Innovative VDA-1102 Ointment Demonstrates Rapid and Promising Efficacy in Addressing Unmet needs in CTCL care
London (UK) January 2nd , 2025 – Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), is a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments. Vidac Pharma Holdings Plc. is pleased to announce the receipt of the final report from the Helsinki Committee of Beilinson Hospital regarding its groundbreaking clinical study for Cutaneous T-Cell Lymphoma (CTCL). The report, submitted to the Israel Ministry of Health, highlights promising results, enabling the Company to proceed with a pivotal Phase 2-3 trial. If successful, this will mark a significant step toward product registration. This Clinical Trial was performed under the direction of Prof. Emilia Hodak one of Key Opinion Leader in the field.
CTCL, a rare and debilitating lymphoma, affects patients for years with symptoms such as severe skin inflammation and lesions caused by cancerous T-cells circulating in the blood and lymphatic system. Currently, there is no widely accepted standard-of-care drug for CTCL. VDA-1102, the Company’s innovative topical ointment, blocks the hyperglycolysis characteristic of cancer cells while providing effective and targeted treatment.
Promising Results from Phase 2a Clinical Study
The Company recently completed a Phase 2a open-label, proof-of-concept study evaluating the safety and efficacy of VDA-1102 ointment in adult patients with relapsed Stage 1 Mycosis Fungoides (MF), the most common form of CTCL. Key findings include:
- Objective Response Rate (ORR): 56% of patients achieved a clinical response.
- Complete Response (CR): Achieved in 22% of patients by week 8.
- Partial Response (PR): Achieved in 34% of patients by weeks 8-12, with continued improvement through week 16.
- No Disease Progression: All study participants maintained progression-free status during the 4-month study.
- Time to Response: VDA-1102 demonstrated rapid efficacy, with responses observed within 8-12 weeks—substantially faster than existing treatments.
The efficacy of VDA-1102 compares favorably with current therapies such as nitrogen mustard (VALCHLOR®), which reports a 13% CR and median response time of 26 weeks, and retinoids (TARGRETIN®), which report a 2% CR after 16 weeks.
Mechanism of Action and Remote Effects
The study also suggests that VDA-1102 may have effects beyond the direct treatment area, likely due to its mechanism of action, which involves potentiating T-cells both directly and through modulation of the tumor microenvironment.
Safety and Tolerability
VDA-1102 was well tolerated, with no deaths or serious adverse events reported. Drug-related Treatment Emergent Adverse Events (TEAEs) were mild and localized, except for one case of moderate pruritus. Higher doses (20% VDA-1102) were associated with a slightly higher incidence of TEAEs compared to the lower dose (10%).
Next Steps
The compelling results of the Phase 2a study pave the way for the Company to initiate a full-scale Phase 2-3 trial. Success in these trials could establish VDA-1102 as a breakthrough treatment for CTCL, addressing an urgent unmet need in oncology.
1 https://www.valchlorhcp.com/efficacy-data-and-clinical-study
2 https://www.targretinhcp.com/clinical-studies
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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), while interim results in Cutaneous T-cell Lymphoma (CTCL) yielded a positive effect in Phase 2 trials in humans.
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.