Bambusa Therapeutics Initiates Subcutaneous Dosing of BBT001 in Atopic Dermatitis, Following Compelling Intravenous Proof-of-Concept Data

First patient dosed as Bambusa expands global development of its long-acting bispecific antibody targeting both IL-4Rα and IL-31

High-concentration subcutaneous formulation designed to combine BBT001’s emerging profile of rapid, deep and durable clinical activity with convenient administration and the potential for infrequent maintenance dosing

Milestone demonstrates continued execution of Bambusa’s strategy to bring together efficacy, durability and dosing convenience in a single differentiated therapy for patients with chronic inflammatory skin disease

BOSTON, October 1, 2026 /PRNewswire/ — Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biotechnology company advancing next-generation, long-acting bispecific antibodies for immunology and inflammation (I&I), today announced that the first patient has been dosed in the subcutaneous (SC) cohort of its ongoing global Phase 1 clinical trial of BBT001 at a clinical research center in New Zealand. BBT001 is Bambusa’s half-life-extended, bispecific antibody engineered to block IL-4Rα and IL-31 signaling, with the goal of addressing both Type 2 inflammation and itch in patients with atopic dermatitis (AD) and other Type 2 inflammatory skin diseases. The initiation of SC dosing follows the potentially transformative preliminary proof-of-concept results already achieved with intravenously administered BBT001 and expands Bambusa’s evaluation of a potentially more convenient treatment approach for chronic use in AD patients.

“Subcutaneous dosing represents an important step in advancing BBT001 as a differentiated, long-acting and convenient therapy for patients with atopic dermatitis,” said Thang Ho, Ph.D., Co-Founder and Chief Development Officer of Bambusa Therapeutics. “The prolonged half-life observed in healthy volunteers and patients, together with the compelling clinical activity demonstrated in our intravenous proof-of-concept study and our high-concentration subcutaneous formulation, provides a strong foundation for the late-stage development of BBT001. We are now focused on translating BBT001’s rapid, deep and durable clinical profile into a convenient subcutaneous therapy with the potential for infrequent maintenance dosing. This study represents an important part of our advancement of the BBT001 development program, with preparations for our Phase 2b study already underway.”

Compelling Clinical Proof of Concept Data

In July 2026, Bambusa reported preliminary results from a randomized, double-blind, placebo-controlled proof-of-concept cohort enrolling biologic-naïve patients with moderate-to-severe AD from New Zealand and the United States. After four weeks of treatment, BBT001 demonstrated rapid, deep and durable clinical activity:

  • Rapid and deep skin responses: Statistically significant placebo-adjusted EASI improvement was observed beginning at Week 1 (35.6%; p=0.0012), deepening to 79.0% at Week 6 (p<0.0001), with a 64% placebo-adjusted EASI-75 response at Week 6. The placebo-adjusted EASI reduction deepened through Week 6 and remained sustained throughout the follow-up period.
  • Rapid and progressively greater itch relief. BBT001 reduced PP-NRS scores as early as Day 1, with improvements deepening throughout treatment and remaining sustained for eight weeks after the last dose.
  • Durable pharmacology: Type 2 inflammatory biomarkers, including TARC and IgE, were substantially suppressed, with effects sustained for eight weeks following the last dose.
  • Favorable emerging profile: BBT001 was observed to be well tolerated, with no cases of conjunctivitis reported and low immunogenicity. An approximately 33-day half-life, together with sustained clinical and pharmacodynamic activity, support the potential for maintenance dosing as infrequently as once every three months.


About the BBT001-001 SC Cohort in AD Patients

The SC cohort is part of Bambusa’s global Phase 1 BBT001-001 study and is evaluating 12 weeks of treatment with SC BBT001 in biologic-naïve patients with moderate-to-severe AD. The cohort is currently enrolling up to 45 patients across the United States, Australia, Europe and New Zealand. Patients will receive five doses of BBT001 at either 360 mg or 720 mg, or the placebo, administered subcutaneously.

