Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.
Tessa Therapeutics Ltd. has a closed a $126 million series A financing round to advance its ongoing clinical development, which includes the initiation of a pivotal trial of autologous CD30-CAR-T therapy (TT-11) and advancement of allogeneic CD30.CAR EBVST therapy (TT-11X) programs.
Investors are backing imaging diagnostics company Magnetic Insight Inc. with $17 million to develop its magnetic particle imaging (MPI) technology. The clinical imaging application consists of two core technologies: hardware and a tracer that, together, produce 3D images of how a patient’s body works. Venture firm Celesta Capital led the series B round with Alumni Ventures Group, Gaingels and existing investors 5AM Ventures and Sand Hill Angels participating.
Tessa Therapeutics Ltd. has a closed a $126 million series A financing round to advance its ongoing clinical development, which includes the initiation of a pivotal trial of autologous CD30-CAR-T therapy (TT-11) and advancement of allogeneic CD30.CAR EBVST therapy (TT-11X) programs.
Healiva SA, a Swiss wound care specialist, emerged from stealth mode having acquired two cell therapy assets from Smith & Nephew plc. Financial terms were not disclosed, but they included an up-front payment as well as “deferred benefits,” Healiva CEO and founder Priyanka Dutta-Passecker told BioWorld. The deal means that the Lugano-based company – which was formed in 2020 – could be booking revenues as early as 2023.
LONDON – Quell Therapeutics Ltd. has raised $156 million in an oversubscribed series B, enabling it to start a phase I/II trial of its engineered T regulatory (Treg) cell therapy for promoting long-term immune tolerance in liver transplant patients, averting the need for chronic immunosuppression.
Vigencell Inc., a company focused on immune cell therapy, raised ₩99.4 (US$85.17 million) through an IPO on South Korea’s Kosdaq board and plans to use the funds to drive its R&D and company operations. “We particularly want to increase the competitiveness of our pipeline by advancing our technology and clinical development,” Vigencell CEO Tai-Gyu Kim told BioWorld. “We will also expand our discovery of new candidates and R&D in general, as well as updating our facilities and hiring researchers.”
China is making strides in cell and gene therapy, notably so with a 61% surge in the number of clinical trials in six years, a new report by Ernst & Young showed. While analysts noted the increasing innovation efforts and cross-border collaborations, concerns remain if quality will be compromised by speed.
LONDON – Syncona Ltd. has unveiled its fifth cell therapy startup, Resolution Therapeutics Ltd., which arrives on the scene with a £26.6 million (US$35.6 million) series A to exploit the ability of macrophages to stimulate liver repair.
SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials.
