MYTX-011 / Mythic Therap - LARVOL DELTA

MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study. (ASCO 2025) - P1 | "MYTX-011 is well tolerated with low rates and severity of AEs commonly associated with cytotoxic and cMET-targeting agents. Preliminary anti-tumor activity suggests MYTX-011 can potentially benefit a wide range of cMET-expressing NSCLC pts. Dose expansion is currently ongoing as of January 2025."

Clinical • Metastases • P1 data • Fatigue • Hematological Disorders • Keratitis • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Ocular Inflammation • Oncology • Ophthalmology • Pain • Pneumonia • Solid Tumor • Squamous Cell Carcinoma • EGFR

Mythic Therapeutics Presents Compelling Efficacy Data from its Phase 1 KisMET-01 Study Supporting Best-in-Class Potential of Novel cMET- ADC, MYTX-011, in Non-Small Cell Lung Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - P1 | N=250 | KisMET-01 (NCT05652868) | Sponsor: Mythic Therapeutics | "Initial efficacy data for Mythic’s pH-engineered cMET-directed antibody-drug conjugate (ADC) demonstrates meaningful anti-tumor activity across all cMET expression levels, histologies, and actionable genetic alterations; Preliminary overall response rate (ORR) of 36% in patients with cMET low tumors, 39% in patients with cMET high tumors and 50% in tumors with EGFR mutations and cMET high/intermediate levels, with response durations of up to 8.9 months observed; Preliminary data suggest the potential for MYTX-011 to address the high unmet need in the up to 60% of previously treated patients with NSCLC whose tumors have progressed after prior therapies."

P1 data • Non Small Cell Lung Cancer

Mythic Therapeutics to Present Compelling Efficacy Data from Phase 1 KisMET-01 Study Supporting Best-in-Class Potential of Investigational cMET ADC, MYTX-011, in Non-Small Cell Lung Cancer (Businesswire) - "Mythic Therapeutics...will present data from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with non-small cell lung cancer (NSCLC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation, which includes an updated data cut as of April 24, 2025, is the first disclosure of efficacy data for MYTX-011, demonstrating meaningful anti-tumor activity in cMET+ NSCLC across cMET levels, histologies, and actionable genetic alterations....Full data as of April 24, 2025, to be released on Saturday, May 31, 2025."

P1 data • Non Small Cell Lung Cancer

Mythic Therapeutics to Present Updated Dose Escalation Data from Phase 1 KisMET-01 Study on MYTX-011 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "Mythic Therapeutics...announced that updated dose escalation results from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC), will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting."

P1 data • Non Small Cell Lung Cancer

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 (Businesswire) - "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....The Company will present additional data from its Phase 1 KisMET-01 study at an upcoming major medical conference."

P1 data • Preclinical • Non Small Cell Lung Cancer

MYTX-011: A pH-dependent anti-cMET ADC exhibits potent activity in multiple epithelial tumor models with clinically actionable mutations and varying levels of cMET expression (AACR 2025) - "Further, there were no antagonistic effects of combining MET TKI and MYTX-011 in METex14 PDX models, indicating the potential of MYTX-011 in combination with approved MET TKIs. Together, these findings highlight the potential of MYTX-011 as a therapeutic candidate for treating a broad range of cMET-expressing cancers with clinically actionable mutations."

Preclinical • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • KRAS • MET

Assessing Safety & Tolerability of MYTX-011, a cMET ADC in the Phase 1 KisMET-01 Study (ADC London 2025) - "• Reviewing the safety and tolerability of c-MET targeting agents focusing on c-MET ADCs • Explaining MYTX-011 preclinical data and performance • Describing the safety profile of MYTX-011 in a dose escalation first-in-human Phase 1 NSCLC study"

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Exploring Preclinical Characterisation of pH Dependent AnticMET ADC MYTX-011 Designed for Enhanced Tumour Delivery (ADC London 2025) - "• Outlining rationale and engineering of MYTX-011, a cMET targeting ADC • Assessing comprehensive preclinical in vitro and in vivo characterisation in various animal models • Evaluating MYTX-011 PK data and safety in non-human primates"

