Articles from CEL-SCI Corporation

CEL-SCI Announces Proposed Public Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants in lieu thereof) in a best efforts public offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
By CEL-SCI Corporation · Via Business Wire · December 27, 2024
CEL-SCI Highlights Biological Rationale for the Use of Multikine in the Confirmatory Registration Head and Neck Cancer Study
CEL-SCI Corporation (NYSE American: CVM) today highlights strong biological rationale for the use of Multikine in the confirmatory registration head and neck cancer study. This study of 212 newly diagnosed locally advanced, resectable head and neck cancer patients was given the go-ahead as a confirmatory registration study by FDA and will focus on those patients who showed a 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine in the prior Phase 3 study.
By CEL-SCI Corporation · Via Business Wire · December 12, 2024
U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025
CEL-SCI Corporation (NYSE American: CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company’s approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine® (Leukocyte Interleukin, Injection)*. This study will focus on the treatment of newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low (TPS <10) PD-L1 tumor expression. This Registration Study, slated to commence in the first quarter of 2025, will enroll approximately 212 patients and prospectively confirm the favorable safety profile and the very favorable efficacy results demonstrated in the target population in CEL-SCI’s prior Phase 3 randomized study of 928 patients.
By CEL-SCI Corporation · Via Business Wire · November 7, 2024
FDA’s Oncologic Drugs Advisory Committee Decision on Checkpoint Inhibitors Substantiates Potential of CEL-SCI’s Multikine® to Address Major Treatment Gap for PD-L1 Negative Cancer Patients
CEL-SCI Corporation (NYSE American: CVM) today announced the potential positive impact on the clinical development of its immunotherapy Multikine® (Leukocyte Interleukin, Injection)* resulting from a recent U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting, a public forum.
By CEL-SCI Corporation · Via Business Wire · October 22, 2024
CEL-SCI Selects Ergomed as CRO as it Gears Up for Confirmatory FDA Registration Study of Multikine® in Head and Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer.
By CEL-SCI Corporation · Via Business Wire · October 1, 2024
CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation
CEL-SCI Corporation (NYSE American: CVM) today reported new data from its concluded Phase 3 study of Multikine® (Leukocyte Interleukin, Injection)* that were presented at the European Society for Medical Oncology (ESMO) 2024 Congress on Saturday, September 14, 2024 in a 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”. This data is highly relevant to CEL-SCI’s 212 patient confirmatory Registration Study which has received the U.S. Food and Drug Administration’s (FDA) go-ahead and is currently under preparation.
By CEL-SCI Corporation · Via Business Wire · September 16, 2024
CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress
CEL-SCI Corporation (NYSE American: CVM) today reported it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain. A 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 by the study’s co-author József Tímár MD, PhD, DSc, a prominent and highly respected pathologist.
By CEL-SCI Corporation · Via Business Wire · September 10, 2024
The UK’s Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance
CEL-SCI Corporation (NYSE American: CVM) today reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate Multikine in a pediatric population as part of license and marketing clearance review in the UK.
By CEL-SCI Corporation · Via Business Wire · September 4, 2024
CEL-SCI Corporation Reports Third Quarter Fiscal 2024 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · August 15, 2024
CEL-SCI Announces Closing of $10.8 Million Offering
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a cancer immunotherapy company, today announced the closing of its previously announced best-efforts offering of 10,845,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) was sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $10,845,000, before deducting placement agent fees and other offering expenses. All the shares and Pre-Funded Warrants in the offering were offered by the Company.
By CEL-SCI Corporation · Via Business Wire · July 29, 2024
CEL-SCI Announces Pricing of $10.8 Million Offering
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a cancer immunotherapy company, today announced the pricing of a best-efforts offering of 10,845,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). All of the shares and Pre-Funded Warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be $10,845,000. The offering is expected to close on July 29, 2024, subject to satisfaction of customary closing conditions.