The primary endpoints are safety and tolerability. Secondary endpoints include pharmacokinetics, including half-life, and immunogenicity. Exploratory endpoints include pharmacodynamic measures and clinical activity, including change from baseline in Eczema Area and Severity Index (EASI) and Peak Pruritus Numerical Scale (PP-NRS) and the proportion of patients achieving a validated Investigator Global Assessment (vIGA-AD) score of 0 or 1.

About BBT001

Bambusa Therapeutics’ lead clinical program, BBT001, is a potential first-in-class, multi-targeting, half-life-extended bispecific antibody engineered to block both IL-4Rα and IL-31 signaling. By simultaneously addressing core Type 2 inflammation and directly targeting pathways that drive itch, BBT001 is designed to provide faster, deeper, and more durable relief for patients with AD and other Type 2 inflammatory skin diseases.

Bambusa previously presented Phase 1 data in healthy volunteers and in AD patients that support favorable safety results, positive pharmacokinetic and pharmacodynamic activity, and the potential for quarterly maintenance dosing. Bambusa is currently evaluating BBT001 in multiple ongoing placebo-controlled clinical trials, including studies in patients with AD and chronic spontaneous urticaria.

About Bambusa Therapeutics

Bambusa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation, multi-targeting medicines designed to transform patient care across chronic immunology and inflammation diseases. We combine advanced protein engineering with half-life extension technology and high-concentration subcutaneous delivery to improve durability, convenience, and clinical differentiation. Bambusa’s vision is to deliver transformative medicines for patients across every stage of life and help define the next era of I&I therapies.

  • BBT001 is a half-life-extended bispecific antibody targeting interleukin-4 receptor alpha (IL-4Rα) and interleukin-31 (IL-31) with first-in-class potential. It is currently in development for atopic dermatitis and chronic spontaneous urticaria.
  • BBT002 is a half-life-extended bispecific antibody targeting IL-4Rα and interleukin-5 (IL-5) with pipeline-in-a-molecule and first-in-class potential. It is currently in development for Type 2 inflammatory disorders including asthma, chronic obstructive pulmonary disease and chronic rhinosinusitis with nasal polyps.
  • BBT003 and BBT004 are preclinical programs focused on gastroenterology and autoantibody-driven autoimmune diseases, respectively.

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Jon Lieber

Chief Financial Officer

Jonathan I. Lieber, MBA, is Chief Financial Officer of Bambusa Therapeutics. Jonathan brings more than 30 years of financial, strategic, and business experience across the life sciences industry.

Jonathan joined Bambusa from Rallybio Corporation, where he has served as Chief Financial Officer since 2023. Previously, he served as Chief Financial Officer of Applied Genetic Technologies Corporation and as a Managing Director at Danforth Advisors, where he provided strategic and operational financial leadership to life sciences companies. Earlier in his career, Jonathan served as Chief Financial Officer of Histogenics Corporation, Metamark Genetics, Repligen Corporation, Xcellerex, and Altus Pharmaceuticals. He began his career in healthcare investment banking at Salomon Brothers/Salomon Smith Barney and Cowen and Company/SG Cowen.

Jonathan currently serves on the boards of directors of Decoy Therapeutics, MindWalk Holdings, and Zola Therapeutics. He holds a B.S. in Business Administration and Finance from Boston University and an MBA in Finance from New York University’s Leonard N. Stern School of Business.

Todd James

Executive Vice President, Chief Financial Officer

Todd R. James serves as Chief Financial Officer of Bambusa Therapeutics, where he leads the company’s finance organization, capital markets strategy, and investor relations.

Prior to joining Bambusa, Mr. James founded TRJ BioAdvisors, where he advised biotechnology CEOs and Boards on capital markets strategy, investor relations, corporate communications, and special situations including mergers and acquisitions, shareholder activism defense, and clinical data disclosures.

Previously, Mr. James served as Senior Vice President of Corporate Affairs and Investor Relations at Viridian Therapeutics. Earlier, he held leadership roles of increasing responsibility at Acceleron Pharma, where he was a member of the Executive Committee and built the company’s investor relations, corporate communications, and broader external stakeholder engagement functions. During his tenure, he supported multiple public equity financings totaling more than $1 billion prior to the company’s $11.5 billion acquisition by Merck.

Earlier in his career, Mr. James served as a Senior Vice President at The Trout Group / Trout Capital and began his career at Thomson Financial providing capital markets intelligence to publicly traded biotechnology companies.

