ASX Health Stocks: Chimeric and Recce announce exciting results from Phase 1 clinical trials
Health & Biotech
Health & Biotech
The ASX 200 Health Index (XHJ) is trading lower by 1.40% at the time of writing, compared to the broader index which is down by 0.35%.
Cell therapy specialist Chimeric Therapeutics (ASX:CHM) has just announced the final results of its Phase 1 clinical trial of its CORE NK platform.
The CORE NK platform stands for Clinically validated, Off the shelf, Robust, Enhanced Natural Killer, and itwas completed at the Case Comprehensive Cancer Center in Ohio, US.
Chimeric said the results were encouraging, demonstrating an optimal safety profile and strong early signs of clinical benefits.
Of the six patients with solid tumours (colorectal cancer and colon cancer) treated with Chimeric’s CORE NK, a 33% Disease Control Rate (DCR) was demonstrated, with 2 of the 6 patients achieving a best response of stable disease by day 28.
One of the 2 patients who had achieved stable disease at day 28 maintained their disease stability at day 100.
All patients tolerated CORE NK well, with no dose limiting toxicities, no cytokine release syndrome, and no graft versus host disease.
Chimeric says it now wants to develop the platform further with plans to increase the administered CORE NK doses.
“We are incredibly excited to share these data as we believe that it demonstrates the transformational potential for our CORE NK platform,” said Jennifer Chow, Chimeric CEO.
“We now look forward to rapidly advancing the multiple development paths planned for CORE NK in both blood cancers and solid tumors,” she said.
An Independent Safety Committee has unanimously recommended Recce Pharma (ASX:RCE)‘s Phase I intravenous clinical trial of RECCE 327 (R327) to go ahead, following good safety results demonstrated by the 10 healthy human subjects in Cohort 3.
The Committee has now recommended that Cohort 4 – or patients to be dosed with 1,000mg of R327 – to commence.
Recce says it could complete Cohort 4 dosing by the end of this week.
According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.
The FDA has awarded R327 with a Qualified Infectious Disease Product designation, labelling it for Fast Track Designation plus 10 years of market exclusivity post approval.
The Phase I trial of R327 is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide’s CMAX clinical trial facility.
The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000mg.
Recce expects to have all Phase I dosing complete by the second quarter of this year.