By CEL-SCI Corporation · Via Business Wire · July 26, 2024
CEL-SCI’s Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results
CEL-SCI Corporation (NYSE American: CVM) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial's findings are reliable, the conclusions are valid, and to minimize the risk that bias has distorted the results.
By CEL-SCI Corporation · Via Business Wire · July 26, 2024
CEL-SCI Appoints Robert Watson as Chairperson of the Board
CEL-SCI Corporation (NYSE American: CVM) today announced that Robert (“Bob”) Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.
By CEL-SCI Corporation · Via Business Wire · July 8, 2024
CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population
CEL-SCI Corporation (NYSE American: CVM) today announced the Company’s Chief Scientific Officer, Dr. Eyal Talor, delivered a presentation titled “Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT” at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary on Tuesday, June 18, 2024. Dr. Talor presented during the Cancers/Tumors session which he Chaired along with Dr. Elizabeth Tran of Purdue University.
By CEL-SCI Corporation · Via Business Wire · June 18, 2024
Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor
CEL-SCI Corporation (NYSE American: CVM) today announced Dr. Giovanni Selvaggi, an oncology key opinion leader instrumental in successfully bringing several drugs to market has joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi joins CEL-SCI as the Company recently received its go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer.
By CEL-SCI Corporation · Via Business Wire · June 6, 2024
CEL-SCI Corporation Reports Second Quarter Fiscal 2024 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2024, as well as key recent clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · May 16, 2024
CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced a significantly positive outcome from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the path to approval for its first-line investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection). Based on strong safety and efficacy data from CEL-SCI’s completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).
By CEL-SCI Corporation · Via Business Wire · May 8, 2024
CEL-SCI Appoints Mario Gobbo to Its Board of Directors
CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Mario Gobbo to its Board of Directors.
By CEL-SCI Corporation · Via Business Wire · April 23, 2024
CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology
CEL-SCI Corporation (NYSE American: CVM) today announced the peer reviewed scientific journal Frontiers in Immunology published an article regarding CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology in the treatment of rheumatoid arthritis (RA) titled: “Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines”. CEL-SCI’s LEAPS team, along with outside collaborators from U.S. and Europe, reviewed published/presented results from pre-clinical animal model of antigen-specific LEAPS therapeutic vaccines, such as CEL-4000 and CEL-5000, made specific for the treatment of RA, and compared these findings with published results of other RA-therapies that either suppress or alter the immune response in order to treat RA.
By CEL-SCI Corporation · Via Business Wire · March 19, 2024
CEL-SCI Corporation Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
By CEL-SCI Corporation · Via Business Wire · March 6, 2024
CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · February 15, 2024
CEL-SCI Announces Closing of $7.75 Million Public Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 3,875,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company.
By CEL-SCI Corporation · Via Business Wire · February 13, 2024
CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction of customary closing conditions.
By CEL-SCI Corporation · Via Business Wire · February 9, 2024
CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head & Neck Cancer Drug
CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine® (Leukocyte Interleukin, Injection)* cGMP state-of-the-art dedicated manufacturing facility commissioning has been completed.
By CEL-SCI Corporation · Via Business Wire · February 6, 2024
European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine®
CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). According to the opinion letter:
By CEL-SCI Corporation · Via Business Wire · January 31, 2024
CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments
CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2023, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · December 22, 2023
UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced that the British National Institute for Health and Care Excellence (NICE) has selected Multikine* (Leukocyte Interleukin, Injection) to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK. This published report informs UK doctors, patients, and other interested parties that NICE has started the review of Multikine and is soliciting public comment.
By CEL-SCI Corporation · Via Business Wire · December 4, 2023
CEL-SCI Announces Closing of $5 Million Public Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 2,490,000 shares of its common stock to a single investor at a public offering price of $2.00 per share, for gross proceeds of approximately $5 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock were offered by the Company.
