Race Oncology has appointed a CRO to support development of RC220. Pic: Getty Images.
Health & Biotech
Special Report: Race Oncology appoints contract research organisation (CRO) George Clinical International to support development of its lead drug RC220 bisantrene.
Race Oncology (ASX:RAC) says the CRO was selected after an extensive and rigorous selection process by the clinical-stage biotech’s clinical team and along with its clinical trial expertise brings access to a supplementary network of key opinion leading clinical oncologists with extensive expertise in the treatment of solid tumours with anthracyclines.
RAC says George Clinical International is a leading global CRO with more than 20 years of operation, extensive trial experience globally and impressive track record of success conducting oncology trials at all phases in the US, China, South-East Asia, New Zealand and Australia.
The CRO will assist RAC in the refinement and efficient execution of the proposed Phase Ia/1b study of peripherally administered intravenous RC220 bisantrene in combination with a standard-of-care (SOC) regimen of chemotherapy drug doxorubicin (Adriamycin) in patients with advanced solid tumours.
RAC has kicked off working with George Clinical International through a start-up agreement (SUA) at a cost of $1,071,067.
Additional payments will be made to George Clinical under a master service agreement (MSA) throughout the study after completion of key milestones, with the total cost dependent on the number of recruited patients and other variables of trial execution.
The current estimated CRO cost of the Phase 1 trial is $6m based on the recruitment of 34 patients, with additional costs for drug supply, pharmacokinetics and biomarker analysis.
RAC says the Phase 1 trial will be conducted under an open label in two stages across multiple sites in Australia, Hong Kong and South Korea.
The first 1a Phase will study ascending doses of RC220 bisantrene to determine safety, tolerability, pharmacokinetics, m6A RNA effects, and the maximum tolerated dose alone and in combination with doxorubicin.
In the second 1b Phase the optimal dosage of RC220 bisantrene in combination with doxorubicin will be assessed for additional safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals.
The Phase 1 trial will use a Bayesian design allowing for greater trial flexibility and speed but how long the trial will take is difficult to answer.
“While efficient in terms of patient numbers and cost, Bayesian trial designs can be difficult to estimate accurate timelines as the number of patients needed is not fixed,” RAC says in an ASX announcement.
“Our current best estimate is that the trial should complete recruitment during 2026.”
The final trial protocol and start of the trial is subject to human ethics and institutional approvals.
Bisantrene is an anthracene-based chemotherapy, with a history dating back to the 1970s and 1980s where it was originally developed by small French pharmaceutical firm Lederle Laboratories.
Research on Bisantrene confirms its ability to lower the risk of cardiotoxicity and provide cardio-protection when used in conjunction with anthracyclines, a group of drugs used in cancer treatment.
While effective in patients and approved for treating acute myeloid leukemia (AML) in France, bisantrene’s complex administration prevented commercialisation.
RAC has reformulated the drug to enable easy clinical use through standard infusion via arm or leg veins and exploring its anticancer and cardio-protective properties alongside known standards of care.
When tested against a panel of 143 cancer cell lines representing more than 20 human tumour types, bisantrene has previously been shown to kill more than 79% of the cells at clinically achievable drug concentrations.
Further, when the cancer cells were treated with mixtures containing bisantrene and the widely used doxorubicin, greater cell-killing was seen in 86% of tumour cells relative to doxorubicin alone.
Bisantrene has also been shown to be effective in combination with another SOC drug decitabine, significantly improving cancer cell-killing across 143 tumour cell lines than either drug used alone.
RAC chief medical officer Dr Michelle Rashford says the Phase 1a/1b study will be significant in the ongoing development of RC220.
“This is a key foundational study to establish important safety and drug absorption kinetics for RC220 and provide appropriate doses for effective combination with doxorubicin to advance the development of RC220 for clinical cardiac benefit to patients treated with anthracyclines while providing improved outcomes,” Rashford says.
“We are delighted George Clinical can support this significant step for Race and through the selection process their responsiveness and clinical insight has impressed us.
“I and the rest of Race clinical team look forward to working with George Clinical on this and future trials.”
It’s been a big week for RAC, which on Tuesday announced the US FDA had extended Rare Paediatric Disease Designation (RPDD) to RC220 to treat acute myeloid leukaemia (AML) in children.
“This agreement with George Clinical is a significant milestone for Race to bring RC220 bisantrene to the clinic to potentially protect patients from the heart damage caused by anthracyclines while improving the treatment of their cancer,” CEO Dr Daniel Tillett says.
“I welcome the opportunity for Race to work with George Clinical and wish to thank the Race clinical team for their hard work and dedication in reaching this agreement.”
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.
Health & Biotech
Health & Biotech
Health & Biotech