Mr. James has been recognized multiple times by Institutional Investor as a member of the All-America Executive Team for excellence in biotechnology investor relations. He holds a B.A. in Economics with a concentration in Finance from Moravian University.

Jen Salstrom

Vice President, Clinical Development

Bio here.

BBT002

Type 2 (T2) inflammatory diseases are characterized by skewed T2 immune responses driven by T2 cytokines including IL-4, IL-13, and IL-5. In specifics, IL-4 and IL-13, acting through IL-4Rα, promote Th2 polarization, IgE production, barrier dysfunction, mucus hypersecretion, and tissue remodeling, while IL-5 sustains eosinophil maturation, survival, and effector damage. These cytokines drive T2 inflammation across the airways, skin, and gut, contributing to diseases such as chronic obstructive pulmonary disease (COPD), asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergy, chronic spontaneous urticaria (CSU), and eosinophilic esophagitis (EoE), and making them key therapeutic targets1. Dual targeting IL-4Rα and IL-5 offers advantages over single targeting of IL-4Rα or IL-5 or upstream alarmin proteins (e.g., TSLP, IL-33) by preventing escape (or “leakage”2) of the downstream T2 cytokines (IL-4, IL-13 and IL-5) and providing complete inhibition of the pathogenic inflammation.

BBT002 blocks the entire spectrum of Type 2 cytokines (IL-4, IL-13, and IL-5) while incorporating Fc mutations that eliminate unwanted effector functions and extend half-life for longer dosing intervals. The dual targeting design positions it to provide more comprehensive benefits over current single targeting therapies across T2 inflammatory diseases, particularly those with significant eosinophilic inflammation, while eliminating the risk of eosinophilia associated with anti-IL-4Rα monotherapy.

  1. Nature Reviews Immunology: Allergy and Immunology Study (2025) — https://www.nature.com/articles/s41423-025-01261-2
  2. Wiley Online Library: Allergy Journal Article (2023) — https://onlinelibrary.wiley.com/doi/full/10.1111/all.16537

BBT001

BBT001 is a bispecific IgG1 antibody for Type 2 inflammatory dermatological conditions. Using a 2+2 format, it simultaneously engages IL-4Rα and IL-31 to deliver faster and synergistic efficacy compared to existing treatments.

The drug incorporates Fc modifications that enhance FcRn affinity and extend half-life, enabling longer dosing intervals.

BBT001’s innovation addresses a critical treatment gap. While targeting IL4/13 tackles the fundamental Th2 inflammatory cascade, it does not effectively reduce IL-31 levels, providing only slow, moderate itch relief. This leaves patients trapped in the destructive “itch-scratch cycle” where continuous scratching compromises skin barrier function and perpetuates inflammation.

BBT001’s direct IL-31 targeting is designed to immediately affect sensory nerves, rapidly reducing itchiness while accelerating skin lesion improvement. This dual-pathway approach promises to break the itch-scratch cycle more effectively than single-target therapies, potentially transforming treatment for Type 2 inflammatory dermatological conditions.

Mike Malynn

Director, Finance

Mike Malynn is Director, Finance at Bambusa. Mike brings seven years of finance and operations experience scaling biotech companies and drives Bambusa’s financial strategy to support our mission of delivering transformative treatments. Prior to joining Bambusa, Mike led U.S. operations and supported portfolio companies from inception through seed stage as Finance Manager at Gordian Ventures. He was also the first finance employee at Silicon Therapeutics, where he built the finance function and helped drive the company’s acquisition by Roivant Sciences.

Based in Boston, Massachusetts, Mike holds a B.S.B.A in Business Economics from Suffolk University, graduating Summa Cum Laude.

Shaoyang Yeh, DPhil

Associate Director, CMC

Shaoyang Yeh, DPhil, is Associate Director of CMC at Bambusa Therapeutics. Shaoyang brings extensive process development and CMC experience from leadership roles at MabPlex USA (antibody drug conjugates), Emergent BioSolutions (Phase III vaccines), and BioLegend/Revvity (diagnostic antibodies and reagents). At MabPlex, he worked directly with clients on process design, technology transfer, and regulatory filings for novel biologic products.

