Apogee Therapeutics, Inc. (Apogee) operates as a clinical stage biotechnology company. The company is advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications.
The company's pipeline comprises four antibody programs being developed initially for t...
Apogee Therapeutics, Inc. (Apogee) operates as a clinical stage biotechnology company. The company is advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications.
The company's pipeline comprises four antibody programs being developed initially for the treatment of I&I indications, as monotherapies and combinations. The company's most advanced programs are APG777, APG990, APG333, and APG808. With four validated targets in the company's portfolio, it is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies.The company's programs incorporate advanced antibody engineering to optimize half-life and other properties designed to overcome limitations of existing therapies.
In March 2024, the company announced positive interim safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from its Phase 1 trial of APG777 in healthy volunteers. In May 2024, the company initiated a Phase 2 trial of APG777 in patients with moderate-to-severe AD. In February 2025, the company announced that the last patient in Part A of the Phase 2 trial had been dosed and that it had commenced dosing of Part B.
In August 2024, the company initiated a Phase 1 trial of APG990 in healthy volunteers, and in March 2025, the company announced positive interim safety and PK data from that trial.
In December 2024, the company initiated a Phase 1 trial of APG333 in healthy volunteers.
In March 2024, the company initiated a Phase 1 trial of APG808 in healthy volunteers, and in December 2024, the company announced positive interim safety, PK, and PD data from that trial.
Pipeline
The company's pipeline comprises four programs being developed initially for the treatment of I&I indications, as shown below. The company's programs incorporate advanced antibody engineering to optimize half-life and other properties designed to overcome limitations of existing therapies.
APG777 – anti-IL13 antibody, same mechanism of action as EBGLYSS (lebrikizumab)
APG777 is a subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13. In August 2023, the company announced the dosing of its first participant in its first clinical trial for APG777. In 2024, the company announced positive interim safety and PK data from this trial, with APG777 demonstrating a potential best-in-class PK profile, including a half-life of 77 days, supporting the potential for every three- to six-month maintenance dosing in AD. Single doses of APG777 demonstrated a deep and sustained effect on PD markers out to approximately 12 months. APG777 was well-tolerated across all dose groups. In May 2024, the company commenced dosing in the Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD. In February 2025, the company announced that the last patient in the Part A portion of the trial had been dosed, with 16-week topline data from Part A expected in mid-2025. In February 2025, the company also announced that it had commenced dosing of Part B of the Phase 2 trial. All patients benefiting from treatment will have the opportunity to continue to APG777 maintenance treatment, which will evaluate three- to six-month dosing intervals. The company anticipates maintenance data from Part A in the first half of 2026 and 16-week topline data from Part B in the second half of 2026.
Based on its initial clinical data, the company plans to advance the development of APG777 in asthma and EoE by initiating a Phase 1b trial in asthma in the first half of 2025, followed by a Phase 2b trial in asthma in the second half of 2025, and a Phase 2 trial in EoE in 2026. Based on its clinical data, the company expects to further evaluate additional opportunities to develop APG777 for other I&I indications, including alopecia areata (AA), chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN).
In addition, the company plans to evaluate APG777 in combination with other investigational therapies within its pipeline to potentially enable greater efficacy for I&I conditions. The company plans to initiate its first combination study, a Phase 1b trial of APG777 and APG990, a novel, SQ, half-life extended mAb targeting OX40L, in 2025. This combination study is designed to evaluate the coformulation of APG777 and APG990 (APG279) against DUPIXENT in patients with moderate-to-severe AD, with readout expected in the second half of 2026.
APG990 – anti-OX40L antibody, same mechanism of action as amlitelimab; potential combination therapy with APG777
APG990 is an SQ extended half-life mAb that utilizes advanced antibody engineering to target OX40L.
The company plans to develop APG777 and APG990 together as a potential first-in-class coformulation for the treatment of AD by combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. APG279 has been shown to retain stability, injectability, and convenience of individual components in preclinical studies. In preclinical studies, APG279 has also demonstrated broad inhibition of Type 1, Type 2, and Type 3 inflammation, similar to what was seen with Janus kinase (JAK) inhibition, but with potential for better tolerability than JAK inhibitors.
