Therapeutic Class

Biogen Upping Stake in Biosimilars JV

Biogen has agreed to pay around US$700 million (€602 million) to increase its stake in biosimilars joint venture Samsung Bioepis from 5.4% to 49.9%. Samsung Bioepis was formed in 2012 as a joint venture between Samsung BioLogics and Biogen to develop biosimilar drugs. Under terms of the deal, Biogen had the option to increase its single-digit involvement to 49.9% by mid-2018, something the firm announced it would be doing Thursday. “We are very pleased with the progress made to date…

Industry Looks to ‘Lucrative’ Opportunities for Off-the-Shelf Cell Therapies

Allogeneic cell therapies have greater commercial potential than autologous products, an industry survey finds. Respondents also believe there are a lack of third-party capabilities to make these new therapies. When Novartis’s Kymriah (tisagenlecleucel) received the regulatory thumbs up in August 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb described regenerative medicines as being “no longer the stuff of science fiction.” The approval of Gilead/Kite’s Yescarta (axicabtagene ciloleucel) weeks later helped cement the safety and commercial potential of CAR-T…

J&J Repurposing US Site to Support CAR-T Manufacturing

Johnson & Johnson is renovating a facility in the US to make anti-cancer CAR-T candidate LCAR-B38M licensed from Legend Biotech last year. In December 2017, J&J subsidiary Janssen Biotech, Inc., entered into the chimeric antigen receptor (CAR) T-cell space through a US$350 million (€304 million) collaboration and licensing deal with Chinese firm Legend Biotech. Legend’s oncology candidate, LCAR-B38M, targets the B-cell maturation antigen (BCMA) and is under review in China. At the Goldman Sachs Annual Global Healthcare Conference earlier this…

CAR-T Firm Autolus Raises $150m in IPO

Autolus Therapeutics has gone public and says it is looking to build its own T cell therapy manufacturing capabilities. Autolus launched its initial public offering (IPO) in May, and today the firm said it has raised approximately US$150 million ( €129 million) and has begun trading on the Nasdaq Global Select Market under the ticker symbol “AUTL.” The London, UK-based firm is a gene therapy developer working on personalized Chimeric Antigen Receptor (CAR) T cell therapies for cancer using its…

Pfenex: Bacterial System Overcomes Protein Challenges, Inhouse and Out

“The more you engineer a protein, the less natural it becomes,” says Pfenex executive Patrick Lucy. The firm is using its clinically validated microbial expression platform to overcome these challenges for both its own product pipeline and its partners. In May, Pfenex announced positive Phase III data showing its lead candidate PF708 is comparable with Eli Lilly’s osteoporosis drug Forteo (teriparatide). The candidate – classed as a biosimilar in Europe but being filed in the US as a therapeutic equivalent…

WuXi Pumps $20m into Conjugation and Fill/Finish Site

WuXi Biologics has begun building a biologics conjugation and drug product plant in China to support antibody-drug conjugate (ADC) services. To be known as DP3, the 6,000m2 facility will be the third drug product site for the contract development and manufacturing organization (CDMO) and is expected to be open next year. The facility in Wuxi City, China will offer both clinical and commercial antibody-drug conjugate (ADC) services and will be an extension of similar conjugation and fill/finish operations at WuXi’s…

BioSymphony No. 1: Oncobiologics Wins First CDMO Deal

Sonnet BioTherapeutics has contracted Oncobiologics to develop and manufacture four undisclosed biologic compounds. The Master Services Agreement (MSA) with Sonnet BioTherapeutics is the first to leverage Oncobiologics’ BioSymphony Platform, consisting of in-house monoclonal antibody (mAb) development and manufacturing capabilities. Lawrence Kenyon, Oncobiologics’ CFO, told BioProcess Insider the platform is used in a small biotech company setting, which results in a “more efficient and timely process for bringing mAbs forward.” He continued: “Our goal, and the purpose of the platform, is…

Sanofi: ‘Ablynx Nanobody Tech Will Fuel Innovation’

Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter​ sent to the firm in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…