Based in San Diego, Shaoyang holds bachelor’s degrees in Bioengineering and Biology from UC San Diego, a master’s in Biomedical Engineering from Cornell, and a DPhil in Engineering Science from Oxford, focusing on tissue engineering and bioprocessing.

Tracy Ji, MD

Director, Clinical Operations

Xiaoping (Tracy) Ji, MD is a Director, Clinical Operations at Bambusa. Leveraging over 19 years of clinical trial experience in her strategic leadership role, she previously served as Project Director at LabCorp, managing global Phase I-III trials across Australia, USA, and EU. Prior to LabCorp, Tracy worked with several global pharmaceutical companies including GSK, Novartis, Roche, and Eisai, gaining extensive knowledge in trial management from both sponsor and CRO perspectives.

 Based in Beijing, China, Tracy holds a Postgraduate Diploma in Public Health from the University of Auckland, New Zealand, complemented by a Bachelor of Clinical Medicine from Heilongjiang University of Chinese Medicine.

Wei Liang, PhD

Director, Development Sciences

Wei Liang, Ph.D., is the Director, Development Sciences at Bambusa and brings over 13 years of post-Ph.D. research and development experience across multiple disease areas to his role. Wei previously served as the Associate Director, R&D at Ansun Biopharma, where he led the cell therapy R&D programs and contributed to the development of a biologic drug candidate. Prior to that, he served as Associate Director I at BioDuro-Sundia, where he rebuilt and led its Oncology San Diego division.

Wei earned his B.S. from the University of Science and Technology of China and completed his Ph.D. at the City of Hope Comprehensive Cancer Center. He continued his research training with postdoctoral work at City of Hope and UC, San Diego.

Lisa Li, MD

Senior Director, Clinical Operations

Lisa Li is a Senior Director, Clinical Operations at Bambusa. Lisa brings extensive clinical operations expertise to her current role, with experience spanning a broad range of therapeutic areas, including infectious disease, dermatology, oncology, pain, rare disease, In addition to operational leadership, Lisa also contributed to corporate strategic initiatives, including supporting the sale of clinical assets during company restructuring at Vital Therapies.

Originally from Beijing, China, Lisa holds a medical degree and earned an MSc in Human Nutrition from the University of Glasgow. She is currently based in San Diego, California.

Jingjing Jiang, MD, PhD

Senior Director, Development Sciences

Dr. Jingjing Jiang is Senior Director of Development Sciences at Bambusa Therapeutics. With expertise in translational research and development sciences, she has a strong track record of building R&D teams, advancing therapeutic platforms, and bridging preclinical and clinical research. Jingjing has held roles at biotech companies of various sizes, including Poseida Therapeutics, contributing to innovative drug development across multiple therapeutic modalities.

Jingjing holds an M.D. from Zhejiang University and a Ph.D. in Biomedical Engineering from UC Irvine.

Melody Zhu, PhD

Vice President, Corporate Development and Strategy

Melody (Yun) Zhu, PhD, is the Vice President, Corporate Development & Strategy at Bambusa Therapeutics. Melody brings extensive cross-functional experience spanning R&D, business strategy, and external innovation across the pharmaceutical and biotech industries. Prior to joining Bambusa, Melody served as Director of External Innovations at BioNTech in Shanghai, where she led the search and evaluation of potential in-licensing opportunities, including assets from Duality and MediLink. Melody also held leadership roles at Sanofi driving portfolio development across Immunology & Inflammation and Oncology, contributing to programs including Dupixent and Itepekimab. She began her career in strategy consulting with Boston Consulting Group (BCG) and IQVIA.

Originally from China, Melody earned her Ph.D. in Biochemistry from The Chinese University of Hong Kong, and her B.S. in Biochemistry from Nanjing University.

