Mythic Therapeutics Presents Trial in Progress Poster on Investigational cMET-Targeting Antibody-Drug Conjugate (ADC) MYTX-011 at American Society of Clinical Oncology (ASCO) Annual Meeting

The Phase 1 KisMET-01 clinical trial enrolls patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC)

Waltham, Mass., May 25, 2023 Mythic Therapeutics, a clinical-stage biotechnology company focused on the development of next-generation antibody-drug conjugate therapies for the treatment of a wide range of cancers, today announced that it will present a Trial in Progress poster on its investigational cMET-targeting ADC, MYTX-011, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL, from June 2-6, 2023.

The poster presentation will highlight the trial design, dosing regimen and study protocol for the company’s ongoing Phase 1 KisMET-01 clinical trial evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MYTX-011 in subjects with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

“We’re looking forward to the presentation of this Trial in Progress poster and to the potential of our KisMET-01 Phase 1 clinical trial in NSCLC. This presentation follows the announcement of our first patient dosed earlier this year,” said Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer at Mythic Therapeutics. “By harnessing our novel FateControl™ technology, designed to improve ADC efficacy against a broad set of molecular targets and patient profiles, we aim to expand the use of ADCs to patients who have previously not been eligible for treatment due to their level of target expression or tumor type.”

Details of the presentation are as follows:

Title: Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate (ADC) MYTX-011 in Subjects with Non-Small Cell Lung Cancer.
Presenter: Alexander Spira, MD, PhD, FACP, Next Oncology Virginia
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: Sunday, June 4, 2023, from 8:00 AM – 11:00 AM CDT / 9:00 AM – 12:00 PM ET
Location: Hall A
Poster Board Number: 131a
Published Abstract Number: TPS9147

“There continues to be a high unmet need for patients with NSCLC as many either do not respond to, or develop resistance to, existing treatment options,” said presenting author and KisMET-01 study investigator Alexander Spira, MD, PhD, FACP, Next Oncology Virginia. “Additionally, we’re excited to explore the potential for MYTX-011 in the Phase 1 KisMET-01 trial to provide a solution for the limitations of traditional ADCs, which have demonstrated potential efficacy as monotherapy only in patients whose tumors express high levels of cMET.”

The KisMET-01 Phase 1 clinical trial will be conducted in two parts—dose escalation and dose expansion—with patients receiving MYTX-011 intravenously every 21 days. Part 1 will assess the safety and tolerability of escalating doses of MYTX-011 as a single-agent in patients with advanced NSCLC to identify the recommended Phase 2 dose (RP2D). The dose escalation schedule is based on the Bayesian Optimal Interval (BOIN) design and doses may be escalated or de-escalated based on the BOIN algorithm. The recommended Phase 2 dose to be studied in Part 2 will be identified as a biologically active dose at or below the maximum tolerated dose.

Part 2 will include patients with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations and will be initiated once the RP2D has been determined. Patients will be enrolled into different cohorts based on cMET overexpression and/or presence of MET genetic alterations and the safety, tolerability and preliminary anti-tumor activity of MYTX-011 will be assessed. cMET positivity thresholds for enrollment into the dose expansion cohorts were selected based on anti-tumor activity of MYTX-011 in preclinical models, published data for responses to cMET targeting agents and on the prevalence of cMET expression in clinical NSCLC samples.

Preclinical proof of concept data for MYTX-011 were recently presented at the American Association for Cancer Research Annual Meeting 2023.

About MYTX-011

MYTX-011, an investigational 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.

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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