Archive: Company News
Company News: Curetis Announces Excellent Study Data and Multi-Region Launch of Unyvero BCU Blood Culture Application Cartridge
– Interim data from prospective multicenter evaluation show 98% concordance with conventional microbiology
– Unyvero results on average available 24 hours earlier than in conventional microbiology, enabling rapid decision on appropriate antibiotic therapy
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the broad commercial roll-out of its new Unyvero BCU Blood Culture Application Cartridge, which was introduced during ECCMID in April 2016. The roll-out has been initiated in Europe, the Middle East and Asia via Curetis’ internal sales force and the company’s distribution partner network.
The market launch is supported by excellent interim data from an external, prospective, multicenter evaluation comparing the performance of the BCU Application Cartridge against the performance of conventional microbiology work-up of positive blood cultures that is ongoing at three European hospitals.
The interim analysis on approximately 100 patient samples demonstrated a 98% concordance with conventional microbiology. Additional pathogens that escaped detection by conventional microbiology were found in several cases. On average, Unyvero results were available 24 hours earlier and in some cases up to two days earlier than results obtained by routine diagnostic methods. The data also confirm compatibility with most commonly used blood culture systems, namely BacT/ALERT® (BioMérieux) and BD BACTEC™ (Becton Dickinson).
Curetis expects to finalize the prospective evaluation during the third quarter of 2016 and is planning to submit a joint publication with the clinical investigators of the study to a peer-reviewed medical journal.
“The new Unyvero Application for blood cultures has truly proven its worth in our microbiology laboratory, thanks to its broad coverage of pathogens, the identification of antibiotic resistances and its easy handling,” said Dr. Monika Huber, senior physician and private lecturer of the Institute of Pathology and Bacteriology, at SMZ Otto Wagner Spital in Vienna, Austria, one of the clinical investigators of the study. “Even with mixed infections, excellent results are obtained within a few hours – a very valuable time gain for bringing adequate therapy to the patient.”
“We are very pleased with these first data from the prospective evaluation of our BCU Blood Culture Application,” said Dr. Achim Plum, CCO of Curetis, “They demonstrate the versatility and utility of our new BCU Application Cartridge in the rapid and reliable identification of pathogens and antibiotic resistance markers in positively flagged blood cultures. The results also indicate its significant potential to improve the management of critically ill patients with blood stream infections.”
Company News: Anergis to Present New Data on Lead Compound AllerT at the 35th European Academy of Allergy and Clinical Immunology (EAACI) Congress 2016
– Additional clinical Phase IIb data on the safety and efficacy of AllerT published in the Journal of Allergy and Clinical Immunology
– Composition-of-matter patent granted for AllerT by the European Patent Office
Anergis, a company developing proprietary ultra-fast allergy immunotherapeutics, today announced upcoming presentations, the publication of new clinical data and the strengthening of the IP position of its proprietary, clinical-stage COP immunotherapy lead compound AllerT for the treatment of patients with allergy to birch pollen.
Presentations at the EAACI 2016
On June 13 and 14, Anergis will present new clinical data on AllerT at the 35th European Academy of Allergy and Clinical Immunology (EAACI) Congress (Vienna, Austria, June 11-15, 2016).
Two scientific presentations will feature new findings on the mechanism of action and on the safety and tolerability of AllerT, Anergis´ most advanced product based on the company´s proprietary Contiguous Overlapping Peptide (COP) platform.
