narmafotinib (AMP945) / Amplia Therap, Cancer Therapeutics CRC - LARVOL DELTA

Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel in first-line patients with advanced pancreatic cancer (ACCENT trial) a Phase 1b 2a study-Interim analysis (AACR 2026) - P1/2 | "Narmafotinib combined with Gem/NabP met its primary efficacy endpoint whilst having a limited impact on the overall safety and tolerability of chemotherapy. Given narmafotinib is dosed intermittently in this study (12/28 days per cycle), and noting its favorable safety and tolerability profile, subsequent studies including pivotal trials will utilise daily dosing, which may further enhance efficacy."

Clinical • Combination therapy • Metastases • P1/2 data • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel as first-line treatment for patients with metastatic pancreatic cancer (ACCENT trial): Phase 2a results. (ASCO-GI 2026) - P1/2 | "Narmafotinib combined with Gem/NabP was associated with manageable toxicity and the P2a study met its primary efficacy endpoint. OS data is awaited and further studies are planned."

Clinical • Combination therapy • Metastases • P2a data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Phase 1b/2a of narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel (Abraxane) standard of care as first-line therapy in patients with advanced pancreatic cancer (ACCENT trial): interim analysis (AACR 2024) - P1/2 | "Based on this promising Phase 1b data, 400 mg of narmafotinib has been selected for RP2D and the trial will proceed through Simon's Two Stage design and enrol up to 50 patients as part of the Phase 2 expansion cohort."

Clinical • Combination therapy • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Amplia Therapeutics and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) have finalised the clinical trial protocol for the planned PRROSE Phase 2 ovarian cancer study, marking an important milestone toward study commencement. (Amplia Therapeutics Press Release) - "The PRROSE trial will investigate Amplia’s FAK inhibitor, narmafotinib, in combination with standard-of-care chemotherapy in women with high-grade serous ovarian cancer whose tumours demonstrate a poor response to chemotherapy prior to planned interval debulking surgery. Next steps: ethics and site governance submissions will now be progressed; site activation and patient recruitment are planned before the end of 2026."

Clinical protocol • Ovarian Cancer

Amplia Therapeutics will partner with US drug maker Eli Lilly & Company on a Phase 1b/2b clinical trial to assess the combination of Amplia’s investigational focal adhesion kinase (FAK) inhibitor narmafotinib with Eli Lilly’s investigational KRAS G12C inhibitor olomorasib (Small Caps) - "The companies have entered an agreement that will see Eli Lilly’s in-kind supply of olomorasib for the trial evaluate the safety and efficacy of the novel targeted therapy combination as a second-line treatment in patients with advanced stage non-small cell lung cancer (NSCLC)....Amplia will commence work in late 2026 at sites in Australia and the US, with both companies moving towards finalising the clinical study protocol and associated documents....The new trial will build on promising clinical data from Amplia’s ACCENT study..."

Licensing / partnership • New trial • Non Small Cell Lung Cancer

Amplia Therapeutics Limited…announces that a scientific manuscript detailing extensive preclinical studies of narmafotinib in pancreatic cancer has been made publicly available on the biology preprint server bioRxiv… (Amplia Therapeutics Press Release) - "Key findings reported in the manuscript include: (i) Reduction of tumour fibrosis , a hallmark of pancreatic cancer that contributes to treatment resistance and impaired drug delivery; (ii) Enhanced anti-tumour activity when combined with chemotherapy across multiple preclinical pancreatic cancer models; (iii) Reduced cancer dissemination and metastatic spread in a model of metastatic pancreatic cancer..."

Preclinical • Pancreatic Cancer

ACCENT: AMP945 in Combination With Nab-paclitaxel and Gemcitabine for Treatment of Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=62 | Active, not recruiting | Sponsor: Amplia Therapeutics Limited | Trial completion date: May 2026 ➔ Feb 2027 | Trial primary completion date: May 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Amplia Announces Publication of New FAK Inhibitor Patent Application (GlobeNewswire) - "The patent application further expands Amplia’s FAK intellectual property portfolio and, if granted, would provide protection for the novel molecules described, and their use, out to 2046. Amplia’s patent portfolio covers its lead drug narmafotinib, currently in clinical trials for pancreatic and ovarian cancer, and a second drug candidate (AMP886) being investigated in preclinical studies. The new patent application describes additional chemical compounds closely related to narmafotinib that also demonstrate potent and selective activity against FAK."

