Liver Abscess

Klebsiella pneumoniae is responsible for severe infections and stands out for its high resistance to antibiotics PHAXIAM's anti-Klebsiella pneumoniae phages to enter pre-clinical development to assess their efficacy in lung, blood and urinary tract infections, in addition to the three major targets already developed (S. aureus, P. aeruginosa, E. coli) PHAXIAM Therapeutics (Nasdaq & Euronext: FR0011471135), today announces the launch of a new preclinical development targeting a strong antimicrobial-resistant bacteria, Klebsiella pneumonia. Klebsiella pneumoniae (K. pneumoniae) causes a wide range of infections, including pneumonia, urinary tract infections, bacteremia and liver abscesses, and mainly infects immunocompromised people. However, the emergence and spread of hypervirulent and multi-resistant strains of this bacterium have recently extended its potential targets to people with no health problems. In Western countries, we estimate that between 3% and 5% of pneumonias are linked to an infection caused by K. pneumoniae. Worldwide, K. pneumoniae is responsible for 11.8% of hospital-acquired pneumonia. In high-risk patients (alcoholics and septicemics), the mortality rate associated with this kind of infection is between 50 and 100%1. The incidence of K. pneumoniae resistances is evaluated between 90-100,000 patients in the US and EU52, mainly in Urinary Tract infections and Respiratory Tract infections. Recent studies in Europe and the United States3,4 also revealed the existence of K. pneumoniae strains with an exceptionally high level of antimicrobial resistance, making them even more difficult to treat. The results of these studies demonstrated a worrying trend among the samples collected, which may even be resistant to enzyme-inhibiting antibiotics that have recently been developed but have not yet been marketed. This level of antimicrobial resistance in K. pneumoniae strains had never been observed before. Selected phages will be evaluated on a wide range of infections in which PHAXIAM already benefits from considerable expertise, such as lung, blood and urinary tract infections. This will enable the Company to capitalize on preclinical models validated with its three historical phage families, mutualize certain developments within the same indication and accelerate the progression to clinical phases. Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, stated: “With the launch of this new program, PHAXIAM Therapeutics deploys its strategy in line with the plan presented during the merger, and reaffirms its position at the forefront of the fight against antimicrobial resistance. K. pneumoniae bacteria represents a new target with a high medical need, affecting a large population worldwide, and for which antibiotics offer only a limited therapeutic solution. Our anti-Klebsiella phages will thus complement an already extended phage portfolio for the clinical indications we are targeting, and reinforce our ability to efficiently address a broad spectrum of resistant bacterial infections.” About PHAXIAM Therapeutics PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. PHAXIAM is listed on the Nasdaq Global Select Market in the United States (ticker: PHXM – to be modified to a new symbol) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. 1 John V. Ashurst; Adam Dawson ET AL., 2022. 2 Five main European countries: France, Germany, UK, Spain & Italy 3 Highly multidrug-resistant Gram-negative bacterial infections in war victims in Ukraine, 2022; The Lancet Infectious Diseases 4 NIH investigates multidrug-resistant bacterium emerging in community settings; National Institutes of Health (NIH) The content above comes from the network. if any infringement, please contact us to modify.

Boston-based GI Dynamics designed its EndoBarrier endoscopically delivered device therapy as a non-surgical, alternative treatment for type 2 diabetes and obesity for patients who do not have adequate control of their conditions through their current medication and lifestyle. According to a news release, data from the study were presented at the annual Digestive Disease Week (DDW) conference last month. Results from the multicenter, randomized, sham-controlled trial of a duodenal jejunal bypass liner (DJBL) for treating type 2 diabetes mellitus were presented by Dr. Christopher C. Thompson, Professor at Harvard Medical School and Director of Endoscopy at Brigham and Women’s Hospital. The study enrolled patients from 2013 to 2015 and included subjects randomized to DJBL and a sham procedure with moderate-intensity lifestyle intervention. Primary endpoints included safety, defined as an incidence of serious adverse event (SAE)-related early device removal of ≤15%, and efficacy of glycemic control demonstrated by mean change in HbA1c at 12 months with a superiority margin of ≥0.4% HbA1c over sham. Analysis demonstrated that the EndoBarrier met both overall glycemic control efficacy and SAE-related device removal safety endpoints while also providing clinically significant weight loss and comorbidity improvement. GI Dynamics had put a stop to the ENDO trial in 2015 before completing enrollment due to a higher than anticipated incidence of liver abscesses. The company launched a new U.S. FDA investigational device exemption study (STEP-1) in 2019 to study EndoBarrier. It is currently enrolling patients across five sites in the U.S. “Insulin therapy is associated with poor long-term outcomes in patients with type 2 diabetes mellitus and obesity, and bariatric surgery is effective for glycemic control but is higher risk than medical therapy. EndoBarrier is a less invasive intermediate alternative for this struggling population,” Thompson said in the release. “This novel approach is promising and has the potential to offer patients and clinicians another safe and effective treatment option.”

