NEW YORK – Elicio Therapeutics on Wednesday said the first patient with KRAS-driven cancer has been treated with its therapeutic vaccine ELI-002 in a Phase I/II trial.
The multi-center AMPLIFY-201 trial will enroll about 160 patients with KRAS-mutated solid tumors who have circulating tumor DNA after surgery or chemotherapy. The first patient to receive the lymph node-targeting vaccine was enrolled at MD Anderson Cancer Center.
The study will include patients with KRAS-driven pancreatic, colorectal, ovarian, bile duct, gallbladder, and non-small cell lung cancer. The researchers will use an investigational ctDNA test to identify patients with minimal residual disease before signs of relapse show up in imaging. They will also test patients for KRAS/NRAS G12D or G12R mutations.
"The AMPLIFY-201 trial is a great example of the use of liquid biopsies to identify patients with minimal residual disease who test positive for circulating tumor DNA following surgery and chemotherapy," Julian Adams, Elicio's chairman, said in a statement, estimating that around a quarter of all cancer patients have RAS mutations in their tumors.
The trial will have three phases. In Phase IA, up to 18 patients will be split into three dose escalation cohorts to determine the recommended Phase II dose. Phase IB will include an additional 17 patients in each cohort, up to 51 patients total, to assess ELI-002's preliminary anti-tumor activity and changes in baseline tumor biomarkers. In the Phase II portion, researchers will enroll 90 pancreatic cancer patients who will be randomized to receive ELI-002 or observation.
Elicio's ELI-002 is developed and delivered using the company's Amphiphile, or AMP, platform. The vaccine is made up of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant, which is targeted to the lymph nodes to enhance immune cell activity.
"ELI-002 targets the seven most common KRAS mutations and has the potential to become a multi-targeted mKRAS therapy that can prevent disease recurrence in patients with KRAS-driven tumors," Adams said.
Elicio expects to report initial safety, dose-escalation, and correlative biomarker data from AMPLIFY-201 by the first half of 2022.