Ensartinib Hydrochloride

Dr. Selvaggi, a veteran immuno-oncology executive brings more than 30 years of oncology experience and a proven track record of advancing global clinical programs, with novel cancer therapies to registration, strengthening Biond's efforts to advance the clinical development of BND-67 and BND-22 MISGAV, Israel, June 22, 2026 /PRNewswire/ -- Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company developing first-in-class immunotherapies for cancer and immune-mediated diseases, today announced the appointment of Giovanni Selvaggi, M.D. CMO. Dr. Selvaggi is a physician-scientist and oncology drug development executive with extensive experience spanning academic medicine, global pharmaceutical companies, and biotechnology organizations. Over the course of his career, he has led the clinical development of multiple oncology programs from early-stage research through regulatory submissions, including immuno-oncology therapies, targeted therapies, cancer vaccines, and oncolytic viruses. Dr. Selvaggi most recently served as CMO of Xcovery Holdings, where he led the clinical development and regulatory strategy for ensartinib, including its global Phase 3 program and regulatory interactions with the U.S. Food and Drug Administration. He also held senior leadership positions at Bristol Myers Squibb, where he led immuno-oncology clinical development programs in small cell lung cancer, mesothelioma, and non-small cell lung cancer, contributing to the regulatory filing of nivolumab in small cell lung cancer. Earlier in his career, Dr. Selvaggi held senior development roles at Novartis Oncology, GlaxoSmithKline, Oncolytics Biotech, and Imugene. He is a board-certified pulmonologist and thoracic oncology specialist who spent more than a decade treating patients and conducting clinical research in lung cancer and mesothelioma at the University of Turin and San Luigi Hospital in Italy. "We are delighted to welcome Giovanni to Biond at a transformative stage in the Company's growth," said Tehila Ben Moshe, Ph.D., Co-Founder and Chief Executive Officer of Biond Biologics. "Biond now has two highly differentiated clinical-stage immunotherapy programs, including BND-22, currently advancing in Phase 2 studies, and BND-67, which recently entered a first-in-human study to evaluate BND-67. Giovanni brings a unique combination of deep oncology expertise, immuno-oncology leadership, and hands-on experience advancing innovative therapies from early clinical development through regulatory filings. We believe his clinical leadership and experience will further strengthen our ability to execute our clinical strategy and unlock the full potential of our first-in-class pipeline." "I am excited to join Biond at a crucial development stage and contribute to the advancement of its innovative immunotherapy portfolio," said Giovanni Selvaggi, M.D. "Biond has built a compelling pipeline based on novel biological insights and differentiated mechanisms of action. BND-67 represents a particularly exciting opportunity to unlock the full potential of T-cell immunity through a completely new approach to restoring physiological CD28 signaling. I look forward to working with the talented team at Biond to improve outcomes for patients with cancer." About Biond Biologics Biond Biologics is a private, clinical-stage biotechnology company developing first-in-class immunotherapies targeting novel pathways across both the innate and adaptive immune systems. The company's pipeline includes clinical-stage programs in oncology, alongside a growing portfolio of discovery and preclinical programs in immune-mediated diseases. Biond's clinical pipeline includes BND-22, a first-in-class antibody that acts as a multi-cell checkpoint inhibitor targeting the ILT2 receptor advancing in a phase 2 study. BND-22 enhances the anti-tumor activity of both innate and adaptive immune cells by blocking the interaction between ILT2 and HLA-G, for the treatment of solid tumors. In addition, Biond is developing BND-67, a next-generation immunotherapy and a first-in-class asset targeting CD28 shedding, a novel immune evasion mechanism with the potential to redefine T-cell modulation in cancer. Given the central role of CD28 in T-cell activation, BND-67 introduces a fundamentally new approach to restoring immune responsiveness. By preserving CD28 signaling, it enhances effector T-cell activity while selectively inhibiting regulatory T-cell function, driving a potent and sustained anti-tumor response. The program is IND-ready, with a Phase 1 trial planned for Q2 2026 Biond was founded in 2016, by Tehila Ben Moshe, Ph.D., Ori Shilo, and a team of accomplished scientists and drug developers from the Israel biopharmaceutical industry. . Company contact: Tal Sines VP of Business Development Biond Biologics Ltd. +972-4 884 4337 [email protected] SOURCE Biond Biologics Ltd. 21% more press release views with Request a Demo

Pfizer (NYSE: PFE) reported seven-year follow-up data from the Phase III CROWN trial showing that 55% of previously untreated ALK-positive non-small cell lung cancer patients receiving lorlatinib (Lorbrena) remained alive without disease progression — a landmark in a disease where durable control at this timepoint has not previously been documented. The CROWN trial is a randomized, open-label, Phase III study that enrolled 296 patients with previously untreated ALK-positive advanced or metastatic NSCLC, randomized 1:1 to lorlatinib (n\=149) or Pfizer’s Xalkori (crizotinib) (n\=147). The seven-year analysis, an unplanned post-hoc assessment prompted by the fact that median progression-free survival remained unreached at both the three- and five-year marks, was based on investigator tumor assessment and presented at the 2026 ASCO Annual Meeting (Abstract #8502), with simultaneous publication in Annals of Oncology. At seven years, the probability of remaining alive without progression was 55% (95% CI: 46–63) with lorlatinib versus 3% (95% CI: 1–8) with crizotinib. Investigator-assessed median PFS was not reached in the lorlatinib arm, with a hazard ratio of 0.19 (95% CI: 0.13–0.26), representing an 81% reduction in the risk of progression or death. The intracranial data were similarly striking: lorlatinib reduced the risk of intracranial progression by 94% (HR 0.06; 95% CI: 0.03–0.12), with no new intracranial progression events observed after the first 30 months. At the time of analysis, 44% of patients in the lorlatinib arm remained on treatment, compared with 3% in the crizotinib arm. The safety profile was consistent with prior analyses. Grade 3/4 adverse events occurred in 77% of lorlatinib patients versus 57% with crizotinib, though treatment-related discontinuations were low and comparable — 5% versus 6%, respectively — with no new permanent discontinuations due to treatment-related adverse events after the first 26 months on lorlatinib. Lorlatinib is a third-generation ALK/ROS1 tyrosine kinase inhibitor engineered specifically to overcome resistance mutations that limit earlier-generation agents and to penetrate the blood-brain barrier — properties that appear central to the durability seen in CROWN. The first-line ALK-positive NSCLC space now includes several approved oral agents: Roche’s Alecensa (alectinib), Takeda’s Alunbrig (brigatinib), Novartis’s Zykadia (ceritinib), and, most recently, Xcovery’s Ensacove (ensartinib), approved in December 2024. Cross-trial comparisons are limited by differences in patient populations, follow-up duration, and analytical methods, but no other agent in this class has reported a median PFS that remains unreached at seven years. Overall survival data from CROWN remain immature, and those results will be the next material readout for the program. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.