Peptide News Digest

Clinical Trials News

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.

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Sapience Therapeutics Lucicebtide ASCO 2026 Phase 2 Update (May 22): First-in-Class C/EBPβ Peptide Antagonist Shows Durable PFS + OS in Window-of-Opportunity Newly Diagnosed Glioblastoma

Sapience Therapeutics announced May 22 positive Phase 2 clinical and pharmacodynamic data update from its lucicebtide (ST101) trial in glioblastoma ahead of the ASCO 2026 Annual Meeting (May 29-June 2 Chicago). The Phase 2 Window-of-Opportunity study evaluates lucicebtide alone and in combination with standard-of-care chemoradiation, with dosing both before and after surgical resection. Nine patients were evaluable for analysis; the maturing data show durable progression-free and overall-survival improvements with a well-tolerated safety profile. Lucicebtide is a first-in-class peptide antagonist of CCAAT/enhancer-binding protein β (C/EBPβ) — a transcription factor that drives tumor aggressiveness, immune evasion, and stemness in glioblastoma. The 125-patient program across recurrent GBM monotherapy and newly diagnosed combination cohorts is the largest peptide-mechanism dataset in GBM to date. The Monday June 1 poster session details the efficacy, pharmacodynamics, and safety in newly-diagnosed patients.

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Corbus Pharmaceuticals CRB-701 ASCO 2026 Pre-Meeting Detail (May 22): Phase 1/2 Nectin-4 ADC in HNSCC + Cervical Cancer; Oral Cervical Session May 29, HNSCC Poster May 30, Mid-2026 Registrational Study Start in 2L HNSCC

Corbus Pharmaceuticals announced ASCO 2026 abstracts featuring updated clinical data from the Phase 1/2 study of CRB-701 (SYS6002), a next-generation antibody-drug conjugate targeting Nectin-4. The oral presentation in cervical cancer is scheduled for Thursday May 29 at 4:57 PM CDT; the head and neck squamous cell carcinoma (HNSCC) poster on Friday May 30 at 4:30 PM CDT. The data will include clinical response durability and HNSCC patient-subgroup analysis. Corbus reached broad alignment with the FDA on registrational-study designs in second-line HNSCC and cervical cancer, enabling potential accelerated approval based on objective response rate and full approval on overall survival. The company expects to initiate a registrational study for CRB-701 in second-line HNSCC mid-2026. CRB-701 targets the same Nectin-4 antigen as enfortumab vedotin (Padcev) and Bicycle Therapeutics' zelenectide pevedotin — the second-line HNSCC opportunity is the segment where the three programs will compete most directly.

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TRIUMPH-1 Dysesthesia Signal Mechanism Discussion: 12.5% at 12 mg Tied to Glucagon-Receptor Activation, Dose-Dependent, Mild and Resolving in TRIUMPH-4 Follow-On

The TRIUMPH-1 dysesthesia signal (skin tingling, paresthesia-like sensations) that BMO Capital flagged Thursday merits a mechanistic look. The signal appeared in 12.5% of participants on retatrutide 12 mg in TRIUMPH-1, but was NOT reported in the Phase 2 retatrutide program. TRIUMPH-4 (December 2025 readout) recorded dysesthesia in approximately 20.9% of participants on the highest dose — most cases mild and resolving during ongoing treatment. The mechanistic explanation is tied to retatrutide's glucagon-receptor activation: glucagon signaling drives small-fiber sensory neuropathy patterns through downstream effects on c-AMP-mediated nociceptor sensitization. The pattern is dose-dependent (4 mg essentially no signal, 9 mg modest, 12 mg the peak). The clinical question is whether dysesthesia stays mild and reversible at commercial scale or whether a small fraction of patients develop persistent or more severe sensory disturbances. The signal is the differentiator from tirzepatide (no glucagon arm) and semaglutide (no glucagon, no GIP).

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Retatrutide MASLD Phase 3 (NCT06859268) Enrollment Continues — 86% Phase 2 Liver-Fat Reduction Baseline; H1 2027 Topline Expected

Eli Lilly's retatrutide MASLD Phase 3 program (NCT06859268) continues enrollment across multiple international sites following the December 2025 Phase 2 readout that documented 86% mean liver-fat reduction at 48 weeks on 12 mg dosing. The Phase 3 trial enrolls adults with biopsy-confirmed MASH stages F2-F3 with primary endpoint at week 52 measuring MASH resolution without worsening of fibrosis. The 86% liver-fat reduction substantially exceeds the resmetirom 38-46% benchmark from the MAESTRO-NAFLD-1 reference cohort. Topline data is expected H1 2027; full results at AASLD or EASL 2027. The MASLD Phase 3 sits alongside TRIUMPH-3 (obesity + CVD) and TRIUMPH-OUTCOMES (10,000-patient cardiovascular outcomes trial reading 2027) as the second 2027 retatrutide catalyst. If positive, retatrutide files for MASH labeling alongside the obesity NDA — potentially within the same FDA submission window.

