Therapeutic Class

Allogene building Cali allogeneic CAR-T facility

Allogene has confirmed it is building a 118,000 square foot cell therapy manufacturing facility in Newark, California to support its AlloCAR T candidates. Last month, Allogene Therapeutics revealed to BioProcess Insider its intentions to establish a manufacturing facility in the San Francisco Bay area. The firm did not provide projections at the time, but has now said it has entered a lease agreement at a site in Newark, California to build a 118,000 square foot cell therapy manufacturing facility. “This…

Merck accessing cancer vaccine tech through $300m acquisition

Merck & Co. will acquire Immune Design for $300 million, adding cancer immunization and adjuvant systems technologies to its portfolio. The deal, expected to close early in the second quarter of 2019, sees Merck & Co. (known as MSD outside of North America) acquire late-stage Californian immunotherapy firm Immune Design for $5.85 (€5.15) per share in cash, totaling around $300 million. “Our primary interest to acquire Immune Design is related to their unique portfolio of approaches to cancer immunization and…

Big data-science for cell therapies: Mogrify boosted by $3.7m funding

All current cell therapies are failing on at least one of three key performance indicators: efficacy, safety and scalability, says Mogrify’s new CEO Darrin Disley. Cambridge, UK-based firm Mogrify is looking to transform the cell therapy space through its technology platform that it claims makes it possible to transform – or ‘transmogrify’ – any mature human cell type into any other without going through a pluripotent stem cell or progenitor cell state. The firm has bolstered its position by raising…

AveXis on gene therapies: ‘We’ll get better at this and it will get cheaper’

AveXis has spent about $1 billion in preparing to launch its spinal muscular atrophy (SMA) gene therapy later this year. The Novartis subsidiary is pumping a further $60 million into its North Carolina facility. In May 2018, Gene therapy firm AveXis announced a $55 million (€49 million) investment to establish a manufacturing center in Durham County, North Carolina. Nine months on, and AveXis is doubling down on the site, revealing plans to invest a further $60 million and create 200…

Immunomedics: Data integrity and quality issues cited in FDA 483

The US FDA found antibody-drug conjugate developer Immunomedics to have manipulated data during an inspection last year. In January 2019, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Immunomedics for its antibody-drug conjugate (ADC) candidate sacituzumab govitecan, being developed to treat breast cancer. The firm said at the time: “The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need…

Photo opp: How imaging companies focused on cell and gene therapies

Fujifilm and Nikon say their respective moves into regenerative medicine came from a rich heritage in imaging services such as X-rays and microscopes. In January 2018, Fujifilm Corporation, through its contract development and manufacturing organization (CDMO) business Fujifilm Diosynth Biotechnologies (FDB), opened an 80,000 square-foot facility in Texas for the production of clinical and commercial gene therapies. Months later it announced plans to expand the site, adding gene therapy fill/finish capabilities. Investments in such an innovative field as gene therapies…

Big Pharma and CAR-T: Testing the water or in at the deep end?

Following Novartis and Gilead’s success, others are “scrambling to build up their T-Cell capabilities,” say venture capitalists. We look at where Big Pharma stands in this blossoming sector. Big Pharma firms will be looking at strategies to enter the chimeric antigen receptor (CAR) T-cell space, if they have not already, spurred on by the approvals in 2017 of Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) . This was the view of commentators and analysts at Phacilitate in Miami, Florida last month. Anna…

VBAs and marketing campaign to aid RNAi Onpattro ramp up, says Alnylam

Around 200 patients have so far been treated with Onpattro (patisiran), the first approved RNA interference (RNAi) drug, bringing in $12.5 million for Alnylam. In August 2018, the US Food and Drug Administration (FDA) and the European Commission (EC) approved Alnylam Pharmaceuticals’ Onpattro for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The approvals heralded in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. Onpattro works by silencing a portion of RNA involved…

Roche looks to delivery device to keep Lucentis biosimilars at bay

Roche says its Port Delivery System will keep Lucentis (ranibizumab) competitive against upcoming biosimilar competition. Lucentis pulled in CHF 1.66 billion ($1.66 billion) in US sales for Roche in 2018, up 18% on the year before. The drug is marketed in Europe by fellow Swiss firm Novartis. The firm attributed the increase to the “ongoing rollout of prefilled syringes and sales increases in all approved indications.” The monoclonal antibody, approved for eye conditions including neovascular (‘wet’) age-related macular degeneration, macular…

GSK boosts oncology pipeline through Merck and Tesaro deals

The acquisition of Tesaro and a codevelopment deal with Merck KGaA has helped double the size of GlaxoSmithKline’s clinical oncology pipeline from eight to 16. Earlier this week, GSK formed an alliance with Germany’s Merck to codevelop and commercialize a bifunctional fusion protein immunotherapy intended to treat multiple cancers. Merck has received an upfront payment of €300 million ($340 million) from GSK and could receive a further €500 million in development milestone payments. The candidate, M7824 (proposed International Nonproprietary Name…