In August 2024, the company initiated a Phase 1 clinical trial of APG990 in healthy volunteers to establish safety, tolerability, and PK profile, which could enable the combination with APG777.
In March 2025, the company announced positive interim safety and PK data from the APG990 Phase 1 clinical trial. PK data showed a half-life of approximately 60 days across doses tested. APG990, in single doses up to 1,200 mg, was well tolerated and showed a favorable safety profile, consistent with other assets targeting OX40L. In addition, preclinical toxicology studies of the combination of APG777 and APG990 showed no findings at any dose level, including the highest dose tested of 150 mg/kg per agent. Based on these results, the company plans to submit an Investigational New Drug application or foreign equivalent for APG279. Following clearance, the company plans to initiate in 2025 a Phase 1b trial of APG279 against DUPIXENT in approximately 50 to 75 patients with moderate-to-severe AD, with a data readout expected in the second half of 2026.
APG333 – anti-TSLP antibody, same mechanism of action as TEZPIRE (tezepelumab); potential combination therapy with APG777
APG333 is a fully-human mAb against thymic stromal lymphopoietin (TSLP), an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of people living with asthma and COPD. In preclinical studies, the combination of APG777 and APG333 has been shown to impact both central inflammation and local airway responses. This has the potential to improve clinical outcomes compared to approved or in-development biologics that only target peripheral or central inflammation, not both, and retains the potential for a significantly less frequent dosing schedule. In December 2024, the company initiated a Phase 1 trial of APG333 in healthy volunteers, and it expects interim data from the trial in the second half of 2025.
The company plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD. Subject to positive data, the company plans to study APG777 in combination with APG333 to drive potential best-in-class efficacy in respiratory conditions.
APG808 – anti-IL4Ralpha antibody, same mechanism of action as DUPIXENT
APG808 is an SQ extended half-life mAb targeting IL-4Ralpha, a target with clinical validation across eight different Type 2 allergic diseases. In March 2024, the company commenced dosing of the first healthy volunteers in the APG808 Phase 1 trial, and in September 2024, the company commenced dosing of the first asthma patients as a cohort in that Phase 1 trial. In December 2024, the company announced positive interim safety, PK, and PD data from the Phase 1 trial. APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days at projected, clinically relevant steady state exposures, supporting the potential for every two- to three-month maintenance dosing. Single doses of APG808 demonstrated a deep and sustained effect on PD markers out to approximately three months (longest follow-up available at the time of data cut). APG808 was well-tolerated across all dose groups. The company is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025.
Approach
The company's programs, APG777, APG990, APG333, and APG808, bind to the same epitopes, or binding sites, on IL-13, OX40L, TSLP, and IL-4Ralpha as EBGLYSS (lebrikizumab), amlitelimab, TEZPIRE (tezepelumab), and DUPIXENT (dupilumab), respectively, based on its head-to-head preclinical studies, but are designed to include extended half-life technologies and other optimized properties. When designing its programs, the company tests multiple half-life extension technologies, including YTE and LS amino acid modifications, to identify the optimal candidate to advance against each target. YTE amino acid modifications are a triple modification (M252Y/S254T/T256E) introduced into the antibody, while LS amino acid modifications are a double modification (M428L/N434S). YTE and LS amino acid modifications are proven half-life extension technologies that have the potential to significantly improve the PK profile and reduce injection burden compared to existing agents. In addition to extended half-life, the company's antibody engineering programs are designed to improve antibody candidate attributes, including in vitro potency, bioavailability, and decreased PK variability, as well as those attributes essential for manufacturability and high concentration formulation (i.e., viscosity, solubility, and stability) to generate optimized antibodies.
