BBT002 / Bambusa Therapeutics - LARVOL DELTA

BBT002, a tetravalent bispecific antibody targeting human IL-4Rα and IL-5, demonstrated enhanced efficacy over single-pathway targeting antibodies in an ovalbumin (OVA)-induced asthma mouse model (ERS 2026) - " An OVA-induced asthma model using hIL4/hIL4Rα/hTSLP/hTSLPR or hIL4/hIL4Rα mice was utilized to evaluate BBT002's efficacy in comparison to dupilumab, a tezepelumab analogue or an anti-IL-5 mAb. These findings indicate that BBT002 may offer broader and more potent anti-T2-inflammatory and disease-alleviating effects than mAbs targeting a single cytokine or alarmins, supporting BBT002 as a differentiated therapeutic."

Bispecific • Preclinical • Asthma • Immunology • Inflammation • Pneumonia • Respiratory Diseases • IL33 • IL4 • IL5 • TSLP

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT002, a Novel Bispecific IL-4Rα/IL-5 Antibody, Across Multiple Healthy Volunteer (HV) Populations: Results from Two Phase I Studies (ERS 2026) - P1 | "BBT002 showed favorable safety, robust and sustained PK/PD activity in multiple HV populations, supporting its potential in patients with a high T2 inflammatory burden."

Bispecific • Clinical • P1 data • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL4 • IL5

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without Comorbid Asthma (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: Bambusa Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ Jun 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment open • Trial completion date • Trial primary completion date • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P1 | N=286 | Recruiting | Sponsor: Bambusa Therapeutics | N=98 ➔ 286 | Trial completion date: Mar 2027 ➔ Jul 2027 | Trial primary completion date: Oct 2026 ➔ Jan 2027

Enrollment change • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases

The Company also expects to present data from the MAD cohorts of the BBT002 Phase 1 trial in healthy volunteers at European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026, taking place June 12-15, 2026 (PRNewswire-Asia) - "BBT002 is being evaluated in ongoing Phase 1b/2a trials in patients with COPD and CRSwNP, with topline results anticipated by year-end 2026 and the first half of 2027, respectively."

P1 data • P1/2 data • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps

Bambusa Therapeutics…Announces First Patient Dosed in Phase 1b/2a CRSwNP Trial (PRNewswire-Asia)

Trial status • Chronic Rhinosinusitis With Nasal Polyps

Bambusa Therapeutics Presents Positive Preliminary Phase 1 BBT002 Data at American Thoracic Society 2026 (ATS 2026) International Conference… (PRNewswire-Asia) - "The ATS 2026 oral presentation...highlights the following data:...(i) BBT002 demonstrated rapid, robust, and sustained depletion of EOS for more than 8 weeks following a single dose compared to baseline....; (ii) BBT002 demonstrated dose-dependent, rapid, deep, and sustained reduction in TARC for at least 8 weeks following a single dose compared to baseline...; (iii) BBT002 achieved rapid, complete, and sustained inhibition of pSTAT6 for at least 8 weeks following a single dose compared to baseline."

P1 data • Chronic Obstructive Pulmonary Disease

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT002, a Novel Bispecific IL-4Rα/IL-5 Antibody: Results From the Single- and Multiple-ascending Dose Healthy Volunteers Portions of a Phase I Study (ATS 2026) - No abstract available

Clinical • P1 data • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

BBT002-001: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients with Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma (clinicaltrialsregister.eu) - P1 | N=36 | Not yet recruiting | Sponsor: Bambusa Therapeutics Inc.

New P1 trial • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma (clinicaltrials.gov) - P1/2 | N=64 | Not yet recruiting | Sponsor: Bambusa Therapeutics

New P1/2 trial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Bambusa Therapeutics | Phase classification: P1/2 ➔ P1

Phase classification • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The first person with chronic obstructive pulmonary disease (COPD) has now been dosed with BBT002, an experimental medication being developed by Bambusa Therapeutics, in an ongoing Phase 1b clinical trial (COPD News Today) - "The trial (NCT06944925) is evaluating BBT002’s safety and pharmacological properties against a placebo in up to 98 healthy adults and people with COPD, ages 35 to 75. The study may still be recruiting participants at a study site in Perth, Australia."

Trial status • Chronic Obstructive Pulmonary Disease

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1/2 | N=68 | Recruiting | Sponsor: Bambusa Therapeutics

New P1/2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

BBT002, a tetravalent bispecific antibody targeting human IL-4Rα and IL-5, demonstrated synergistic efficacy in vitro and in a porcine pancreatic elastase (PPE)-induced COPD mouse model (ERS 2025) - "hIL4/hIL4Rα knock-in C57BL/6 mice with PPE-induced COPD were utilized to evaluate BBT002's efficacy compared to Dupilumab. The findings suggest BBT002's dual-targeting approach could deliver broader and stronger anti-inflammatory effects than single-target therapies, leading to a better outcome for COPD patients."

Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • ELANE • IL4 • IL5

Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT002, A Novel Platform-In-A-Molecule Bispecific Antibody for Broad I&I Conditions and U.S. FDA Clearance of IND Application for BBT001 (The Manila Times) - "Bambusa Therapeutics, Inc...today announced that it has completed the initial dosing in healthy volunteers (HV) in its clinical trial for BBT002, a novel, half-life extended bispecific antibody designed as a "platform in a molecule" with broad applications across respiratory, dermatology, and gastroenterology....The Phase 1 clinical trial...is a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating BBT002 in healthy volunteers and adults with COPD....Interim safety and pharmacokinetic data are anticipated in the first quarter of 2026....Separately, Bambusa also announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to proceed with the clinical development of BBT001, a novel multi-targeting, half-life extended bispecific antibody for the treatment of atopic dermatitis and other inflammatory skin diseases."

IND • Trial status • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease

BBT002: A Novel Tetravalent Bispecific Antibody Targeting IL4Ra and IL5 for Enhanced Asthma Therapy (ATS 2025) - "The TF-1 cell proliferation assay was utilized to compare the effects of BBT002 with a dupilumab analogue and a mepolizumab analogue, focusing on the benefits of simultaneous blockade versus single-target inhibition. These findings indicate that BBT002's dual pathway inhibition provides a promising therapeutic advantage for asthma patients, delivering broader and more robust anti-inflammatory effects than single-target therapies, all while allowing for a more convenient dosing regimen."

Asthma • Immunology • Inflammation • Respiratory Diseases • IL13 • IL4 • IL4R • IL5 • STAT6

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Bambusa Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Bambusa Therapeutics

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Bambusa Therapeutics Raises Approximately $90 Million in Series A Financing to Advance Next-generation Bispecific Antibodies for Immunology & Inflammation Diseases (PRNewswire) - "Bambusa Therapeutics, Inc...today announced the successful completion of its oversubscribed Series A financing of approximately $90 million. The round was led by new investor RA Capital Management, with participation from new investors including Janus Henderson Investors, Redmile Group, Invus, and ADAR1 Capital Management. All existing investors also participated. The funding will support the advancement of Bambusa's lead programs through Phase I trials and drive further pipeline development...Two of Bambusa's four programs are on track to enter the clinic in Q1 2025 and mid-2025, respectively. BBT001...intended to supplant the current standard of care for a range of dermatological conditions. BBT002...created as a 'platform in a molecule' with applications across respiratory, dermatology, and gastroenterology indications...BBT003 and BB004, also have best-in-disease potential in the inflammatory bowel diseases and rheumatological indications."

Financing • New P1 trial • Dermatology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatology