Archive: Company News
Company News: Kappaproct Drastically Reduces the Need for Colectomy in Patients with Severe Ulcerative Colitis
– InDex Pharmaceuticals reports positive clinical data in peer-reviewed journal Inflammatory Bowel Diseases –
InDex Pharmaceuticals today announced the publication of positive data from the Company’s compassionate use program with its lead compound Kappaproct. In the program, eight treatment-refractory ulcerative colitis (UC) patients that had been elected for colectomy received Kappaproct, a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9).
The findings showed that Kappaproct induced a pronounced and rapid reduction in the colitis activity index for all treated patients within 1 week following a single intracolonic administration. Further improvements were evident at week 4, resulting in a clinical response rate after a single-dose treatment with Kappaproct of 71%, with 43% in clinical remission. By week 12, the clinical response and remission rates had reached 82% and 71%, respectively. A follow-up period of over 2 years post treatment indicated that all but one of the treated patients had avoided the need for colectomy, with the longest patient being in symptom-free remission for over 27 months.
The article “Topical Treatment with the Toll-like Receptor Agonist DIMS0150 Has Potential for Lasting Relief of Symptoms in Patients with Chronic Active Ulcerative Colitis by Restoring Glucocorticoid Sensitivity”, was published in the journal Inflammatory Bowel Diseases (DOI 10.1002/ibd.23019).
Kappaproct is currently in a European multicenter phase III trial called COLLECT (NCT01493960) for the treatment of chronic active UC patients not responding to available therapy. Results are expected for Q1 2014.
Company News: Merus Announces Appointment of Jason Avery as Chief Business Officer
Merus B.V., a biopharmaceutical company focused on multispecific human antibody therapeutics, announced today that Jason Avery has been appointed as Chief Business Officer.
With a professional background as Head of Business Development at Affitech A/S and Chief Business Officer at Cambridge Antibody Technology, Jason Avery brings extensive industry experience to Merus.
“Jason comes to Merus with a wealth of experience in Business Development, in particular in the antibody space, and we are delighted to have him join the team,” said Dr Ton Logtenberg, CEO of Merus B.V. “As our multispecific human antibody platforms have matured and consistently yield lead candidates for clinical development, Jason’s expertise will be invaluable to reach our ambitious business goals.”
“Merus is one of the most impressive companies in the antibody technology and product space,” said Jason Avery. “The combination of MeMo®, the common light-chain transgenic mouse, and Merus’ antibody format technology facilitates unprecedented ease in the discovery, development and manufacturing of bispecific antibodies. I look forward to progressing the commercial success of Merus´ discriminative pipeline of owned and partnered antibody products. I am very excited to be joining such an experienced management team.”
Company News: Anergis Reaches Important Milestones with Second Product Candidate AllerR
– US Regulatory path for new vaccine against ragweed pollen allergies established –
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has reached several preclinical development milestones with AllerR, a novel allergy vaccine candidate for the treatment of patients with allergies to ragweed pollen. In addition, the company received positive feedback from the FDA on its AllerR development program.
In the development of AllerR, its second allergy vaccine candidate, Anergis reached essential preclinical milestones and held its first meeting with the US FDA in preparation for the first clinical trial of AllerR in patients allergic to ragweed pollen.
In preclinical experiments carried out by Anergis, binding of the AllerR peptides to IgE antibodies of allergic patients remained consistently undetectable in all conditions tested. In mice pre-sensitized to ragweed pollen, AllerR, unlike natural ragweed allergens, did not elicit an anaphylaxis-like response. And, importantly, AllerR was found to elicit antibody responses in mice, in which the antibodies recognized the natural ragweed allergens. Following collection of these data, Anergis held a pre-IND meeting with the U.S. FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol.
Company News: InDex Pharmaceuticals Appoints Stig Løkke Pedersen as Board Member
– Former Lundbeck Executive Brings Strong Commercial Experience and Extensive Pharmaceutical Industry Network –
InDex Pharmaceuticals today announced that Stig Løkke Pedersen has been appointed as a new member of the Board of Directors. Mr. Pedersen brings to InDex Pharmaceuticals over 25 years of longstanding life sciences industry experience in commercial operations and leadership.
Mr. Pedersen previously served as Executive Vice President of Commercial Operations at H. Lundbeck A/S. He joined Lundbeck in January 1992, being responsible for the company’s business development activities. Following a period as Managing Director of Lundbeck Netherlands, he became part of the corporate senior management in 1998. Mr. Pedersen was appointed Executive Vice President in April 2003 and held the position as EVP for Commercial Operations from 2007 until June 2011, when he resigned from his position at Lundbeck. Mr. Pedersen is a Partner at Executive Capital A/S and serves as the Chairman of the Board of Directors at Chemometec A/S and Nuevolution A/S. He is a member of the Board of Directors at MSI Methylation Sciences Inc. and a member of the Advisory Board of Atrium Partners A/S and JSB-Partners, as well as an advisor to the Lundbeck Foundation.