NewsSTERNA BIOLOGICALS

Marburg, Germany, July 17, 2024

sterna biologicals GmbH (sterna), a clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, today announced a strategic update to the development and commercialization of its lead therapeutic candidate, hgd40.

Marburg, Germany, December 14, 2021

• GIANT-1 study to evaluate once-daily oral inhalation of novel catalytic antisense oligonucleotide formulation SB010 in patients with moderate to severe Type-2 driven asthma
• Standard of care remains insufficient for large number of these asthmatics
• Study incorporates digital therapy to enhance patient device handling, increase adherence, reduce drop-out rates and generate maximally reliable data through reduction of inter-patient variability

Marburg, Germany, November 23, 2021

• Phase IIa proof-of-concept (POC) study with novel catalytic antisense oligonucleotide SB010 in patients with moderate to severe asthma initiated.
• Innovative study design combines pharmacological therapy with VisionHealth’s Kata® Clinical, a unique combination of artificial intelligence, and computer animation to enhance patients’ device handling, adherence, reduce drop-out rates and generate maximally reliable data due to reduced inter-patient variability

Marburg, Germany, January 07, 2021

• Following successful completion of the company’s Series A – 1st closing with EUR 12.0 million in April 2020, sterna now has successfully completed a 2nd closing with another EUR 10.0 million, bringing the Series A total to EUR 22.0 million
• Proceeds from the 2nd closing will fund phase IIb preparatory activities including toxicology studies and CMC work for SB010 in moderate to severe asthma as well as the completion of an oral formulation project for SB012 laying the foundation for phase I/IIb studies in moderate to severe ulcerative colitis
• sterna’s approach to down-regulate master transcription factor GATA-3 using a DNAzyme (enzymatic antisense oligonucleotide) could provide a truly novel, first-in-class, broad-spectrum, non-steroidal, anti-inflammatory therapy across type 2 inflammatory diseases

Marburg, Germany, May 26, 2020

• Proceeds to fund next Phase 2 clinical study with SB010 in moderate to severe asthma and oral formulation work for SB012 in ulcerative colitis 
• Sterna’s approach to down-regulate master transcription factor GATA-3 using a DNAzyme (enzymatic antisense oligonucleotide) enables broad-spectrum, simultaneous intervention in key type 2 inflammatory processes 
• Topical treatment with SB010 and SB012 is expected to become a novel, safe and efficacious therapeutic option for chronic inflammatory diseases with high unmet medical need. 

Marburg, Germany, November 07, 2019 
Sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, today announced that the Company will participate and present at the following partnering and investor conferences in November:

Marburg, Germany, 25 July 2019

• sterna biologicals selected as one of a group of top-tier European biotech companies to present at the European Biotech Investor Day on August 1, 2019 in New York City
• CEO Christian Pangratz to discuss the Company’s robust development progress and next phase of growth fueled by sterna’s first-in-class DNAzyme hgd40 in Phase 2 development for asthma and ulcerative colitis

Marburg, Germany, 08 July 2019

• Industry veteran Dr. Marion Wencker strengthens sterna’s management team as consulting CMO
• Financial expert Dr. Thomas Klaue recently joined sterna as consulting CFO

sterna biologicals GmbH & Co. KG (Sterna), an innovative clinical-stage immunology company developing novel biological treatments for chronic inflammatory diseases, announced today that the Company has recently appointed Dr. Marion Wencker as consulting Chief Medical Officer and Dr. Thomas Klaue as consulting Chief Financial Officer.

Marburg, Germany, September 05, 2018 

• Feasibility studies show excellent data with SB010 across a selection of high efficiency hand-held nebulizers
• Company well positioned to advance SB010 into late-stage clinical development

Sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced today that the Company has successfully completed in vitro device feasibility studies with its asthma drug candidate, SB010. These studies support the selection of the most efficient and user-friendly device options for late-stage development and commercialization of SB010.

Marburg, Germany, September 05, 2018

• Key preparatory steps to conduct phase IIb trials initiated, including CMC and regulatory activities in the EU and US
• Devices for SB010 in asthma selected, oral formulation work for SB012 in ulcerative colitis (UC) started

Sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, today provided an update on its preparations for phase IIb clinical development of its GATA-3 antagonist drug candidates SB010 and SB012.

Marburg, Germany, June 5, 2018

• Comprehensive data set presented at Digestive Disease Week® in the U.S.
• SB012 was safe and well tolerated and led to marked clinical and endoscopic improvement in patients with active ulcerative colitis
• Further support of GATA-3 antagonism as promising treatment approach for variety of chronic inflammatory diseases

sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced that the full data set from the successful SECURE study (NCT 02129439), a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with the GATA-3 specific DNAzyme formulation SB012, was presented during an oral session on June 5th at Digestive Disease Week® in Washington, DC.

