BARDA and Locus in tie-up to tackle UTIs with phages

By Jane Byrne contact

- Last updated on GMT

© GettyImages/iLexx
© GettyImages/iLexx

Related tags: phage, UTI, Cancer, Immune-oncology

Locus Biosciences has signed a contract with BARDA to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).

The biotech’s crPhage technology works by targeting the DNA of specific bacteria, destroying their cells while leaving non-target bacteria in the human body unaffected. 

The deal marks another milestone for Locus on the phage front following its announcement of its US$818M deal with Johnson & Johnson in 2019​ and the start of its Phase 1 clinical trial earlier this year.

Cost-reimbursement contract

The Biomedical Advanced Research and Development Authority (BARDA), part US Department of Health and Human Services (HHS), will provide up to US$77m in funding to Locus as part of a US$144m program to support Phase 2 and 3 clinical trials and other activities required to seek marketing approval from the US Food and Drug Administration (FDA) for LBP-EC01.

Joseph Nixon, senior vice president of business development at Locus Biosciences, said the partnership with BARDA is a cost-reimbursement contract. Locus is responsible for all product development work and that agency will reimburse Locus for the majority of the costs incurred. BARDA will also contribute expertise in an advisory capacity, he said. 

“We are gaining a substantial amount of funding support that will allow us to take the crPhage program targeting E. coli all the way to the commercial market.”

E. coli threat

LBP-EC01 has dual mechanism of action, utilizing the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR-Cas3, said Locus.

This dual mechanism makes LBP-EC01 significantly more effective at killing E. coli cells than corresponding natural bacteriophages, as shown both in laboratory tests and in small animal models of urinary tract infection, claims the developer. The mechanism also makes LBP-EC01 effective in killing E. coli strains regardless of whether they are resistant to antibiotics, it added.

Both the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring development of new treatments.

Worldwide, an estimated 150 million people are affected by UTIs each year. About 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Up to 40% of UTI patients experience a recurrence within months of the first episode.

Clinical trials and route to market

Locus initiated its Phase I trial for LBP-EC01 in January 2020, for which it says it expects to complete patient enrollment for that trial within the next 30 to 60 days.

“We anticipate commencing the Phase II trial that is funded under the BARDA collaboration in the summer to fall [Autumn] of 2021,”​ said Nixon.

What kind of timeline to commercialization does the company anticipate?

“There are a lot of uncertainties in drug development, so it is too early to say for sure when crPhage products will reach the market.  However, if all goes well, we anticipate that we could submit a BLA to the FDA for approval as early as 2025 crPhage could be commercially available in 2026,”​ he told BioPharma-Reporter.

Beyond the urinary tract

Beyond UTI treatment, the company says it is looking to target unmet medical needs in bacterial infections and microbiome indications in oncology, immunology and neuroscience therapeutic areas.

“In collaboration with Johnson & Johnson we are also working on crPhage products targeting two common pathogens that cause infections of the respiratory tract and other body sites.

“Locus also has a robust research program evaluating potential treatments for inflammatory bowel disease, improving patient responses to immune-oncology therapies, fighting infections in patients receiving immune checkpoint inhibitors, and colorectal cancer,”​ said the product development VP.

Several other companies are developing bacteriophage therapeutics but Nixon said most of them use cocktails of natural or ‘wild-type’ bacteriophages isolated from the environment. 

“Locus’s advantage over these competitors is that crPhage are significantly more effective at killing target bacteria compared to their wild-type counterparts. It is also not clear that patents covering wild-type bacteriophage cocktails will provide adequate commercial protection,” ​he claimed. 

Related news

Show more

13 comments

Show more

herpes cure

Posted by unice,

I'm here to testify about the great work Dr Smith did for me. I have been suffering from (HERPES) disease for the past 5 years and had constant pain, especially in my knees. During the first year,I had faith in God that i would be healed someday.This disease started circulating all over my body and i have been taking treatment from my doctor, few weeks ago i came across a testimony of one lady on the internet testifying about a Man called Dr Smith on how he cured her from HIV Virus. And she also gave the email address of this man and advise anybody to contact Dr Smith for help for any kind of sickness that he would be of help, so I emailed him on ( Smithherbalcure@gmail.com ) telling him about my (HERPES Virus) he told me not to worry that i was going to be cured!! Well i never believed it,, well after all the procedures and remedy given to me by this man few weeks later i started experiencing changes all over me as Dr Smith assured me that i will be cured,after some time i went to my doctor to confirmed if i have be finally healed behold it was TRUE, So friends my advise is if you have such sickness or any other at all you can contact Dr Smith via email. { Smithherbalcure@gmail.com } or what sapp him on(+2348102652355 ) DR Smith CAN AS WELL CURE THE FOLLOWING DISEASE:- HIV/AIDS HERPES CANCER ALS hpv eye problem etc.

Report abuse

Herpes cure

Posted by Roland Joe,

I already gave up on ever getting cured of HSV2 because i have try many treatment none of them work out for me i have be to different hospital they always tell me same thing there is no cure for herpes when i came across a post about Dr oyagu, in the net from a lady called Rebecca i contacted him and he reassured me with his herbal medicine which i took according to the way he instructed, that how i was cured. I doubted at first because i have been to a whole lot of reputable doctors, tried a lot of medicines but none was able to cure me. so i decided to listen to him and he commenced treatment, and under two weeks i was totally free from Herpes. i want to say a very big thank you to DR oyagu for what he has done in my life. feel free to leave him a message on email oyaguherbalhome@gmail.com and also WhatsApp him +2348101755322.. or vist his website https://oyaguspellcaster.wixsite.com/oyaguherbalhome He can still be able to help you with this herbs medicine: 1...ALS CURE/DIABETES CURE/EPILESY/HPV CURE/LUPUS/HEPATITIS/CANCER/GOUT

Report abuse

HERPES CURE

Posted by anne davis,

I have been suffering from Herpes for the past 3 years and 8 months, and ever since then i have been taking series of treatment but there was no improvement until i came across testimonies of Dr.Aba on how he has been curing different people from different diseases all over the world, then i contacted him as well. After our conversation he sent me the medicine which i took according to his instructions. When i was done taking the herbal medicine i went for a medical checkup and to my greatest surprise i was cured from Herpes. My .heart is so filled with joy. If you are suffering from Herpes or any other disease you can contact Dr.Aba today on this Email address: dr.abaherbalhome@gmail.com or WhatsApp him on this Tell.Number +2348107155060.

Report abuse

Follow us

Products

View more

Webinars