Amplia Therapeutics Ltd.

Highlights

• Results from the Phase 2a ACCENT trial in pancreatic cancer have been presented at the specialist conference ASCO Gastrointestinal Cancer Symposium
• Updated data analysis continues to show that Narmafotinib combination compares favourably with gemcitabine and Abraxane combination alone.

Key Highlights from the Quarter

• Further promising developments from the ongoing ACCENT trial of narmafotinib in metastatic pancreatic cancer were presented, including additional confirmed responses and an interim median Progression Free Survival figure of 7.6 months. This latter result is a 2-month improvement on historical data for chemotherapy alone.
• Ethics approval was obtained in Australia for the new trial of narmafotinib, investigating a combination with the chemotherapy FOLFIRINOX, and the first patients in this trial have been dosed.
• A key patent protecting narmafotinib has been allowed by the US Patent and Trademarks Office.
• Completion of a capital raise of A$27.5 million (before costs), funding the company into 2027.

Release Highlights:

• Amplia Therapeutics (ASX: ATX) announced that a patient in its ACCENT trial for metastatic pancreatic cancer achieved a pathological complete response (pCR), an extremely rare outcome indicating no remaining cancer cells following surgical removal of tumors.
• This result followed a significant reduction in the size and number of liver metastases and the primary pancreatic tumor after treatment with Amplia’s FAK inhibitor narmafotinib combined with gemcitabine and Abraxane, prompting a change in treatment to include surgery.
• The ACCENT trial, now in its second phase, continues to assess efficacy, safety, and survival outcomes across sites in Australia and South Korea, with narmafotinib being positioned as a promising therapeutic candidate in fibrotic cancers like pancreatic cancer.

Release Highlights:

Watch CEO, Dr Chris Burns and COO, Dr Rhiannon Jones, discuss what has been happening at Amplia Therapeutics this month here: https://www.youtube.com/watch?...

• Amplia Therapeutics (ASX: ATX) continues to participate in key global oncology and biotech meetings, including at Bio Korea in Seoul and ASCO in Chicago, where the company has presented updated data from its ACCENT trial and received strong interest and encouragement from the medical and investor communities.
• The ACCENT trial of narmafotinib combined with chemotherapy in pancreatic cancer patients has achieved its pre-set goal of 15 partial responses, with over 20 patients still ongoing and more data expected soon; a second trial involving a different chemo combination is in the startup phase with ethics submissions underway.
• Amplia released its FY23–24 annual report and latest quarterly shareholder update, both now accessible via their newly launched website where investors can subscribe to updates and submit questions to the team.

Release Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) is pleased to announce the appointment of Dr. Jason Lickliter as Chief Medical Officer role. alongside his role at Nucleus Network, a leading phase 1 clinical trials organization. The appointment comes at a pivotal time as Amplia prepares for the release of critical data from the ACCENT Phase 2a trial and progresses plans to launch a new Phase 1b/2a clinical trial combining narmafotinib with a modified FOLFIRINOX chemotherapy regimen
• Dr Jason Lickliter began his involvement with Amplia Therapeutics in 2021 as a clinical adviser. In this capacity, he chaired the company’s clinical trial safety committee and provided key guidance on the design and implementation of the Phase 1 trial of narmafotinib (AMP945) in healthy volunteers, as well as offering continued input into the ongoing ACCENT trial evaluating narmafotinib in patients with advanced pancreatic cancer.
• Amplia’s lead drug candidate narmafotinib (AMP945), a highly selective focal adhesion kinase (FAK) inhibitor, has shown promising preclinical results and successfully completed a healthy volunteer study and Phase 1b dose-finding study in pancreatic cancer patients. The compound is currently under evaluation in the Phase 2a portion of the ACCENT trial to assess efficacy, and preparations are well underway to initiate a US and Australian Phase 1b/2a trial of narmafotinib combined with modified FOLFIRINOX under an open Investigational New Drug (IND) approval from the US FDA.