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Amplia Therapeutics - Quarterly Activities and Cash Flow Reports - December 2025
Globenewswire· 2026-01-30 13:45
Core Insights - Amplia Therapeutics Limited is making significant progress in the clinical development of its FAK inhibitor, narmafotinib, particularly for metastatic pancreatic cancer, with promising results from ongoing trials [2][3][17] Clinical Trial Updates - The ACCENT trial, which combines narmafotinib with gemcitabine and Abraxane®, has reported an overall response rate of 35%, significantly higher than the 23% response rate for chemotherapy alone [3][17] - The mean duration on trial for patients was 219 days, with some patients remaining on the study for over 12 months, indicating the drug's potential to halt cancer progression [4] - The AMPLICITY trial has commenced, investigating narmafotinib in combination with FOLFIRINOX chemotherapy, with patient recruitment ongoing in Melbourne and Sydney [6][7] Regulatory and Commercial Developments - Positive feedback from the US FDA has been received regarding the dose optimization strategy for narmafotinib, which supports its planned Phase 2b/3 trial [8] - A key patent for narmafotinib has been granted, extending protection until at least 2040 in the US and other jurisdictions [9] - Amplia has successfully uplisted to the US-based OTCQB Venture Market, enhancing its visibility and investor reach [10] Preclinical Studies - The second phase of a research collaboration with Next & Bio has been initiated, focusing on evaluating narmafotinib against patient-derived pancreatic cancer cells with specific genetic mutations [11] Financial Update - Amplia reported a cash position of $31.5 million at the end of December 2025, with net operating cash inflows of $2.4 million during the quarter [13] - The company received $3.8 million from government grants and tax incentives, while outflows included $0.9 million for staff and administration costs, and $0.9 million for research and development [14]
NARMAFOTINIB Large-Scale Manufactre Complete
Globenewswire· 2026-01-22 13:30
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 Melbourne, Australia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF ...
Amplia Enters into Second Agreement with Korean Specialist Drug Screening Company Next&Bio to Explore Combination Therapy with FAK Inhibitor and kRAS Inhibitors
Globenewswire· 2025-12-19 13:45
Core Insights - Amplia Therapeutics Limited has entered the second phase of a research collaboration with Next & Bio to further investigate the efficacy of its FAK inhibitors in treating pancreatic cancer [2][3][4] - The collaboration aims to explore the synergistic effects of Amplia's FAK inhibitor narmafotinib in combination with kRAS inhibitors, which target genetic mutations present in over 90% of pancreatic cancers [3][4][9] - Initial studies have shown that narmafotinib demonstrated promising activity against patient-derived pancreatic cancer cells, with plans to present this data at an upcoming scientific conference [3][6] Company Overview - Amplia Therapeutics is an Australian pharmaceutical company focused on developing a pipeline of FAK inhibitors for cancer and fibrosis, particularly in fibrotic cancers like pancreatic and ovarian cancer [7] - Narmafotinib (AMP945) is Amplia's leading FAK inhibitor, which has shown significant potential in preclinical studies and is currently undergoing clinical trials in combination with established chemotherapies [8][10] Collaboration Details - The partnership with Next & Bio, a preclinical drug screening company, leverages patient-derived cell models to provide more accurate and predictive results for pancreatic cancer treatment [5][6] - The collaboration is expected to enhance Amplia's strategic positioning for future partnerships and commercial growth opportunities [6]