Resolution Therapeutics Ltd. is preparing for a phase I/II trial of its autologous engineered macrophage cell therapy, RTX-001, in the treatment of end-stage liver disease and has raised £63.5 million (US$83.3 million) to complete the study and to add further fibrotic and inflammatory disease programs to its portfolio. Recruitment to the study, to be conducted at 15 sites in Spain and the U.K., is due to start before the end of 2024, with the monocyte-derived patient macrophages being processed and modified at a facility in Edinburgh.
In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. While the programs and targets have yet to be disclosed, BMS is expanding its CAR T development, begun more than five years ago, with this deal.
Capricor Therapeutics Inc. has expanded its commercialization and distribution deal with Nippon Shinyaku Co. Ltd. to include the EU and the U.K. for deramiocel, Capricor’s lead asset, in treating Duchenne muscular dystrophy (DMD). In the new agreement, Capricor will receive an up-front payment of $20 million. Capricor will handle development and manufacturing duties for deramiocel while Nippon Shinyaku will be responsible for the sales and distribution.
The newest data show increased survival times for heavily pretreated patients receiving Briacell Therapeutics Corp.’s breast cancer treatment. The company’s phase II results produced positive overall survival data using the cell-based immunotherapy Bria-IMT to treat late-stage metastatic breast cancer.
Cellular immunotherapy is the Lamine Yamal of cancer therapy. It is easy to forget how young the field is – and that as stunning as it is to watch in action already, it is still reaching its full potential. One aspect of doing so is working in a broader range of tumor types. The field made a giant step toward that goal with last week’s approval of Tecelra (afamitresgene autoleucel, Adaptimmune Therapeutics plc), the first CAR T cell to be approved for treatment of a solid tumor.
To be successful, CAR T-cells need a balance between being effective and overkill. Researchers from the University of Pennsylvania and Vittoria Biotherapeutics Inc. have eliminated the CD5 signaling pathway of their CAR Ts to prevent the immunosuppressive brake effect. In return, this improved their proliferation and antitumor activity in T cell lymphomas.
Artiva Biotherapeutics Inc. raised $167 million through an upsized IPO, with funds aimed at the development of its lead AlloNK program for systemic lupus erythematosus and other autoimmune indications. Just a few days ago, the San Diego based company had aimed to sell 8.4 million shares between $14 and $16 each, but it raised the number of shares offered to 13.92 million and lowered the price to $12 each. The upsize brings Artiva’s shares outstanding following the IPO to about 22.8 million, giving the company a market cap of $273.6 million based on the IPO price.
New company Pan Cancer T BV is preparing for a clinical trial of a next-generation T-cell receptor-engineered T cell it has designed to remove the current barriers and make T-cell therapies effective in treating solid tumors. Its products have two distinguishing features: They are targeted at antigens the company has shown are exclusively and robustly expressed by multiple solid cancers, and have a minor genetic modification that enhances the durability of autologous TCR-Ts in the tumor microenvironment after they are administered back into a patient.
The industry is looking, with renewed hope, to the “promise” of messenger RNA (mRNA) therapeutics for a wide range of diseases beyond COVID-19, and not only in vaccine form but also for gene and cell therapies.
Phase I/II data of IDCT (rebonuputemcel), a cell therapy in development for chronic and progressive lumbar degenerative disc disease and one that has both regenerative medicine advanced therapy and fast track designations in the U.S., has been published in the International Journal of Spine Surgery for showing statistically significant improvements in pain, disability and quality of life.
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