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GeoVax Labs, Inc. (OTCQB: GOVX) is a clinical-stage biotechnology company specializing in developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers.
Utilizing novel proprietary platforms like the modified vaccinia ankara - virus-like particle (MVA-VLP) vaccine platform, GeoVax's pipeline includes ongoing human clinical trials for a next-generation COVID-19 vaccine and gene-directed therapy for head and neck cancers.
Additional research programs focus on preventive vaccines against infectious diseases like Monkeypox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg, and Lassa), and Zika virus, along with immunotherapies for various solid tumors.
Recent achievements include positive initial safety and immune response findings from a Phase 2 clinical trial evaluating GEO-CM04S1, the COVID-19 vaccine, as a heterologous booster in 63 healthy adults who previously received the Pfizer or Moderna mRNA vaccine. The trial has demonstrated statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants.
GeoVax Labs, Inc. (Nasdaq: GOVX) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Awarded BARDA Project NextGen (PNG) contract worth over $350 million to advance GEO-CM04S1, their next-generation COVID-19 vaccine, into a 10,000-participant Phase 2b study.
2. Partnered with Allucent, a global CRO, to conduct the Phase 2b trial.
3. Advancing Gedeptin® into an expanded Phase 2 clinical trial for first-recurrence head and neck cancer, with activation expected in H1 2025.
4. Produced first lot of GEO-CM04S1 with a commercial manufacturing platform.
5. Q2 2024 net loss of $5,064,042 ($1.99 per share), compared to $5,927,620 ($3.79 per share) in Q2 2023.
6. Cash balance of $1,561,712 as of June 30, 2024.
GeoVax Labs, Inc. (Nasdaq: GOVX) has announced plans for a Phase 2 trial of its Gedeptin® cancer therapy following a clinical advisory committee review. The trial will focus on first-recurrence head and neck cancer, combining Gedeptin with an immune checkpoint inhibitor. This decision comes after reviewing the completed PNP-002 Phase 1b/2a and PNP-001 Phase 1 trials, which demonstrated acceptable safety and efficacy in advanced head and neck squamous cell carcinoma (HNSCC) patients.
The planned Phase 2 trial aims to establish the efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor. It will involve approximately 6 patients, with pathologic response rate as the primary endpoint. GeoVax anticipates trial activation during the first half of 2025. The company is also pursuing development plans for Gedeptin in additional solid tumor indications in partnership with leading academic oncology centers.
GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company focused on developing immunotherapies and vaccines for cancer and infectious diseases, has announced it will release its second quarter 2024 financial results on Tuesday, August 6, 2024, after U.S. markets close. The company will host a live conference call and webcast at 4:30 p.m. ET on the same day to discuss the financial results and provide a corporate update.
Investors and interested parties can join the conference call using the following details:
- Domestic: (800) 715-9871
- International: +1 (646) 307-1963
- Conference ID: 3852178
A webcast of the call will be available at https://edge.media-server.com/mmc/p/qj3e68n8, with a replay accessible for three months after the event.
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