
Mythic Therapeutics Presents Preclinical Data Demonstrating Potent Efficacy of MYTX-011 Across a Broad Range of Tumor Xenograft Models Harboring Clinically Relevant Mutations at the American Association for Cancer Research (AACR) Annual Meeting
WALTHAM, Mass.--(BUSINESS WIRE)-- Mythic Therapeutics, a clinical-stage biotechnology company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, today presented preclinical data demonstrating the potential of MYTX-011 to treat multiple tumor types, regardless of mutation status or cMET expression level, in a poster session at the AACR Annual Meeting in Chicago, Illinois.
'These findings highlight the broad therapeutic potential of MYTX-011 across a variety of cMET-expressing cancers and the opportunity to expand the treatable patient population to patients with EGFR, KRAS and MET mutations, which have shown reduced response rates in clinical studies of other anti-cMET ADCs in development,' said Brian Fiske, Ph.D., chief scientific officer and co-founder of Mythic. 'These preclinical data reinforce our confidence in the ongoing Phase 1 dose escalation trial of MYTX-011. Building on last year's promising preliminary data, we remain highly optimistic and eagerly await additional readouts.'
MYTX-011 is a novel cMET-targeted DAR 2 vcMMAE ADC with an antibody that has been engineered to have pH-dependent binding, which results in higher internalization and payload delivery to tumor cells with a range of cMET expression.
In the study, pH-dependent binding of MYTX-011 translated to potent efficacy in tumor xenografts regardless of mutation status, including models harboring MET exon 14 skipping, KRAS and EGFR mutations. Notably, MYTX-011 demonstrated anti-tumor activity in low or moderate cMET-expressing non-small cell lung cancer (NSCLC) KRAS G12C xenografts as well as tyrosine kinase inhibitor-resistant xenografts bearing EGFR T790M mutations. Additionally, live cell imaging studies demonstrated how FateControl™ technology drives increased uptake of MYTX-011 antibody in cMET-expressing tumor cells compared to a non-engineered parent antibody. In previous studies, a benchmark ADC was either inactive or had greatly reduced efficacy.
These findings support the continued clinical advancement of MYTX-011, which is currently being evaluated in the ongoing Phase 1 KisMET-01 trial in NSCLC.
The Company will present additional data from its Phase 1 KisMET-01 study at an upcoming major medical conference.
About MYTX-011
MYTX-011, an investigational cMET-targeting ADC, leverages Mythic's innovative FateControl™ technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).
About Mythic Therapeutics
Mythic Therapeutics is a product-platform company developing a pipeline of antibody-drug conjugates (ADCs) designed to exhibit unparalleled therapeutic index and efficacy. The Company's FateControl™ technology aims to enhance ADC uptake in targeted tissues by manipulating the fate of the ADC within the cell, thereby expanding the diseases and patient profiles that could be treated with Mythic's ADCs. The company's major investors include Venrock, Viking Global Investors, and First Round Capital.
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Registrational Study Led by MSD NSCLC not achieving a pCR after neoadjuvant therapy followed by surgery. NSCLC expressing PD-L1 >50% pre-treated NSCLC with EGFR mutations or other genomic alterations EGFR-mutated, advanced non-squ NSCLC progressed on prior EGFR-TK metastatic sg NSCLC About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. 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About Kelun-Biotech Kelun-Biotech( a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel coupled drug products in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ View original content to download multimedia: SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Based on the encouraging data from this study, sac-TMT was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy in March 2025. This marks the first global approval of a TROP2 ADC for a lung cancer indication. The published results are based on OptiTROP-Lung03, an open-label, randomized, multicenter registrational study evaluating the efficacy and safety profile of sac-TMT monotherapy versus docetaxel for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who have failed after treatment with an EGFR-TKI and platinum-based chemotherapy. A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until disease progression, intolerable toxicity or other reason for discontinuation, with a median follow-up time of 12.2 months (Data cutoff date: December 31, 2024). Sac-TMT achieved statistically significant and clinically meaningful outcomes compared to docetaxel: Confirmed objective response rate (ORR) (As assessed by blinded independent review committee (BIRC): 45% (95% CI, 35-56) vs 16% (95% CI, 7-30). 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Meanwhile, Merck Sharp & Dohme(the tradename of Merck & Co., Inc., Rahway, NJ, USA)is also conducting five global Phase III clinical trials of sac-TMT for NSCLC in regions where it has exclusive rights. Professor Li Zhang, National Lead Principal Investigator, Medical Oncologist and Deputy Director of the Lung Cancer Research Centre at Sun Yat-Sen University, stated: "EGFR mutation is the most common driver alteration in NSCLC. The prevalence of EGFR mutations reaches 28.2% among NSCLC patients in China. Although third-generation EGFR-TKIs have become the standard of care for advanced EGFR-mutant NSCLC and may significantly improve PFS, acquired resistance remains inevitable. Combining EGFR-TKIs with chemotherapy can offer additional survival benefits to some patients, but this approach is limited by safety concerns and may compromise future treatment options, posing significant clinical challenges. 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Registrational Study Led by Kelun-Biotech OptiTROP-Lung03: Sac-TMT monotherapy versus docetaxel for locally advanced or metastatic EGFR-mutant NSCLC after treatment failure with EGFR-TKI and platinum-containing chemotherapy; OptiTROP-Lung04: Sac-TMT monotherapy versus pemetrexed in combination with platinum for locally advanced or metastatic non-squamous NSCLC with EGFR mutations that have failed EGFR-TKI therapy; OptiTROP-Lung05: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC; OptiTROP-Lung06: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for the first-line treatment of PD-L1-negative locally advanced or metastatic non-squamous NSCLC; OptiTROP-Lung07: First-line treatment of locally advanced or metastatic NSCLC with EGFR mutations by sac-TMT in combination with ositinib. Registrational Study Led by MSD NSCLC not achieving a pCR after neoadjuvant therapy followed by surgery. NSCLC expressing PD-L1 >50% pre-treated NSCLC with EGFR mutations or other genomic alterations EGFR-mutated, advanced non-squ NSCLC progressed on prior EGFR-TK metastatic sg NSCLC About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) based on the OptiTROP-Breast01 study and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy based on the OptiTROP-Lung03 study. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. 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About Kelun-Biotech Kelun-Biotech( a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel coupled drug products in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ View original content to download multimedia: SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.