MedNess: bite-size biopharma and medtech news

FDA Approves CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
“Before today, patients with radioactive iodine-refractory differentiated thyroid cancer who have progressed following prior VEGFR-targeted therapy were facing aggressive disease and no standard treatment option,” said Marcia S. Brose, M.D., Ph.D., Chief, Cancer Center Operation Sidney Kimmel Cancer Center at Jefferson Torresdale Hospital, Co-Director, Community Based Clinical Trials, Sidney Kimmel Cancer Center at Thomas Jefferson University, and principal investigator of COSMIC-311. “In the COSMIC-311 pivotal phase 3 trial, CABOMETYX extended the time patients live without progression of their cancer. The FDA approval of CABOMETYX is an important advancement for these patients who are badly in need of new treatment options.”

FDA accepts for Priority Review BLA for Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma
“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma. We look forward to potentially introducing the first LAG-3-blocking antibody, and Bristol Myers Squibb’s third distinct checkpoint inhibitor, to help patients in need.”

First Patient Dosed in Randomized Study Evaluating TPST-1120/atezolizumab/ bevacizumab triplet in First-Line Regimen for HCC
“The initiation of this randomized TPST-1120 study in collaboration with Roche marks significant progress in the advancement of the Tempest clinical pipeline,” said Sam Whiting, MD, Ph.D., chief medical officer of Tempest. “We continue to be excited about TPST-1120’s mechanism of action and are encouraged by its safety profile and early signals of clinical benefit seen in both monotherapy and combination studies. The Tempest team looks forward to further evaluation of TPST-1120 in this randomized combination in the first-line treatment of patients with HCC.”

Beam Therapeutics targets chronic Hepatitis B infection with base editors
Beam Therapeutics’ cytosine base editors (CBEs)  reduce viral markers, including hepatitis B surface antigen (HBsAg) expression, and prevent viral rebound of hepatitis B virus (HBV) in in vitro models, according to preclinical data. In HBV infected cells, CBEs can target the covalently closed circular DNA (cccDNA) minichromosome at multiple locations, introducing precise and permanent stop codons in the viral genome, which are intended to silence the viral genes without the risk of the chromosomal rearrangements. In the study, infected human hepatoma HepG2-NTCP cells, which are susceptible to HBV infection, and long-term primary human hepatocyte co-cultures, were multiplex edited with selected HBV-targeting gRNAs and mRNA-encoding CBEs. Editing efficiency of 30%-60% was observed with no viral rebound in long-term infected primary hepatocytes.