Additional Confirmed Response Reported as Part of Amplia Investor Presentation

Rhea-AI Summary

Amplia Therapeutics (OTCQB:INNMF) reported an additional confirmed partial response in the ongoing ACCENT trial for metastatic pancreatic cancer, bringing the confirmed objective response rate to 35% (19/55).

The ACCENT trial tests narmafotinib combined with gemcitabine and nab-paclitaxel; the 35% ORR is presented alongside a historical benchmark ORR of 23% from the MPACT trial for gemcitabine and nab-paclitaxel alone. Updated ACCENT data were presented by CEO Dr Chris Burns at the Life Sciences Virtual Investor Forum on December 11 (US ET) / December 12 (AEDT), and the ASX announcement was authorised by the CEO.

Positive

• Confirmed ORR 35% (19/55) in ACCENT trial
• Additional confirmed partial response recorded in ACCENT
• Data presented at Life Sciences Virtual Investor Forum Dec 11–12, 2025

Negative

• ORR comparison is versus historical MPACT benchmark, not randomized control

HIGHLIGHTS

• An additional confirmed partial response has been recorded in the ongoing ACCENT trial
  
  
• This brings the confirmed Objective Response Rate to 35%
  
  
• Updated data to be presented at the Life Sciences Virtual Investor Forum

Melbourne, Australia, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), is pleased to announce that an additional confirmed partial response (PR) has been recorded in the ongoing ACCENT trial in metastatic pancreatic cancer. The trial investigates the combination of the Company’s best-in-class FAK inhibitor narmafotinib in combination with the chemotherapies gemcitabine and nab-paclitaxel (Abraxane®).

The additional PR brings the confirmed objective response rate (ORR) to 35% (19/55) which compares favourably to the ORR of 23% recorded for gemcitabine and nab-paclitaxel alone in the benchmark MPACT trial upon which ACCENT is based.

A presentation outlining the data from the ACCENT trial was presented by Amplia CEO Dr Chris Burns at the Life Sciences Virtual Investor Forum on Thursday December 11 at 3pm US ET (Friday December 12 7am AEDT).

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

About Amplia Therapeutics Limited

Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on X (@ampliatx) and LinkedIn.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumors. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has already achieved its primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.6 months has also been reported. A second trial – AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.

Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com 

U.S. Contact:
Robert Giordano
rjgiordano@ggrouplifesciences.com 
+1 917 327 3938

Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital 
+61 423 139 163

U.S. Media:
media@ampliatx.com

FAQ

What ORR did Amplia Therapeutics report for ACCENT trial (INNMF) on Dec 12, 2025?

Amplia reported a confirmed objective response rate of 35% (19/55) in the ACCENT trial.

How does ACCENT trial ORR for INNMF compare to the MPACT benchmark?

The ACCENT ORR of 35% compares to a 23% ORR reported in the benchmark MPACT trial.

When and where were Amplia's updated ACCENT trial data presented?

Updated ACCENT data were presented at the Life Sciences Virtual Investor Forum on Dec 11, 2025 (US ET) / Dec 12, 2025 (AEDT).

What treatment combination is being tested in the ACCENT trial reported by INNMF?

The trial tests the FAK inhibitor narmafotinib combined with gemcitabine and nab-paclitaxel (Abraxane).

How many confirmed responses underpin the reported 35% ORR in ACCENT?

The 35% ORR is based on 19 confirmed responses out of 55 evaluable patients.