Hematology

The FDA has accepted the company’s plan to address its current IND clinical hold on HEMO-CAR-T.

Review top news and interview highlights from the week ending September 15, 2023.

Patients were newly diagnosed and had acute myeloid leukemia positive for FLT3-iTD mutations.

A final analysis of data from CARTITUDE-1 was also presented at SOHO 2023, which revealed a PFS of 24.9 months in treated patients.

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

Beam Therapeutics also expects to announce initial data from its BEACON trial in sickle cell in 2024.

Zilebesiran is being evaluated as a monotherapy in the KARDIA-1 study and as a combination therapy in KARDIA-2, which will report topline data in early 2024.

The CAR T-cell therapy, marketed as Yikaida in China, has been approved for second-line treatment for patients with refractory/relapsed large B-cell lymphoma.

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

Review top news and interview highlights from the week ending September 1, 2023.

In a small sample of patients, the CRISPR–Cas9–edited CD34+ hematopoietic stem- and progenitor-cell therapy showed expected safety while inducing red cell fetal hemoglobin.

In recent data from the phase 3 VITAL trial, EB-101 decreased pain and improved wound healing.

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

The FDA’s decision was based on data from the randomized, open-label phase 3 COMMANDS clinical trial.

The company also recently entered into a collaboration with Roche and was invested in by Astellas.

Review top news and interview highlights from the week ending August 25, 2023.

Because of the lack of neurotoxicity seen in patients treated thus far, Nexcella believes NXC-201 may have potential to serve as an outpatient treatment.

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

The company also reported that WU-NK-101 has received orphan drug designation for treating acute myeloid leukemia from the FDA.

Surveyed clinicians and nurses from Rady Children's Hospital San Diego identified important factors and considerations needed in a potential SMD tool.

Review top news and interview highlights from the week ending August 18, 2023.

Bluebird's gene-edited cell therapy has a PDUFA date of December 20, 2023.

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

Mustang reported new data and responses from a multicenter phase 1 trial evaluating its CAR T-cell therapy in patients with NHL, FL, and WM.

The partial clinical hold was originally placed in June 2023 in relation to the death of a patient participating in the trial.