On January 30, 2023 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new drug candidates 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 December 2022 (Press release, Amplia Therapeutics, JAN 30, 2023, View Source [SID1234626628]).
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Key Highlights from the Quarter
• Completion of recruitment of first cohort of patients into ACCENT Phase 2 clinical trial of AMP945 in pancreatic cancer;
• Encouraging data for AMP886 in a preclinical model of Acute Myeloid Leukemia (AML);
• Dr Christopher Burns appointed as CEO.
Operations Update
Clinical Development
During the Quarter, Amplia announced completion of enrolment of the first cohort of patients in the Company’s Phase 1b/2a ACCENT clinical trial of focal adhesion kinase inhibitor AMP945. The trial tests whether AMP945 enhances the efficacy of gemcitabine/nab-paclitaxel standard-of-care chemotherapy in frontline patients with advanced pancreatic cancer.
By the end of 2022, seven sites in Melbourne, Sydney and Brisbane had been opened to recruit patients into the ACCENT trial. To help raise the profile of the trial amongst pancreatic cancer specialists and oncologists, the company sponsored and attended the Australasian Gastro-Intestinal Trials Group (AGITG) Annual Scientific Meeting in Melbourne in November.
Non-clinical Development
Studies completed during the Quarter also showed that AMP886, Amplia’s second FAK inhibitor, may have utility in the treatment of acute myeloid leukemia (AML). In addition to inhibiting FAK, AMP886 also potently blocks activity of the two related kinases FLT3 and VEGFR3. The company has now shown that AMP886 inhibits AML in an industry-standard MV4-11 disease model carrying a common mutation in FLT3. Patients whose disease carries this mutation often have more rapid progression and significantly worse prognosis. Furthermore, in this model AMP886 enhances the efficacy of venetoclax, a drug approved to treat AML as part of combination therapy. Additional studies exploring the potential of AMP886 in AML and other cancers are underway.
Management
Dr Christopher Burns was appointed as CEO and Managing Director of Amplia Therapeutics on 5th December. Dr Burns was a founder of Amplia Therapeutics and has been a Board member since May 2018.
Financial update
Amplia finished the December 2022 quarter with cash of $10.6 million (September 2022: $11.7 million). During the quarter, the Company had net cash outflows of $1.1 million in relation to operating activities (September 2022: $1.1 million).
Operating cashflows included outflows and inflows of:
• $0.7 million for staff and administration/corporate costs; and
• $0.5 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 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 $172,929 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 In the coming quarter, the Company expects to report further progress in the ACCENT trial including updates on progression towards optimal dose selection. Work on a regulatory submission to South Korea is well advanced which, if approved, will allow sites to be opened that should further enhance recruitment rate.
Studies continue on the novel metabolite of AMP945 identified in samples from the Phase 1 clinical trial. The presence of the metabolite is not anticipated to impact timelines for the pancreatic cancer trial currently underway.
Non-clinical studies of Amplia’s second FAK inhibitor, AMP886, are ongoing to identify the best clinical opportunities for this compound. Additional non-clinical studies with AMP945 are also underway to explore and support clinical application of the drug in other oncology and non-oncology indications. 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.