The following scientific communications will be presented:
Presentation Title: “Bet v 1-derived contiguous overlapping peptides activate human B- and T Cell responses in human”
Presenter: Alexander Kettner
Time and Date: Monday, June 13, 2015, at 12:15pm CET
Session: Thematic Poster Session LB TPS 5: New Treatment Modalities in Immunotherapy
Abstract #: 1539
Presentation Title: “The emerging tolerability and safety profile of COP’s (Contiguous Overlapping Peptides) containing both T and B cell epitopes in patients with birch allergic rhino-conjunctivitis”
Presenter: Kim Simonsen
Time and Date: Tuesday, June 14, 2016, at 10:30am CET
Session: Oral Abstract Session OAS 20: Safety and Efficacy of Allergen-specific Immunotherapy
Abstract #: A-716-0072-01932
Publication of Phase IIb Data in the Journal of Allergy and Clinical Immunology
Moreover, detailed clinical data from the first Phase IIb field-based study with AllerT were recently published online in the leading peer-reviewed Journal of Allergy and Clinical Immunology.[1] The trial examined the safety and efficacy of a two-month allergen-specific immunotherapy with COPs derived from the major birch pollen allergen Bet v1 in patients with allergic rhinoconjunctivitis in conditions of natural pollen exposure. The primary endpoint was the change in the combined rhinoconjunctivitis symptom and medication score (RSMS) vs placebo.
In this randomized, double-blind, placebo-controlled trial, 239 patients from 23 centers in 7 European countries received 5 preseasonal subcutaneous injections of either a placebo or AllerT at 50μg or 100μg doses.
The change in the RSMS was highly statistically significant vs the placebo in the 50μg group (p=0.015), and both active groups showed significant improvements in quality of life and nighttime nasal symptoms scores. AllerT injections were well tolerated, with a higher frequency of systemic adverse events in the 100μg group.
This study clearly demonstrated that only five injections in a 2-month treatment course with ultra-fast COP allergy immunotherapy provided a clinically meaningful reduction of seasonal allergy symptoms during the first season post treatment, without inducing more safety concerns than conventional SCIT injections. Furthermore, the treatment was shown to trigger a particularly strong IgG4 specific response, a crucial parameter of successful immunotherapy.
In 2015, Anergis released preliminary results from the second pollen season showing that the clinical response in the same group of patients was still present during the second season – without repeated treatment.[2]
New European Patent Granted on AllerT
In April 2016, Anergis was granted a composition-of-matter patent (patent no. 2393511) from the European Patent Office (EPO) on its AllerT product candidate for the treatment of patients with birch pollen allergy, thereby further broadening the geographical coverage of COP-based product patents.
“The Phase IIb trial described in the Journal of Allergy and Clinical Immunology is one of two main studies, which were integrated in this year’s EAACI presentation of the initial safety and tolerability profile of AllerT,” said Vincent Charlon, Chief Executive Officer of Anergis. “These consolidated data show that AllerT is not only efficacious for at least two yearly seasons without repeated treatment, but is also well tolerated across a broad range of doses tested. The ATIBAR trial currently in preparation is designed to deliver definitive efficacy and safety data at two doses of AllerT to identify the lowest effective dose prior to conducting the final Phase III confirmatory trial of AllerT.”
[1] Spertini F, DellaCorte G, Kettner A, de Blay F, Jacobsen L, Jutel M, Worm M, Charlon V, Reymond C, Efficacy of two months of allergen specific immunotherapy with Bet v 1-derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis: results of a Phase IIb study, Journal of Allergy and Clinical Immunology (2016), doi:10.1016/j.jaci.2016.02.044.
[2] Phase IIb follow-up trial of sustained efficacy of AllerT™ allergy vaccine during a second birch pollen season. Della Corte G.1, Jutel M.2, Jacobsen L.3, De Blay F.4, Worm M.5, Spertini F.6, Rak S.7, Kettner A.1, Reymond C.1, Charlon V.1
1Anergis SA, Epalinges, Switzerland, 2Wroclaw Medical University, Wroclaw, Poland, 3Allergy Learning, Copenhagen, Denmark, 4CHRU, Strasbourg, France, 5Charité – Universitätsmedizin Berlin, Berlin, Germany, 6CHUV, Lausanne, Switzerland, 7Sahlgrenska University Hospital, Gothenberg, Sweden
Company News: Curetis and Axonlab sign multi-market European distribution agreement
– Axonlab to become exclusive distributor for all Unyvero products in selected Central and Eastern European countries
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, and Axon Lab AG, a service company focusing on medical diagnostics, life science and software solutions for the healthcare sector, today announced the signing of an exclusive, three-year distribution agreement for Curetis’ Unyvero products in Central and Eastern European countries, including Austria, the Czech Republic, Slovakia, Slovenia and Croatia. The agreement also includes contractual minimum purchase commitments by Axonlab.