Marburg, Germany, May 29, 2018

• Further insights and data from Phase 2a trial in ulcerative colitis

Sterna biologicals GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced today that further insights and data from a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with its DNAzyme candidate SB012 will be presented at Digestive Disease Week® (DDW) in Washington, DC, June 2-5, 2018.

Marburg, Germany, April 19, 2018

• Investigator initiated study sponsored and funded by DZL (German Center for Lung Research) in patients with moderate to severe eCOPD
• Primary endpoint and key secondary endpoints met

Sterna biologicals GmbH & Co. KG (“sterna”), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced that data from a randomized, double-blind, placebo-controlled, multicenter phase IIa trial with SB010 in chronic obstructive pulmonary disease (COPD) patients with eosinophilic airway inflammation have been published in the peer-reviewed medical journal, Respiratory Research[i].

Marburg, Germany, February 19, 2018

• Data presented at the 13th Congress of ECCO (European Crohn's and Colitis Organisation).
• SB012 was safe and well tolerated and led to marked clinical and endoscopic improvement in patients with active ulcerative colitis. This represents a further validation of GATA-3-antagonism for the treatment of a variety of chronic inflammatory diseases.

sterna biologicals GmbH & Co. KG ("sterna"), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced that positive data from the SECURE study (NCT 02129439), a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with its GATA-3 specific DNAzyme formulation SB012, were presented at the 13th Congress of ECCO (European Crohn's and Colitis Organisation).

Marburg, Germany, 01 February 2018
sterna biologicals GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, today announces its participation in the following key scientific and partnering conferences in the first half of 2018:

13th Congress of ECCO - European Crohn's and Colitis Organisation
Date: February 14-17, 2018 in Vienna, Austria

Marburg, Germany, 8 January 2018

sterna biologicals GmbH & Co. KG (Sterna), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, announced today that the Company has appointed Christian M. Pangratz as Chief Executive Officer. He brings over 25 years of life sciences experience, notably in the areas of strategic planning, corporate and business development, alliance and project management, new product planning, marketing and sales.

Marburg, Germany, 11 September 2017

• Results presented today at the European Respiratory Society International Congress 2017 in Milan, Italy

sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that investigator Dr Timm Greulich from the Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University Marburg, will present key results of the recently completed Phase II clinical trial of SB010 at the European Respiratory Society (ERS) Congress held in Milan, Italy, 9 to 13 September 2017.

Marburg, Germany, 01 May 2017
sterna biologicals GmbH & Co. KG ("sterna biologicals") is pleased to announce that two of its co-founders, Prof. Dr. Holger Garn and Prof. Dr. Harald Renz, were selected to receive this year's Paul Martini Prize. The prize is one of the most prestigious prizes in the field of medicine in Germany and is awarded by the Paul Martini Foundation for exceptional research achievements in the development of novel clinically relevant therapeutic approaches. The prize will be awarded today on the occasion of the 123rd Congress of the German Society for Internal Medicine in Mannheim.

Marburg, Germany, 10 October 2016

• Paper summarizing role of GATA-3 in ulcerative colitis published in Gastroenterology
• SECURE study of SB012 in patients with moderate to severe ulcerative colitis continues to progress (NCT02129439)

sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that detailed mechanistic investigations of the role of GATA-3 in ulcerative colitis, performed primarily by Prof Markus Neurath's group in Erlangen (Germany), were published in Gastroenterlogy (Popp et al, 2016).

Marburg, Germany, 17 May 2015

• SB010 Phase IIa proof-of-concept results published in the New England Journal of Medicine
• SB010 Phase I programme results published in the Journal of Allergy and Clinical Immunology
• SB010 development programme comprising four completed clinical trials demonstrates excellent safety profile combined with efficacy comparable to monoclonal antibodies

Marburg, Germany, 3 Sept 2014

• German Center for Lung Research (DZL) to conduct investigator-initiated trial of SB010 in patients with eosinophilic COPD
• Further data from Phase IIa trial of SB010 in asthmatic patients to be presented at the European Respiratory Society International Congress 2014 in Munich, Germany

Marburg, Germany, 14 May 2014
sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today that Prof Harald Renz will present key results of the recently completed Phase IIa clinical trial of SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2-driven asthma, at the upcoming American Thoracic Society (ATS) 2014 International Conference being held in San Diego, CA, 16 to 21 March.

Marburg, Germany, 29 April 2014

• Phase IIa clinical trial of SB012 (the SECURE trial) approved by regulatory agencies

sterna biologicals GmbH & Co. KG ("sterna biologicals") announced today a significant expansion of the company's clinical development pipeline. In addition to SB010 for the treatment of Th2-driven asthma and SB011 for the treatment of atopic dermatitis, SB012 joins these two promising drug candidates as a further GATA-3 antagonist in a major chronic inflammatory indication.

