Vyome to Present Compelling Phase 2 Clinical Data on VT-1953 for Treatment of MFW at AACR 2026
Complete Phase 2 clinical data on the efficacy and safety of VT-1953 in MFW patients accepted for presentation at the annual meeting of the American Association for Cancer Research
Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND) today announced that the company will present its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for malodor and other symptoms of Malignant Fungating Wounds ("MFW") at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place on April 17-22, 2026, in San Diego.
Venkat Nelabhotla, CEO of Vyome, stated that, "There are currently no FDA approved drugs to treat malodor and other symptoms of MFW. We plan to have FDA interactions in Q2 2026 on the pivotal study design. Recent third-party analysts estimated the total addressable U.S. market to be approximately USD 2.2 billion. Inflammation is one of the biggest healthcare problems facing the world today."
The research will be presented at the session "Phase II and Phase III Clinical Trials in Progress." Vyome will highlight mechanistic insights together with detailed clinical data comparing the VT-1953 active treatment with vehicle treatment in a Phase 2 study. VT-1953 is a first-in-class treatment for malodor and other symptoms of MFW in advanced cancer patients, which acts by a dual mechanism of action, inhibiting DNA Gyr and modulating MD2/TLR interactions, an inflammatory signal. MFW is a rare, debilitating condition that occurs in ~10% of advanced cancer patients, severely impacting the quality of life.
"We are delighted that AACR found our data compelling for presentation at the annual meeting. Based on our promising clinical data underpinned by strong mechanistic alignment, we are advancing VT-1953 into pivotal studies," said Shiladitya Sengupta, Associate Professor of Medicine at Harvard Medical School, Co-founder and Board member of Vyome.
The details of the presentation at the 2026 AACR Annual Meeting are:
American Association for Cancer Research Annual Meeting 2026, San Diego
Date: April 21, 2026, 9:00 AM - 12:00 PM
Session title: (PO.CTP01.03) Phase II and Phase III Clinical Trials in Progress
Presentation number and title: CT208 / 3 - Final results from a phase 2 trial testing safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound
Authors: Arshit Narang, MBBS, Prashant Prakash Lad, MD, Shiladitya Sengupta PhD
About Vyome Holdings, Inc.
Vyome is building the world's premier platform spanning the US-India innovation corridor. Based in Cambridge, MA, Vyome's immediate focus is on leveraging its clinical-stage assets to transform the lives of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning across the US-India innovation corridor, Vyome seeks to deliver lasting value to shareholders in a hyper cost-efficient manner while upholding global standards of quality and safety. To learn more, please visit www.vyometx.com
Forward-Looking Statements
Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "target," "believe," "expect," "will," "shall," "may," "anticipate," "estimate," "would," "positioned," "future," "forecast," "intend," "plan," "project," "outlook", and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements include, but are not limited to, statements contained in this press release relating to Vyome's business strategy, the timing and subject of our AACR presentation, and our interactions with the FDA. Forward-looking statements are based on Vyome's current expectations and assumptions regarding Vyome's business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Vyome's actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. Vyome cautions you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, Vyome's ability to leverage the India innovation corridor and otherwise advance VT-1953 into clinical development in a capital-efficient manner; Vyome's ability to raise capital to fund continuing operations; our ability to protect Vyome's intellectual property rights; the impact of any infringement actions or other litigation brought against Vyome; competition from other providers and products; Vyome's ability to develop and commercialize products and services; changes in government regulation; Vyome's ability to complete capital raising transactions; and other factors relating to Vyome's industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause Vyome's actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Vyome's assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.
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