145 stories across all digests
Clinical trial coverage on Peptide News Digest pulls in Phase 1 through Phase 3 readouts across the peptide universe — GLP-1 obesity and cardiometabolic trials (SELECT, SURMOUNT-4, ACHIEVE-3, REDEFINE-1, SYNCHRONIZE-1), peptide vaccine work (AMPLIFY-201, MEL39), peptide-drug conjugate trials, and antimicrobial peptide programs.
Most of the noise sits with Lilly and Novo, but the interesting reads are usually elsewhere: Bicycle Therapeutics on solid tumors, Lirum on Ewing sarcoma, Cerapedics on lumbar fusion, Pelage on hair loss. Real-world evidence and registry data also land here when they reframe what the randomized trials showed.
Each entry names the sponsor, the phase, and the endpoint. Browse the latest below, or jump to the readouts by drug at #semaglutide, #tirzepatide, or #orforglipron.
Bicycle's EphA2-targeting bicyclic peptide-drug conjugate nuzefatide pevedotin (BT8009) at 6.5 mg/m² Q2W plus nivolumab achieved 40% confirmed ORR (4/10) in metastatic urothelial patients who had progressed on checkpoint inhibitors, and 100% (3/3) in MMAE-naive EphA2+ patients. No Grade ≥3 treatment-related adverse events of clinical interest. Presented at AACR 2026 on April 20.
Greenwich LifeSciences presented FLAMINGO-01 Phase III open-label data at AACR 2026 showing GLSI-100 (the 9-amino-acid GP2 HER2 peptide plus GM-CSF adjuvant) produced a ~4x increase in delayed-type hypersensitivity to GP2 across 247 non-HLA-A*02 patients — from 5.2% at baseline to 20.4% at months 4-6 (p<0.001). GP2 is the C-terminal transmembrane fragment of the HER2/neu protein.
BriaCell's Bria-IMT + checkpoint inhibitor combination preserved overall health status and key functional quality-of-life measures in its pivotal Phase 3 study in heavily pretreated metastatic breast cancer patients who had failed ADC, CPI, and CDK4/6 inhibitor therapy. Phase 2 biomarker analyses identified mitotic circulating tumor cells as prognostic and PD-L1 in tumor-macrophage fusion cells as predictive of checkpoint benefit. Presented at AACR April 20.
Enara Bio presented ENA101 at AACR 2026 on April 20, a first-in-class bispecific T-cell engager targeting DARKFOX — a novel cancer-specific 'dark antigen' peptide presented by HLA-A*03:01 and expressed in multiple solid tumors. Preclinical data showed low-picomolar potency and complete tumor regression in xenograft models with once-weekly dosing. IND submission planned for 2H 2026.
Circle Pharma presents early clinical data for CID-078 in the AACR 2026 Clinical Trials Plenary (Sunday, April 19, 1:00-3:00 PT). CID-078 is a first-in-class orally bioavailable macrocyclic peptide cyclin A/B RxL inhibitor evaluated in a Phase 1 multicenter trial (NCT06577987) for advanced solid tumors with RB1 alterations. The plenary slot — a coveted showcase for private biotechs — tests whether macrocyclic peptides can establish themselves as a third modality alongside small molecules and biologics.
Fedora Pharmaceuticals presented eight posters at ESCMID Global 2026 in Munich today highlighting FPI-2119, a first-in-kind derivative of the lactivicin class for Gram-negative infections. As a non-β-lactam antibiotic, FPI-2119 is not susceptible to β-lactamases. Posters demonstrated concentration-dependent bactericidal activity and low resistance frequency against Pseudomonas aeruginosa, maintained activity against β-lactamase-expressing E. coli strains, and activity against resistant Campylobacter, Salmonella, and Shigella.
Leukogene Therapeutics presents two posters at AACR 2026 showcasing its proprietary M2T platform, designed to harness MHC class II-engaging mechanisms to redirect immune response against acute myeloid leukemia and pancreatic cancer. CEO Sandeep Gupta framed the platform as targeting two of the most lethal and treatment-resistant cancers. Posters appear in the Bi- and Tri-Specific Antibody Therapies session on April 21.
