On May 15, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease (NDD) and cancer through the inhibition of SEMA4D reported financial results for the first quarter ended March 31, 2023 and provided a corporate update on key programs and financing in the first five months of the year (Press release, Vaccinex, MAY 15, 2023, View Source [SID1234631749]).
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"Vaccinex continues to make important progress in our clinical programs to develop pepinemab, our proprietary immunotherapy product candidate, to improve patient outcomes in neurodegenerative disease and cancer," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. "We completed enrollment in the Phase 1b/2 SIGNAL-AD (Alzheimer’s Disease) study, which we expect will read-out when all participants have completed 12 months of double-blind treatment in mid-2024. In parallel, we submitted a briefing document to the FDA with additional data to support use of the Huntington’s Disease Cognitive Assessment Battery (HD-CAB) as a meaningful measure of cognitive benefit in a planned Phase 3 study intended to demonstrate evidence of treatment efficacy in Huntington’s Disease (HD). FDA agreement on a study design that, if positive, could meet requirements for regulatory approval is an important issue to partner/finance such a study based on the promising data obtained in our completed phase 2 SIGNAL trial (Nature Medicine). FDA has advised that they expect to provide a written response later this month."
Dr. Zauderer continued, "In our oncology program, we reached the targeted enrollment of 36 patients specified for a pre-planned interim analysis of responses to treatment in the Phase 1b/2 KEYNOTE-B84 trial of pepinemab in combination with KEYTRUDA for first-line head and neck cancer. We expect to meet with our collaborator, Merck, in early June to review the results and consider plans for continued development of this novel immunotherapy combination. Separately, we initiated enrollment in a Phase 1b/2 study to evaluate pepinemab in combination with BAVENCIO/avelumab in patients with metastatic pancreatic cancer (PDAC). In addition, an innovative investigator sponsored trial combining pepinemab with adoptive cell therapy for breast cancer continues to enroll patients at the Moffitt Cancer Center. This trial is based on preclinical studies demonstrating that antibody blockade of SEMA4D increases tumor targeting and efficacy of a dendritic cell vaccine."
Summary of Recent Milestones and Upcoming News
Neurodegenerative Disease:
Huntington’s Disease Program: Submitted briefing documents along with a Type C meeting request to the FDA related to the proposed plan for a Phase 3 study of pepinemab in HD. FDA has indicated that they expect to provide a written response later this month to the questions posed in the briefing package.
Alzheimer’s Disease Program: Enrollment completed in the Phase 1b/2 SIGNAL-AD study evaluating pepinemab as a potential treatment for people with mild dementia due to Alzheimer’s Disease (NCT04381468). The study builds on learnings from the previously completed Phase 2 SIGNAL study in HD. Topline data from this SIGNAL-AD study are expected in mid-2024, after the last enrolled patients will have received 12 months of treatment.
Oncology:
KEYNOTE B-84: The Phase 1b/2 KEYNOTE B-84 study reached targeted enrollment of 36 patients for a pre-planned interim analysis. This open-label, Phase 1b/2 study (NCT04815720) is evaluating first line therapy of pepinemab in combination with KEYTRUDA, Merck & Co. Inc’s (MRK) anti-PD-1 therapy, in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Vaccinex plans to complete the interim analysis in May and to publicize results in June, 2023 after meeting with Merck to discuss the next steps.
ASCO 2023 Annual Meeting: Two abstracts will be presented at the Annual Meeting of the American College of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held in Chicago from June 3-6. The first will describe the Vaccinex-sponsored Phase 1b/2 PDAC Study to evaluate pepinemab in combination with BAVENCIO/avelumab as second line combination immunotherapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC, NCT05102721). This Vaccinex-sponsored study will be conducted with the University of Rochester Cancer Center and Wilmot Cancer Institute, with grant support from a Gateway Discovery Award. Prior studies suggest that treatment with pepinemab may promote the infiltration and activation of dendritic cells and CD8+ cells into the tumor microenvironment, rendering "cold" tumors such as PDAC immunologically "hot" and leading to enhanced efficacy of immune checkpoint inhibitors (ICIs) such as avelumab. The second abstract presents rationale and update of an ongoing Phase 1/2 trial evaluating pepinemab in combination with adoptive cell therapy for breast cancer patients and will be presented by our collaborators, Dr. Hyo S. Han and Dr. Brian Czerniecki of the Moffitt Cancer Center (NCT05378464). In preclinical studies, it was shown that SEMA4D antibody blockade in combination with a dendritic cell vaccine improved trafficking of dendritic cells to tumors and stimulated adaptive tumor immunity, resulting in improved regression of both primary and distant tumors. ASCO (Free ASCO Whitepaper) is the largest clinical oncology meeting in US and affords an opportunity to discuss progress and strategy with partners and collaborators.
