Celldex Therapeutics(US:CLDX)2025-05-08 20:06Clinical Trials and Efficacy - Barzolvolimab (CDX-0159) achieved primary efficacy endpoints in Phase 2 studies for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), with statistically significant mean changes from baseline to week 12 compared to placebo[65]. - The company initiated Phase 3 studies in CSU in July 2024, following successful Phase 2 results, and plans to present follow-up data through week 76 in 2025[81]. - Ongoing Phase 2 studies for Barzolvolimab include eosinophilic esophagitis (EoE), prurigo nodularis (PN), and atopic dermatitis (AD), with enrollment ongoing for AD initiated in December 2024[73][82]. - The Phase 2 study in chronic inducible urticaria (CIndU) achieved all secondary endpoints, which were highly statistically significant and clinically meaningful[81]. - Barzolvolimab demonstrated a statistically significant mean change from baseline to week 12 in UAS7 compared to placebo at all dose levels, with a mean change of -23.87 for 300 mg Q8W, -23.02 for 150 mg Q4W, and -17.06 for 75 mg Q4W[92]. - At week 12, 37.5% of patients in the 300 mg group achieved complete control (UAS7=0), compared to 51.1% in the 150 mg group and 22.9% in the 75 mg group, while only 6.4% in the placebo group achieved the same[92]. - Approximately 72% of patients had angioedema at baseline, with barzolvolimab showing significant improvements in AAS7 across all doses at week 12, achieving a >8 point improvement compared to placebo[95]. - Long-term treatment data presented indicated sustained and deepening disease efficacy over a 52-week treatment period, with improved urticaria control and reduced disease impact on quality of life[96]. - The primary endpoint of the Phase 3 studies will evaluate the clinical effect of barzolvolimab in reducing urticaria activity (UAS7) at week 12[97]. - Barzolvolimab demonstrated a complete response in 71% of patients treated with 150 mg Q4W and 52% of patients treated with 300 mg Q8W at Week 52[98]. - 74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well-controlled disease (UAS7<6) at Week 52[98]. - In a Phase 1b trial, 95% of patients with ColdU and SD achieved a complete response with a single dose of 3 mg/kg[103]. - The median duration of complete response for ColdU patients was 77+ days, while for SD patients it was 57+ days[103]. - At Week 12, 46.9% of patients receiving 150 mg Q4W and 53.1% receiving 300 mg Q8W had a negative provocation test compared to 12.5% in the placebo group[108]. - The study reported a statistically significant improvement in Critical Temperature Threshold (CTT) of -8.82°C for 150 mg Q4W and -9.61°C for 300 mg Q8W[108]. - 58.6% of patients in the 150 mg Q4W group and 68.8% in the 300 mg Q8W group achieved Urticaria Control Test scores >12 at Week 12[108]. - In a Phase 1b study for Prurigo Nodularis (PN), 57% of patients receiving 3.0 mg/kg barzolvolimab achieved a ≥4-point decrease in Worst Itch-Numerical Rating Scale (WI-NRS) at week 8, compared to 25% in the placebo group[114]. - The study showed that 29% of patients on the 3.0 mg/kg dose achieved clear or almost clear skin according to Investigator Global Assessment (IGA) at week 8, with no patients in the placebo or 1.5 mg/kg groups achieving this[114]. - The company has initiated a Phase 2 study for Eosinophilic Esophagitis (EoE) with approximately 160,000 patients in the U.S. estimated to have undergone treatment in the last 12 months, of which about 48,000 are biologic-eligible[119]. - A Phase 2 study for Atopic Dermatitis (AD) has been initiated, targeting a population where two-thirds of patients do not achieve complete control with first-line systemic therapy, indicating a significant unmet need[121]. - The company plans to present data from the EoE study in the second half of 2025, with a focus on reducing esophageal intraepithelial mast cell count as the primary endpoint[120]. Financial Performance - Total research and development expenses for the three months ended March 31, 2025, were $52.614 million, compared to $31.661 million for the same period in 2024, reflecting a 66% increase[79]. - The company incurred an aggregate of $459.7 million in research and development expenses over the past five years through December 31, 2024[78]. - Total revenues for the three months ended March 31, 2025, were $695,000, a 346% increase compared to $156,000 for the same period in 2024[131]. - The net loss for the three months ended March 31, 2025, was $53.8 million, representing a 64% increase from a net loss of $32.8 million for the same period in 2024[132]. - Cash, cash equivalents, and marketable securities totaled $673.3 million as of March 31, 2025, sufficient to meet estimated working capital requirements through 2027[143]. - Net cash used in operating activities was $54.4 million for the three months ended March 31, 2025, compared to $40.6 million for the same period in 2024[145]. - Investment and other income increased by $1.1 million to $8.9 million for the three months ended March 31, 2025, compared to $7.8 million for the same period in 2024[140]. - Product development expenses surged by 107% to $32.2 million for the three months ended March 31, 2025, compared to $15.5 million for the same period in 2024[138]. - General and administrative expenses rose by 19% to $10.8 million for the three months ended March 31, 2025, compared to $9.1 million for the same period in 2024[139]. - The company expects revenue to decrease over the next twelve months due to a reduction in services under existing agreements[133]. - The company plans to raise additional capital through various means, including licensing drug candidates and possible business combinations[144]. Strategic Development - The company is focusing on developing a next-generation bispecific antibody platform, with CDX-622 as the first candidate targeting chronic inflammation pathways[73]. - The company emphasizes the importance of raising sufficient capital to fund ongoing clinical studies and meet long-term liquidity needs[64]. - The company plans to explore strategic partnerships to maximize the value of its technology and product portfolio while ensuring the expeditious development of each product[69]. - Barzolvolimab's manufacturing process has been successfully scaled up to produce larger cGMP batches in support of late-stage trials and potential commercialization[125]. - The company is developing CDX-622, a bispecific antibody targeting TSLP and SCF, which is expected to offer enhanced therapeutic benefits in inflammatory and fibrotic disorders[128]. - In the Phase 2 PN study, patients are being randomized to receive barzolvolimab injections of 150 mg or 300 mg every 4 weeks, with a total enrollment of approximately 120 patients[118]. - The Phase 2 study for AD will include up to 120 patients, with a primary endpoint of evaluating clinical efficacy using the Peak Pruritus Numerical Rating Scale (PP-NRS) at week 16[124]. - The company has expanded clinical development of barzolvolimab into PN, addressing a significant unmet need as there is currently only one FDA-approved therapy for this condition[112].