Phase I
Moderna invested heavily in mRNA technology to manufacture some 900 million doses of the COVID-19 vaccine. Now, the company has created an mRNA-based vaccine to prevent HIV.
The company initiated the use of splenic nerve simulation last month as part of a small clinical trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
The researchers believe Keytruda and possibly other anti-PD-1 checkpoint inhibitors might help the immune system track the last signs of HIV while also preventing HIV’s ability to hide.
Vaccinex announced positive interim response data in a Phase Ib study assessing pepinemab in combination with Merck’s vaunted checkpoint inhibitor, Keytruda.
The FDA placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected adverse events.
In addition to the induction of both mucosal and systemic immunity, advantages of an intranasal approach include the lack of needles, low cost and thermostability under normal refrigeration temperature.
Shares of Mustang Bio have fallen more than 13% in premarket trading after announcing the FDA had placed a hold on the company’s Investigational New Drug application for its bubble boy gene therapy.
Sixty-three percent of patients met the primary endpoint of a 2-point or greater improvement in disease severity without worsening of fibrosis.
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