One Cancer Is Rising Rapidly in Younger People, And Bacteria Could Be Why
Colibactin has already been linked to this cancer type, but the relationship hasn't been specifically studied in people under the age of 50 before. It may go some way to explaining why bowel (or colorectal) cancer is on course to be the leading cancer-related cause of death in young adults in the next few years.
Analyzing cancer tissue samples from 981 individuals across 11 countries, an international team of researchers looked for cancer-causing mutations in the DNA genome. In more than half of the early-onset cases, these mutations matched up with damage caused by colibactin.
"These mutation patterns are a kind of historical record in the genome, and they point to early-life exposure to colibactin as a driving force behind early-onset disease," says computational biologist Ludmil Alexandrov of the University of California San Diego.
So how is this exposure happening? The researchers aren't sure, but we do know that colibactin is produced by certain strains of Escherichia coli in the gut, and the data suggests that the damaging exposure probably happens in the first 10 years of life.
One of the more likely scenarios is that childhood infections are producing colibactin, which then damages DNA in the bowel. These harmful mutations then make cancer more likely later on, typically long after the colibactin has disappeared.
Specifically, colibactin-related DNA mutations were 3.3 times more common in adults diagnosed under the age 40, compared to those diagnosed at age 70 or above. For cancer in older people, the DNA patterns were more often associated with normal aging.
"If someone acquires one of these driver mutations by the time they're 10 years old, they could be decades ahead of schedule for developing colorectal cancer, getting it at age 40 instead of 60," says Alexandrov.
Previous research has identified several associations that could be contributing to the rise in colorectal cancer at a relatively young age. Studies have pointed to ultra-processed food, and too many sugary or alcoholic beverages, for example.
Here, the suggestion is that lifestyle or environmental factors very early on in life may also be planting seeds of the disease. Further research is needed to know for sure, though with recent science funding cutbacks in the US, that research is by no means guaranteed.
The researchers also want to take a closer look at how colibactin and its related DNA scars could be protected against, as well as how the different factors affecting this kind of cancer risk may vary between countries.
"It's possible that different countries have different unknown causes," says computational biologist Marcos Díaz-Gay of the Spanish National Cancer Research Center. "That could open up the potential for targeted, region-specific prevention strategies."
The research has been published in Nature.
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Miami Herald
a day ago
- Miami Herald
UTILITY Therapeutics Announces Acquisition by Alembic Pharmaceuticals Inc.
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PIVYA has a unique mechanism of action that targets the cell wall of gram-negative bacteria. Additional U.S. prescribing information about PIVYA can be found at "We are thrilled that Alembic Pharmaceuticals understands the clinical and commercial value of PIVYA and will bring this proven treatment to female patients in need across the U.S.," said Tom Hadley, President and CEO of UTILITY therapeutics. "With current therapies failing and the armament of uUTI antibiotics perilously thin, PIVYA provides U.S. clinicians with a new and effective treatment option that has a long safety record. We are grateful for the support of our Board of Directors and investors, including the AMR Action Fund, whose collective support was instrumental in helping us obtain FDA approval for PIVYA." The UTILITY therapeutics Ltd. Board of Directors and Observers includes: Alan S. Roemer, MBA, MPH, Chairman of the BoardMorten Sommer, PhD, Co-FounderRasmus Toft-Kehler, PhD, Co-FounderAndrew Davis, Independent DirectorLarry Edwards, Independent DirectorThomas Hadley, President & CEOHenry Skinner, PhD, MJur, MBA, AMR Action FundTero Wennberg, PhD, Observer, LEO PharmaHenni-Karoliina Ropponen, PhD, Observer, AMR Action Fund "The acquisition of UTILITY and the commercialization of PIVYA are important steps in Alembic's strategic goal to provide branded pharmaceutical products to the U.S. healthcare market," said Craig Salmon, President of Alembic Pharmaceuticals, Inc. "PIVYA will further enhance Alembic's ability to build long-term value by combining global research, regulatory, and manufacturing strengths with a sharpened focus on specialty segments. Alembic plans to make PIVYA available in the U.S. in the 4th quarter of 2025." "I am excited to see Alembic drive the commercialization of PIVYA, which is uniquely positioned to help millions of American women with urinary tract infections," said Dr. Morten Sommer, Professor of microbiology at the Technical University of Denmark, and co-founder and board member of UTILITY therapeutics. "With a novel mechanism of action, not previously deployed in the U.S., PIVYA can become a cornerstone of the treatment of urinary tract infections based on its first-line positioning in the Infectious Disease Society of America treatment guidelines. On behalf of the co-founders, investors, and Board of Directors, we are excited that PIVYA will help address the societal impact of the uUTI disease burden in women." About PIVYA (pivmecillinam oral tablets 185mg) PIVYA, an oral prodrug of mecillinam, is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. Mecillinam demonstrated in vitro activity against Enterobacterales in the presence of some beta-lactamases and extended-spectrum beta-lactamases (ESBL) of the following groups: CTX-M, SHV, TEM, AmpC. The inhibitory action of mecillinam on PBP-2 results in low cross-resistance with certain beta-lactams. The frequency of resistance to mecillinam in E. coli range from8×10-8 to 2×10-5 when exposed to 32-256 times MIC. PIVYA has been proven safe and effective in three clinical trials with the most common Adverse Reactions Occurring in ≥1% of Patients Receiving PIVYA (Adjusted for Study Size); Nausea (4.3%), Diarrhea (2.1%), Vulvovaginal candidiasis (1.8%), Genital pruritus (1.8%), and Headache (1.4%). PIVYA demonstrated strong response in three controlled clinical trials comparing different PIVYA dosing regimens to placebo (Trial 1), to another oral antibacterial drug (Trial 2), or to ibuprofen (Trial 4) evaluated the efficacy of pivmecillinam for the treatment of uUTI. Efficacy was assessed in the Microbiological Intent-to-Treat (micro-ITT) population which included all randomized subjects with a positive baseline urine culture defined as ≥105 colony-forming-units (CFU)/mL of a uropathogen where CFU count was available and no more than 2 species of microorganisms, regardless of colony count, and no baseline pathogen was non-susceptible to the active comparator. The composite response rates (composite endpoint of clinical cure and microbiological response), as well as clinical cure and microbiological response rates of the recommended 185 mg three times daily dosing regimen. Composite Response Rates (Clinical Cure and Microbiological Response) at TOC in the uUTI trials (Micro ITT Population) Clinical Cure Rates (Micro-ITT Population) Microbiological Response Rates (Micro-ITT Population) Contraindications Serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to PIVYA or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).Primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism such as carnitine transporter defect or other inborn errors of metabolism (e.g., methylmalonic aciduria, or propionic academia).Acute porphyria. 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PIVYA has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases. Mecillinam, an intravenous (IV) formulation, may be developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting. For more information, contact David Cobb, Alembic SOURCE: Utility Therapeutics Ltd.
Yahoo
a day ago
- Yahoo
Air pollution and herbal medicines could be behind lung cancer in non-smokers, study finds
Air pollution and traditional herbal medicines could be major risk factors contributing to the development of lung cancer in people with no history of smoking, a groundbreaking new study has found. While smoking is a major risk factor for lung cancer, rates of the malignancy appear to be increasing among those who have never smoked, even with tobacco use declining globally. Previous studies have shown that lung cancer disproportionately affects non-smoking women, particularly those with Asian ancestry, and is more prevalent in East Asia than in Western nations. Now, a new study, published on Wednesday in the journal Nature, provides compelling evidence that air pollution and herbal medicines could be behind genetic mutations linked to the development of lung cancer in non-smokers. 'We are seeing this problematic trend that never-smokers are increasingly getting lung cancer, but we haven't understood why,' said Ludmil Alexandrov, an author of the study from the University of California San Diego. 'Our research shows that air pollution is strongly associated with the same types of DNA mutations we typically associate with smoking.' Most lung cancer prevalence studies haven't separated data of smokers from that of non-smokers, providing limited insights into potential causes in those patients. The latest study collected data from never-smokers worldwide and used genomics to find environmental factors likely behind these cancers. 'This is an urgent and growing global problem that we are working to understand regarding never-smokers,' said Maria Teresa Landi, co-author of the study from the US National Cancer Institute. While previous studies have shown a potential link between air pollution and lung cancer in never-smokers, the new research goes further by revealing a genomic link. In this comprehensive study, scientists analysed lung tumours from 871 never-smokers living in 28 regions with different levels of air pollution across Africa, Asia, Europe and North America. Researchers used genome sequencing methods to identify distinct patterns of genetic mutations which act like molecular fingerprints of past exposures. They then compared the genomic data with pollution estimates based on satellite and ground-level measurements of fine particulate matter. This helped them estimate long-term exposure of the patients to air pollution. The study found that never-smokers living in more polluted environments had significantly more mutations in their lung tumours, particularly the kinds which directly promote cancer development. Scientists also found more molecular signatures in this group, which are linked to cancer and serve as a record of all past exposures to mutation-causing environmental factors. For instance, these individuals had a nearly 4-fold increase in a mutational signature molecule linked to tobacco smoking and a 76 per cent increase in another signature linked to ageing. 'What we see is that air pollution is associated with an increase in somatic mutations, including those that fall under known mutational signatures attributed to tobacco smoking and ageing,' said Marcos Díaz-Gay, co-author of the study. Scientists found that the more pollution someone was exposed to, the more mutations were found in their lung tumours, as well as greater signs of their cells undergoing accelerated ageing. Another environmental risk unravelled by the study was aristolochic acid, a known cancer-causing chemical found in some traditional Chinese and Ayurvedic herbal medicines. This chemical, extracted from plants of the birthwort family, was found linked to a signature mutation in lung tumours of never-smokers from Taiwan. Although ingestion of this plant chemical has been linked previously to bladder, gut, kidney, and liver cancers, the latest study is the first to report evidence that it may contribute to lung cancer. 'This raises new concerns about how traditional remedies might unintentionally raise cancer risk,' Dr Landi said. 'It also presents a public health opportunity for cancer prevention, particularly in Asia.' The study also found an intriguing new mutation signature which appears in the lung tumours of most never-smokers but is absent in smokers. 'We don't yet know what's driving it,' Dr Alexandrov said. 'This is something entirely different, and it opens up a whole new area of investigation.'
