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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 (Nasdaq: APGE) has initiated dosing in its Phase 1 clinical trial for APG990, a novel half-life extended monoclonal antibody targeting OX40L for atopic dermatitis (AD) treatment. The trial, involving healthy volunteers, will assess safety, tolerability, and pharmacokinetics. Interim data is expected in 2025.
Apogee plans to start a combination trial of APG777 and APG990 in 2025, potentially offering enhanced efficacy in AD and other inflammatory and immunology (I&I) diseases. This approach combines IL-13 inhibition (APG777) with OX40L inhibition (APG990), targeting multiple inflammation pathways.
The company has advanced three programs to clinical trials within 12 months, demonstrating rapid progress in developing differentiated treatments for major I&I diseases.
Apogee Therapeutics (Nasdaq: APGE) reported pipeline progress and Q2 2024 financial results. Key highlights include:
1. Advancement of APG777 with Phase 2 Part A data expected in 2H 2025
2. APG808 interim Phase 1 data due in Q4 2024
3. APG990 Phase 1 trial initiation accelerated to Q3 2024
4. Addition of APG333, targeting TSLP, to enter clinic in 2025
5. Planned combination studies of APG777+APG990 and APG777+APG333
Financial position: $790 million in cash, cash equivalents, and marketable securities, providing runway into 2028. Q2 2024 R&D expenses were $33.2 million, G&A expenses $10.9 million, and net loss $33.8 million.
Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotechnology company, announced the appointment of Lisa Bollinger, MD, to its board of directors. Dr. Bollinger, with over 30 years of experience in drug development and regulatory affairs, previously served as VP, Global Regulatory Affairs and Clinical Safety at Merck. She brings extensive expertise in pediatrics and regulatory processes, having held significant roles at the FDA and Amgen. Apogee CEO Michael Henderson emphasized her role in advancing the company's pipeline, including treatments for atopic dermatitis and COPD. Dr. Bollinger expressed enthusiasm for contributing to Apogee's mission to develop innovative therapies for diseases with high unmet needs.
Apogee Therapeutics (Nasdaq: APGE), a clinical-stage biotech company focused on developing biologics for atopic dermatitis, COPD, asthma, and other inflammatory and immunology conditions, announced its participation in two upcoming investor conferences. The Jefferies Global Healthcare Conference will take place on June 6, 2024, at 8:30 a.m. ET, followed by the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024, at 11:20 a.m. ET. Live and archived webcasts of these events will be accessible through the company's website.
Apogee Therapeutics announced the dosing of the first patient in its Phase 2 trial of APG777 for atopic dermatitis (AD). APG777 is a novel subcutaneous monoclonal antibody targeting IL-13, with a half-life extended to approximately 75 days. Phase 1 results indicated a potentially best-in-class profile. The Phase 2 study combines typical Phase 2a and 2b into a single protocol, with an expected 16-week proof-of-concept data in 2H 2025. The trial aims to improve clinical responses with fewer injections. APG777's potential for treating asthma and other inflammatory diseases is also being explored.
Apogee Therapeutics, a clinical-stage biotechnology company, reported pipeline progress and first quarter financial results. The company initiated Phase 2 trials for APG777 targeting atopic dermatitis, dosed the first participant in the Phase 1 trial for APG808 targeting chronic obstructive pulmonary disease, and selected a development candidate for APG990. Additionally, Apogee raised $483 million through a public offering, maintaining a cash position of $816 million. Despite positive pipeline advancements, the company reported an increase in R&D and G&A expenses resulting in a net loss of $32.1 million for the first quarter of 2024.
Apogee Therapeutics, a clinical-stage biotechnology company, will participate in the 2024 Bank of America Healthcare Conference. The CEO and CFO will engage in a fireside chat to discuss the company's advancements in biologics for various medical conditions. The event will be webcasted for investors.
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