Latest news with #Multikine
Int'l Business Times
6 days ago
- Health
- Int'l Business Times
Saudi Arabia Advances Cancer Care with Potential Approval of Multikine Immunotherapy
In a pivotal development in cancer care, Saudi Arabia may become the first country in the world to approve CEL-SCI Corporation 's investigational immunotherapy, Multikine, for commercial use in treating head and neck cancer. The US-based biotech company has submitted an application to the Saudi Food and Drug Authority (SFDA) for Breakthrough Medicine Designation, a fast-track regulatory pathway that could make Multikine available to patients as early as this summer. This move comes after favorable engagement between CEL-SCI and SFDA reviewers announced in April of this year, positioning Saudi Arabia at the forefront of global innovation in oncology. If approved, Multikine would represent a new era in immuno-oncology by becoming the first neoadjuvant (pre-surgical) immunotherapy available for advanced primary head and neck cancer. The Unmet Need in Head and Neck Cancer Head and neck cancers (HNCs) account for 5% of all cancer cases in Saudi Arabia, which is around 650–700 new cases every year. Mostly affecting men attributed to tobacco use, including cigarettes, shisha, and smokeless tobacco like shamma . In the southern provinces like Jazan, shamma use is linked to high oral cancer rates, including among women. Head and neck cancers are often diagnosed at advanced stages, with 80% or more of patients having lymph node involvement at diagnosis. The most common subtypes in the Kingdom are oral cavity and nasopharyngeal carcinomas. Despite advances in surgery and radiation, 5-year survival rates have plateaued at 50%, so there is a big need for more effective first-line treatment options. The Science Behind Multikine Multikine (Leukocyte Interleukin, Injection) is a unique immunotherapeutic biologic composed of a carefully calibrated mix of natural cytokines derived from activated human white blood cells. Unlike checkpoint inhibitors used in later-stage cancers, Multikine is designed to be administered before surgery, while the patient's immune system is still intact and the tumor is present as a target. In CEL-SCI's global Phase III trial , the largest ever conducted in head and neck cancer, Multikine demonstrated a statistically significant improvement in five-year survival rates for a defined patient subgroup: those treated with surgery followed by radiation but not chemotherapy. Among these patients, five-year survival improved from 48.6% to 62.7%, effectively cutting the risk of death nearly in half. Multikine also showed strong safety results, with no late toxicities reported and notable improvements in patient-reported quality of life. Some patients experienced complete tumor regression before surgery, supporting the idea that Multikine may sensitize tumors to subsequent standard treatments. Alignment with Saudi Vision 2030 The approval of Multikine fits perfectly into Saudi Vision 2030 , the national framework for economic diversification and innovation that includes transforming the healthcare and biotech sectors. Central to this transformation is the localization of pharmaceutical manufacturing, attracting clinical research, and becoming a regional hub for medical innovation. The SFDA's Breakthrough Medicine Designation, modeled after similar programs in the U.S. and EU, is a direct byproduct of this strategy. It aims to expedite the approval of therapies that show significant clinical promise in addressing unmet medical needs. By targeting a cancer type with limited first-line advancements, Multikine qualifies as a prime candidate for such accelerated evaluation. Saudi Arabia has also shown leadership in adopting advanced oncology treatments. The country recently became the first in the region to manufacture CAR-T cell therapies domestically, reducing costs and access times for blood cancer patients. The addition of Multikine would continue this trend of delivering next-generation therapeutics within the Kingdom. Oncology Infrastructure Ready for Innovation Saudi Arabia's oncology infrastructure has matured significantly over the last decade. Institutions like King Faisal Specialist Hospital & Research Centre (KFSHRC), King Fahad Medical City (KFMC), and Princess Noorah Oncology Center are now equipped with the latest technologies, including proton therapy and precision diagnostics. These institutions routinely adopt new cancer treatments and maintain specialized head and neck cancer teams composed of ENT surgeons, radiation oncologists, medical oncologists, and rehabilitation professionals. The availability of multidisciplinary tumor boards and growing use of tele-oncology services further support the clinical integration of innovative therapies like Multikine. The Ministry of Health's e-Platform for oncology consultations ensures that even patients in remote regions can access national expertise, which is an essential element as the country decentralizes specialist care under the Vision 2030 framework. Regional and Global Impact If Saudi Arabia approves Multikine in 2025, it will not only be a therapeutic breakthrough for patients but also a model for fast-tracking drug development in the MENA region. CEL-SCI has already announced plans to partner with a local manufacturer in the Kingdom to supply Multikine across the Middle East and North Africa. The implications go beyond geography. An early Saudi approval will strengthen CEL-SCI's case for conditional approvals in other jurisdictions, including Canada and the EU, where the company has filed parallel regulatory submissions. What's Ahead Multikine's journey of over a decade of clinical development is the potential of immunotherapy to improve survival in areas where there are few options. Saudi Arabia's regulatory and clinical leadership may now be the launchpad for this innovation. For patients newly diagnosed with head and neck cancer in the Kingdom, this means more than hope. It soon means potential access.
