Additional Confirmed Response Reported as Part of Amplia Investor Presentation
MWN-AI** Summary
Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF) has announced encouraging results from the ongoing ACCENT trial concerning its best-in-class FAK inhibitor, narmafotinib, used in combination with conventional chemotherapies gemcitabine and nab-paclitaxel (Abraxane®) for treating metastatic pancreatic cancer. A new confirmed partial response (PR) brings the trial’s overall confirmed Objective Response Rate (ORR) to 35%, with a total of 19 responses out of 55 participants. This marks a significant improvement compared to the 23% ORR observed in the benchmark MPACT trial, which solely evaluated gemcitabine and nab-paclitaxel.
CEO Dr. Chris Burns showcased these findings during the Life Sciences Virtual Investor Forum on December 11, emphasizing the positive trajectory of the ACCENT trial. The drug narmafotinib is noted for its targeted inhibition of the Focal Adhesion Kinase (FAK) protein, which is overexpressed in pancreatic cancer, marking it as a valuable therapeutic target in oncology. The most recent data also includes an interim median progression-free survival (PFS) of 7.6 months, showcasing potential clinical benefits for patients.
Amplia is advancing its focus on fibrotic cancers beyond pancreatic cancer, which includes ovarian cancer, with FAK inhibitors. Additionally, the company has launched a second trial, AMPLICITY, exploring the synergistic effects of narmafotinib combined with FOLFIRINOX chemotherapy in advanced pancreatic cancer patients.
For further insights into Amplia's ongoing innovations, stakeholders can visit www.ampliatx.com, as well as follow the company on social media platforms. The latest results underline Amplia's commitment to improving outcomes in challenging cancer treatments, reinforcing its strategic position within the biotech sector.
MWN-AI** Analysis
Amplia Therapeutics Limited (ASX: ATX; OTCQB: INNMF) recently announced a positive development in its ongoing ACCENT trial for metastatic pancreatic cancer, with an additional confirmed partial response (PR) bringing the objective response rate (ORR) to 35%. This figure surpasses the 23% ORR established by the benchmark MPACT trial, indicating a potentially significant advancement in treatment efficacy.
Given these developments, Amplia presents an intriguing opportunity for investors. The combination of narmafotinib—a best-in-class FAK inhibitor—with established chemotherapies gemcitabine and nab-paclitaxel (Abraxane®) suggests enhanced therapeutic potential for patients who previously had limited options. The achievement of a confirmed response rate higher than historical benchmarks signals a possible competitive advantage in a market that is desperate for effective treatments for advanced pancreatic cancer, a notoriously difficult-to-treat disease.
Furthermore, the interim median progression-free survival (PFS) of 7.6 months reported in the trial may position Amplia favorably amongst peers. As more data is released and presented at events like the Life Sciences Virtual Investor Forum, market sentiment could see a positive shift, potentially driving the stock price higher.
For current investors and those considering entry into the market, monitoring the follow-up progress from both the ACCENT trial and the recently initiated AMPLICITY trial will be essential. Future announcements related to patient outcomes and the potential for expanded clinical applications will serve as key indicators of both the company’s trajectory and stock performance.
In conclusion, while challenges in the biotech sector are prevalent, Amplia’s recent success in its clinical trials positions it as a compelling investment opportunity worth tracking closely as results continue to emerge.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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**
How does the updated Objective Response Rate of 35% in the ACCENT trial for Amplia Therapeutics Ltd INNMF compare to other treatments in the metastatic pancreatic cancer landscape?
What are the potential implications of the confirmed partial responses in the ongoing ACCENT trial for the future development of narmafotinib by Amplia Therapeutics Ltd INNMF?
Can you elaborate on the significance of achieving a median progression-free survival of 7.6 months in the ACCENT trial for Amplia Therapeutics Ltd INNMF?
How does the FAK inhibitor narmafotinib differentiate itself from other current treatments based on the data presented for Amplia Therapeutics Ltd INNMF?
**MWN-AI FAQ is based on asking OpenAI questions about Amplia Therapeutics Ltd (OTC: INNMF).
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