VIENNA, VA, United States

Cel-Sci Corporation

www.cel-sci.com
VIENNA, VA, United States
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News Article | June 12, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) announced today that during its annual Shareholder’s Meeting on June 12, 2017, a 1-for-25 reverse split was authorized for its outstanding shares of common stock. CEL-SCI expects the split to be implemented on June 15, 2017. When the market opens on June 15, 2017, the common stock will trade under a new CUSIP number 150837 607 but the Company's ticker symbol, CVM, will remain unchanged. The CUSIP number for public warrants will remain the same and the warrant's ticker symbol, CVM WS, will also remain unchanged. When the reverse stock split becomes effective, every 25 shares of common stock will be converted into 1 share of common stock. The reverse stock split will not eliminate any shareholders of record since any fractional share resulting from the reverse stock split will be rounded to the nearest whole share. The exercise price for the warrants that trade under the symbol CVM WS will be adjusted from $1.25 to $31.25 and 25 warrants will be required to purchase one share. The exercise price of all other 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. Therefore we believe that this is an appropriate time to implement a reverse split that will bring our share price to levels where more individual investors, more institutional investors, as well as funds, can buy and trade the 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 reverse stock split although stockholders may do so if they wish. Please direct any questions you might have concerning the reverse stock split to your broker or our transfer agent Computershare Trust Company by calling (800) 962-4284. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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 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 the Company's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2016. The Company undertakes no obligation to publicly release the results 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.


VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) announces the publication of data from rheumatoid arthritis (RA) studies in Vaccine, a leading peer-reviewed journal for researchers interested in vaccines and vaccination. The paper titled “An epitope-specific DerG-PG70 LEAPS vaccine modulates T cell responses and suppresses arthritis progression in two related murine models of rheumatoid arthritis” and is available at http://www.sciencedirect.com/science/article/pii/S0264410X17306072. As described in the article, investigators from Rush University Medical Center evaluated CEL-SCI’s CEL-4000 rheumatoid arthritis vaccine candidate in 2 animal models that resemble the RA disease process in humans better than other animal models. The CEL-4000 (DerG-PG70 LEAPS) treatment vaccine was given to these animals after the onset of RA symptoms. CEL-4000 inhibited disease progression and demonstrated a shift from a pro-inflammatory to an anti-inflammatory environment, as indicated by significant decreases in both RA visual scores and histopathological changes in animals receiving CEL-4000 treatment vaccine. The authors concluded that CEL-4000 exerts its therapeutic effect by interacting with CD4+ cells, which results in an antigen-specific down-modulation of pathogenic CD4+ cell responses through up modulation of CD4+ FoxP3+ Treg cells. Although the precise causes of RA are not known, the disease is thought to be maintained in animals and humans by pro-inflammatory immune responses. The activation of the CD4+ FoxP3+ Tregs (immune regulatory T cells) is therefore believed to be important in the down regulation of the pro-inflammatory processes that otherwise drive this disease. Dr. Zimmerman, CEL-SCI’s Senior Vice President of Research, Cellular Immunology and the inventor of the technology underlying CEL-4000, stated, “Current treatments for RA focus on the alleviation of symptoms and delaying disease progression. Our vaccination approach attempts to treat RA by impacting the pro-inflammatory immune response so that the body’s joints are no longer attacked by it.” “Based on these data and results from prior studies, we believe CEL-4000 could be a potentially valuable asset in the treatment of rheumatoid arthritis and it could be positioned as a first-line treatment to inhibit disease progression in newly diagnosed patients. We are pleased to advance the development of CEL-4000 through the support of the National Institutes of Health and look forward to advancing it into clinical trials in the future,” CEL-SCI CEO Geert Kersten added. This study was supported in part by funding of a Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health (NIH). The study was conducted in collaboration with Drs. Katalin Mikecz and Tibor Glant, and their research team at Rush University Medical Center in Chicago, Illinois. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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 and 10-K/A for the year ended September 30, 2016. 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.


News Article | June 5, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today announced that it has responded to the U.S. Food and Drug Administration’s (FDA) most recent communication from May 2017 about the clinical hold imposed on the Company’s Phase 3 head and neck cancer study with Multikine* (Leukocyte Interleukin, Inj.). The hold issues addressed in the FDA communication were that the study’s Investigator Brochure (IB) and the “Dear Investigator” letter need to be revised. Specific deficiencies and their locations in each of the documents were identified, and directions were given as to the specific information that should be included in the revisions of these documents. CEL-SCI revised the documents exactly as directed by the FDA. If the FDA finds the revisions made to the two documents to be satisfactory, CEL-SCI is hopeful that all of the clinical hold issues have now been addressed, and the FDA will consider lifting the clinical hold. As of September 2016, nine hundred twenty-eight (928) head and neck cancer patients have been enrolled and have completed treatment in the Phase 3 study. In accordance with the study protocol, the FDA’s instructions, and subject to the clinical hold, CEL-SCI continues to follow these patients. The study endpoint is a 10% increase in overall survival of patients between the two main comparator groups in favor of the group receiving the Multikine treatment regimen. The determination if the study end point is met will occur when there are a total of 298 deaths in those two groups. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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 and 10-K/A for the year ended September 30, 2016. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold.


