Peptide News Digest

#Clinicaltrials-Gov

2 stories

Clinical Trials · View digest

Alnylam Pharmaceuticals (NASDAQ: ALNY) Enters the Obesity Race With First-in-Human Phase 1 Randomized Double-Blind Placebo-Controlled Single-Ascending-Dose Study (NCT07624071) of ALN-6222, an Investigational Subcutaneous siRNA With an Undisclosed Molecular Target Administered as a Single Dose in Adults With Obesity; Trial Enrolls Approximately 88 Participants With BMI 30 to Less Than 40 kg/m² and HbA1c Below 6.5% at a Single Trial Site in Mount Royal, Canada, With Trial Completion Targeted for December 2027

Alnylam Pharmaceuticals (NASDAQ: ALNY) confirmed a first-in-human Phase 1 trial of ALN-6222, an investigational subcutaneous siRNA therapeutic in adults with obesity, in a July 22 filing update on ClinicalTrials.gov (NCT07624071). The randomized, double-blind, placebo-controlled, single ascending dose study will enroll approximately 88 participants with a BMI of 30 to less than 40 kg/m² and an HbA1c below 6.5% (excluding participants with diabetes). The primary endpoints are safety and pharmacodynamics; secondary endpoints include changes in body weight and metabolic markers. The molecular target of ALN-6222 has not been publicly disclosed. The trial is set to run through December 2027 at a single site in Mount Royal, Canada. ALN-6222 marks Alnylam's first clinical-stage entry into the obesity therapeutic area, joining a broader wave of nucleic-acid, peptide, and peptide-fusion modalities entering the space beyond the GLP-1 incumbents (Wegovy, Ozempic, Mounjaro, Zepbound) and the Alnylam-PeptiDream peptide-siRNA conjugate collaboration announced in 2021. Alnylam separately reports Q2 2026 earnings later this week and is expected to discuss the ALN-6222 program on the call.

Clinical Trials · View digest

ONVAX-01 Personalized Peptide Nanovaccine Plus Anti-PD-1 Antibody and Chemotherapy Phase 1/2 Trial in Advanced Pancreatic Cancer Recruiting (NCT07637786, Late June 2026 Listing) — Targets KRAS Neoantigens in a Tumor with 90% KRAS-Mutation Prevalence

A Phase 1/2 study (NCT07637786) of ONVAX-01, a personalized peptide nanovaccine, in combination with an anti-PD-1 antibody and standard-of-care chemotherapy in patients with advanced pancreatic cancer began recruiting in late June 2026. The trial design has participants receive doses of the nanovaccine along with intravenous infusions of an anti-PD-1 checkpoint inhibitor plus chemotherapy, with serial imaging and blood-marker monitoring for tumor response. ONVAX-01 sits in the same broad therapeutic space as Elicio Therapeutics' ELI-002 7P (which missed its Phase 2 AMPLIFY-7P primary disease-free survival endpoint on June 15) but with a different delivery vehicle (nanoparticle self-assembly versus amphiphile-modified CpG oligonucleotide adjuvant). KRAS mutations drive approximately 90% of pancreatic ductal adenocarcinoma cases and 50% of colorectal cancers, making KRAS-targeting peptide vaccines one of the highest-impact unmet targets in solid-tumor oncology. The peptide nanovaccine modality has roots in 2022 case-report literature on neoantigen nanovaccine immunotherapy in advanced pancreatic cancer and broader nanovaccine work using DP7-C antimicrobial peptide as carrier-plus-adjuvant.