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Bicycle Therapeutics Duravelo-2 Phase 2 Detailed Data (May 22): 65% ORR (17/26) and 58% BICR-Confirmed ORR (15/26) at 27-Week Cutoff for Zelenectide Pevedotin + Pembrolizumab in 1L Urothelial Cancer

Bicycle Therapeutics' formal post-ASCO 2026 press release Friday morning specified the headline Phase 2 numbers from yesterday's abstract release. In the Duravelo-2 combination cohort, the optimal zelenectide dose plus pembrolizumab 200 mg every three weeks produced 65% ORR (17/26 evaluable patients) regardless of confirmation, with 58% BICR-confirmed ORR (15/26) at the 27-week cutoff in previously untreated locally advanced or metastatic urothelial cancer. An additional confirmed BICR response observed after the cutoff would bring the rate to 62%. The trial tested two dose schedules: 5 mg/m² weekly and 6 mg/m² two-weeks-on-one-week-off; the optimal dose moves forward in the Phase 3 expansion. Treatment retention was high and dose-limiting adverse events limited. The 65% Phase 2 ORR matches the 65% Phase 1 Duravelo-1 ORR (13/20) — pharmacology consistency across two different patient populations, an unusual durability signal for a peptide-drug conjugate.

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BriaCell ASCO 2026 Follow-On Press Release (May 22): Final Phase 2 Bria-IMT Median Overall Survival 16.6 Months in Heavily Pretreated Metastatic Breast Cancer With Phase 3 Formulation

BriaCell's formal post-ASCO 2026 press release Friday morning specified the headline number from yesterday's abstract release. Final Phase 2 median overall survival with Bria-IMT plus checkpoint inhibitor reached 16.6 months in heavily pretreated metastatic breast cancer patients using the Phase 3 formulation — a substantial improvement over historical post-ADC, post-CPI, post-CDK4/6-failure populations where median OS typically runs 8-10 months. The release also specified positive quality-of-life data from the ongoing Phase 3 study and biomarker analyses confirming the predictors of anti-cancer response observed in Phase 2 carry forward into the Phase 3 cohort. The three poster presentations plus three publication-only abstracts at ASCO 2026 (May 29-June 2) will detail 12- and 24-month survival, treatment tolerability, and circulating-tumor-cell biomarker work. The 16.6-month median OS sets the bar BriaCell needs to clear or beat in the ongoing Phase 3 to support its accelerated approval ambitions.

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Eli Lilly TRIUMPH-1 Phase 3 Topline (May 21): Retatrutide Delivers 28.3% Weight Loss at 12 mg / 25.9% at 9 mg / 19.0% at 4 mg Over 80 Weeks, 45.3% Reach ≥30% Loss, 30.3% in BMI ≥35 Extension at 104 Weeks

Eli Lilly announced TRIUMPH-1 topline results May 21 from the 80-week Phase 3 registrational trial of retatrutide — a first-in-class GIP/GLP-1/glucagon triple-receptor agonist — in 2,339 adults with obesity or overweight and at least one weight-related comorbidity, without diabetes. Mean body weight loss was 28.3% (70.3 lbs) at 12 mg, 25.9% at 9 mg, and 19.0% at 4 mg, all versus 2.2% on placebo. All three doses met the primary and key secondary endpoints. 45.3% of participants achieved ≥30% weight loss — bariatric-surgery territory. A 104-week extension in adults with baseline BMI ≥35 saw mean weight loss reach 30.3% (85.0 lbs) on 12 mg. Full data presentation is scheduled for ADA 2026 in New Orleans (June 5-8). Lilly's NDA filing follows the TRIUMPH-2 (obesity + T2D) and TRIUMPH-3 (obesity + established cardiovascular disease) readouts expected later in 2026.