News Article | May 10, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended March 31, 2017. CEL-SCI's net loss available to common shareholders for the quarter ended March 31, 2017 was ($8,409,489) or ($0.05) per basic and diluted share, versus ($8,844,855) or ($0.07) per basic and diluted share during the quarter ended March 31, 2016. The net loss available to common shareholders for the six months ended March 31, 2017 was ($4,872,687) or ($0.03) per basic and diluted share, versus ($6,503,042) or ($0.06) per basic and diluted share during the same six months ended March 31, 2016. During the six months ended March 31, 2017, the Company’s cash decreased by approximately $1.4 million. Significant components of this decrease include net proceeds from the sale of the Company’s stock of approximately $5.8 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $7.2 million. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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 and 10-K/A for the year ended September 30, 2016. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold on enrollment of additional new patients.


News Article | May 12, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today announced it has changed the date for its annual meeting from June 9, 2017 to June 12, 2017. The Company’s annual meeting is now scheduled for Monday, June 12, 2017 at 10:30 a.m. local time. The meeting will be held at 4820-C Seton Drive, Baltimore, MD 21215. No changes have been made to the record date or the proposals to be brought before the annual meeting, which are presented in the Proxy Statement that the Company filed with the Securities and Exchange Commission (SEC) on April 27, 2017. Stockholders who have already submitted a proxy or voting instructions do not need to take any further action. The Company's Proxy Statement and Annual Report filed by the Company with the SEC are available on the SEC's website at http://www.sec.gov. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.


The invention is related to peptide constructs, i.e., polypeptides obtained by linking together two or more peptides based on or derived from different molecules, which are useful in the treatment or prevention of autoimmune diseases, specifically rheumatoid arthritis (RA) and compositions containing same, methods for producing same and methods for using same; wherein the peptide constructs have the formula P_(1)-x-P_(2 ) where Whereas said treatment being of the individual itself or of ex vivo treatment of isolated DC and or with further labeling with drug, dye or radioisotope and administration back into the patient of the activated and possibly modified DCs for detection, identification, localization and treatment thereof.


The invention is related to peptide constracts, i.e., polypeptides obtained by linking together two or more peptides based on or derived from different molecules, which are useful in the treatment or prevention of cancer or the treatment of autoimmune diseases and compositions containing same, methods for producing same, and methods for using same: wherein the peptide constructs have the formula P_(1)-x-P_(2 )where P_(2 )is a peptide associated with forms of cancer or an autoimmune condition and P_(1 )is a peptide which will bind to a class of immune cells such as dendritic cells. The peptide construct can cause the maturation of immature dendritic cells to a more mature state. The peptide construct or the more mature dendritic cells can be administered to a subject to a modulate or to initiate an immune response against cancer cells, and can be sued with dyes, radioisotopes, or therapeutic agents for detection of the immune target and/or treatment of cancer and autoimmune conditions.


A vaccine for immunization against Type A influenza virus is provided having an immunologically effective amount of peptide constructs obtained by linking together two or more peptides based on or derived from different molecules, and methods for producing the same. The peptide constructs have the formula P_(1)-x-P_(2 )or P_(2)-x-P_(1 )where P_(1 )is associated with Type A influenza highly conserved protein such as but not limited to M2e matrix protein, NP1 nucleoprotein, HA2 core 1, and HA2 core 2, where P_(2 )is a peptide construct causing a Th1 directed immune response by a set or subset of T cells to which the peptide P_(1 )is attached or that binds to a dendritic cell or T cell receptor causing said set or subset of dendritic cell or T cells to which the peptide P_(1 )is attached to initiate and complete, an immune response, and x is a direct bond or divalent linker for covalently bonding P_(1 )and P_(2).


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2014

DESCRIPTION (provided by applicant): Currently, FDA-licensed pharmaceuticals used to treat rheumatoid arthritis (RA) focus largely on alleviation of symptoms, either through pain management, general immunosuppression, or by antagonizing cytokines such as TNF-?. Despite recent advances in biologic therapies, these treatments do not address the underlying autoimmune condition. Ligand epitope antigen presentation system (L.E.A.P.S. ) conjugates are a peptide vaccine platform designed to modulate the immune response in an antigen-specific manner. LEAPS are composed of two peptide components, an immune cell binding ligand (ICBL) and a peptide (epitope) implicated in an infectious or autoimmune disease. The ICBLs include peptide J from human -2 microglobulin, with Th1-polarizing activity, and peptide derG (or G) from human MHC class II chain with Th2 polarizing activity. In mice with collagen-induced arthritis (CIA), a Th17-mediated disease, a J-collagen peptide conjugate reduced disease severity by suppressing


Patent
Cel-Sci Corporation | Date: 2012-05-24

The invention is related to peptide constructs, i.e., polypeptides obtained by linking together two or more peptides based on or derived from different molecules, which are useful in the treatment or prevention of influenza virus and other infectious diseases. Compositions containing the same, methods for producing the same, and methods for using the same are also disclosed, wherein the peptide constructs have the formula P_(1)-x-P_(2), where P_(2 )is a peptide associated with an infectious agent and P_(1 )is a peptide that will bind to a class of immune cells, such as dendritic cells. The peptide construct can cause the maturation of immature dendritic cells to a more mature state. The peptide construct or the more mature dendritic cell can be administered to a subject to modulate or initiate an immune response against an infectious agent. Dyes, radioisotopes, or therapeutic agents conjugated with the dendritic cells can be used for localization of the immune target and/or prophylactic or therapeutic treatment of the disease.

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