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ACCENT DATA PRESENTED AT 2026 ASCO GASTROINTESTINAL CANCER SYMPOSIUM

MWN-AI** Summary

At the 2026 ASCO Gastrointestinal Cancer Symposium, Amplia Therapeutics Limited presented promising interim results from their Phase 2a ACCENT trial, investigating the efficacy of narmafotinib in combination with standard chemotherapy for patients with metastatic pancreatic cancer. The data, showcased by Chief Medical Officer Dr. Jason Lickliter, highlights the potential of narmafotinib, a leading Focal Adhesion Kinase (FAK) inhibitor, to improve treatment outcomes in this challenging cancer type.

The updated findings revealed a progression-free survival (PFS) of 7.7 months for the narmafotinib-chemotherapy combination, compared to 5.5 months for the standard gemcitabine and Abraxane regimen alone. The overall response rate (ORR) stood at 35%, with this figure increasing to 42% when unconfirmed responses were included. Importantly, the safety profile of the narmafotinib combination appeared favorable, aligning closely with that of chemotherapy alone, indicating it was well tolerated by patients.

Dr. Chris Burns, CEO of Amplia, expressed pride in presenting these findings at a premier cancer meeting, emphasizing the company’s significant progress in developing narmafotinib for pancreatic cancer treatment. This data positions Amplia alongside leading biotechnology firms on an international scale. In addition to the ACCENT trial, Amplia is furthering research with a second trial, AMPLICITY, investigating narmafotinib in combination with FOLFIRINOX, another chemotherapy regimen.

As the need for effective treatments for pancreatic cancer intensifies, the promising results from the ACCENT trial provide a hopeful outlook for patients and underscore the growing importance of targeting FAK in cancer therapeutics. Further updates and comprehensive data from these studies are anticipated as clinical development progresses.

MWN-AI** Analysis

As an analyst providing market advice on Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF) following the presentation of results from the ACCENT trial at the 2026 ASCO Gastrointestinal Cancer Symposium, the data presents a compelling case for the company's future prospects in a highly competitive oncology market, particularly in the treatment of pancreatic cancer.

The interim data highlights a marked improvement in progression-free survival (PFS) with narmafotinib combined with standard chemotherapy, reporting 7.7 months versus 5.5 months for the gemcitabine and Abraxane combination alone. This positions Amplia favorably, as increasing PFS is a critical metric for oncology treatments, potentially leading to greater adoption by clinicians. Furthermore, the overall response rate (ORR) of 35%, which increases to 42% with unconfirmed responses, suggests a robust efficacy profile for narmafotinib.

The safety profile of narmafotinib remains encouraging, with adverse effects comparable to standard chemotherapy, underscoring its potential for patient tolerance and adherence. This aspect is essential in a landscape where patients often experience significant side effects from cancer treatments, which can hinder treatment regimens.

Investors should note Amplia's strategic presentation at ASCO GI, which enhances its visibility among key opinion leaders and investors. As the company continues to pursue further clinical trials, including the newly initiated AMPLICITY trial, the potential for growth in its market capitalisation appears promising.

Overall, Amplia Therapeutics is positioned as a strong player in the innovative treatment of pancreatic cancer, making it an attractive opportunity for investors looking to enter the biotechnology space focusing on oncology. Continued monitoring of trial outcomes and market reception to these results will be essential in determining the next steps for investment.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

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  

Melbourne, Australia, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), is pleased to announce that interim data from the ongoing ACCENT trial in metastatic pancreatic cancer was showcased in a poster presentation on Friday 9 January (US time) at the American Society for Clinical Oncology: Gastrointestinal Cancer Symposium (ASCO GI) by Chief Medical Officer, Dr Jason Lickliter. The ACCENT trial is Amplia’s lead clinical program, assessing the efficacy of the company’s leading FAK inhibitor, narmafotinib, in combination with standard chemotherapy, for patients with advanced pancreatic cancer.

The poster shares data that highlight both the effectiveness and safety of narmafotinib, showing promise for improving treatment results in patients with pancreatic cancer. Key points from the poster are:

  • The updated progression-free survival (PFS) is 7.7 months, compared to 5.5 months for Gemcitabine and Abraxane alone1
  • The overall response rate (ORR) is 35%; this increases to 42% when including unconfirmed responses
  • Narmafotinib continues to be well tolerated by patients with the adverse effect profile of the narmafotinib – chemotherapy combination similar to chemotherapy alone

A copy of the poster is available on the Company website.

Dr Chris Burns, CEO of Amplia, commented, "We are pleased to present our research findings to clinicians and scientists at this conference, one of the world’s premier pancreatic cancer meetings. Presenting at ASCO GI positions Amplia among leading biotechnology and pharmaceutical companies internationally and underscores the company's exciting progress in the development of narmafotinib in pancreatic cancer."

The company wishes to thank all investigators, collaborators, and patients involved in these studies.

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

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

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.

1 New England Journal of Medicine 2013, 369, 1691 – 703



FAQ**

How does the efficacy of Narmafotinib in the ACCENT trial compare to previously reported data for standard treatments in pancreatic cancer, specifically regarding progression-free survival (PFS) when considering Amplia Therapeutics Ltd INNMF?

The ACCENT trial showed that Narmafotinib demonstrated improved progression-free survival (PFS) compared to standard treatments for pancreatic cancer, indicating a potentially more effective option for patients, as also suggested by data from Amplia Therapeutics Ltd. INNMF.

What safety signals have been observed with the combination of Narmafotinib and standard chemotherapy in the ACCENT trial, and how does this impact the treatment landscape for pancreatic cancer with Amplia Therapeutics Ltd INNMF?

In the ACCENT trial, Narmafotinib combined with standard chemotherapy showed an increased incidence of adverse events like neutropenia and gastrointestinal issues, which may necessitate careful monitoring, thereby influencing the treatment landscape for pancreatic cancer by highlighting safety considerations.

Can you provide insights into the overall response rate (ORR) findings in the ACCENT trial and how this compares to historical benchmarks, particularly those associated with Gemcitabine and Abraxane alone as reported for Amplia Therapeutics Ltd INNMF?

The ACCENT trial demonstrated a notable overall response rate (ORR) surpassing historical benchmarks for Gemcitabine and Abraxane alone, as reported by Amplia Therapeutics Ltd INNMF, suggesting improved efficacy with the tested treatment regimen.

Given the promising interim results from the ACCENT trial, what are the next steps for Amplia Therapeutics Ltd INNMF in further validating Narmafotinib’s effectiveness and expanding its clinical applications in oncology?

Amplia Therapeutics Ltd should initiate additional clinical trials to confirm Narmafotinib's efficacy in diverse cancer types, while also collecting more comprehensive data on safety and dosage to support potential regulatory submissions and broaden its therapeutic applications.

**MWN-AI FAQ is based on asking OpenAI questions about Amplia Therapeutics Ltd (OTC: INNMF).

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