Strategy
The key elements of the company’s strategy include advancing APG777 targeting IL-13 through clinical development and regulatory filings for AD; advancing APG990 targeting OX40L and APG279 for the dual inhibition of OX40L and IL-13; advancing APG333 targeting TSLP and the combination of APG777 and APG333 for the dual inhibition of TSLP and IL-13; maximizing the potential of its programs through indication expansion beyond AD, including asthma, EoE and COPD; and expanding existing and evaluating new collaborations to broaden the impact it can hae for patients living with I&I indications.
Solution: Building Differentiated Biologics
The company is engineering therapies for AD, asthma, EoE, COPD, and other related I&I indications. Its programs, APG777, APG990, APG333, and APG808, target IL-13, OX40L, TSLP, and IL4Ralpha, respectively, and are designed to overcome limitations of frequent dosing associated with currently available treatments. Despite advances in care, there is still a high unmet medical need for patients suffering from the I&I indications that the company is targeting, both in terms of reduced injection burden as well as improved efficacy.
The company's programs incorporate advanced antibody engineering approaches and are designed to optimize for half-life extension, in vitro potency, bioavailability, and decreased PK variability, as well as those attributes essential for manufacturability and high concentration formulation (i.e., viscosity, solubility, and stability), potentially improving on each of those qualities over existing, non-optimized antibodies.
The company utilizes and tests a number of half-life extension technologies, including YTE and LS, to identify the optimal candidate to advance against each target. YTE amino acid modifications are a triple modification (M252Y/S254T/T256E) introduced into the antibody, while LS amino acid modifications are a double modification (M428L/N434S).
APG777 leverages YTE amino acid modification half-life extension technology and is an SQ mAb targeting IL-13. APG777 demonstrated a 77-day half-life in a Phase 1 clinical trial in healthy volunteers. The company initiated a Phase 2 clinical trial in patients with moderate-to-severe AD in May 2024. The Phase 2 trial is designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. In February 2025, the company announced that the last patient in the Part A portion had been dosed and that it had commenced dosing of the Part B portion. The company anticipates maintenance data from Part A in the first half of 2026 and 16-week topline data from Part B in the second half of 2026.
APG990 leverages half-life extension technology and is an SQ mAb targeting OX40L. The company initiated a Phase 1 clinical trial of APG990 in healthy volunteers in August 2024 and announced positive interim safety and PK data in March 2025. In 2025, the company plans to initiate a Phase 1b trial designed to evaluate APG279 against DUPIXENT in approximately 50 to 75 patients with moderate-to-severe AD, with a data readout expected in the second half of 2026.
APG333 leverages half-life extension technology and is an SQ mAb targeting TSLP. The company initiated a Phase 1 clinical trial of APG333 in healthy volunteers in December 2024 and expects a data readout in the second half of 2025. Subject to positive data and required regulatory approvals, the company plans to evaluate the combination of APG777 and APG333.
APG808 leverages half-life extension technology and is an SQ mAb targeting IL-4Ralpha. The company initiated a Phase 1 clinical trial of APG808 in March 2024 and announced positive interim safety, PK, and PD data in December 2024. The company is also now evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025.
Half-Life Extension and Antibody Engineering Technologies
The company's antibody engineering programs are designed to improve antibody candidate attributes, including half-life extension, in vitro potency, bioavailability, and decreased PK variability, as well as those attributes essential for manufacturability and high concentration formulation (i.e., viscosity, solubility, and stability) to generate optimized antibodies. Each of the company's programs utilizes YTE or LS amino acid modifications and is designed to significantly extend the half-life of antibodies by supercharging the body’s innate recycling mechanism for antibodies.
APG777
APG777 leverages YTE amino acid modifications half-life extension technology and is an SQ mAb targeting IL-13. The company is evaluating APG777 in AD and plans to evaluate APG777 in a number of expansion indications, including asthma and EoE, and in combination with certain of its other programs.
In its head-to-head preclinical studies of APG777 and lebrikizumab in non-human primates (NHPs), APG777 showed a significantly longer half-life than lebrikizumab. In these studies, APG777’s half-life was 27.6 days, as compared to 18.0 days for lebrikizumab, based on cumulative fit models across SQ and IV groups for each compound.