By CEL-SCI Corporation · Via Business Wire · November 20, 2023
CEL-SCI Announces Pricing of $5 Million Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 2,490,000 shares of its common stock to a single investor at an offering price of $2.00 per share, for gross proceeds of approximately $5 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on November 20, 2023, subject to satisfaction of customary closing conditions.
By CEL-SCI Corporation · Via Business Wire · November 16, 2023
CEL-SCI Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today released a letter to shareholders from the Company’s CEO, Geert Kersten. The very comprehensive letter details the data reported on the efficacy of Multikine (Leukocyte Interleukin, Injection)* in the head and neck cancer target patient population as well as CEL-SCI’s plan to file for immediate regulatory approval. The shareholder letter can be read in full on the Company’s website (https://cel-sci.com/) or by clicking HERE.
By CEL-SCI Corporation · Via Business Wire · October 30, 2023
CEL-SCI Releases Video Detailing Recent Phase 3 Findings & its Plans to Seek Immediate Regulatory Approvals
CEL-SCI Corporation (NYSE American: CVM) today released a video presentation in which the Company’s CEO, Geert Kersten, shares the most recent data presented at the European Society for Medical Oncology (ESMO) Congress and the data’s impact on propelling the Company’s immunotherapy drug Multikine* (Leukocyte Interleukin, Injection) toward regulatory approval for the treatment of newly diagnosed, advanced squamous cell carcinoma of the head and neck (SCCHN). Mr. Kersten carefully explains how it is that patients in the target group who were treated with Multikine had a 5-year survival rate of 73% as compared to only 45% for those who did not receive Multikine, cutting the risk of death by half. He goes on to present CEL-SCI’s regulatory submissions plan and timelines based on these compelling findings for a patient population that has not had a new treatment approved in in the U.S. in many decades.
By CEL-SCI Corporation · Via Business Wire · October 24, 2023
5-Year Head & Neck Cancer Survival Increased From 45% to 73% in CEL-SCI’s Target Population, Cutting Risk of Death in Half, as Presented at Leading Cancer Conference ESMO 2023
CEL-SCI Corporation (NYSE American: CVM) today announced that it has finalized the selection criteria for the head and neck cancer target population to be treated with the Company’s immunotherapy drug Multikine (Leukocyte Interleukin, Injection). Five-year survival in the target population was 73% alive for Multikine-treated patients vs only 45% alive in the control who did not receive Multikine, with the five-year risk of death cut in half for Multikine-treated subjects in the target population versus the control. These data, which are statistically significant and accompanied by strong hazard ratios, are a crucial achievement on the path for the approval of Multikine. CEL-SCI presented the data for the first time at the European Society for Medical Oncology (ESMO) Congress in Spain on October 22, 2023. The selection criteria for this target population were developed based on the completed Phase 3 randomized controlled trial, advice from regulators, and advice from physician consultants associated with the University of California San Diego Cancer Center and Yale Medical School, recognized as among the nation’s most esteemed immuno-oncologists in head and neck cancer.
By CEL-SCI Corporation · Via Business Wire · October 23, 2023
CEL-SCI Readies Its Multikine Manufacturing Facility for Commercial Scale Production
CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine* (Leukocyte Interleukin, Injection) cGMP state-of-the-art dedicated manufacturing facility commissioning is substantially complete, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine in the treatment of head and neck cancer.
By CEL-SCI Corporation · Via Business Wire · October 19, 2023
CEL-SCI Files Request With the UK’s MHRA Regarding Path to Approval for Multikine in the Treatment of Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer.
By CEL-SCI Corporation · Via Business Wire · October 5, 2023
CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the European Medicines Agency’s (EMA’s) Scientific Advice Working Group.
By CEL-SCI Corporation · Via Business Wire · September 26, 2023
CEL-SCI Corporation Reports Third Quarter Fiscal 2023 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2023, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · August 11, 2023
CEL-SCI Announces Closing of Public Offering
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 2,500,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $5,000,000, before deducting underwriting discounts and offering expenses.
