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Company News: Merus Receives EP Patent Covering the Expression of Defined Antibody Combinations
Merus B.V., a biopharmaceutical company focused on multispecific human antibody therapeutics, announced today that it has been granted the first European patent covering its Oligoclonics® technology from a patent family that already comprises 4 issued US patents. The Oligoclonics® technology entails the manufacturing of at least three antibodies with different specificities by a single production cell line, thereby providing for combinations of human antibodies as a single therapeutic.
It has been demonstrated in clinical trials and disease models that combinations of antibodies are more efficacious than therapies based on single monoclonal antibodies alone. The Oligoclonics® technology is designed to provide important developmental and therapeutic value. It offers a platform for the stable, high-yield production of fully human, natural IgG antibody combinations by a single cell line using strategies currently exploited for conventional monoclonal antibodies in a manner that is cost-effective and acceptable to regulatory authorities.
“The therapeutic antibody field is moving towards combination therapies, either by combining individual monoclonal antibodies or by applying bispecific formats, to overcome the limited potency of monoclonal antibodies often observed in indications like oncology,” said Ton Logtenberg, CEO of Merus. “The Oligoclonics® technology provides a platform that allows for the cost-effective development and manufacturing of multispecific combinations of antibodies with more potent clinical effects. The key to the Oligoclonics® technology is that all antibodies produced by the clonal manufacturing cell line share a common light chain (cLC). With our recent announcement of MeMo®, a transgenic mouse for the generation of human cLC monoclonal antibodies, we are complementing our technology base with the aim to expand our pipeline of innovative cLC antibody products.”
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.