Numab Therapeutics is an oncology-focused biopharmaceutical company is developing multi-specific antibodies that enable the pursuit of novel therapeutic strategies based on its proprietary MATCH technology platform. Numab’s lead candidate, ND021 is a next-generation tri-specific immuno-oncology drug targeting the tumour-immunity suppressive PD-L-1 pathway and the tumour-immunity activating 4-1BB/CD137 pathway as well as Serum Albumin in a single therapeutic molecule. This combined approach will provide patients suffering from various cancer types with a unique novel treatment opportunity characterized by an improved benefit-to-risk profile compared to the current standard of care and other combinatorial immunotherapy approaches currently in clinical development.
The Zurich based company has today announced the start of its international, multi-centre Phase 1/2 clinical study after dosing the first patient in its ND021 program. The study will initially enrol up to 102 cancer patients at four major clinical sites across the United States and Taiwan and will expand to additional centres as the study progresses. In the first part, the study will investigate the safety and tolerability of ascending doses of NM21-1480 – the company’s clinical lead molecule in the ND021 program – in patients with various forms of solid tumours. Through the study, the team will establish a recommended dose for continued clinical development. The trial will subsequently explore the anti-tumour activity of the compound in patients suffering from selected tumour types.
“Advancing NM21-1480 into clinical trials is an exciting and transformative step for Numab Therapeutics,” said David Urech, Founder and Chief Executive Officer of Numab Therapeutics. “Our team has immense faith in the capability of NM21-1480 to invigorate anti-cancer immunity. The unique properties of this molecule are exemplary for our mission to deliver the highest quality of immuno-oncology drugs aiming at better patient outcomes.”
NM21-1480 represents a next-generation checkpoint modulator. Its mechanism of action and preclinical data suggest that it will overcome several limitations of the current standard of care checkpoint modulator therapy. The differentiating profile of NM21-1480 over the standard of care is based on its molecular design as a monovalent tri-specific antibody fragment. NM21-1480 binds and blocks immune-suppressive PD-(L)1 signalling with best-in-class potency and at the same time triggers 4-1BB-mediated T cell stimulation specifically in the tumour microenvironment to avoid systemic toxicities. NM21-1480 was optimized to bind selected epitopes of the respective targets with balanced affinities in order to maximize the synergistic effect of PD-L1 blockade and 4-1BB agonism in patients with varying PD-L1 expression levels.