Patent • Ovarian Cancer • Pancreatic Cancer

Amplia Therapeutics Limited…announces that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen (Amplia Therapeutics Press Release) - "The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients....The study will enrol patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027....New Phase 2b study builds on compelling Phase 1b/2a ACCENT study data to lay foundation for Phase 3 registrational study."

New P2b trial • Pancreatic Cancer

Amplia Therapeutics Limited…and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) announces that they have entered into an agreement to conduct a new clinical study investigating the Company’s lead drug narmafotinib in ovarian cancer (Amplia Therapeutics Press Release) - "The study is an investigator-initiated clinical trial led by Dr Gwo Yaw Ho of Monash Health and Monash University, and sponsored and coordinated through ANZGOG....The study is expected to enrol approximately 15–20 patients with high-grade serous ovarian cancer (HGSOC) who demonstrate poor response to up-front standard-of-care platinum-based chemotherapy prior to planned interval debulking surgery. The trial, to be called the PRROSE trial, will evaluate the safety of narmafotinib in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) in this patient population."

New trial • High Grade Serous Ovarian Cancer

A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=67 | Active, not recruiting | Sponsor: Amplia Therapeutics Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Future Outlook (Amplia Therapeutics Press Release) - "The ACCENT and AMPLICITY trials are ongoing and further updates will be reported as significant findings become available. Planning for new clinical studies with narmafotinib is well underway, including the registration-enabling study of narmafotinib in combination with gemcitabine and Abraxane."

New trial • Trial status • Pancreatic Ductal Adenocarcinoma

Co-treatment with FAK and PARP inhibitors for the treatment of homologous recombination-proficient high grade serious ovarian cancer (AACR 2026) - "HRD cancers are treated with PARP inhibitors (e.g. Niraparib) while HRP cancers are treated with bevacizumab, an anti-angiogenesis agent. FAK inhibition through treatment with narmafotinib impacts PARP1 protein expression, cleavage, and overall PARylation levels, implicating functional interaction between FAK and PARP pathways within the cell. These results provide an unexpected avenue to evaluate PARP inhibition as a viable therapy for HRP tumors."

High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • HRD

Amplia Therapeutics limited…announces that an oral presentation highlighting mature data from the Company’s ACCENT trial in metastatic pancreatic cancer is being delivered today at the annual meeting of the AACR (Amplia Therapeutics Press Release) - "The key points from the presentation are:...(i) Independent (central) reading of data identified 5 confirmed Complete Responses (CR’s) from 64 patients, an 8% CR rate compared to a 0.2% rate for chemotherapy alone; (ii) A response rate of 36% is observed (23 of 64 patients); 42% if unconfirmed responses included; (iii) A Disease Control Rate (DCR) of 70% was determined, compared to 50% for chemotherapy alone; (iv) Median overall survival (mOS) was found to be 11.1 months, while median progression-free survival (mPFS) was 7.7 months, both showing improvements of over two months compared to chemotherapy alone."

P1/2 data • Pancreatic Cancer

Narmafotinib (AMP945) in combination with gemcitabine and nab paclitaxel in first-line patients with advanced pancreatic cancer (ACCENT trial) a phase 2a study: Interim analysis (AACR 2025) - P1/2 | "Preliminary Part B analysis on the initial 26 patients showed narmafotinib to be safe and well-tolerated with promising signs of efficacy."

Clinical • Combination therapy • Metastases • P2a data • Oncology • Pancreatic Cancer • Solid Tumor

Amplia Therapeutics has halted further recruitment in its AMPLICITY trial in advanced pancreatic cancer, after three dose-limiting toxicities were linked to the chemotherapy regimen mFOLFIRINOX rather than to its lead drug narmafotinib (TipRanks) - "Eight patients have been treated so far, with five remaining on study and continuing to receive the narmafotinib–mFOLFIRINOX combination under ongoing safety monitoring. The company said the decision reflects both the recognized toxicity profile of FOLFIRINOX and an anticipated shift in clinical practice towards less aggressive chemotherapy regimens. Amplia will focus resources on its ACCENT trial, where narmafotinib combined with gemcitabine and Abraxane has already delivered a 36% response rate and reported interim progression-free survival of 7.7 months, potentially strengthening its position in the evolving pancreatic cancer treatment landscape."

