Archive: Company News
Company News: International team led by Humabs BioMed identifies novel therapeutic antibody candidates isolated from Zika-infected patients
– Broad implications for new strategies to develop Zika virus diagnostics and treatments
– Data published in Science*
Humabs BioMed SA, a Swiss antibody therapeutics company, today announced a publication in the renowned scientific journal Science describing an in-depth analysis of the human antibody and T cell immune response to the Zika virus infection with implications for diagnostics, vaccine and treatment development.* The article is the result of an international team led by Humabs.
Zika virus is a mosquito-borne flavivirus with homology to Dengue virus. After its introduction into Brazil in 2015, Zika virus has spread rapidly in Latin America and in February 2016, the World Health Organization (WHO) declared it a Public Health Emergency of International Concern. While the main route of Zika virus infection is through bites by mosquitos, the virus may also be spread sexually and vertically from mother to child during pregnancy. Most of the Zika virus infections are asymptomatic or cause only mild symptoms. However, Zika virus infection can lead to neurological complications, such as Guillain-Barré Syndrome in adults and, of even greater concern, congenital birth defects such as microcephaly and other defects in the developing fetus. As of today, there is no preventive vaccine or specific therapy available.
The study published in Science reports the first characterization of the human immune response to ZIKV infection, showing that most of the antibodies elicited by Zika virus infection cross-react with Dengue virus. These cross-reactive antibodies are poorly neutralizing, but can potently enhance Zika virus and Dengue virus infection in vitro. Antibody-dependent enhancement occurs through binding of the tail of antibodies to Fc receptors that are found on multiple cell types, including macrophages and placental endothelial cells. These receptors can internalize viral particles coated by antibodies leading to virus replication and spread in cells otherwise not targeted by the virus. Since placental Fc receptors transfer maternal antibodies to the developing fetus, maternal antibodies to Dengue virus may also possibly help Zika virus transmission across the placenta. The antibody-dependent enhancement phenomenon is well known in cases of secondary Dengue infections, representing a risk factor for the development of a more severe disease. Importantly, the study demonstrates that cross-reactive antibodies induced by Zika virus infection can lethally enhance infection by Dengue virus, suggesting that Zika virus infection in humans may predispose to more severe infections with Dengue virus. “In contrast to the broad cross-reactivity observed with antibodies, we found that the T cell responses is to a large extent Zika-specific, a finding that may mitigate the severity of Dengue infection in Zika immune individuals,” said Federica Sallusto, co-last author of the study and Director of the Center of Medical Immunology at the IRB.
The study also illustrates the use of antibodies specific for the Zika virus in a blockade-of-binding assay that might be used as a highly specific serological diagnostic tool in large cohort clinical and epidemiological studies to investigate the risk of Zika virus disease enhancement and the real incidence rate of Zika virus congenital infection in areas endemic for other flaviviruses.
A highly potent neutralizing antibody was identified and engineered into the “LALA” form to not bind Fc receptors and shown to inhibit the enhancement of Zika virus infection by plasma derived from either Zika virus or Dengue virus infected patients and to protect animals when given before and after animals were challenged lethally with Zika virus. This class of highly potent antibodies holds the promise of being developed in their LALA versions as therapeutics to both prevent congenital Zika virus infection in pregnant women at risk of contracting Zika virus infection by directly neutralizing Zika virus, and also to serve as potential inhibitors of disease enhancement and transplacental infection by pre-existing cross-reactive antibodies.
“It took only four months to functionally select, clone and characterize more than 100 anti-Zika virus antibodies from the initial screening of human B cells derived from four convalescent patients. The most potent antibody capable to neutralize Zika virus in a preclinical model is now being developed by Humabs as an effective anti-Zika virus therapy to prevent congenital infections. I believe that our discoveries will also have a significant impact on the development of novel diagnostic approaches,” said Davide Corti, CSO and Senior VP of Humabs.
“This study represents another example of the rapid pathway established at Humabs for the isolation of large numbers of anti-infective antibodies and for the discovery and development of the best in class antibodies as potential new therapies against emerging pathogens,” said Filippo Riva, CEO of Humabs.
The study is the result of an international collaboration between the Swiss Biotech company Humabs BioMed SA and the Institute for Research in Biomedicine (IRB), Università della Svizzera italiana (USI), together with the University of California, Berkeley (US), Public Health England, Porton Down (UK), the Policlinico San Matteo IRCCS, Pavia (IT), the Swiss Tropical and Public Health Institute, Basel (CH), and the Centre for Tropical Medicine, Ho Chi Minh City (VN). The study was partially funded by the Swiss National Science Foundation and the European Research Council, the US National Institutes of Health and the Italian Ministry of Health.
