Jens Stegemann, Ph.D.
Chief Executive Officer, Co-Founder
Breath Therapeutics – a Zambon Group Company is pursuing groundbreaking therapies by unleashing the true potential of inhaled drug delivery.
Our approach combines novel formulations of existing drugs with cutting-edge inhalation technology for the treatment of rare respiratory diseases with high unmet medical need. We are developing drug-device combinations designed to rapidly deliver high concentrations of drugs to the site of action in the lung. Our approach increases effective dosing in the lung while minimizing systemic exposure which could lead to new treatment solutions with enhanced efficacy and safety.
In our lead program, BOSTON, we are evaluating the first therapy for bronchiolitis obliterans syndrome (BOS), a devastating lung disease with very high mortality that commonly affects patients who have received lung or stem cell transplantation.
Dr. Stegemann led the spin off and financing of Breath Therapeutics. He brings 20 years of executive management experience in marketing, sales, business and corporate development in small biopharmaceutical companies specializing in respiratory and infectious diseases.
Ms. Burger has over 15 years expertise in senior finance functions for biotech and Medtech companies throughout Europe and has served as lead advisor in numerous transactions, financings and structuring projects.
Dr. Denk has over 15 years of industry expertise in pharmaceutical operations and regulatory affairs.
Dr. Henig brings over 20 years of clinical and development leadership experience at biopharmaceutical companies, in combination with an extensive academic background in pulmonary and transplant medicine.
Mr. Shadday has more than 20 years of global commercial expertise in strategic and operational marketing and sales functions with leadership roles in US, Europe, Latin America and Asia Pacific.
Dr. Stegemann led the spin off and financing of Breath Therapeutics. He brings 20 years of executive management experience in marketing, sales, business and corporate development in small biopharmaceutical companies specializing in respiratory and infectious diseases.
Mr. Seghezzi is the Managing Partner of Sofinnova Partners, which he joined in 2006. He seeded and served on the Boards of several companies which were successfully sold or went public on Nasdaq.
Dr. Nägler joined Gimv’s as a Partner in 2011. He began his professional career in 2002 at Atlas Venture in London and Munich, and later joined Ventech, a Paris-based venture capital firm.
Arthur Franken is a Partner at Gilde Healthcare and is focusing on venture and growth capital investments in the biopharm, medtech, diagnostics and digital health sectors.
Dr. Gupta has over 25 years of drug development, regulatory and senior management within the biopharmaceutical industry. Dr. Gupta is the Principal of Global Bio-Pharma. Prior, she was Executive Vice President of Development and Chief Medical Officer of Insmed Incorporated.
Boston
Our clinical-stage BOSTON program is advancing the first therapy for bronchiolitis obliterans syndrome, a rare and devastating lung disease with no approved treatments available.(1)
Bronchiolitis Obliterans Syndrome (BOS)
BOS is a rapidly progressive disease that usually leads to respiratory failure and death within one to two years after diagnosis.(2) BOS is caused by an inflammatory process triggered by the immune system that irreversibly destroys the airways of the lungs. BOS is most commonly seen in patients following lung transplantation and allogeneic hematopoietic stem cell transplant, though it is also associated with autoimmune disease and exposure to environmental contaminants.
This disease is particularly devastating to those who have already undergone complex and costly lung transplants, as nearly 50 percent of that patient population develops BOS within five years after transplantation.(3)
1. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Meyer KC, et al. Eur Respir J 2014; 44: 1479–1503 | DOI: 10.1183/09031936.00107514
2. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth adult lung and heart-lung transplant report—2018; Focus theme: Multiorgan Transplantation. Chambers DC, et al. J Heart Lung Transplant; Volume 37, Issue 10,1169 – 1183
2. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth adult lung and heart-lung transplant report—2018; Focus theme: Multiorgan Transplantation. Chambers DC, et al. J Heart Lung Transplant; Volume 37, Issue 10,1169 – 1183
3. International Society for Heart and Lung Transplantation presentation slides. J Heart Lung Transplant 2017; Oct; 36(10):1037-1079
4. Company internal market research based on country-specific reports for lung transplants and stem cell transplantations
4. Company internal market research based on country-specific reports for lung transplants and stem cell transplantations
BOS is devastating to lung transplantation (LTx) and allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients.
- LTx
- 5,000
annual procedures
- 31,000
people living with
- 21,500
affected by BOS
- alloHSCT
- 32,000
annual procedures
- 140,000
people living with
- 8,500
affected by BOS
BOS Prevalence Cases Currently Estimated for US, EU, JAPAN (4)
No approved treatment exists today for the treatment of BOS
According to BOS guidelines published in the European Respiratory Journal, “currently available therapies have not been proven to result in significant benefit in the treatment of BOS.”
Barker et al., NEJM 2014; 370:1820-8
Liposomal Cyclosporine A for Inhalation (L-CsA-i)
The BOSTON program combines L-CsA-i, a novel proprietary liposomal formulation of the immunosuppressive drug cyclosporine with a customized drug-specific high-performance inhalation technology of the Investigational eFlow® Nebulizer System (PARI Pharma).
