1ST Biotherapeutics has signed a clinical trial collaboration and supply agreement with Merck & Co (MSD) to assess FB849 plus Keytruda (pembrolizumab) for advanced solid tumours.

Under the deal, FB849 plus Keytruda will be evaluated in a Phase I/II clinical trial for treating advanced solid tumour patients.

This first-in-human, multicentre, open-label trial will analyse the tolerability, safety, pharmacokinetics, and initial efficacy of FB849 as a single agent, as well as in combination with MSD’s Keytruda. 

Subject recruitment in the trial is slated to commence in the second half of 2023.

FB849 is a small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor of 1ST Biotherapeutics while Keytruda is an anti-programmed cell death protein 1 (PD-1) therapy of MSD.

1ST Biotherapeutics founder and CEO Jamie Jae Eun Kim said: “We are hopeful that combining FB849 with Keytruda may induce an effective anti-tumour response and show an additive benefit for patients with advanced solid tumours. 

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“This collaboration will play an important role in the advancement of this programme and marks further validation of our differentiated drug discovery and development approach.”

The company develops treatments for rare diseases, neurodegenerative ailments and immuno-oncology. 

Its pipeline comprises investigational therapies that have disease modification and favourable pharmacological properties.

MSD recently reported the latest findings from two trials of sotatercept in adult patients with pulmonary arterial hypertension.