Ifebemtinib

Ifebemtinib in combination with garsorasib in NSCLC showed ORR of 90.3% and DCR of 96.8% Ifebemtinib is a highly selective, orally administered, focal adhesion kinase inhibitor with significant synergies with a broad spectrum of therapeutic modalities NANJING, China, May 30, 2024 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against tumor-treatment resistance and metastasis, today announced results from the Phase Ib/II clinical trial of ifebemtinib, the company's focal adhesion kinase (FAK) inhibitor, in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation, for the first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation. These results will be featured in a poster presentation (Abstract: 8605 | Poster #469) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL. As of the cutoff date of May 10, 2024, a total of 33 subjects were enrolled in the study. Among the 31 evaluable patients, the antitumor responses were assessed and summarized as follows: The objective response rate (ORR) was 90.3% (95% CI: 74.3, 98.0), and the disease control rate (DCR) was 96.8% (95% CI: 83.3, 99.9). A total of 28 partial responses (PRs) and two stable diseases (SDs) were reported. Twenty-six out of 28 PRs were confirmed thus far. The data for median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) are still maturing. The overall safety profile of the combination of ifebemtinib with garsorasib is consistent with either ifebemtinib or garsorasib monotherapy. Most treatment-related adverse events (AEs) were Grade 1 or 2, and some Grade 3 AEs were reported. "The objective responses in patients exceeded our initial expectations. The combination regimen was well tolerated with known, non-overlapping, and manageable AEs from both agents," said Zhengbo Song, M.D., Associate Professor, Director of Phase 1 Unit, Zhejiang Cancer Hospital, University Chinese Academy of Sciences and Principal Study Investigator. "These data warrant further investigation to assess the potential of ifebemtinib to impact the future standard of care for KRAS G12C mutant-driven NSCLC, with or without immunotherapies in the combination regimen." "We are highly encouraged by the results of the current clinical study of ifebemtinib in NSCLC. RAS mutations account for approximately 30 percent of all cancer patients, and KRAS mutations, including the G12C mutation, wreak havoc in many people with solid tumors, including lung, pancreatic, and colorectal cancers," stated James McLeod, M.D., Chief Medical Officer of InxMed. "With recent rapid advances in KRAS G12C inhibitors comes the need for further improving clinical responses and safety/tolerability profiles of treatment regimens. We have studied FAK tumor biology and designed the combination therapy with KRAS inhibitors based on our deep understanding of FAK's roles in the tumor defense mechanism. We are pleased to see that ifebemtinib significantly amplifies the clinical responses of the combination regimen." Dr. McLeod added, "The current data set, albeit early with PFS and DOR data, is still maturing but is consistent with the results from our clinical trials in other tumor types. These initial findings demonstrate the potential of ifebemtinib to become an anchor component in combination regimens with chemotherapies, targeted therapies, or immunotherapies. We will continue further exploring the clinical utility of ifebemtinib in combination therapy and certainly welcome collaborations with global leaders in cancer therapies." About Ifebemtinib Ifebemtinib (IN10018, BI853520) is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, ifebemtinib has demonstrated therapeutic synergies with chemotherapy agents, targeted therapies, and immunotherapies. InxMed is currently pursuing a registrational trial in platinum-resistant ovarian cancer in China, and multiple proof-of-concept trials are ongoing in lung, colorectal, melanoma, and pancreatic cancers, with select tumor types to progress into pivotal clinical trials. Thus far, more than 600 patients have been treated with ifebemtinib, and a favorable safety and tolerability profile was observed. Ifebemtinib was granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track designation from the U.S. Food and Drug Administration (FDA). InxMed plans to submit a New Drug Application to the NMPA in early 2025. About InxMed InxMed Co. Ltd is a clinical-stage biotech company developing innovative therapies against tumor treatment resistance and metastasis. Established in 2018, InxMed has built an efficient engine for clinical translational research driven by an in-depth understanding of disease biology. InxMed's pipeline includes several compounds targeting tumor defense mechanisms with highly differentiated therapeutic candidates. For more information, visit en.inxmed.com. SOURCE InxMed Ltd

