Therapeutic Class Archives - Page 45 of 53 - BioProcess InternationalBioProcess International

Novartis growing CAR-T network amid slow Kymriah sales

Novartis says it remains confident Kymriah will pull in $200 million in 2019 through the remediation and ramp-up of its CAR-T manufacturing network. For the third quarter 2018, Kymriah (tisagenlecleucel) netted Novartis $20 million (€17.4 million), making a total of $48 million for the first nine months of the year. The product became the first chimeric antigen receptor (CAR) T-cell to be approved in August 2017. Elizabeth Barrett, chief executive officer of oncology at Novartis, said the sales figures were…

Roche ups cell therapy interest through SQZ expansion deal

by Dan Stanton

Roche has expanded its partnership with SQZ Biotechnologies to codevelop therapeutics derived from peripheral blood mononuclear cells (PBMCs) in a deal worth up to $1 billion. In 2015, Swiss Biopharma Roche partnered with SQZ to use its B cell engineering technology in the development of cell therapies for cancer. This week, the firm has expanded the partnership to jointly develop and commercialize products based on antigen presenting cells (APCs) created by the SQZ platform. “SQZ entered into a first collaboration…

MaSTherCell wins Iovance deal as commercial cell therapy demand increases

by BPI Staff

Cell therapy CDMO MaSTherCell will produce late-stage clinical supply of an adoptive cell therapy for Iovance Biotherapeutics from its facility in Belgium. Iovance has selected MaSTherCell S.A., a cellular therapy-focused contract development and manufacturing organization (CDMO) and subsidiary of Orgenesis, to manufacture an adoptive cell therapy using its tumor infiltrating lymphocyte (TIL) product as it goes into late-stage trials in Europe. The manufacturing will take place from MaSTherCell’s plant based in Belgium, which according to a spokesperson from the CDMO…

Aglaris talks automated and closed cell therapy platform

by Dan Stanton

Anglo-Spanish firm Aglaris has developed an autonomous, closed production system for the manufacture of cell therapies such as T-cells and MSCs (Mesenchymal Stem Cells). According to new CEO Steven Docksey, the platform overcomes many issues associated with this new product class. “Most current processes are intensive, manual techniques derived and scaled-up from the cell preparation techniques used in research labs – adapting existing tools to the job. There is little in the way of genuine innovation that has come to…

Novartis’ Kymriah partner doubling capacity on global viral vector demand

by Dan Stanton

Oxford BioMedica – the sole manufacturer of the lentiviral vector for CAR-T Kymriah – will up capacity with a fourth facility to support future platform and pipeline deals. Oxford BioMedica, has signed a fifteen year lease on a new facility at its site in Oxford, UK-based, which when operational will more than double the firm’s bioprocessing capacity. The 7,800m2 facility – the fourth plant at the site – will contain four GMP clean room suites and two fill and finish…

Merck drops Lantus biosimilar, blames pricing and production cost concerns

by Dan Stanton

Merck & Co. has ended the commercialization of Lusduna, a version of Sanofi’s Lantus (insulin glargine), and will pay Samsung Bioepis a termination fee of around $155 million. In 2014, Merck & Co. (known as MSD outside of North America) entered into an agreement with Korean biosimilar maker Samsung Bioepis to commercialize an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. The product, Lusduna, formerly MK-1293, was approved in Europe in January 2017…

BMS invests in Compugen, grants access to Opdivo for combo trial

by Dan Stanton

Compugen has gained access to top-selling programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) through collaboration and a $12 million investment from Bristol-Myers Squibb. Israeli early-phase biotech Compugen’s candidate COM701, a first-in-class therapeutic antibody targeting PVRIG, will be investigated in combination with Bristol-Myers Squibb’s monoclonal antibody (MAb) Opdivo (nivolumab) after signing a clinical partnership with the big pharma firm. “We discovered PVRIG as immune checkpoint proteins using our computational target discovery platform. We prioritized this target among the marketable other internal programs…

Biosimilar round-up: Deal-breaking, approvals, and patents

by Dan Stanton

Mundipharma acquires Cinfa; Sandoz resolves dispute with AbbVie; FDA favours Celltrion and Teva’s rituximab. Welcome to the heady world of biosimilars. First up is an acquisition in the biosimilars space, with Cambridge, UK-based Mundipharma bolstering its portfolio through the purchase of Spanish drugmaker Cinfa Biotech. Financial have not been divulged, but Mundipharma gains immediate access to Pelmeg, a biosimilar which is looking to take a slice of the global $4.5 billion pegfilgrastim market. Pelmeg received recommendation for approval on September…

In-house investments let Synthon keep control of ADC production

by BPI Staff

Synthon Biopharmaceuticals chose to develop its antibody-drug conjugate (ADC) capabilities in-house to keep control of planning and product quality. Aad Van de Leur, COO of Synthon Biopharmaceuticals, spoke at KNect365’s Bioproduction Congress in Dublin, Ireland this week on the need to adapt biomanufacturing strategies and technologies for next generation therapies, using his own firm’s antibody-drug conjugate (ADC) capabilities as an example. “With the introduction of innovative high-potent biopharmaceuticals like antibody-drug conjugates (ADCs) the industry had to adapt and move to…

Hoba (cell) banks on Selexis to advance neuropathic pain program

by Dan Stanton

Selexis will use its SUREtechnology platform to develop a research cell bank to help advance Hoba Therapeutic’s neuropathic pain candidate HB-086. The Danish firm Hoba Therapeutics has selected cell line development firm Selexis to help express viable levels of its clinical candidate HB-086 (recombinant human Meteorin) in Chinese hamster ovary (CHO) cells. The candidate is a 31 kD secreted protein that promotes neurite outgrowth and glial differentiation in the central nervous system. “We do not have a conclusive scientific explanation…