Cel-Sci Corporation - CVM STOCK NEWS

CEL-SCI (NYSE: CVM) announced FDA agreement on using PD-L1 biomarker for patient selection in its upcoming Multikine Registration Study for head and neck cancer, starting Q1 2025. The study will focus on patients with low PD-L1 tumor expression, following promising results from a previous Phase 3 study where patients showed 73% vs. 45% five-year survival rate compared to control group. The new study will enroll approximately 212 patients with newly diagnosed locally advanced primary head and neck cancer without lymph node involvement. Multikine shows better effectiveness in patients with low PD-L1 expression, which represents about 70% of head and neck cancer cases.

CEL-SCI (NYSE American: CVM) announced potential positive implications for its immunotherapy Multikine® following a recent FDA Oncologic Drugs Advisory Committee (ODAC) meeting. The ODAC voted against the risk-benefit profile of PD-L1 inhibitors in various cancers for patients with low PD-L1 expression. This decision highlights a major treatment gap for low and negative PD-L1 cancer patients.

CEL-SCI's Multikine has shown survival benefit and favorable safety profile in a Phase 3 study of treatment-naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression. The company believes Multikine is the only neoadjuvant immunotherapy demonstrating overall survival benefit in this population. CEL-SCI plans to use low PD-L1 expression as a selection criterion in its upcoming FDA confirmatory Registration Study.

CEL-SCI (NYSE American: CVM) has announced a renewed collaboration with Ergomed Clinical Research for its upcoming FDA confirmatory Registration Study of Multikine® in head and neck cancer. The study, set to enroll 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on those with no lymph node involvement and low PD-L1 tumor expression. Ergomed will provide global comprehensive clinical operations support to ensure efficient trial execution.

This partnership builds on their previous successful collaboration in the largest Phase 3 trial ever conducted in head and neck cancer. CEL-SCI has also received pediatric waivers from the UK's MHRA and the EMA. The study is planned to commence in Q1 2025 across multiple countries. In prior studies, Multikine showed promising results, with a 5-year survival rate of 73% vs 45% in the control group for the target population.

CEL-SCI (NYSE American: CVM) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).

These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.

CEL-SCI (NYSE American: CVM) announced it will present new data from its Phase 3 study of Multikine at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain. The poster, titled 'Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy,' will be presented on September 14, 2024.

CEL-SCI has received FDA approval to start a confirmatory Registration Study of Multikine for head and neck cancer treatment, based on strong safety and efficacy data from its completed IT-MATTERS Phase 3 study. The study's co-author, Dr. József Tímár, a respected pathologist and Professor at Semmelweis University, will present the findings. CEL-SCI plans to release a press release with the new data before market open on September 16, 2024.

CEL-SCI (NYSE American: CVM) has received a pediatric waiver from the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) for Multikine®, its treatment for head and neck cancer. This waiver exempts CEL-SCI from evaluating Multikine in patients under 18 years old as part of the license and marketing clearance review in the UK. CEO Geert Kersten stated that this decision accelerates the path to marketing approval in the UK, while the company prepares to start its confirmatory FDA Registration Study in the U.S. and other locations. The waiver is seen as a positive step towards future marketing clearance for Multikine.

CEL-SCI (NYSE American: CVM) reported its Q3 fiscal 2024 financial results and key developments. Highlights include:

1. Positive bias analysis results for Multikine, supporting its role in increasing patient survival.

2. FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer treatment.

3. Presentation at IDDST Congress showcasing Multikine's efficacy in patients with low tumor PD-L1 expression.

4. Board strengthening with new appointments.

5. R&D expenses decreased to $4.7 million from $5.7 million year-over-year.

6. G&A expenses reduced to $2.0 million from $2.5 million year-over-year.

7. Post-quarter equity fundraise of $10.85 million completed on July 29, 2024.

CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has closed a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The company plans to use the net proceeds to fund the development of Multikine, its lead investigational therapy, as well as for general corporate purposes and working capital. ThinkEquity acted as the sole placement agent for this best-efforts offering. CEL-SCI is preparing to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024. The company's focus remains on activating the immune system to fight cancer and infectious diseases.

CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has announced the pricing of a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The offering, expected to close on July 29, 2024, aims to fund the development of Multikine, their lead investigational therapy, and general corporate purposes. ThinkEquity is acting as the sole placement agent for this best-efforts offering. CEL-SCI's Multikine has completed a pivotal Phase 3 clinical trial for head and neck cancer and received Orphan Drug Status from the FDA. The company plans to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024.