Adverse events • Trial suspension • Pancreatic Cancer

Amplia Therapeutics Reports Four Additional Complete Responses and Improved Overall Survival Data in ACCENT Pancreatic Cancer Trial (Amplia Therapeutics Press Release) - "The data confirm that five (5) patients have achieved a complete response (CR) in the Phase 1b/2a trial of narmafotinib combined with chemotherapy resulting in an unprecedented rate of CRs of 7.8% (5/64). A median Overall Survival of 11.1 months has also been determined which is a 2 month improvement compared to chemotherapy alone, with no additional toxicity burden. The Company has been chosen to present trial data at the prestigious annual meeting of the American Association of Cancer Research (AACR) being held in April 2026..."

P1/2 data • Pancreatic Cancer

Poster Presentation Demonstrating Combination Benefit of Narmafotinib in Preclinical KRAS-Mutated Cancer Models (Amplia Therapeutics Press Release) - "Data...was presented at the AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics....Data showing narmafotinib activity in preclinical models of pancreatic cancer, lung cancer and ovarian cancer are presented....In particular, the data indicates that narmafotinib blocks resistance pathways that can emerge with kRAS inhibitor treatment, thereby enhancing efficacy and durability of response."

Preclinical • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer

AMPLIA RECEIVES R&D TAX REBATE TOTALLING $3.77 MILLION (Amplia Therapeutics Press Release) - "The refund relates to expenditure incurred in R&D activities associated with the Company’s FAK inhibitors, narmafotinib (AMP945) and AMP886....The funds will contribute to the further progression of both the ACCENT and AMPLICITY clinical trials of narmafotinib along with additional supporting R&D activities."

Commercial • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Amplia Therapeutics Limited…announces that Amplia’s COO Dr.Rhiannon Jones is presenting today at the Emergence 2026 conference (Amplia Therapeutics Press Release) - "The presentation outlines recent progress from the Company’s ACCENT clinical trial in pancreatic cancer and outlines forthcoming development milestones."

P1/2 data • Pancreatic Cancer

Amplia Therapeutics Announces Opening of US Sites for AMPLICITY Pancreatic Cancer Trial (Amplia Therapeutics Press Release) - "The two sites - University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) - join the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues."

Trial status • Pancreatic Cancer

Future Outlook (Amplia Therapeutics Press Release) - "Over the coming months mature data will become available from the ACCENT trial, whilst progress with the AMPLICITY trial will also be announced. Additional preclinical data, including from the Next & Bio collaboration, will also be disclosed demonstrating new opportunities for narmafotinib in the treatment of pancreatic and other cancers."

P2a data • Preclinical • Trial status • Pancreatic Ductal Adenocarcinoma

Narmafotinib Large-Scale Manufacture Complete (Amplia Therapeutics Press Release) - "Successful completion of the first large-scale manufacture of narmafotinib which produced approx. 13 kg of drug. Successful transition of process and production from an R&D facility to a commercial manufacturing environment - a key step in Phase-3 readiness. Sufficient drug supply to support Amplia’s pancreatic cancer trials and other planned studies, supporting the Company's clinical development pipeline."

Commercial • Pancreatic Cancer

Amplia Showcases Promising Pancreatic Cancer Data for Narmafotinib at ASCO GI (TipRanks) - "The trial, which evaluates narmafotinib in combination with standard chemotherapies gemcitabine and Abraxane, shows a progression-free survival of 7.7 months versus 5.5 months for chemotherapy alone and an overall response rate of 35%, rising to 42% including unconfirmed responses, while maintaining a safety profile comparable to chemotherapy alone."

P2a data • Pancreatic Cancer

Amplia Therapeutics to Present at 2026 ASCO Gastrointestinal Cancers Symposium (The Manila Times) - "The poster, titled Narmafotinib (AMP945) in combination with gemcitabine and nab-paclitaxel as first-line treatment for patients with metastatic pancreatic cancer (ACCENT trial): Phase 2a results, will present updated data from the ongoing ACCENT trial. The full abstract will be published 5pm US ET, January 5th, 2026."

P2a data • Pancreatic Cancer