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Kymera Therapeutics Announces First Patient Dosed in BREADTH Phase 2b Asthma Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader
Globenewswire· 2026-01-29 12:00
Core Insights - Kymera Therapeutics has initiated dosing in its BREADTH Phase 2b clinical trial for KT-621, targeting moderate to severe eosinophilic asthma, with data expected in late-2027 [1][2] - The company is also conducting the BROADEN2 Phase 2b trial for atopic dermatitis, with results anticipated by mid-2027 [1][3] - KT-621 is a first-in-class oral degrader of STAT6, aimed at treating Type 2 inflammatory diseases, showing promising results in earlier studies [4] Group 1: Clinical Trials - The BREADTH Phase 2b trial is a global, randomized, double-blind, placebo-controlled study involving approximately 264 adult patients over 12 weeks, focusing on the efficacy, safety, and tolerability of KT-621 [2] - The primary endpoint of the BREADTH trial is the change in forced expiratory volume in one second (FEV1) from baseline, with secondary endpoints assessing additional safety and quality of life measures [2] - The BROADEN2 trial is parallel to the BREADTH trial and is expected to accelerate the development of KT-621 for multiple Type 2 indications [3] Group 2: Product Information - KT-621 is designed to degrade STAT6, a key transcription factor in IL-4/IL-13 signaling, which drives Type 2 inflammation [4] - In Phase 1 studies, KT-621 demonstrated significant STAT6 degradation and reductions in Type 2 inflammatory biomarkers, along with improvements in clinical endpoints and patient-reported outcomes [4] - The drug has the potential to address a wide range of Type 2 diseases affecting over 140 million patients globally, including asthma and atopic dermatitis [4] Group 3: Industry Context - Asthma is a chronic inflammatory lung disease with significant unmet treatment needs despite existing therapies [5] - The ongoing development of KT-621 reflects the industry's focus on innovative oral treatments that can provide biologics-like efficacy for inflammatory diseases [4][6] - Kymera Therapeutics is positioned as a pioneer in targeted protein degradation, aiming to develop effective therapies for conditions that are difficult to treat with conventional methods [6][7]
Skye Bioscience Highlights Attributes of its Peripherally-restricted CB1 Inhibitor Antibody at Keystone Obesity Conference
Globenewswire· 2026-01-29 12:00
Core Insights - Skye Bioscience, Inc. presented findings on nimacimab, a potential first-in-class monoclonal antibody for obesity treatment, at a recent conference, highlighting its efficacy and safety profile when combined with other therapies [1][2][4] Group 1: Nimacimab's Mechanism and Efficacy - Nimacimab is designed to be a peripherally-restricted CB1 receptor inhibitor, minimizing neuropsychiatric side effects associated with previous CB1-targeting drugs [3] - The studies indicated that nimacimab, when combined with lower doses of incretin agonists, could maintain a favorable safety profile while achieving significant efficacy [2][6] - In combination with suboptimal doses of tirzepatide, nimacimab resulted in weight loss of 39% and 46% respectively, demonstrating its additive effects [6] Group 2: Long-term Treatment and Maintenance - The weight loss effects of nimacimab were durable even after treatment discontinuation, with a significant reduction in weight rebound (approximately 80% blunted) [6] - Nimacimab can serve as a maintenance therapy following the discontinuation of tirzepatide, enhancing weight loss outcomes [6] Group 3: Clinical Development and Strategy - Skye is conducting a Phase 2a clinical trial for nimacimab in obesity, assessing its combination with a GLP-1R agonist (Wegovy®) [4] - The company's strategy focuses on developing next-generation therapeutics that modulate G-protein coupled receptors, aiming for clinical and commercial differentiation [4]
Study Results of Novel TYK2 Inhibitor Soficitinib in Patients with AD Published by JAMA Dermatology
Globenewswire· 2026-01-29 08:17