Preclinical • Oncology

KisMET-01: Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Mythic Therapeutics | N=150 ➔ 250

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • MET

MYTX-011 in patients with previously treated locally advanced or metastatic NSCLC: Initial dose escalation results in the phase 1 KisMET-01 study. (ASCO 2024) - P1 | "MYTX-011 has been well tolerated with low rates of common MMAE or MET targeted therapy-associated AEs. Preliminary anti-tumor activity and PK supports the development of MYTX-011 in a wide range of cMET-expressing NSCLC pts. Dose escalation is currently ongoing as of Feb 2024."

Clinical • Metastases • P1 data • Dry Eye Disease • Fatigue • Hematological Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ophthalmology • Pain • Pulmonary Disease • Solid Tumor • Squamous Cell Carcinoma • MET

MYTX-011: A pH-Dependent Anti-c-MET Antibody-Drug Conjugate Designed for Enhanced Payload Delivery to c-MET-Expressing Tumor Cells. (PubMed, Mol Cancer Ther) - P1 | "These results highlight the potential of MYTX-011 for treating a broader range of patients with NSCLC with c-MET expression than other c-MET-targeting ADCs. A first-in-human study is ongoing to determine the safety, tolerability, and preliminary efficacy of MYTX-011 in patients with NSCLC (NCT05652868)."

Journal • Tumor cell • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Mythic Therapeutics Presents Initial Dose Escalation Data from Ongoing Phase 1 KisMET-01 Study on MYTX-011 at the American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - P1 | N=150 | KisMET-01 (NCT05652868) | Sponsor: Mythic Therapeutics | "Mythic Therapeutics...announced initial dose escalation results from its ongoing Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Annual Meeting....As of April 30, 2024, 42 patients had been enrolled and received at least one dose of MYTX-011. Data from 41 patients was available by data cutoff and median follow-up was 15 weeks. Patients were dosed between 1.0 to 6.7 mg/kg on a once every three weeks schedule (Q3W). Treated patients had a median of three prior lines of therapy. As of data cutoff, PK data were available in patients who received doses 1.0 to 5.0 mg/kg. PK of MYTX-011 showed nearly dose proportional exposure up to 5.0 mg/kg. "

P1 data • Non Small Cell Lung Cancer

Mythic Therapeutics to Present Data from Phase 1 KisMET-01 Study on MYTX-011 at the American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "Mythic Therapeutics...announced that it will present initial dose escalation results from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Annual Meeting."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MYTX-011: A pH-dependent anti-cMET ADC with increased payload delivery in vivo and potent activity against cMET-expressing tumors of various epithelial origins (AACR 2024) - "MYTX-011 was also highly active in cMET+ xenograft models derived from gastric (non-MET amplified), esophageal, and head and neck cancers. Together, these findings highlight the potential of MYTX-011 as a therapeutic candidate for treating a broader range of cMET-expressing malignancies."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • EGFR • MET

MYTX-011: a pH-dependent anti-cMET antibody-drug conjugate designed for enhanced payload delivery to cMET expressing tumor cells. (PubMed, Mol Cancer Ther) - P1 | "These results highlight the potential of MYTX-011 for treating a broader range of NSCLC patients with cMET expression than other cMET targeting ADCs. A first in human study is ongoing to determine the safety, tolerability, and preliminary efficacy of MYTX-011 in patients with NSCLC (NCT05652868)."

Journal • Tumor cell • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mythic Therapeutics Announces Publication of Preclinical Data Highlighting the Differentiating Properties of MYTX-011 in Molecular Cancer Therapeutics (Businesswire) - "Mythic Therapeutics...announced the publication of preclinical data highlighting the differentiating properties of its investigational cMET-targeting ADC, MYTX-011, in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR)....MYTX-011 drove four-fold higher net internalization than a non-pH engineered parent ADC in non-small cell lung cancer (NSCLC) cells and showed increased cytotoxicity against a panel of cell lines from various solid tumors, including head and neck, gastric, pancreatic, esophageal, bladder, kidney and skin cancer. A single dose of MYTX-011 showed at least three-fold higher efficacy than a benchmark ADC in mouse xenograft models of NSCLC ranging from low to high cMET expression."

