JOHNS HOPKINS UNIVERSITY

At the 2024 San Antonio Breast Cancer Symposium, experts discussed FDA approvals for ribociclib and inavolisib in HR+/HER2- BC, emphasizing treatment optimization, clinical trial design, and addressing ovarian/reproductive toxicities. Ribociclib's approval was based on NATALEE trial data showing improved invasive disease-free survival (iDFS) with safety concerns. Inavolisib, targeting PIK3CA mutations, showed improved progression-free survival (PFS) with post-marketing commitments for further evaluation. The session highlighted the need for comprehensive data analysis and monitoring of fertility impacts.

Evotec SE and Novo Nordisk select first three projects for LAB eN² drug discovery accelerator, focusing on cardiometabolic diseases from Boston University, Harvard University, and Joslin Diabetes Center. The program expands to include five new academic institutions, offering initial Discovery Award funding and potential additional funding up to IND application stage, with Novo Nordisk maintaining the option to further develop and license specific programs.

E. Madan led experiments, data analysis, and manuscript writing. A.M.P., V.V., A.K., and P.B. contributed to experiments, data analysis, and manuscript preparation. J.W. handled biostatistical analysis and data interpretation. T.B. and D.A. focused on microscopy, data interpretation, and figure preparation. P.C.M., G.B., M.D.B., I.D., H.K., and D.O. assisted with biostatistical analysis and data interpretation. A. Gogna and A.B. helped with figure preparation and live-cell videos. M.L.P., M.Y., D.Z., S.P., S.K., K.B., P.M., I.C., E.A.F., A.K.P., S.M., C.J.P., A.L., M.N., S.C., K.G., K.C.G., and K.S.S. contributed to pathology data collection and analysis. T.F.A., E.G., A. Gustafsson, G.L., L.N., E.Y., and R.S.-F. worked on 3D scaffold and organoid experiments. K.D.P.D. assisted with PDX experiments. N.M., M.J.P., K.J.-J., and S.H. focused on exosome biology experiments. Z.S. and W.L.R. worked on multiplexing experiments. M.B. and P.J. handled FISH experiments. H.O.R., F.A.T., and R.B. contributed to MR imaging data analysis. K.G.A., J.A., G.X., G.S., and S. Singh designed and produced mAbs. S.D., C.L.d.S., A.M.F., D.T., S.R.G., K.P., G.G., G.L.W.G.R., and H.W. edited the manuscript. A.M.H., A.R., and C.L. worked on mass spec analysis. A.S. and P.B.F. provided laboratory resources and collaboration. G.M.C., Y.L., A.L.O., L.L., and A.A.T. handled CRISPR-off experiments. A.S.P., U.M., R.D., A.K.G., K.S., and D. Chelmow contributed to ovarian cancer expertise. R.P., J.K., S.R., H.R., S. Sayeed, K.P.K., D. Connolly, K.P.N., M.O.I., M.P.K., C.M., M.A., A.L.-B., D.J., K.D.M., A. Tzankov, S.B., E.A.R., and R.C.M. assisted with pathology data collection. A. Tsung and D.S. fostered clinical collaborations. J.T. provided mouse tumor models and funding. A.P.S., R.W., K.J.W., and E. Moreno helped with manuscript writing and funding. R.G. designed the study, organized collaborations, and provided overall supervision and funding.

The Fed's monetary easing, marked by a 50-basis-point rate cut, is reshaping global capital flows, particularly towards emerging markets (EMs). This shift, driven by widening interest rate differentials and a weakening US dollar, enhances the appeal of EM assets. However, the influx of capital brings risks such as currency appreciation and potential asset bubbles, necessitating careful policy calibration. Geopolitical risks and China's policy stance further complicate the landscape, highlighting the delicate balance EMs must manage to attract investment while maintaining stability.

Tiziana Life Sciences expands Phase 2 trial of foralumab nasal spray for nonactive SPMS, adding six sites in the U.S. Northeast. The trial aims to reduce microglial activity and inflammation, with preliminary data showing 80% reduction in microglial activity and 70% reduction in fatigue among patients. The FDA has granted fast track designation to foralumab for nonactive SPMS treatment.

Colorado will offer regulated psilocybin therapy starting in 2025, with applications for facilitators and businesses opening on Dec. 31. The first healing centers are expected to accept patients by summer 2024. The program, developed since Proposition 122 passed in 2022, aims to address mental health issues and mirrors Oregon's model with added safety measures. Local municipalities can regulate where these businesses operate, with some already setting restrictions.

St. Elizabeth Cancer Care, led by Dr. Douglas Flora, has evolved significantly, attracting top oncologists and specialists from renowned institutions. The program's success is attributed to its collaborative culture, advanced clinical trials, personalized medicine, and a comprehensive whole-person care model. The recent CMS 5-star rating underscores its commitment to excellence, enhancing recruitment and patient care.

Tiziana Life Sciences expands Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS) with esteemed institutions in the Northeast U.S., aiming to address a significant unmet need in MS treatment.

Tiziana Life Sciences expands Phase 2 trial for intranasal foralumab in non-active SPMS to prestigious Northeast US centers, including Yale, Johns Hopkins, Cornell, Buffalo, UMass, and Thomas Jefferson, aiming to address unmet medical needs and centralize PET scans at Invicro.

Givinostat (Duvyzat) showed favorable outcomes in Duchenne muscular dystrophy (DMD) patients but not in Becker muscular dystrophy (BMD) patients, according to a systematic review. The drug, approved by the FDA, demonstrated reduced muscle decline in DMD patients, with less fat fraction in muscles and improved muscle tissue. However, it showed no effect on fibrosis in BMD patients. Givinostat has a limited side effect profile compared to prednisone, but its high cost poses a challenge.