Vaccinex (VCNX) – Initial Phase 1b data read out in mid-2023 and topline results in 2024

Research & Analysis BioPharma
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Vaccinex (VCNX) is pioneering a differentiated approach to treating neurodegenerative disease through the inhibition of semaphorin 4D (SEMA4D), a key driver of neuroinflammation. The company’s lead drug candidate, pepinemab, blocks SEMA4D and has potential as a disease-modifying treatment for Huntington’s, Alzheimer’s and other neurodegenerative diseases.

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 by preventing inflammatory reactivity of pepinemab during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the development and maintenance of neurons in the brain. Additional data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T-cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in oncology and neurodegenerative disease.

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Pipeline and Milestones:

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Upcoming Catalyst: In Q1Vaccinex is set to release an interim analysis from its Phase 1/2 KEYNOTE-B84 trial of Pepinemab and KEYTRUDA (pembrolizumab) as a treatment for recurrent or metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC).

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I see the opportunity as well for an M&A play given the strong partnership with MERCK.

Position: Shares (announced it in the position system a while ago)

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Phase 1/2 KEYNOTE-B84 was enrolled to 65 participants and the the study completed the initial safety run-in phase.

Results: The safety run-in phase (n = 3) is complete, and the combo appeared to be well-tolerated with no DLTs observed; SMC approved continuation to dose expansion. Strikingly, two of the three patients have been observed to experience a complete response (CR). Biomarker analysis revealed that tumors in both responders expressed low levels of PD-L1 (CPS < 20). The third patient progressed prior to first scan, suffering several unrelated SAEs attributed to a pre-existing co-morbidity. Conclusions: The ongoing KEYNOTE-B84 study completed the initial safety run-in phase, with two of three subjects achieving CR. Phase 2 will evaluate pepinemab, a SEMA4D inhibitor, as a novel strategy to potentially overcome resistance and enhance activity of pembro in R/M HNSCC

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Up 60% in pre-market on Patent News, sold 90% of the position, will keep 10% for the actual data catalyst

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Phase 1b/2 KEYNOTE-B84 (NCT04815720) Study is on track with 36 subjects enrolled, Company expects to conduct a planned interim analysis and disclose the results in mid-2023.

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Additional Catalyst for 2024 (Alzheimer lotto ticket):

Expect to complete patient enrollment in the randomized Phase 1/2a SIGNAL-AD Alzheimer’s study in April 2023 with topline data anticipated mid-2024

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  • today announced that it has completed enrollment goal in the SIGNAL-AD clinical trial for people with mild dementia due to Alzheimer’s Disease (NCT04381468).
  • Topline data from the study are expected in mid-2024, after the last enrolled patients will have received 12 months of treatment.
  • we are expecting FDA response to proposed plans for the design of a Phase 3 study in HD. Study data have been submitted to the FDA and a response is anticipated on or before May 16, 2023
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