On July 22, 2022 Race Oncology reported that The June 2022 quarter (Q4 FY 2022) was highlighted by the successful completion of the Phase 1b stage of the relapsed or refractory Acute Myeloid Leukaemia (R/R AML) trial of Zantrene (bisantrene dihydrochloride) running at the Chaim Sheba Medical Centre, Israel (ASX announcement: 27 May 2022) (Press release, Race Oncology, JUL 22, 2022, View Source [SID1234617042]). Encouraging clinical responses were observed in a very heavily pre-treated AML patient population with 3 of the 6 patients bridged to a stem cell transplant. The study led by Professor Arnon Nagler now advances to the Phase 2 efficacy stage with the intention of recruiting up to 17 patients.
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A second highlight was the discovery that Zantrene protects the hearts of mice from the damaging effects of anthracyclines (specifically doxorubicin)-even when the chemotherapeutic dose was increased and without significant additional toxicity or bone marrow suppression (ASX announcement: 30 June 2022).
Our extramedullary AML clinical trial received all ethics and regulatory approvals and is expected to treat the first patient in the current quarter-Q3 CY 2022 (ASX announcements: 6 April 2022 and 12 May 2022). This is the first clinical trial in the world to investigate the targeting of FTO as a potential cancer therapy.
Highly promising melanoma preclinical results in cells, organoids and mice was announced, showing Zantrene is able to aid overcoming immune therapy resistance, and synergise with BRAF and MEK kinase inhibitors (ASX announcements: 22 June 2022; 28 June 2022).
Race announced an on-market share buyback for up to 4 million Race Oncology ordinary shares over the next 12 months (ASX announcement: 9 June 2022). The on-market buyback allows the company to take advantage of share price volatility through opportunistic share purchases during periods when the share price does not reflect the robust outlook for the company. Race Oncology Ltd ABN 61 149 318 749 Registered office: L36, 1 Macquarie Place, Sydney NSW 2000 www.raceoncology.com Race continues to progress its Three Pillar Strategy to capitalise on the RNA therapeutics opportunity in cancer and cardioprotection provided by Zantrene.
Management commentary Race CEO Phillip Lynch said: "We were particularly pleased to see the human heart cell data corroborated in a whole mouse model, confirming that Zantrene when used with doxorubicin protects from cardiac damage, while also improving anti-cancer efficacy. We are now developing clinical programs as we pursue realisation of this high value opportunity for Zantrene." Race CSO Daniel Tillett said: "Race made major advances this quarter, both in the clinic and in the lab. Advancement of the relapsed / refractory AML clinical trial at Chaim Sheba from Phase 1 to Phase 2 and progressing the EMD AML trial through the regulatory process were important clinical milestones achieved in the quarter. The mouse cardioprotection, melanoma immunotherapy and kinase inhibitor results have further highlighted the outstanding potential of Zantrene."
Race Chairman John Cullity said: "The Race team has again delivered for Shareholders. While preclinical, the reported cardioprotection data are groundbreaking. As a former clinician, I’m entirely alert to the impact that select chemotherapies have on the heart. It is remarkable that Zantrene might both enhance cancer cell kill while protecting the heart – so potentially reshaping cancer therapeutics. We possess an obligation to take this program forward with all purpose." –––– Key events of the quarter
On 6 April 2022, Race announced that it had human ethics approval for its open label clinical trial of Zantrene in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS)(BISECT). This is the first clinical trial in the world to investigate the targeting of FTO as a potential cancer therapy.
On 12 May 2022, Race announced it had received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene in patients with extramedullary Acute Myeloid Leukaemia or high-risk Myelodysplastic Syndrome (BISECT). A site meeting was scheduled for 31 May 2022 to initiate the trial and allow recruitment of the first patient.