BOSTON DEVELOPMENT PROGRAM
L-CsA-i* for the Treatment of Bronchiolitis Obliterans Syndrome (BOS)
*Liposomal Cyclosporine A for Inhalation (L-CsA-i)
**Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
**Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Currently, there is no expanded access program for
L-CsA-i. If you are interested in learning more about the BOSTON clinical trials for BOS, please see the
People with BOS and Family FAQ
BOSTON CLINICAL STUDIES
In our BOSTON program, we are conducting two global phase 3 trials to study L-CsA-i in the treatment of BOS associated with lung transplantation. In parallel, we will conduct two additional supportive trials in patients with BOS.
Our BOSTON Phase 3 trials build on existing clinical experience and over 1,100 patient months of exposure with L-CsA-i. The BOSTON program is supported by leading international centers and specialists in lung transplant and allogeneic hematopoietic stem cell transplantation.
L-CsA-i has received orphan drug designation from the FDA and EMA for the treatment of bronchiolitis obliterans. Conditioned upon receiving necessary regulatory approvals, we are preparing market access and product launch plans in the U.S., EU and other global markets. Full commercial-scale production is established for L-CsA-i and the drug-specific Investigational eFlow® Nebulizer System (PARI Pharma).
L-CsA-i, a Liposomal Formulation of Cyclosporine, Demonstrates Therapeutic Potential for Bronchiolitis Obliterans Syndrome (BOS)
ATS Dallas 2019
Liposomal Cyclosporine A for Inhalation (L-CsA-i) to Treat Bronchiolitis Obliterans Syndrome: Novel Formulation and Drug-Specific Delivery System Improve Tolerability
ISHLT Orlando 2019
Liposomal Cyclosporine A for Inhalation (L-CsA-i) to Treat Bronchiolitis Obliterans Syndrome (BOS): Novel Formulation With Therapeutic Potential for Patients With BOS Following allo-HSCT
EBMT Frankfurt 2019
Impact
Our IMPACT program seeks to translate new evidence in the pathophysiology of pulmonary hypertension into a breakthrough disease-modifying drug therapy.(4,5)
Pulmonary Hypertension (PH)
PH is a rare disorder of the pulmonary vasculature with fatal outcome. Despite numerous approved drug products that provide symptomatic relief and delay disease progression, the mortality in PH remains unacceptably high.(6)
IMPACT Drug Candidate
We have identified a very promising drug candidate for the treatment of certain forms of PH. Breath Therapeutics has the skills to combine the promising drug candidate with a proprietary formulation and highly customized nebulizer device to bring a new approach to the treatment of PH.
IMPACT Studies
IMPACT is an early-stage development program for the treatment of pulmonary vascular disease. We will bring our expertise in formulation, aerosol delivery and clinical development together to design a first-in-class therapy.
4. Emerging therapeutics in pulmonary hypertension. MK Hensley, et al. Am J Physiol Lung Cell Mol Physiol (2018); 314: L769–L781, 2018. First published February 1, 2018; doi:10.1152/ajplung.00259.2017.
5. Translational advances in the field of pulmonary hypertension. SS Pullamsetti, et al. Am J Respir Crit Care Med (2017); 195(4), 425-437
6. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Benza RL, et al. Chest (2012); 448-456
Pulmonary Hypertension (PH) Prevalence Cases in US, EU5, Japan by PH-Subtype
- 72,510
pulmonary arterial hypertension (PAH) – WHO class 1
- 48,900
chronic thromboembolic pulmonary hypertension (CTEPH) – WHO class 4
- 78,720
due to lung disease and/or hypoxia – WHO class 3
- 106,610
due to left heart disease – WHO class 2
- 48,090
due to miscellaneous causes – WHO class 5
According to pulmonary hypertension industry reports.
The basis for a successful inhalation therapy is precise and fast drug delivery into the small airway of the lungs. This requires a uniquely designed drug formulation paired with a high-performance, drug-specific nebulizer.
Drug Carrier
For our BOSTON program, we use proprietary, lyophilized, unilamellar liposomes as carrier for the drug. Liposomes are excellent carriers for insoluble molecules like cyclosporine A, but we will always select the best solution for future programs.
Nebulizer Device
Successful aerosol drug-device combinations also depend on optimum device characteristics and performance. For our lead program BOSTON, we utilize the Investigational eFlow® Nebulizer System (PARI Pharma) optimized for use with our liposomal cyclosporine A formulation. PARI’s eFlow® Technology platform allows us to design proprietary custom-made devices for drug- and indication-specific use for all future products.
NEWS
Media
EXPERTS DISCUSS BOS AND THE BOSTON PIVOTAL PHASE 3 STUDIES
BreathBlue
The company is dedicated to protecting our climate and removing CO2 from the atmosphere. To help offset the CO2 emissions we produce as a company, which is mainly related to business air travel, we have partnered with the Blue Planet Certificate. Our BreathBlue initiative supports the reforestation projects of Naturefund, a non-profit environmental protection organization that purchases land to preserve habitats worldwide. Each month, the company plants 40 new trees in a reforestation project in the Andes, Bolivia. To learn more and to become a Blue Planet Certificate partner, please visit blueplanetcertificate.com.
CAREERS
People living with rare lung diseases are at the center of everything we do. If you have an interest in joining our innovative team, we would like to hear from you. Please send your cover letter and resume to careers@breath-therapeutics.com.