Squamous cell carcinoma of the oral cavity

KØBENHAVN, Denmark I October 07, 2024 I FluoGuide A/S (STO:FLUO) Copenhagen, Denmark – FluoGuide A/S (“FluoGuide” or the “Company”),a biothech company specializing in precision cancer surgery, today announced the submission of the Clinical Trial Application (CTA) for phase II trial in head and neck cancer (oral squamous cell carcinoma cancer). Redeye will host a live streaming event regarding the head and neck trial on 18 October 2024, at 10:00 am CET. The CTA submission follows strong clinical topline data for FG001 tested in a proof-of-concept phase II clinical trial in patients with head and neck cancer and is a step on the path to the patients and commercialization. Feedback from and discussions with key opinion leaders around the globe, has confirmed the ample needs patients with head and neck cancers have and led to a detailed understanding of the clinical trial design. Additionally, the Company obtained feedback on how to optimize the positioning of FG001 from a regulatory, partnering and commercial perspective to fully utilize the opportunities, condensed in the design of the trial (CT-005). Regulatory and clinical evaluation and discussions with Principal Investigator, Prof. Dr. Max Witjes, has led to the submitted trial design. The phase II trial (CT-005) is designed as a single center trial to: First interim data are expected in H2 2025. Depending on data from the trial and feedback from regulatory authorities, the Company is planning to do a multisite registration trial as the next step supporting approval and subsequent commercialization. FluoGuide will review the trial and its outlook at a live streaming event hosted by Redeye on 18 October 2024, at 10:00 am CET, where Redeye analyst Christian Binder will interview CEO Morten Albrechtsen and CSO Andreas Kjær. About FluoGuide FluoGuide is a biotech company specializing in precision cancer surgery. FluoGuide’s lead product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light, which binds to the uPAR receptor, widely expressed in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of local recurrence after surgery and surgical complications, improving cancer treatment and outcomes for patients, while also reducing healthcare costs. Moreover, FluoGuide’s technology platform may also be utilized for photothermal therapy (PTT), which kills cancer cells through heating them with the use of near-infrared light. A technique that spares healthy surrounding tissue from damage, offering a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery. FluoGuide is listed on the Nasdaq First North Growth Market in Stockholm under the ticker symbol “FLUO”. For more information about FluoGuide’s pipeline, technology, and upcoming events, visit www.fluoguide.com About head and neck cancer Head and neck cancer includes cancers in the head and neck region of the body. Head and neck cancers are frequently not completely removed or removed with insufficient margins to the surrounding normal tissue and requires follow up treatment with chemoradiotherapy. Chemoradiotherapy causes both short- and long-term side effects that can be avoided if the surgical removal of the cancer is complete the first time. Head and neck cancers are often occurring in close anatomical proximity to small vital structures such as blood vessels supplying the brain and many important nerves. Further, cosmetic considerations are important for most locations of head and neck cancers. Surgical precision is therefore essential for surgical removal of head and neck cancers. Most head and neck cancers arise from squamous cells and are called squamous cell carcinomas. It is the 6th most common cancer. Worldwide, head and neck cancer accounts for approximately 950,000 newly diagnosed patients (incidence) annually and approximately 450,000 patients die annually due to head and neck cancer. In USA and EU head and neck cancer accounts for approximately 63,000 and 136,000 newly diagnosed patients annually, respectively. Head neck cancer in rest of the world accounts for approximately 750,000 cases annually. Sources: World Health Organization (International Agency for Research on Cancer), Global Cancer Observatory (iarc.fr) , Gal TJ et al. Treatment trends in oropharyngeal carcinoma: Surgical technology meets the epidemic. Oral Oncology, Vol 97, 2019, p 62-68 (2) Cramer JD et al. The changing therapeutic landscape of head and neck cancer. Nat. Rev. Clin. Oncol. 16, 669-683 (2019); For more information on the Company, its uPAR technology platform and pipeline, please visit www.fluoguide.com SOURCE: FluoGuide

VIENNA, Va.--( BUSINESS WIRE )-- 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. CEL-SCI has received the go-ahead from the U.S. Food and Drug Administration (FDA) to commence a confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from its IT-MATTERS completed Phase 3 study. Dr. Timar is Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary, and served as the Director of the Central Pathology Laboratory for the IT-MATTERS study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching. 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 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), 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. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without Multikine at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary head and neck cancer patients who present with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients (globally) 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, 2023. 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.

DURHAM, N.C.--(BUSINESS WIRE)-- GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, today announced upcoming presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois from May 31st to June 4th. Presentations include new clinical validation results for a novel signature identifying patients with head and neck squamous cell carcinoma (HNSCC) that may benefit from treatment beyond typical surgical resection. The results are from GeneCentric’s ongoing collaboration with Neil Hayes, MD, MPH, at the University of Tennessee Health Science Center’s Center for Cancer Research, and Jose P. Zevallos, MD, MPH, at the University of Pittsburgh School of Medicine, to discover and develop new prognostic and/or predictive signatures to aid in the treatment selection for patients with HNSCC. In addition, GeneCentric will present updated findings from its development of a novel RNA-based immune checkpoint inhibition predictive response signature (ICI-PRS) that optimizes the selection of patients with a primary diagnosis of urothelial cancer who are potential candidates for anti-PD-(L)1 inhibition treatment. Details of the ASCO presentations are as follows: Title: Clinical validation of a mesenchymal gene expression signature for prognosis and treatment decision making in early-stage oral cavity squamous cell carcinoma. Session: Head and Neck Cancer Date: June 2, 2024, 9:00am – 12:00pm CDT Abstract/Poster Number: 6091/407 Title: Prediction of immune checkpoint inhibitor (ICI) response in patients with urothelial cancer (UC) by a novel RNA-based ICI response signature (ICI-PRS). Session: Publication Only: Genitourinary Cancer — Kidney and Bladder Abstract: e16502 The poster and abstracts will be accessible under the News & Events section of the Company’s website following the conference. About GeneCentric GeneCentric Therapeutics, Inc., a leader in RNA-based genomic biomarker and next-generation companion diagnostic development, is based in Durham, North Carolina. They have developed a deep pipeline of gene signatures and related diagnostic tests by parsing the complexity of tumor biology using their RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform and artificial intelligence technology to identify responder populations to oncology therapeutics. Using GeneCentric’s EXpressCT (Expression Signatures Through Circulating Tumor Signals) platform, these signatures can be applied to liquid biopsy. GeneCentric commercializes its technology through strategic collaborations with biopharma and diagnostics companies in applications throughout preclinical testing, clinical drug development and commercialization lifecycle phases. For more information, visit or follow us on LinkedIn.