Press Releases
Precis Engineering + Architecture, a design firm with offices in Ambler, Pa., and Cary, N.C., has appointed G. Edward Richert, PE, LEED AP, as Director – Engineering Services in Cary. Richert has over 30 years of experience in pharmaceutical and biotechnology facility design and operations on both the owner/client and consulting engineering sides. In his role, he serves as a technical resource across disciplines, supports business development, and oversees project deliverable quality controls. He holds M.S. and B.S. degrees in Engineering Science from the University of Florida, is a registered professional engineer in 11 states, and is a member of ASHRAE and ISPE.
CStone Pharmaceuticals reported a major clinical validation milestone for CS2009, its investigational PD-1/VEGF/CTLA-4 trispecific antibody, at ESMO 2026. Data from more than 300 patients across multiple solid tumors support proof of mechanism, safety, and concept. CS2009 demonstrated an ORR of 87.5% in first-line PD-L1-high NSCLC and 28.0% in heavily pretreated NSCLC, with a median DOR of 10.5 months. In first-line mCRC, combination with XELOX achieved an ORR of 63.6% and DCR of 100%. The safety profile showed low rates of severe CTLA-4-associated and VEGF-related toxicities. CStone plans global Phase III trials by end of 2026 and is seeking partnerships.
Octane Biotech Inc. and Currus Biologics announced the successful automation of the CUR-001 manufacturing process on Octane's Cocoon Platform. CUR-001 is Currus' lead clinical candidate from its BEAT bispecific antibody platform, combining a mesothelin-targeting CAR T-cell therapy with a BEAT bispecific antibody to address solid tumors. The transfer follows FDA clearance of Currus' IND for CUR-001 in September 2026, allowing a first-in-human Phase 1 basket trial in mesothelin-positive advanced refractory solid tumors, with the first patient expected to be dosed in early 2027. The Cocoon Platform is a closed, automated system that reduces hands-on operator time and viral vector usage, lowering manufacturing costs. For the Phase 1 trial, CUR-001 will be manufactured at Cell Therapies Pty Ltd (CTPL) in Melbourne, where technology transfer has been completed. The companies will continue collaborating as CUR-001 advances through clinical development.
CRIO and Eli Lilly and Company won the SCDM Innovation Award in the Clinical Data Science Implementation Excellence category for their collaboration on a global Phase 3 Alzheimer's disease prevention trial. The trial spanned more than 120 sites in five countries and enrolled over 2,000 patients. CRIO deployed its Central eSource platform for the pilot, achieving 70% site adoption, a 59% reduction in on-site monitoring visits, 30% lower cost per monitoring visit, 30-day faster site startup, and a 24% improvement in monitoring effectiveness. Lilly has begun expanding Central eSource to additional studies, and CRIO is incorporating lessons learned to enhance future deployments.
Appian [Nasdaq: APPN] and PSI CRO announced the launch of their first joint AI-powered process orchestration solution that automates clinical trial site identification and selection across therapeutic areas, indications, and geographies. The live solution is the first step in a shared vision to build a scalable platform connecting automation, AI, and process orchestration across the full clinical trial lifecycle. The solution brings previously manual, decentralized steps into a single digital process, integrating with PSI's core systems and data warehouse and Appian's AI and process intelligence capabilities. PSI and Appian plan to evaluate further use cases to extend AI-powered process orchestration across the clinical trial lifecycle.
mzio GmbH announced the launch of mzassist, a vendor-neutral AI and automation control layer for multimodal mass spectrometry data processing on its open-source mzmine platform. mzassist uses the Model Context Protocol (MCP) open standard to connect mzmine to a user's approved MCP-compatible AI assistant, enabling natural-language setup and execution of complete mass spectrometry workflows while keeping raw data on the lab's computer and leaving parameter decisions to deterministic mzmine algorithms. The tool was previewed at the 8th Munich Metabolomics Meeting on October 13, 2026, and will be available with mzmine 4.11 in October 2026, included in mzmine COMMUNITY for academic users and mzmine PRO for commercial customers.
Axion BioSystems announced the launch of Synexus, a first-of-its-kind platform for disease research and therapeutic development. Synexus combines microelectrode array (MEA), high-density MEA (HD-MEA), and electrical imaging to connect function and morphology on the same plate, enabling single-cell resolution in high-throughput, label-free workflows. The platform supports noninvasive assessment of human neural and cardiac cultures, including iPSC-derived cells, and offers Pixel HD technology with more than 138,000 electrodes per well at 12.5 µm spacing across 96 wells. Synexus is designed to help pharmaceutical researchers generate more informative assays for compound prioritization, neurotoxicity and cardiotoxicity assessment, and mechanistic research. It builds on Axion's 15 years of experience and its Maestro MEA technology, with more than 1,500 systems installed worldwide.
The START Center for Cancer Research and Istituti Fisioterapici Ospitalieri (IFO) have formed a strategic partnership to create a new START early-phase clinical trial site within the Regina Elena National Cancer Institute in Rome. The collaboration aims to expand access to investigational cancer therapies for patients in Rome, the Lazio region, and across Italy. Italy records approximately 390,000 new cancer diagnoses annually but has a lower number of clinical trials relative to its population than several major Western European markets. The Rome site will be START's first in Italy, integrating into its global network of 17 locations and nearly 1,000 active studies. Leaders from START and IFO highlighted the potential to bring early-phase research closer to patients and strengthen clinical research activity in Italy.
Kivo, a GxP-compliant document and process management platform for life sciences, reported over 200 percent growth in biotech sponsors keeping trial master files and regulatory assets on its platform. Sponsors now manage more than 3,000 drug programs in Kivo. The company said its customers attracted more than $3 billion in investment in the last year. Kivo also noted increased sponsor adoption for TMF ownership, influenced by the ICH E6(R3) guideline, and its participation in the CDISC Vendor Committee and TMF Reference Model development.
Woven Health Collective has won a 2026 Healthcare Marketing Impact Award Gold for 'From Clues to Clarity: Recognizing ATTR-CM,' a virtual reality experience created for BridgeBio. Presented by Modern Healthcare and Ad Age, the Technology-Driven Campaign of the Year award recognizes strategic, creative, and results-driven health care marketing. The program helps health care professionals explore the patient experience of undiagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) through immersive technology, combining motion-capture animation, visual and audio cues, and haptic feedback. Developed in four months, it was introduced to BridgeBio's field force and reached HCP audiences at major 2026 conferences, generating approximately 100 unique, in-depth engagements.