ActivMAb Platform Technology:
Nature Communications Paper: Vaccinex and its collaborators published a report in Nature Communications, March 30, 2023, "A Vaccinia-based system for directed evolution of GPCRs in mammalian cells", describing a novel way that the ActivMAb platform can be used for functional studies and drug discovery of the "hard to drug" class of membrane-associated G protein-coupled receptors (GPCRs) and ion channels. The publication highlights the potential for the ActivMAb system to generate improved variants of any GPCR in a mammalian signaling system, enabling a better understanding of the functional properties of these complex receptors and the potential development of new and valuable drugs against these important targets.
First ActivMab-based clinical program: Vaccinex’s partner, Surface Oncology, announced the initiation of a Phase 1/2 study of SRF114, a fully human monoclonal antibody targeting CCD8, for the potential treatment of solid tumors. SRF114 is the first clinical candidate to emerge from the ActivMAb platform.
Financial Results for the Three Months Ended March 31, 2023:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2023 were $3.3 million, as compared to $6.4 million as of December 31, 2022.
Cash and Cash Equivalents and Marketable Securities: Subsequent Events.
On May 15, 2023, the Company closed the private placement of approximately 7.9 million shares of its common stock for aggregate gross proceeds of $3.0 million, following the private placement that raised $2.0 million in aggregate gross proceeds on March 31, 2023. FCMI Parent Co. ("FCMI"), which is controlled by Albert D. Friedberg, the chairman of the Company’s board of directors, purchased shares in both the March and May 2023 transactions and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of its board of directors, purchased shares in the March transaction. The Company intends to use the net proceeds from these private placements to fund the ongoing development and clinical trials of its lead drug candidate, pepinemab, in Alzheimer’s disease and in cancer and for working capital and general corporate purposes.
Research and Development Expenses. Research and development expenses for the quarter ended March 31, 2023 were $3.8 million as compared to $3.0 million for the comparable period in 2022.
The increase in research and development expenses is primarily attributable to increased patient enrollment in the SIGNAL-AD study and the Phase 1b/2 KEYNOTE B84 study in R/M HNSCC.
General and Administrative Expenses. General and administrative expenses for the quarter ended March 31, 2023 were $1.7 million as compared to $1.6 million for the comparable period in 2022.
Essentially flat level of general and administrative expenses reflects careful cost control measures.
Revenue. Vaccinex recorded revenue for the quarter ended March 31, 2023 of $0.6 million in recognition of a milestone payment from Surface Oncology, following dosing of the first patient in a Phase 1/2 study for SRF114.
Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended March 31, 2023 was $5.0 million and $(0.10) per share compared to $4.6 million and $(0.12) per share for the comparable period in 2022.
Full financial tables are included below. For further details on Vaccinex’s financials, please refer to its Form 10Q filed May 15, 2023 with the SEC.
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov link.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.
BAVENCIO/avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.
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 inflammatory reactions in the brain as well as in tumor immune evasion. Data show that by preventing deleterious inflammatory gliosis during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the function and health of neurons in the brain. Additional clinical 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 neurodegenerative disease and oncology. Pepinemab has been administered to more than 400 patients and appears to have a favorable safety and tolerability profile.
About ActivMAb
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique capabilities for multi-pass membrane targets such as G-protein-coupled receptors (GPCRs) and ion channels. The ActivMAb technology has five main applications: complex membrane antigen presentation, antibody or antigen discovery, directed evolution, and protein optimization. The first clinical candidate selected through use of this technology (SRF114, a fully human monoclonal antibody targeting CCR8 for the potential treatment of solid tumors), recently entered development in a Phase 1/2 study sponsored by our licensee, Surface Oncology. Vaccinex has entered into multiple antibody discovery collaborations with leading biopharmaceutical companies.