TAY-R1 will be an orally bioavailable medicine effective in the treatment of cancer and genetic diseases. For example, TP53 is the most commonly mutated tumour suppressor gene in cancer, yet there are no approved drugs capable of restoring normal P53 function. We have demonstrated that Tay-Enable™ technology can restore full length, functional, P53 protein containing a premature termination codon (PTC) in this gene.
As a systemic drug, TAY-R1 could benefit cancer patients with premature termination codon (PTC) mutations in other tumour suppressor genes, and in individuals with PTC mutations responsible for around 8000 known genetic diseases, including cystic fibrosis and Duchene’s muscular dystrophy.
TAY-R2 will be a locally applied therapy discovered using our propriety soft drug capabilities, validated by the nomination of the clinical candidate VYN201 (TAY-B1, see below). TAY-R2 aims to restore normal skin or lung function. For patients with recessive dystrophic epidermolysis bullosa (RDEB), TAY-R2 will prevent severe wounding, disability, and premature deaths. In cystic fibrosis, TAY-R2 will improve lung function, prevent fibrosis and extend patients’ lives.
TAY-R2 could help treat hundreds of known genetic conditions, providing significant indication expansion opportunities.
Our first product, TAY-B1 was designed to be locally active, potently reducing inflammatory and fibrotic biology by inhibition of the BET bromodomain proteins (BRD2, BRD3, BRD4 and BRDT). TAY-B1 is a soft drug that is locally active but with minimal effects on other tissues/organs, to deliver a safe and highly effective drug.
TAY-B1 was licensed to VYNE Therapeutics in 2021 and has now completed a Phase 1b study in vitiligo patients, and has demonstrated proof of concept after just 16 weeks of treatment.
As a soft drug, TAY-B1 was designed to be safely and rapidly eliminated from the body and in a Phase 1 pharmacokinetic study, blood levels of the drug were below the limit of quantification. TAY-B1 also has outstanding pre-clinical efficacy in psoriasis and wound healing models.
Many inflammatory and fibrotic diseases would be best treated by an oral drug that can reach all affected tissues. To deliver a safe, effective medicine Tay developed an orally dosed, bromodomain 2 selective BET inhibitor. TAY-B2 is highly selective, orally bioavailable, and highly effective in pre-clinical disease models of inflammation and organ fibrosis, with picomolar efficacy in cells for key inflammatory cytokines. TAY-B2 (designated VYN202 by VYNE) was licensed to VYNE Therapeutics in 2023 and is expected to begin Phase 1a and 1b clinical trials in 2024.
Tay Therapeutics’ partnering strategy focusses on forming relationships with companies that have the capabilities and resources to develop assets through clinical PoC milestones. Having expertise in indications such as inflammation and rare diseases, our partners will need to share the same values and desire to bring new therapeutics to patients.
Tay’s strategy is validated through an Option License Agreement signed with VYNE Therapeutics in April 2021 and the subsequent exercise of the options for both TAY-B1 and TAY-B2. VYNE is a NASDAQ listed biotech dedicated to developing innovative and differentiated therapies for the treatment of immune-inflammatory disorders. The transaction and subsequent licenses have brought considerable revenues to Tay. To date, over £6 million has been received from research, option, upfront and development milestones.
The license to TAY-B1 was exercised in August 2021 and subsequently VYNE has developed a topical formulation that completed preclinical development and has completed a phase 1b clinical study which demonstrated proof of concept in vitiligo patients. TAY-B1 is now known as VYN201.
The license to TAY-B2 was exercised on 28th April 2023 and initiation of a phase 1a and 1b clinical trials are planned for 2024.
Tay intends to develop Tay-Enable™ projects (TAY-R1 and TAY-R2) to phase 2a proof of concept in patients with partnerships being considered in preclinical and for clinical development. Such an approach enables risk and cost sharing with partners.