Tr1x Inc. has announced that the FDA has cleared its IND application for its engineered Tr1 Treg cell therapy TRX-103 for treatment-refractory Crohn’s disease.

Shinobi Therapeutics Inc. has been awarded non-dilutive grant funding of up to $59 million by the Japanese Agency for Medical Research and Development (AMED).

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.

Umoja Biopharma Inc. has received clearance from the FDA to begin a first-in-human trial of its CAR T product UB-VV111. The company expects to dose the first patient by the end of 2024.

Astellas Pharma Inc.’s subsidiaries Astellas Institute for Regenerative Medicine (AIRM) and Universal Cells Inc. have entered into a research collaboration with Osaka University to develop a pluripotent stem cell-derived cartilage organoid cell therapy for the treatment of intervertebral disc degenerative disease.

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.

Myogenica Inc., a University of Minnesota startup company, has obtained IND approval from the FDA for Myopaxon, an induced pluripotent stem cell (iPSC)-derived muscle stem cell product to regenerate skeletal muscle. A planned study will evaluate intramuscular injections of Myopaxon in non-ambulatory adult patients with Duchenne muscular dystrophy.

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.

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.