Tuvatexib

Actinic keratosis is a pre-cancerous area of thick, scaly, or crusty skin. Credit: Douglas Cliff via Shutterstock. Vidac Pharma has secured €600,000 ($645,651) in additional funding to support the clinical development of its two lead cancer candidates. The funding from existing investors, announced at the company’s recent shareholder meeting, will enable Vidac to initiate a new Phase IIb trial for its lead candidate VDA-1102 (tuvatexib) ointment. The hexokinase 2 inhibitor is being investigated in advanced cases of actinic keratosis, a skin condition that can progress to cutaneous squamous cell carcinoma (SCC). Alongside VDA-1102, the UK-based biotech continues preclinical studies of VDA-1275. Both candidates target the metabolic pathways of cancer cells by disrupting hexokinase 2 interactions with mitochondrial channels, aiming to reverse the high-energy demands of tumours and promote cancer cell death. VDA-1275 is being developed as a systemic drug for the treatment of solid tumours. Interim data from a Phase IIa study (NCT02844777) released in January 2023 showed a 56% objective response rate (ORR), with 22% complete responses (CR), observed between eight and 12 weeks. This compares to the standard-of-care treatment mechlorethamine, which has a 13% CR and a longer median response time of 26 weeks. Final results are expected in Q4 2024. Vidac has also completed a Phase IIb clinical trial (NCT03538951) for VDA-1102 in actinic keratosis. In a post-hoc analysis, the therapy demonstrated a 40% complete clearance of lesions and an 80% overall reduction in lesion count. The study also indicated that patients with advanced actinic keratosis responded more favourably to the treatment than those with less severe forms. Based on these findings, the upcoming Phase IIb trial will focus specifically on patients with advanced actinic keratosis. Unlike conventional actinic keratosis treatments that directly destroy abnormal cells, through topical therapies, cryotherapy, or photodynamic therapy, VDA-1102 works by reprogramming cancer cell metabolism. This selective approach aims to spare healthy cells, and in the Phase IIa trial, resulted mostly in mild, localised side effects, with one moderate case. Standard actinic keratosis treatments, by contrast, can cause skin inflammation, scaling, or burning, and are often invasive. In the announcement accompanying the funding, Vidac’s CEO Max Herzberg said: “I want to thank our board, advisers, team and shareholders for their support for our entirely new approach in oncology, with drugs that reverse the supercharged metabolism of cancer cells.” In June 2024, Almirall ’s Klisyri (tirbanibulin) secured FDA-expanded approval to treat larger actinic keratosis areas to up to 100cm² from the previous maximum of 25cm². Klisyri works by blocking cell division and killing abnormal cells. The most common side effects are local skin reactions, including erythema (reddening of the skin), flaking/scaling, crusting, swelling and the formation of sores and ulcers. Innovations in the pharma and medical device landscape are looking to expedite the diagnosis of skin cancers. In July 2023, the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH), awarded $2m in funding to Enspectra Health through the Small Business Innovation Research (SBIR) programme. The grant will fund the development of deep learning algorithms that can predict which actinic keratosis skin lesions are likely to turn into SCC.

Vidac Pharma receives Japanese Patent Office Notice of Allowance for VDA-1275 cancer drug candidate London (UK), March 27, 2024 (07:30 CET) – Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments, today announces it has received a Notice of Allowance from the Japanese Patent Office for the composition and methods of use for its VDA-1275 drug candidate, which has shown multiple promising effects in preclinical studies. “Receiving this notice from the Japanese authorities adds to our excitement about VDA-1275, Vidac’s next and powerful anti-cancer drug candidate. In recent preclinical studies, this new molecule has shown effects, both directly against a variety of tumors in animal trials, and through powerful synergistic effects in combination with two widely used types of chemotherapy in human liver organoids,” Vidac Pharma Chief Executive Officer Max Herzberg said. Last month, Vidac announced results showing that VDA-1275 statistically significantly increased survival in a murine colorectal cancer model as a stand-alone treatment, with a survival benefit similar to Opdivo in a head-to-head comparison. In a 3-D organoid model of human liver cancer, it reduced the concentrations of sorafenib and cisplatin needed to achieve IC50 cancer cell viability by 50% and 95%, respectively. Finally, VDA-1275 triggered an immune response through several mechanisms. The company will publish these results in a peer-reviewed publication. Both VDA-1275 and the more advanced VDA-1102, which is in separate Phase 2 testing of advanced actinic keratosis and of cutaneous T cell lymphoma, disrupt the interaction between hexokinase 2 (HK2) and the voltage-dependent anion channels (VDACs) in mitochondria. Cancer cells overexpress HK2, which catalyzes the first step of the glucose metabolism necessary to fuel tumor growth. HK2 blocks VDACs, which prevents apoptosis, supports cancer cell proliferation, and suppresses immune responses. Clinical data for Vidac’s first-generation metabolic checkpoint modulator candidates have shown powerful effects in halting cancer cell proliferation and restoring immune-sensitivity and apoptosis. For more information please contact: Vidac Pharma Holding PlcDr Max Herzberg20-22 Wenlock RoadLondon N1 7GUUnited Kingdomhttp://www.vidacpharma.com/investors@vidacpharma.com+972-54-4257381+972-77-9300647Cohesion BureauGiovanni Ca’ ZorziInvestor Relationsgiovanni.cazorzi@cohesionbureau.comSophie BaumontMedia Relations sophie.baumont@cohesionbureau.com About Vidac Pharma Vidac Pharma is a clinical-stage biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and onco-dermatologic diseases. Vidac develops first-in-class anti-cancer drugs by modifying the hyper glycolytic tumor microenvironment, targeting the overexpression and wrong anchoring of the Hexokinase 2 metabolic checkpoint (HK2) in cancer cells, to renormalize tumor microenvironment and selectively provoke their programmed death without affecting surrounding normal tissue. VDA-1102, a first drug candidate of Vidac Pharma has shown to be effective against advanced Actinic Keratosis (AK) and interim results in Cutaneous T-cell Lymphoma (CTCL) gave positive effect in Phase 2 trials in humans.www.vidacpharma.com Important information The information in this press release does not constitute a public offer to sell or a solicitation to submit an offer to buy or subscribe to shares of Vidac Pharma Holding PLC, but is for informational purposes only. The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Attachment 20240327 - VIDAC PR Japan patent VDA1275