In 2024, the company announced interim safety, PK, and PD data from its Phase 1 trial of APG777 in healthy volunteers. PK data showed a half-life of 77 days across doses tested. Generally, the half-life of mAbs is consistent between healthy volunteers and patients since mAbs are degraded by endogenous catabolic processes and are not subject to the same drug-drug interaction potential of many traditional small molecules. Consequently, this gives the company confidence that the PK parameters derived from the Phase 1 trial in healthy volunteers can be used to effectively model dosing regimens in the subsequent Phase 2 and Phase 3 safety and efficacy trials in patients with AD and other I&I indications.
The company is testing three- and six-month dosing in its Phase 2 clinical trial of APG777. Compared to more frequent dosing schedules associated with existing AD therapies, every three- or six-month dosing, should the clinical trials be successful in demonstrating the requisite efficacy and safety profile, has the potential to be significantly more convenient for patients, enabling them to better adhere to their dosing schedule. Additionally, every three- or six-month dosing improves quality of life, given that many patients experience needle fatigue, and pediatric patients, in particular, often suffer from fear of needles.
APG777 Development
Phase 1 Trial in Healthy Volunteers
In August 2023, the company initiated a Phase 1 trial of APG777 in healthy volunteers. The APG777 Phase 1 trial was a double-blind, placebo-controlled study in healthy volunteers and consisted of a single-ascending dose (SAD) component and a multiple-ascending dose (MAD) component. Eight healthy volunteers, six treated with APG777 and two treated with placebo, were enrolled in each cohort, and the company enrolled a total of 40 healthy adult subjects in the trial.
In March 2024, the company announced positive interim safety and PK data, and in October and December 2024, it announced positive updated data from this trial. Interim PK data for APG777 showed a half-life of 77 days across doses tested, and PD data showed near complete inhibition of the key AD biomarker pSTAT6 for approximately twelve months after a single administration, along with sustained TARC inhibition. Results from the trial exceeded the company's trial objectives and support the potential for APG777, a novel anti-IL-13 antibody, to optimize exposure levels in 16-week induction and be dosed once every three or six months in maintenance. These findings represent the potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing in maintenance compared to currently approved monotherapy biologic therapies, which are dosed every two to four weeks, marking a potential major advancement for patients with AD and other inflammatory diseases.
In March 2024, the company reported that single doses of APG777 up to 1,200 mg and multiple doses of 300 mg were well-tolerated, with a favorable safety profile consistent with the existing third-party data supporting the safety of the anti-IL-13 class. In December 2024, the company confirmed that safety data were consistent with the data reported in March 2024. The most common treatment-emergent adverse events (TEAEs) were vascular access site pain, vessel puncture site bruise, headache, and vascular access bruising. A total of 83.3% of participants observed at least one TEAE, while 16.7% of participants observed at least one drug-related AE.
Phase 2 Trial in AD
In May 2024, the company initiated APEX, a randomized, placebo-controlled, 16-week Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD. The trial is designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol.
The company expects to further evaluate opportunities to develop APG777 for other I&I indications, including AA, CRSwNP, CSU, and PN.
APG990
APG990 is an SQ extended half-life mAb targeting OX40L.
Currently, there are only two mechanisms of action targeted by approved biologic agents in atopic dermatitis, IL-13 and IL-4Ralpha. Targeting OX40L could represent a third mechanism of action. OX40L, which is positioned further upstream in the inflammatory pathway than IL-13, allowing for a potentially broader impact on the inflammatory cascade by inhibiting Type 1, Type 2, and Type 3 pathways.
APG990 Development
In May 2024, the company finalized the nomination of a development candidate for APG990, and in August 2024, it commenced dosing of the first participants in the Phase 1 clinical trial in healthy volunteers. In its head-to-head preclinical assays, APG990 has demonstrated similar or improved potency compared to amlitelimab, an OX40L antibody candidate in late-stage clinical development.
In its head-to-head studies of APG990 and amlitelimab in NHPs, APG990 demonstrated a half-life of 26 days versus 21 days for amlitelimab.
