Editors' (re)View: BARDA bucks for MCM; Landmark Alzheimer’s approval

July 5, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 1

Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.

BARDA bucks for MCM

This week, Moderna announced that it had received a $176 million project award through BARDA's Rapid Response Partnership Vehicle (RRPV) consortium to expedite the development of mRNA-based pandemic influenza vaccines.

The drugmaker plans to use the funding to support the final stages of developing an mRNA vaccine aimed at licensing a pre-pandemic vaccine for H5 — a severe avian flu virus that poses a high risk of spreading to humans.

BARDA began socializing the idea of the RRPV consortium in 2022, calling it the “next generation in health security acquisitions” and requesting feedback from the industry.

The partnership model is designed to enhance all steps within the medical countermeasure (MCM) product life cycle, from early-stage development through advanced development, procurement, sustainment and commercialization, including manufacturing infrastructure. Its purpose is to solicit future MCM products, by reimagining how BARDA will partner with product developers prior to and during a pandemic response.

This rethink of BARDA’s approach was born from Biden's American Pandemic Preparedness Plan, published in September 2021. The 27-page plan outlined what was needed to shore up the country's biodefense and pandemic preparedness.

BARDA’s first RRPV award was given to Allucent, a CRO, this past May. The $25.5 million award will support a COVID vaccine decentralized clinical trial that will enable better vaccine correlates of protection data collection from larger and more diverse populations.

BARDA followed this up by handing out another $551,167,891 for next-gen COVID vaccines through the RRPV consortium in June. This included:

  • $453 million Vaxart to conduct a phase 2b comparative study evaluating the San Francisco-based drugmaker’s oral solid dose COVID vaccine candidate against an FDA-approved mRNA vaccine comparator
  • $34 million to Castlevax, part of the Mount Sinai Health System, to conduct a phase 2b study comparing CastleVax’s next-generation COVID booster vaccine candidate with a currently licensed COVID vaccine
  • $24 million to GeoVax to test its COVID vaccine candidate — that may provide broader, longer protection — against an FDA-approved COVID vaccine
  • $40 million to Georgia-based Cyanvac to develop and test its intranasal vaccine candidate against an FDA-approved mRNA vaccine comparator

As COVID becomes endemic, it’s encouraging news the government is taking a next-generation approach to prevention and continuing to search for vaccine platforms that can better meet societal needs. What’s even more important is that the government is taking lessons learned during the pandemic and using them to better prepare for the next public health crisis. —Karen Langhauser

Landmark Alzheimer's approval

Earlier this week, we saw the FDA approval of Eli Lilly's donanemab, branded as Kisunla, a once-monthly IV infusion therapy for early symptomatic Alzheimer's disease, covering mild cognitive impairment and mild dementia stages.

Unlinke Leqembi, Kisunla is the first amyloid plaque-targeting therapy that allows patients to stop treatment once amyloid plaques are cleared, potentially reducing treatment costs and the number of infusions. This approach not only promises improved patient outcomes but also eases the treatment burden for those affected by the disease.

While Eli Lilly's initial bid for accelerated approval was rejected by the FDA in January 2023 due to insufficient long-term data, relying on data from the phase 3 TRAILBLAZER-ALZ 2 trial, Lilly's application for traditional approval demonstrated a 29% reduction in memory decline among Alzheimer's patients. The trial's unique design, allowing treatment completion based on amyloid plaque assessment and including participants based on tau protein levels, initially delayed the FDA's decision as they convened an advisory committee meeting. The drug later received unanimous backing.

This approval means that Kisunla will now compete with Eisai and Biogen's Leqembi, which also targets beta-amyloid plaques and received traditional approval for the same indication last July.

Current Alzheimer's treatments temporarily improve symptoms of memory loss and cognitive function by enhancing brain chemicals. However, they do not stop the progression of the disease, as Alzheimer's continues to cause brain cell decline. 

But future — and recently approved — Alzheimer's treatments aim to address the underlying disease process. Research is focusing on strategies like targeting beta-amyloid plaques and tau tangles, reducing inflammation, and exploring the heart-brain connection. Other approaches include potential cancer treatments and enzyme blockers that reduce beta-amyloid production.

Efforts are also being made to accelerate the development of new treatments. Initiatives like the Critical Path for Alzheimer's Disease (CPAD) consortium are fostering data sharing and standardization among pharma companies, nonprofits, and government agencies.

With all hands on deck and two recent landmark approvals, Alzheimer’s treatments are looking up. — Andrea Corona

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'