elarekibep (PRS-060) / Pieris Pharmaceuticals - LARVOL DELTA

APATURA: Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2a | N=72 | Terminated | Sponsor: AstraZeneca | Active, not recruiting ➔ Terminated; The decision was based on lung findings from a non-clinical 13-week Good Laboratory Practice (GLP) toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.

Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CORIN • CRP

Pieris Pharmaceuticals Provides Strategic Update and Announces Restructuring (Yahoo Finance) - "AstraZeneca has now informed the Company of its decision to terminate the parties' R&D collaboration agreement and hand back elarekibep along with discontinuing the remaining discovery program...Pieris' management and board of directors have assessed several strategic options, which will include focusing on execution of new or expanded partnerships to advance its therapeutic programs, including cinrebafusp alfa (PRS-343), PRS-220 and PRS-400...Pieris will prioritize capital preservation, with cash, cash equivalents and investments totaling approximately $54.9 million as of June 30, 2023....'One track is accelerating partnering discussions of PRS-220 and PRS-400. A second focal area is diligently selecting the best possible development partner and deal structure to re-initiate clinical development of cinrebafusp alfa, our former lead immuno-oncology asset, which has shown 100% ORR in five patients in a HER2+ gastric cancer trial that was discontinued for strategic reasons."

Commercial • Licensing / partnership • Pipeline update • Asthma • Gastric Cancer • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

APATURA: Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2a | N=72 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=210 ➔ 72 | Trial completion date: Feb 2024 ➔ Jul 2023 | Trial primary completion date: Feb 2024 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CORIN • CRP

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects (clinicaltrials.gov) - P1 | N=30 | Terminated | Sponsor: AstraZeneca | Completed ➔ Terminated; This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.

Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pieris Pharmaceuticals Announces AstraZeneca Discontinuation of Phase 2a Trial of Elarekibep (PRS-060/AZD1402) Due to New Non-Clinical Safety Findings From 13-week Toxicology Study (Issuer Direct) - "Pieris Pharmaceuticals, Inc...announced that partner AstraZeneca yesterday communicated to Pieris its decision to discontinue and cease dosing in the ongoing clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor under development for the treatment of asthma. This decision was based on lung findings from a non-clinical 13-week GLP toxicology study with dry powder inhaler-formulated elarekibep, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development. AstraZeneca's decision was made independent of any data from the Phase 2a study. Pieris will expedite a review of the implications of the data and AstraZeneca's decision on the program and will review its overall corporate priorities prior to sharing a further update."

Trial termination • Asthma • Immunology • Respiratory Diseases

Pulmonary Delivery of PRS-400 Anti-Jagged-1 Anticalin Proteins Reduce Inflammation-driven Goblet Cell Metaplasia and Mucus Hypersecretion In Vivo (ATS 2023) - "While their binding affinity is similar to that of antibodies, their small size and biophysical properties make Anticalin proteins uniquely suitable for lung delivery via inhalation, as demonstrated by the ongoing evaluation of PRS-060/AZD1402 in a Phase 2 asthma study, and of PRS-220 in a Phase 1 IPF study. Our data demonstrate that Jagged-1-targeting Anticalin proteins potently inhibit Jagged-1/Notch 2 activation in vitro and reduce mucin expression and goblet cell differentiation ex vivo and in vivo. PRS-400 has broad potential as an inhaled therapy for patients with muco-obstructive lung diseases to reduce mucus burden and restore epithelial homeostasis."

Preclinical • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • IL13 • NOTCH2

Pieris Pharmaceuticals Reports First Quarter 2023 Financial Results and Business Updates (Issuer Direct) - "Enrollment for elarekibep (PRS-060/AZD1402) Phase 2a study for asthma continues to progress with topline clinical data anticipated by mid-2024; successful safety review completed for 10 mg dose cohort; PRS-220, inhaled Anticalin protein for idiopathic pulmonary fibrosis (IPF), continues in Phase 1 study with topline results expected H2 2023; PRS-400, inhaled Anticalin protein for muco-obstructive respiratory disease, advances toward anticipated development candidate nomination H2 2023; New preclinical data to be presented at the American Thoracic Society (ATS) 2023 International Conference in May 2023 for both PRS-220 and PRS-400."

