Healthcare & Laboratory News

Reuters (6/12, Burger, Kraemer) reports BioNTech agreed Thursday to acquire CureVac “for about $1.25 billion worth of BioNTech shares...to boost its work on new mRNA-based cancer treatments.” The deal “underscores BioNTech’s long-term pursuit of new cancer treatments as it aims to show that its success as Pfizer’s COVID-19 vaccine partner, which left its balance sheet flush with billions of euros in cash, was not a fluke.” Under the deal, “CureVac shareholders stand to receive a premium of 55% over the three-month average share price, and leave them with a stake of about 4%-6% in BioNTech.” The agreement also marks the end to “CureVac’s years-long legal fight over alleged mRNA patent infringement by BioNTech and for a share of vaccine revenues, where CureVac has made little progress.”

Multiple Sclerosis News Today (6/12, Wexler) reports a study found that “children with pediatric-onset multiple sclerosis (POMS) experience biological aging at a faster rate than children without the disease.” For their analyses, researchers “assessed a type of biological aging called epigenetic aging” that refers to “certain chemical modifications in the DNA that influence how specific regions are packaged and how genes in those regions are read.” They utilized “four different models to calculate epigenetic age and, with all four models, epigenetic age tended to be higher in children with POMS.” The results “suggest children with POMS experience accelerated biological aging relative to their peers and the researchers think this may help scientists and clinicians better understand how the disease develops over time.” The study was published in Neurology.

HealthDay (6/12) reports a study found that “for patients with metastatic melanoma, mitochondrial (MT) haplogroup T (HG-T) is associated with resistance to an anti-programmed cell death protein-1-based immune checkpoint inhibitor (ICI).” In the study, researchers “discovered and validated significant associations of MT HG-T with resistance to an anti-programmed cell death protein-1-based ICI, both as a single agent and in combination; HG-T was found to be independent of established tumor predictors.” In addition, “a unique nivolumab-resistant baseline peripheral CD8+ T-cell repertoire was exhibited by patients belonging to HG-T compared with other MT haplogroups (pooled odds ratio, 3.46). This was validated in a clinical trial and in an independent standard-of-care ICI cohort.” The study was published in Nature Medicine.

Infectious Disease Advisor (6/11, Kuhns) reports a study found that “fecal microbiota, live-jslm (REBYOTA® [RBL]) is effective for preventing recurrent Clostridioides difficile infection (CDI) among high-risk patients in both clinic and at-home settings.” Researchers observed that at “8 weeks following RBL administration, the overall treatment success rate was 83.0%. However, 14.8% of patients experienced CDI recurrence, and 2.2% had missing outcome data. Overall, home-based administration of RBL was associated with significantly higher treatment success rates than clinic-based administration (87.3% and 62.5%, respectively).” Subgroup analyses indicated “no significant differences in treatment success rates in patients stratified by age, antibiotic washout period, number of prior CDI episodes, or prior bezlotoxumab use.” The study was published in Infectious Diseases and Therapy.

Renal & Urology News (6/11, Persaud) reports a study found that “in patients with immunoglobulin A nephropathy (IgAN), higher levels of proteinuria and lower baseline estimated glomerular filtration rate (eGFR) are strongly associated with adverse kidney outcomes – even at proteinuria levels previously considered low-risk.” Researchers observed that “among 655 patients with IgAN from Kaiser Permanente Southern California health system followed for a median of 3.1 years, 36% reached a composite endpoint of a 50% or greater decline in eGFR, kidney failure, or death.” They noted the “risk for the composite endpoint increased markedly with higher levels of proteinuria.” The findings suggest “that proteinuria of 0.5 g/g or higher, not the traditional 1 g/g or higher threshold, may mark the beginning of heightened risk for disease progression.” The study was published in Nephrology Dialysis Transplantation.

Infectious Disease Advisor (6/11, Basilio) reports a study found that “individuals with multiple underlying medical conditions are at increased risk for influenza-associated hospitalization, but the risk can be partially mediated in high-risk populations through annual vaccination.” In an analysis including 870,888 unique patients, researchers saw that “43,326 ARI-associated hospitalizations and 1403 influenza-associated hospitalizations occurred during the study period. Patients aged 65 years and older exhibited the highest prevalence of influenza vaccination, and those with underlying conditions were more likely to report seasonal influenza vaccination than those with none across all age groups.” They observed that “adults with congestive heart failure exhibited the highest overall rates for both ARI- and influenza-associated hospitalizations. In general, the rate of both outcomes increased as the number of underlying conditions increased.” The study was published in Infectious Diseases and Therapy.

The New York Times (6/11, Gay Stolberg) reports that HHS Secretary Robert F. Kennedy Jr. “on Wednesday named eight doctors and researchers, including four who have spoken out against vaccination in some way, to replace roughly half the members he fired from an expert panel that advises the” CDC. The health secretary “made the announcement Wednesday on the social media platform X, two days after he fired all 17 members of the Advisory Committee on Immunization Practices.” Also covering the story are the Washington Post (6/11, Sun, Weber), CNN (6/11, Owermohle), Reuters (6/11, Aboulenein, Steenhuysen, Erman), The Hill (6/11, Choi, Weixel), NBC News (6/11, Bendix, Edwards), and the AP (6/11, Stobbe).

Rare Disease Advisor (6/10, Murphy) reports, “The choice of method used to measure serum levels of neurofilament light chain (NfL) should be considered when using it as a biomarker for transthyretin amyloid polyneuropathy (ATTR-PN), according to a study.” Investigators “found that the Ella automated immunoassay reported higher levels of NfL than the Single Molecule Array (SiMoA) immunoassay in 55 symptomatic and presymptomatic patients with hereditary ATTR-PN.” Rare Disease Advisor adds, “The Ella method reported a mean NfL concentration of 27.5 pg/mL in comparison to a mean concentration of 15.9 pg/mL using the SiMoA method,” while “Bland-Altman analysis found a mean bias of 15.4 pg/mL between the 2 methods.” The findings were published in the European Journal of Neurology.

Bloomberg Law (6/10, Langreth, Subscription Publication) reports Gilead Sciences announced the FDA had “placed on hold trials of a new experimental once-weekly HIV drug combination therapy after white blood cell counts dropped in some of the patients.” The studies involved taking two experimental HIV drugs, GS-1720 and GS-4182, together. Gilead explained the FDA suspended the trials due to a “safety signal” triggered by a decline in lymphocyte levels in some patients given the therapy.

Rare Disease Advisor (6/10, Garlapow) reports, “Neutrophil-to-lymphocyte ratio (NLR) and lymphocyte-to-monocyte ratio (LMR) were independent predictors of 1-year mortality in patients with cirrhosis-associated hepatocellular carcinoma (HCC), according to a study.” Investigators found that “NLR outperformed other noninvasive serum-based indices.” The data indicated that “a novel nomogram that integrates these markers alongside clinical variables demonstrated strong prognostic utility, with a concordance index of 0.808...for 12-month mortality.” The findings were published in the Journal of Clinical and Experimental Hepatology.