Marburg, Germany, 06 March 2014

• Phase I trial of SB011 for the treatment of atopic dermatitis successfully completed

• First patient enrolled in Phase IIa proof-of-concept trial

sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today successful completion of a Phase I study assessing the irritation potential of SB011 in healthy volunteers. SB011 is an emulsion containing 2% GATA-3-specific DNAzyme and employs sterna biologicals’ proprietary dermal delivery system which has demonstrated excellent protective and skin penetration enhancing effects in pre-clinical studies.

Marburg, Germany, 21 February 2014

• Significant improvement in lung function in both early and late phase asthmatic response

• Outstanding safety profile confirmed

sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today top-line results of its recently completed phase IIa proof-ofconcept trial of SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2- driven asthma. The study – a randomised, double-blind, parallel group, multi-centre clinical trial – was designed to establish efficacy of SB010 in improving lung function (FEV1) as measured by the area under the FEV1 curve (AUC) in the late phase asthmatic response after specific allergen challenge compared to placebo treatment.

Marburg, Germany, 01 October 2013
sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that two clinical trials evaluating SB011 for the treatment of atopic dermatitis were filed with regulatory agencies. This comprehensive clinical programme will generate important data regarding safety, tolerability, and efficacy of the drug candidate. SB011 is based on the same GATA-3-specific DNAzyme as SB010 and incorporates sterna biologicals’ proprietary dermal delivery system which is well-suited to deliver large molecules to relevant strata of the skin and effectively protects the DNAzyme against bacteria and harmful enzymes.

Marburg, Germany, 04 September 2013

• Results of Phase I programme to be presented at ERS 2013 in Barcelona

sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that the last patient was enrolled in a Phase IIa proof-ofconcept trial (NCT01743768) evaluating SB010, an inhaled first-in-class GATA-3 antagonist for the treatment of Th2-driven asthma. The study – a randomised, double-blind, parallel group, multi-centre clinical trial – seeks to establish efficacy of SB010 in improving lung function (FEV1) in the late phase asthmatic response after specific allergen challenge compared to placebo treatment.

Marburg, Germany, 15 July 2013

• No plasma accumulation effects evident in multiple-dose setting

Data published in Toxicology and Applied Pharmacology (Turowska et al., 2013) found that the DNAzyme used in sterna biologicals’ drug candidate SB010, a first-in-class inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma, is well-suited for infrequent and convenient dosing approaches.

Marburg, Germany, 07 Januar 2013

• Multicentre, randomised, double-blind clinical trial to assess safety, tolerability, efficacy, pharmacodynamics, and pharmacokinetics of SB010 in 38 asthmatic patients

sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that the first patient was enrolled in a Phase IIa proof-ofconcept trial of SB010 (NCT01743768). The study’s primary endpoint is the improvement in lung function (FEV1) in the late asthmatic response after allergen challenge. SB010 (10mg dose) or placebo will be administered once daily in two parallel groups of 19 patients each over 28 treatment days. The study will be conducted in seven centres in Germany. Further trial-specific details are available at www.clinicaltrials.gov.

Marburg, Germany, 11 September 2012 

• SB010 was safe and well-tolerated across all dose levels

• Phase IIa proof-of-concept trial filed with regulatory agencies

sterna biologicals GmbH & Co. KG (“sterna biologicals”) announced today that SB010, a DNAyzme-based GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma, successfully completed its comprehensive Phase I development programme.

Marburg, Germany, 09 May 2012

• Superior results achieved compared to other drug carrier systems such as W/O emulsions, microemulsions, and submicron emulsions

A paper published in the International Journal of Pharmaceutics (Schmidts et al., 2012) found that the formulation employed in sterna biologicals’ drug candidate SB011 is an excellent dermal delivery system for DNAzymes.

Marburg, Germany, 27 March 2012 

• Results support favourable safety profile observed in toxicological studies and in recently completed first clinical trial of SB010

A paper published in Nucleic Acid Therapeutics (Dicke et al., 2012) found that the DNAzyme used in sterna biologicals’ drug candidate SB010, a novel inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma, does not lead to unspecific immune cell activation.

Marburg, Germany, 27 February 2012

• sterna biologicals completes first-in-man study of SB010, an inhaled GATA-3 antagonist for the treatment of moderate to severe Th2-driven asthma
• SB010 was safe and well-tolerated across all dose levels

sterna biologicals GmbH & Co. KG (“sterna biologicals”) is pleased to announce successful completion of a Phase I clinical trial of its novel inhaled GATA-3 antagonist SB010 for the treatment of moderate to severe Th2-driven asthma.

Marburg, Germany, 07 November 2011

sterna biologicals GmbH & Co. KG ("sterna biologicals") is pleased to announce first dosing of its novel inhaled GATA-3 antagonist SB010 for the treatment of moderate to severe Th2-driven asthma in a phase I clinical trial. The trial is a randomised, double-blind, placebo-controlled assessment of safety and tolerability of single ascending doses of SB010 in 48 male subjects conducted by CRS Clinical Research Services Mannheim GmbH in Mannheim, Germany.