New P2a trial • New trial • P1 data • P2a data • Preclinical • Asthma • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

Pieris Pharmaceuticals Announces Successful Completion of Safety Review for 10 mg Dose of Phase 2a Trial of Elarekibep (PRS-060/AZD1402) (BioSpace) - "Pieris Inc...announced the successful safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated elarekibep (PRS-060/AZD1402)....Upon completion of the phase 2a study and availability of topline data, which Pieris expects to be reported by mid-2024....For this safety review, 13 asthma patients, controlled on standard of care (medium dose inhaled corticosteroids with long-acting beta agonists), received elarekibep twice daily over four weeks to establish the safety profile and pharmacokinetics of the dry powder formulation of elarekibep at the 10 mg dose. Following completion of enrollment and observation, AstraZeneca evaluated, compared to placebo, the incidence of adverse events, changes in laboratory markers (immuno-biomarkers, clinical chemistry, and hematology), and forced expiratory volume in one second."

P2a data • Trial status • Asthma • Immunology • Respiratory Diseases

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

APATURA: Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2a | N=210 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jul 2023 ➔ Feb 2024 | Trial primary completion date: Jul 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CORIN • CRP

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pieris Pharmaceuticals Reports Full-Year 2022 Financial Results and Business Updates (Pieris Press Release) - "Enrollment is ongoing in the multi-center, placebo-controlled Phase 2a study of dry powder inhaler-formulated elarekibep, an IL-4 receptor alpha (IL-4Rα) inhibitor being developed for the treatment of moderate-to-severe asthma. Topline results measuring placebo-adjusted FEV1 improvement at four weeks are now expected to be reported by the middle of 2024 based on AstraZeneca's most recent projections....R&D expenses were $53.0 million for the year ended December 31, 2022, compared to $66.7 million for the year ended December 31, 2021. The decrease was due to lower overall program costs for both elarekibep..."

Commercial • P2a data • Asthma • Immunology • Respiratory Diseases

Mapping knowledge structure and research of the biologic treatment of asthma: A bibliometric study. (PubMed, Front Immunol) - "The search strategies were as follows: topic: TS=(biologic* OR "biologic* product*" OR "biologic* therap*" OR biotherapy* OR "biologic* agent*" OR Benralizumab OR "MEDI-563" OR Fasenra OR "BIW-8405" OR Dupilumab OR SAR231893 OR "SAR-231893" OR Dupixent OR REGN668 OR "REGN-668" OR Mepolizumab OR Bosatria OR "SB-240563" OR SB240563 OR Nucala OR Omalizumab OR Xolair OR Reslizumab OR "SCH-55700" OR SCH55700 OR "CEP-38072" OR CEP38072 OR Cinqair OR "DCP-835" OR DCP835 OR Tezspire OR "tezepelumab-ekko" OR "AMG-157" OR tezspire OR "MEDI-9929" OR "MEDI-19929" OR MEDI9929 OR Itepekimab OR "REGN-3500"OR REGN3500 OR "SAR-440340"OR SAR440340 OR Tralokinumab OR "CAT-354" OR Anrukinzumab OR "IMA-638" OR Lebrikizumab OR "RO-5490255"OR "RG-3637"OR "TNX-650"OR..."

