Therapeutic Class

Establish gene therapy tech early says Daiichi as it inks Ultragenyx deal

Daiichi Sankyo has licensed a commercial-scale gene therapy manufacturing technology from Ultragenyx Pharmaceutical in a $200m deal. The Japanese firm will use Ultragenyx’s HeLa producer cell line and HEK293 transfection system for adeno-associated virus (AAV) manufacture in its gene therapy development programs. Masayuki Yabuta, head of Daiichi’s biologics division, set the deal as part of a wider investment in the firm’s gene therapy business. “In order to provide these drugs to patients in the future, manufacturing technology must be established…

Takeda, CSL and others working on plasma-derived COVID-19 therapies

Takeda says COVID-19 therapy accord will work on TAK-888 and other plasma-derived meds developed by its partners. The Japanese drug firm teamed up with CSL Behring, Biotest, BPL Group, LFB and Octapharma this week. The aim is to turn blood plasma from recovered patients into treatments for COVID-19. The initial focus will be TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine. But a Takeda spokeswoman told us the idea is to work on all in-progress development efforts. “Companies collaborating as part…

BAT biotech using tobacco to make COVID-19 vaccine candidate

British American Tobacco (BAT) will use its tobacco-based expression technology to make a not-for-profit vaccine candidate targeting the novel coronavirus. The vaccine candidate has been developed by Kentucky BioProcessing (KBP), the wholly owned subsidiary of the Big Tobacco firm BAT. “KBP recently cloned a portion of the genetic sequence encoding the selected coronavirus antigen – a substance which induces an immune response in the body and the production of antibodies,” a BAT spokesperson told this publication. “This sequence was then…

In-house advanced therapy production paves way for smaller facilities, expert

Cell and gene facilities will get smaller according to an expert, who says automation and the vogue for in-house manufacturing will drive the change. Traditional biopharmaceutical manufacturing has relied on processes or platforms that can be used to make a range of products. For example, CHO-based expression systems are used to make many of the best-selling therapeutic proteins. While the specific processes differ for each product, the technologies and methods are common. The platform approach has influenced facility design. Most…

Growing interest in stem cells for COVID-19 ailments, says Cynata

Stem cell therapies can treat COVID -19 complications says Cynata Therapeutics, which is in talks with potential development partners. The Australian biotech announced it was in talks in a March R&D update, telling investors industry interest in using mesenchymal stem cells (MSCs) to treat patients with conditions caused by severe COVID-19 infection had increasing. CEO Ross Macdonald confirmed talks are ongoing but told us “We cannot disclose the names of any of the companies or other parties with which we…

Allogene turns to MaxCyte’s tech for its off-the-shelf CAR-T therapies

MaxCyte says its clinically validated electroporation technology will help increase efficiency and improve yield of Allogene’s allogeneic CAR-T therapy candidates. Pfizer-backed biotech Allogene launched in 2018 with a focus on developing allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. To achieve this, the firm has regularly stressed the importance of manufacturing, devoting “considerable time and resources” to the process. Now the firm has inked a deal to use MaxCyte’s ExPERT platform to develop and advance its candidates through to…

Sensationalist press propagating unfounded COVID-19 therapies, says ISCT

Industry consortium the International Society for Cell & Gene Therapy (ISCT) has warned of the dangers of unproven therapies as unscrupulous players look to take advantage of COVID-19 uncertainties. The 1918 Spanish flu outbreak saw the advocation of a host of unproven remedies by the media and advertising firms. These included tobacco, heroin, cocaine, laxatives, malted milk, and literal snake oil. Over a hundred years on with the world caught up in another pandemic, quack remedies and snake oil are…

Univercells buys plant, launches CDMO to service booming cell & gene sector

Belgium-based bioprocess tech firm Univercells has launched Exothera, a process development and viral vector manufacturer set to serve the robust cell and gene therapy sector. Fresh from a €50 million ($54 million) investment from global investment firm KKR, Univercells launched cell and gene therapy contract development and manufacturing organization (CDMO) Exothera today. While the KKR investment supports Univercells’ manufacturing technologies and plays a role in developing and commercializing its biprocessing equipment, it did not directly drive the creation of the…

Evonetix raises $30m to advance ‘DNA on a chip’ platform

Evonetix will use the funding to accelerate the development of its DNA synthesis technology platform aimed at enabling synthetic biology. We spoke to CEO Tim Brears to find out more. Cambridge, UK-based Evonetix was founded in 2015 with a focus on synthetic biology. In 2018, a Series A round raised $12.3 million and now the firm has raised $30 million in a Series B investment, led by west-coast investor Foresite Capital. The funding will be used to accelerate internal technology…

Grist for the MIL: CDMO Cognate making cell therapies for WindMIL

WindMIL Therapeutics has upped a contract with Cognate BioServices to make its marrow-infiltrating lymphocyte (MIL) cell therapies but says it is developing plans to eventually build in-house manufacturing capabilities. WindMIL, a cancer immunotherapy firm developing autologous cell therapies based on its marrow-infiltrating lymphocytes (MILs), initially began working with contract development and manufacturing organization (CDMO) Cognate last year. Now the firm has expanded the contract to add extra clinical manufacturing capacity. “We are securing one additional manufacturing suite at Cognate’s Memphis,…