CEL-SCI Corp. is a biotechnology company, which engages in the research, development and manufacture of investigational immunotherapy products for the treatment of cancer and infectious diseases. Its product pipeline includes Multikine and Ligand Epitope Presentation System (LEAPS). Multikine is an investigational immunotherapy for the potential treatment of head and neck cancers. LEAPS is categorized into LEAPS-H1N1-DC, a product candidate for the treatment of pandemic influenza for hospitalized patients and CEL-2000 and CEL-4000, which are vaccine candidates for the treatment of rheumatoid arthritis. The company was founded by Maximilian de Clara on March 22, 1983 and is headquartered in Vienna, VA.
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- The FDA published draft guidance on March 9, 2026, establishing formal requirements for drug manufacturers responding to Form 483 inspectional observations for the first time. - The guidance applies to domestic and foreign facilities manufacturing human and animal drugs regulated by CDER, CBER, and CVM, including combination product manufacturers. - FDA recommends an eight-element response format including executive summaries, detailed investigation reports, and comprehensive corrective and preventive action (CAPA) plans with measurable outcomes. - The guidance emphasizes systemic quality system assessments beyond individual observations, requiring companies to identify root causes and broader compliance issues.
- CEL-SCI received FDA approval to proceed with a 212-patient confirmatory registration study for Multikine in PD-L1 low head and neck cancer patients, with enrollment expected to begin in Spring 2026. - The company filed for Breakthrough Medicine Designation for Multikine in Saudi Arabia and completed manufacturing preparations at its cGMP facility for the upcoming registration trial. - Previous Phase 3 data showed Multikine achieved 73% long-term survival versus 45% without treatment, with a 66% reduction in death risk for patients with low to zero PD-L1 expression. - CEL-SCI plans to seek early U.S. approval based on pre-surgical tumor response data expected by 2028, targeting approximately 100,000 patients annually.
- CEL-SCI Corporation completed a $5.7 million stock offering to fund its confirmatory Phase 3 trial for Multikine, a neoadjuvant immunotherapy targeting head and neck cancer patients with low PD-L1 expression. - The company faces severe liquidity constraints with only $1.93 million in cash as of Q1 2025 and quarterly burn rate of approximately $7 million, creating an urgent need for additional funding. - Multikine previously demonstrated a 73% five-year survival rate versus 45% for standard care in a specific patient subset, earning FDA Orphan Drug designation. - The confirmatory trial will enroll 212 patients and represents CEL-SCI's final opportunity to validate decades of research in neoadjuvant immunotherapy for head and neck cancer.
- CEL-SCI Corporation has raised $5 million through a public offering of 2 million shares at $2.50 per share to fund the continued development of its cancer immunotherapy Multikine. - The company's Multikine therapy, designed to boost patients' immune systems before conventional treatments, has received FDA approval for a confirmatory Registration Study following promising Phase 3 results. - The upcoming study will enroll 212 newly diagnosed head and neck cancer patients with specific characteristics, targeting a population of approximately 100,000 patients annually.
- CEL-SCI received FDA clearance for a 212-patient confirmatory registration study of Multikine in squamous cell head and neck cancer patients with specific biomarker criteria. - Previous IT-MATTERS study demonstrated significant survival benefit, with 73% survival in Multikine-treated patients versus 45% in control group at five years. - The company has appointed Ergomed as CRO for the global trial starting Q1 2025, secured $5 million in funding, and estimates trial costs at $30 million.
- CEL-SCI's Multikine showed significant pre-surgical tumor regression in head and neck cancer patients within three weeks, a finding confirmed by pathology. - The FDA has approved CEL-SCI's plan to use PD-L1 as a biomarker for patient selection in the confirmatory Phase 3 trial, focusing on patients with low PD-L1 expression. - A confirmatory 212-patient Registration Study is set to commence, designed to confirm efficacy and safety results from a previous Phase 3 trial, with full enrollment expected by Q2 2026. - Multikine demonstrated a 73% 5-year survival rate in patients with low PD-L1 expression, compared to 45% in the control group, indicating a potential new standard of care.
- CEL-SCI Corporation has priced a $5 million public offering of 16.13 million shares at $0.31 per share to fund continued development of Multikine, a first-line cancer immunotherapy. - The company has received FDA clearance to conduct a confirmatory Registration Study for Multikine in 212 patients with locally advanced head and neck cancer who have specific characteristics. - Multikine is designed to boost the immune system's ability to target tumors while it's still intact, potentially improving survival outcomes for cancer patients.
- CEL-SCI's Multikine has received FDA approval for a confirmatory registration study involving 212 patients with head and neck cancer. - The study will focus on patients who demonstrated a 73% survival rate with Multikine, compared to 45% in control groups, in a prior Phase 3 trial. - The trial targets newly diagnosed, locally advanced head and neck cancer patients without lymph node involvement and low PD-L1 tumor expression. - Multikine previously showed significant tumor regression within three weeks of pre-surgical therapy, including five complete regressions in Phase 3.
- CEL-SCI has partnered with Ergomed for a confirmatory FDA registration study of Multikine in head and neck cancer, building on prior successful collaborations. - The study will enroll 212 patients with locally advanced primary head and neck cancer, focusing on those with no lymph node involvement and low PD-L1 expression. - Previous studies showed Multikine improved 5-year survival rates to 73% compared to 45% in the control group for the target population. - The confirmatory study is set to commence in Q1 2025 across multiple countries, marking a crucial step toward potential marketing approval.
