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Additional data from SIGNAL Huntington’s disease (HD) trial support continued development in HD and in Alzheimer’s disease (AD)
Phase 1/2 Study to Evaluate Pepinemab in Combination with KEYTRUDA® in Advanced, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for H1 2021
Ended the quarter with cash and cash equivalents of
Pepinemab Clinical Updates:
- Huntington’s Disease. The company reported post-hoc analysis of data from the SIGNAL phase 2 clinical trial evaluating our lead drug candidate, pepinemab, for the treatment of Huntington’s disease (HD). While this mid-stage trial did not meet pre-specified co-primary endpoints, the company believes study results show encouraging metrics across several endpoints that provide a strong rationale for continued development in neurodegenerative diseases. In particular, the company believes an important cognitive benefit is reflected in the observed effect of pepinemab on the HD-Cognitive Assessment Battery Composite score (p=0.007), a broad measure of cognitive improvement. The company believes that the treating physicians’ Clinical Global Impression of Change provided a further signal of benefit as fewer pepinemab treated patients experienced deteriorating health status. Finally, the company believes pre-specified imaging analysis of brain in patients with early manifest disease demonstrated a significant treatment-related reduction in normal disease-associated brain atrophy and loss of brain metabolic activity.
- Non-Small Cell
Lung Cancer(NSCLC). CLASSICAL-Lung Clinical Trial. The recently completed CLASSICAL-Lung study evaluated pepinemab in combination with the anti-PD-L1 checkpoint inhibitor BAVENCIO® (avelumab) for the treatment of advanced (stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC). Near topline data for this trial presented at the virtual American Society of Clinical Oncology(ASCO) conference in late May 2020suggested that combination therapy induces an objective response rate that is a factor of two greater than observed with avelumab alone. The company believes that it is particularly striking that this was seen in the more difficult to treat PD-L1 negative and PD-L1 low population.
- Head and Neck Cancer. The company announced a clinical collaboration with Merck, known as MSD outside the US and
Canada, to evaluate the combination of pepinemab with Merck’s anti-PD-1 therapy, KEYTRUDA®, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This cancer indication is notable for the relatively high levels of SEMA4D expression, which has been shown to induce correspondingly high levels of myeloid suppressor cells that block anti-cancer immune responses. Pepinemab is known to have a dual mechanism of action the both increases infiltration and activation of CD8+ cytotoxic T cells and reduces myeloid derived suppressor cells (MDSC). The company believes that HNSCC is, therefore, representative of cancer indications of special interest for treatment with pepinemab in combination with KEYTRUDA®. A 65-patient study is planned for H1 2021.
- Alzheimer’s Disease. The mechanism of action of pepinemab in slowing cognitive deterioration and brain atrophy that were demonstrated in the SIGNAL study in Huntington’s disease, are believed to be equally applicable to neurodegeneration and cognitive decline associated with Alzheimer’s disease. The company is planning to initiate a Phase 1/2 study of pepinemab in AD in 2021 with partial funding support received from both the Alzheimer’s Association and from the Alzheimer’s
Drug Discovery Foundation.
- Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the
Winship Cancer Institute of Emory Universityto evaluate pepinemab in combination with checkpoint inhibitors in “Window of Opportunity” studies in colorectal, pancreatic, head and neck cancer and melanoma.
Other Third Quarter Accomplishments:
- As summarized above,
Maurice Zauderer, Ph.D., president and chief executive officer of Vaccinex, presented additional data from the SIGNAL Huntington’s Disease study at the virtual Huntington’s Study Group(HSG) 2020 Annual Meeting.
- The company has entered into several new biotech and major pharma collaborations to employ our novel discovery platform for structural studies and to select high value antibodies against difficult multipass membrane receptors.
Upcoming Anticipated Milestones:
- H1 2021 – Planned initiation of a Phase 1b/2 clinical trial of pepinemab in combination with KEYTRUDA® for the treatment of patients with HNSCC.
- 2021 – Planned initiation of Alzheimer’s disease Phase 1/2 study.
Financial Results for the Three Months Ended September 30, 2020:
Research and Development Expenses. Research and development expenses for the three months ended
General and Administrative Expenses. General and administrative expenses for the three months ended
Forward Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding
Source: Vaccinex, Inc.