News briefing: Locus Biosciences bags up to $12.1M for CRISPR antibacterial; Old Vertex drug heads to PhIII for dementia
In its latest effort to spur the development of new antibacterial drugs, the non-profit CARB-X is awarding Locus Biosciences up to $12.1 million for its CRISPR Cas-3-enhanced bacteriophage for serious recurring urinary tract infections (rUTIs).
The Morrisville, NC-based biotech will receive up to $2.05 million initially, followed by up to $10 million more if it meets certain milestones. Its candidate, LBP-KP01, targets Klebsiella pneumoniae, a common cause of antibiotic-resistant infections like rUTIs. The CARB-X funds will support preclinical development, potentially leading up to Phase I.
“This funding is another important validation of Locus’ rapid development of innovative CRISPR-Cas3 enhanced bacteriophage products, enabling Locus to advance a robust pipeline that includes products targeting four of the most common bacterial pathogens as well as products targeting microbiome-related disorders such as inflammatory bowel disease, pharmaceutical response to immune-oncology therapies, infections associated with immune checkpoint inhibitors and colorectal cancer,” Locus CEO Paul Garofolo said in a statement.
LBP-KP01 is a bacteriophage cocktail, engineered with a CRISPR-Cas3 construct. The approach “has the potential to kill with laser-sharp precision the bacteria causing an infection without causing damage to other cells,” CARB-X R&D chief Erin Duffy said in a statement.
Back in September, BARDA promised Locus up to $77 million for its LBP-EC01 program, intended to treat recurrent UTIs caused by E. coli. The award started with $11 million and extends 5 years. If approved, the E. coli and K. pneumoniae cocktails could treat more than 90% of UTIs, according to CARB-X.
CARB-X is a global non-profit partnership led by Boston University to support the development of products that target antibiotic-resistant bacterial infections. Since 2016, it’s given out 72 awards totaling $257 million, with the potential for more funds if milestones are met. It plans on pouring up to $480 million total in non-dilutive funding into antibacterial development by 2022. — Nicole Feudis
An old Vertex drug heads to Phase III for dementia
EIP Pharma has reported new positive data for an old Vertex drug and hopes to send it into Phase III next year.
The company was evaluating neflamapimod, a p38 kinase inhibitor in-licensed from Vertex in 2014, in a Phase II study for Lewy body dementia. The study met its primary endpoint, with patients on the drug showing a greater improvement in cognition than patients on placebo, per an attention and executive function assessment.
EIP said the treatment effect emerged by the fourth week and maintained levels through the 16-week study period. The p-value on the primary endpoint was 0.015.
There were no serious drug-related side effects. The study itself enrolled 91 patients and randomized them evenly into the drug arm and placebo arm. – Max Gelman
Verrica heralds success in genital warts
The FDA just rebuffed Verrica’s bid for their first approved drug, handing them a CRL for a drug/device topical treatment known as VP-102 in molluscum contagiosum. But the company is trying to expand the drug’s potential for whenever they can get it across the finish line.
On Tuesday, they announced the drug had cleared an 87-person Phase II for external genital warts. In the study, 35% of patients on the drug saw their warts clear, compared with 2% of patients who received the placebo (technically known as a “vehicle” in dermatological studies).
With a Phase III in common warts already scheduled, that sets up Verrica to have VP-102 in late stage for three indications. Still, they will have to deal with the issues they say the FDA flagged in the CRL, including human factors study and CMC issues. — Jason Mast
Israeli life sciences fund raises new $300 million round
Peregrine Ventures, an Israeli life sciences fund, announced today that it had secured a new $300 million round, more than triple the size of its previous pot.
The firm focuses on $20-$30 million in companies either nearing an M&A or an IPO. Much of their focus so far has been on med tech and health tech, but they’ve had several biotech placements and plan to continue those with the newest fund. That includes investments in Otic Pharma (now known as Novus) and Raziel Therapeutics.
“With the renewed focus on biotech, health, and life science in the wake of the Covid-19 crisis, the potential of Peregrine Growth is great,” co-founder and managing partner Eyal Lifschitz said in a statement. – Jason Mast