MYTX-011

Mythic Therapeutics has ended operations, terminating its sole clinical trial after failing to raise enough money to move forward, Endpoints News has learned. The Boston-area biotech “pursued various capital solutions during 2025 to fund its continued operations and despite the promise of MYTX-011 such efforts were not successful,” CEO George Eliades said in an emailed statement to Endpoints on Tuesday. Mythic is “in the process of winding down and selling assets, and several are still available.” Mythic cited a “business decision” for abandoning work on MYTX-011, according to an update posted to the US federal clinical trials database Tuesday. The biotech was testing the antibody-drug conjugate in a Phase 1 in the US, Australia, Europe, South Korea and Taiwan. The startup emerged with a $103 million Series B in 2021 after it was founded in 2017 by Alex Nichols and Brian Fiske . While Mythic hadn’t announced another funding round since then, it did disclose a $30 million financing in an SEC filing last December. Mythic was working to make ADCs more precise. ADCs have been one of the hottest modalities in cancer drug development in recent years, attracting multibillion-dollar buyouts, licensing deals, major financings and multiple approvals. The biotech didn’t appear to have a pharmaceutical partner. Early-stage biotechs will routinely look to larger biopharma companies for collaboration or licensing deals to help fund their R&D. MYTX-011, which had FDA fast track designation, was being evaluated in patients with non-small cell lung cancer. The trial began in 2023 and enrolled 227 people. Preliminary data were presented at the American Society of Clinical Oncology annual confab in May. Mythic’s investors included Viking Global, Venrock Healthcare Capital Partners, Foresite Capital and Perceptive Advisors, among others.

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 WALTHAM, MA, USA I May 31, 2025 I 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 updated data from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC candidate, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC), in a poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. MYTX-011 is a novel ADC engineered with pH-dependent binding to more precisely deliver anti-tumor payload across a range of cMET expression levels, with the goal of reducing toxicity and expanding the number of patients who can benefit from ADC therapy. “We are highly encouraged by these early efficacy data demonstrating meaningful anti-tumor activity which underscore how our differentiated pH-dependent design may help unlock the full promise of ADCs to reshape cancer treatment and expand patient reach, regardless of histology and molecular subtype,” said George Eliades, Ph.D., President and Chief Executive Officer at Mythic Therapeutics. “Together with a manageable tolerability profile, these findings support the potential of MYTX-011 to establish a new standard of care for pretreated NSCLC patients in second- and later-line settings, where effective treatment options remain extremely limited. We look forward to evaluating MYTX-011 in Part 2 of the study and plan to present updated expansion cohort data at an upcoming medical conference.” Data presented were from 66 patients treated at efficacious dose levels (≥4.0 mg/kg) administered once every three weeks (Q3W) in Part 1 of the dose escalation portion of the study. Patients had a median of three, and up to 10, prior lines of therapy with nearly half (45%) receiving prior taxane treatments. Preliminary results show: MTYX-011 demonstrated favorable pharmacokinetics (PK) and excellent stability. The overall safety profile of MYTX-011 was consistent with previously reported data, and no new safety signals were identified. The most common treatment-related adverse events (TRAEs) of any grade in 20% or more of patients included, blurred vision (47%), keratopathy (41%), keratitis (32%), nausea (29%), peripheral neuropathy (24%), fatigue (23%), and increased AST (21%). Grade 3 or higher TRAEs in 5% or more of patients included blurred vision (20%), keratopathy (18%), neutropenia (14%), and keratitis (11%). 11 of the 12 reports of neutropenia and 12 of the 16 cases of peripheral neuropathy occurred in patients treated at doses of 5.8 mg/kg or higher. Ocular AEs led to treatment discontinuation in four patients (6%), with three of the four patients receiving doses of 5.8 mg/kg or higher. Based on clinical data and favorable PK, a 5.0 mg/kg dose on a Q3W regimen with a 2-on, 1-off dose break schedule was selected as the recommended Phase 2 dose, which will be compared to a 4.0 mg/kg Q3W dose in Part 2 of the trial. “The early data from the MYTX-011 study, showing compelling anti-tumor activity and durable responses in patients with lung cancer, together with a well-tolerated safety profile, are highly encouraging,” said Rebecca Heist, M.D., MPH, Medical Oncologist, Massachusetts General Hospital, Cancer Center. “These findings suggest that MYTX-011 has the potential to become a promising new treatment option for a broad range of NSCLC patients, and we are eager to continue evaluating its efficacy and safety in the ongoing dose expansion phase of the study.” About KisMET-01 KisMET-01 ( NCT05652868 ) is a multicenter, first-in-human Phase 1 study of MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC. The study is comprised of two parts: dose escalation (Part 1) in patients with NSCLC of any histology of cMET expression with cMET analyzed whenever tumor tissue is available, followed by dose expansion (Part 2) in cMET-positive (cMET+) patients selected by immunohistochemistry (Ventana SP44). cMET levels are defined as high (≥50% tumor cells with 3+ staining), intermediate (≥25% and <50% with 3+ staining), low (≥25% with 2+ staining, excluding high and intermediate), and ultra-low (≥75% excluding high, intermediate, and low). About MYTX-011 MYTX-011 is an investigational cMET-targeting ADC, which leverages Mythic’s innovative FateControl™ technology. FateControl™ ADCs are pH engineered to unbind their target after internalization, intended to improve both tumor uptake and drug exposure for improved safety, tolerability and efficacy. 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. For more information, visit: www.mythictx.com and follow on LinkedIn . SOURCE: Mythic Therapeutics