TransThera Sciences (Nanjing), Inc. (HKEX: 2617) and Shanghai Allist Pharmaceuticals Co., Ltd. (SSE: 688578) have entered a clinical trial collaboration and supply agreement to run a Phase II study combining TransThera’s dual AXL/FLT3 inhibitor TT-00973-MS with Allist’s third-generation EGFR tyrosine kinase inhibitor firmonertinib mesylate in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR-sensitive mutations. Under the agreement, TransThera will sponsor and fund the Phase II study, while Allist will supply firmonertinib free of charge. Financial terms were not disclosed.
Deal context
TT-00973-MS is described by TransThera as an internally developed dual inhibitor of AXL and FLT3 receptor tyrosine kinases. AXL upregulation is a documented mechanism of acquired resistance to EGFR-targeted therapy in NSCLC, and preclinical data cited by the company show activity in AXL-overexpressing xenograft models. TransThera completed a Phase I trial of TT-00973-MS in patients with solid tumors as of December 31, 2025, reporting tolerability and responses in some patients; no detailed efficacy or pharmacokinetic data were disclosed in the announcement.
Firmonertinib mesylate is a third-generation EGFR-TKI developed by Allist, positioned in the same class as osimertinib. The drug holds Breakthrough Therapy Designation from both China’s National Medical Products Administration and the US FDA across several EGFR mutation subtypes, including exon 20 insertion mutations and EGFR PACC mutations. The combination rationale is mechanism-based: firmonertinib suppresses EGFR-driven tumor growth while TT-00973-MS targets the AXL pathway that commonly mediates escape from EGFR inhibition.
The planned Phase II study is multi-center and open-label. Both parties have indicated intent to use Phase II results as the basis for deciding whether to jointly advance a Phase III trial, though no formal option rights or financial terms for that potential next stage have been defined.
TransThera has pursued a broader strategy of testing its kinase inhibitors in combination regimens across multiple tumor types. The company dosed the first patient in a Phase II trial of tinengotinib combined with fulvestrant in previously treated HR+/HER2-negative relapsed or metastatic breast cancer in March 2026, and in the same month received Phase II approval for tinengotinib combined with novel hormone therapy in metastatic castration-resistant prostate cancer in China. In April 2026, the company dosed the first patient in a confirmatory Phase III trial of tinengotinib monotherapy for advanced cholangiocarcinoma.
Industry and transaction context
The scientific premise of pairing an AXL inhibitor with an EGFR-TKI to address resistance has attracted attention across the industry. Bemcentinib, an AXL inhibitor developed by BerGenBio, has been evaluated in combination with osimertinib in EGFR-mutant NSCLC in investigator-led studies, though that program has not advanced to a pivotal trial. The TT-00973-MS program is differentiated by its dual AXL/FLT3 profile, though the clinical relevance of FLT3 inhibition in this NSCLC context is not established in published literature independent of TransThera’s materials.
The EGFR-TKI combination space in China has seen sustained activity. Innovent Biologics (HKEX: 01801) and ASK Pharma received NMPA approval for limertinib, another third-generation EGFR-TKI, for first-line NSCLC treatment in April 2025, illustrating the competitive density of the class in China. Hansoh Pharma (HKEX: 03692) also received Breakthrough Therapy Designation from the NMPA for its fourth-generation EGFR-TKI HS-10504 in May 2026, reflecting continued investment in next-generation agents designed to address resistance to current third-generation drugs. That competitive context reinforces the rationale for combination strategies that target resistance mechanisms in parallel with EGFR inhibition, rather than relying on sequential monotherapy switching.
This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/
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