Core Insights - The Phase II study of soficitinib, a novel TYK2 inhibitor, shows promising safety and efficacy for treating moderate-to-severe atopic dermatitis (AD) [1][6] Study Design and Results - The study was a double-blind, placebo-controlled trial with 75 participants randomized to receive either soficitinib at 80 mg, 120 mg, or a placebo [2] - The primary endpoint focused on safety and efficacy, with key efficacy measured by the percentage change in Eczema Area and Severity Index (EASI) at week 4 [2] - Soficitinib demonstrated significant efficacy, with percentage improvements in EASI at week 4 being 78.2% for the 80 mg group, 72.5% for the 120 mg group, and 16.7% for the placebo group [3] Efficacy Endpoints - Both soficitinib doses achieved a statistically significant higher EASI-75 response rate of 64.0% compared to a 56.0% difference from placebo [3] - The 80 mg soficitinib group had a greater percentage of patients achieving a Validated Investigator Global Assessment score of 0 or 1, with a 36.0% response rate compared to 4.0% in the placebo group [3] Quality of Life and Pruritus Relief - Soficitinib provided rapid relief from pruritus, with significant improvements observed as early as day 2, peaking at week 4 [4] - In the soficitinib groups, 72.0% of patients achieved an improvement of 4 points or more at week 4, compared to 16.0% in the placebo group [4] Safety Profile - Soficitinib exhibited a favorable safety profile, with treatment-related adverse events being mild or moderate, comparable to placebo [5] - All treatment-emergent adverse events in the 80 mg group were mild [5] Future Development - Patient enrollment for the Phase III clinical trial of soficitinib in AD has been completed, with 579 patients enrolled [8] - Soficitinib is also being developed for other T-cell related autoimmune disorders, including vitiligo, with a Phase II trial completed for 162 patients [8] Company Overview - InnoCare is a biopharmaceutical company focused on developing first-in-class and best-in-class drugs for cancers and autoimmune diseases, with operations in China and the United States [9]
Bristol Myers Squibb (BMY), Microsoft (MSFT) Partner to Enhance Early Lung Cancer Detection Through AI
Yahoo Finance· 2026-01-29 07:07
Bristol-Myers Squibb Company (NYSE:BMY) is one of the best inexpensive stocks to buy now. On January 20, Bristol Myers Squibb announced a partnership with Microsoft (NASDAQ:MSFT) to enhance the early detection of lung cancer. The collaboration centers on integrating Bristol Myers’ oncology expertise with Microsoft’s advanced AI-enabled radiology platform. By using these digital tools, the companies aim to streamline the identification of non-small cell lung cancer, ensuring patients are guided toward optim ...
WuXi Biologics and Sinorda Biomedicine Enter Strategic Collaboration to Accelerate Development and Manufacturing of Innovative Bispecific Antibody
Prnewswire· 2026-01-29 02:39
Core Viewpoint - WuXi Biologics and Sinorda Biomedicine have announced a strategic collaboration to develop and manufacture SND006, a novel bispecific antibody aimed at treating inflammatory bowel disease (IBD) and other autoimmune diseases [1][2]. Company Overview - WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) that provides end-to-end solutions for biologics from concept to commercialization [4]. - The company employs over 12,000 skilled professionals across multiple countries, including China, the United States, Ireland, Germany, and Singapore [5]. - As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, with 74 in Phase III and 25 in commercial manufacturing [5]. Collaboration Details - Under the agreement, Sinorda Biomedicine will utilize WuXi Biologics' expertise in biologics development to advance SND006's preclinical studies and clinical supply, expediting the Investigational New Drug (IND) application process [2]. - Sinorda Biomedicine has completed in vitro functional validation studies for SND006 and plans to submit IND applications to the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) in 2026 [2]. Future Prospects - The collaboration aims to expand further into Sinorda Biomedicine's pipeline, which includes multiple integrated projects from molecule discovery to clinical manufacturing [2]. - Both companies believe that this partnership will accelerate the IND filings of innovative biologics, addressing unmet medical needs in autoimmune diseases [3]. Sinorda Biomedicine Overview - Established in 2010, Sinorda Biomedicine focuses on the R&D and industrialization of innovative drugs for digestive tract diseases, tumor immunity, and autoimmune diseases [8][9]. - The company has successfully commercialized its self-developed drug for gastric acid-related diseases and has ongoing clinical research for solid tumor treatments [10].
Nona Biosciences Co-founds Innovative Alliance for Translational Medicine in Immunological Diseases, Advancing a New IIT-Driven Ecosystem
Prnewswire· 2026-01-29 01:00
IITs represent an important pathway for exploring new drug indications and therapeutic strategies and serve as a key driver of medical innovation. Over the next three years, the Alliance plans to advance 10–20 innovative therapeutic candidates to the proof-of-concept stage in clinical development. Through this platform, Nona Biosciences will gain earlier and deeper insights into unmet clinical needs and access to leading scientific research capabilities, ultimately accelerating the development of innovative ...