Circle Pharma presents "Orally Bioavailable Peptide Macrocycles Disrupting Intracellular Protein-Protein Interactions: Selective Inhibitors of the RxL-binding Site of Cyclin Family Proteins" at AACR's Chemistry to the Clinic Part 3 session on Saturday, April 18, 12:30-2:00 p.m. PST. The presentation covers CID-078, an orally bioavailable macrocycle with dual activity blocking cyclin A/B protein-protein interactions, selectively targeting tumor cells with RB1 alterations.
Oncopeptides AB (Nasdaq Stockholm: ONCO) will present preclinical data on its SPiKE platform at AACR 2026, showing synergistic effects when combining an affibody-derived bispecific engager with expanded adaptive NK cells (ADAPT-NK) in a humanized multiple myeloma mouse model. The approach leverages peptide-scaffold targeting to direct NK-cell cytotoxicity at malignant plasma cells in difficult-to-treat cancers.
Longhorn Vaccines and Diagnostics presents preclinical data on DRG5-BD11, a bispecific IgM monoclonal antibody targeting bacterial peptidoglycan and HSP16.3 across gram-positive, gram-negative, and mycobacterial pathogens. In vitro assays demonstrated 82% opsonophagocytic killing against E. coli and 74% against Mycobacterium smegmatis, supporting its potential as a broad-spectrum anti-infective for AMR-driven sepsis.
Bicycle Therapeutics will present Phase 1/2 clinical results for BT5528 (nuzefatide pevedotin), an EphA2-targeting Bicycle Drug Conjugate, in combination with nivolumab in patients with advanced solid tumors at AACR 2026. Additional preclinical posters cover BT5528 activity in head and neck squamous cell carcinoma and pancreatic ductal adenocarcinoma xenograft models, plus a novel phage-display-derived bicyclic peptide for EphA2-specific PET imaging.
Circle Pharma secured a coveted oral plenary slot at AACR 2026 to present early Phase 1 clinical activity data for CID-078, a first-in-class orally bioavailable macrocyclic peptide cyclin A/B RxL inhibitor for patients with advanced solid tumors harboring RB1 alterations. The plenary (Sunday, April 19) validates macrocyclic peptides as viable oral oncology drugs — a major milestone for the modality.
Eli Lilly announced positive topline results from ACHIEVE-4, the longest Phase 3 study of Foundayo (orforglipron) to date in 2,700+ adults with type 2 diabetes across 15 countries. The pre-planned analysis showed a 57% lower risk of all-cause death (HR 0.43, p=0.002), while meeting non-inferiority for the prespecified cardiovascular endpoint (HR 0.84). Lilly plans to submit Foundayo for type 2 diabetes to the FDA by end of Q2.
MeiraGTx announced positive 3-year Phase 1 AQUAx data for AAV-hAQP1, a gene therapy delivering the aquaporin-1 water channel protein via Stensen's duct to the parotid glands of head-and-neck cancer survivors with grade 2/3 radiation-induced dry mouth. Clinically meaningful XQ symptom improvements and unstimulated salivary flow increases were maintained through 3 years. BLA submission planned H1 2027.
CLINUVEL presented afamelanotide (Scenesse) vitiligo data at the American Academy of Dermatology annual meeting to 20,000+ delegates. The Phase III CUV105 trial has completed enrollment of 200+ patients across 3 continents. Clinical cases showed repigmentation after 20 weeks maintained through 6-month follow-up, even in patients with active disease. Topline results expected H2 2026.
A study of 220,043 patients published in Diabetes, Obesity and Metabolism found that combining GLP-1 receptor agonists with SGLT2 inhibitors reduced all-cause mortality by 29%, the cardiovascular composite outcome by 19%, and heart failure risk by 22% compared to SGLT2 inhibitor use alone over 1.3 years of median follow-up.
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.
Mechanistic data from the REMODEL trial presented at the 2026 World Congress of Nephrology showed semaglutide decreased renal fat, lowered arterial resistance, and stabilized cortical fibrosis. Biopsies revealed reduced immune cells around glomeruli, and transcriptomic analysis identified glomerular endothelial cells as the most responsive cell type to treatment.