Climb Bio (CLYM) Leerink Global Healthcare Conference 2025 summary

Strategic focus and pipeline overview

• Targeting immune-mediated diseases with unmet need, focusing on monoclonal antibodies for broad therapeutic potential.

• Pipeline includes two main assets: Budo (CD19 monoclonal antibody) and CLYM116 (anti-APRIL antibody).

• Budo is being developed for membranous nephropathy (PMN), ITP, and SLE, with subcutaneous formulation achieved.

• CLYM116 was in-licensed this year, featuring half-life extension and pH-dependent binding for enhanced potency.

• Both assets are supported by strong biological rationale and early data, with significant commercial opportunity.

Clinical data and development plans

• Budo showed promising phase 1b results in PMN, with 60% achieving complete renal response and strong B-cell suppression.

• Next PMN study will expand dose range to optimize B-cell suppression and clinical response.

• ITP program will use objective platelet count endpoints, aiming for stable response rates above current standards.

• SLE program leverages CAR-T data showing immune reset, aiming to replicate with antibody therapy in highly active patients.

• CLYM116 preclinical head-to-head data expected later this year, with rapid transition to clinical studies if results are positive.

Differentiation and competitive positioning

• Budo offers higher CD19 affinity and subcutaneous administration, differentiating it from existing CD19 therapies like Uplizna.

• Subcutaneous formulation enables broader disease targeting beyond neurological orphan indications.

• Deep B-cell suppression is linked to better long-term outcomes, guiding dose selection for future studies.

• SLE landscape is crowded, but B-cell targeted therapies show the greatest efficacy; Budo aims for high efficacy in this space.

• IP and regulatory exclusivity strategies are in place to protect innovation for both assets.