Lisata Therapeutics aims to start a new Phase Ib/IIa trial of its lead candidate drug LSTA1 in glioblastoma later this year.
The trial will study LSTA1’s use alongside the standard of care (SOC) versus the SOC and placebo.
According to Lisata CEO David Mazzo, added that the company aims to enrol 30 subjects in the active arm in approximately one year. The study will focus on efficacy endpoints such as progression-free survival and overall survival.
The trial will take place in the Baltic region, specifically in Estonia and Latvia. This was initially shaped by the company’s collaboration with a research group from Estonia’s University of Tartu
Mazzo commented that Lisata aims to have data from this trial ready by mid-2025.
The company’s lead candidate LSTA1 is a cyclic peptide that is designed to modify the tumour microenvironment by binding to alpha-V integrins expressed in tumours, per the company’s website. Once the drug binds to these integrins, it is cleaved to a linear peptide fragment that binds to a second receptor neuropilin-1. This activates an uptake pathway that enables anticancer drugs to penetrate solid tumours more efficiently, states the website.
Beyond this, the company is working on enrolling patients and expanding to further sites in the Phase II BOLSTER advanced solid tumour basket trial (NCT05712356). The trial studies the drug in three different solid tumour types; gastroesophageal cancer, head and neck cancer and cholangiocarcinoma.
Mazzo said that the trial will not only take place in Canada and the US but also potentially in Asia and Europe. In Europe, the trial could have sites in countries such as Germany, Netherlands and Spain.
He added that the company is considering sites in Singapore, South Korea and Taiwan.
The sites in all these countries are either in startup mode or in the discussion and feasibility assessment stage. Sites in some of these countries will become active in the summer. As per the study’s ClinicalTrials.gov entry, the trial is currently recruiting patients at three sites in the US. The company plans to recruit patients on all three arms of the trial by the end of next year.
Outside of this, the New Jersey-headquartered company is roughly two-thirds into completing patient enrollment for its Phase IIb ASCEND trial (NCT05042128) that investigates LSTA1’s use in metastatic pancreatic ductal adenocarcinoma patients in Australia and New Zealand.
Lisata expects to have earliest data from this trial in H2 2024, he added.
However, Mazzo said that the company is also open to licensing agreements and partnerships for its CD34+ platform. He added that the company has advanced programs in this platform such as in coronary microvascular dysfunction, as far as it can afford to.