Yahoo
21-05-2025
- Business
- Yahoo
CEL-SCI Announces Proposed Public Offering
VIENNA, Va., May 21, 2025--(BUSINESS WIRE)--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 ("Pre-Funded Warrants") in lieu thereof) in an underwritten public offering. All of the shares of common stock (and/or Pre-Funded Warrants) 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. The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital. ThinkEquity is acting as sole book-running manager for the offering. The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying base prospectus describing the terms of the offering has been or will be filed with the SEC on its website at Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying base prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the proposed offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its annual report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as may be required under applicable securities law. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. View source version on Contacts Gavin de WindtCEL-SCI Corporation(703) Sign in to access your portfolio
Yahoo
19-05-2025
- Business
- Yahoo
CEL-SCI Announces Combination of Common Stock
VIENNA, Va., May 19, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) announced today that during its annual Shareholder's Meeting on May 19, 2025, a combination was authorized for its outstanding shares of common stock. On May 19, 2025, the Board of Directors approved a 1 for 30 combination of common stock. CEL-SCI expects the combination to be implemented on May 20, 2025. When the market opens on May 20, 2025, the common stock will trade under a new CUSIP number 150837 706, but the Company's ticker symbol, CVM, will remain unchanged. When the combination of stock becomes effective, every 30 shares of common stock will be converted into 1 share of common stock. The combination of common stock will not eliminate any shareholders of record since any fractional share resulting from the combination of common stock will be rounded to the nearest whole share. The exercise price of all outstanding warrants and options, as well as the shares issuable upon the exercise of the outstanding warrants and options, will also be proportionately adjusted. "We believe that the next few months may present us with a number of major catalysts. Hopefully this will lead to more interest from investors. The combination of common stock is needed for two reasons: 1) our low stock price prohibits many funds from investing in CEL-SCI and 2) the major US stock exchanges have made it clear that they want listed companies to have a higher share price. Therefore we believe that this is an appropriate time to implement a combination that will bring our share price to levels where more investors, as well as funds, can buy and trade our stock. We appreciate the continued support of our shareholders as we advance our investigational drug and drug candidates through our clinical development program with a goal towards delivering better treatment alternatives for cancer, autoimmune and infectious diseases," stated CEL-SCI CEO Geert Kersten. It is not necessary for stockholders to exchange their existing stock certificates for new stock certificates in connection with the combination of common stock although stockholders may do so if they wish. Please direct any questions you might have concerning the combination of common stock to your broker or our transfer agent Computershare Trust Company by calling (800) 962-4284. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. View source version on Contacts COMPANY CONTACT:Gavin de WindtCEL-SCI Corporation(703) 506-9460
Business Wire
19-05-2025
- Business
- Business Wire
CEL-SCI Announces Combination of Common Stock
When the combination of stock becomes effective, every 30 shares of common stock will be converted into 1 share of common stock. The combination of common stock will not eliminate any shareholders of record since any fractional share resulting from the combination of common stock will be rounded to the nearest whole share. The exercise price of all outstanding warrants and options, as well as the shares issuable upon the exercise of the outstanding warrants and options, will also be proportionately adjusted. 'We believe that the next few months may present us with a number of major catalysts. Hopefully this will lead to more interest from investors. The combination of common stock is needed for two reasons: 1) our low stock price prohibits many funds from investing in CEL-SCI and 2) the major US stock exchanges have made it clear that they want listed companies to have a higher share price. Therefore we believe that this is an appropriate time to implement a combination that will bring our share price to levels where more investors, as well as funds, can buy and trade our stock. We appreciate the continued support of our shareholders as we advance our investigational drug and drug candidates through our clinical development program with a goal towards delivering better treatment alternatives for cancer, autoimmune and infectious diseases,' stated CEL-SCI CEO Geert Kersten. It is not necessary for stockholders to exchange their existing stock certificates for new stock certificates in connection with the combination of common stock although stockholders may do so if they wish. Please direct any questions you might have concerning the combination of common stock to your broker or our transfer agent Computershare Trust Company by calling (800) 962-4284. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Business Wire
15-05-2025
- Business
- Business Wire
CEL-SCI Reports Fiscal Second Quarter 2025 Financial Results
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended March 31, 2025, as well as key recent clinical and corporate developments. 'We are highly encouraged about the latest development for the commercialization of Multikine in global markets. Based on guidance from the Saudi Food and Drug Authority (SFDA), we intend to file for drug approval based on the wealth of data from our completed Phase 3 study,' stated CEL-SCI CEO, Geert Kersten. Corporate and Clinical Developments include: Multikine resulted in up to 95% improvement in quality of life. CEL-SCI published new data from its Phase 3 study of Multikine in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR). The article titled 'Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study' included a comprehensive presentation of results from CEL-SCI's Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer. The new, previously unpublished findings included the following patient quality of life data: Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites. QoL improvements in Multikine treated patients included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing. 95.1% of complete responders to Multikine reported improved QoL. Complete responders to Multikine treatment reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) quality of life measures. 89.4% of partial responders to Multikine reported improved quality of life measures. CEL-SCI is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients, reviewed and concurred to by the U.S. Food and Drug Administration (FDA). This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI's previously completed randomized controlled Phase 3 trial. CEL-SCI is in talks with potential partners. Given Multikine's excellent survival data, strong statistics and the recent focus on PD-L1 as a diagnostic biomarker for predicting the most effective treatment strategy for head and neck cancer, as well as its favorable safety profile, CEL-SCI is pursuing discussions with key parties that may be interested in partnering with CEL-SCI. Financial Results During the three months ended March 31, 2025, net loss was $6.6 million compared to $7.2 million in the prior year period. Basic and diluted net loss per common share increased to $0.08 for the three months ended March 31, 2025, compared to $0.14 for the three months ended March 31, 2024. The Company has instituted several cost-cutting measures including reductions in salaries. In demonstration of his deep commitment to the Company and Multikine's potential to significantly improve patient outcomes, CEO Geert Kersten has been and is currently working without taking a salary. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
