Vaccinex, Inc. - VCNX STOCK NEWS

Vaccinex (NASDAQ: VCNX) announced new biomarker data showing that pepinemab enhanced clinical activity of immune checkpoint inhibitors in HPV-negative head and neck cancer (HNSCC). Data from two studies, the Phase 2 KEYNOTE-B84 and a neoadjuvant treatment study, demonstrated that pepinemab combination treatments induced mature lymphoid aggregates correlating with clinical benefit in immunotherapy resistant tumors. The findings will be presented at the Society for Immunotherapy of Cancer's Annual Meeting on November 8th, 2024.

The research suggests pepinemab can overcome limitations of immune checkpoint inhibitors, particularly in patients who typically don't benefit from immune checkpoint monotherapy.

Vaccinex (VCNX) announced new findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer's disease. The study revealed that pepinemab treatment inhibits the expression of plasma GFAP and p-tau 217 biomarkers during Mild Cognitive Impairment (MCI). The treatment showed promising trends in slowing cognitive decline in mild dementia patients with MMSE scores of 22-26. Proteomic analysis of Cerebrospinal Fluid identified several proteins typically increasing during AD progression that were inhibited by pepinemab. Additionally, using a Brain-Chip model, pepinemab demonstrated ability to inhibit or reverse damage caused by toxic alpha synuclein aggregates, suggesting potential applications in other neurodegenerative diseases.

Vaccinex (NASDAQ: VCNX) announced upcoming presentation of new efficacy and safety data from its SIGNAL-AD phase 1b/2 trial of pepinemab for Alzheimer's disease at the CTAD Conference in Madrid on October 31, 2024. The study focuses on pepinemab's ability to block SEMA4D, a molecule highly upregulated in damaged neurons during AD progression. The treatment aims to prevent harmful astrocyte activation that may accelerate disease progression. Key outcomes include impacts on cognitive decline and disease progression biomarkers. Notably, pepinemab shows potential benefits for brain vascular integrity, addressing a common concern with current AD treatments that can cause microhemorrhages.

Vaccinex (Nasdaq: VCNX), a clinical-stage biotech company focusing on neurodegenerative disease treatment, has announced the exercise of outstanding warrants resulting in $6.2 million in gross proceeds. The transaction involves:

1. Immediate exercise of warrants to purchase 1,067,492 shares at $5.636 per share
2. Issuance of 827,483 shares and pre-funding of 240,009 shares
3. New warrants issued for up to 1,601,238 additional shares at $5.636 per share, expiring in 5 years

Notably, entities affiliated with the CEO and Board Chairman accounted for 51% of the securities in the transaction. The closing is expected on September 18, 2024, subject to customary conditions.

Vaccinex (VCNX) has reported positive results from its SIGNAL-AD Phase 1b/2 trial of pepinemab in early-stage Alzheimer's disease (AD). The study showed a statistically significant difference (p=0.0297) in FDG-PET signal in the medial temporal cortex after 12 months of treatment compared to placebo. Pepinemab was well-tolerated in AD patients.

Key findings include:

• Reduction in blood levels of GFAP (astrocyte reactivity marker) and p-tau 217 (neuronal damage marker) in patients with Mild Cognitive Impairment (MCI) due to AD
• Apparent slowing of cognitive decline in MCI patients, as measured by iADRS and ADAS-Cog 13 assessments
• No discernible effect on biomarkers or cognitive decline in patients with early dementia

Vaccinex aims to pursue a development partnership for continued research in AD and other neurodegenerative diseases, including Huntington's Disease.

Vaccinex (VCNX) reported positive results from its SIGNAL-AD Phase 1b/2 trial of pepinemab in Alzheimer's Disease (AD). The trial met its primary safety endpoint, with no serious treatment-related adverse events. A key secondary endpoint showed statistically significant improvement in brain metabolic activity in patients with Mild Cognitive Impairment (MCI) due to AD.

The results mirror previous findings in Huntington's disease, suggesting pepinemab's potential efficacy in early-stage neurodegenerative diseases. While not powered for cognitive effects, the study indicates pepinemab may be most effective in early MCI stages. Vaccinex is exploring late-stage development partnerships for AD treatment.

Vaccinex (Nasdaq: VCNX) will present topline data for its phase 1b/2 SIGNAL-AD study of pepinemab in Alzheimer's disease at the Alzheimer's Association International Conference on July 31, 2024. The study aims to evaluate the safety and efficacy of targeting reactive astrocytes with pepinemab, a SEMA4D blocking antibody.

Key outcomes will include safety, tolerability, and the impact on brain metabolic activity and astrocyte reactivity. The company hypothesizes that pepinemab can slow disease progression by blocking SEMA4D signaling in astrocytes. Vaccinex believes pepinemab could be an attractive alternative or complementary treatment to anti-Aβ antibodies like Leqembi™ or Kisunla™, given its different mechanism of action and good tolerability in previous trials.

Vaccinex announced the completion of the last patient visit in its Phase 1b/2 SIGNAL-AD study of pepinemab for Alzheimer's Disease (AD). The database lock is expected in June, with key outcomes to be reported in July.

Pepinemab targets astrocyte reactivity and neuroinflammation, believed to accelerate AD progression. Key endpoints include safety, tolerability, brain metabolic activity, and biomarkers like GFAP and p-tau 217. The study also uses cognitive scales to assess treatment effects on cognitive decline.

Funded partly by $4.75 million from the Alzheimer’s Drug Discovery Foundation and a $0.75 million grant from the Alzheimer’s Association, pepinemab has shown potential to offer alternative or complementary treatment to existing anti-Aβ therapies.

Vaccinex has announced its first quarter 2024 financial results and updates on the SIGNAL-AD Phase 2a study for Alzheimer’s disease treatment using pepinemab. The last patient visit is scheduled for early June 2024, with data analysis by early July. Key highlights include the study's potential to slow neurodegenerative disease progression, funded partly by $4.75 million from the Alzheimer's Drug Discovery Foundation, and $0.75 million from the Alzheimer's Association. Financial highlights feature cash equivalents of $3.0 million, reductions in R&D expenses to $3.4 million, and a net loss decrease to $3.9 million. However, Nasdaq has flagged the company for non-compliance with equity standards. In response, Vaccinex has submitted a compliance plan.