Amid this morning's market panic, there is one stock - Avacta - that’s bucking the trend.
Today this groundbreaking cancer therapeutic / diagnostics firm said that the US FDA had granted its highly promising AVA6000 Pro-doxorubicin therapeutic, orphan-drug designation (ODD) for the treatment of soft-tissue sarcoma (STC).
Why is this important?
Well first & foremost, it offers another major end-market opportunity for AVA6000. This time being in rare diseases such as STC, where there’s currently few effective treatments and malignancies often become metastatic. Indeed, the American Cancer Society estimates that in 2022 alone, 13,190 new patients will be diagnosed with STC, and regrettably 5,130 will die.
Better still, the news provides another marvelous endorsement of AVA6000 and more broadly AVCT’s proprietary pre|CISION FAP-activated delivery platform. Especially as the FDA has almost certainly granted the ODD based on a review of the existing preclinical data - which (if ultimately successful) would provide the company with tax credits and other incentives, including 7 years of US market exclusivity. A “significant commercial advantage”.
With regard to future development, it is far too early at this stage, to accurately predict how this new medical indication would be progressed in terms of further clinical studies, timescales, investments, etc. Albeit needless to say it could add material upside to Avacta’s risk-based drug pipeline & valuation.
CEO Alastair Smith commenting: "We are delighted to receive Orphan Drug Designation from the FDA for AVA6000, which is a reflection of the high quality of the preclinical data and the potential benefit the pre|CISION platform can bring to cancer patients.”