L-DOS47 is the company’s first immunoconjugate-based drug candidate being developed based upon its new DOS47 technology, which is designed to use an innovative approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.
The trial steering committee for LDOS002 has reviewed the safety data for the twelfth group and recommended that the company can begin enrollment of patients into the thirteenth group of the study as no dose limiting toxicities were observed.
The Central Ethics Committee and the Polish Competent Authority have approved an additional four group dose levels based on safety information provided by the company.
The approval now allows the trial steering committee to recommend dose escalation up to cohort sixteen.
The additional four group dose levels are 5.76, 7.66, 10.19 and 13.55 µg/kg.
A total of 40 patients have been successfully dosed in the Phase I/II clinical safety study LDOS002 and they were given at least two prior lines of approved therapies before starting treatment with the investigational product L-DOS47.
Of these 40 patients, seven continued to receive investigational therapy past cycle 4; and one patient in group nine (1.84µg/kg) completed ten cycles of LDOS-47 treatment before discontinuing the study.
The company said that the decision to continue dosing is based on radiological assessments completed after every second cycle and clinical evaluation by the investigator.
Currently, the company plans to release information from a data review of the first 12 groups in the fourth calendar quarter of this year, assuming the collection of data for group 12 patients proceeds as anticipated.
Helix president and CEO Robert Verhagen said: "As we continue to understand the safety of L-DOS47, we also learn about the potential clinical benefit to patients with non-small cell lung cancer.
"We plan to continue dose escalation to maximize our flexibility of dosing and identifying optimal trial design parameters in future studies."
Currently, L-DOS47 is being clinically evaluated as a treatment for certain patients with non-small cell lung cancer (NSCLC).