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* “Specificity, cross-reactivity and function of antibodies elicited by Zika virus infection,” by K. Stettler; M. Beltramello; S. Bianchi; F. Vanzetta; A. Minola; S. Jaconi; E. Cameroni; D. Corti at Humabs BioMed SA in Bellinzona, Switzerland; D.A. Espinosa; E. Harris at University of California, Berkeley in Berkeley, CA; V. Graham; S. Dowall; B. Atkinson; R. Hewson at Public Health England in Salisbury, UK; A. Cassotta; F. Mele; M. Foglierini; M. Pedotti; L. Simonelli; L. Varani; A. Lanzavecchia; F. Sallusto at Università della Svizzera italiana in Bellinzona, Switzerland; A. Cassotta; A. Lanzavecchia at ETH Zurich in Zurich, Switzerland; E. Percivalle; F. Baldanti at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy; C.P. Simmons at University of Oxford in Oxford, UK; C.P. Simmons at Center for Tropical Medicine in Ho Chi Minh City, Vietnam; C.P. Simmons at University of Melbourne in Melbourne, VIC, Australia; C.P. Simmons at Peter Doherty Institute in Melbourne, VIC, Australia; J. Blum at Swiss Tropical and Public Health Institute in Basel, Switzerland; J. Blum at University of Basel in Basel, Switzerland. http://science.sciencemag.org/lookup/doi/10.1126/science.aaf8505
Company News: InDex Pharmaceuticals publishes results from COLLECT study
InDex Pharmaceuticals AB today announced the publication of the results from COLLECT, a clinical study of the Toll-like receptor 9 (TLR9) agonist cobitolimod as a first-in-class treatment for patients with moderate to severe ulcerative colitis (UC). The paper, published in the peer-reviewed Journal of Crohns and Colitis (JCC), supports the potential of cobitolimod as a novel treatment for moderate to severe active ulcerative colitis.
In the COLLECT study, 131 patients with moderate to severe active UC and an inadequate response to conventional therapy received either 30 mg of cobitolimod or placebo as two single rectal doses at week 0 and week 4, in addition to standard of care therapies. The study was conducted at 38 sites in seven European countries.
Despite not meeting the primary endpoint of inducing clinical remission measured at week 12, defined by a clinical activity index (CAI)/Rachmilewitz score of ≤4, cobitolimod showed statistically significant improvement on important secondary endpoints at week 4. These included:
- symptomatic remission (no blood in stool together with a normal stool frequency), reached in 32% of the patients in the cobitolimod group compared to 14% in the placebo group (p=0.02),
- registration remission (clinical remission with concurrent mucosal healing), achieved in 21% of the patients in the cobitolimod group versus 4.7% in the placebo group (p=0.02).
A statistical significant improvement was also evident in the combined score of symptomatic remission and mucosal healing, achieved in 21% in the cobitolimod group vs. 2.3% in the placebo group (p=0.02). This is the endpoint that the regulatory authorities as well as the scientific community consider the most relevant for the disease. Moreover, a significant improvement was seen in the histology score at week 4. Cobitolimod was well tolerated and no safety signals compared to the placebo group were evident.
“The data from the COLLECT study shows that cobitolimod is a promising and well-tolerated potential novel therapeutic option for patients with moderate to severe active ulcerative colitis, for which there is an unmet medical need,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “InDex is currently preparing for the next clinical study with cobitolimod, which will be a phase IIb study to optimize the dosing regimen with the goal to provide substantially higher efficacy, while maintaining the compound’s superior safety profile.”
Principal investigator of the COLLECT study, Professor Christopher Hawkey commented: “In active ulcerative colitis the goal of treatment is to induce remission, characterized by a reduction in stool frequency and blood in stool, accompanied by an improved or normalized endoscopic score. The COLLECT study demonstrates that cobitolimod can achieve these goals, also in patients who are refractory to some currently available treatments.”
The publication has the title “Clinical effects of a topically applied Toll-like receptor 9 agonist in active moderate to severe ulcerative colitis”. The publication and the acknowledgement to all investigators can be found at http://ecco-jcc.oxfordjournals.org, Atreya R et al. J Crohns Colitis. 2016 May 20. pii: jjw103.
Company News: David Coorey Joins Agena Bioscience to Lead Europe, Middle East, and Africa Business
Agena Bioscience today announced the appointment of David Coorey as Vice President and Managing Director, EMEA.
David joins Agena Bioscience from Becton Dickinson, where he most recently held the position of Business Unit Director for the Diagnostic Systems Division. David brings over 20 years’ experience leading strategy and commercialization across a range of medical device, genomics, and diagnostic companies such as Affymetrix, Gambro Healthcare, and Fresenius Kabi.
