Core Viewpoint - Connect Biopharma's collaborator, Simcere Pharmaceutical, has submitted a New Drug Application for rademikibart to treat atopic dermatitis in China, indicating significant progress in the development of this potential best-in-class therapy for inflammatory diseases [1][2]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory diseases, with rademikibart as its lead product candidate targeting IL-4Rα [6]. - Simcere Pharmaceutical is an R&D-driven company focusing on therapeutic areas such as neuroscience, anti-oncology, autoimmune, and anti-infection [5]. Product Development - Rademikibart is a fully human monoclonal antibody that targets IL-4Rα, blocking the Th2 inflammatory pathway, which is relevant for treating atopic dermatitis and asthma [4]. - The AD market in China presents a considerable opportunity, with an estimated 70 million patients suffering from the condition [3]. Collaboration Agreement - In 2023, Connect Biopharma and Simcere entered an exclusive license and collaboration agreement for rademikibart in Greater China, granting Simcere exclusive rights for development, manufacturing, and commercialization [2][3]. - Connect Biopharma is eligible for milestone payments totaling approximately $110 million and tiered royalties on net sales in Greater China [3].

Core Insights - Palisade Bio, Inc. has appointed Emil Chuang, MB BS FRACP to its Board of Directors, enhancing its clinical strategy in treating Fibrostenotic Crohn's Disease and Ulcerative Colitis [1][9] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases [10] Leadership Experience - Dr. Chuang brings nearly 25 years of pharmaceutical and clinical experience, including contributions to drug development programs that led to two successful regulatory approvals: infliximab for pediatric Crohn's disease and lorcaserin for morbid obesity [3][4] - His previous roles include Chief Medical Officer at Intrinsic Medicine and leadership positions at Nestlé Health Science, Takeda, and Progenity, with over 80 peer-reviewed publications to his name [6][7] Strategic Importance - The addition of Dr. Chuang is expected to provide valuable insights into the company's clinical programs, particularly in inflammatory bowel diseases [5][6] - The company aims to leverage Dr. Chuang's expertise to advance its pipeline and address unmet medical needs in the therapeutic landscape [6]

Core Insights - Apogee Therapeutics announced positive results from the Phase 2 APEX clinical trial of APG777, demonstrating significant efficacy in treating moderate-to-severe atopic dermatitis [2][3][4] Group 1: Trial Results - APEX Part A met all primary and key secondary endpoints, achieving a 71.0% decrease in Eczema Area Severity Index (EASI) from baseline at Week 16 [1][9] - APG777 showed an EASI-75 response rate of 66.9%, which is the highest reported for any biologic in a global study, with a placebo-adjusted rate of 42.5% [1][3][9] - The trial included 123 adult patients, randomized 2:1 to receive APG777 or placebo, with a dosing regimen of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12 [4][9] Group 2: Safety and Tolerability - APG777 was well tolerated, with a safety profile consistent with other agents in its class, and serious treatment-emergent adverse events (TEAEs) were rare at 1.2% compared to 2.4% in the placebo group [1][9] - The discontinuation rate due to adverse events was low at 2.4% for APG777-exposed patients [9] Group 3: Future Developments - APEX Part B is set to test higher doses of APG777, with readout expected in mid-2026, and the initiation of a Phase 3 trial planned for 2026 [1][3][6] - The company is also conducting a Phase 1b head-to-head trial of APG279 against DUPIXENT, with results anticipated in the second half of 2026 [1][3]

Core Insights - APG777 has shown significant efficacy in treating moderate-to-severe atopic dermatitis, achieving a 71.0% reduction in EASI from baseline at Week 16, surpassing the placebo group which had a 33.8% reduction [1][9] - The drug demonstrated an EASI-75 response rate of 66.9%, the highest for any biologic in a global study, with a placebo-adjusted rate of 42.5% [1][3][9] - A favorable safety profile was observed, with serious treatment-emergent adverse events being rare at 1.2% compared to 2.4% in the placebo group [9] Clinical Trial Results - The Phase 2 APEX trial Part A enrolled 123 adult patients, randomized 2:1 to receive APG777 or placebo, with a dosing regimen of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12 [4][9] - Key secondary endpoints included EASI-90 and Validated Investigator Global Assessment (IGA) 0/1, with EASI-90 achieving 33.9% compared to 14.7% in placebo (p < 0.05) and vIGA 0/1 at 34.9% compared to 17.3% in placebo (p < 0.05) [9] - Rapid onset of itch relief was noted, with a 50.7% reduction in Itch NRS from baseline by Week 1 compared to 23.2% in the placebo group (p < 0.01) [9] Future Developments - APEX Part B is set to test higher doses of APG777, with results expected in mid-2026, while the maintenance phase readout from Part A is anticipated in the first half of 2026 [1][6] - The company is also conducting a Phase 1b trial of APG279, a combination therapy, with readout expected in the second half of 2026 [2][3] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including atopic dermatitis [2][8] - The company aims to optimize efficacy and dosing through advanced antibody engineering, targeting well-established mechanisms of action [8][10]

Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, targeting conditions such as atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), and chronic obstructive pulmonary disease (COPD) [3] - The company aims to overcome limitations of existing therapies by utilizing advanced antibody engineering to optimize properties like half-life, with a focus on achieving best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies [3] Upcoming Events - Apogee Therapeutics will report Part A 16-week data from the Phase 2 APEX trial of its lead program APG777 on July 7, 2025, followed by a conference call and webcast at 8:00 a.m. ET to discuss the results [1][2] Product Pipeline - APG777 is the most advanced program of Apogee, initially developed for the treatment of atopic dermatitis, which is identified as the largest and one of the least penetrated I&I markets [3] - The company has four validated targets in its portfolio, indicating a broad pipeline and depth of expertise aimed at delivering value and meaningful benefits to patients underserved by current standard care [3]

Core Insights - Hoth Therapeutics' investigational candidate HT-001 achieved a 100% response rate in at least one primary efficacy endpoint in its ongoing Phase 2a clinical study for EGFR inhibitor-induced skin toxicities [2][7] - The company will host a Key Opinion Leader event to discuss the interim results and potential impact of HT-001 on supportive care standards for oncology patients [1] Clinical Trial Highlights - The Phase 2a trial (CLEER-001) demonstrated that 100% of enrolled patients achieved at least one primary endpoint of clinical dermatologic improvement [7][8] - Over 65% of patients reported reductions in pain and pruritus, with 0% requiring dose reduction or discontinuation of their EGFR inhibitor therapy [7][8] - HT-001 is a once-daily topical gel that targets neuroinflammatory pathways without causing immunosuppression or systemic toxicity [4] Mechanism of Action - HT-001 is formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA) that mitigates inflammatory pathways triggered by EGFR inhibition, particularly those driven by Substance P [4][5] - Preclinical data showed significant reductions in dermatitis and alopecia severity, as well as inflammatory markers in rat models co-treated with erlotinib [5][9] Regulatory and Development Pathway - HT-001 is being advanced under the 505(b)(2) regulatory pathway, which allows the use of existing safety data to expedite development [10] - The company is currently planning a Phase 2b/3 trial following the ongoing Phase 2a trial [13]

Dr. Clark Brings 25 Years of Experience Treating Retina Diseases and Developing Emerging Therapies as a Principal Investigator in Over 70 Clinical Trials and as an Early Pioneer of VEGF Inhibitors ANX007 is the Only Investigational Program Shown to Significantly Preserve Vision and Central Retinal Photoreceptors Critical for Visual Acuity Enrollment of Phase 3 ARCHER II Trial Expected to be Completed in Q3 2025, with Topline Data Expected in Second Half of 2026 BRISBANE, Calif., June 18, 2025 (GLOBE NEWSWIR ...

Company Overview - Avalo Therapeutics, Inc. is a clinical stage biotechnology company focused on the treatment of immune dysregulation [3] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [3] Leadership Appointment - Dr. Rita Jain has been appointed to Avalo's Board of Directors, bringing over two decades of leadership experience in biopharmaceutical development [2] - Dr. Jain's previous roles include Executive Vice President and Chief Medical Officer at ChemoCentryx, where she advanced the development of Tavneos® [2] - Her expertise spans clinical development, regulatory strategy, and executive leadership across multiple therapeutic areas, including immunology and inflammation [2] Product Development - AVTX-009 is currently in a Phase 2 trial for hidradenitis suppurativa (HS), with results expected in the middle of next year [2] - The drug is a humanized monoclonal antibody that binds to interleukin-1β (IL-1β), a key driver in the inflammatory process, and is implicated in various autoimmune and inflammatory diseases [4] - Inhibition of IL-1β is considered a validated target for therapeutic intervention in multiple inflammatory diseases [4]

Ramat Gan, Israel, June 16, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that Dr. Sari Fishman, Vice President of Business Development, will present an update on the Company’s ongoing Phase IIa study in pancreatic cancer during partnering meetings at the 2025 BIO International Convention, taking place J ...

AnaptysBio (ANAB) FY Conference June 11, 2025 08:40 AM ET Speaker0 All right. Good morning. And it's my pleasure to introduce Dan Vega, President and CEO of Adaptive Bio as our next speaker. Dan, welcome. It's the time for me to host you at the Goldman Sachs Conference. Conference. So thank you for being here. Before we kick off with the Q and A, I'm going to turn it to you for a quick opening remark. Speaker1 Perfect. Well, thanks for having me here today. It's my pleasure to be here. We have a lot going o ...