Race Oncology says certificate of analysis issued by Ardena for first cGMP batch of bisantrene formulation RC220
Confirms RC220 meets all cGMP specifications required for a human IV drug
product
Company says major milestone in the progress of RC220 for use in human clinical trials
Special Report: Race Oncology has been issued a Certificate of Analysis (CoA) for its first current Good Manufacturing Practice (cGMP) batch of proprietary bisantrene formulation RC220.
Race Oncology (ASX:RAC) says issuance of the milestone CoA confirms the drug product meets stringent quality specifications required for human use.
RAC says Ardena was entrusted to manufacture the cGMP RC220 drug product, ensuring it adhered to exacting standards mandated by key global regulatory bodies, including the European Medicines Agency (EMA), US Food & Drug Administration (FDA), and Australian Therapeutic Goods Administration (TGA).
RAC’s pioneering bisantrene formulation is engineered to facilitate the safe administration of the drug to patients through intravenous (IV) infusions via peripheral veins, such as those in the arms or legs.
Th CoA achievement builds upon the successful research and development efforts carried out by the company’s laboratory team at the University of Wollongong.
Improving delivery of proven drug
Bisantrene is a small molecule anthracene-based chemotherapeutic that was originally developed by a small French pharmaceutical company called Lederle Laboratories in the 1970s and 1980s.
Studies have shown that bisantrene reduces risk of cardiotoxicity and demonstrates cardio-protection when used in conjunction with anthracyclines, a class of drugs used in cancer chemotherapy.
While it was very effective in patients and was even approved for the treatment of Acute Myeloid Leukaemia (AML) in France, it was not commercialised due to the drug being difficult to use.
RAC has now reformulated bisantrene so that it can be easily used in the clinic through standard infusion via an arm or leg vein.
RAC is developing bisantrene to address the high unmet need of patients across multiple oncology indications, with an initial focus on metastatic breast cancer (lead indication) and acute myeloid leukaemia (AML), exploring anti-cancer plus cardio-protection in synergy with known standards of care.
Enough vials for clinical trials
The recent manufacturing campaign yielded a cGMP batch comprising 2600 vials of RC220 with the CoA attesting that the drug fulfills the stringent manufacturing quality criteria required for IV products intended for human use.
RAC says 1799 of the manufactured vials will be available for patient use, which is enough to treat more than 150 patients and will satisfy the requirements of all planned human clinical trials over the next several years.
RAC says additional batches of cGMP RC220 will be manufactured as needed and at increasing scale to ensure that the biotech meets future clinical trial needs and can demonstrate to regulators and pharmaceutical partners that the drug can be produced consistently at commercial scale.
Wide range of tests conducted
Compliance with cGMP quality standards satisfies the prerequisites for assessing new IV drug products in Phase 1 and 2 clinical trials across Asia-Pacific, Europe, and the USA.
RAC says a wide range of tests were conducted under cGMP standards to accurately measure the amount of bisantrene, impurity levels and the moisture content of drug product vials to ensure that the formulation contents adhere to narrow, prespecified limits.
The vials were examined for appearance, the time to reconstitute the dry powder (how long it takes to dissolve a vial of RC220 upon the addition of water), and the pH of the solution.
The vials were also tested for sterility with no detectable bacteria and for the absence of endotoxins (bacterial cell wall components), which can cause serious adverse reactions
if injected into a patient.
Final step before human clinical trial
RAC says the final step required before RC220 can be used in human clinical trials is completion of GLP toxicology and safety pharmacology studies.
The company says these studies are progressing well and remain on track for completion in late Q2 CY24.
RAC is forecasting to start human trials in H2 CY24 with significant progress been made by its clinical team preparing the extensive documentation required to undertake a Phase 1 trial in Australia.
‘Major Milestone and accomplishment’
CEO Dr Daniel Tillett says the original developers of bisantrene, Lederle Laboratories, tried for nearly a decade to make a formulation of the drug that could be delivered via a peripheral vein without success.
“Reaching this point in the development of bisantrene is a major milestone and accomplishment,” Tillett says.
“It is a testament to the dedication and skill of the Race team that we were able to accomplish what Lederle could not.
“I, along with the entire team at Race, are looking forward to completing the GLP toxicology testing of RC220 in the coming months and beginning the clinical program that will give patients access to bisantrene in a format that is both easier and safer to use.”
CMO Dr Michelle Rashford says the company is yet another step closer to undertaking its Phase 1 trial.
“This is a major milestone to have reached and means we have manufactured RC220 to a standard suitable to start our Phase 1 clinical trial here in Australia,” Rashford says.
This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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