On April 2, 2024 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 fourth quarter ended December 31, 2023 and provided a corporate update on key programs (Press release, Vaccinex, APR 2, 2024, View Source [SID1234641706]).
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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):
In June 2024, anticipate completing planned 12-months treatment of patients with mild Alzheimer’s disease in the randomized, double-blind, Phase 1b/2a SIGNAL-AD trial of pepinemab vs placebo (NCT04381468). This study was funded in part by the Alzheimer’s Drug Discovery Foundation and by a grant from the Alzheimer’s Association. Topline data is expected in Q3 2024.
Following last patient last visit we will evaluate the impact of treatment on brain metabolic activity, a key biomarker of clinical progression in AD, together with other biomarkers of disease progression and initial assessment of treatment effects on cognition employing several validated, clinically meaningful cognitive scales for AD.
An improving AD-drug development environment, based on FDA’s recent full approval of LEQEMBI, enables the pathway to reimbursement and supports partnering and 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 is believed to reduce neuroinflammation and to protect and restore healthy astrocyte and neuronal functions (Nature Medicine 2022, View Source).
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 anti-Aβ for greater efficacy.
Head and Neck Cancer:
As previously reported, analysis of interim data from the first 36 patients in the single-arm, Phase 2 KEYNOTE-B84 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 treatment 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 predictive of positive response to checkpoint inhibitors.
Further research has suggested strategies to exploit this unique feature of pepinemab treatment in combination with KEYTRUDA so as to further enhance and expand treatment benefit. This will be the focus of continuing development.
Financial Results for the Year Ended December 31, 2023:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on December 31, 2023 were $1.5 million, as compared to $6.4 million as of December 31, 2022.
In October 2023, the Company raised gross proceeds of $9.6 million from the sale of common stock and warrants to purchase common stock to certain investors including entities controlled by Albert D. Friedberg, the chairman of the Company’s board of directors and Maurice Zauderer, President and CEO of Vaccinex. Subsequently, on February 8, 2024, the Company completed a private placement of common stock and warrants to purchase common stock for gross proceeds of $3.7 million and on March 28, 2024 raised $1.5 million in a public offering and an additional $1.24 million on similar terms in a parallel private placement of common stock and warrants to purchase common stock. The Company was very pleased to also receive a $1.75 million investment from the Alzheimer’s Drug Discovery Foundation (ADDF) on March 29, 2024 in a private placement of preferred stock together with a common warrant to purchase common stock. ADDF has been a leading and visionary supporter of research in AD for 25 years and this was the second such award received by Vaccinex from this distinguished foundation. Details of all these transactions are available in 8-K and other periodic reports filed with the Securities and Exchange Commission (S.E.C.).
Research and Development Expenses. Research and development expenses for the year ended December 31, 2023, were $16.6 million as compared to $14.0 million for the comparable period in 2022.
General and Administrative Expenses. General and administrative expenses for the year ended December 31, 2023 were $6.9 million as compared to $6.2 million for the comparable period in 2022.
Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the year ended December 31, 2023, was $20.3 million and $(43.68) compared to $19.8 million and $(98.05) for the comparable period in 2022.
Full financial tables are included below. The Company effected a 1-for-15 reverse stock split in Q3 2023 and 1-for-14 reverse stock split in Q1 2024. All share and share amounts have been retro-actively restated to give effect to the reverse stock splits. For further details on Vaccinex’s financials and the reverse stock splits, refer to its Form 10-K filed April 2, 2024, with the SEC.
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. Over 600 patients have been treated or enrolled in clinical trials of pepinemab in different indications and pepinemab appears to be well-tolerated and to have a favorable safety profile.