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Climb Bio Announces CLYM116 Preclinical Data Highlighting Potential for Best-In-Class Therapeutic for IgAN
Globenewswire· 2025-09-29 11:00
New preclinical data demonstrate deeper IgA reduction and a longer half-life compared to first-generation anti-APRIL monoclonal antibody CLYM116 Phase 1 trial initiation expected in Q4 2025, with initial biomarker and dosing interval data anticipated mid-year 2026 Company to host R&D Spotlight Webcast today, September 29, 2025 WELLESLEY HILLS, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, ...
Jade Biosciences (NasdaqCM:JBIO) Conference Transcript
2025-09-16 18:02
Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM: JBIO) - **Focus**: Development of best-in-class therapeutics for autoimmune diseases, particularly through high-affinity monoclonal antibodies sourced from Paragon Therapeutics [2][36] Key Points on IGAN and Therapeutic Landscape - **Lead Program**: Anti-APRIL antibody (Jade 101) targeting Immunoglobulin A Nephropathy (IGAN) with a market potential exceeding $10 billion in the U.S. [3][37] - **Clinical Stage**: Recently transitioned to a clinical stage company with the first cohort dosed, aiming for first-in-human readout in the first half of next year [4][38] - **Current Treatment Landscape**: Most patients currently receive ACE inhibitors or ARBs, with additional therapies like SGLT2s and immunosuppressants added if proteinuria targets are not met [6][40] - **Emerging Therapies**: New KDIGO guidelines propose that all patients should receive agents proven to reduce pathogenic IgA, positioning selective anti-APRIL therapies as frontline treatments [7][41][42] Jade 101 Development Insights - **Dosing Schedule**: Targeting a subcutaneous injection every eight weeks, which is more convenient than existing therapies [3][37] - **Potency and Affinity**: Jade 101 has a femtomolar affinity to APRIL, significantly higher than competitors, allowing for effective suppression at lower doses [13][47] - **Mechanism of Action**: Designed to prevent large immune complex formation, reducing immunogenicity risks and enhancing pharmacokinetics [16][49] Clinical Data and Efficacy - **Phase Two Data**: Previous studies showed that full APRIL suppression led to significant proteinuria reduction and stabilization of eGFR, with a safety profile comparable to placebo [20][54] - **Long-term Goals**: Aiming to achieve proteinuria levels below 0.3 grams per day to minimize long-term kidney failure risks [22][55] Future Development Plans - **Phase One Trial**: Scheduled for the first half of next year in New Zealand, with plans for a targeted open-label phase two study to quickly gather proof of concept data [56][58] - **Regulatory Interactions**: Engaging with regulators to ensure efficient development pathways, particularly in light of new therapies entering the market [59][61] - **Exploration of Other Indications**: Potential expansion into other IGM-driven diseases, pending positive phase one results [63][64] Financial Position - **Funding**: Closed the last quarter with $221 million, sufficient to fund operations through 2027, including the advancement of Jade 101 and other programs [32][66] Conclusion - Jade Biosciences is positioned to capitalize on the growing market for IGAN therapies with its innovative anti-APRIL antibody, Jade 101, and is actively pursuing clinical development while maintaining a strong financial foundation.
突传利好!开盘直线拉升
Zhong Guo Ji Jin Bao· 2025-06-09 02:05
Group 1 - The US and Japan are in negotiations regarding tariffs, with Japan considering reaching an agreement before the G7 summit on June 15 [2][8] - The Nikkei 225 index opened with a rise of over 1%, reflecting positive market sentiment due to tariff negotiations [2][3] - The KOSPI index in South Korea also saw an increase of over 1.8%, indicating a similar positive reaction in the Korean market [6] Group 2 - Japan's chief trade negotiator, Akizumi, reported progress in the tariff negotiations but noted that no agreement has been finalized yet [8][9] - There is a possibility that negotiations may continue during the G7 summit, with Japan aiming to reach an agreement by then [9][10] - South Korea's President Lee Jae-myung has initiated discussions with President Trump to coordinate on tariff issues, emphasizing the importance of reaching a satisfactory agreement [10][11] Group 3 - Japanese semiconductor and pharmaceutical sectors are leading the market gains, with companies like Sosei Group and Otsuka Pharmaceutical showing significant stock price increases [11][12] - Otsuka Pharmaceutical reported positive interim results for its drug sibeprenlimab in treating IgA nephropathy, showing a 51.2% reduction in proteinuria compared to the placebo group [13] - New Star Trading Co., a clothing manufacturer for GAP and Walmart, saw its stock rise nearly 30%, reflecting strong market performance [14]