The U.S. Food and Drug Administration (FDA) has approved the acceleration of dose escalation in a Phase 1 clinical trial in the United States to evaluate Helix BioPharma‘s immuno-conjugate L-DOS47 for the treatment of advanced recurrent or metastatic non-squamous non-small cell lung cancer.
“This was a significant achievement in the advancement of the study,” Steve Demas, chief operating officer of Helix, said in a press release.
L-DOS47 is Helix’s first immuno-conjugate based drug candidate. It was developed based on the company’s proprietary DOS47 platform technology designed to modify the micro-environmental conditions of cancer cells in a way that leads to their destruction.
In addition to the U.S. trial (NCT02309892), L-DOS47 also is being evaluated in Poland, (NCT02340208), as a treatment for non-small-cell lung cancer (NSCLC).
In Poland, L-DOS47 is being evaluated for its safety, tolerability, and the preliminary effectiveness of certain ascending doses. Initially, it is being evaluated as a monotherapy in patients with inoperable, locally advanced, recurrent or metastatic non-squamous NSCLC.
In the U.S., the open-label, dose-escalation study aims to determine the safety and tolerability of L-DOS47 in combination with Alimta (pemetrexed) and Paraplatin (carboplatin).
To maximize the number of patients receiving a potentially active dose of L-DOS47, the study will implement an accelerated dose design up to 6 micrograms/kg followed by a standard 3+3 design for the final two dosing cohorts, 9 and 12 micrograms/kg, respectively.
In the U.S., the study is currently recruiting patients at two locations: the University of Texas, MD Anderson Cancer Center and University Hospitals Case Medical Center in Cleveland, Ohio.
During the Biotech Showcase on Jan. 10, 2017 in San Francisco, Helix provided an update on the U.S. trial results. They revealed that patients treated with a dose of up to 0.78 micrograms/kg had not reported any dose-limiting toxicities.
At that point, three of the six patients had achieved a partial response, with the best tumor response showing a 44% reduction in the sum of target lesions. Three patients continued L-DOS47 monotherapy after induction therapy with L-DOS47 in combination with Alimta and Paraplatin.
To date, 85 patients have received L-DOS47 in dosages ranging from 0.12 micrograms/kg to 13.55 micrograms/kg in all completed and ongoing studies. Repeated administrations of L-DOS47 for doses up to 13.55 micrograms/kg were considered safe and well-tolerated.
Helix began enrolling patients in the third dosing cohort of the U.S. study in July 2017, following a Safety Review Committee’s positive recommendation.
