Climb Bio (NASDAQ:CLYM) outlined its clinical development strategy and upcoming data readouts during a fireside chat at H.C. Wainwright’s BioConnect Conference, with management emphasizing two biologic drug programs aimed at immune-mediated diseases, including nephrology and hematology indications.
H.C. Wainwright analyst Ram Selvaraju, who hosted the discussion, said his firm covers Climb Bio with a buy rating and a 12-month price target of $20 per share. Susan Altschuller, chief financial officer of Climb Bio, and Perrin Wilson, chief business officer, represented the company at the event.
Altschuller said Climb was founded in 2024 through the shell of Eliem Therapeutics and built around budoprutug, also referred to as Budo, a naked monoclonal antibody targeting CD19. She said the asset had produced “compelling” early data in five patients, including complete B-cell depletion, autoantibody serum negativity and a 60% complete renal response in proteinuria.
Budoprutug Positioned as a Core Pipeline Asset
Altschuller said Climb is evaluating budoprutug in three ongoing studies: a phase 2 study in primary membranous nephropathy, or PMN; a phase 1b study in immune thrombocytopenia, or ITP; and a phase 1b study in systemic lupus erythematosus, or SLE. She said all ongoing trials are expected to generate data this year. The company also has the ability to formulate budoprutug for subcutaneous administration, she added.
Management framed CD19 as a differentiated target compared with CD20, noting that CD19 is expressed across a broader range of the B-cell lineage, including cells associated with autoantibody production. Altschuller said the company views Amgen’s UPLIZNA, an anti-CD19 antibody used in rare neurological diseases, as an important commercial and clinical analog. She said Climb sees parallels for budoprutug in nephrology and hematology.
Altschuller also contrasted the antibody approach with more complex modalities such as CAR-T therapies and T-cell engagers, saying budoprutug does not carry the same risks of cytokine release syndrome or ICANS associated with those approaches. She said a redosing profile and potential use in community settings could support broader adoption if clinical data are favorable.
PMN Data Expected in the Second Half
In PMN, Altschuller said the company expects data in the second half of this year from the first 15-patient cohort in its phase 2 study, dosed at 200 milligrams. She said the company hopes to recapitulate the earlier five-patient phase 1b data, which included patients dosed at 100 milligrams and 200 milligrams.
Altschuller said Climb has a therapeutic window to explore higher doses, including up to 1,000 milligrams based on prior data generated in patients with B-cell malignancies. She said a key question for the program is whether higher doses can produce more of an “immune reset,” allowing some patients to have a treatment-free interval while others may need chronic dosing.
Management said Climb is enrolling only PLA2R-positive PMN patients in the phase 2 study. Altschuller said approximately 75% of PMN patients have disease driven by PLA2R, and the company plans to use PLA2R autoantibody data to help select a phase 3 dose rather than waiting solely for proteinuria data.
On competition, management cited Roche’s Gazyva, which is being studied in PMN, as well as other approaches including CD38-targeting therapies and BAFF/APRIL-targeted drugs. The company argued that a CD19 antibody could offer advantages through deeper B-cell depletion and potentially less frequent dosing.
ITP and SLE Programs Add Additional Readouts
In ITP, management said the company is looking at B-cell depletion and platelet response, including durable platelet response, as key measures. For later-line ITP, management said BTK and SYK inhibitors have set a benchmark of roughly 40% to 50% of patients achieving some response, with about 20% achieving a durable response.
The company said it plans to present data at the European Hematology Association meeting from the first ITP cohort, which included six patients treated with a 250 milligram dose. Management said the presentation will include B-cell and platelet data.
Altschuller described SLE differently from PMN and ITP, calling it more of a “translational experiment” for Climb. She said that if budoprutug shows an impact in SLE through deep B-cell and tissue-level depletion, the company may consider partnering for that broader indication.
CLYM116 Targets IgA Nephropathy
Climb’s second asset, CLYM116, is an APRIL-only sweeper monoclonal antibody being developed for IgA nephropathy. Altschuller said the program was licensed from Mabworks in China and that Climb presented non-human primate data last September. The company expects healthy volunteer data this summer.
Altschuller said CLYM116 is designed with pH-dependent binding to APRIL, allowing the antibody to bind APRIL extracellularly, release it in the endosome for degradation and recycle through FcRn. She said the antibody also includes a half-life-extending mutation. In non-human primates, she said Climb observed two to three times the half-life and deeper, more durable IgA suppression compared with sibeprenlimab.
Management said IgA nephropathy may require lifelong therapy and argued that dosing interval, efficacy and safety will be important competitive factors. The company also said updated treatment guidelines and the arrival of disease-modifying therapies could support market development in the indication.
Company Says Cash Runway Extends Into 2028
Altschuller said Climb is well capitalized after raising an additional $110 million at the end of April, giving the company runway into 2028. She said the funding supports multiple upcoming clinical readouts and could allow Climb to move into pivotal studies in PMN, IgA nephropathy and ITP if proof-of-concept data support advancement.
Altschuller said the company is balancing what it can execute independently as a small company with areas where partnering may make sense, particularly for broader indications. She said that by the end of this year, Climb expects to have a clearer view of budoprutug’s profile, including both intravenous and subcutaneous formulations, and the potential path forward for additional indications.
About Climb Bio (NASDAQ:CLYM)
Climb Bio Therapeutics, Inc is a clinical-stage biotechnology company focused on the discovery and development of engineered protein therapeutics for the treatment of cancer and immune-mediated disorders. The company's mission centers on designing biologics with enhanced specificity and functional activity to engage key cellular targets and improve patient outcomes in areas of high unmet need.
At the heart of Climb Bio's approach is its proprietary protein engineering platform, which combines mammalian cell display, directed evolution and computational modeling.
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The article "Climb Bio Teases Key Budoprutug, CLYM116 Readouts at BioConnect" first appeared on MarketBeat.
