DAY 1 - DAILY NEWS CPHI FRANKFURT 2025

6 NEWS DAILY NEWS CPHI 2025 FRANKFURT DAY 1 | 28th October 2025 Bristol Myers Squibb announced a definitive agreement to acquire Orbital Therapeutics, a biotechnology company developing RNA medicines that reprogram the immune system in vivo, for $1.5 billion. This acquisition will grant BMS the rights to Orbital’s lead candidate OTX-201, an in vivo CAR-T treatment that targets autoimmune disease through B-cell depletion to reset the immune system. According to a company press release, OTX-201 is an RNA immunotherapy preclinical candidate currently in IND-enabling studies. The candidate consists of an optimized circular RNA encoding a CD19-targeted CAR for in vivo expression and delivered via targeted LNPs. In addition to OTX-201, BMS will acquire Orbital’s proprietary RNA platform, which is designed to deliver durable, programmable therapies via circular and linear RNA engineering, advanced LNP delivery, and AIdriven design. “In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases,” said Robert Plenge, MD, PhD, Executive VP, CRO, BMS, in the press release. “This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options.” “This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine,” said Ron Philip, CEO, Orbital Therapeutics, in the release. “Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead program, OTX201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer, and more accessible compared to today’s complex therapies.” Bristol Myers Squibb inks $1.5 billion orbital therapeutics acquisition Thermo Fisher Scientific introduced the Molecular Microscope Diagnostic System for Lung (MMDx Lung) on October 8th, a new diagnostic tool designed to aid pathologists in determining lung transplant rejection and injury. According to a company press release, the MMDx Lung profiles gene expression data from lung biopsies and compares each sample to a reference set of over 896 lung biopsies. Following the assessment, the system provides molecular scores associated with injury, graft dysfunction, and rejection. MMDx Lung was developed and validated by Kashi Clinical Laboratories, a provider of clinical and molecular tests for various health conditions and disorders. According to the release, this laboratorydeveloped test is intended for clinical use by the CLIA-certified laboratory performing the test. This test has not been cleared or approved by the US FDA or CE marked in the EU as an in vitro diagnostic test. In the United States, MMDx Lung is delivered through a collaboration with Kashi. “The diagnosis of rejection and injury in lung transplants is very challenging,” said Phil Halloran, Director, Alberta Transplant Applied Genomics Center and CEO, Transcriptome Sciences, in the release. “Based on technology developed by the investigators in the INTERLUNG study, we believe MMDx Lung will better diagnose rejection and detect Chronic Lung Allograft Dysfunction (CLAD)-related molecular changes, and thus provide a better guide for treatment and potentially for clinical trials, as a step toward improving survival of lung transplants.” “Accelerating clinical decision-making through the delivery of high quality, rapid results, is central to our mission of advancing health and healing to every patient we serve,” said Dr. Todd Johnson, CEO, Kashi Clinical Laboratories, in the release. “We’re proud to expand our collaboration with Thermo Fisher Transplant Diagnostics to deliver services for lung, in addition to kidney and heart transplant testing.” Thermo Fisher Scientific introduces lung transplant diagnostic system

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