TAY-R1 will be an orally bioavailable medicine capable of treating a range of cancers and genetic diseases. TP53 is the most commonly mutated 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 P53 protein to cancer cells.
As a systemic drug, TAY-R1 could benefit patients with premature termination codon (PTC) mutations in other tumour suppressor genes, and those with PTC mutations causing around 8000 known genetic diseases, including cystic fibrosis and Duchene’s muscular dystrophy.
TAY-R2 will be a topical therapy benefiting from our propriety soft drug capabilities, which is already validated through the discovery of the clinical candidate VYN201 (TAY-B1, see below). TAY-R2 aims to restore normal skin function in patients, preventing severe wounding, disability, and premature deaths for patients with recessive dystrophic epidermolysis bullosa (RDEB). TAY-R2 is applicable to around 1000 known genetic skin conditions, providing indication expansion opportunities.
Our lead 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 body sites, to deliver a safe and highly effective drug. TAY-B1 is licenced to VYNE Therapeutics (designated VYN201 by VYNE) and clinical development is underway, with a Phase 1b clinical trial in vitiligo in progress. TAY-B1 is effective in animal models of lung fibrosis (inhalation), rheumatoid arthritis (injection) and in a range of inflammatory and fibrotic skin conditions. VYNE Therapeutics are developing the drug for a new, undisclosed route of administration (clinic ready 2023).
Many inflammatory and fibrotic diseases would be best treated by an oral drug that can reach all affected body sites. We wanted to deliver a safe, effective medicine and so developed a bromodomain 2 selective BET inhibitor for oral dosing. TAY-B2 is highly selective, orally bioavailable, and highly effective in pre-clinical disease models of inflammation and organ fibrosis. TAY-B2 (designated VYN202 by VYNE) was licensed to VYNE Therapeutics and will be developed into the clinic for a range of diseases.
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 licence to TAY-B1 was exercised in August 2021 and subsequently VYNE has developed a topical formulation that completed preclinical development and is now in a phase 1b clinical study for vitiligo. Other formulations are also in development. TAY-B1 is now known as VYN201.
The license to TAY-B2 was exercised on 28th April 2023 and preclinical development will commence.
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.