Accellix

Agilent Technologies is set to acquire Canadian CDMO BIOVECTRA, expanding its gene editing and mRNA capabilities to support high-growth market areas. 📈 #CDMO #advancedtherapies https://lnkd.in/gWWrkEaj

Positive results from a clinical trial (NCT05859997) provide early validation for allogeneic CAR-T cell therapy to treat autoimmune diseases. TyU19, a genetically engineered allogeneic CAR-T therapy targeting CD19 developed by BRL Medicine, was administered to three patients. ✅ Complete B cell depletion was observed within two weeks ✅ Remission experienced by all 3 patients without severe adverse events, including cytokine release syndrome, during the six month follow up While the sample size is small, these results demonstrate the high safety and potential of off-the-shelf CAR-T cells in treating severe refractory autoimmune diseases. https://lnkd.in/g5HKS3ud #allogeneic #cartcelltherapy #autoimmunedisease

The FDA has accepted Atara Biotherapeutics' BLA for tabelecleucel (tab-cel®), a significant milestone for the company. Tab-cel is the first-of-its-kind allogeneic T-cell therapy to treat Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adults and pediatric patients who have received at least one prior therapy. The PDUFA date is set for January 15, 2025. https://lnkd.in/dmf5vYQY

Exciting news! uniQure has received the first-ever FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational gene therapy, AMT-130, to treat Huntington’s disease. This groundbreaking designation was granted thanks to the positive 24-month data from the ongoing Phase I/II clinical trial. #HuntingtonsDisease #RMAT #genetherapy https://lnkd.in/gknrSqGz

Vertex Pharmaceuticals has released new Phase I/II data evaluating their stem cell-derived islet cell therapy, VX-880, to treat type 1 diabetes. All 12 patients who received a single full dose infusion of VX-880 demonstrated islet cell engraftment and glucose-responsive insulin production by Day 90. Based on these positive results, the trial will be expanded to enroll ~37 participants as company progresses toward pivotal development. #diabetes #stemcelltherapy https://lnkd.in/dU97PBQM

Q3 is well underway. Here are 5 FDA decisions to watch out for including two novel psychiatric medicines, as well as drugs from Gilead Sciences, Ascendis Pharma, and Adaptimmune: https://lnkd.in/gwRfeyub

Johnson & Johnson and Legend Biotech have released positive interim results from the landmark Phase 3 CARTITUDE-4 trial. This latest data point demonstrates significant overall survival improvement in multiple myeloma patients and builds on the growing body of evidence showing the benefit of Carvykti. #cartcelltherapy #multiplemyeloma https://lnkd.in/dqQriADP

Carisma Therapeutics has been granted FDA Fast Track Designation for CT0525, a first-in-class, ex vivo gene-modified autologous CAR-Monocyte cell therapy to treat HER2+ solid tumors. This approach has the potential to overcome key challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the TME, and antigen heterogeneity. Phase 1 clinical data is expected to be available by 2024 year-end.  #immunotherapy #solidtumors https://lnkd.in/gtNw3eqD

Exciting news from Adicet Bio, Inc! ADI-270 gets FDA IND clearance, becoming the first gamma delta CAR-T cell therapy candidate to enter clinical trial evaluation for solid tumors. The armored allogeneic CAR-T candidate will be tested in patients suffering from relapsed or refractory renal cell carcinoma, marking another milestone in the fight against cancer! #cartcelltherapy #solidtumors https://lnkd.in/gaUSEfqV

Kyverna Therapeutics' autologous CD19-directed CAR T cell therapy KYV-101 receives FDA IND clearance, which will allow the initiation of the KYSA-8 Phase II trial to evaluate the treatment of patients with refractory stiff-person syndrome (SPS). #cartcelltherapy #autoimmunedisease https://lnkd.in/gnsVfq6S