Race Oncology has shared further interim results from their preclinical cardioprotection program in collaboration with researchers from the University of Newcastle. This program aimed at exploring the use of Zantrene (bisantrene dihydrochloride) as a cardioprotective agent which offered synergy with anti-cancer treatments. Zantrene was found to protect the hearts of mice from the damaging effects of anthracyclines (specifically doxorubicin) even when the chemotherapeutic dose was increased without significant additional toxicity or bone marrow suppression.

Zantrene was found to protect the hearts of mice from the damaging effects of anthracyclines (specifically doxorubicin) even when the chemotherapeutic dose was increased without significant additional toxicity or bone marrow suppression.

Chief Scientific Officer, Dr Daniel Tillett said: ”Extending the initial cardioprotection study from cells to hearts is a major step forward for Race. We now know Zantrene is not only able to protect human heart muscle cells from anthracycline induced death, but that this also applies to hearts in animals. When combined with the historical clinical data around Zantrene heart safety, we believe Zantrene may offer millions of patients a unique combination of cardioprotection with enhanced anti-cancer efficacy. Such opportunities are rare in oncology.”

Associate Professor Aaron Sverdlov said: “To date, there are no widely used or wellestablished strategies to protect the heart against chemotherapy-induced damage. Furthermore, the concept of potential cancer therapy that is not only non-cardiotoxic, but cardioprotective has not been evaluated or even entertained. These results suggest that Zantrene, an effective anti-cancer agent, can concomitantly provide protection against toxic effects on the heart from one of the most used chemotherapy agents, doxorubicin. This is the first evidence of its kind to demonstrate that there is a therapy that both targets the cancer and protects the heart! This has the potential to improve health outcomes for countless cancer patients and survivors by both improving their cancer treatment while preventing development of cardiovascular disease.”

Chief Executive Officer, Mr Phillip Lynch said, “It’s pleasing to see our strategic ambitions for cardioprotection independently validated at an animal level which enables us to prioritise clinical translation. We are committed to producing further preclinical data that will continue to prove the case for this opportunity for Zantrene. It’s certainly a large commercial opportunity and one that’s got significant potential to improve modern chemotherapy.”

Race Receives Governance Approval for Extramedullary AML & MDS Human Trial

RAC has received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene® (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Human ethics approval for this trial has been granted (ASX Announcement: 5 April 2022).

Representatives of the Race Oncology clinical team, the contract research organisation Paraxel, and associated clinical teams of the Calvary Mater Hospital are scheduled to meet for site initiation and training on the 31 May 2022. Completion of this site training will enable the first patient to be recruited into the trial.

This open label Phase 1 trial with a dose expansion Phase 2 stage will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design at trial sites in Australia and Europe.

Zantrene Highly Effective in a Mouse Model of Extramedullary AML

Race has shared interim results from the extramedullary acute myeloid leukaemia (EMD AML) preclinical program led by eminent cancer researcher, Associate Professor Nikki Verrills of The University of Newcastle and Hunter Medical Research Institute.

This research found that low dose Zantrene in combination with decitabine can kill AML tumours in a mouse model of extramedullary AML and builds on the results of earlier AML clinical trials. Race is rapidly advancing Zantrene into the clinic as a possible new treatment option for patients with EMD AML.

Chief Scientific Officer, Dr Daniel Tillett said, “The results from Prof Verrills laboratory are highly supportive of our upcoming EMD AML Phase 1/2 trial for Zantrene. This work further builds on the 2020 Phase 2 trial of Prof Arnon Nagler, who identified Zantrene as showing encouraging efficacy in EMD AML. The optimised drug combination and schedule identified in this preclinical mouse study will be rapidly translated to the clinic via our EMD AML trial.”

Chief Executive Officer, Mr Phillip Lynch said, “These results provide support for our well advanced EMD AML clinical trial and provides important guidance for the study’s design and treatment protocol.”

Compelling Preclinical Kidney Cancer Results for Zantrene

RAC has shared final results from the clear cell renal cell carcinoma (a dangerous form of kidney cancer) preclinical program led by eminent cancer researcher, Associate Professor Nikki Verrills of The University of Newcastle and Hunter Medical Research Institute (ASX announcement: 25 March 2021).

This research found that Zantrene on its own and in combination with known kidney cancer drugs can kill kidney cancer cells at clinically relevant concentrations. These results support advancing Zantrene into the clinic as a possible new treatment option for advanced kidney cancer patients.

Chief Scientific Officer, Dr Daniel Tillett said:

“The results from Prof Verrills laboratory are highly encouraging and supportive of our clinical plans for Zantrene in kidney cancer. Advanced kidney cancer has a large unmet need for improved treatment options and Zantrene in combination with existing treatments may offer new hope for patients with this devastating disease.”

Chief Executive Officer, Mr Phillip Lynch said,

“We are again pleased to note Zantrene’s effectiveness both in isolation and in combination with other known kidney cancer treatments. This result encourages clinical translation, and we look forward to determining an optimal approach for progressing clinical study."

Race’s Share Purchase Plan has closed heavily over scribed at $43.9m. $29.7m of the raised funds will be accepted to support the FTO solid tumour Phase 1b/2 clinical trail, European EMD AML Phase 2 trial, Improved Zantrene formulations & new molecule development.