By CEL-SCI Corporation · Via Business Wire · July 20, 2023
CEL-SCI Announces Pricing of Public Offering
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $5,000,000, before deducting underwriting discounts, and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on July 20, 2023, subject to satisfaction of customary closing conditions.
By CEL-SCI Corporation · Via Business Wire · July 17, 2023
CEL-SCI Announces Proposed Public Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced that it intends to offer to sell shares of its common stock in an underwritten public offering. The Company expects to grant the underwriter a 45-day option to purchase up to an additional 15% of the number of shares of common stock sold in this offering to cover over-allotments, if any. All of the shares of common stock are being offered by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
By CEL-SCI Corporation · Via Business Wire · July 17, 2023
CEL-SCI Concludes Positive Meeting With U.S. FDA Concerning Multikine’s Approval for Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced it has concluded a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the path forward for bringing Multikine* (Leukocyte Interleukin, Injection) immunotherapy to market for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN). During the recent meeting, the FDA acknowledged the longstanding need for improved treatments for head and neck cancer.
By CEL-SCI Corporation · Via Business Wire · July 14, 2023
CEL-SCI Reports Phase 3 Tumor PD-L1 Biomarker Data Demonstrate Multikine’s Increased Efficacy and Points to Potential for Combination With Checkpoint Inhibitors for Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced new data from a biomarker analysis of its pivotal Phase 3 study in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 10, 2023 in Montreal, Canada, in the presentation titled “Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study”. The Leukocyte Interleukin Injection (LI) [aka Multikine*] talk, was delivered by Philip Lavin, PhD, lead biostatistician for over 80 regulatory approvals/clearances who has also served on multiple U.S. Food and Drug Administration (FDA) review panels. Dr. Lavin is the lead biostatistician for CEL-SCI’s IT-MATTERS study.
By CEL-SCI Corporation · Via Business Wire · July 11, 2023
CEL-SCI to Present Novel Data at AHNS 11th International Conference on Head and Neck Cancer—New Patent to Be Filed
CEL-SCI Corporation (NYSE American: CVM) today announced it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in Montreal, Canada.
By CEL-SCI Corporation · Via Business Wire · June 22, 2023
Histopathology and Tumor Biomarker Analysis Confirm CEL-SCI’s Multikine Significantly Prolonged Overall Survival in Head & Neck Cancer—Phase 3 Data Presented at ESTRO 2023
CEL-SCI Corporation (NYSE American: CVM) today announced that the latest results from its pivotal Phase 3 study of Multikine, a presurgical cancer immunotherapy, were presented at the European Society for Radiotherapy and Oncology (ESTRO) 2023 Congress in Vienna, Austria in a poster presentation titled “Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma SCCHN)” during the Head & Neck Cancer Session on Saturday, May 13, 2023.
By CEL-SCI Corporation · Via Business Wire · May 15, 2023
CEL-SCI Corporation Reports Second Quarter Fiscal 2023 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2023, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · May 12, 2023
CEL-SCI Announces $1.35 Million Underwritten Confidentially Marketed Public Offering of Common Stock
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of its underwritten confidentially marketed public offering of 794,117 shares of common stock at an offering price of $1.70 per share. The closing of the offering is expected to take place on or about May 2, 2023, subject to the satisfaction of customary closing conditions. In addition, the Company expects to grant the underwriter a 30-day option to purchase up to an additional 15 percent of the shares of common stock to cover over-allotments.
By CEL-SCI Corporation · Via Business Wire · April 27, 2023
CEL-SCI to Pursue Canada’s Conditional Approval Pathway for Multikine in the Treatment of Head & Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced it has held a productive pre-submission meeting with Canada’s regulator to determine the best regulatory path toward market approval. Based on the existing data that was summarized and presented, Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions policy. Additional discussions explored how patients at lower risk for recurrence could be targeted for treatment, and what sort of post-market commitments could help ensure that only the most suitable patients would be treated with Multikine®* (Leukocyte Interleukin Injection), based on the best available evidence.
