Race Oncology Ltd (ASX:RAC) has signed an agreement with leading global contract development and manufacturing organisation (CDMO), Ardena Holding NV, which strengthens the company's existing manufacturing programs by serving as a primary source for EU-compliant supplies required for EU clinical studies.
Through this agreement, Ardena becomes an additional partner for Good Manufacturing Practice (cGMP)-standard manufacturing capability for Race’s flagship intravenous (IV) formulation of bisantrene, RC220.
The agreement also provides a backup source for US and Australian clinical programs.
Bisantrene is a potent inhibitor of the Fatso/Fat mass and obesity-associated (FTO) protein. Overexpression of FTO has been shown to be the genetic driver of a diverse range of cancers.
Race is exploring the use of bisantrene as a new therapy for melanoma and clear cell renal cell carcinoma, which are both frequent FTO over-expressing cancers. It has also discovered that bisantrene protects from anthracycline-induced heart damage, while in tandem acting with anthracyclines and proteasome inhibitors to improve their ability to target cancer.
The initial development budget contracted with Ardena is approximately US$1 million.
Why Ardena?
Ardena is a fully integrated CDMO which assists biopharma companies with services spanning the drug development life cycle. RAC couldn’t go past Ardena’s long track record of providing sterile injectable products for all stages of clinical development.
“We are pleased to welcome Ardena as a manufacturing partner, adding to our existing contracted manufacturing capability,” Race CEO and managing director Damian Clarke-Bruce said.
“Ardena’s position in Europe ensures ease of access to RC220 product for our European clinical trials and adds a second source of FDA-compliant pharmaceutical grade product.”
It is expected that Ardena will deliver Race’s first EU and international-compliant GMP supplies by the end of 2023.
Over the coming months, the companies will work together on technology transfer, so that it can start the program.
The agreement with Ardena is for an initial period of five years.