On April 25, 2023 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 31 March 2023 (Press release, Amplia Therapeutics, APR 25, 2023, View Source;[email protected] [SID1234630494]).
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Key Highlights from the Quarter
• Review of available data from patients in Cohort 1 of the ACCENT trial of AMP945 in
pancreatic cancer, concluded that dose escalation to a further cohort was appropriate
• Recruitment of three patients into Cohort 2 of the ACCENT trial
• Presentations of data from preclinical and clinical studies of AMP945 in pancreatic cancer presented at two high-profile cancer conferences
Operations Update
Clinical Development
Amplia’s primary focus is progression of the Phase 1b/2a ACCENT clinical trial. This trial tests whether our best-in-class focal adhesion kinase inhibitor AMP945 enhances the efficacy of standard-of-care gemcitabine/nab-paclitaxel chemotherapy in frontline patients with advanced pancreatic cancer (see ClinicalTrials.gov under the identifier NCT05355298). The trial is recruiting patients at seven sites in Melbourne, Sydney and, most recently, Brisbane, and the rate of patient recruitment is meeting expectations. Opening of the Brisbane site at Greenslopes Medical Centre received considerable media attention increasing our ability to recruit patients into the trial. We have also made progress on a regulatory submission to South Korea which, if approved, will allow sites to be opened in that country that should further enhance recruitment rate in the Phase 2a portion of the trial.
During the Quarter, Amplia announced that review of available safety, pharmacokinetic and pharmacodynamic data from patients in Cohort 1 of the Phase 1b portion of the trial indicated that dose-escalation to a second patient cohort was warranted. Importantly, this second cohort of patients was recruited during the quarter. The clinical trial continues.
Non-clinical Development
Preclinical studies of AMP945, along with AMP886, Amplia’s second FAK inhibitor, are being undertaken with academic collaborators and contract research organizations to explore additional clinical potential for these drugs in cancer and fibrotic diseases. Results from some of these preclinical studies have been recently presented at separate top-tier cancer conferences, one in Australia and one in the US, to help raise the profile of the Amplia assets amongst researchers, clinicians and potential partners. A strategy day with the Board, key scientific advisers and Amplia staff, held during the quarter helped refine our preclinical plans, and data from these additional studies will be reported in due course.
Financial update
Amplia finished the March 2023 quarter with cash of $9.3 million (December 2022: $10.6 million).
During the quarter, the Company had net cash outflows of $1.3 million in relation to operating activities (December 2022: $1.1 million). Operating cashflows included outflows and inflows of:
• $0.7 million for staff and administration/corporate costs; and
• $0.7 million for research and development costs, which primarily related to Contract Research Organisation (CRO), manufacturing and other Chemistry, Manufacturing and Control (CMC) related costs incurred in relation to the first stage of the Phase 2 clinical trial for AMP945.
Research and development expenditure is forecast to increase in the coming quarters in line with the progression of Phase 1b/2a of the ACCENT clinical trial for AMP945.
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 $147,500 and relate to payments to the CEO/Managing Director
in line with employment contracts and payments to the Non-Executive Directors.
Outlook and future activities
Over the coming quarter, the Company expects to report further progress in the ACCENT trial as we finalise dose selection for the Phase 2 portion of the trial. Further progress on the regulatory submission to South Korea will also be reported.
Preclinical studies with AMP945 in additional cancer and non-cancer indications are underway to identify further clinical and commercial opportunities for the drug. Preclinical studies of Amplia’s
second FAK inhibitor, AMP886, are ongoing to identify optimal development pathways for this compound. Data generated from these studies will be communicated as they are received.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.