Peptide News Digest

AACR Peptide Oncology Data, SURMOUNT-5 Tirzepatide vs Semaglutide, Compounded GLP-1 Secret Shopper, CMS BALANCE Deadline

Tirzepatide beats semaglutide 21.6% vs 15.4% in SURMOUNT-5, Bicycle PDC hits 40% ORR, 69/74 medspas still sell compounded GLP-1s, AACR peptide vaccines advance.

11 stories · Covering clinical-trials, regulatory, research, industry

Editor's Note

Monday's AACR 2026 peptide oncology slate delivered the most substantive data yet: Bicycle Therapeutics' nuzefatide pevedotin hit 40% ORR in checkpoint-refractory urothelial cancer, Greenwich's GP2 vaccine showed durable immune responses across 247 patients, and BriaCell's Bria-IMT preserved quality of life in heavily pretreated breast cancer. Meanwhile, the first definitive head-to-head GLP-1 trial — SURMOUNT-5 — showed tirzepatide beats semaglutide 21.6% vs 15.4% weight loss, giving Lilly a clear data point for prescribers. On the regulatory side, a 'secret shopper' study found 69 of 74 medspas surveyed still sell compounded semaglutide despite FDA resolving the shortage, underscoring how entrenched the gray market has become — a problem CMS's BALANCE Model application deadline today is meant to address by offering $50 Medicare copays on branded GLP-1s. The week's signal: peptide therapeutics are maturing simultaneously on data, regulation, and market access.

Clinical Trials

SURMOUNT-5 Head-to-Head: Tirzepatide Delivers 21.6% Weight Loss vs Semaglutide's 15.4%

The first definitive Phase 3B head-to-head trial of Lilly's tirzepatide versus Novo Nordisk's semaglutide in 750 patients with obesity over 72 weeks showed tirzepatide produced 21.6% mean weight loss vs semaglutide's 15.4%. 36.2% of tirzepatide patients achieved ≥25% weight loss vs 19.4% on semaglutide. Results published April 20 give Lilly a clear comparative data point in the GLP-1 market share battle.

#tirzepatide #semaglutide #mounjaro #wegovy #surmount-5 #obesity #glp-1 #head-to-head
Clinical Trials

Bicycle Therapeutics Nuzefatide Pevedotin Hits 40% ORR in Checkpoint-Refractory Urothelial Cancer

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.

#bicycle-therapeutics #nuzefatide-pevedotin #epha2 #peptide-drug-conjugate #urothelial-cancer #aacr-2026
Regulatory

Secret Shopper Study: 69 of 74 Medspas Still Sell Compounded Semaglutide Despite FDA Shortage Resolution

A University of Colorado Anschutz-led secret shopper study presented at Obesity Medicine Association 2026 surveyed 75 weight-loss clinics and medspas across two US states. 69 of 74 still offered compounded semaglutide and 65 of 74 offered compounded tirzepatide despite FDA resolving the name-brand shortages. Four source facilities had received FDA warnings or state licensing discipline since 2023 — three related to sterile compounding. Many clinics report using 'additive' formulations to skirt compounding restrictions.

#compounded-glp-1 #semaglutide #tirzepatide #fda #compounding #weight-loss-clinics #medspa
Clinical Trials

Greenwich LifeSciences FLAMINGO-01 GP2 Vaccine Drives 4x Delayed-Type Hypersensitivity Response in Open-Label Data

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.

#gp2 #glsi-100 #greenwich-lifesciences #breast-cancer #her2 #peptide-vaccine #aacr-2026
Clinical Trials

BriaCell Bria-IMT Phase 3 Peptide Vaccine Preserves Quality of Life in Heavily Pretreated Breast Cancer

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.

#briacell #bria-imt #breast-cancer #peptide-vaccine #immunotherapy #aacr-2026
Clinical Trials

Enara Bio Debuts ENA101, First-in-Class DARKFOX-Targeting Peptide T-Cell Engager at AACR

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.

#enara-bio #ena101 #darkfox #t-cell-engager #peptide-immunotherapy #aacr-2026 #solid-tumors
Research

BioNTech/Genentech Autogene Cevumeran Pancreatic Cancer Vaccine Shows Durable T-Cell Response at Six Years

Nearly half of participants in a Phase 1 trial of BioNTech/Genentech's personalized mRNA neoantigen vaccine autogene cevumeran remain alive up to six years after treatment, with T-cell responses showing no signs of waning. Eight of 16 patients produced durable CD8+ T cells targeting tumor neoantigens after nine doses, with the immune memory still detectable at six-year follow-up. A Phase 2 trial is underway.

#autogene-cevumeran #mrna-vaccine #pancreatic-cancer #neoantigen #biontech #genentech #immunotherapy
Regulatory

CMS BALANCE Model Application Deadline Today Sets Up $50 Medicare GLP-1 Copays Starting July

April 20, 2026 is the CMS application deadline for Medicare Part D plans to participate in the BALANCE Model, which will offer Wegovy, Zepbound KwikPen, and Foundayo at $50 copay with a $245/month net price starting July 1. CMS added Foundayo to the Medicare GLP-1 Bridge on April 6 following FDA approval, extending coverage to Lilly's new oral GLP-1.

#cms #medicare #glp-1 #balance-model #wegovy #zepbound #foundayo #pricing
Industry

Pheochromocytoma Market Forecast: Lutathera PRRT Peptide-Radionuclide Therapy Drives 7.3% CAGR Through 2036

A DelveInsight market analysis published April 20 projects 7.3% CAGR growth in the pheochromocytoma and paraganglioma treatment market through 2036, driven by SSTR2 analogs and peptide receptor radionuclide therapies including Novartis's Lutathera (lutetium-177 dotatate). PRRT remains one of the few FDA-approved peptide therapeutics for rare neuroendocrine tumors, binding SSTR2 to deliver targeted radiation.

#lutathera #prrt #novartis #peptide-radionuclide #pheochromocytoma #neuroendocrine #sstr2
Research

UNMC Expands Antimicrobial Peptide Database to 6,309 Entries, Launches AMPIP Pipeline Tool

University of Nebraska Medical Center's Guangshun Wang lab released APD6, the expanded antimicrobial peptide database, containing 6,309 peptides (3,379 natural AMPs, 2,290 synthetic, 373 AI-predicted) as of January 2026. New features include the Antimicrobial Peptide Information Pipeline (AMPIP) and expanded functional wheel covering anticancer and antidiabetic activity — positioning APD6 as the most comprehensive reference for AMP drug discovery as AI-assisted antibiotic design accelerates.

#antimicrobial-peptides #apd6 #unmc #database #amps #drug-discovery #ai
Research

Scorpion Venom Peptides Emerge as Novel Ion Channel Modulators for Neurotherapeutics

A Frontiers in Pharmacology review cataloged 176 neuropeptides across 16 families found in the venoms of 107 scorpion species, highlighting Buthus martensii Karsch (BmK) peptides as selective ion channel modulators. Examples include MarTX (selective for BK(α+β4) channels) and BmKTX (Kv1.3 blocker) — positioning scorpion venom as an underexplored source of next-generation neurotherapeutic leads for pain, epilepsy, and autoimmune conditions.

#venom-peptides #scorpion #neuropeptides #ion-channels #bmk #neurotherapeutics #drug-discovery