Phase 1 is the gate where peptide drug-development programs prove out half-life, immunogenicity, and acute tolerability in humans for the first time. Most peptide Phase 1 programs run 12-18 months from IND to topline data — single-ascending-dose and multiple-ascending-dose studies typically enroll 40-90 healthy volunteers or patients across 4-6 escalating dose cohorts. Coverage here tracks the active Phase 1 trials that anchor near-term clinical inflection points across obesity, oncology, and rare-disease peptide programs.
Active Phase 1 programs covered on the site include Avacta's AVA6103 (FAP-exatecan PDC, FOCUS-01 trial, first patient March 2026), MetaVia's DA-1726 (oxyntomodulin analog, Part 3 higher-dose titration data due ADA 2026), BriaCell's Bria-PROS+ (prostate cancer cell immunotherapy, clinical supplies completed May 2026), Aivocode's CAQK (brain-injury tetrapeptide, IND-enabling work ongoing), and a deeper bench of oral peptide platforms from Pinnacle Medicines, Pinnacle Biologics, and Ridgeview Sciences.
Stories here cover first-patient announcements, dose-escalation milestones, and pharmacokinetic readouts that move candidates toward Phase 2. See #clinical-trials, #ind-enabling, and #peptide-drug-conjugate for adjacent threads.
Dana-Farber Cancer Institute researchers led by David Reardon (Director, Center for Neuro-Oncology) and Catherine Wu (Chief, Division of Stem Cell Transplantation and Cell Therapies) presented Phase 1 data at ASCO 2026 on NeoVax — a personalized neoantigen peptide vaccine — combined with pembrolizumab in newly diagnosed glioblastoma. The study excluded dexamethasone (an immune suppressant) and added pembrolizumab to enhance anti-tumor activity. Vaccine-stimulated anti-tumor activity was still evident in some patients after one year, with vaccine-specific T cells migrating into the brain and tumors following vaccination. The MGMT-methylated patient subgroup showed median survival meaningfully exceeding historical observations, though the authors emphasized this requires cautious interpretation given the lack of a randomized comparator arm. The timing of pembrolizumab administration didn't affect immune-response stimulation, but pembrolizumab-before-NeoVax-priming may extend overall survival. NeoVax adds to the personalized neoantigen vaccine cohort (BioNTech autogene cevumeran, Moderna intismeran autogene, Evaxion EVX-01) anchoring the broader peptide cancer vaccine field.
Avacta Therapeutics reported unaudited preliminary results for the 12 months ended December 31, 2025 on Tuesday May 19, 2026, and disclosed that the first patient received treatment in FOCUS-01 — the Phase 1 clinical trial of AVA6103, a FAP-activated exatecan peptide-drug conjugate — in March 2026. AVA6103 is the second pre|CISION-enabled candidate in the Avacta clinical pipeline, after AVA6000 (FAP-Dox, which has Phase Ia/Ib data scheduled at ASCO 2026 in salivary gland cancers). The pre|CISION platform attaches a peptide tetrazolyl moiety cleaved by FAP (fibroblast activation protein) overexpressed in cancer-associated fibroblasts, allowing systemic administration of cytotoxic payloads without the dose-limiting toxicity that constrains free exatecan. FOCUS-01 is enrolling adults with advanced solid tumors. AVA6103 expands the platform from doxorubicin (in AVA6000) to exatecan — a topoisomerase I inhibitor with potency advantages in HER2-low and triple-negative breast cancer.
MetaVia confirmed Monday May 18 that three late-breaking abstracts have been accepted at the ADA 2026 Scientific Sessions (June 5-8 New Orleans). DA-1726 is a once-weekly subcutaneous oxyntomodulin analog functioning as a GLP-1R/GCGR dual agonist for obesity and MASH; Phase 1 Part 3 higher-dose titration results will be presented, with full Phase 1 trial data expected in Q4 2026. Vanoglipel (DA-1241) is a first-in-class GPR119 agonist that promotes endogenous release of GLP-1, GIP, and PYY from the gut; the ADA poster covers synergistic preclinical effects in combination with resmetirom (Madrigal's MASH therapy) and with metformin for type 2 diabetes. The three-poster slate positions MetaVia as one of several mid-cap obesity-pipeline names with clinical data inflections clustered into the ADA + ASCO + EASD 2026 calendar.
Asahi Kasei initiated a Phase I trial in Japan of AK1940, a selective TNF receptor 1 antagonist peptide discovered jointly with PeptiDream for autoimmune and inflammatory diseases. The trial will assess PK, safety, and tolerability of single and multiple subcutaneous doses in healthy volunteers; preclinical models showed high TNFR1 selectivity and anti-inflammatory activity without blocking TNFR2 signaling.
A Phase 1 trial published in Nature Medicine showed that FLC-Vac, a therapeutic peptide vaccine targeting the DNAJ-PKAc fusion protein in fibrolamellar hepatocellular carcinoma, combined with nivolumab and ipilimumab achieved 75% disease control (9/12 patients) and 25% partial response rate. All responders showed tumor-specific T cell responses.