Therapeutic Class

Novartis’ Kymriah partner doubling capacity on global viral vector demand

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

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

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

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

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

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…

Yescarta: Gilead boasts 60 CAR-T clinics and counting

There are now 60 different centers certified to administer CAR-T therapy Yescarta says Gilead Sciences says, which plans to add more as further indications are approved. In October 2017, the US Food and Drug Administration (FDA) approved the second chimeric antigen receptor T-cell therapy in the form of Yescarta (axicabtagene ciloleucel), developed by Kite which had recently been acquire by Gilead Sciences for $11.9 billion (€10.2 billion). Yescarta is made by isolating peripheral blood mononuclear cells – including T-cells –…

Sanofi and Regeneron gain approval for skin cancer MAb

The US FDA has approved skin cancer drug Libtayo, a programmed cell death protein-1 (PD-1) inhibitor developed through a Sanofi and Regeneron collaboration. In 2007, Sanofi teamed up with Regeneron Pharmaceuticals to discover, develop, and commercialize fully-human therapeutic antibodies. While the discovery collaboration ended last year, Sanofi still owns a 22% stake in Regeneron. The the firms also continue to develop and commercialize a number of monoclonal antibodies, including its metastatic cutaneous squamous cell carcinoma (CSCC) product cemiplimab which the two…

Double deal with Asterias gives Novo Nordisk CA stem cell plant

Novo Nordisk will pay Asterias $2 million to lease a facility in Fremont, California for the supply of stem cell-based therapies. An manufacturing tech licensing deal is also an option. Danish drugmaker Novo Nordisk intends to set up manufacturing capabilities for its clinical phase stem cell therapies for type 1 diabetes and other chronic diseases from 2019 onwards after subleasing the plant in California from Asterias Biotherapeutics. The 44,000 square feet current good manufacturing practices (cGMP) facility is used as…

Pandion selects Just to cut cost of bispecific Ab development

Just Biotherapeutics says smart design and optimization of the molecule and the manufacturing process will speed the development of Pandion Therapeutics’s lead bispecific antibody PT101. Just Biotherapeutics has entered into a master services agreement for the development and clinical manufacturing of Pandion Therapeutics’ lead candidate. Pandion is a biotech located in Cambridge, Massachusetts developing bispecific antibodies for the tissue-specific treatment of patients with autoimmune and inflammatory diseases and organ transplants. The firm completed a $58 million (€50 million) Series A…