Cell therapy weekly: Novartis faces production glitch over Kymriah
This week: Two new partnerships will bring further cell and immunotherapy innovation to China and Hong Kong and HemaCare expands cell therapy services
The news highlights:
Variability in Kymriah for diffuse large B-cell lymphoma causes headache for Novartis
International memorandum of understanding will produce new Joint Center for Immunotherapy
Mesoblast-Tasly Pharmaceutical Group alliance will bring heart failure cell therapy to China
HemaCare expands scientific team to increase cell therapy services
Novartis (Switzerland) has run in problems in the production of its personalized CAR-T therapy, Kymriah. In the move from clinical trials to commercial production of Kymriah for diffuse large B-cell lymphoma (DLBCL), the necessary percentage of viable cells according to the specification has not been met. There have been no problems in production of Kymriah for its initial indication to treat young patients with leukemia and Novartis is working closely with the FDA as it resolves this issue.
In an emailed statement to Fierce Pharma, the company said, “Novartis is committed to sharing this information with treating physicians so they can make the best decision with their patients. For cases where the product does not meet commercial specifications, we have developed an Expanded Access Program path to deliver treatment, when possible.We are committed to resolving this as quickly as possible and to serving all patients who may be able to benefit from this transformative therapy.”
The Hong Kong Polytechnic University (PolyU; Hong Kong) will work with Axis Therapeutics, a newly established joint venture by Athenex, Inc. (NY, USA) and Xiangxue Pharmaceutical (Guangzhou, China), to set up a Joint Center for Immunotherapy. PolyU has worked on the first three drugs to be developed in Hong Kong that received Investigational New Drug (IND) application approval from FDA.
Professor Ping-kong Alexander Wai, Vice President (Research Development), PolyU, remarked, “Partnerships between academia and industry have been very fruitful, leading to significant innovations in the form of medicines and better treatments.”
Mr YongHui Wang, Chairman and CEO, Xiangxue Pharmaceutical, commented, “We are expecting to explore a new and promising immunotherapy technology in the global scene. The new generation TCR-T, named HATac, is a breakthrough technology. The development of this technology in collaboration with our new partners holds great promise for the treatment of solid tumors.”
Mesoblast (Australia) has entered into a strategic alliance with Tasly Pharmaceutical Group (China) to develop, manufacture and commercialize Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product candidates MPC-150-IM, for the treatment or prevention of chronic heart failure, and MPC-25-IC, for the treatment or prevention of acute myocardial infarction.
Chairman of Tasly Pharmaceutical Group Yan Kaijing said: "We are very excited to partner with Mesoblast, the premier cellular medicines company, to provide innovative products that have the potential to make a major impact on the high growth cardiovascular market in China. This aligns well with our corporate strategy to be the lead provider of therapies for patients with cardiovascular conditions in China.”
HemaCare has hired two new members of the senior leadership team to develop new products and services in the support of cell therapy and product lifecycle management. Dominic Clarke, joining as Global Head of Cell Therapy, will provide scientific insight and advanced support, gained from previous positions at Charter Medical and BioLife Solutions, whilst Brad Taylor, a new Senior Product Manager, will manage the product lifecycle strategy and holds a PhD in Molecular Biology and Genetics from Friedrich-Alexander University (Germany) and completed a postdoctoral fellowship in the department of surgical oncology at the University of Illinois (IL, USA).
“After a great start to the year and strong interest from partners, HemaCare is attracting unmatched talent and expanding its presence as the leading cell provider,” said Pete van der Wal, President and CEO, HemaCare. “These two new hires will enable HemaCare to serve both new and existing customers with uniquely developed product offerings and service solutions.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.