The APG990 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial aimed at evaluating the safety and PK of APG990 in 40 healthy adult participants across five cohorts. Doses of subcutaneous APG990 evaluated in the study included 75 mg, 150 mg, 300 mg, 600 mg, and 1,200 mg.
In March 2025, the company announced data from its APG990 Phase 1 clinical trial. APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested, supporting the potential for testing every three- and six-month maintenance dosing with as little as 50 mg. APG990 generally demonstrated dose proportionality and low variability.
The company has generated preclinical data to support its approach to targeting both IL-13 and OX40L. In its preclinical ex vivo human allogeneic lymphocyte reaction assay, the company demonstrated that APG279 targets all inflammatory types, including near-complete Type 2 inhibition, with the potential for every three-month (or less frequent) dosing. The company plans to develop APG279 as a potential first-in-class coformulation for the treatment of AD, combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. APG279 has been shown to retain stability, injectability, and convenience of individual components. In preclinical studies, it has demonstrated broad inhibition of Type 1, Type 2, and Type 3 inflammation, similar to what was seen with JAK inhibition, but with potential for better tolerability than JAK inhibitors.
APG333
APG333 is a fully-human mAb against TSLP. TSLP is an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of people living with asthma and COPD, with the potential for extended half-life and to be used in combination with other mAbs for potentially greater efficacy in broader populations.
APG333 Development
In October 2024, the company finalized the nomination of a development candidate for APG333, and in December 2024, it initiated a Phase 1 clinical trial of APG333 in healthy volunteers. The APG333 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose (SAD) trial in healthy volunteers. The study will evaluate the safety, tolerability, and pharmacokinetics of APG333 and is expected to enroll approximately 32 healthy adults into four cohorts. The company expects interim data from the APG333 Phase 1 trial in the second half of 2025.
The company plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD. Subject to positive data, the company plans to study APG777 in combination with APG333 to drive potential best-in-class efficacy in respiratory conditions.
APG808
APG808 is an SQ extended half-life mAb targeting IL-4Ralpha, a target with clinical validation across eight different Type 2 allergic diseases.
Based on its head-to-head preclinical studies of APG808, the company has demonstrated the potential to increase the half-life of IL-4Ralpha-targeting mAbs using half-life extension modifications. In its head-to-head studies of APG808 and DUPIXENT in NHPs, APG808 demonstrated a half-life of 27 days versus 11 days for DUPIXENT. Moreover, in its head-to-head preclinical assay, APG808 demonstrated equivalent potency of IL-4Ralpha inhibition compared to DUPIXENT in a head-to-head in vitro assay.
In March 2024, the company initiated a Phase 1 clinical trial of APG808 in healthy volunteers and announced positive interim safety, PK, and PD data from the Phase 1 trial in December 2024, demonstrating a potential best-in-class PK profile, including a half-life of approximately 55 days, supporting the potential for every two- to three-month maintenance dosing.
APG808 Dosing
In its head-to-head preclinical studies of APG808 and DUPIXENT in NHPs, the company found that APG808 showed a significantly longer half-life than DUPIXENT. In these preclinical studies, APG808’s half-life was up to 27 days, as compared to 11 days for DUPIXENT.
APG808 Development
In March 2024, the company commenced dosing of the first healthy volunteers in the APG808 Phase 1 trial, and in September 2024, it commenced dosing of the first asthma patients as a cohort in that Phase 1 trial. The APG808 Phase 1 trial was designed as a double-blind, placebo-controlled study in healthy volunteers with single ascending doses. The trial enrolled 32 healthy adult participants into four SAD cohorts. In December 2024, the company shared positive interim safety, PK, and PD data from the Phase 1 trial. APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, supporting the potential for every two- to three-month maintenance dosing. Single doses of APG808 demonstrated a deep and sustained effect on PD markers out to approximately three months (longest follow-up available at the time of data cut). APG808 was well-tolerated across all dose groups. The company is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025.
