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Initiated Phase 2 study of pepinemab in combination with KEYTRUDA® in advanced, recurrent or metastatic head and neck cancer
Announced publication of results from CLASSICAL-Lung phase 1b/2 clinical trial in non-small cell lung cancer in the peer-reviewed journal
“During the first quarter and subsequent period, we achieved notable progress across our proprietary clinical programs in cancer and neurology as well as our technology partnerships,” stated
“Continued analysis of the full data set from our Phase 2 SIGNAL trial in Huntington’s disease indicates that pepinemab can provide a cognitive benefit in this and potentially other neuroinflammatory and neurodegenerative indications with significant unmet medical needs. To that end, we remain on track to initiate a Phase 1/2a trial of pepinemab in Alzheimer’s disease by the end of the second quarter while we continue to engage in discussions with potential partners regarding a planned Phase 3 trial in Huntington’s disease.
“Finally, during the quarter we announced that we entered into a licensing agreement with Surface Oncology following on delivery and qualification of a fully human anti-CCR8 antibody. This is meaningful as we continue to leverage our proprietary ActivMab platform as a potential source of non-dilutive funding that can help advance our other programs.”
Pepinemab Clinical Updates:
- Head and Neck Cancer. Subsequent to the end of the first quarter,
Vaccinexannounced it initiated a Phase 2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for advanced, recurrent or metastatic head and neck cancer. Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, we believe there is a strong rationale for development in this indication.
The study is expected to enroll up to 65 subjects and key endpoints are expected to include objective response, duration of response, progression free survival and overall survival.
- Alzheimer’s Disease. By the end of the second quarter,
Vaccinexintends to initiate a Phase 1/2a clinical trial of pepinemab in Alzheimer’s disease, funded in part by a $750,000development grant from the Alzheimer’s Association under the 2020 Part the Cloud Program, as well as a $3 millionaward from the Alzheimer’s Drug Discovery Foundation.
The awards are based in part on earlier findings that treatment with pepinemab prevented the characteristic loss of glucose transport in the brain during underlying Huntington’s disease progression as detected by conventional FDG-PET imaging. Uptake of glucose, the main source of energy in the brain, is also known to decline with underlying disease progression in Alzheimer’s disease, and multiple studies in Alzheimer’s disease have shown that decline in glucose transport correlates with cognitive decline. The randomized, placebo-controlled, multi-center study is anticipated to enroll 40 subjects for 12 months treatment duration.
- Huntington’s disease. Based on analysis of the full data set from the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD),
Vaccinexdetermined that pepinemab appeared to confer cognitive benefit to patients as determined from results of the Huntington’s Disease Cognitive Assessment Battery (HD-CAB). As a result, Vaccinexbelieves that a phase 3 trial is warranted and is currently engaged in discussions of such a study with several potential pharmaceutical partners.
- 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 short term “Window of Opportunity” studies in colorectal, pancreatic, and head and neck cancer and melanoma.
Other First Quarter and Recent Accomplishments:
- Announced the publication of results from the CLASSICAL-Lung phase 1b/2 clinical trial in non-small cell lung cancer in the peer-reviewed journal
Clinical Cancer Research. The publication presents data showing that pepinemab is clinically active when combined with BAVENCIO®, a checkpoint inhibitor, and that the combination was well-tolerated with no major new safety signals identified. It was of particular interest that the combination appeared to extend treatment benefit to immunotherapy naïve patients whose tumors were PD- L1 negative or low, a patient population that has, in general, been less responsive to immunotherapy. Combination treatment also appeared to halt or reverse tumor progression (partial response or stable disease) in select patients with primary or acquired resistance to anti-PD-1/L1 therapy.
- Entered into multi-project deals with two leading pharmaceutical companies focused on leveraging Vaccinex’s ActivMAb® antibody discovery and novel viral display platform for drug discovery against difficult but important multi-pass membrane receptors such as GPCR and ion channels.
- Announced that Surface Oncology will be exercising its option to license an anti-CCR8 antibody discovered using Vaccinex’s ActivMAb® platform. The terms of agreement with Surface Oncology providedthat Surface Oncology pay technology access and licensing fees to
Vaccinexin addition to providing research funding, and that Vaccinexwill qualify for development milestone payments and royalties.
$32 millionin net proceeds through its existing open sale market agreement, or ATM, facility.
Upcoming Anticipated Milestone Dates:
- Q2 2021 – Initiation of Alzheimer’s disease Phase 1/2a trial
- Mid-2022 – Initial data from open label head and neck cancer trial
- Late 2022/Early 2023 – Data from randomized Alzheimer’s trial
Financial Results for the Three Months Ended
Revenue. Revenue for the three months ended
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
- Cash and
Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2021were $29.4 million, as compared to $10.6 millionas of December 31, 2020. The increase in cash was a result of $32 millionin net proceeds raised by the Company through its ATM facility.
Forward Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding
Source: Vaccinex, Inc.