Product Development

Pfizer/BioNTech’s late-phase COVID-19 vaccine trial speedier than Moderna, yet utility conclusions dubious from either trial’s interim analysis, experts say

Although Pfizer (NYSE:PFE)/BioNTech’s (NASDAQ:BNTX) late-phase COVID-19 vaccine trial is designed to report interim data earlier and has the potential for a broader label than Moderna’s (NASDAQ:MRNA) vaccine, the former’s results could leave vaccinators unclear about which patient group would be best suited to use the vaccine. Uncertainty about how to best use both vaccines would be an issue if FDA approval comes via an Emergency Use Authorization (EUA), as premature results at such an early stage would lack detail.

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vTv’s azeliragon study for Alzheimer’s disease and type 2 diabetes has posthoc analysis, potential biological support but some skepticism remains, experts say

Despite failing a Phase III trial for Alzheimer’s disease (AD), vTv Therapeutics’ (NASDAQ:VTVT) azeliragon could have an improved chance of success in an ongoing Phase II and planned Phase III for patients with AD and type 2 diabetes, some experts said. A Phase III posthoc analysis based on a potential biological connection between AD and diabetes could prove promising, though there has been a long history of unsuccessful therapeutic attempts to target mild-to-severe AD, experts said.

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BCG vaccines best repositioned for COVID-19 prophylaxis than therapeutic investigation, yet may only offer reduced disease severity, not full protection, investigators say

The Bacillus Calmette-Guérin (BCG) vaccines being investigated for COVID-19 are likely to have a better shot in the prophylactic setting than in patients positive for SARS-CoV-2, investigators said. These vaccines are more inclined to reduce the risk of severe disease rather than offering complete protection due to their nonspecific mechanism, they noted.

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Sarepta’s Phase II SRP-9001 for DMD has most experts touting 3% microdystrophin increase benchmark for FDA accelerated approval

Sarepta Therapeutics’ (NASDAQ:SRPT) SRP-9001 gene therapy for Duchenne Muscular Dystrophy (DMD) has most experts touting a minimum 3% increase in the Phase II microdystrophin primary endpoint necessary to attain clinical significance. If this benchmark is hit, as expected, the company should secure a regulatory nod if it files for FDA accelerated approval.

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Arena’s Phase IIb etrasimod faces uphill climb to match Regeneron’s Dupixent in atopic dermatitis, dermatologists say

Arena Pharmaceuticals’ (NASDAQ:ARNA) etrasimod drew dermatologist skepticism about its potential to report positive results in its Phase IIb trial in moderate-to-severe atopic dermatitis (AD) due to its broad mechanism and current data lacking relevance in AD. Regeneron Pharmaceuticals’ (NASDAQ:REGN) Dupixent (dupilumab) is well established in AD treatment, further raising the bar for clinical relevance, they added.

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Repurposing efforts for Fibrogen's, Blade's, Boehringer's and Roche's IPF drugs in COVID-19 holds water despite lung pathology differences

There is rationale for evaluating antifibrotics in COVID-19 given the SARS-CoV-2 virus’ impact on the lungs, but several unknowns persist on the overlap between idiopathic pulmonary fibrosis (IPF) and COVID-19 related fibrosis, making the therapeutic impact of antifibrotics unclear, experts noted. While Fibrogen’s (NASDAQ:FGEN) idiopathic pulmonary fibrosis (IPF) data is strong enough for pamrevlumab to be considered in Phase II, the potential of Blade Therapeutics’ BLD-2660 is tougher to determine given the existence of only in vitro data for the product, they noted.

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Sinopharm’s, Sinovac’s positive COVID-19 vaccine immunogenicity data undercut by durability, manufacturing challenges ahead, experts say

Despite positive early immunogenicity data for Sinopharm’s and Sinovac’s (NASDAQ:SVA) inactivated virus vaccines, experts noted the path to approval is filled with obstacles in proving durable protection and ironing out manufacturing.

In contrast with live-attenuated vaccines, inactivated vaccine efficacy hinges on multiple shots as well as an adjuvant, making the choice of adjuvant key, some noted. Sinopharm and Sinovac have so far only reported seroconversion rates.

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BMS’ and bluebird’s ide-cel for r/r multiple myeloma has experts weighing market expectations despite anticipated FDA approval

Bristol-Myers Squibb’s (NYSE:BMY) and bluebird bio’s (NASDAQ:BLUE) CAR-T therapy BB2121 (ide-cel) for relapsed and refractory multiple myeloma (r/r MM) has experts debating market uptake prospects, despite assumed FDA approval.

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Roche’s tiragolumab/Tecentriq combination elicits need for longer-term data despite significant ORR; tolerability profile could prove advantageous, experts say

Roche’s (SIX:ROG) Phase II tiragolumab/Tecentriq (atezolizumab) combination as a first-line (1L) treatment in non-small cell lung cancer (NSCLC) needs longer-term efficacy data to solidify its potential, experts said. Still, the tolerability profile bodes well in comparison to other 1L therapies, they added.

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Inovio’s COVID-19 vaccine advantage of having stable, flexible DNA plasmid comes with limitations; need for administration device a utility obstacle, experts say

While Inovio’s (NASDAQ:INO) DNA plasmid vaccine for COVID-19, INO-4800, has some advantages, such as being more stable than mRNA or flexible enough to code for more than one viral antigen, they come with caveats, experts said. Its real-world utility is also likely to be stymied by the need for a device to insert the DNA plasmid into the host cell, they added.

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