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Apogee Therapeutics, Inc. (Nasdaq: APGE) is a clinical-stage biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma, and other inflammatory and immunology (I&I) conditions. Apogee is pioneering antibody programs that address the unmet needs in these therapeutic areas by leveraging advanced antibody engineering to improve half-life and efficacy.
Apogee’s leading programs include APG777 and APG808. APG777 is a novel, subcutaneous, extended half-life monoclonal antibody targeting IL-13, a critical cytokine in inflammation and a primary driver of AD. The company is currently conducting a randomized, placebo-controlled Phase 2 clinical trial for APG777 in patients with moderate-to-severe AD, with promising interim results from the Phase 1 trial showing a half-life of approximately 75 days. This supports the potential for maintenance dosing every three or six months, significantly reducing the treatment burden compared to existing therapies.
APG808, targeting IL-4Rα, is being developed for COPD and other I&I diseases. Apogee has successfully initiated its first clinical trial with APG808 ahead of schedule, marking a significant milestone in the company's journey to transform patient care. Initial interim data from this trial is expected in the second half of 2024, with subsequent trials planned for asthma and COPD.
Financially, Apogee is well-capitalized, with a robust $816 million cash position following a successful upsized public offering. This financial strength supports its ambitious pipeline advancements and operations into 2028.
Collaborations, such as the strategic partnership with Paragon Therapeutics, bolster Apogee’s development capabilities. This partnership focuses on the discovery and development of antibodies to tackle specific therapeutic targets, enhancing Apogee’s innovation in biologics.
With a broad pipeline and deep expertise, Apogee Therapeutics aims to deliver meaningful benefits to patients who are underserved by current standard-of-care treatments, driving forward the future of biotech solutions for inflammatory and immunological diseases.
Apogee Therapeutics (APGE) has initiated dosing in its Phase 1 clinical trial of APG333, a novel subcutaneous half-life extended monoclonal antibody targeting TSLP for respiratory and inflammatory conditions. The trial marks the company's fourth clinical program in under 18 months.
The Phase 1 trial is designed as a double-blind, placebo-controlled study in healthy volunteers, evaluating safety, tolerability, and pharmacokinetics. The study will enroll approximately 32 healthy adults across 4 cohorts, with interim data expected in second half of 2025.
The company plans to explore APG333 initially for asthma treatment, with potential combination therapy with APG777. Preclinical studies of the APG777 + APG333 combination have shown promising results in inhibiting inflammation with potential for less frequent dosing.
Apogee Therapeutics (APGE) shared positive updates during its 2024 R&D Day, highlighting progress across its inflammatory and immunology pipeline. APG808 showed positive Phase 1 data with a 55-day half-life, supporting 2-3 month dosing potential. APG777 demonstrated promising 12-month data with a 77-day half-life, suggesting possible annual dosing. The company accelerated its APG777 Phase 2 Part A trial topline data to mid-2025.
The company achieved preclinical proof-of-concept for both APG777 + APG990 and APG777 + APG333 combinations for various conditions including atopic dermatitis, asthma, and COPD. A Phase 1b head-to-head trial against DUPIXENT is planned for 2025 with data expected in 2H 2026.
Apogee Therapeutics (Nasdaq: APGE) announced the agenda for its upcoming virtual R&D Day scheduled for December 2, 2024. The event will feature presentations from key opinion leaders including Dr. Emma Guttman-Yassky and Dr. David Singh, alongside the company's management team. The agenda includes discussions on APG808 Phase 1 clinical trial interim results, APG777 updates, and strategies for addressing atopic dermatitis, asthma, and COPD treatments. The presentations will focus on the company's approach to inflammatory and immunology conditions, particularly through IL-13 and combination therapies.
Apogee Therapeutics (Nasdaq: APGE) has announced its inaugural virtual R&D Day, scheduled for December 2, 2024, at 10:00 a.m. ET. The event will showcase the company's progress in developing novel biologics for inflammatory and immunology (I&I) conditions, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease.
