Mythic Therapeutics Announces First Subject Dosed in Phase 1 KisMET-01 Clinical Trial of cMET-Targeting Antibody-Drug Conjugate (ADC) MYTX-011 for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

MYTX-011 incorporates Mythic’s FateControl™ technology, which holds the potential to dramatically improve ADC efficacy, thereby expanding the number of NSCLC patients eligible for this targeted therapy

Waltham, Mass., April 4, 2023Mythic Therapeutics, a biotechnology company focused on the development of next-generation antibody-drug conjugate-based therapies for the treatment of a wide range of cancers, today announced that the first subject has been dosed in the Phase 1 KisMET-01 clinical trial of MYTX-011. MYTX-011 is a cMET-targeting ADC being investigated for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC).

“Today’s announcement of our first subject dosed represents a significant step towards increasing the number of lung cancer patients eligible for treatment using ADCs, including those whose cancers express moderate cMET levels,” said Brian Fiske, PhD, Chief Scientific Officer and Co-Founder at Mythic Therapeutics. “At Mythic, we are focused on our vision of unlocking the full potential of MYTX-011 as well as our broader pipeline of ADCs incorporating FateControl™ technology, which represents a fundamentally new paradigm for ADC therapies.”

The KisMET-01 Phase I clinical trial is an open-label, multi-center, dose escalation and dose expansion study that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MYTX-011 in subjects with locally advanced, recurrent or metastatic NSCLC. The study will be conducted in two parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify the dose(s) to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations, which are currently populations with an unmet medical need.

MYTX-011, a cMET-targeting ADC, leverages Mythic’s innovative FateControl™ technology, which allows ADCs to actively navigate inside of cells to potentially increase 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.

The first patient was dosed at Sarah Cannon Research Institute (SCRI) at Tennessee Oncology in Nashville, Tennessee, under the care of Melissa Johnson, MD, Director, Lung Cancer Research, SCRI. “Although ADCs have been around for decades, their clinical benefit has been limited to a subset of diseases and targets with specific characteristics, such as high levels of target expression,” said Dr. Johnson. “With cMET overexpression occurring in up to 70% of NSCLC tumors,[1],[2] patients need better treatment options to address lower levels of cMET target expression. We look forward to evaluating the potential of MYTX-011 to expand the use and eligibility of ADCs for patients with NSCLC.”

More information about the clinical trial is available at (identifier: 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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[1] Lee YJ, Han JY, Lee GK, et al. C-MET overexpression as a resistance biomarker to epidermal growth factor receptor tyrosine kinase inhibitors in EGFR-mutant non-small cell lung cancer. J ClinOnc. 2016;34:15_suppl, e20660-e20660.
[2] Moosavi F, Giovannetti E, Saso L, Firuzi O. HGF/MET pathway aberrations as diagnostic, prognostic, and predictive biomarkers in human cancers. Critical Rev Clin Lab Sci. 2019;56(8):533.