NANJING, China, Dec. 19, 2023 /PRNewswire/ -- InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies against drug resistance, and Escugen, a clinical-stage antibody–drug conjugate (ADC) company, today announced that InxMed licensed EZWi-Fit® linker-payload platform from Escugen for the development of the next generation tumor-associated antigens (TAAs) targeting ADCs. The license agreement provides InxMed with right to use EZWi-Fit® platform on the several novel ADC candidate molecules. InxMed will have the right for development, manufacturing, and commercialization of these ADC candidate molecules. InxMed is developing next generation TAAs targeting ADCs with significant improvement of efficacy and therapeutic window. Meanwhile, the company is developing solutions to boost ADC's efficacy including enhancing ADC penetration via FAK inhibitor and developing stroma targeting ADC to create synergy. InxMed is positioned to invent next generation ADCs, with the attributes to be more tumor selective and potent, and broad combination potential. The novel antibodies discovered by InxMed to be equipped with payload from EZWi-Fit®platform will be one of key differentiations. About InxMed InxMed is a clinical-stage biotech company established in the end of 2018. The company dedicates on developing innovative therapies against tumor resistance and metastasis. InxMed is committed to build an efficient engine for clinical translational science and proof of concept platform driven by in-depth understanding of disease biology. InxMed has translational medicine and clinical teams at Nanjing，Shanghai and Beijing in China, and has team members located in the United States, Canada and Australia. Through its own discovery research and development, and collaborative research and development, InxMed has built a highly differentiated, and intrinsic synergistic pipeline. InxMed has completed several rounds of financing totaling more than 100 million US dollars raised. Its first developing drug, IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), received Fast-track Designation from the U.S. Food and Drug Administration and Breakthrough Therapy Designation from the China National Medical Products Administration against platin resistant ovarian cancer. The pivotal clinical trial is ongoing. About EZWi-Fit ® EZWi-Fit® is the State-of-the-Art ADC platform technology invented by Escugen with the global IP rights. It couples a potent Topoisomerase I inhibitor with high and homogeneous drug-antibody ratio (DAR) to the antibody with a stable cleavable linker. The proprietary chemical modification of the linker not only confers the conjugates with excellent hydrophilicity, but also minimizes the de-conjugation of the linker-payload. Outstanding Pharmacokinetic features so derived provides ADC with substantial in vivo efficacy, which is superior to that of GGFG-Dxd ADC in multiple CDX and PDX models, involving different targets and antibodies. Great By-stander Effect of the linker-payload warrants specific and significant efficacy in various low affluence and high heterogenicity target expressing tumor models, which is even resistance to MMAE and Dxd ADC. The EZWi-Fit® derived ADC is well tolerated in the Non-Human Primate toxicology studies, without reaching the Maximum Tolerable Dose (MTD) at 60-80 mg/kg. With this edge-cutting technology, Escugen is quickly expanding the Frist-in-Class ADC pipeline to satisfy the unmet medical needs. About Escugen Escugen was founded in 2017，focusing on the development of innovative Antibody Drug Conjugates (ADC) for cancer therapy. The founders of Escugen are veterans of biotech industry, with rich working experience gained in the leading companies of both China and the US. The expertise of its research team covers antibody discovery, bio-conjugation, process development, quality research, preclinical and clinical studies. The most advanced project, ESG401, currently in PhIb/II clinical trials, is a TROP-2 ADC that uses an innovative stable cleavable linker designed for significant reduction of the off-target toxicity. Topoisomerase I inhibitor is the payload, with the Drug-Antibody Ratio (DAR) at 8 homogeneously. Clinical data shows that the tolerable dose of ESG401 is remarkably greater than that of other ADCs to the same target. The incidence of the Off-target toxicity, such as neutropenia, is low and mild, and no diarrhea greater than Grade 3 has been reported. The On-target Off-tumor toxicity, such as stomatitis, was rare. In the patients with heavily treated metastatic triple-negative and HR+/Her-2- breast cancer, promising evidence of efficacy has been observed, including the regression of the visceral and intracranial metastatic lesions. SOURCE InxMed Co., Ltd