Alvotech and Finesse Solutions, Inc. have entered into a collaboration under which Alvotech will employ Finesse’s SmartFactory cGMP single-use biomanufacturing platform suite, designed for scalable, flexible and cost-efficient manufacturing and lab technology. SmartFactory will add capacity to allow Alvotech to expand its biosimilars business. Additionally, Finesse customers will have access to Alvogen’s commercial, FDA-approved biomanufacturing facility.  

Dr. Andreas Herrmann, chief executive officer of Alvotech, said, “This partnership allows us to leverage Finesse’s single-use bio-manufacturing automation platform, combining best-of-breed bio-process equipment from upstream through downstream. This strategic relationship provides us with much-needed additional manufacturing capacity and scale-up capabilities, which will allow us to expedite our ambitions to become a global leader in the high-growth biopharmaceutical industry. The first manufacturing suite will be in place by the end of 2015.”  

Dr. Barbara Paldus, chief executive officer of Finesse, said, “Alvotech is capitalizing on the extraordinary flexibility afforded by SmartFactory, and together we will be able to implement cutting-edge, innovative solutions for established and development-stage biosimilars processes. The Alvotech facility will showcase our latest SMART technologies in process control, batch automation and data management. This partnership will also provide us with an important path to offer full-scale commercial manufacturing to our customers.”

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Catalent, CiRA In Regenerative Therapy Pact
Catalent Pharma Solutions has entered an agreement with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans. Catalent will manufacture an anti-CORIN monoclonal antibody using its GPExcell line expression technology for a planned clinical research project to develop an iPS cell-based transplant therapy for Parkinson’s disease at CiRA, which is directed by professor Dr. Shinya Yamanaka, the joint winner of the Nobel Prize in Physiology or Medicine in 2012 related to her work with iPS.  

The anti-CORIN monoclonal antibody was developed through a research collaboration between CiRA and KAN Research Institute, Inc., a subsidiary of Eisai Co. Catalent has already engineered cell lines producing the anti-CORIN monoclonal antibody for CiRA, which has been shown to be useful for sorting CORIN-expressing cells in in vitro studies at CiRA.  

Catalent will conduct further clonal selection and manufacturing for CiRA, and upon regulatory approval, the selected dopaminergic neurons derived from iPS cells will be transplanted into patients for a possible clinical research program. Catalent will also provide formulation, production, and sterile fill/finish of the monoclonalantibody, aspects of the project for CiRA.

“It is a great honor to work with a team led by the world renowned Dr. Jun Takahashi,” said Shingo Nakamura, Catalent’s director of Biologics, Japan. “We are very excited to help accelerate the development of a unique regenerative therapy using our GPEx technology and look forward to working with CiRA to bring better treatments to market faster.”  

Jonathan Arnold, vice president and general manager of Catalent Biologics, added, “We are witnessing an increased demand for biologics in the Asia Pacific market. Our GPEx technology, our expertise, and access to Antibody Drug Conjugates, combined with our investment in state-of-the art manufacturing facilities, mean that we are ideally placed to act as a partner to CiRA in this exciting project.”

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Xenetic Biosciences Relocates To Lexington, MA
Xenetic Biosciences, Inc. has opened its new corporate headquarters and R&D facility in Lexington, MA. The company has relocated from London, UK and currently has seven employees in Lexington with plans to grow to 14 by the end of the year.

Scott Maguire, chief executive officer of Xenetic said,“The opening of Xenetic’s new corporate headquarters in Lexington marks an important new phase in the company’s 17-year history. Moving our development operations to the MA biotech corridor is an important step in our transition to becoming an innovative biopharmaceutical company based and publicly listed in the U.S. We believe that we are much more strongly positioned to execute on our mission to develop and commercialize leading next-generation biologic drugs and novel oncology therapeutics.”

Robert Coughlin, president and chief executive officer of MassBio said, “We are very excited by Xenetic’s decision to relocate to Massachusetts. We look forward to working with Xenetic in the years ahead as the Company continues its growth as a U.S.-listed company.”

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ProBioGen, Merus Sign GlymaxX License Agreement
ProBioGen AG and Merus B.V. have signed a non-exclusive commercial option and license agreement granting Merus access to ProBioGen’s GlymaxX fucose-engineering technology to enhance the ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity for its lead product, a bispecific anti-cancer antibody. The license covers clinical development and production.
Financial details were not disclosed.  

“We are very satisfied to see our GlymaxX technology being applied to Merus’ promising bispecific cancer antibody candidate. This underlines the superiority of our ADCC enhancement technology and its ability to deliver smart and flexible solutions for optimized biopharmaceutical products,” said Volker Sandig, chief scientific officer of ProBioGen AG. “We are convinced that our GlymaxX technology will make a significant contribution to develop powerful new antibodies against any diseases in which enhanced ADCC activity translates into therapeutic benefit.”  

