Jasper's cell therapy conditioning agent shows promise in small study; ViiV's Rukobia sees approval in Europe
Jasper Therapeutics, broadly aimed at making cell therapy safer, released preliminary data for its complement to stem cell transplants on Monday.
The biotech is running an open-label Phase I trial of its lead program JSP191, an anti-CD117 monoclonal antibody that targets the stem cell factor receptor, as a conditioning agent in patients aged 65 to 74 with myelodysplastic syndromes or acute myeloid leukemia that are undergoing blood cell transplantation. Six patients have received the treatment thus far, and all six showed successful engraftment.
Researchers also saw donor myeloid chimerism of at least 95% in five of six evaluable patients at 28 days. Three of the five also showed that residual disease could not be found, indicating a “complete eradication,” Jasper said.
Jasper’s theory behind JSP191 is that it blocks the stem cell factor from binding to CD117 and disrupts survival signals, causing the stem cells to die off. That creates an “empty space” of sorts in the bone marrow, allowing for donor or gene-corrected transplanted stem cells to engraft.
The company launched out of Stanford, emerging from stealth in late 2019 with a $35 million Series A round.
Europe approves Rukobia for drug-resistant HIV
GSK’s ViiV saw the FDA approve its twice-daily pill for HIV back in July, but now they’ve received the green light on another continent.
The European Union on Monday granted Rukobia the thumbs up for use in combination with other antiretroviral therapies in adults with drug-resistant HIV, about two months after the CHMP noted its positive opinion. In the randomized cohort of the drug’s pivotal trial, 60% of the 272 patients who received Rukobia in addition to optimized background therapy saw undetectable HIV viral load after 96 weeks.
“There still remains a small subset of people living with multi-drug resistant HIV who are at risk of having their disease progress,” ViiV CEO Deborah Waterhouse said in a statement. “We aim to meet the diverse needs of the HIV community.”
Rukobia functions by targeting the first step of the HIV life cycle and shows no cross-resistance to other currently licensed antiretroviral classes, ViiV says. That can help HIV patients who have struggled to suppress their viral levels using other treatments.
ViiV also notched an approval in the US for Cabenuva last month, becoming the first FDA-approved injectable for HIV. The therapy will look to replace the daily oral pills that are currently standard of care in treating HIV-positive adults.