Journal • Asthma • Cough • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Elarekibep (PRS-060/AZD1402): a new class of inhaled Anticalin medicine targeting IL-4Ra for T2 endotype asthma. (PubMed, J Allergy Clin Immunol) - "Lcn1 can be re-engineered into the Anticalin antagonist PRS-060, exemplifying a new class of inhaled topical, long-acting therapeutic with potential to treat T2 endotype asthma."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CCL11 • IL13 • IL4 • IL4R

"Streamlinig opex cos of prs060 delay" (@maddstone1)

Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2a | N=225 | Recruiting | Sponsor: AstraZeneca | N=345 ➔ 225 | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Jan 2023 ➔ Jun 2023

Enrollment change • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CORIN • CRP

Pieris Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update (Pieris Press Release) - "AstraZeneca continues to enroll part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402, an IL-4 receptor alpha inhibitor Pieris is developing with AstraZeneca for the treatment of moderate-to-severe asthma....Topline results are now expected to be reported by the third quarter of 2023."

Enrollment status • P2a data • Asthma • Immunology • Respiratory Diseases

Anticalin®-based therapeutics: Expanding new frontiers in drug development. (PubMed, Int Rev Cell Mol Biol) - "The small size and stable structure support their development as inhalable biologics in the field of respiratory diseases as already demonstrated for PRS-060/AZD1402, an Anticalin protein currently undergoing clinical development for the treatment of asthma. Cinrebafusp alfa and PRS-344/S095012 antibody-Anticalin bispecific proteins were designed to reduce potential systemic toxicity by localizing the activity to the tumor, and are currently in clinical development in immuno-oncology. Furthermore, the ease in generating bi- and multispecifics as well as the small and stable structure prompted the investigation of Anticalin proteins for the CAR T space, opening additional potential treatment options based on Anticalin protein therapies."

Journal • Asthma • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases

Pieris Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update (BioSpace) - "Pieris Pharmaceuticals, Inc...reported financial results for the first quarter of 2022 ended March 31, 2022, and provided an update on the Company's recent and anticipated future developments....R&D expenses were $14.1 million for the quarter ended March 31, 2022, compared to $16.6 million for the quarter ended March 31, 2021. The decrease is due to lower program costs, as work related to the Company's sponsored phase 1 trial of PRS-060/AZD1402 was largely complete in 2021..."

Commercial • Asthma • Immunology • Respiratory Diseases

Pieris Pharmaceuticals Reports Full-Year 2021 Financial Results and Provides Corporate Update (Issuer Direct) - "R&D expenses were $66.7 million for the year ended December 31, 2021, compared to $46.5 million for the year ended December 31, 2020....These increases were partially offset by lower manufacturing costs on PRS-060, which were fully reimbursed."

Commercial • Reimbursement • Asthma • Immunology • Respiratory Diseases

Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2a; N=345; Recruiting; Sponsor: AstraZeneca; Active, not recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CRP

Pieris Pharmaceuticals Announces Successful Completion of Safety Milestone and Initiation of Efficacy Portion of Phase 2a Trial of PRS-060/AZD1402 (Yahoo News) - "Pieris Pharmaceuticals, Inc...today announced the successful completion of the sponsor safety review of part 1a of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402....Completion of part 1a allows the start of enrollment for part 2a (efficacy of the low and medium doses) and part 1b (safety of the high dose) of the study....AstraZeneca is now expected to begin enrollment of part 2a of the study to evaluate efficacy, safety, and pharmacokinetics of PRS-060/AZD1402 administered twice daily to asthma patients...FEV1 improvement compared to placebo will be the primary endpoint in this portion of the study. AstraZeneca is also now expected to begin enrollment of part 1b of the study to evaluate the safety of the high dose in asthma patients controlled on standard of care who will receive PRS-060/AZD1402 twice daily over four weeks."

Enrollment status • Trial status • Asthma • Immunology • Respiratory Diseases

Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2a; N=345; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2022 ➔ Oct 2022; Trial primary completion date: Jun 2022 ➔ Oct 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CRP

Pieris Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Corporate Update (Yahoo Finance) - "Dosing has been completed in part 1a (safety) of the global phase 2a study of PRS-060/AZD1402...Pieris and AstraZeneca expect to announce topline data from the entire phase 2a study next year....Pieris will have the options to co-develop and, separately, co-commercialize PRS-060/AZD1402 in the United States."

P2 data • Trial status • Asthma • Immunology • Respiratory Diseases