On November 13, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs (Press release, Vaccinex, NOV 13, 2023, View Source [SID1234637566]).
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Vaccinex achieved several important clinical milestones for pepinemab in both Alzheimer’s disease and Head and Neck Cancer.
Alzheimer’s Disease (AD):
Completed enrollment in the randomized, double-blind, Phase 1b/2a SIGNAL-AD trial of pepinemab in patients with mild Alzheimer’s disease (NCT04381468), funded in part by the Alzheimer’s Drug Discovery Foundation and by a grant from the Alzheimer’s Association.
Anticipate completing 12-months treatment in June 2024 at which time we will evaluate the impact of treatment on brain metabolic activity, a key biomarker of clinical progression in AD, as well as treatment effects on cognition employing several validated, clinically meaningful Alzheimer’s cognitive scales.
An improving AD-drug development environment, based on FDA’s recent full approval of LEQEMBI, enables the pathway to reimbursement and supports further investment in Alzheimer’s Disease drug development.
As previously reported, pepinemab has a differentiated mechanism of action, blocking SEMA4D, which is upregulated in neurons during stress of Alzheimer’s and Huntington’s disease and triggers the transformation of astrocytes and microglia from normal homeostatic functions to neuroinflammatory activity. Blockade of SEMA4D restores healthy astrocyte and neuronal functions while reducing neuroinflammation (Nature Medicine 2022).
We believe that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of anti-Aβ amyloid antibodies would make pepinemab attractive as a potential alternative to anti-Aβ antibodies or possibly for use in combination with an anti-Aβ for greater efficacy.
The potential impact of the AD program on Vaccinex valuation and financial resources make this Vaccinex’s most important near-term catalyst.
Head and Neck Cancer:
As previously reported, analysis of interim data from the first 36 patients in the single-arm, Phase 2 KEYNOTE B-84 study (NCT04815720) evaluating pepinemab in combination with KEYTRUDA in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) suggests that the combination of pepinemab and KEYTRUDA resulted in an approximately 2X increase in objective responses (ORR) and progression free survival (PFS) in the subset of patients with hard-to-treat PD-L1-low tumors compared to historical response rates for checkpoint monotherapy in this population.
Biomarker data indicate that treatment induced the formation of highly organized lymphoid aggregates in tumor that correlate with disease control and have previously been shown to be important for positive response to checkpoint inhibitors.
Vaccinex and Merck are currently in the design stages for an expansion of the KEYNOTE-B84 study that may extend benefits to more patients.
Recent Milestones and News
Clinical Trials in Alzheimer’s Disease (CTAD) Conference Presentation:
In a highlighted podium presentation at the CTAD Conference on September 28, 2023. Vaccinex’s Senior Vice President for Clinical Development, Terrence Fisher, PhD, described the many physiological parallels between neurodegenerative processes in Alzheimer’s and Huntington’s disease (HD). A key common feature is the contribution of astrocyte activation (astrogliosis) to brain inflammation and damage. Vaccinex scientists have demonstrated that the stress of disease in both AD and HD leads to upregulation of SEMA4D in neurons and that this can trigger astrocytes to switch from their normal supportive physiological functions to inflammatory activity. This transition is marked by release of glial fibrillary acidic protein (GFAP), a characteristic astrocyte protein, into blood. Importantly, treatment with pepinemab was shown to result in a significant reduction in plasma GFAP levels in HD patients. Elevated plasma GFAP levels have also been reported to correlate with Aβ amyloid deposits in brain and to be associated with higher risk of dementia and faster rates of cognitive decline in AD.
ActivMAb Platform Technology:
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), is in a Phase 1/2 study sponsored by our licensee, Surface Oncology, recently acquired by Coherus Biosciences, Inc. (transaction closed September 8, 2023). The technology and its potential applications for drug discovery against complex membrane protein targets including the "hard to drug" class of membrane-associated G protein-coupled receptors (GPCRs) and ion channels is also being utilized in multiple Vaccinex antibody discovery collaborations with leading biopharmaceutical companies.
Financial Results for the Three Months Ended September 30, 2023:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on September 30, 2023 were $0.1 million, as compared to $6.4 million as of December 31, 2022.
During Q3 2023, the Company raised finances of $1.3 million. On August 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.20 million shares1 of common stock for aggregate proceeds of $0.7 million. Similarly, on September 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.25 million shares of common stock for aggregate proceeds of $0.6 million. 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 approximately 0.14 million shares of common stock for gross proceeds of $0.3 million.
In addition, on October 3, 2023, the Company issued and sold to certain investors (i) 7,600,000 shares of the Company’s common stock together with common warrants to purchase up to 7,600,000 shares of common stock and (ii) 2,000,000 pre-funded warrants to purchase up to 2,000,000 shares of common stock together with common warrants to purchase up to 2,000,000 shares of common stock, at a purchase price of $1.00 and $0.999, respectively, for aggregate gross proceeds of $9.60 million. FCMI, which is controlled by Albert D. Frieberg, the chairman of the Company’s board of directors, and Vaccinex (Rochester) L.L.C. purchased 3,000,000 and 500,000 shares of our common stock and accompanying common warrants, respectively, for an aggregate purchase price of $3.50 million.
Finally, in Q3 2023, the Company recorded a receivable of $0.9 million for the Employee Retention Credit. The Company expects to receive the cash proceeds by the end of 2023 or early Q1 2024.
Research and Development Expenses. Research and development expenses for the quarter ended September 30, 2023 were $4.4 million as compared to $3.4 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 HNSCC.
General and Administrative Expenses. General and administrative expenses for the quarter ended September 30, 2023 were $1.5 million as compared to $1.4 million for the comparable period in 2022.
The increase was attributable to increased legal and patent related services.
Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended September 30, 2023 was $4.9 million and $(1.09) compared to $4.8 million and $(1.67) for the comparable period in 2022.
Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10-Q filed November 13, 2023 with the S.E.C.
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and glial cells in the brain and dendritic cells in immune tissue. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.