Therapeutic Class

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,…

Autolus hires MolMed to add vector flexibility

Autolus Therapeutics says hiring MolMed as a contractor for its CAR-T programs was about adding flexibility. The biotech announced contracted MolMed to develop and manufacture vectors for its candidate CAR-T cancer therapy programs this week. Under the deal MolMed will make viral vectors to support Autolus’ various clinical trial programs. An Autolus spokeswoman told us “MolMed is a future supplier. “The MolMed relationship is Autolus taking the normal and prudent step to build flexibility and parallel supply for vector.†The…

Lonza looks to Cocoon to drive autologous cell therapy paradigm shift

Lonza has partnered with several academic clinical centers to assess the manufacture of cell therapies in a decentralized setting using its automated Cocoon point-of-care (PoC) platform. Swiss contract development and manufacturing organization (CDMO) Lonza announced independent research collaborations with Stanford University School of Medicine, Fred Hutchinson Cancer Research Center, and Parker Institute for Cancer Immunotherapy. The collaborations will see the tech transfer of cell therapy manufacturing processes developed at the respective research institutes into the Cocoon platform. The Cocoon system…

Individualized gene therapy: FDA considering device-like manufacturing approval process

CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed. Individualized gene therapy approvals at the US Food and Drug Administration (FDA) could speed up using a 510(k)-like process under consideration. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said the FDA needs a workable pathway not requiring new authority from Congress to deal with the growing sector. During…

Vaccines, plasma and stem cells: How industry hopes to take on COVID-19

The biopharma space has stepped up its efforts to both prevent and treat the coronavirus (SARS-CoV-2) that is threatening to bring the world to its knees. A month is a very long time when it comes to infectious diseases. The first cases and deaths from the novel coronavirus (COVID-19) led to a response to contain the virus, but the difficulties of containment and the nature of international travel means cases and deaths have become global. The latest statistics place the…

Staffing: Cell and gene therapy sector needs reinforcements

Cell and gene therapy manufacturers need staff with laboratory skills and GMP know-how, according to an expert from Texas A&M. Cell and gene therapies attract a lot of attention. In recent years products like Yescarta, Kymriah and Zolgensma and the debate about their prices – $373,000, $475,000 and $2.1m respectively – have dominated the headlines. In industry circles the focus has shifted to the manufacture of such therapies. Developers are working to ensure there are sufficient vectors, or to make…

Coherus eyes ophthalmology biosimilars prize

In-licensing a Lucentis biosimilar goes “hand-in-hand†with its internally developed Eylea biosimilar, says Coherus BioSciences. Californian biosimilar developer Coherus acquired the US commercial rights in November to commercialize a version of Lucentis (ranibizumab) from Bioeq, a joint venture between Polpharma Group and Strüngmann Group. The ophthalmic monoclonal antibody pulled in US sales of CHF 1.83 billion ($1.9 billion) for Roche/Genentech in 2019. Concurrently, Coherus has a biosimilar candidate looking to take on Regeneron’s Eylea (aflibercept) in the form of CHS-2020.…

Ori biotech adds traceability to cell therapy platform in deal with TrakCel

Ori Biotech has partnered with software firm TrakCel to add supply chain monitoring technology to its cell and gene therapy manufacturing system. The non-exclusive deal – financial terms of which were not disclosed – will allow cell and gene therapy developers and contract development and manufacturing organizations (CDMOs) that use the Ori platform to monitor manufacturing processes in real-time using Trakcel’s technologies. The firms plan to develop “suitable points of integration in order for a shared data platform to be…

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

Potential upcoming approvals and launches of subcutaneous formulations of monoclonal antibodies could prove a boon for Halozyme, which licenses its Enhanze technology to Janssen and Roche, among others. In 2019, Halozyme Therapeutics announced its pancreatic cancer drug candidate PEGPH20 did not meet a Phase 3 study’s main goal of improving how long patients lived. As such, the firm laid plans to restructure, ending its R&D oncology operations in favor of growing its formulation platform offering, Enhanze. The technology consists of…