4. Investigator Sponsored Trial in AML
• Bisantrene (RC220) + decitabine in patients unable to tolerate high-intensity chemotherapy and have failed previous lines of therapy (similar to Sheba 2 but using RC220)
• Estimated start H2 24 – H1 25, interim results H2 26, final readout H2 28
• Using low dose RC220 regimen
• Aim to provide P2 data supporting use of bisantrene in low intensity AML combo protocols that are compatible with venetoclax
• Cost-efficient method of building AML data package (assumes RAC portion of funding covered by option exercise)
I think the investigator-sponsored model makes sense to be continued in AML. Sheba 1 and 2 provided good PoC for bisantrene in AML in this patient population. I’m happy that development in this therapeutic area is continuing without limiting the resources available for the solid tumour trials. This trial is necessary to demonstrate RC220’s effectiveness in AML and the new dosing regimen will hopefully prove successful, adding value to bisantrene by hopefully providing data supporting use in current AML treatment algorithms.
5. Comparison with August Strategy:
•
Solid tumours now the clinical focus of the company, cash on hand being utilised to push the development program of RC220 in solid tumours forward, with AML taking second priority position
• Commencement of RAC’s RC220 clinical development program in solid tumours scheduled to start in H2 24 (pending availability of RC220 manufactured at scale) which is in-line with the mBC trial from the August strategy.
• Ph 1b/2a RC110 AML Australian trial scrapped in favour of an investigator sponsored P2 trial using low dose RC220. The previous strategy had highlighted Q4 2023 as the start pf the Phase 1b/2a AML trial which is now delayed to H2 2024 given the preference to use RC220.
Broadly speaking I’m in favour of the new strategy, I had said on these forums that I didn’t necessarily see any issues with the old strategy. Although having now seen the alternative, I’m glad that RAC have decided to devote all available resources to developing bisantrene in solid tumours. I’m happy with the decision to terminate development of RC110 in favour of RC220. I don’t see much value in RC110, although I know that some posters had called for licensing out RC110 for some cash to help with furthering the development of RC220. Maybe this is still an option, watch and wait on this front.
Broadly speaking I’m in favour of the new strategy, I had said on these forums that I didn’t necessarily see any issues with the old strategy. Although having now seen the alternative, I’m glad that RAC have decided to devote all available resources to developing bisantrene in solid tumours. I’m happy with the decision to terminate development of RC110 in favour of RC220. I don’t see much value in RC110, although I know that some posters had called for licensing out RC110 for some cash to help with furthering the development of RC220. Maybe this is still an option, watch and wait on this front.
6. Estimated Timelines
(20min delay)