By CEL-SCI Corporation · Via Business Wire · April 19, 2023
CEL-SCI’s Multikine Phase 3 Cancer Study Shows 43% Survival Extension
CEL-SCI Corporation (NYSE American: CVM) today reported new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN). A poster presentation titled “Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment naïve locally advanced primary squamous cell carcinoma of the head & neck: the IT-MATTERS Study” was delivered by Eyal Talor, Ph.D., CEL-SCI’s Chief Scientific Officer on March 8, 2023 at the 10th European Congress on Head & Neck Oncology (ECHNO) in Lisbon, Portugal.
By CEL-SCI Corporation · Via Business Wire · March 8, 2023
CEL-SCI to Present New Phase 3 Data at European Congress on Head & Neck Oncology
CEL-SCI Corporation (NYSE American: CVM) today announced it will present new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), on March 8, 2023 at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal. CEL-SCI will publish a summary of the findings shortly after the presentation.
By CEL-SCI Corporation · Via Business Wire · March 3, 2023
CEL-SCI Corporation Reports First Quarter Fiscal 2023 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2022, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · February 15, 2023
CEL-SCI Reports Fiscal 2022 Financial Results and Clinical & Corporate Developments
CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2022, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · December 28, 2022
CEL-SCI Corporation Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
By CEL-SCI Corporation · Via Business Wire · November 22, 2022
CEL-SCI’S Multikine Reduced 5-year Death Rate From 54% to 22% in Phase 3 Study Patients Who Were Early Tumor Responders Prior to Any Standard of Care Treatment
CEL-SCI Corporation (NYSE American: CVM) today announced the availability to the public of an oral presentation delivered by Dr. Philip Lavin of groundbreaking tumor response and increased overall survival in head and neck cancer. This presentation includes data presented at the European Society for Medical Oncology (ESMO) Annual Congress on September 10, 2022 in Paris, France. The ESMO poster presentation was titled “Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study (Clinicaltrials.gov NCT01265849).”
By CEL-SCI Corporation · Via Business Wire · October 17, 2022
CEL-SCI’S Phase 3 Data Presented at ESMO 2022: Neoadjuvant Multikine Achieved Groundbreaking Tumor Response & Extended Overall Survival in Locally Advanced Head and Neck Cancer
CEL-SCI Corporation (NYSE American: CVM) today announced two poster presentations were delivered at the European Society for Medical Oncology (EMSO) annual Congress on September 10, 2022 in Paris, France. Data presented were from the Company's pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck.
By CEL-SCI Corporation · Via Business Wire · September 12, 2022
CEL-SCI Corporation Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
By CEL-SCI Corporation · Via Business Wire · September 7, 2022
CEL-SCI Corporation Announces Phase 3 Multikine® Head and Neck Cancer Results Posted on Clinicaltrials.gov
CEL-SCI Corporation (NYSE American: CVM) announced today that the results of its 10-year IT-MATTERS pivotal Phase 3 clinical trial in head and neck cancer with its investigational immunotherapy Multikine®* (Leukocyte Interleukin, Injection) have been posted on clinicaltrials.gov per U.S. government requirements. (See https://clinicaltrials.gov/ct2/show/results/NCT01265849?term=multikine&draw=2&rank=2). Clinicaltrials.gov is the largest clinical trial database in the world. It is run by the U.S. National Library of Medicine at the National Institutes of Health. Some of the trial’s results were published in two peer-reviewed abstracts and a poster at the ASCO conference in June 2022. (See https://www.businesswire.com/news/home/20220527005092/en/.) Additional results will be published in scientific journals and presented in scientific forums in the future.
