On July 31, 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 30 June 2023 (Press release, Amplia Therapeutics, JUL 31, 2023, View Source [SID1234633510]).
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Key Highlights from the Quarter
• Completion of Cohort 2 and currently dosing Cohort 3 in the Phase 1b stage of the ACCENT trial
• Reported exciting preclinical data showing AMP945 enhances the activity of an alternate treatment for pancreatic cancer called FOLFIRINOX, in a model of the disease
• Initiated a study with CSIRO to explore topical delivery of our FAK inhibitors for wound healing
• Announced the name narmafotinib for AMP945
Operations Update Clinical Development
The primary focus of the company continues to be the ACCENT clinical trial. This trial, in advanced pancreatic cancer patients, tests the activity of our FAK inhibitor AMP945 in combination with standard-of-care chemotherapy of gemcitabine and nab-paclitaxel (see ClinicalTrials.gov, identifier NCT05355298). The trial is in two phases: the first is a dose-escalation phase to identify an optimal dose of AMP945 that is safe and tolerable; and the second is a dose-expansion phase where activity of the optimal dose is determined in a larger patient group. We are recruiting patients at seven sites in Melbourne, Sydney and Brisbane and during the quarter completed dosing cohort 2, and are currently dosing patients in cohort 3, of the dose-escalation stage of the trial.
We anticipate moving to the Phase 2a dose escalation stage of the trial in the coming months and planning is well advanced to bring on additional sites in South Korea.
Non-clinical Development
Preclinical studies of AMP945 continue to explore additional opportunities for the drug. Over the quarter we reported exciting preliminary data from our collaborators at the Garvan Institute in Sydney that we disclosed at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in Chicago. This preclinical data demonstrates that AMP945 enhances the activity of an alternative treatment for pancreatic cancer called FOLFIRINOX, in a mouse model of the disease. The potential beneficial effects of AMP945 when combined with FOLFIRINOX is particularly exciting given that FOLFIRINOX is the standard treatment for pancreatic cancer in many countries, including the US.
This quarter we also reported initiation of a collaboration with CSIRO to investigate topical delivery of our FAK inhibitors to wounds and burns. This research builds on published work in the scientific literature showing that FAK inhibition can speed up wound healing and reduce scarring.
Finally, we announced in June that the World Health Organization has granted the international nonproprietary name (INN) narmafotinib for AMP945.
Financial update
Amplia finished the June 2023 quarter with cash of $7.8 million (March 2023: $9.3 million). During the quarter, the Company had net cash outflows of $1.4 million in relation to operating activities (March 2023: $1.3 million). Operating cashflows included outflows and inflows of:
• $0.8 million for staff and administration/corporate costs; and
• $0.6 million for research and development costs, which primarily related to Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the first stage of the Phase 1b/2a clinical trial for Narmafotinib (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 Narmafotinib.
Successful Research and Development Tax Incentive Advanced Overseas Finding (AOF) outcome
The Company received a positive outcome on the AOF that was pending at the time the Company submitted its FY23 Annual Report (30 May 2023). The positive outcome results in the Company expecting a further $1,260,024 for its Research and Development Tax Incentive refund for FY23, taking the total expected refund to $2,408,458.
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 payments to the CEO/Managing Director’s 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. Results from these studies will be reported in due course.