Oncology

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

Acclaim-1, Acclaim-2, and Acclaim-3 will evaluate Reqorsa in combination with osimertinib, pembrolizumab, and atezolizumab, respectively.

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.

NKGen Biotech’s trial for SNK02 was initiated following the clearance of an investigational new drug application by the FDA in October 2022.

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.

Initial data from the combination substudy are expected in the second half of 2023.

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

Review top news and interview highlights from the week ending August 18, 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 new orphan drug designation follows a recently received fast track designation for Reqorsa in combination with Tecentriq for an extensive-stage small cell lung cancer indication.

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

A presentation at EHA 2023 showed important safety and efficacy data with CD22 CAR T cells in heavily pretreated patients with large B-cell lymphoma and pointed to how this may shed light on sequencing in this field.

The formal hold comes approximately 2 months after Seattle Children’s paused the trial in accordance with the clinical study protocol stopping rules.

Kyle Garland, PhD, a senior scientist at Eterna Therapeutics, discussed the company’s preclinical work with partner Factor Bioscience that was presented at ASGCT’s 2023 conference.

Both Adaptimmune and Replay have placed their bets on targeting cancer testis antigens for synovial sarcoma and myxoid/round cell liposarcoma cell therapy.

Review top news and interview highlights from the week ending August 11, 2023.

The assistant member in the Department of Head and Neck-Endocrine Oncology at Moffitt Cancer Center spoke about A2B530's mechanism of action and how it could represent a leap forward in the application of CAR T-cell agents for patients with solid tumors.

The first participant was dosed with LBL-033 in April 2023 in Nanjing Lead Biolabs's ongoing trial in China.

The professor of medicine and pediatrics at Washington University in St. Louis discussed the current investigative landscape for cell therapy in treating sarcomas.

KMA.CAR-T is directed at Kappa Myeloma Antigen, a receptor exclusively appearing on myeloma cells in kappa-type MM.

The TIL therapy's PDUFA date has been pushed back to February 24, 2024.

The associate professor at MD Anderson Cancer Center discussed challenges with developing cell therapy for sarcoma and how TCR NK therapy's unique characteristics may prove useful.

The phase 2 ALPHA2 trial of ALLO-501A should complete enrollment in 2024.

Review top news and interview highlights from the week ending August 4, 2023.

Four years after submitting its initial BLA for remestemcel-L for steroid-refractory acute graft versus host disease, Mesoblast has encountered another hurdle toward possible approval.