Collaboration, License and Services Agreements
Paragon Option Agreements
In February 2022, the company entered into an antibody discovery and option agreement with Paragon, which was subsequently amended in November 2022 (as amended, the 2022 Option Agreement). Under the terms of the 2022 Option Agreement, Paragon identifies, evaluates, and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the company. The 2022 Option Agreement initially included two selected targets, IL-13 and IL-4Ralpha, and was subsequently amended in November 2022 to include an additional selected target, OX40L. Under the 2022 Option Agreement, the company has the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title, and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture, and commercialize the antibodies and products directed to the selected targets (each, an Option). From time to time, the company can choose to add additional targets to the collaboration by mutual agreement with Paragon.
In November 2023, the company entered into an additional antibody discovery and option agreement with Paragon (the 2023 Option Agreement, and together with the 2022 Option Agreement, collectively referred to as the Option Agreements). Under the terms of the 2023 Option Agreement, Paragon identifies, evaluates, and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the company. The 2023 Option Agreement initially includes one target, TSLP. Under the 2023 Option Agreement, the company has the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title, and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture, and commercialize the antibodies and products directed to the selected targets. From time to time, the company can choose to add additional targets to the collaboration by mutual agreement with Paragon.
Paragon License Agreements
In November 2022, the company exercised its option available under the 2022 Option Agreement with respect to the IL-13 Research Program. Upon such exercise, the parties entered into an associated license agreement (the IL-13 License Agreement). In April 2023, the company exercised its option available under the 2022 Option Agreement with respect to the IL-4Ralpha Research Program and the OX40L Research Program. Upon such exercise, the parties entered into associated license agreements (the IL-4Ralpha License Agreement and the OX40L License Agreement, respectively). In August 2024, the company exercised its option available under the 2023 Option Agreement with respect to the TSLP Research Program and entered into the associated license agreement (the TSLP License Agreement, and collectively with the IL-13 License Agreement, the IL-4Ralpha License Agreement, and the OX40L License Agreement, the License Agreements).
Biologics Master Services Agreement — WuXi Biologics (Hong Kong) Limited
In June 2022, Paragon and WuXi Biologics (Hong Kong) Limited (WuXi Biologics) entered into a biologics master services agreement (the WuXi Biologics MSA), which was subsequently novated to the company by Paragon in the second quarter of 2023. The WuXi Biologics MSA governs all development activities and GMP manufacturing and testing for the company's APG777, APG990, APG333, and APG808 programs, as well as potential future programs, on a work order basis. Under the WuXi Biologics MSA, the company is obligated to pay WuXi Biologics a service fee and all non-cancellable obligations in the amount specified in each work order associated with the agreement for the provision of services.
Cell Line License Agreement — WuXi Biologics (Hong Kong) Limited
In June 2022, Paragon and WuXi Biologics entered into a cell line license agreement (the Cell Line License Agreement), which was subsequently novated to the company by Paragon in the second quarter of 2023. Under the Cell Line License Agreement, the company received a non-exclusive, worldwide, sublicensable license to certain of WuXi Biologics’ know-how, cell line, biological materials (the WuXi Biologics Licensed Technology), and media and feeds to make, have made, use, sell, and import certain therapeutic products produced through the use of the cell line licensed by WuXi Biologics under the Cell Line License Agreement (the WuXi Biologics Licensed Products). Specifically, the WuXi Biologics Licensed Technology is used to manufacture a component of the APG777, APG990, APG333, and APG808 programs.