The presentation will feature management updates focusing on APG777's potential in atopic dermatitis treatment, combination therapy strategies, and commercial opportunities in I&I markets. Key opinion leaders will discuss the current treatment landscape and emerging opportunities for patients with these conditions.
Apogee Therapeutics (APGE) reported Q3 2024 financial results and pipeline updates. The company highlighted positive 9-month results from APG777's Phase 1 trial, supporting its potential best-in-class profile with a 75-day half-life. Key financial metrics include $753.8M in cash providing runway into 2028, R&D expenses of $45.7M, and a net loss of $49.0M. The company is advancing multiple clinical programs, including APG777 (Phase 2 data expected 2H 2025), APG808 (Phase 1 interim data in Q4 2024), and APG990 (Phase 1 interim data in 1H 2025). Additionally, APG333 was selected as a development candidate with Phase 1 initiation planned for late 2024 or early 2025.
Apogee Therapeutics (APGE), a clinical-stage biotech company focused on inflammatory and immunology treatments, announces its participation in three major investor conferences this November. The company will present at the Guggenheim Inaugural Healthcare Innovation Conference on November 12 at 3:00 p.m. ET, the Stifel 2024 Healthcare Conference on November 18 at 10:20 a.m. ET, and the Jefferies London Healthcare Conference on November 20 at 10:30 a.m. ET. Live and archived webcasts will be accessible through Apogee's website investor section.
Apogee Therapeutics (APGE) announced updated positive results from its Phase 1 trial of APG777, a novel anti-IL-13 antibody for atopic dermatitis treatment. The trial demonstrated a well-tolerated safety profile with doses up to 1,200mg, showing a half-life of approximately 75 days - three to five times longer than current treatments. Key findings include dose-proportional pharmacokinetics, near-complete inhibition of pSTAT6, and sustained TARC inhibition up to 9 months. The company expects to report Phase 2 proof-of-concept data in 2H 2025, with potential for maintenance dosing every 3-6 months compared to current biweekly or monthly treatments.
Apogee Therapeutics (Nasdaq: APGE) has announced an upcoming poster presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) 2024 Annual Scientific Meeting in Boston from October 24-28, 2024. The presentation will showcase data up to 9 months from the ongoing Phase 1 clinical trial of APG777, a novel half-life extended anti-IL-13 antibody for treating atopic dermatitis and other inflammatory diseases.
The poster, titled "APG777, anti-IL-13 monoclonal antibody, demonstrates extended half-life and sustained inhibition of Type 2 inflammatory biomarkers," will be presented on Friday, October 25, from 2:00-6:00 p.m. ET at the Hynes Convention Center. The presentation will be available on Apogee's website on October 24.
Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotechnology company, has announced its participation in the Stifel 2024 Immunology and Inflammation Summit. The company's management will engage in a fireside chat on September 18, 2024, at 12:30 p.m. E.T. / 9:30 a.m. P.T.
Apogee specializes in developing novel biologics for major inflammatory and immunology (I&I) markets, focusing on treatments for atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), and other I&I indications. Their approach aims to offer potentially differentiated efficacy and dosing options.
Interested parties can access a live and archived webcast of the presentation through the News & Events page in the Investors section of Apogee Therapeutics' website.
Apogee Therapeutics (Nasdaq: APGE) has appointed Jeff S. Hartness as Chief Commercial Officer. With over 25 years of biotech industry experience, Hartness brings extensive expertise in product launches, market access strategy, pricing, and policy. He joins from Bausch Health, where he most recently served as Executive Vice President on the Global Executive Leadership Team. Prior to that, he spent 15 years at Sanofi Pharmaceuticals focused on market access and launch execution.
CEO Michael Henderson highlighted Hartness's experience in leading launch strategies for major portfolios and navigating both emerging and established markets. Hartness expressed enthusiasm for Apogee's potential to address unmet needs in inflammatory and immunology conditions, particularly in atopic dermatitis and other I&I diseases.
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