Arbor Biotechnologies, a genetic medicines company that claims to have the most extensive gene-editing toolbox in the industry, is also building a substantial war chest. The company has raised $215 million in financing as it works to advance its lead programs toward clinical testing. The Series B financing announced Tuesday was led by Temasek, Ally Bridge Group, and TCG Crossover. Cambridge, Massachusetts-based Arbor, uses machine-learning techniques and artificial intelligence to mine its database of billions of proteins. Doing so enables the company to discover the enzymes that have potential use in CRISPR gene editing. Cas9, a type of enzyme called a nuclease, might be the best known of the cutting enzymes used in CRISPR editing. Arbor claims that it has discovered more than 60 nuclease families as well as more than 70 CRISPR transposases, another type of enzyme. Arbor’s CRISPR toolbox encompasses DNA nucleases, RNA nucleases, and transposases. The company uses those enzymes in its genetic medicines, which are designed to edit the genetic errors that cause disease. So far, Arbor is preclinical. The company’s lead programs are for liver and central nervous system diseases. In a prepared statement, Arbor CEO Devyn Smith said Arbor plans to use the new capital to advance those programs toward clinical testing. The cash will also be used to advance pipeline programs and to support further investment in its discovery technology. “While our primary focus has been on developing our bespoke CRISPR nucleases, we are also looking to progress our other precision editing innovations, such as CRISPR transposases,” Smith said. The financing is the latest development in what has been a busy year for Arbor. The company has brought on a flurry of new hires, including Smith, who joined in April. The company has also been making business development progress. In August, Vertex Pharmaceuticals inked a new partnership with Arbor, expanding on an alliance initially begun in 2018. Under the new pact, Boston-based Vertex will use Arbor’s CRISPR gene-editing technology for the research and development of new ex-vivo cell therapies. At the top of Vertex’s wish list is engineering islet cells, a type of cell in the pancreas that produces insulin, as a potential new therapy for type 1 diabetes. Vertex is also interested in developing therapies for blood disorders sickle cell anemia and beta thalassemia. The upfront payment to Arbor was not disclosed but the companies said that potential milestone payments could reach up to $1.2 billion. Applications of CRISPR in therapeutic applications has moved toward smaller cutting enzymes that leave more room for additional cargo Arbor has published research about Cas13d, stemming from the company’s technology platform. The enzyme is part of the Cas13 family. Its smaller size makes it applicable for RNA manipulation and detection. However, Arbor faces competition in the race to go smaller, particularly as biotechs pursue gene-editing therapies that do their work in vivo—inside the patient. Mammoth Biosciences touts a toolbox that includes Cas14 and CasPhi enzymes, which are both smaller than Cas9. South San Francisco-based Mammoth announced a $150 million Series D round of funding in September. Late last month, Mammoth and Vertex announced an alliance focused on developing in vivo gene-editing therapies for two undisclosed genetic diseases. The deal pays Mammoth $41 million up front, with $650 million more tied to milestones. Arbor was founded in 2016, based on research from MIT. The biotech raised a $15.6 million Series A round of funding in 2017. The latest financing added new investors Arrowmark Partners, Deep Track Capital, Great Point Ventures, Illumina Ventures, Janus Henderson Investors, Logos Capital, Ono Venture Investment, Piper Heartland Healthcare Capital, Ridgeback Capital Investments, Section 32, Surveyor Capital, T. Rowe Price Associates, Tao Capital Partners, funds managed by Tekla Capital Management, Woodline Partners, and a global investment fund that was undisclosed. Additionally, Vertex also invested, as well as earlier investor ARCH Venture Partners. Photo by Flickr user Jason Baker via a Creative Commons license