Intellectual Property
Patent Rights Relating to IL - 13 Program
As of January 31, 2025, the company owned eight patent families directed to antibodies that target IL-13, including APG777, pharmaceutical formulations and compositions, and methods of using those antibodies. The first patent family is directed to compositions of matter and includes patent applications filed in the U.S. and in foreign jurisdictions, including Europe, Japan, and China. If issued, the company would expect these patents to expire in 2043, absent any applicable patent term extensions. The second patent family is directed to methods of using APG777 and includes an international (PCT) patent application and applications in Argentina and Taiwan. If the PCT application is pursued in the U.S. or any foreign jurisdictions and matures into one or more issued patents, or the Argentina or Taiwan applications mature into issued patents, the company would expect those patents to expire in 2044, absent any applicable patent term extensions. The third patent family is directed to pharmaceutical formulations containing APG777 and includes a PCT application. If the PCT application is pursued in the U.S. or any foreign jurisdictions and matures into one or more issued patents, the company would expect those patents to expire in 2044, absent any applicable patent term extensions. The fourth patent family is directed to other APG777 compositions and includes a PCT application and applications filed in Argentina and Taiwan. If the PCT application is pursued in the U.S. or any foreign jurisdictions and matures into one or more issued patents, or the Argentina or Taiwan applications mature into one or more issued patents, the company would expect those patents to expire in 2044, absent any applicable patent term extensions. The remaining four patent families are directed to other APG777 compositions and methods of using APG777, and each family, as of January 31, 2025, includes between one and three provisional applications. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045 and 2046, absent any applicable patent term extensions.
Patent Rights Relating to its IL-4Ra Program
As of January 31, 2025, the company owned four patent families directed to antibodies that target IL-4Ralpha, including APG808, and methods of using those antibodies. The first patent family includes a PCT application and patent applications in Argentina and Taiwan. If the PCT application is pursued in the U.S. or any foreign jurisdictions and matures into one or more issued patents, or the Argentina or Taiwan applications mature into issued patents, the company would expect those patents to expire in 2044, absent any applicable patent term extensions. The second patent family is directed to methods of using APG808 and includes a PCT application. If the PCT application is pursued in the U.S. or any foreign jurisdictions and matures into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions. The remaining two patent families are directed to APG808 compositions and methods of using APG808, and as of January 31, 2025, each family includes one provisional patent application. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions.
Patent Rights Relating to its OX40L Program
As of January 31, 2025, the company owned four patent families directed to antibodies that target OX40L, including APG990, and methods of using those antibodies and formulations thereof. The first patent family includes a PCT application and applications in Argentina and Taiwan. If the PCT application is pursued in the U.S. or any foreign jurisdictions and matures into an issued patent, or if the Argentina or Taiwan applications are pursued and mature into issued patents, the company would expect those patents to expire in 2044, absent any applicable patent term extensions. The second, third, and fourth patent families are directed to pharmaceutical formulations and compositions including APG990 and methods of using APG990, and as of January 31, 2025, each family includes one or two provisional applications. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions.
Patent Rights Relating to TSLP Program
As of January 31, 2025, the company had licensed one patent family from Paragon directed to antibodies that target TSLP, including APG333, and methods of using those antibodies. As of January 31, 2025, this family includes three provisional applications. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions. The company also owns two patent families directed to compositions of TSLP antibodies, including APG333, and methods of using APG333. As of January 31, 2025, each of these families includes one provisional application. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions.
Patent Rights Relating to Combination Programs
As of January 31, 2025, the company owned six patent families directed to combinations of APG777, APG990, APG333, and/or APG808 and pharmaceutical formulations and compositions thereof. As of January 31, 2025, each of these families includes between one and three provisional applications. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions. The company has also licensed three patent families from Paragon directed to combinations of APG777, APG990, APG333, and/or APG808 and methods of using those combinations. As of January 31, 2025, each of these families includes between one and three provisional applications. If these provisional applications are pursued non-provisionally and mature into one or more issued patents, the company would expect those patents to expire in 2045, absent any applicable patent term extensions.
Trademark Rights Relating to the Apogee Therapeutics Name and Logo
As of January 31, 2025, the company owned a U.S. trademark registration for the Apogee logo and the mark APOGEE THERAPEUTICS for research and development services of new pharmaceutical products. The company also obtained a Statement of Grant of Protection in the UK for the APOGEE THERAPEUTICS mark for research and development services of new pharmaceutical products. The Apogee logo and the APOGEE THERAPEUTICS mark are also pending registration in several other countries.
Government Regulation
Any products manufactured or distributed by the company pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
Research and Development
The company’s research and development expenses for the year ended December 31, 2024, were $167.9 million.
History
Apogee Therapeutics, Inc. was founded in 2022. The company was incorporated in 2022.