Preclinical • Bladder Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer

Mythic Therapeutics Presents Preclinical Data on MYTX-011, an Investigational cMET-Targeting Antibody-Drug Conjugate (ADC), at the American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "Mythic Therapeutics...presented preclinical data from MYTX-011, its investigational cMET-targeting ADC, at the American Association for Cancer Research (AACR) Annual Meeting....FateControl technology incorporated in MYTX-011 enables increased delivery of ADC payload to tumors in a NSCLC xenograft model with moderate cMET expression. MYTX-011 is efficacious against cMET-expressing xenograft models derived from multiple solid tumor types including gastric, esophageal, and head and neck cancers."

Preclinical • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer

KisMET-01: Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Mythic Therapeutics

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • MET

FDA Grants Fast Track Status to MYTX-011 for NSCLC With cMET Overexpression (OncLive) - "'While a small fraction of NSCLC tumors highly express cMET, a much broader patient population have tumors which overexpress cMET, but at lower levels,' Rebecca Heist, MD...'It's important we continue investigating the potential of MYTX-011 for patients with NSCLC who need new approaches to treating their cancer as many either do not respond to, or develop resistance to, existing treatment options.'"

Fast track designation

Mythic Therapeutics Receives FDA Fast Track Designation for MYTX-011 for Patients with Non-Small Cell Lung Cancer (NSCLC) with cMET Overexpression (Businesswire) - "Mythic Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer (NSCLC) with cMET overexpression. This designation encompasses NSCLC patients with any level of cMET overexpression, including low and intermediate."

Fast track designation • Non Small Cell Lung Cancer

Mythic Therapeutics to Present New Preclinical Data on MYTX-011, Investigational cMET-Targeting Antibody-Drug Conjugate (ADC), at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - "Mythic Therapeutics...announced that it will present new preclinical data on MYTX-011, its investigational cMET-targeting ADC, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held in Boston, MA, from October 11-15, 2023."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MYTX-011 is a highly internalized ADC with anti-tumor activity across a spectrum of NSCLC preclinical models with various levels of cMET expression. (AACR-NCI-EORTC 2023) - No abstract available

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

WATCH: @AlexSpiraMDPhD discusses a phase 1 study of the antibody-drug conjugate MYTX-011 in patients with non–small cell lung cancer. #lcsm #Oncology

Dr Spira on the Ongoing Investigation of MYTX-011 in NSCLC (OncLive) - "Alexander I. Spira...Phase I Program, clinical assistant professor, Johns Hopkins School of Medicine, discusses a phase 1 study (NCT05652868) of the antibody-drug conjugate (ADC) MYTX-011 in patients with non–small cell lung cancer (NSCLC)....The phase 1 portion of the trial is currently ongoing and enrolling patients, Spira concludes."

Video

In Proof-of-Concept NSCLC Trial, Mythic Hoping to Show Broad Utility of Antibody-Drug Conjugate (Precision Oncology News) - "The Waltham, Massachusetts-based firm began a Phase I trial this year of its lead program studying MYTX-011 in patients with locally advanced, recurrent, or metastatic non-small cell lung cancer with cMET overexpression, MET amplification, or MET exon 14 skipping mutations....Similarly, in exploring its ADC in patients with a range of MET expression, Mythic designed the KisMET-01 trial to include separate cohorts of NSCLC patients characterized by high or intermediate MET expression....The company expects to complete the dose-escalation portion of the study in 2025 and the dose-expansion portion in 2027, said Gilles Gallant, Mythic's chief development officer. Fiske added that the firm hopes to have some early data next year. Gallant also noted that the firm expects to open the trial at sites outside the US soon."

P1 data • Trial status • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor