The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kleo Pharmaceuticals‘ KP1237, an investigational treatment for multiple myeloma. The designation grants various development incentives to medications that address rare disorders affecting fewer than 200,000 people annually in the U.S. Incentives include regulatory support and financial benefits that will help accelerate the…
A five-year grant of more than $2 million from the National Cancer Institute (NCI) will support research investigating the link between prostate cancer cells and the fatty cells — adipocytes — found in bone marrow. Izabela Podgorski, PhD, associate professor of pharmacology at Wayne State University School of Medicine in Michigan, will lead the project being funded by the the…
Compass Therapeutics‘ CTX-2026, an antibody targeting the protein BTN3A1, could be therapeutic in ovarian cancer by helping the immune system destroy cancer cells, preclinical data show. The study, “BTN3A1 governs antitumor responses by coordinating αβ and γδ T cells,” was published in the journal Science. The body’s immune system is responsible for fighting off infections…
TTC-352, an investigational oral treatment for patients with metastatic ER-positive breast cancer that no longer responds to hormone therapy, was found to be safe and tolerable at high dose in a Phase 1 clinical study. The treatment also showed a potential for effectiveness, with half of those who finished the trial achieving stable disease for…
Events are underway to mark World Alzheimer’s Month, observed every September to raise global awareness about the disease and challenge the stigma regarding dementia. September 21 has been designated World Alzheimer’s Day. Approximately 44 million people worldwide have Alzheimer’s disease, the most common form of dementia and an irreversible progressive neurological disorder. In the U.S., roughly 5.5 million…
Newk’s Cares is honoring the legacy of co-founder Lori Newcomb this September during Ovarian Cancer Awareness Month with fundraising initiatives online and at the more than 100 Newk’s Eatery restaurants. Newk’s Cares is the philanthropic arm of Newk’s Eatery, the Jackson, Mississippi-based fast-casual restaurant chain. It was established in 2014, a year after Newcomb, an…
A Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma has been placed on hold by the U.S. Food and Drug Administration (FDA), the company announced in a press release. The MELANI-01 study (NCT04142619) was assessing the safety and clinical activity of different doses of UCARTCS1A,…
Opdivo (nivolumab) significantly prolongs the time patients with resected esophageal or gastroesophageal junction (GEJ) cancer live without signs of disease after receiving chemoradiation therapy followed by cancer removal surgery, interim data from a Phase 3 trial show. Consistent with data from previous studies, Opdivo demonstrated a favorable safety profile in this setting. This is the…
The first participant has been dosed in the Phase 2 clinical trial IRENE, which is evaluating Incyte‘s immunotherapy retifanlimab in combination with the oncolytic virus pelareorep, by Oncolytics Biotech, as a treatment for locally advanced or metastatic triple-negative breast cancer (TNBC). The trial (NCT04445844) is currently recruiting patients at the Rutgers Cancer Institute of New…
Axsome Therapeutics announced plan to soon open a Phase 3 clinical trial of AXS-05, its investigational oral treatment for Alzheimer’s disease-related agitation, after U.S. Food and Drug Administration (FDA) officials confirmed an earlier study was pivotal. Results from this new efficacy trial, to open before year’s end, are expected to support a new drug application (NDA) seeking…