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TRIUMPH-1 Safety Profile: 4.1% / 6.9% / 11.3% Discontinuation on 4 / 9 / 12 mg Retatrutide vs 4.9% Placebo; Transient ALT Elevations Normalize by Week 24

TRIUMPH-1's safety profile landed alongside the efficacy headline. Discontinuation rates due to adverse events were 4.1%, 6.9%, and 11.3% on retatrutide 4 mg, 9 mg, and 12 mg respectively, versus 4.9% on placebo. The most common adverse events were nausea, diarrhea, constipation, and vomiting — generally mild-to-moderate, concentrated during dose escalation, and decreasing over time. The hepatic-enzyme signal that appeared in TRIUMPH-4 (December 2025) reappeared as transient ALT elevations in a subset of participants on 9 mg and 12 mg dosing, normalizing by week 24. Liver fat dropped >80% on 8-12 mg dosing, supporting the interpretation that the transient transaminitis reflects hepatic triglyceride mobilization rather than hepatotoxicity. The 12 mg discontinuation rate at 11.3% sits modestly above tirzepatide 15 mg in SURMOUNT-1 (~7%) and Wegovy 2.4 mg in STEP 1 (~6.5%) — a tolerability gap that prescribers and patients will weigh against the efficacy gain.

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Novo Nordisk AMAZE-12 Phase 3 Amycretin Trial Begins Recruitment May 18 — Dual GLP-1/Amylin Receptor Agonist for Weight Maintenance

Novo Nordisk's AMAZE-12 Phase 3 trial of amycretin — a dual GLP-1 and amylin receptor agonist — began recruiting on May 18, 2026. The trial evaluates amycretin specifically for weight maintenance after initial weight loss, distinguishing it from AMAZE-1 (which measures body weight change over 84 weeks). The amycretin clinical rationale rests on Phase 1 weekly subcutaneous dosing producing 22% weight reduction at 36 weeks and oral formulation producing 13.1% at 12 weeks — both reported in the Lancet earlier in 2026. Amycretin sits within Novo's next-generation pipeline alongside CagriSema (cagrilintide + semaglutide, FDA filing under review with decision expected late 2026) and the orexin-related pipeline acquired via Centessa. The amycretin program is structurally Novo's most direct response to Lilly's retatrutide.

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Avacta AVA6000 ASCO 2026 Salivary Gland Cancer Data (May 21): 90% Combined Disease Control, 2 Confirmed Partial Responses + 7 Minor Responses in 30 Phase 1b Patients

Avacta's AVA6000 — a fibroblast activation protein (FAP)-activated peptide-drug conjugate releasing doxorubicin selectively in the tumor microenvironment — released Phase 1a/1b data at ASCO 2026 in salivary gland cancers. Of 30 patients in the Phase 1b cohort treated at 250 mg/m² and above, two experienced confirmed partial responses (>30% tumor shrinkage) and seven experienced minor responses (10-30% shrinkage). The combined Phase 1a + 1b disease control rate reached 90%. Phase 1a data in 11 patients at the same dose range showed 1 confirmed partial response, 4 minor responses, 1 progression, and 5 stable disease — a 91% disease control rate. The favorable safety profile continued versus conventional doxorubicin, with no severe cardiac toxicity events. The data anchors Avacta's planned Phase 2/3 expansion in adenoid cystic carcinoma — the most common salivary gland cancer subtype, with no FDA-approved systemic therapy.

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Bicycle Therapeutics Duravelo-2 ASCO 2026 Data (May 21): Zelenectide Pevedotin + Pembrolizumab in 1L Urothelial — Oral Presentation Monday June 1, Abstract 4516

Bicycle Therapeutics released Duravelo-2 Phase 2/3 interim analysis data at ASCO 2026 — zelenectide pevedotin (BT8009, a Nectin-4-targeting bicyclic peptide-MMAE conjugate) plus pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer. The full data presentation is scheduled for Monday June 1, 8:30-8:36 AM CT in the GU Cancers oral session (Abstract 4516). The Duravelo-1 monotherapy comparator anchor — 65% ORR (13/20) in cisplatin-ineligible 1L mUC at 5 mg/m² + pembrolizumab combination, with median DOR 11.1 months in the monotherapy expansion — sets the bar for what the Duravelo-2 combination interim must clear. Bicycle's five-abstract ASCO package includes the oral Duravelo-2 piece plus four posters covering Duravelo-1 monotherapy update, BT5528 EphA2 monotherapy and combination cohorts, and BT8009 second-line urothelial data.

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BriaCell ASCO 2026 Final Phase 2 Bria-IMT Survival Data (May 21): Cell-Immunotherapy + Checkpoint Inhibitor in Heavily Pretreated Metastatic Breast Cancer

BriaCell released final randomized Phase 2 Bria-IMT survival and quality-of-life data at ASCO 2026 alongside biomarker analyses from the ongoing Phase 3 study. Bria-IMT — a whole-cell allogeneic peptide-and-cell immunotherapy combined with checkpoint inhibitor — has been studied in heavily pretreated metastatic breast cancer patients who have failed antibody-drug conjugate, checkpoint, and CDK4/6 inhibitor therapy. The Phase 2 data set covers 12- and 24-month survival, treatment tolerability, and circulating-tumor-cell biomarker work. The Phase 3 program added Penn Medicine's Abramson Cancer Center as a site on May 13, joining Smilow Cancer Hospital at Yale New Haven and the Los Angeles Cancer Network. The six-abstract BriaCell package at ASCO 2026 — three poster presentations and three publication-only abstracts — establishes the company as the largest peptide-immunotherapy presence at this year's meeting.

