Phase I

The drug, created by Vaxart, has just completed its Phase I trial and had submitted an Investigational New Drug application to move forward.
With the Alzheimer’s Association International Conference conference last week, there were plenty of clinical trial news and updates. Here’s a look.
Clinical-stage biotech company Vaxart announced Thursday that a second dose of its oral norovirus vaccine boosted immunity in clinical trial participants who had previously received the vaccine more than a year prior.
The company’s pipeline was strengthened in the second quarter with three strategic collaborations in immuno-oncology, immuno-neurology, and HIV.
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
One of the eagerly anticipated presentations at the AAIC being held this week is Biogen and its partner Eisai on their controversial drug ADUHELM™ (aducanumab). Biogen is also presenting new data on a different Alzheimer’s drug with another partner, Ionis Pharmaceuticals.
The companies will co-finance a clinical study to test the combination of SHP2 inhibitor BBP-398 and OPDIVO in treating patients with advanced solid tumors KRAS mutations.
Abeona Therapeutics’ shares popped 18.32% in pre-market trading after New York and Cleveland-based company announced magnetic resonance imaging (MRI) data from its Phase I/II Transpher A trial in San Filippo Syndrome Type A (MPS IIIA).
Updated trial data show patients treated with BioMarin Pharmaceutical’s severe hemophilia A gene therapy expressed substantially lower factor VIII levels after five years compared with one year, calling into question the drug’s long-term benefits.
It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.
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