The $29.7m from the share purchase plan means 9.9 million new ordinary fully paid shares at $3.00 per share will be issued. This represents approximately 6.6% of RAC's issued capital as at 21 December 2021.

Race's Managing Director and CEO, Mr Phil Lynch commented:

“The Race team has been humbled by the extraordinary show of shareholder support for our Share Purchase Plan and we sincerely thank all those who participated. The number of applications reflects enthusiasm for the significant potential of our lead drug Zantrene, and this enables us to implement our planned clinical and drug development plans across the three-pillar program. We move into 2022 in an exceptional position, with many critical, reportable milestones ahead of us.”

Race’s Chief Scientific Officer and Executive Director, Dr Daniel Tillett said,

“I would like to personally thank all our shareholders for their generous support of our plans for Zantrene. It is extremely humbling to have so many of our shareholders willing to join and support us on the exciting journey to bring Zantrene back to patients in need. ”

United States Patent No. 11,147,800 entitled COMBINATORIAL METHODS TO IMPROVE THE THERAPEUTIC BENEFIT OF BISANTRENE AND ANALOGS AND DERIVATIVES THEREOF

Race Oncology (“Race”) is pleased to announce that it has been issued a new patent (US patent no. 11,147,800) on its cancer drug, Zantrene® (bisantrene dihydrochloride), by the United States Patent and Trademarks Office (USPTO). This patent expires on 25 July 2034.

This is Race’s sixth granted patent on Zantrene in the United States. “The new US patent provides Race with further protection around uses of Zantrene (and related chemical structures) that improve the efficacy of Zantrene treatments”, said Race’s CEO Phillip Lynch.

This new patent further expands the therapeutic utility of Zantrene (and related chemical structures), in particular - methods that improve the therapeutic efficacy of Zantrene and reduce side effects.

The new patent builds on Race’s existing Zantrene patents granted in the USA in 2018 (US 9,993,460 and US 9,974,774), 2019 (US 10,500,192), 2020 (US 10,548,876) and in 2021 (US 11,135,201), further strengthening Race’s growing IP position for Zantrene.

Race Oncology has announced this morning that the first patient has been dosed in the Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia.

This investigator-led trial supervised by Professor Arnon Nagler will use Zantrene® (bisantrene dihydrochloride) in a novel three drug combination which has demonstrated compelling efficacy in pre-clinical studies (ASX Announcement: 10 May 2021). Prof Nagler was the Principal Investigator of the Phase 2 investigator-initiated trial where Zantrene was used as a single agent in R/R AML patients and reported an impressive 40% clinical response rate (ASX Announcement: 16 June 2020). The trial will run in parallel with a separate Australian Phase 2 trial in patients with extramedullary AML (ASX Announcement: 2 June 2021). Both trials are key components of Race's Three Pillar strategy.

The trial is expected to take 36 to 40 months to complete with full patient recruitment over approximately 18 months. 

I anticipate that there will be plenty of newsflow to come, as given the trial is open-label, RAC expects that data will be reported at interim points throughout the trial.

• This Phase 1b/2 relapsed/refractory Acute Myeloid Leukaemia (R/R AML) trial will use Zantrene® (bisantrene dihydrochloride) in combination with fludarabine and clofarabine
• The treatment of the first patient in this trial is an important step in advancing Zantrene® to approval for use in adult R/R AML
• The study is being led by Professor Arnon Nagler of the Chaim Sheba Medical Center, Israel, who previously conducted the Phase 2 single agent Zantrene® R/R AML trial which demonstrated a 40% clinical response

Race Executes Key Contract for Israel Phase 2 AML Trial

• Contract signed to support Race’s Phase 2 relapsed/refractory Acute Myeloid Leukemia (AML) trial at the Chaim Sheba Medical Center in Israel
• Trialog Clinical Trials Ltd to supply trial drugs and provide other clinical services
• Clinical trial contract is in final stages with the first patient expected to be treated in Q3 CY 2021

Race Strategic Update March 2021

• Race updates its Three Pillar Strategy, detailing intended programs and activities
• The update confirms progress on all Three Pillars, and shares concrete steps towards increasing value for Bisantrene, through its application to broader cancer indications
• Committed programs are funded through calendar 2021.

Race Initiates FTO-Directed Kidney Cancer Preclinical Study

• Race enters a collaborative preclinical research program with The University of Newcastle to explore use of Bisantrene as a novel FTO-directed treatment for clear cell renal cell carcinoma (ccRCC)
• Research designed to demonstrate the utility of Bisantrene to treat this dangerous kidney cancer with important unmet clinical needs
• The project is Race’s second step under Pillar 1 of its Three Pillar strategy, which is aimed at demonstrating Bisantrene’s potential in inhibiting FTO in humans

Race Initiates FTO Melanoma Preclinical Study

• Race enters collaborative preclinical research program with The University of Newcastle to explore use of Bisantrene as a novel FTO directed treatment for melanoma
• Research designed to identify drug combinations that improve upon current standard of care melanoma treatment with focus on immune checkpoint resistance
• Project is Race’s first step under Pillar 1 of its Three Pillar strategy, designed to demonstrate Bisantrene’s potential in inhibiting FTO in humans