The candidate has a protease-cleavable linker combined with a topoisomerase-1 inhibitor payload that kills cancer cells by the “bystander effect”. Image credit: Shutterstock/Javier Regueiro.

The US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for CUSP06, allowing its manufacturer OnCusp Therapeutics to start a Phase I clinical trial assessing its use for ovarian cancer and other advanced solid tumours.

The antibody drug conjugate targets cadherin-6, which is a protein overexpressed in cancer cells – including those found in the ovaries. The candidate has a protease-cleavable linker combined with a topoisomerase-1 inhibitor payload that kills cells by the “bystander effect”. The biopharma claims its asset has a stronger effect than competitor antibody drug conjugates, and reported potent anti-tumour activity in preclinical models in April 2023.

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OnCusp Therapeutics says it is developing its drug to help tackle chemoresistance, one of the biggest challenges in cancer therapy. The exatecan payload in CUSP06 is a weak substrate for drug efflux pumps that cause chemoresistance.

The dose-escalating Phase I trial will assess the safety and tolerability of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumours. The company will aim to find a maximum tolerated dose and a recommended expansion dose.

OnCusp Therapeutics acquired exclusive global rights outside of China for CUSP06 from Multitude Therapeutics in June 2022.

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“We are delighted to announce the IND approval for our flagship programme, CUSP06, which has demonstrated excellent anti-tumor efficacy across diverse in vivo cancer models with both high and low CDH6 expression,” stated Dr. Bing Yuan, Chairman and CEO of OnCusp Therapeutics.

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“This achievement is a testament to the dedication and expertise of our exceptional team. As our first asset to receive FDA approval for clinical trials, this marks a transformative milestone for OnCusp and reaffirms our commitment to developing game-changing treatments for cancer patients.”