The market may be tumbling today, but that hasn't stopped one ASX All Ords share from racing higher.
Its shares are up a sizeable 9% to $3.26 at the time of writing.
Which ASX All Ords share?
The share in question today is Race Oncology Ltd (ASX: RAC).
It is a clinical stage biopharmaceutical company focused on cancer care. Its lead asset, RCDS1, is a small molecule anticancer agent that has demonstrated therapeutic activity in cancer patients with a well characterised safety profile.
Race Oncology is also advancing a proprietary formulation of RCDS1 (RC220) to address the high unmet needs of patients across multiple oncology indications, as well as exploring the use of RC220 as a low intensity treatment for acute myeloid leukaemia and other cancers.
This morning, the ASX All Ords share announced that the Republic of Korea Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) application to evaluate the safety, tolerability, and pharmacokinetics of RC220 in combination with doxorubicin in solid tumour patients. This is subject to minor updates of the trial protocol.
According to the release, the MFDS IND approval follows a detailed review of the comprehensive RC220 data package. This includes dossier modules covering non-clinical pharmacology and toxicology, chemistry, manufacturing and controls (CMC) for the active pharmaceutical ingredient drug substance and the RC220 drug product, specifications and analytical methods, together with the clinical trial protocol.
Important milestone
The ASX All Ords share's CEO and managing director, Dr Daniel Tillett, believes this is an important milestone for RC220 and the company. He said:
IND approval from the Korean MFDS is the result of focused effort from the Race team, working closely with the Korean regulators to achieve this important milestone. This approval allows patient enrolment in Korea and confirms the strength of the RC220 data package. We look forward to collaborating with our clinical partners in Korea to evaluate the potential of RC220 in combination with doxorubicin as a treatment option for adult patients with solid tumours.
The Korean healthcare and regulatory systems are internationally recognised for their high standards. Patient recruitment into oncology trials in Korea has historically been robust. We are excited to commence patient enrolment in Korea and further progress our global development strategy for RC220.
Following today's gain, the Race Oncology share price is now up 175% since this time last month.
