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Company News: PharmaEngine and Nanobiotix Sign Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3
– Partnership will accelerate NBTXR3 clinical program and develop Asian market –
French Nanobiotix S.A. announced today that it entered into a strategic partnership with PharmaEngine, Inc. for the rapid development of NBTXR3, the lead product from the NanoXray pipeline of Nanobiotix. Nanobiotix is a nanomedicine company developing novel cancer nanotherapeutics, while PharmaEngine is a specialty pharma company focused on the development of in-licensed oncology drugs.
The partnership aims to accelerate the global clinical development of NBTXR3 as PharmaEngine will add its Asia-based complementary clinical development strengths and will conduct further clinical studies.
Under the terms of the agreement, PharmaEngine will receive exclusive rights to develop and commercialize NBTXR3 in the Asian-Pacific region, including Australia, China, India, Japan, Korea, Taiwan and other countries, while Nanobiotix retains exclusive rights for the rest of the world. Nanobiotix retains an option to re-acquire the rights for the entire Asian-Pacific territory except for China and Taiwan, according to pre-defined conditions in exchange for termination payments and agreed-upon royalties.
Nanobiotix will receive an initial upfront payment of US$ 1 million and is eligible for further development and commercialization milestone payments which may amount to a total of US$ 56 million plus tiered, up to double-digit royalties on net product sales in the Asian-Pacific region.
PharmaEngine will further fund the clinical development of NBTXR3 in three different indications. The clinical studies will be initiated according to an agreed upon time schedule and development plan with the goal to commence clinical studies in two indications within 18 months. The parties have agreed to share the data to enable an efficient and focused global development in multiple indications.
Company News: Curetis AG Signs Distribution Deal in Middle East with ATC
– Kuwait Ministry of Health clears Unyvero™ Solution for clinical evaluation –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that it has signed an exclusive distribution deal for its Unyvero™ solution with Advanced Technology Company K.S.C. (ATC). ATC will become the exclusive distributor of the Unyvero Solution including consumables for the six Gulf Cooperation Council (GCC) countries and the Lebanon.
Placement of instruments will start in the third quarter this year. A clinical evaluation project of the Unyvero™ Solution has been approved by the Kuwait Ministry of Health and will take place at leading clinical sites in the country. Curetis, ATC and the clinical investigators will cooperate closely during this phase, and are planning to publish evaluation data in 2013 at a renowned international medical conference.
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.