“The GlymaxX technology substantially improves the ADCC activity of one of our lead bispecific antibodies for the treatment of solid tumors so that it further enhances the tumor cell killing capacity of an already very potent molecule,” said Mark Throsby, chief scientific officer of Merus B.V.

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MedImmune, biOasis Enter Drug Delivery Platform Pact
biOasis Technologies, Inc. has entered an agreement with MedImmune, the biologics R&D arm of AstraZeneca, under which MedImmune will evaluate the therapeutic effect of biOasis’ next-generation Transcend brain delivery platform on its preclinical assets. The Transcend platform offers the ability to transport compounds across the blood-brain barrier and target the central nervous system more efficiently.

“Our working relationship with MedImmune began in November 2012. In our collaboration, we demonstrated transport of MedImmune’s antibodies into the brain using our first-generation Transcend vector,” said Dr. Reinhard Gabathuler, chief scientist at biOasis. “In addition, we introduced our second-generation Transcend vector into this collaboration and other programs we have underway, where we have observed equivalent or increased antibody transport into the brain. We feel that this next generation of Transcend will have specific advantages in transporting certain biologics into the brain.”

“MedImmune is pleased to be entering into this new agreement with biOasis,” said Dr. Carl Webster, associate director, Antibody Discovery and Protein Engineering, MedImmune. “Our recently completed initial collaboration was very positive and led us to decide to undertake this second project to investigate the therapeutic effect and utility of biOasis’s technology.”

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WuXi PharmaTech, PBI In Biomarker Alliance
WuXi PharmaTech and Pacific Biomarkers (PBI) have entered a collaboration under which PBI will provide access to its portfolio of validated biomarker assays to support WuXi’s clinical trial testing services, including bioanalysis and central lab services for pharma and biopharma companies performing clinical trials in China.

PBI’s biomarkers include therapeutics areas of cardiovascular diseases, diabetes, obesity, acute kidney injury, musculoskeletal disorders, and inflammation. WuXi offers clinical biomarker services in anatomic pathology, hematology, genomics, and soluble biomarkers focusing on oncology and infectious diseases.

“We are very pleased to reach this agreement with Pacific Biomarkers, which broadens WuXi’s biomarker capabilities in support of our clients’ clinical development,” said Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech. “Biomarkers are a new and important tool in the development of personalized medicines for many serious diseases.”

“Partnering with WuXi enables us to realize considerable value in our biomarker assets,” said Ronald Helm, chief executive officer of Pacific Biomarkers. “This agreement will allow us to support a broader spectrum of companies developing medicines in Asia with special emphasis on clinical trials performed in China.”

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Hawaii Biotech Wins DoD Contract
Hawaii Biotech, Inc. has been awarded a contract from The Department of Defense, Defense Threat Reduction Agency to develop drugs that block botulinum toxin, the toxin that causes the life-threatening disease, botulism, for which there is no currently available therapeutic drug.

The contract, valued at approximately $5.5 million, has a first-year period of performance through early 2014, followed by three option years. Hawaii Biotech will work to improve its current anti-botulinum toxin inhibitor drug candidates that have demonstrated activity in preclinical testing. The goal will be to enhance the stability, bioavailability and safety of these drug candidates for human use.

“This contract, in addition to the $7.4 million grant for an anti-anthrax drug, demonstrates the confidence that Federal agencies have in Hawaii Biotech’s ability to develop these drug candidates, as well as our historic commitment to vaccines for tropical and emerging diseases such as West Nile Virus,” said Dr. Elliot Parks, chief executive officer of Hawaii Biotech. “Hawaii Biotech is now fully engaged in the development of therapeutic drugs to combat infectious diseases that pose potential bioterrorism threats, as well as continuing development of vaccines for infectious agents.”

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Cobra Biologics, BioCancell Enter CTM Pact
Cobra Biologics and BioCancell have entered an agreement for the manufacture of BioCancell’s BC-821 cancer drug for clinical trials. The Phase I trial, scheduled to begin in 2015, will examine the use of BC-821 as a treatment for several cancer indications such as non-small-cell lung carcinoma, ovarian cancer, glioblastoma and liver metastasis.

Cobra will provide GMP manufacture and aseptic fill/finish of BC-821 plasmid DNA, before releasing it for clinical trials. Cobra’s DNA programs offer full regulatory support from a dedicated Quality Assurance (QA) team.

Peter Coleman, chief executive officer of Cobra Biologics, said, “Cobra has been manufacturing plasmid therapeutics and DNA vaccines for more than 16 years and I am delighted that we are able to announce this partnership with BioCancell. Our DNA platform process is based on Cobra’s pioneering heritage in gene therapy manufacturing and technology development.”