," said Maurice Zauderer, CEO . "Data from the interim analysis will help to define the potential regulatory and product development path for pepinemab in HNSCC."
Dr. Zauderer continued, "We previously reported that we believe combination immunotherapy with pepinemab and KEYTRUDA results in improved responses to treatment in patients whose tumors express low levels of PD-L1 biomarker (CPS<20), a subset of HNSCC patients who have had historically low response rates to anti-PD-1/L1 antibodies administered as single agents. We continue to observe a pattern of improved and durable responses in this difficult to treat patient population. Pepinemab in combination with KEYTRUDA appears to be well tolerated and does not appear to alter the safety profile associated with KEYTRUDA. With continued positive results, we believe that this combination immunotherapy could be a promising treatment option for patients with R/M HSNCC who otherwise have limited treatment alternatives. We thank all of the patients, their concerned families, and the investigators and study sites for their ongoing support of the KEYNOTE-B84 study and look forward to sharing the results of the interim analysis with the medical community and investors."
About the KEYNOTE-B84 Study
The KEYNOTE-B84 study was designed to evaluate the use of pepinemab, in combination with anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as first line treatment for patients with R/M HSNCC who are immunotherapy naïve. Patients in the Phase 2 dose-expansion segment receive pepinemab, dosed intravenously (IV) at 20 mg/kg, with pembrolizumab, dosed at 200 mg IV, every three weeks.
The ongoing Phase 2 study plans to enroll approximately 62 patients in total. With enrollment of the first 36 study subjects completed, Vaccinex will conduct a planned interim analysis on all study subjects who have received at least one cycle of pepinemab/pembrolizumab treatment and completed a tumor evaluation at or before 9-weeks of treatment.
Primary outcome measures include an assessment of safety (defined as treatment emergent adverse events (TEAE’s) and efficacy, determined by the Objective Response Rate (ORR), defined as complete response (CR) or partial response (PR). Secondary outcome measures will assess disease response and survival across standard parameters including duration of response (DOR), overall survival (OS) and progression free survival (PFS). The study will also include assessments of biomarkers in blood and tumor to evaluate tumor-directed immune responses.
Vaccinex has global commercial and development rights to pepinemab. The Company is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck and Co, Inc. Rahway, NJ, USA. Additional information about the study is available at: clinicaltrials.gov link.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, NJ, USA.
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in tumor immunity and in inflammatory reactions in the brain. Preclinical and clinical data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T-cells and reverses immunosuppression within the tumor microenvironment. Additional data show that pepinemab prevents damaging neuroinflammatory reactivity and preserves normal homeostatic and metabolic functions of astrocytes and microglia, two types of glial cells that play a crucial role in the development and maintenance of neurons in the brain. Pepinemab is being evaluated in several studies in oncology and neurodegenerative disease, including an ongoing phase 2 study in Alzheimer’s disease that is expected to readout in mid-2024.