Mythic Therapeutics is set to present promising efficacy data from its Phase 1 KisMET-01 clinical trial evaluating MYTX-011 in patients with advanced non-small cell lung cancer (NSCLC) at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31.
The presentation will feature updated dose escalation results as of April 24, 2025, marking the first public disclosure of efficacy data for MYTX-011, a novel cMET-targeting antibody-drug conjugate (ADC). According to preliminary findings, the investigational therapy has demonstrated meaningful anti-tumor activity in cMET-positive NSCLC patients across various cMET expression levels, histologies, and actionable genetic alterations.
"We're encouraged by the updated dose escalation results from the KisMET-01 study, which demonstrate the potential of MYTX-011 to offer a new therapeutic option for patients with advanced NSCLC," said George Eliades, Ph.D., President and Chief Executive Officer at Mythic Therapeutics.
Study Design and Patient Population
The KisMET-01 trial (NCT05652868) is a multicenter, first-in-human Phase 1 study evaluating MYTX-011 in patients with previously treated, locally advanced or metastatic NSCLC. The trial consists of two parts: dose escalation (Part 1) in patients with NSCLC of any histology or cMET expression, followed by dose expansion (Part 2) in cMET-positive patients selected by immunohistochemistry using the Ventana SP44 assay.
For the study, cMET expression levels are categorized as:
- High: ≥50% tumor cells with 3+ staining
- Intermediate: ≥25% and <50% with 3+ staining
- Low: ≥25% with 2+ staining (excluding high and intermediate)
- Ultra-low: ≥75% (excluding high, intermediate, and low)
The data will be presented by Dr. Rebecca Heist, Medical Oncologist at Massachusetts General Hospital Cancer Center, during a poster session focused on metastatic non-small cell lung cancer.
Innovative Technology Platform
MYTX-011 employs Mythic's proprietary FateControl™ technology, which represents a potential advancement beyond conventional linker-payload approaches in ADC development. The technology is designed to allow ADCs to actively navigate inside cells, potentially increasing delivery of anti-cancer agents to tumor cells while minimizing impact on healthy tissues.
The FateControl™ platform engineers ADCs to be pH-sensitive, enabling them to unbind from their target after cellular internalization. This mechanism is intended to improve tumor uptake and drug exposure, potentially enhancing safety, tolerability, and efficacy profiles compared to traditional ADCs.
Addressing Unmet Needs in NSCLC Treatment
Despite recent advances in targeted therapies and immunotherapies, many NSCLC patients still experience disease progression and require additional treatment options. cMET alterations, including amplification and exon 14 skipping mutations, are known oncogenic drivers in NSCLC, making it a rational therapeutic target.
The development of MYTX-011 addresses an important area of unmet need, particularly for patients who have progressed on standard therapies. If successful, this novel ADC could provide a new treatment avenue for patients with cMET-positive NSCLC, regardless of expression level or histological subtype.
Company Background
Mythic Therapeutics is a clinical-stage biotechnology company focused on developing next-generation ADC therapies for various cancers. The company's approach centers on enhancing ADC uptake in targeted tissues by manipulating the fate of the ADC within cells, potentially expanding the range of diseases and patient profiles that could benefit from ADC therapy.
The company is backed by prominent investors including Venrock, Viking Global Investors, and First Round Capital, highlighting significant confidence in Mythic's technological platform and development pipeline.
The full presentation of the KisMET-01 trial data is scheduled for Saturday, May 31, 2025, at the ASCO Annual Meeting, where more detailed efficacy and safety results are expected to be disclosed.
