On July 30, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2024 (Press release, Amplia Therapeutics, JUL 31, 2024, View Source [SID1234645176]).
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Key Highlights from the Quarter
• Updated data and analysis from the Phase 1b ACCENT trial in pancreatic cancer presented at the prestigious annual meetings of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
• Recruitment in the ACCENT Phase 2a trial has progressed well and in early June we reported 24 of 26 patients had been recruited.
• The inaugural meeting of the Company’s Clinical Advisory Board was held.
Operations Update
Clinical Development
The strategic priority for the company over the last quarter has been timely execution of the Phase 2a portion of the ACCENT trial in pancreatic cancer. The ACCENT clinical trial explores the safety, tolerability, and most importantly, efficacy of the Company’s best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy drugs gemcitabine and Abraxane, in newly diagnosed patients with advanced pancreatic cancer.
The Company reported dosing the first patient in the Phase 2a ACCENT trial in January this year using the dose identified from the Phase 1b trial. In March 2024, the Company reported that 11 patients had been dosed in the Phase 2a trial at that time, and in June we reported that 24 patients of the 26 required had been recruited to the trial.
The Phase 2a stage of the ACCENT trial is open at six sites in Australia-in Melbourne, Sydney and Brisbane-and at five hospitals in the Republic of Korea, in and around the capital Seoul. Korea was chosen as a second country in which to conduct the trial given the excellent medical and clinical trial facilities and capabilities in the country.
The Phase 2a trial is being conducted using Simon’s Two-Stage Design, a commonly used method for Phase 2 clinical trials. The trial design was chosen as it can result in efficient determination of whether a new drug has sufficient promise to warrant further development. In the ACCENT trial, the first stage consists of efficacy assessment in a group of 26 patients where a confirmed complete or partial response in six (6) patients in considered sufficiently promising to warrant continuation of the trial. In the second stage of the trial an additional 24 patients will be enrolled, giving a total of 50 patients. The decision about the drug’s efficacy is made based on the combined results of both stages.
It is important to note that the formal term ‘confirmed partial response’ means that there is at least a 30% reduction in the overall size of tumour lesions, sustained over a two-month period, with no new tumour lesions. Given that the ACCENT trial is focused on patients with advanced pancreatic cancer, a >30% reduction in tumour size represents a significant therapeutic response in this aggressive disease. In the Phase 1b stage of the ACCENT trial completed in October last year, we reported that six out of the fourteen patients on the trial recorded a partial response.
In April we presented a poster with updated analysis of data from the ACCENT Phase 1b trial at the world’s foremost scientific meeting in cancer research, the annual meeting of the AACR (Free AACR Whitepaper). In addition to the excellent response rate observed for the fourteen patients on the trial, significantly higher than predicted from historical studies of gemcitabine and Abraxane treatment alone, we also presented data showing there was a clear dose-dependence in response, where four of the six partial responses observed were from the highest dosing cohort. This, combined with other data, strongly suggests that the responses observed are related to effects from the drug narmafotinib. This data was subsequently published in the abstracts for the annual ASCO (Free ASCO Whitepaper) meeting in May. During the conference, the inaugural meeting of the Company’s Clinical Advisory Board was also held to discuss the ACCENT trial progress, as well as strategy and plans for additional trials of narmafotinib in pancreatic cancer. The CAB consists of five world-class clinical oncologists, with expertise in pancreatic cancer from Australia, the US and Canada.
Financial update
Amplia finished the June 2024 quarter with cash of $4.8 million (March 2024: $3.4million). During the quarter, the Company had net operating cash outflows of $2.5 million in relation to operating activities (March 2024: $2.0 million outflow).
Operating cashflows included:
• Outflows of $0.7 million for staff and administration/corporate costs; and
• Outflows of $1.8 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the Phase 1b/2a clinical trial for narmafotinib (AMP945).
During the quarter the Company undertook a two for five, fully underwritten pro-rata nonrenounceable Entitlement offer and raised $4.27m (before costs) receiving significant support from new and existing institutional investors and the Company’s Directors.
Payments to Related Entities
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $112,500 and relate to paymentsto the CEO/Managing Director in line with employment contracts and payments to the Non-Executive Directors.
Outlook and future activities
The Company will continue to focus on timely execution of the Phase 2a portion of the ACCENT trial. Additional clinical opportunities for narmafotinib, including a potential clinical trial in ovarian cancer, are also being actively explored.