Through the partnership, Curetis expands its distribution network by four additional countries and transfers the commercialization responsibilities for one of its former direct selling territories (Austria) to Axonlab. The agreement is part of Curetis’ expanded commercial effort in Western Europe and allows the companies to leverage Curetis’ existing installed base in Austria, with Axonlab acquiring multiple commercially installed Unyvero Systems for cash up-front.
Axonlab will deploy a core team of several dedicated molecular diagnostics commercial representatives covering these markets. This deployment structure will ensure optimal resource allocation for Curetis in the region.
Axonlab has dedicated microbiology and molecular diagnostics franchises and direct offices in each of the countries covered under the agreement, and it is well positioned to accelerate the commercial launch of Unyvero in the CEE markets.
Curetis will continue its direct sales programs in its home market of Germany, as well as in Switzerland, the UK, France and the Benelux region.
“We are excited to partner with Curetis for the commercial distribution of the Unyvero Platform with all of its current and future Application Cartridges in several of our core markets in Europe,” said Guido Mueller, General Manager Austria of Axonlab. “We believe that Unyvero offers unique and differentiated syndromic panels to our customers in hospitals and microbiology laboratories. This collaboration is expected to be another driver for our future growth here at Axonlab in the years ahead.”
Dr. Achim Plum, Chief Commercial Officer of Curetis N.V., added, “This strategic commercial distribution agreement for multiple markets in Central and Eastern Europe makes perfect business sense for Curetis. We expect that the Axonlab partnership will allow us to accelerate the commercial roll-out of Unyvero products in smaller markets, such as Austria, while adding several new markets to our distribution portfolio. Moreover, the agreement allows us to focus our direct commercial efforts on the largest Western European markets, such as the UK, France, Benelux and Germany as well as Switzerland, to drive our growth. We currently have a presence in more than thirty countries, either directly or through our ten distribution partners. We plan to continue expanding this worldwide network through the addition of new commercial partners.”
Company News: ISA Pharmaceuticals Appoints Bart Bergstein as Chairman of the Supervisory Board
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced the appointment of Bart Bergstein as Chairman of its Supervisory Board. ISA´s current Chairman Pieter van der Meijden will remain a member of the Supervisory Board.
Bart Bergstein has a strong track record in working with life sciences companies. He is a co-founder of Forbion Capital Partners, a leading European venture capital firm. At Forbion, he invested in numerous healthcare companies and served as a non-executive director on the board of many portfolio companies. He also has operational experience, serving as CFO of Cellnovo Group SA, where he successfully executed an IPO on Euronext Paris. He started his career at ABN AMRO bank, where he initiated the life sciences team within ABN AMRO private equity, and in his last position headed the Private Equity Life Sciences Team as Managing Director Life Sciences. With his team at ABN AMRO, he built a portfolio of life sciences investments valued at EUR 100m, realizing multiple highly profitable exits. In addition to his role at ISA Pharmaceuticals, Bart holds various non-executive board positions in leading-edge life sciences companies.
“We are really pleased that Bart Bergstein is joining ISA Pharmaceuticals´ Supervisory Board, as he has a wealth of expertise in life sciences investments and in advancing innovative companies,” said Pieter van der Meijden, current Chairman of ISA´s Supervisory Board. “I am convinced he will be an excellent successor as Chairman of the Board and provide valuable guidance during this exciting phase of the company’s development.”
“ISA Pharmaceuticals has the potential to be a leader in the emerging field of cancer vaccination therapy. Its technology holds great promise for improving patient outcomes by offering a benign, yet potent therapeutic approach,” said Bart Bergstein. ”Furthermore, ISA has the capability to advance its technology towards personalized vaccine therapy, developing patient-specific therapeutic vaccines that have already proven their merit in preclinical testing.”