Therapeutic Class

Gilead’s Kite building MD plant to support commercial CAR-Ts

A 20-acre site in Frederick, Maryland will support the production of Kite’s commercial CAR-T therapies, including Yescarta, from 2021. Kite, acquired by Gilead Sciences for US$11.9 billion in August 2017, is one of only two firms to so far see regulatory success for a chimeric antigen receptor (CAR) T-cell therapy. Yescarta (axicabtagene ciloleucel) joined Novartis’ Kymriah on the market after being approved in October 2017. To support Yescarta and its pipeline of CAR-T and T-cell therapies, the firm announced it is…

Novasep boosts viral vector offering with access to DNA Flap tech

An agreement between Novasep and Theravectys gives the French CDMO access to the Institut Pasteur’s DNA FLAP technology to produce GMP-grade lentiviral vectors for clinical. The DNA Flap tech allows efficient lentivector-mediated gene transfer either ex vivo or in vitro. It consists of a specific DNA sequence derived from the lentiviral genome, which includes the cPPT and CTS cis-active sequences, required to enable the import of the lentivirus genome into the cell nucleus of non-replicating cells. Theravectys holds a license…

J&J keeping Remicade biosimilars at bay through price drops

Johnson & Johnson’s Remicade continues to hold 92% of the market by volume three years since infliximab biosimilars arrived in the US. Johnson & Johnson (J&J) opened the first quarter 2019 reporting season this week by announcing an 8% year-on-year growth in its pharmaceutical’s division to $10.2 billion (€9 billion). For its immunosuppressive monoclonal antibody Remicade (infliximab), US sales – representing 70% of global sales for the firm – fell 15.5% compared to the same period last year, to $774…

Allele SCM partnership looks to stem cells to treat diabetes

Allele Biotechnology has teamed with SCM Lifescience to develop diabetes therapies using pancreatic beta cells derived from induced pluripotent stem cells (iPSCs). “By nature, pluripotent stem cells like iPSCs can be expanded indefinitely and differentiated into all human tissue types, including pancreatic cells,” a spokesperson from the San Diego-based biotech Allele, told Bioprocess Insider. Therefore, they can be a viable option for diabetes treatment. “iPSC-derived cells are already known to have biological functions, such as blood sugar sensing and insulin…

Enesi and BARDA partner to develop solid dose flu vaccine

The US Biomedical Advanced Research and Development Authority (BARDA) will use Enesi Pharma’s ImplaVax device and formulation technology to develop subcutaneous vaccines against influenza. The public-private collaboration, financials of which have not been divulged, will form part of BARDA’s Division of Research, Innovation, and Ventures (DRIVe) innovative health security technologies portfolio, and looks to provide a cost-effective alternative to traditional vaccines to help improve vaccination uptake. The aim is to help healthcare providers or individuals administer influenza vaccines through the…

Catalent jumps into ‘transformative’ gene therapy space with $1.2bn Paragon buy

Contract manufacturer Catalent has agreed to buy the gene therapy CDMO Paragon Bioservices for $1.2 billion. Paragon Bioservices, a private-equity backed biologics contract development and manufacturing organization (CDMO) focused on gene therapy and next-generation vaccines, will be acquired by fellow CDMO Catalent, the firms announced this morning. According to its website, 50% of Paragon’s current contracts are for gene therapy. The CDMO also supports vaccine products and has previously won contracts from clients including the US Department of Defense (DoD).…

Cell therapy vendors: News from Miltenyi and Saint-Gobain

Bellicum Pharmaceuticals has inked a supply agreement with Miltenyi Biotec; Hitachi Chemical has teamed with Saint-Gobain to address manufacturing challenges – welcome to Bioprocess Insider’s cell therapy services round-up. In an SEC filing, Houston, Texas-based cellular immunotherapy firm Bellicum Pharmaceuticals revealed it has entered a agreement with Miltenyi Biotec GmbH for the supply of “certain products in connection with the development and manufacture of certain of the Company’s products.” The firm will pay Miltenyi a €2 million ($2.3 million) upfront…

Aji Bio opens large-scale oligo production plant in Osaka

Facilitated by its 2016 acquisition of GeneDesign, CDMO Ajinomoto Bio-Pharma has opened a 21,500 square-foot plant in Japan to service the growing oligonucleotide demand. In December 2016, Japan’s Ajinomoto OmniChem acquired nucleic acid drug contract development and manufacturing organization (CDMO) GeneDesign for an undisclosed fee. Nearly two-and-a-half years on and the subsidiary has become absorbed into Ajinomoto’s Bio-Pharma Services division. “GeneDesign – now Ajinomoto Bio-Pharma Services Osaka – provides solid-phase technology for oligonucleotide synthesis capabilities from µg to 10 kg…

Celltrion jumps into ADC space through Canadian partnership

Celltrion has inked a deal with iProgen Biotech to develop a pipeline of antibody-drug conjugates (ADCs). While best known for its portfolio of marketed biosimilars, Korean drugmaker Celltrion has been investing in its internal R&D for novel biotherapeutics and has five antibodies in development for diseases ranging from rabies to influenza. Now the firm is aiming to develop up to four antibody-drug conjugates (ADCs), including one targeting breast cancer, through a partnership agreement with Canadian firm iProgen Biotech. Financial details…

RNAi: Regeneron pumps $800m into ‘potentially game-changing science’

Regeneron will look to develop RNA interference (RNAi) therapeutics for eye and CNS diseases by teaming with and investing in Alnylam Pharmaceuticals. RNA interference (RNAi) therapies are a new class of drugs that work by inhibiting gene expression or translation by neutralizing targeted mRNA molecules. The first – and only – commercial RNAi therapy is Alnylam’s Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) last August for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis…