RAC - Race Oncology

[JohnDe]

Could not see my comment re December entry so here I go again.

Since posting my December selection I have read an item that may indicate the news I was expecting this month may not be ready for posting until possibly January. I still feel there will be a build up in December.

Following a recently completed 2 year investigation with Monash University it looks like RAC will be patenting the results of a range of other unique discoveries found in the investigation. There will probably not be time to bring these new discoveries to trials before the company or its principal product (Bisantrine) is sold in about 4 or 5 years time but they will add a lot of extra value to RAC.

Anything to do with this -

Race Submits Human Ethics Application Package for RC220
Phase 1 Solid Tumour Trial

• Human ethics regulatory package submitted for Race’s Phase 1 trial in solid tumour patients using RC220 bisantrene, with up to 10 additional sites to follow
• Will study RC220 in combination with doxorubicin in adult cancer patients
• First patient recruitment is expected to occur in Q1 2025.

 

[access]

Anything to do with this -

Race Submits Human Ethics Application Package for RC220
Phase 1 Solid Tumour Trial

• Human ethics regulatory package submitted for Race’s Phase 1 trial in solid tumour patients using RC220 bisantrene, with up to 10 additional sites to follow
• Will study RC220 in combination with doxorubicin in adult cancer patients
• First patient recruitment is expected to occur in Q1 2025.

Yes. This Application should now be approved this month and it will be all systems go. Bisantrene has previously received safety approvals so dosage rates with the new easier RC220 method should not take long to present positive results.

 

[access]

RAC could be holding back their Half Year Report in expectation of receiving Ethics Application Approval tomorrow with them hoping to make an announcement tomorrow or before trading on Monday.

My understanding is that Bisantrine has already been proven to work however a problem was that when administered it would tend to crystalise before reaching the heart and organs it was to protect. With the new RC220 formula and method of delivery it would now take about 30 seconds before it will crystalise. With RC220 it takes only 10 seconds for Bisantrine to reach its target.

DYOR

 

[JohnDe]

December 2024 Quarterly Activity Report & Appendix 4C

 

[access]

Share price being hit while waiting for for an ethics approval and waiting for Medical Journal publication.

 

[JohnDe]

It's nice to see a bit of green on a Friday

14 March 2025 – Race Oncology Limited (‘Race’), in collaboration with the Cancer Care Foundation, is pleased to announce that it has received approval from Bellberry HREC to initiate a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics (PK) of RC220 bisantrene alone and in combination with doxorubicin, in patients with solid tumours (ASX announcement: 4 December 2024). This approval allows the Cancer Care Foundation’s lead site, Southside Cancer Care Centre (Miranda, NSW), under the supervision of the Principal Investigator, Dr Mahmood Alam, to commence enrolling patients for the trial, subject to institutional approval and site activation in March 2025.​

 

[access]

Phase 1 trials about to commence in Australia in April. Results will be released progressively so shareholders will not be waiting until the end of the trials.

 

[JohnDe]

Some more green in a sea of red today.

First Australian Clinical Site for RC220 Phase 1 Solid Tumour
Trial Opens for Patient Enrolment

● Lead Australian trial site, Southside Cancer Care Centre (Miranda) is activated to​

begin patient enrolment for the Phase 1 trial of RC220 in advanced solid tumours​

● Study will provide human safety and pharmacokinetic data, identify the maximum​

tolerated combined dose of RC220 and doxorubicin, and provide initial clinical data​

on the cardioprotective, anticancer and m6A RNA activities of RC220.​

 

[access]

Share purchase by management and Directors have been on hold for some time awaiting an announcement. Does not appear to relate to recently announced Phase 1 trials.

 

[JohnDe]

Successful & Safe Dosing of First Patient with RC220 in Phase 1 Solid Tumour Trial

• First patient safely dosed in Phase 1 clinical trial of RC220 in advanced solid tumour patients at lead Australian trial site, Southside Cancer Care
• This Phase 1 trial will determine safety, tolerability and pharmacokinetic data of RC220, plus the maximum tolerated combined dose of RC220 with doxorubicin
• Up to another 32 patients to be recruited across multiple sites in Australia, Hong Kong and South Korea in first stage of the trial.

1 May 2025 – Race Oncology Limited (‘Race’) is pleased to announce the successful and safe dosing of the first patient with RC220 in its Phase 1 clinical trial in advanced solid tumours. The patient was treated by Prof Paul de Souza and his team at the study’s lead trial site, Southside Cancer Care Centre, Miranda, NSW. No phlebitis (vein inflammation) or any other adverse events were reported.

 

[JohnDe]

No announcement and the price has shot up. What is causing this? Probably crash tomorrow.

 

[access]

RAC has first results of Phase 1/2 trials out any day.

Because the results did not come out Friday traders sold out in the last minutes of Friday (end of week and month). Caused my pick to drop out of 3rd place in monthly competition.

 

[JohnDe]

The market likes the news.

Termination of City of Hope Global IP License

• Race Oncology has terminated the global IP license agreement with the City of Hope executed on 7 July 2023
• Legal advice provided to Race is that termination ends all future development, diligence, and royalty liabilities due under the license agreement
• Race retains full freedom to operate and utilise bisantrene in the clinic.

