ANB033 / First Tracks Biotherapeutics - LARVOL DELTA

CD122 ANTAGONISM PREVENTED LUNG AND ESOPHAGEAL INFLAMMATION IN A MURINE MODEL OF EOSINOPHILIA AND REDUCED T CELL ACTIVITY IN HUMANS IN VITRO, SUPPORTING THE EVALUATION OF ANB033 IN AN ONGOING PHASE 1C STUDY IN EOSINOPHILIC ESOPHAGITIS (UEGW 2026) - No abstract available

Preclinical • Eosinophilia • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

CD122 ANTAGONISM PREVENTED INFLAMMATION IN A MURINE MODEL OF CELIAC DISEASE AND INHIBITED THE ACTIVITY OF CYTOTOXIC CD8+ AND ACTIVATED CD4+ T CELLS FROM CELIAC PATIENTS IN VITRO, SUPPORTING THE EVALUATION OF ANB033 IN AN ONGOING PHASE 1B STUDY IN CELIAC DISEASE (UEGW 2026) - No abstract available

P1 data • Preclinical • Celiac Disease • Immunology • Inflammation • CD4

ANB033 (CD122 antagonist) (GlobeNewswire) - "70-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts: Cohort 1 (n=30) is a gluten-challenge study to assess the prevention of mucosal damage through six weeks; Top-line Cohort 1 data reaffirmed for Q4 2026...Cohort 2 (n=40) assesses the possibility of mucosal healing through 12 weeks: Cohort enhanced to enroll up to 40 patients including those with a broad range of histologic (Vh:Cd ratio ≤ 2.5) and symptom severity to further inform future development; Enrollment ongoing with top-line Cohort 2 data anticipated in Q1 2027....Phase 1b trial in EoE ongoing: 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks; Top-line Phase 1b data anticipated in Q3 2027...Plan to initiate Phase 2 trials in two additional indications in H1 2027."

New P2 trial • P1 data • Trial status • Celiac Disease • Eosinophilic Esophagitis • Immunology

ANB033, a Novel CD122 Antagonist in Development for the Treatment of Inflammatory and Autoimmune Diseases, Inhibited IL-15 and IL-2 Signaling in CD8+ and CD4+ T Cells in Vitro and in a Murine Model of GvHD (FOCIS 2026) - "Mice treated with ANB033 demonstrated potent reduction of human CD8+ and CD4+ T cell numbers, reduced body weight loss, and a greater survival benefit compared to isotype control or belatacept (CTLA-4 Ig). ANB033 significantly decreased GvHD-related pathology in the murine model and may provide therapeutic value in T cell mediated inflammatory and autoimmune diseases where IL-15 and IL-2 are pathogenic drivers of disease. These data support the rationale for evaluating ANB033 in an ongoing Phase 1b study in celiac disease."

IO biomarker • Preclinical • Celiac Disease • Graft versus Host Disease • Immunology • Inflammation • CD4 • CD8 • CTLA4 • IL15 • IL2 • STAT5 • STAT5AWqe

ANB033-101: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ANB033 (clinicaltrialsregister.eu) - P1 | N=25 | Recruiting | Sponsor: Anaptysbio Inc. | N=18 ➔ 25

Enrollment change • Celiac Disease • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

ANB033-101: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ANB033 (clinicaltrialsregister.eu) - P1 | N=25 | Recruiting | Sponsor: Anaptysbio Inc.

New P1 trial • Celiac Disease • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

ANB033 (CD122 antagonist) (GlobeNewswire) - "(i) Phase 1b trial in celiac disease ongoing; 60-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts....Top-line Phase 1b data anticipated in Q4 2026; (ii) Phase 1b trial in eosinophilic esophagitis ongoing: 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks; Top-line Phase 1b data anticipated in mid-2027."

P1 data • Trial status • Celiac Disease • Eosinophilic Esophagitis

AnaptysBio Plans First Tracks Spin-Off as Jemperli Royalties Surge, Buybacks Possible (Yahoo Finance) - "...The company expects to create a new company, First Tracks Biotherapeutics, within 'a month or two'. Under the plan, the existing AnaptysBio name will remain with a lean, royalty-based business, while the majority of employees, labs, and development-stage assets will transfer to First Tracks....First Tracks will house development programs (ANB033, rosnilimab, ANB101) and receive a large portion of AnaptysBio’s ~$310 million cash..."

Commercial • dMMR • MSI-H • Endometrial Cancer

ANB033 (CD122 antagonist) (GlobeNewswire) - "(i) Phase 1b trial in celiac disease ongoing....Top-line Phase 1b data for both cohorts anticipated in Q4 2026...; (ii) Phase 1b trial in eosinophilic esophagitis initiated in Q1 2026....Top-line Phase 1b data anticipated in 2027."

P1 data • Trial status • Celiac Disease • Eosinophilic Esophagitis

ANB033-101: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ANB033 (clinicaltrialsregister.eu) - P1 | N=18 | Recruiting | Sponsor: Anaptysbio Inc.

New P1 trial • Celiac Disease • Immunology

ANB033 (CD122 antagonist) (GlobeNewswire) - "(i) Phase 1b cohort in celiac initiated - Top-line Phase 1b data anticipated in Q4 2026; (ii) Plan to initiate an additional Phase 1b trial in a second inflammatory disease in 2026 - Exploring eosinophilic esophagitis as a potential indication."

New P1 trial • P1 data • Trial status • Celiac Disease • Eosinophilic Esophagitis

Biopharma Co Profile (GlobeNewswire) - "AnaptysBio...announced today that its Board of Directors approved plans to explore separating its business into two independent, publicly traded companies, each poised for strong, sustainable growth.....Upon completion, Biopharma Co will be a clinical-stage biotechnology company focused on the development and potential commercialization of innovative therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033 and ANB101."

Commercial • Immunology • Inflammation

Anaptys to Provide Overview of ANB033, a CD122 antagonist, at Virtual Investor Event on Tuesday, Oct. 14 (GlobeNewswire) - "The event will cover: (i) ANB033’s mechanism of action, an antagonist of the CD122 receptor; (ii) Preclinical data and initial Phase 1a data in healthy volunteers; (iii) Celiac disease (CeD) disease biology and Phase 1b trial design."

Clinical protocol • P1 data • Preclinical • Celiac Disease

Anaptys Announces Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "PORTFOLIO UPDATES:...ANB033 (CD122 antagonist): (i) Phase 1 trial ongoing in healthy volunteers; (ii) Plan to initiate Phase 1b cohort for ANB033 in initial indication, celiac disease, by Q4 2025; (iii) Additional information to be disclosed at ANB033-focused R&D event in Q4 2025."

Clinical • New P1 trial • Trial status • Celiac Disease

Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ANB033 (CD122 antagonist): Enrollment ongoing for Phase 1a trial in healthy volunteers. Phase 1b indication to be disclosed at a 2025 R&D event. ANB101 (BDCA2 modulator): Phase 1a trial to initiate in healthy volunteers in Q1 2025....Research and development expenses were $42.6 million and $163.8 million for the three and twelve months ended December 31, 2024, compared to $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab."

Commercial • New P1 trial • Trial status • Immunology

Anaptys Announces Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on Wholly Owned ICM Pipeline:...(i) ANB033 (anti-CD122 antagonist antibody): IND application accepted by FDA in July 2024; Phase 1 trial initiation in healthy volunteers anticipated in Q4 2024; (ii) ANB101 (BDCA2 modulator antibody): Plan to submit IND application in Q4 2024."

IND • New P1 trial • Inflammation