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Novo Nordisk Pre-EASL 2026 Data Drop (May 19): ESSENCE Liver Safety Analysis Confirms Favorable Hepatic Profile for Semaglutide 2.4 mg in MASH

Eight days ahead of EASL Congress 2026 in Barcelona (May 27-30), Novo Nordisk released new analyses from the Phase 3 ESSENCE program showing semaglutide 2.4 mg holds a favorable hepatic safety profile across MASH subgroups, including the first dedicated Japanese MASH cohort and a women-in-menopause subset. Gastrointestinal events remained the leading adverse-event signal, with small discontinuation rates. MASH affects an estimated 250 million people globally with roughly 9 in 10 cases undiagnosed; the trial data reinforce the FDA's August 2025 MASH-with-fibrosis approval and broaden the prescribing case ahead of the EASL plenaries.

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Real-World ECO 2026 Analysis (May 18): 89,718-Patient Cohort Shows BMI Reduction Tiers Track With Obesity-Related Risk Outcomes; 20.8% Gained Weight

An ECO 2026 analysis covered May 18 by ScienceDaily examined 89,718 patients starting GLP-1 therapy — 75.6% semaglutide, 17.5% tirzepatide, 6.9% liraglutide — and stratified BMI change at year one. In the first year, 27% reduced BMI by less than 5%, 22.4% by 5-10%, 14.1% by 10-15%, and 15.8% by ≥15%, while 20.8% actually gained weight. Greater weight loss correlated with larger reductions in obesity-related risk endpoints; patients who gained weight after starting treatment faced worse health outcomes than untreated comparators in several measures.

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Avacta Unaudited 2025 Preliminary Results (May 19): FOCUS-01 First Patient Dosed March 2026 in Phase 1 AVA6103 (FAP-Exatecan pre|CISION-Enabled PDC)

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.

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MetaVia ADA 2026 Late-Breaking Abstracts Confirmed (May 18): DA-1726 Oxyntomodulin Analog Phase 1 Part 3 + Vanoglipel (DA-1241) GPR119 Combination Posters June 7

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.

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BriaCell Pipeline Expansion to Ovarian Cancer (May 15): Bria-OVA+ Personalized Off-the-Shelf Cell-Based Immunotherapy, ATCC Cell-Line Licensing

BriaCell announced May 15 it has expanded its pipeline to include Bria-OVA+, a next-generation personalized off-the-shelf cell-based immunotherapy for ovarian cancer. The company licensed ovarian-cancer cell lines from American Type Culture Collection (ATCC) and has commenced development activities to support production of Bria-OVA+ for potential clinical use. The candidate is designed with additional immune-stimulating components to support enhanced anti-tumor activity, building on Phase 2 efficacy and tolerability data in metastatic breast cancer. The company is targeting ovarian cancer because an estimated 21,010 women in the US will be diagnosed in 2026 and approximately 12,450 will die from the disease, with ovarian cancer remaining the deadliest gynecologic cancer. The expansion adds to the BriaCell platform spanning Bria-IMT (metastatic breast), Bria-OTS+ (next-gen breast and prostate), Bria-PROS+ (prostate), and Bria-BRES+ (breast).

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BriaCell Bria-PROS+ Clinical Manufacturing Completed for Prostate Cancer (May 14) — Penn Medicine Abramson Added to Phase 3 Bria-IMT Breast Cancer Trial (May 13)

BriaCell announced May 14 it has completed manufacturing of clinical supplies for Bria-PROS+, the company's prostate cancer cell-based immunotherapy candidate, positioning the program for an IND filing and Phase 1/2 initiation later in 2026. On May 13, BriaCell added Penn Medicine's Abramson Cancer Center as a clinical site for the pivotal Phase 3 Bria-IMT metastatic breast cancer study, bringing the trial-site network to include Smilow Cancer Hospital at Yale New Haven and Los Angeles Cancer Network. The two announcements come ahead of BriaCell's six accepted ASCO 2026 abstract presentations on Bria-IMT and Bria-OTS+ in metastatic breast cancer, scheduled for the May 29-June 2 Chicago meeting. The May 6 FDA clearance for the Bria-BRES+ clinical study completes a busy two-week operational cadence for the company.