On 18 May 2022, Race announced that it had appointed Dr James Guy Breitenbucher to its Scientific Advisory Board (SAB). Dr Breitenbucher brings to Race an extensive drug discovery and clinical development history, having spent more than 26 years in scientific leadership positions at a range of large and small pharmaceutical companies, including Johnson & Johnson, Convelo Therapeutics, Libra Therapeutics, Dart Neuroscience, Axys Pharmaceuticals, and Bristol Myers Squibb. Race Oncology Ltd ABN 61 149 318 749 Registered office: L36, 1 Macquarie Place, Sydney NSW 2000 www.raceoncology.com
On 27 May 2022, Race announced results from the dose escalation Phase 1b stage of the relapsed or refractory Acute Myeloid Leukaemia (R/R AML) trial running at the Chaim Sheba Medical Centre, Israel. Phase 1b successfully completed after the treatment of the first six patients. Encouraging clinical responses were observed in this very heavily pre-treated AML patient population with 3 of the 6 patients bridged to stem cell transplants. The study led by Professor Arnon Nagler now advances to the Phase 2 efficacy stage with the intention of recruiting up to 17 patients.
On 8 June 2022, Race announced it was expanding the FTO-targeted BISECT (RAC006) clinical trial in extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS) to include five additional trial sites in Spain and Italy and had also signed a new clinical support agreement with global Clinical Research Organisation, Parexel International to support the additional trial monitoring activities. The total study costs are expected to be in the range of A$7.7 million to a maximum of A$15.4 million. The final cost is dependent on the location and number of patients screened and enrolled in the trial.
On 9 June 2022, Race announced the Board has approved an on-market share buyback for up to 4 million Race Oncology ordinary shares over the next 12 months. All committed clinical and preclinical programs as outlined in the November 2021 Share Purchase Plan remain fully funded. The structure of an on-market buyback allows the company to take advantage of share price volatility through opportunistic share purchases during periods in which the share price does not reflect the robust outlook for the company.
On 21 June 2022, Race announced that two peer reviewed research poster abstracts detailing new preclinical data on the anti-cancer uses of Zantrene (also known as bisantrene or CS1) had been published in the prestigious scientific journal, Cancer Research. Publication followed their recent presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Conference in New Orleans, from April 8 – 13, 2022. The first abstract demonstrates Zantrene’s ability to target FTO in the suppression of pancreatic cancer. The second abstract discusses the potential use of Zantrene as an adjunctive treatment to 5-FU based chemotherapy for colorectal cancer patients. These independent results add to Race’s own reported preclinical and clinical data, showing Zantrene’s potential in targeting FTO in AML, melanoma and kidney cancer.
On 22 June 2022, Race announced further interim results from its preclinical melanoma research program (ASX announcement: 19 March 2021). Used at low concentrations, Zantrene was found to enhance cancer immunotherapy in three distinct and complementary ways:
(1) direct killing of melanoma cells;
(2) activation of immune cells targeting the tumour, and
(3) reducing the expression of immune evasion genes in the tumour. The results were supportive of future clinical trials using Zantrene in combination with immune therapy treatments to potentially improve melanoma patient outcomes.
On 28 June 2022, Race announced final results of the preclinical melanoma research program in collaboration with the University of Newcastle. Zantrene in combination Race Oncology Ltd ABN 61 149 318 749 Registered office: L36, 1 Macquarie Place, Sydney NSW 2000 www.raceoncology.com with BRAF and MEK protein kinase inhibitors was found to improve the killing of human melanoma cells and to better target melanoma in organoid and animal tumour models. These discoveries offer potential non-immunotherapeutic pathways for the use of Zantrene in melanoma treatment.
On 30 June 2002, Race announced additional interim results from our preclinical cardioprotection program in collaboration with researchers from the University of Newcastle (ASX announcement: 28 April 2021). 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.
Other news from the quarter Chief Executive Officer (CEO) Phillip Lynch and Chief Scientific Officer (CSO) Daniel Tillett moved to 0.75 FTE level from 1 April 2022. Bonus and Option conditions remain unchanged and will be assessed according to the company’s incentive scheme and assessment of performance versus established goals. Dr Daniel Tillett, Race CSO, presented at the Gold Coast Investment Showcase on 22 and 23 June 2022, and met with both existing and new shareholders through the event. Summary of cash flow and quarterly activity As of 30 June 2022, Race held cash and equivalents of $33.54 million, compared with $35.68 million on 31 March 2022. The net change in cash reserves of $2.14 million reflects continued research expenditure, an expansion of Zantrene inventory for clinical trials, and advancement of other drug development programs. Listing rule 4.7C.3 Payments during the quarter to Related Parties amounted to $208k, comprising payments of salaries and superannuation to executive directors of $165k and board fees to non-executive directors of $43k.