Therapeutic Class

Cobra’s Symbiosis relationship making UK cell and gene competitive

CDMOs Cobra Biologics and Symbiosis have completed a collaboration they say has increased and simplified viral vector production and increased the UK’s competitiveness in cell and gene therapy services. After 18 months, the £4.8 million ($6 million) project has come to an end. The collaboration intended to build up viral vector capabilities while supporting the development of gene therapies in the UK, and the two contract development and manufacturing organizations (CDMOs) say these aims have been achieved. “One key aim…

WuXi invests in ADCs again to prep for commercial products

WuXi Biologics will further expand an antibody-drug conjugate (ADC) facility in China on the expectation of its clients’ projects moving to commercial production. In June 2018, WuXi Biologics announced plans to construct a $20 million (€17.6 million), 6,000 square meter facility for protein conjugates, including ADCs, set to be operational later this year. A year on, and the Chinese contract development and manufacturing organization (CDMO) has said it is further expanding the site in Wuxi city, China adding cGMP commercial…

Orgenesis talks cell therapy development for diabetes

Orgenesis has received Orphan Drug Designation for a potential autologous insulin producing cell therapy to treat severe hypoglycemia-prone diabetes resulting from total pancreatectomy. With the designation, Orgenesis hopes to expedite its Autologous Insulin Producing (AIP) cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy due to chronic pancreatitis. “The therapy is based on taking a small amount of liver cells from the patient. These are propagated to the desired amount of cells…

Lonza building capacity for Gamida’s bone marrow transplant

Lonza will construct suites at its site in The Netherlands dedicated to producing Phase III and commercial supply of Gamida’s bone marrow transplant cell therapy omidubicel. Lonza has produced clinical supply of omidubicel for Gamida but the strategic deal announced today will see the Swiss contract development and manufacturing organization (CDMO) fulfil the future commercial supply from its site in Geleen, The Netherlands. Formerly known as NiCord, omidubicel is the Massachusetts-based cell therapy firm’s lead candidate, currently in Phase III…

Alpine inks iPSCs vision lost therapy deal with Allele

In collaboration with Alpine BioTherapeutics Corporation, Allele Biotechnology and Pharmaceuticals will make therapies for retinal diseases based on induced pluripotent stem cells (iPSCs) The deal, financials of which have not been divulged, sees the two firms enter into a research agreement for developing iPSC-derived cell therapy for treating diseases including blindness caused by Retinitis Pigmentosa, Stargardt disease, and dry AMD. Alpine, which has a patented stem cell differentiation technique used to generate human retinal stem cells from pluripotent stem cells,…

The scale-X factor: Univercells wins $14m grant to make low-cost measles vaccines

Univercells aims to make affordable measles and rubella vaccines using its NevoLine biomanufacturing platform incorporating the scale-X fixed-bed bioreactor. In a consortium with Batavia Biosciences and Natrix Separations, Belgium-based Univercells has been able to develop a manufacturing platform that has slashed the cost of production of inactivated polio vaccine (sIPV). Now, through a $14.3 million (€12.8 million) from the Bill & Melinda Gates Foundation, the firm is looking to adapt the platform to produce low-cost measles and rubella (M&R) vaccines…

Ionis pledges to up its RNA game in SMA and elsewhere

Self-proclaimed pioneer of RNA-targeted medicine Ionis Pharmaceuticals says it is looking to develop an “even better medicine” to Spinraza to treat spinal muscular atrophy (SMA). At its annual meeting of stockholders earlier this month, Ionis Pharmaceuticals spoke about the success of its flagship molecule, Spinraza (nusinersen), an oligonucleotide approved by the US Food and Drug Administration (FDA) in December 2016 for the treatment of SMA. “Spinraza is the standard-of-care for all forms of the disease SMA. It is a medicine…

Servier selects Yposkesi for viral vector supply

The deal brings Servier access to CDMO Yposkesi’ lentiviral vector production for its Phase I allogeneic CAR-T candidate UCART19. Servier has chosen contract development manufacturing and organization (CDMO) Yposkesi to provide the lentiviral vectors for its candidate UCART19, an off-the-shelf chimeric antigen receptor (CAR) T-cell in trials for haematological malignancies. According to the firm, its selection of fellow French CDMO came “after testing lentiviral vectors from several competitors and comparing the costs,” though financial and timelines details have not been…

Zolgensma: We all know the price, but how is it made?

Making Zolgensma, the new “world’s most expensive drug,” is a month-long process that depends on vector tech licensed from Regenxbio. Zolgensma is a gene therapy. It is designed to halt progressive spinal muscular atrophy (SMA) – motor neurone loss and muscle wasting – in people who have a defective version of the gene SMN1. The drug addresses the underlying causes of SMA according to Novartis spokesman Eric Althoff. He told us, “Zolgensma provides a functional copy of the human SMN…

Pluristem looks to cell cultured cannabinoids

Pluristem Therapeutics has filed a provisional patent application to use its 3D cell culturing technology to manufacture cannabinoid-producing cells. Pluristem has several candidates in its pipeline based on placenta-derived, mesenchymal-like adherent stromal cells, has inked a recent study agreement with NASA, and is working with Thermo Fisher to address the lack of technologies available to cell therapy manufacturers for the cultivation and processing of allogeneic products. Now the Israeli cell therapy firm is looking to use its cell culture platform…