US FDA grants fast track designation to Mythic Therapeutics’ MYTX-011 for patients with NSCLC with cMET overexpression

Mythic Therapeutics, a clinical-stage biotechnology company, announced that the US 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.

“Receiving Fast Track designation from the FDA reinforces our focus on addressing the unmet need of patients living with cMET-positive NSCLC, who currently have few effective treatments,” said Brian Fiske, PhD, chief scientific officer and co-founder at Mythic Therapeutics. “We are proud of this significant milestone as it highlights the potential of MYTX-011, which is enabled by our FateControl platform, to expand ADC therapy to more NSCLC patients.”

Fast Track designation is intended to aid the development and expedite the review of drugs to treat serious and life-threatening conditions with unmet medical needs, with the goal of reaching patients earlier. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s clinical trial designs and development plans.

“While a small fraction of NSCLC tumours highly express cMET, a much broader patient population have tumours which overexpress cMET, but at lower levels,” said KisMET-01 study investigator Rebecca Heist, MD, MPH, Massachusetts General Hospital. “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.”

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumour 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. MYTX-011 is currently being evaluated in the phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-centre, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

Mythic Therapeutics is a product-platform company developing a pipeline of antibody-drug conjugates (ADCs) designed to exhibit unparalleled therapeutic index and efficacy.

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