Noah Stansfield

Omidubicel’s BLA was originally accepted for priority review in August of this year.

Statistically significant improvements in cognitive development were only seen in the cohort of patients younger than 30 months.

The gene therapy was approved in the European Union earlier this year.

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ExCellThera is in the process of the expanding the studies into new trial sites in the United States and Europe.

AFNT-111 showed anti-tumor activity in NSG mouse models of breast cancer, pancreatic cancer, and colon cancer.

KYV-101 is an autologous version of a CD19-directed fully human CAR-T construct.

Among the 16 patients treated in the trial, 5 showed stable disease after treatment.

The data included an IRC-assessed ORR of 31.4%.

The patient’s ECOG performance status remained at 0 from screening through the rest of trial participation.

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Several of the first cohort patients have had their Cell Pouch implants for over 3 years and no patients have elected to have their implants removed.

Among the trial’s high dose cohort, 80% of patients did not require supplemental injections for over 2 years.

Preclinical research in an OTOF-knockout mouse model demonstrated reversal of deafness.

The platform is capable of producing lentiviral vectors for preclinical, clinical, and commercial scales with high titers ranging from 1x10^8 TU/ml to 1x10^9 TU/ml.

AlloStem will be evaluated in the CELZ-201 clinical trial for patients with newly diagnosed type 1 diabetes.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

MT-101 is designed for quick delivery to patients with a vein-to-vein time of 8 days.

TIDAL-01 will be evaluated in patients with advanced or metastatic breast carcinoma, colorectal adenocarcinoma, or uveal melanoma.

MRI revealed that participants who achieved sustained or confirmed disability improvement showed significantly less ventricular enlargement at 12 months.

AVR-RD-02 also received ILAP designation in the UK earlier this month.

RZ-001 previously received IND clearance from the South Korean Ministry of Food and Drug Safety in June.

The decision comes after strategic uncertainty regarding a review of preliminary clinical data from GSK’s lete-cel product candidate trial.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Cells produced by this method were also shown to be more potent in animal models than cells made with typical processes.

In preclinical research, T-cells bearing TK-8001's TCR showed better in vivo antitumor activity than T-cells incorporating human donor-derived TCRs.

ITIL-306 utilizes a CoStAR molecule intended to improve cytokine release, cytolytic activity, and proliferation of TILs.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The proportion of patients with concentrations of NfL and MBP above the upper limit of normal decreased from 67% and 63%, respectively, to 12% at 5 years.

In a rodent model, durable auditory brainstem responses to sound were observed after DB-OTO administration.