Latest news with #HNSCC
Yahoo
09-07-2025
- Business
- Yahoo
Merus, Bicara Present Promising HNSCC Trial Data at ASCO 2025, Advance Towards Phase III
Merus (NASDAQ:MRUS) is one of the most promising stocks according to Wall Street analysts. The 2025 Annual Meeting of the American Society of Clinical Oncology/ASCO, held in Chicago, the US, from May 30 to June 3, featured presentations on two highly anticipated trials for head and neck squamous cell carcinoma/HNSCC. The announcements for these presentations were made earlier in May. Merus presented data from its Phase II study of petosemtamab, which is a bispecific monoclonal antibody targeting epidermal growth factor receptor/EGFR and Leucine-rich repeat containing G-Protein coupled receptor 5/LGR5, in combination with Merck's Keytruda (pembrolizumab) for PDL1+ first-line (1L) HNSCC. A scientist looking through a microscope conducting research in an immuno-oncology lab. Bicara presented Phase I/Ib data for its ficerafusp alfa, a bispecific fusion protein targeting EGFR and transforming growth factor beta (TGF-β), also in combination with Keytruda in the same patient population. Both Merus and Bicara are progressing their assets into Phase III clinical development. However, Bicara's ficerafusp alfa is being advanced with a narrower patient population, specifically excluding those positive for human papillomavirus/HPV. Merus (NASDAQ:MRUS) is a clinical-stage immuno-oncology company that develops antibody therapeutics in the Netherlands. While we acknowledge the potential of MRUS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
27-06-2025
- Business
- Business Wire
FDA's Approval of Keytruda for PD-L1 Positive Head and Neck Cancer Patients Signals a Clear Pathway for CEL-SCI's Multikine to Address a Major Unmet Need in PD-L1 Negative Cancer Patients
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today applauded the U.S. Food and Drug Administration's (FDA) approval of Merck's KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test. Merck's application was granted the FDA's priority review on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda's Phase 3 KEYNOTE-689 trial. "The Keytruda approval based on pre-specified interim results strongly implies that Multikine has the potential for accelerated regulatory approval based on favorable post-surgical tumor responses,' stated CEL-SCI's CEO, Geert Kersten. Share Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck's Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda. In contrast to the results of the KEYNOTE-689, CEL-SCI's Phase 3 study showed that Multikine* treated patients whose tumors expressed low (Tumor Proportion Score [TPS <10]) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65], p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI's Phase 3 study had low to zero levels of PD-L1. 'It is encouraging for CEL-SCI that Merck's Keytruda application received the FDA's priority review and that marketing approval was given based on a Phase 3 study's first pre-specified interim analysis. CEL-SCI has received the FDA's go-ahead for a confirmatory Registration Study with 212 patients based on results from the completed Multikine Phase 3 study in head and neck cancer patients. The patients in the Phase 3 study that benefited from Multikine pre-surgery treatment showed an almost 4-year median overall survival advantage over control, and pre-surgery tumor responses to Multikine predicted survival benefit. The Keytruda approval based on pre-specified interim results strongly implies that Multikine has the potential for accelerated regulatory approval based on favorable post-surgical tumor responses,' stated CEL-SCI's CEO, Geert Kersten. 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. 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. * 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.
Associated Press
24-06-2025
- Business
- Associated Press
GeoVax Comments on FDA Approval of Keytruda(R) in Head and Neck Cancer, Underscoring Potential for Gedeptin(R) Combination Therapy
Supports Advancement of GeoVax's Phase 2 Gedeptin(R) Trial in Recurrent Head and Neck Cancer ATLANTA, GA - June 24, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today commented on the U.S. Food and Drug Administration's recent approval of Keytruda(R) (pembrolizumab) for use in resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) tumors expressing PD-L1 as determined by an FDA approved test. This regulatory milestone marks a significant advancement in the curative-intent treatment landscape for head and neck cancer and affirms the therapeutic strategy underlying GeoVax's Gedeptin(R) development program. An editorial by Rosenberg and Vokes in New England Journal of Medicine (NEJM) noted that the study forming the basis of FDA's approval represents the first demonstration of benefit for PD-1 inhibition in the curative setting for HNSCC, with implications for evolving neoadjuvant immunotherapy paradigms. GeoVax is planning to initiate a Phase 2 clinical trial of Gedeptin(R) in combination with a checkpoint inhibitor, such as pembrolizumab, in patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial aims to improve tumor clearance and reduce relapse by combining the immune-priming effect of Gedeptin's targeted cytotoxicity with the systemic immune activation of checkpoint inhibition. The Phase 2 study, expected to launch in 2026, will evaluate pathologic response, recurrence rates, and biomarker-defined immunologic changes when Gedeptin is used as neoadjuvant therapy with checkpoint inhibitors. Importantly, the NEJM editorial emphasized the need to optimize patient selection and treatment duration in the immunotherapy era, aligning with GeoVax's biomarker-driven approach. 'The NEJM publication and FDA approval of Keytruda in resectable HNSCC signals a new era in curative-intent cancer therapy,' said David Dodd, Chairman and CEO of GeoVax. 'By combining Gedeptin therapy with pembrolizumab, we aim to enhance local tumor eradication while unlocking systemic anti-tumor immunity, potentially reducing both local and distant recurrence.' 'We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed,' added Dr. Kelly McKee, GeoVax's Chief Medical Officer. 'We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease.' For more information about the KEYNOTE-689 study, see the June 18, 2025 publication in the New England Journal of Medicine. About Gedeptin Gedeptin(R) is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally via an adenoviral vector encoding purine nucleoside phosphorylase (PNP). Upon systemic administration of fludarabine, the enzyme catalyzes the generation of a cytotoxic agent selectively within the tumor microenvironment. This mechanism provides dual cytotoxicity and immune modulation with minimal systemic exposure. Gedeptin has been granted Orphan Drug Designation by the FDA for the treatment of oral and pharyngeal cancers and is protected by a growing intellectual property portfolio. GeoVax's ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Forward-Looking Statements This release contains forward-looking statements regarding GeoVax's business plans. The words 'believe,' 'look forward to,' 'may,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' 'could,' 'target,' 'potential,' 'is likely,' 'will,' 'expect' and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Company Contact: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected]
