Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
It has gone unnoticed in HIV research until now, but a transcriptomic analysis has detected a molecule that could kill this virus. Scientists at a U.S. military research institute laboratory have found a common factor in human cells that inhibited the replication of HIV-1 in people living with the virus. “Without any manipulation of cells in people with HIV, we have found a host factor that is inhibiting HIV in vivo,” the senior author Rasmi Thomas, chief of the Laboratory of Integrative Multiomics at Walter Reed Army Institute of Research, told BioWorld. Using single cell RNA sequencing (scRNA-seq), the study published on Aug. 2, 2023, in Science Translational Medicine identified this host factor as prothymosin α, a protein isolated from the thymus in 1966 and described in 1984.
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
CAR T-cell immunotherapy is designed with different targets depending on the receptors they will bind to. CARs can also contain different tools, like the concept of a Swiss army knife, with several utensils for different tasks. The goal is to make them more effective and durable. During the second session of the Spotlight on Immuno-Oncology conference, “Novel CAR designs and approaches,” Robbie Majzner, of Stanford University, described expanding the main components of CAR T cells to acquire new functions and act on different cell pathways.
Peptidream Inc. and Modulus Discovery Inc. have nominated the first clinical development candidate arising from the companies’ strategic drug discovery partnership.
Research at Blossomhill Therapeutics Inc. has led to the discovery of new macrocyclic compounds acting as tyrosine kinase inhibitors and reported to be useful for the treatment of autoimmune disease.
A study of the genetic determinants of HIV viral load in 3,879 people of African ancestries has found what is claimed to be the only new variant related to HIV infection discovered in more than two decades of research into how host genomics affects the response to the retrovirus.
“From such a stick, such a splinter,” is a popular Spanish saying to explain how a son resembles his father. Like father, like son. The first Spotlight on Immuno-Oncology conference of the American Society of Gene & Cell Therapy (ASGCT) is the splinter of the ASGCT annual meeting, which brought together a group of experts in this field. It took place on Aug. 1 and 2, 2023, starting with a series of talks on “B Cell Malignancies and Beyond.”
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