“We are delighted to have David lead our Europe, Middle East, and Africa organization,” said Pete Dansky, Chief Executive Officer of Agena Bioscience. “His distinguished track record in building and motivating growth in the EMEA life science and molecular diagnostics industries will help continue to drive Agena Bioscience’s strategy and commercial execution in EMEA.”
Agena Bioscience recently announced the launch of its CE-IVD marked MassARRAY® Dx products for sale in Europe, a genetic analysis system that enables reliable multiplexed analysis of up to hundreds of clinically relevant mutations in a single workflow.
“I’m excited by the potential of Agena Bioscience’s technology to enable better patient care in Europe through the unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing,” said David Coorey.
The MassARRAY System and MassARRAY Dx enable mid-plex targeted profiling of 10’s to 100s of genetic markers. The technology offers a practical solution for today’s clinical and translational research labs with improvements in cost, throughput, reimbursement, and ease of use over alternative methods.
Company News: Curetis Appoints Christopher M. Bernard as Chief Executive Officer of Newly-Formed U.S. Subsidiary
– Former Chief Commercial Officer of Epic Sciences brings valuable experience in sales, marketing and commercialization of in-vitro diagnostic platforms
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that Christopher M. Bernard has been appointed to the newly-created role of President and Chief Executive Officer of the Company’s North American subsidiary Curetis USA, Inc., effective immediately. He will be responsible for the development of the new subsidiary based in San Diego, CA, and will lead the marketing and sales initiatives for Curetis in the U.S.
Curetis USA, Inc. was founded to drive the future development and sales of the Company’s Unyvero Platform in North America. The Company recently announced completion of enrollment in the U.S. FDA trial of Unyvero for the detection of lower respiratory tract infections. Curetis plans to submit the Unyvero LRT55 Cartridge for FDA clearance by the end of 2016, with potential clearance and commercial launch targeted for the first half of 2017.
“We are pleased to have Chris join Curetis as the CEO of our U.S. subsidiary,” commented Oliver Schacht, PhD, CEO of Curetis N.V. “He is a highly accomplished executive with proven ability to develop successful sales and marketing strategies, drive growth for emerging companies, manage operations and deliver on key strategic, commercial and operational objectives. He is an important addition to the leadership team at Curetis and will play a critical role in enhancing the Company’s growing global presence by establishing and leading its U.S. subsidiary, based in San Diego.”
Mr. Bernard joins Curetis with more than 22 years of diagnostics, biopharmaceutical and translational research industry experience, including roles in executive management, strategic development, product commercialization, marketing and sales. Prior to joining Curetis, Mr. Bernard served as Chief Commercial Officer of Epic Sciences, developer of one of the few commercially available platforms that can identify circulating tumor cells in the blood. In this role, Mr. Bernard was responsible for the expansion of Epic’s technology in collaboration with pharmaceutical and biotech companies and leading cancer research centers and the commercialization of Epic’s independent and companion diagnostic products.
Prior to joining Epic Sciences, Mr. Bernard worked at Metabolon, Inc. as an Officer and Senior Vice President, Sales and Marketing, where he rebuilt the company’s Metabolytics business, a business-to-business biochemical profiling service responsible for the company’s total sales at the time. Prior to Metabolon, he served as Vice President, Sales and Marketing and as an Officer of Abaxis, Inc., directing the sales and marketing efforts for the company’s point-of-care diagnostic chemistry platform, Piccolo Xpress®. Mr. Bernard began his career at Cytyc Corporation (Hologic, Inc.), ultimately becoming the regional business director where he was responsible for growth in sales and management of a portfolio of diagnostic products, including ThinPrep® Pap Test and Imager, and NovaSure® endometrial ablation.
Mr. Bernard received a B.A. in Psychobiology from Hiram College, Ohio, where he is a current board member of the Center for Entrepreneurship.
“Curetis is a cutting-edge molecular diagnostics company with tremendous opportunity,” said Mr. Bernard. “I am very excited by this opportunity to lead Curetis USA and support the planned North American commercialization of the Unyvero platform. I look forward to working with Curetis’ outstanding executive team and board to advance the company and position it for further success.”
He added: “This is an exciting as well as strategically important time to be joining Curetis. Once FDA clearance is accomplished, the Unyvero System will make an immediate impact in U.S. hospitals in two key areas: lower respiratory tract infections and antibiotic resistance. In the U.S., there is a death every 10 minutes due to pneumonia, and respiratory infections are the second leading cause of hospitalizations. Coupled with increasing global concern around super bugs that are resistant to standard antibiotics, this makes the timing of a U.S. launch for Curetis ideal.”