Noah Stansfield

Nicole Paulk, PhD, the CEO, founder, and president of Siren Biotechnology, discussed research she presented at ASGCT’s 2023 conference.

AVC-201 utilizes the company’s UniCAR switchable technology platform.

Maria Escolar, MD, the chief medical officer of Forge Biologics, discussed the atypical approach being used in the company’s trial for AAV gene therapy FBX-101.

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

NY-ESO-1 TCR/IL-15 NK previously received clearance of an IND for advanced synovial sarcoma and myxoid/round cell liposarcoma in June 2023.

Magdalena Cichewicz, PhD, a scientist II at Senti Biosciences, discussed preclinical research she presented at ASGCT’s 2023 conference.

Iovance Biotherapeutics also reported that it received positive regulatory feedback from the FDA regarding the IOV-LUN-202 clinical trial for LN-145.

Gary Owens, MS, the associate director for gene therapy discovery at Precision Biosciences, discussed data he presented at ASGCT’s 2023 conference.

XyloCor Therapeutics reported that at the 12-month time point, sustained and continued increases in total exercise duration over baseline measurements were observed.

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

The phase 1/2a clinical trial will take place at the University of Texas MD Anderson Cancer Center, aiming to enroll more than 100 patients.

The new fast track designation is for Reqorsa in combination with Tecentriq for an extensive-stage small cell lung cancer indication.

Mary Jane "MJ" Mulcahey, PhD, OTR/L, CPPC, CLCP, FASIA, the director of the Center for Outcomes and Measurement in the Jefferson College of Rehabilitation Sciences at Thomas Jefferson University, discussed recommendations on outcome measures she presented at the first Annual SCI Investor Symposium.

Among 16 patients who were treated with Caribou Biosciences’ CB-010, the ORR was 94% and the CR rate was 69%.

ARUP Laboratories’ AAV5 DetectCDx utilizes electrochemiluminescence to detect antiAAV5 antibodies in samples of patients’ plasma.

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

Pending clearance of the CTA for OTOF-GT, the company plans to initiate the phase 1/2 Audiogene clinical trial.

Brian Culley, MS, the chief executive officer of Lineage Cell Therapeutics, discussed advancements made with SCI cell therapy OPC1 at the first Annual SCI Investor Symposium.

Among 29 patients who were treated with nusinersen in the RESPOND trial and evaluable for efficacy, most demonstrated an increase in mean total HINE-2 score from baseline.

In terms of safety, Capricor Therapeutics’ CAP-1002 was reported to be well-tolerated.

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

Mary “Nora” Disis, MD, director of University of Washington Medicine’s Cancer Vaccine institute, discussed past and current clinical trials for investigational CAR-T therapies in ovarian cancer.

Mary “Nora” Disis, MD, director of University of Washington Medicine’s Cancer Vaccine institute, discussed research she coauthored that was presented at ASCO’s 2023 conference.

The 2 patients were among 6 who have received treatment in Vertex’s trial so far and were the only 2 evaluable for the primary efficacy end point.

Five patients in the cohort achieved this milestone and Sernova noted a sixth patient in the cohort is still awaiting assessment of islet graft function.

The FDA’s decision to approve this first gene therapy in hemophilia A was based on data from the phase 3 GENEr8-1 clinical trial.

Benitec Biopharma is planning to initiate a phase 1b/2a clinical trial to evaluate BB-301.

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

In addition to the BLA acceptance, Pfizer noted that a European MAA for the gene therapy has been accepted by the EMA.

Among 4 patients who were treated at the highest dose level evaluated using a manufacturing process referred to as Process A, all 4 patients achieved responses.