Wei Lin, MD ScM

Vice President, Clinical Development

Wei Lin, MD, ScM, is Vice President of Clinical Development at Bambusa. Wei brings extensive experience in clinical development across the I&I therapeutic area. Prior to joining Bambusa, she served as Senior Director and Clinical Lead at Everest Medicines, where she was responsible for the global development of a BTK inhibitor in glomerular diseases. Previously, she was Director and Clinical Lead at Pfizer, overseeing rheumatology and inflammatory bowel disease (IBD) programs. There, she successfully led China’s Phase 3 development of tofacitinib for psoriatic arthritis and ankylosing spondylitis, resulting in NDA approvals. Her team also managed multiple clinical programs in systemic lupus erythematosus, ulcerative colitis, systemic juvenile idiopathic arthritis, and dermatomyositis in China.

Originally from Xiamen, China, Wei earned her MD from Peking University and holds a ScM in Epidemiology from Johns Hopkins University.

Wenbing Hu, PhD

Vice President, Head of CMC

Wenbing Hu, PhD, is Vice President and Head of CMC at Bambusa Therapeutics. Wenbing brings extensive expertise in biologics CMC development and manufacturing, previously serving as Senior Director of Pharmaceutical Development at Ansun Biopharma, where he led CMC activities for late-stage clinical trials. Prior to Ansun, Wenbing held leadership roles at Sorrento Therapeutics, overseeing analytical development, quality control, and formulation, and successfully advanced multiple antibody and mRNA projects through clinical phases. His deep experience spans from early-stage CMC development to global regulatory filings and GMP manufacturing operations.

Based in San Diego, California, Wenbing earned his PhD in Analytical Chemistry from the Institute of Chemistry, Chinese Academy of Sciences.

Crystal MacKay

Chief Operating Officer

Crystal MacKay is the Chief Operating Officer at Bambusa. Crystal brings extensive healthcare experience to her current role, having previously served as a Director of Healthcare Investment Banking at BTIG, where she was responsible for transaction execution in the Life Science & Diagnostic Tools and Medical Technology sectors. Crystal built operational expertise through leadership roles at innovative healthcare companies, including Oxford Immunotec, where she played a key role in strategic initiatives during the company’s transition, Strata Pathology Services, and Calloway Laboratories, where she served on the Board of Directors. 

Based in Boston, Massachusetts, Crystal holds a Bachelor of Arts in Business Communications from the University of Massachusetts and maintains securities licenses including SIE, Series 79, and Series 63.

Thang Ho, PhD

Co-Founder and Chief Development Officer

Thang Ho, Ph.D. is the Co-Founder and Chief Development Officer at Bambusa, where he leads an integrated team spanning preclinical research, translational medicine, toxicology, and clinical pharmacology while playing a critical role in shaping the company’s strategy across U.S. and global programs. Prior to Bambusa, Thang served as Director of Clinical Pharmacology and Pharmacometrics at BioNTech, leading clinical pharmacology strategies for innovative programs including cell and gene therapies and immuno-oncology agents. His career also includes scientific roles at Takeda, CytomX, and Vertex Pharmaceuticals.

Trained as a systems pharmacologist and engineer, Thang holds a Ph.D. in Chemical Engineering from the University of Pittsburgh, and earned his B.S. and M.S. in Chemical Engineering from the University of Arkansas. Originally from Da Nang, Viet Nam, Thang is based in Boston, Massachusetts.

Shanshan Xu, MD, PhD

Founder and Chief Executive Officer

Shanshan Xu, MD, PhD, is the Founder and Chief Executive Officer of Bambusa. Shanshan founded Bambusa with a belief that the I&I field is long overdue for innovative approaches and transformative cutting-edge solutions.

Prior to founding Bambusa, Shanshan served as Head of Global External Innovations at BioNTech, where she and her team sourced and executed 13 strategic partnerships and acquisitions to expand BNT’s pipeline. Her most notable accomplishment was identifying and acquiring Biotheus, which brought BNT327 (now partnered with BMS in a deal valued up to $11.1B). In addition, she identified the I&I molecules within Biotheus that ultimately became the foundation of Bambusa. Her portfolio also included the Duality, MediLink and OncoC4 partnerships, Tier 1 oncology programs. Before joining BioNTech in 2020, Shanshan worked on Wall Street as a Research Analyst.

Originally from Harbin, China, Shanshan spent almost half of her life in Mainland China, where she received her medical degree. She also holds a Ph.D. from UC-Irvine and an MBA from MIT.