On April 3, 2014 Astellas Pharma announces the submission of a variation to amend the Marketing Authorisation Application for XTANDI (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated (Press release Astellas, APR 3, 2014, View Source [SID:1234500365]). Enzalutamide is currently approved in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel chemotherapy.
Author: [email protected]
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of complex generic products developed since 1984 (CV Richard Dicicco, APR 2, 2014, View Source [SID:1234501869]). Harvest Moon Pharma develops, manufactures sells and/or licenses-out to the trade, worldwide, these complex generic drug products and biosimilars. After seeking scientific advice from the EMA, Harvest Moon Pharma has biosimilars of adalimumab, rituximab and trastuzumab entering phase I clinical trials in Europe. These mAbs were developed in Europe with comparability studies to both the European and USA reference listed biological, are produced in the USA, and comply with the EMA mAb adopted and revised guidelines. They will be filed in Europe and the USA in 2016. Harvest Moon Pharma offers etanercept, infliximab and bevacizumab which will be filed in Europe and the USA in 2017. Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks often and is widely published in generics, biosimilars and the emerging markets of MENA, APAC and BRICKTM.
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First Plant-based Production of PAT-SM6
On April 2, 2014 Patrys reported that data on the production of PAT-SM6 in an easy-to-grow plant manufacturing system have been published in the leading peer-reviewed journal Proceedings of the National Academy of Sciences (PNAS) (Press release Patrys, APR 2, 2014, View Source [SID:1234500550]). The article titled "Expression and glycoengineering of functionally active hetero-multimeric IgM in plants" is currently available online ahead of a future print edition of the journal.
The study was the result of a research collaboration involving Patrys and the University of Natural Resources and Life Sciences, Vienna, Austria. The collaboration has focused on developing an alternative production system for the manufacture of IgM antibodies (using PAT-SM6) which might significantly reduce production costs while maintaining the quality and functionality of the antibody products.
The study found that relatively high quantities of PAT-SM6 IgM antibody can be made in an easy-to-grow plant manufacturing system. Further, functionality of antibodies very often depends on the attached sugars. It was shown that by modulating the properties of the plants, a process called in planta glycoengineering, this plant expression system can produce fully functional antibodies that are similar to the antibodies generated by the human body. The study demonstrated this novel plant-based process can be successfully applied to generate high yield, functional, human-like IgM antibodies.
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AbCheck to Discover Antibodies for Pierre Fabre
On April 2, 2014 it was announced that AbCheck is now in a research collaboration with Pierre Fabre under which AbCheck will use its AbSieve discovery platform to deliver antibodies against targets provided by Pierre Fabre (External Source, Pierre Fabre, APR 2, 2014, View Source [SID:1234500363]). Pierre Fabre will have full rights to any antibodies selected and will make milestone payments and fees for discovery to AbCheck.
AbCheck says its AbSieve discovery platform combines its phage and yeast display technologies to develop antibodies in formats including full length IgGs as well as customer-specific and novel antibody formats. Its phage display libraries, according to the firm, allow for the discovery of specific high-affinity human antibodies for target proteins; the yeast display technology allows the selection of drug candidates with high affinities and improved drugability from a range of variants.
Previously this year, Pierre Fabre has entered two other cancer related agreements with Redx Pharma and Aurigene, respectively.
Update on phase III clinical trial of investigational MAGE-A3 antigen-specific cancer immunotherapeutic in non-small cell lung cancer
On April 2, 2014 GlaxoSmithKline announced its decision to stop the MAGRIT trial (NCT00480025), a Phase III trial of its MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment (Press release GlaxoSmithKline, APR 2, 2014, View Source [SID:1234500361]).
Data from the trial announced on 20 March 2014 showed that it did not meet its first or second co-primary endpoints as it did not significantly extend disease-free survival (DFSiv) when compared to placebo in either the overall MAGE-A3 positive population (first co-primary endpoint) or in those MAGE-A3-positive patients who did not receive chemotherapy (second co-primary endpoint).
GSK continued with the MAGRIT trial to investigate the third co-primary endpoint of DFS in a gene signature positive sub-population, which was designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment. However, the pre-planned independent third-party analysis of a proportion of the data (to identify a gene signature classifier) has concluded that assessment of the third co-primary endpoint is not feasible due to an insufficient treatment effect.
The trial will be stopped and GSK will now gain access to the un-blinded data, in order to conduct a full assessment of the findings and understand learnings for other aspects of immunotherapy development within GSK.
The Independent Data Monitoring Committee (IDMC) indicated that its review of the current safety information revealed no specific safety concern and the data is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.
MAGRIT, a randomised, double-blind, placebo-controlled trial, evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IB, II and IIIA completely resected non-small cell lung cancer (NSCLC) patients whose tumours expressed the MAGE-A3 gene.