By CEL-SCI Corporation · Via Business Wire · August 19, 2022
CEL-SCI Corporation Reports Third Quarter Fiscal 2022 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2022, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · August 15, 2022
CEL-SCI Appoints Dr. Gail Naughton to Its Board of Directors
CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Dr. Gail K. Naughton to its Board of Directors.
By CEL-SCI Corporation · Via Business Wire · August 8, 2022
CEL-SCI Corporation Announces Reddit AMA with Geert Kersten
CEL-SCI Corporation (NYSE American: CVM) announces that Geert Kersten, Chief Executive Officer, will be on Reddit AMA (“Ask Me Anything”) today at 12:30 PM ET to discuss Multikine and our recent publications at ASCO 2022.
By CEL-SCI Corporation · Via Business Wire · July 14, 2022
CEL-SCI Corporation to Present at LD Micro Invitational
CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced that Geert Kersten, Chief Executive Officer, is scheduled to present at the LD Micro Invitational XII Conference today, June 8, 2022 at 4:30 p.m. EDT. The Conference is taking place in-person at the Four Seasons in Westlake Village, CA from June 7 - 9, 2022.
By CEL-SCI Corporation · Via Business Wire · June 8, 2022
CEL-SCI Presents Phase 3 Multikine Head & Neck Cancer Data at ASCO
CEL-SCI Corporation (NYSE American: CVM) today announced that its abstract and poster titled “Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study” was presented on June 6, 2022 at the American Society of Clinical Oncology (ASCO)’s 2022 ASCO Annual Meeting in Chicago, Illinois.
By CEL-SCI Corporation · Via Business Wire · June 7, 2022
CEL-SCI Announces Publication of ASCO 2022 Abstracts
CEL-SCI Corporation (NYSE American: CVM) today announced the American Society of Clinical Oncology (ASCO) has published two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine® (Leukocyte Interleukin, Inj.)* head and neck cancer clinical trial. The poster will be presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., at the 2022 ASCO Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois.
By CEL-SCI Corporation · Via Business Wire · May 27, 2022
CEL-SCI Corporation Reports Second Quarter Fiscal 2022 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2022, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · May 16, 2022
CEL-SCI Announces Acceptance of Abstracts to ASCO 2022
CEL-SCI Corporation (NYSE American: CVM) today announced that two abstracts related to CEL-SCI’s pivotal Phase 3 head and neck cancer clinical trial were accepted at the American Society of Clinical Oncology (ASCO) meeting being held June 3-7, 2022 in Chicago, IL. After a two-year hiatus, ASCO comes alive in June 2022 under the theme, “Advancing Equitable Cancer Care Through Innovation.” ASCO is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.
By CEL-SCI Corporation · Via Business Wire · April 22, 2022
CEL-SCI Corporation Reports First Quarter Fiscal 2022 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2021, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · February 14, 2022
CEL-SCI Reports Fiscal 2021 Financial Results and Clinical & Corporate Developments
CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2021, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · December 22, 2021
CEL-SCI Corporation Completes Commercial-Scale Buildout of Multikine Manufacturing Facility
CEL-SCI Corporation (NYSE American: CVM) today announced it has completed the expansion of its existing dedicated Multikine* (Leukocyte Interleukin, Injection) cGMP manufacturing facility. The expansion was undertaken in anticipation of filing a Biologics License Application (BLA) which, if approved, will allow Multikine produced in the facility to be commercially distributed. The construction, which began in 2020, expanded the facility and added various upgrades to ensure it will be in compliance with all requirements of the FDA’s Current Good Manufacturing Practice (GMP) regulations. The facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it is licensed. The renovations also anticipate that additional personnel will be required to staff a second manufacturing shift to meet the eventual market demand for Multikine. Following an $11 million investment to increase production, CEL-SCI staff recently moved back into the renovated facility.
By CEL-SCI Corporation · Via Business Wire · October 22, 2021
CEL-SCI Corporation Reports Third Quarter Fiscal 2021 Financial Results
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2021, as well as key clinical and corporate developments.
