JOHN HOPE FRANKLIN CENTER

Bispecific antibodies, with two binding domains, offer targeted therapeutics and address co-administration challenges, gaining traction in biopharma. Initially approved for cancer, they now target various diseases, with 12 approved in the U.S. and more in development. Their dual action reduces patient burden and enhances treatment effects, potentially transforming therapeutic paradigms beyond oncology. The market is projected to grow significantly due to rising chronic disease incidence and technological advancements.

Prepare for fall COVID, flu season by getting updated vaccines; Dr. Nicholas Turner recommends COVID vaccines for all over 6 months, especially those over 65 or with chronic conditions. Updated vaccines target current variants and are available now. Consider COVID testing if it affects treatment or interactions with high-risk individuals. Treat mild COVID like a cold with hydration and over-counter meds. Isolate after symptoms fade and wear a mask for 5 more days.

A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.

A late-stage clinical trial showed liraglutide, similar to Ozempic, reduced BMI in kids ages 6-11 with obesity, with concerns about long-term safety and impact on growth. The trial included 82 children, with liraglutide resulting in a 5.8% average BMI reduction compared to a 1.6% increase in the placebo group. Novo Nordisk has applied to the FDA for approval of liraglutide for weight loss in this age group.

Adaptin Bio's APTN-101, a glioblastoma therapy, received FDA IND clearance. Based on the BRiTE platform, it targets EGFRvIII and CD3 to activate T cells for tumor elimination. Preclinical studies showed successful blood-brain barrier crossing and tumor efficacy.

Former Verily executives launch Highlander Health to use hospital records in real-time for advancing science, reducing clinical trial costs, and improving patient drug matching.

FDA clears APTN-101, a novel brain bispecific T-cell engager, for phase 1 study in patients with grade 4 glioblastoma, targeting EGFRvIII protein associated with aggressive brain tumors.

FDA struggles to resume pre-COVID inspection levels, leaving 2,000 drug manufacturing firms uninspected, raising risks of contamination. Overdue inspections represent 42% of registered plants, including 340 in India and China. Despite efforts, 2023 inspections were down 40% from pre-pandemic levels, with staff attrition and travel restrictions complicating recovery.

Study approved by Fudan University Shanghai Cancer Center (NCT04461990). FUSCC, DUKE, and I-SPY1 cohorts analyzed for breast cancer prognosis and treatment response using DCE-MRI and multiomic data. FUSCC cohort included 466 participants with prognosis information, DUKE 619, and I-SPY1 128. Primary endpoints were relapse-free survival (RFS) and pathological complete response (pCR). Radiomic features extracted and analyzed for prognostic and treatment response prediction.

Vorasidenib, a dual inhibitor of IDH1 and IDH2 mutations, offers a breakthrough in treating IDH-mutated, grade two glioma, significantly improving progression-free survival and crossing the blood-brain barrier effectively.