Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push.
Neukio Biotherapeutics Co. Ltd. has raised $50 million to support preclinical validation and clinical development of new cell therapies for cancer. The series A-1 round was led by CD Capital, Beijing Alwin Asset Management Co. Ltd. and Surplus Capital, with contributions from previous investors Lilly Asia Ventures, Sherpa Healthcare Partners Co. Ltd., and IDG Capital.
Chimeric antigen receptor T-cell therapies and mRNA-based vaccines represent two of the most significant new modalities to gain regulatory approval in the past decade. Capstan Therapeutics Inc. has emerged from stealth with bold ambitions to combine these two approaches in mRNA-programmed cell therapies that will be generated in vivo from patients’ endogenous cells. It has so far secured $165 million in equity funding to pursue that vision.
Scientifically at least, the biggest story coming out of the European Society for Medical Oncology (ESMO) 2022 Congress is the success of cell therapy in solid tumors. “During this ESMO, there is a lot of novelty coming from T-cell therapies,” John Haanen told the audience at his joint keynote speech with Ton Schumacher – so much so that Haanen and Schumacher, both group leaders at the Netherlands Cancer Institute, left antibodies out of their keynote session in order to do justice to the advances in cell therapies.
Arsenal Biosciences Inc. closed on an oversubscribed $220 million series B financing so it could continue developing its programmable cell therapy research programs and its candidates for treating solid tumor malignancies. Arsenal’s lead program is AB-1015 for treating ovarian cancer.
The University of Sydney is investing AU$478 million (US$326.5 million) to build a leading biomedical precinct to fast-track research and shorten the time between discovery and development of transformative therapies.
Access to advanced therapies proved to be a major talking point at a conference in London, following the U.S. approval of Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) cell-based gene therapy for beta thalassemia and its $2.8 million price tag. Regulators in Europe backed Zynteglo in 2019 but Bluebird opted to withdraw the therapy in 2021 after deciding that the complex thicket of pricing bodies in Europe was too difficult to negotiate.
3T Biosciences Inc. raised $40 million in a series A funding round to take forward a platform for identifying novel T-cell receptors (TCR) and their targets, which is based on the work of scientific co-founder K. Christopher Garcia of Stanford University.
Oricell Therapeutics Co. Ltd. has raised $120 million in a series B financing to support development of its cell therapy pipeline and technology platform, as well as the construction of a manufacturing plant. The round was jointly led by Qiming Venture Partners and Quan Capital Management LLC.
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