By CEL-SCI Corporation · Via Business Wire · August 16, 2021
CEL-SCI Corporation Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
By CEL-SCI Corporation · Via Business Wire · July 7, 2021
Discussion of Results of CEL-SCI’s Phase 3 Trial Is Now Available
CEL-SCI Corporation (NYSE American: CVM) today announced that the discussion at the Annual Shareholder Meeting, on July 1, 2021 at 10:00 am EDT, regarding its Phase 3 head and neck cancer trial results is available at https://edge.media-server.com/mmc/p/ou79u5bv.
By CEL-SCI Corporation · Via Business Wire · July 2, 2021
CEL-SCI to Conduct Investor Call Regarding Phase 3 Results Following Annual Shareholder Meeting on July 1, 2021
CEL-SCI Corporation (NYSE American: CVM) today announced that right after its previously scheduled Annual Shareholder Meeting, on July 1, 2021 at 10:00 am EDT, the Company will discuss its Phase 3 head and neck cancer trial results at the conclusion of the Annual Shareholder Meeting. Shareholders and guests alike are welcome to attend the Annual Shareholder Meeting and may do so through the following link www.meetingcenter.io/281205077 on a listen-only basis. At the link, shareholders may enter their control number, while others may sign in as a guest.
By CEL-SCI Corporation · Via Business Wire · June 30, 2021
CEL-SCI’s Multikine® Immunotherapy Produces Significant 14.1% 5-Year Survival Benefit (62.7% Vs 48.6%) in the Group Receiving Surgery Plus Radiotherapy in a Landmark Head and Neck Cancer Phase 3 Study
CEL-SCI Corporation (NYSE American: CVM) today announced results from its 9.5 year pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection)* in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN).
By CEL-SCI Corporation · Via Business Wire · June 28, 2021
CEL-SCI Corporation Invites Participants to Pre-Submit Questions for Annual Shareholder Meeting
CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, invites participants to pre-submit questions for the Company’s upcoming Annual Shareholder Meeting to be held on July 1, 2021 at 10:00 a.m. EDT. Questions can be submitted up until 5:00 p.m. EDT on June 29, 2021. Please email questions to annualmeeting@cel-sci.com and use the subject line, “CVM Call Questions” for this correspondence.
By CEL-SCI Corporation · Via Business Wire · June 25, 2021
CEL-SCI Announces the Closing of $31.7 Million Bought Deal Offering
CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of the offering of 1,400,000 shares of its common stock at a price of $22.62 per share, for total gross proceeds of approximately $31.7 million, before deducting underwriting discounts and other offering expenses payable by the Company. Additionally, the Company has granted the underwriter a 30-day option to purchase up to 210,000 additional shares to cover over-allotments.
By CEL-SCI Corporation · Via Business Wire · June 11, 2021
CEL-SCI Increases Previously Announced Bought Deal to $31.7 Million
CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced that, due to demand, the underwriter has agreed to increase the size of its previously announced offering and purchase on a firm commitment basis 1,400,000 shares of common stock of the Company, at a price to the public of $22.62 per share (the “Public Price”), representing a 5% discount to the closing price per share. The closing of the offering is expected to occur on or about June 11, 2021, subject to customary closing conditions.
By CEL-SCI Corporation · Via Business Wire · June 8, 2021
CEL-SCI Announces Bought Deal Offering
CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced that it has entered into an underwriting agreement with Kingswood Capital Markets, division of Benchmark Investments, LLC under which the underwriter has agreed to purchase on a firm commitment basis a minimum of 1,000,000 shares of common stock of the Company, at a price to the public of $22.62 per share (the “Public Price”), representing a 5% discount to the Company’s June 8, 2021 closing share price. The closing of the offering is expected to occur on or about June 11, 2021, subject to customary closing conditions.
By CEL-SCI Corporation · Via Business Wire · June 8, 2021