Associated Press
a day ago
- Associated Press
UTILITY Therapeutics Announces Acquisition by Alembic Pharmaceuticals Inc.
LONDON, UK / ACCESS Newswire / July 3, 2025 / UTILITY therapeutics Ltd. (UTILITY), a biotechnology company focused on the development of PIVYA (pivmecillinam 185 mg tablets), a penicillin class antibacterial approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncomplicated urinary tract infection (uUTI), today announced that it has been acquired by Alembic Pharmaceuticals, Inc. (Alembic). PIVYA marked the first antibiotic in approximately 20 years to earn FDA approval for uUTI, a common bacterial infection that afflicts millions of women annually. The FDA approved PIVYA in April 2024 for use in female patients 18 years of age and older with uUTI caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. PIVYA has a unique mechanism of action that targets the cell wall of gram-negative bacteria. Additional U.S. prescribing information about PIVYA can be found at 'We are thrilled that Alembic Pharmaceuticals understands the clinical and commercial value of PIVYA and will bring this proven treatment to female patients in need across the U.S.,' said Tom Hadley, President and CEO of UTILITY therapeutics. 'With current therapies failing and the armament of uUTI antibiotics perilously thin, PIVYA provides U.S. clinicians with a new and effective treatment option that has a long safety record. We are grateful for the support of our Board of Directors and investors, including the AMR Action Fund, whose collective support was instrumental in helping us obtain FDA approval for PIVYA.' The UTILITY therapeutics Ltd. Board of Directors and Observers includes: 'The acquisition of UTILITY and the commercialization of PIVYA are important steps in Alembic's strategic goal to provide branded pharmaceutical products to the U.S. healthcare market,' said Craig Salmon, President of Alembic Pharmaceuticals, Inc. 'PIVYA will further enhance Alembic's ability to build long-term value by combining global research, regulatory, and manufacturing strengths with a sharpened focus on specialty segments. Alembic plans to make PIVYA available in the U.S. in the 4th quarter of 2025.' 'I am excited to see Alembic drive the commercialization of PIVYA, which is uniquely positioned to help millions of American women with urinary tract infections,' said Dr. Morten Sommer, Professor of microbiology at the Technical University of Denmark, and co-founder and board member of UTILITY therapeutics. 'With a novel mechanism of action, not previously deployed in the U.S., PIVYA can become a cornerstone of the treatment of urinary tract infections based on its first-line positioning in the Infectious Disease Society of America treatment guidelines. On behalf of the co-founders, investors, and Board of Directors, we are excited that PIVYA will help address the societal impact of the uUTI disease burden in women.' About PIVYA (pivmecillinam oral tablets 185mg) PIVYA, an oral prodrug of mecillinam, is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. Mecillinam demonstrated in vitro activity against Enterobacterales in the presence of some beta-lactamases and extended-spectrum beta-lactamases (ESBL) of the following groups: CTX-M, SHV, TEM, AmpC. The inhibitory action of mecillinam on PBP-2 results in low cross-resistance with certain beta-lactams. The frequency of resistance to mecillinam in E. coli range from 8×10-8 to 2×10-5 when exposed to 32-256 times MIC. PIVYA has been proven safe and effective in three clinical trials with the most common Adverse Reactions Occurring in ≥1% of Patients Receiving PIVYA (Adjusted for Study Size); Nausea (4.3%), Diarrhea (2.1%), Vulvovaginal candidiasis (1.8%), Genital pruritus (1.8%), and Headache (1.4%). PIVYA demonstrated strong response in three controlled clinical trials comparing different PIVYA dosing regimens to placebo (Trial 1), to another oral antibacterial drug (Trial 2), or to ibuprofen (Trial 4) evaluated the efficacy of pivmecillinam for the treatment of uUTI. Efficacy was assessed in the Microbiological Intent-to-Treat (micro-ITT) population which included all randomized subjects with a positive baseline urine culture defined as ≥105 colony-forming-units (CFU)/mL of a uropathogen where CFU count was available and no more than 2 species of microorganisms, regardless of colony count, and no baseline pathogen was non-susceptible to the active comparator. The composite response rates (composite endpoint of clinical cure and microbiological response), as well as clinical cure and microbiological response rates of the recommended 185 mg three times daily dosing regimen. Composite Response Rates (Clinical Cure and Microbiological Response) at TOC in the uUTI trials (Micro ITT Population) Clinical Cure Rates (Micro-ITT Population) Microbiological Response Rates (Micro-ITT Population) Contraindications Warnings and precautions About UTILITY therapeutics Ltd. UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam, for the treatment of urinary tract infections (UTI). Pivmecillinam is an oral prodrug of mecillinam that has been approved by the FDA for the treatment of women with uncomplicated urinary tract infections. PIVYA has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases. Mecillinam, an intravenous (IV) formulation, may be developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting. For more information, contact David Cobb, Alembic Pharmaceuticals [email protected] 908-552-583 SOURCE: Utility Therapeutics Ltd. press release
