Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago.
Adverse events and criteria for determining remission in an otherwise positive early study by Syndax Pharmaceuticals Inc. with oral menin inhibitor SNDX-5613 apparently gave Wall Street pause, and shares (NASDAQ:SNDX) closed at $13.42, down $5.96, or 31%.
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Alnylam, Bioarctic, Eisai, Eli Lilly, Incyte, Ionis, Janssen, Jazz, Leading, Medincell, Morphosys, Ripple, Siteone, Sorrento, Steba, Syndax, T3D.
Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.
At the recent American Association for Cancer Research (AACR) meeting, Blueprint Medicines Corp. unveiled results from the registrational phase II Pathfinder study with Ayvakit (avapritinib) in systemic mastocytosis (SM), adding more promise to the KIT inhibitor class.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aegis, Alzecure, Bergenbio, Checkmate, Erytech, Humanigen, Lyndra, Medivir, Pharmabcine, Sirnaomics, Todos Medical, Transcenta, Ziopharm, Zyus.
Koelis SAS reported the first successful procedures for its platform in 3D fusion imaging-guided focal ablation of prostate cancer at the Clinique Nantes Atlantis in Saint-Herblain, France. These first procedures take place against the background of a multicenter prospective clinical trial starting on the Koelis platform. This includes eight European urology centers, of which six are in France, with data being stored in a dedicated registry.
Heidelberg, Germany-based Affimed NV described its progress at the American Association for Cancer Research meeting and discussed the research in a conference call on 2020 financial results, adding fuel to investor enthusiasm for the firm’s natural killer (NK) cell approach, although the update did not come without some confusion.
With phase III data due from Phathom Pharmaceuticals Inc. in the near term, investor eyes are turning to the ways that lead compound vonoprazan, a potassium-competitive acid blocker, might distinguish itself from proton pump inhibitors (PPIs) in gastroesophageal reflux disease (GERD).