Oncology

The FDA has granted a Fast Track Designation to GCC19CART as a potential treatment for adult patients with relapsed and refractory metastatic colorectal cancer.

ADI-001 has been granted a Fast Track Designation by the FDA a potential treatment for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

David Apelian, MD, PhD, MBA, chief executive officer at BlueSphere Bio; and Warren Shlomchik, MD, cofounder and scientific advisory board chairman at BlueSphere Bio, join CGTL to discuss the company's leading T-cell therapy clinical program.

The phase 1/2 study (NCT05062980) has officially opened enrollment for patients with late-stage non-small cell lung cancer, with plans to initiate patient screening.

Review top news and interview highlights from the week ending April 15, 2022.

Already, NG-641 has shown encouraging preliminary safety and tolerability results in the ongoing phase 1a dose-escalation STAR trial (NCT04053283), which is a first-in-human study for the gene therapy.

While the lower IV dose was generally well-tolerated, the higher dose yielded cases of serious cytokine release syndrome.

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

The decision was based on findings from the phase 1 TRANSCEND NHL 001 clinical trial.

The phase 1, investigator-initiated trial continues to recruit participants with B-ALL.

The novel regimen from BioNTech demonstrated encouraging results in patients with testicular or ovarian cancer.

AFM13 is currently also being evaluated on its own in lymphoma in a phase 2 registrational study.

The first in-human phase 1 clinical trial is being conducted in Japan.

Review top news and interview highlights from the week ending April 8, 2022.

Iovance plans to complete BLA submission for lifileucel by August 2022.

The phase 3 registration study is evaluating AB-205's efficacy in treating damaged stem cell niches.

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

The investigational therapy leverages an advanced overnight nonviral gene delivery manufacturing process that may help it overcome existing treatment limitations.

The FDA has approved second-line axicabtagene ciloleucel as a treatment for adult patients with large B-cell lymphoma following frontline chemoimmunotherapy.

Review top news and interview highlights from the week ending April 1, 2022.

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

Allogene’s clinical hold on their AlloCAR T candidates was previously lifted in January 2022.

Research presented at the EBMT meeting suggests cell expansion may be a good biomarker of both response and outcomes.

Review top news and interview highlights from the week ending March 25, 2022.

A prespecified interim analysis from the phase 3 TRANSFORM study showed an event-free survival benefit with the second-line therapy.

A2 Biotherapeutics is developing CEA- and MSLN- targeted Tmod CAR T-cell therapies.

The professors and researchers from The University of Texas at Austin discussed new findings of Cas9 structure and mechanisms.

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

Seven patients from the trial continued to be followed-up as of the data cut-off date.

Viral vectors have become the most common method for delivering gene therapy; however, pre-existing humoral immunogenicity can potentially render a gene therapy ineffective.