Race has determined with senior expert legal and intellectual property advice that the City of Hope license is no longer of value to its shareholders given the future costs required to maintain the license. The legal advice received by Race is termination of the license ends all development and diligence milestones associated with the agreement, as well as future patent costs, and future royalty payments on sales of bisantrene under the terms of the agreement. Race retains full freedom to operate and to utilise bisantrene in clinical and non-clinical applications, including those related to the epigenetic regulation of mRNA.

 

[access]

Phase 1/2 trial still progressing. A slow boat until results are released.

 

[JohnDe]

“We are delighted to have received human ethics approval for our RC220 Phase 1 trial in Hong Kong with the support of two internationally recognised clinical investigators.​

​

“This trial is a declaration that cardio-oncology cannot be overlooked. RC220 may be the agent that protects the heart against doxorubicin damage and adds efficacy. We are very excited.” ​

Human Ethics Approvals Received for Phase 1 RC220 Trial at Two Hong Kong Hospitals

• Prince of Wales Hospital & Queen Mary Hospital in Hong Kong have received Human Research Ethics Committee (HREC) approval to participate in Race’s Phase 1 clinical trial of RC220 in combination with doxorubicin
• Ethics approvals allows both hospitals to enrol patients, subject to formal approval from the Hong Kong Department of Health (DoH) and site activations.

10 July 2025 – Race Oncology Limited (‘Race’) is pleased to announce HREC approvals have been received from the Institutional Review Board of The University of Hong Kong to commence its Phase 1 clinical trial of RC220 in combination with doxorubicin (RAC-010) at the Prince of Wales and Queen Mary Hospitals (Hong Kong). Formal DoH approval has been received for the Queen Mary Hospital and is expected for the Prince of Wales Hospital in the coming weeks. Site activations will follow in late July/mid-August 2025 enabling patient recruitment to begin.

The RAC-010 clinical trial is designed to assess the safety, tolerability and pharmacokinetics (PK) of RC220 alone and in combination with doxorubicin, in patients with solid tumours.

Dr Herbert Loong, Principal Investigator at Prince of Wales Hospital, Hong Kong commented: “Cancer patients being treated with cardiotoxic agents need the potential cardiac protection and added efficacy that RC220 may bring. We are extremely excited to be recruiting patients to this important trial.”

Dr Roland Ching-Yu Leung, Principal Investigator at Queen Mary Hospital, Hong Kong commented: “This trial is a declaration that cardio-oncology cannot be overlooked. RC220 may be the agent that protects the heart against doxorubicin damage and adds efficacy. We are very excited.”

Race Vice President of Medical, Dr Simon Fisher commented: “We are delighted to have received human ethics approval for our RC220 Phase 1 trial in Hong Kong with the support of two internationally recognised clinical investigators. I wish to thank both Dr Loong and Dr Leung for their support and enthusiasm in progressing RC220 and I look forward to our respective teams working together in the coming months.”

These approvals follow HREC approval for the Southside Cancer Centre (Miranda) (ASX Announcement: 14 March 2025) and Gosford and Wyong Hospitals (ASX Announcement: 31 March 2025). It is expected that additional HREC approvals will be received for up to four additional trial sites in South Korea over the coming months.

 

[JohnDe]

Race Oncology Upcoming 2025 Investor Events

15 July 2025 – Race Oncology Limited (“Race”) is pleased to announce it will be participating in a number
of upcoming investor events and conferences in Australia and Hong Kong in 2025.

Investor Briefing in Hobart, Tasmania – 6 August 2025

Race Oncology wishes to invite shareholders and potential new investors to attend an in-person investor
briefing and light lunch in Hobart on 6 August 2025.

Executive Chairman, Dr Pete Smith and Managing Director and Chief Executive Officer, Dr Daniel Tillett
will both present an update, then host a Q+A session.

 

[access]

Directors, management and even staff are still not permitted to purchase share (since late last year) due to secrecy about something that RAC have been working on.

Shareholders on another discussion site have been throwing their thoughts on what it could be and each time have been advised no by the CEO/MD. So it appears to be something out of left field.

I am still buying.

 

[access]

Nothing changed. Still waiting on updates for Phase 1/2 trials. When trial results or blackout reason are announced things are expected to move fast.
Address being given at an international conference in October may be a telling point.

 

[Dona Ferentes]

RAC off to the races

as high as $2.30

Race Oncology Makes Breakthrough Composition of Matter Intellectual Property Discovery​

● Bisantrene discovered to consist of three photoisomers with different biological and anticancer activities, which rapidly interconvert upon exposure to visible light
● Race has created a range of manufacturing and physical processes to enable the controlled infusion of the pure active (E,E)-bisantrene isomer into patients
● Three patent applications submitted, which if granted, will provide composition of matter intellectual property protection of (E,E)-bisantrene for 20 years.

 

[JohnDe]

I started buying in 2017 and did not sell a single share, until last month when I decided to sell a small parcel. That must have been the universes call to start increasing the price again.