Yahoo
13-06-2025
- Business
- Yahoo
Rakuten Medical Selected to Participate in FDA CEO Forum in San Diego
- Engaged with FDA Commissioner on shared commitment to fast, safe, and affordable patient access to innovative therapies SAN DIEGO, June 13, 2025 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that it was selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA CEO Forum in San Diego, California, on June 13, 2025. Minami Maeda, President of Rakuten Medical, attended the meeting in person as a member of this panel, to discuss with FDA Commissioner Marty A. Makary, M.D., M.P.H., and other industry leaders how the FDA can "modernize its regulatory framework to better support innovation and patient access to safe and effective therapies". Rakuten Medical – whose innovative cancer therapeutic technology, the Alluminox™ platform, is in Phase 3 trials in the U. S. – was selected to join the forum as one of the companies at the front lines of medical discovery. Rakuten Medical's novel treatment modality, known as photoimmunotherapy, is designed to induce rapid and selective depletion of cancer or immunosuppressive cells with minimal impact on surrounding healthy tissue. Moreover, pre-clinical observation have shown that photoimmunotherapy may also stimulate both innate and adaptive anti-tumor immune responses. "Rakuten Medical's Alluminox™ platform has the potential to transform cancer therapy in the U.S.," said Maeda. "We are honored to be recognized by the FDA and invited to contribute to discussions on how regulatory innovation can accelerate the delivery of pioneering treatments to patients. We fully support the FDA's vision of a modern framework that ensures timely access, safety, and affordability." Rakuten Medical is currently conducting a global Phase 3 clinical trial evaluating its ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / Identifier: NCT06699212). A prior Phase 1b/2 study showed promising interim evaluation results, including a 24-month survival rate of 52.4% and a median overall survival (OS) not yet reached. ASP-1929 photoimmunotherapy received the world's first regulatory approval in Japan under the Conditional Early Approval System based on a certain level of efficacy and acceptable safety from Phase 1/2a trial results. It is being delivered to patients in Japan at an affordable price. Disclaimer: Rakuten Medical's Alluminox™ platform-based photoimmunotherapy is investigational outside Japan. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit About Alluminox™ platform The Alluminox™ platform is Rakuten Medical's investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical's pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929Rakuten Medical's first pipeline drug developed on its Alluminox™ platform is ASP-1929, an antibody-dye conjugate comprised of the anti-EGFR antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority. Contact Us View original content to download multimedia: SOURCE Rakuten Medical, Inc. 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Medscape
13-06-2025
- Health
- Medscape
Perioperative Pembro Approved to Up Chance of HNSCC Cure
The FDA has approved a before and after surgery regimen for pembrolizumab to improve outcomes in resectable locally-advanced head and neck squamous cell carcinoma (HNSCC). Specifically, the new approval is for HNSCC tumors that express PD-L1, with pembrolizumab as a single agent in the neoadjuvant setting, followed by radiation plus/minus cisplatin after surgery, and continuing as a single agent for maintenance. FDA said the approval is the first for HNSCC in 6 years, but it is also another approval for a perioperative immunotherapy cancer regimen. Oncologists and the agency have been frustrated that company trials don't include an arm to answer the question of if immunotherapy helps both before and after surgery, of if one or the other is enough. Even so, Barbara Burtness, MD, a head and neck oncologist at Yale University, Connecticut, told Medscape Medical News that she'll offer the new pembrolizumab regimen to resectable patients given the strength of pembrolizumab's approval trial, KEYNOTE-689, because it offers the chance of a cure when tumors are resectable. 'Many of us think it's the new standard of care,' she told Medscape. KEYNOTE-689 was a multicenter, open-label trial that included 682 patients with resectable stage III-IVa disease whose tumors had a PD-L1 combined positive score of at least 1. Approval was based on the 682 patients, not the total population of 714. Half the subjects were randomized to the current standard of care: upfront surgery followed by radiotherapy with or without cisplatin. The other half were randomized to pembrolizumab add-on: 200 mg pembrolizumab every 3 weeks for two cycles before surgery, then pembrolizumab 200 mg every 3 weeks for three cycles afterwards with radiotherapy plus/minus cisplatin, followed by pembrolizumab at the same dose every 3 weeks for 12 cycles as maintenance. Cisplatin was added after surgery if patients were at high risk for recurrence, meaning that tumor removal was not complete or patients had spread beyond their lymph nodes. Median event-free survival was 59.7 months with pembrolizumab vs 29.6 months without it (hazard ratio, 0.70; P =.00140). Overall survival was immature, but there was no decrease with pembrolizumab add-on. There were no new safety signals in the trial. Pembrolizumab labeling warns of immune-mediated adverse events, infusion-related reactions, and embryo-fetal toxicity; 1.4% of pembrolizumab subjects in KEYNOTE-689 were not able to have surgery because of side effects. FDA noted pembrolizumab should be administered before chemotherapy when given on the same day.
