London (UK), January 29, 2024 - Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a groundbreaking new way of treating cancer, today announces favorable findings from a Phase 2a interim analysis of its lead drug candidate VDA-1102 in Mycosis Fungoides (MF), a form of Cutaneous T-Cell Lymphoma (CTCL) and a rare "orphan" disease which might command fast-track regulatory processing . The data provide further signs of the efficacy and safety of Vidac Pharma's family of non-toxic small molecules in treating cancer.
The interim analysis of 50% of subjects showed an Objective Response Rate (ORR) of 56%, with 22% complete response (CR), and 34% partial response. Responses were observed between 8 and 12 weeks. These results compare favorably to the standard of care of mechlorethamine, which has a 13% CR and a much longer median response time of 26 weeks. Side-effects were local and mild in severity, except in one case, which was moderate. All patients recovered, however, and the disease did not progress in any of the patients during the 4 months of the study.
"These interim results are another important confirmation that Vidac Pharma's approach of attacking cancer at its core has substantial therapeutic potential. Our drug candidates reverse the abnormal metabolism that is a characteristic of all cancer cells, halting tumor proliferation and immune-resistance. What we are seeing bears the promise of applying these drugs across a wide range of cancers," said Vidac Pharma Chief Executive Officer Max Herzberg.
The interim results come from more than 50% of planned patients - 9 out of 16 - in an open-label within-subject placebo-controlled study into the efficacy and safety of VDA-1102 as a topical ointment treatment for 12 weeks in adult subjects with relapsed stage-1 MF. Next milestones are full-population interim results, expected in the second quarter, and final results in Q4.
Vidac Pharma is developing a breakthrough new technology which reverses the abnormal metabolism of cancer cells - known as the Warburg effect - by preventing the Hexokinase 2 (HK2) enzyme from blocking the VDAC mitochondrial relay channels. Clinical data have shown the powerful effects this can have in halting cancer cell proliferation and restoring programmed cell death. Vidac's lead drug candidate VDA-1102 is also at the clinical development stage for patients with actinic keratosis (AK), for which the company will soon launch a second Phase 2b study.
For more information please contact:
| Vidac Pharma Holding Plc Dr Max Herzberg 20-22 Wenlock Road London N1 7GU United Kingdom http://www.vidacpharma.com/ investors@vidacpharma.com +972-54-4257381 +972-77-9300647 | Cohesion Bureau Giovanni Ca' Zorzi Investor Relations giovanni.cazorzi@cohesionbureau.com Sophie Baumont Media 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 was proven effective against advanced Actinic Keratosis (AK) and Cutaneous T-cell Lymphoma (CTCL) 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.
