Vidac obtains funding for skin cancer ointment trials

Vidac Pharma has announced an additional €600,000 ($645,651) in funding from existing investors to further the clinical development of its two primary cancer treatments. This funding, revealed during the company's recent shareholder meeting, will allow Vidac to commence a new Phase IIb clinical trial for its leading candidate, VDA-1102 (tuvatexib) ointment. This hexokinase 2 inhibitor is being tested in patients with advanced actinic keratosis, a skin condition that can develop into cutaneous squamous cell carcinoma (SCC).

Alongside VDA-1102, Vidac Pharma, a UK-based biotechnology company, is also continuing preclinical studies of another candidate, VDA-1275. Both drug candidates aim to disrupt the metabolic pathways of cancer cells by inhibiting hexokinase 2 interactions with mitochondrial channels, thus reducing the high-energy demands of tumors and promoting the death of cancer cells. VDA-1275 is being developed as a systemic treatment for solid tumors.

In January 2023, interim data from a Phase IIa study (NCT02844777) showed a 56% objective response rate (ORR) with 22% of patients experiencing complete responses (CR) within eight to 12 weeks. This is a significant improvement compared to mechlorethamine, the standard-of-care treatment, which has a 13% CR and a median response time of 26 weeks. Final results from this study are anticipated in the fourth quarter of 2024.

Vidac Pharma has also completed a Phase IIb clinical trial (NCT03538951) for VDA-1102 in actinic keratosis. Post-hoc analysis indicated a 40% complete clearance of lesions and an 80% overall reduction in lesion count. The study also found that patients with advanced actinic keratosis responded better to the treatment compared to those with less severe forms of the condition. Consequently, the upcoming Phase IIb trial will target patients with more advanced stages of actinic keratosis.

Unlike traditional treatments for actinic keratosis, which destroy abnormal cells through methods like topical therapies, cryotherapy, or photodynamic therapy, VDA-1102 focuses on reprogramming the metabolism of cancer cells, aiming to spare healthy cells. In the Phase IIa trial, this approach led to mostly mild, localized side effects, with one moderate case reported. Standard treatments often result in skin inflammation, scaling, or burning and can be quite invasive.

Max Herzberg, CEO of Vidac Pharma, expressed gratitude to the board, advisers, team, and shareholders for their support of the company’s innovative approach in oncology. He highlighted the unique mechanism of their drugs, which aim to reverse the enhanced metabolism of cancer cells.

In related news, in June 2024, Almirall's Klisyri (tirbanibulin) received expanded FDA approval to treat larger areas of actinic keratosis, increasing the maximum treatment area from 25cm² to 100cm². Klisyri works by blocking cell division and killing abnormal cells, with the most common side effects being local skin reactions such as erythema, flaking, crusting, swelling, and the formation of sores and ulcers.

Innovations in the pharmaceutical and medical device sectors are accelerating the diagnosis of skin cancers. In July 2023, the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH), provided a $2 million grant to Enspectra Health through the Small Business Innovation Research (SBIR) program. This funding will support the development of deep learning algorithms to predict which actinic keratosis lesions are likely to progress to SCC.