Global Markets

Porton Advanced raises $80m for CGT CDMO Operations

Chinese cell and gene therapy (CGT) CDMO Porton Advanced Solutions has completed an $80 million Series B round¬†to expand its business into new markets. The Suzhou, China-based company has built an integrated contract development and manufacturing organization (CDMO) platform that provides plasmids, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and microbial vectors used for gene therapy. Currently, Porton has a 40,000 square-foot R&D and GMP production facility that has been operating for over two years. It expects a…

Novartis waves goodbye to biosimilars with Sandoz split

Novartis will spin-off its generics division Sandoz, which includes a portfolio of eight biosimilar products. In 2018, Novartis granted its generic and biosimilar medicine division Sandoz more autonomy while claiming to be ‚Äúcompletely committed‚ÄĚ to the business. Since then, analysts and investors have been hedging their bets as to when the inevitable spin-off would therefore occur. Following a strategic review last year, the Swiss firm has now cemented a separation plan to be completed by the second half of 2023.…

Thermo Fisher opens $105m single-use Nashville site

Thermo Fisher says its manufacturing plant in Lebanon, Tennessee is the largest single-use bioproduction facility across its network and will bring materials closer to customers. The $105 million expansion is part of a long-term $650 million investment the company announced¬†last March, and Thermo Fisher Scientific said the Greater Nashville plant will allow the firm to meet increasing demand for materials required to manufacture vaccines and therapies for cancer and various diseases. ‚ÄúThe biotherapeutic market has been rapidly adopting single use…

Gilead buys back China rights to ADC Trodelvy for $455m

Shanghai Everest Medicines has returned the rights for Trodelvy (sacituzumab govitecan) to Immunomedics, a subsidiary of Gilead Sciences, in an agreement worth up to $455 million. In 2009, Everest acquired rights to the Trop-2 antibody-drug conjugate (ADC) candidate in an $835 million deal ($65 million upfront). Two months ago, Everest was approved to launch Trodelvy in China¬†as a third-line therapy for metastatic triple-negative breast cancer (TNBC). Everest will receive $280 million¬†in upfront payments and up to¬†$175 million¬†in future milestones. The…

NIIMBL’s Project Call 5.2 looks to address shifting bio-bottlenecks

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will fund a further 14 projects to address the changing challenges in the biomanufacturing space. Launched in March 2017 as a cooperative agreement with the National Institute for Standards and Technology (NIST), NIIMBL looks to bring industry, academia, and government together to accelerate implementation of advanced biomanufacturing. The Institute‚Äôs biannual project calls look to overcome barriers to communication and innovation for biologics technology development, regulatory standards, and workforce development, and the…

Tonix looks to live virus vaccines to prevent the spread of monkeypox

Tonix Pharmaceuticals claims that using a smallpox vaccine model could stop the spread of monkeypox. The technology is being applied to vaccines against COVID-19, smallpox, and monkeypox. According to Seth Lederman, CEO of Tonix, the firm has ‚Äúrecreated a vaccine that we think is similar to what Edward Jenner used‚ÄĚ in 1798. While Lederman told us the undisclosed cell line is ‚Äúpretty standard‚ÄĚ in its technique, TNX-801 is a live virus vaccine based on synthesized horsepox (sHPXV) that it claims…

Flu has no off-season when it comes to manufacturing, says CSL Seqirus

The 2022/23 influenza season could see Seqirus produce 55 million vaccines for the US alone, but fluctuating demand across hemispheres means the firm must manage scalability in a variety of ways. Seqirus has long had a leading role in the seasonal influenza space through its portfolio of products, including both egg-based and cell-based vaccine.¬†And last month, the firm began shipping its portfolio across the US and claimed it is prepared to supply more than 55 million doses, if required. To…

Sanofi inks cancer antibody deal and invests $305m in Innovent

Suzhou Innovent Biologics will develop two Sanofi cancer candidates in China¬† with Sanofi investing $305 million in Innovent at a 20% premium to current prices. The drug candidates are (1) tusamitamab ravtansine, an anti-CEACAM5 antibody-drug conjugate in Phase III trials, and (2) non-alpha IL-2 in Phase II trials (combined with Innovent‚Äôs PD-1, sintilimab). Innovent will be responsible for China clinical development of both Sanofi candidates, but will commercialize only tusamitamab ravtansine. Sanofi will be eligible for $81 million in milestones…

OriCell plans CAR-T plant after $120m funding boost

OriCell Therapeutics has closed a $120 million Series B financing set to support its cell therapy and bispecific immunotherapy pipeline. The Shanghai, China-based company also plans to build a clinical/commercial manufacturing plant, though the location or further details are yet to be revealed. OriCell has two chimeri antigen receptor (CAR) T candidates that are close to clinical stage, one for advanced liver cancer and the other for multiple myeloma. It is also developing a PD-L/4-1BB bispecific antibody that it partnered…

Charles River looks to CGT growth to offset ‚Äėbumpiness‚Äô in CDMO biz

Stabilizing acquired CDMO businesses is proving ‚Äúelusive and expensive‚ÄĚ say analysts, but Charles River is confident cell and gene therapies entering the clinic will be the foundation of future growth. For the second quarter 2022, Charles River Laboratories reported revenue from its manufacturing segment of $195 million, down 1.5% on the same quarter last year. Furthermore, the company is reducing its 2022 financial guidance from revenue growth of 13.5-15.5% to 9-11% in part due to ‚Äúheadwinds associated with the CDMO…