Altimmune (ALT) Shares Slide On $75 Million Stock Offering
Benzinga· 2026-01-28 21:13
Core Viewpoint - Altimmune Inc has announced a $75 million registered direct offering of common stock, leading to a significant decline in its share price [1][9]. Group 1: Offering Details - The company has entered a securities purchase agreement for the sale of 17,045,454 shares of common stock, or pre-funded warrants [2]. - The offering is expected to generate approximately $75 million in gross proceeds, priced at about $4.40 per share, and is anticipated to close around January 29, subject to customary conditions [3]. Group 2: Use of Proceeds - Net proceeds from the offering will be used to fund preparations for the upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH), along with working capital and general corporate purposes [4]. Group 3: Stock Performance - Currently, Altimmune's stock is trading 17.4% above its 20-day simple moving average and 19.8% above its 100-day simple moving average, indicating short-term strength despite the recent decline [5]. - Over the past 12 months, shares have decreased by approximately 26.33% and are closer to their 52-week lows than highs [5]. - The stock's RSI is at 78.59, indicating overbought territory, while the MACD shows bullish momentum, suggesting a potential correction may be due [6]. Group 4: Company Overview - Altimmune is a clinical-stage biopharmaceutical company focused on developing treatments for obesity, metabolic diseases, and liver diseases, with its product candidate pemvidutide being a dual receptor agonist currently in clinical development [7]. - The recent stock offering is significant as it aims to fund further development of pemvidutide, which could address major health issues [8].
Kalaris to Present Phase 1 Clinical Data for TH103 at the Macula Society Annual Meeting
Globenewswire· 2026-01-28 21:05
BERKELEY HEIGHTS, N.J., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Kalaris Therapeutics, Inc. (NASDAQ: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company developing differentiated therapies for retinal diseases, today announced that clinical data from its Phase 1 study of TH103 will be presented at the 49th Annual Meeting of the Macula Society, taking place February 25-28 in San Diego, California. TH103 is a novel investigational therapy engineered by VEGF scientific pioneer Dr. Napoleone Ferrara to achie ...
University of Virginia Signs Master Research Collaboration Agreement with AstraZeneca to Accelerate Pre-Clinical Innovation
Globenewswire· 2026-01-28 21:01
Charlottesville, VA, Jan. 28, 2026 (GLOBE NEWSWIRE) -- The University of Virginia (UVA) today announced the signing of a Master Research Collaboration Agreement with AstraZeneca designed to expedite pre-clinical research partnerships between the global biopharmaceutical company and UVA’s schools and departments. The agreement streamlines processes and enables AstraZeneca’s research and development teams to work more effectively and efficiently across UVA’s breadth of scientific expertise, infrastructure and ...
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2026-01-28 21:01
Core Insights - Nurix Therapeutics has initiated the DAYBreak™ registrational program for bexobrutideg in relapsed/refractory chronic lymphocytic leukemia (CLL), supported by promising Phase 1 clinical data showing an 83% objective overall response rate and a median progression-free survival of 22.1 months [1][4][5] - The company reported financial results for the fiscal quarter ending November 30, 2025, highlighting a revenue increase to $84 million for the year, primarily due to $30 million in license revenue from Sanofi [2][19] - Nurix has a strong cash position with $592.9 million in cash and marketable securities, enabling continued investment in clinical programs and pipeline expansion [1][23] Clinical Development - Bexobrutideg demonstrated durable therapeutic effects in heavily pretreated CLL patients, achieving a median duration of response of 20.1 months across all doses tested [4] - The ongoing Phase 1b cohort showed higher response rates and a favorable trend toward longer progression-free survival at the 600 mg dose, which has been selected as the recommended Phase 2 dose [4][5] - Encouraging Phase 1 data for bexobrutideg in Waldenström macroglobulinemia (WM) showed a 75% objective response rate, reinforcing its potential as a therapeutic option across BTK-driven B-cell malignancies [6][7] Financial Performance - Revenue for the fiscal year ended November 30, 2025, was $84 million, up from $54.5 million in the previous year, driven by collaboration milestones and license revenue [19] - Research and development expenses increased to $316.9 million for the year, reflecting accelerated clinical trial activities [20] - The net loss for the year was $264.5 million, compared to $193.6 million in the previous year, with a net loss per share of $3.05 [23] Strategic Collaborations - Nurix is advancing its IRAK4 degrader program (GS-6791) in collaboration with Gilead, with promising preclinical data supporting its potential in autoimmune and inflammatory diseases [9] - The company continues to strengthen its collaborations with Sanofi and Pfizer, focusing on the development of targeted protein degradation medicines [21] Upcoming Initiatives - Nurix plans to initiate a global randomized confirmatory Phase 3 trial in the first half of 2026 to support full approval of bexobrutideg [14] - The company is also enrolling patients in a Phase 1b cohort for bexobrutideg in autoimmune hemolytic anemia, aiming to expand its therapeutic applications [15]