MEDTECH, INDUSTRIAL IMPACT
Businesswire | April 03, 2023
Sonoma Biotherapeutics, Inc. and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases. The collaboration will bring together Regeneron’s industry-leading VelociSuite® technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Biotherapeutics’ pioneering approach to developing and manufacturing gene-modified Treg cell therapies.
Under the terms of the agreement, Sonoma Biotherapeutics will receive $75 million in upfront payments, which includes a $30 million equity investment in Sonoma by Regeneron. Sonoma is also eligible to receive a $45 million development milestone payment. Regeneron and Sonoma will jointly research and develop Treg cell therapies for ulcerative colitis, Crohn’s disease and two other undisclosed indications, with a Regeneron option for a fifth indication. The parties will equally co-fund research and development for all potential products and share equally any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States. Sonoma will also retain full ownership of its lead cell therapy candidate, SBT-77-7101, and other programs in development.
“We are thrilled to collaborate with Regeneron with the goal of developing best-in-class Treg therapies for ulcerative colitis, Crohn's, and other diseases,” said Jeff Bluestone, Ph.D., Co-founder and Chief Executive Officer of Sonoma Biotherapeutics. “Regeneron has a track record of seeking out pioneers in their fields and forging successful partnerships. This collaboration will combine Regeneron’s proven technology and clinical expertise with Sonoma Bio’s proprietary Treg platform and Treg research enterprise to develop therapies that restore balance to the immune system and potentially cure disease.”
“Regeneron’s investigational pipeline includes a diverse range of cutting-edge scientific approaches, and we are pleased to expand this toolkit further through a partnership with Sonoma to explore the potential of engineered Treg cell therapies with enhanced functionality and the ability to target specific tissues,” said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. “Both Regeneron and Sonoma have strong foundations in basic scientific research, and by bringing together our complementary expertise, we hope to harness the power of Tregs to make further progress in the treatment of autoimmune and inflammatory diseases.”
Treg cells act as sentinels that survey the body for unwanted immune attacks and rebalance the immune system. Tregs as a therapeutic modality potentially possess multiple therapeutic effects, within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory disease. Emerging research shows that enhanced Treg cells work directly at the site of inflammation and have the potential to create a durable response. This paradigm-shifting approach could possibly transform treatments for autoimmune and inflammatory diseases.
About Sonoma Biotherapeutics
Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle.
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INDUSTRIAL IMPACT, MEDICAL
Businesswire | May 05, 2023
Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications to assist in diagnosing cancer, announced it is working with Visiopharm, an artificial intelligence (AI)-driven precision pathology software provider, to bring a wider range of AI products to doctors and patients. Visiopharm’s AI applications will be deployed and natively integrated into the Paige Platform to be accessed through FullFolio™, Paige’s AI-powered clinical worklist, and viewed within FullFocus®, Paige’s whole-slide image viewer. This deep integration offers users greater diagnostic efficiency and quality insights when reviewing IHC-stained slides and creates a seamless user experience for Visiopharm’s image analysis applications, to help pathologists deliver faster, more accurate and more reproducible cancer diagnoses.
“Improving the pathologist experience to ultimately improve patient care is at the heart of our technology. The Paige and Visiopharm integration offers pathologists thorough image analysis and quantitative assistance on whole-slide images within one AI-native integrated platform,” said Dr. David Klimstra, Co-Founder and Chief Medical Officer of Paige. “With this partnership, Paige is furthering our aim to provide the richest portfolio of AI applications delivered through a single platform. In this way, we can increase the impact AI has in helping pathologists diagnose cancer and continue to make the adoption of digital pathology more productive.”
The Paige Platform is interoperable and designed to enable labs to deploy AI-based diagnostic products from AI vendors like Visiopharm, creating one seamless pathology workflow from a single interface. It also integrates with most major scanner vendors and allows bi-directional integration with LIS systems, facilitating a truly open and comprehensive experience.
Digital labs often employ digital technologies from different manufacturers for cancer diagnosis. With AI from Visiopharm and Paige together on a single platform, these labs can have streamlined access to digital images and combined insights together in one place.
Dr. Michael Grunkin, CEO of Visiopharm, stated, "Visiopharm, a global leader in AI-driven precision pathology, delivers standardized decision support for complex tissue biomarkers. Our fully automated (zero-click) applications use a cascade of deep learning networks for slide quality control, tissue detection, tumor identification, and biomarker quantification. Designed to work across various technologies and providers, we join Paige in our commitment to making this technology accessible worldwide on top pathology platforms."
About Paige
Paige is using the power of AI to drive a new era of cancer discovery and treatment. To improve the lives of patients with cancer, Paige has created a cloud-based platform that transforms pathologists’ workflow and increases diagnostic confidence as well as productivity, all on a global scale. Paige is the first company to receive FDA approval for a clinical AI application in digital pathology. The same Paige technology empowers pharmaceutical companies to evaluate treatment options more effectively for patients and design new biomarkers for drug development, so every patient gets precise treatment options.
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MEDTECH, INDUSTRIAL IMPACT
Prnewswire | April 06, 2023
ConcertAI, LLC a leader in AI Software-as-a-Service (SaaS) technology and Real-world Evidence solutions for life sciences and healthcare, announced the release of its next generation of Clinical Trial Optimization (CTO 2.0).
"Trial sponsors have a range of new imperatives they're trying to meet: assuring that the trial population is reflective of the ultimate population that would have access to the drug; to set and meet diversity goals for those ethnic, racial and economic groups that are uniquely, negatively impacted by a disease; and meeting ever higher productivity imperatives for identifying and activating sites faster and working with those sites most likely to accrue to the pre-activation feasibilities," said Jeff Elton, Ph.D. CEO of ConcertAI. "Meeting these goals requires working with sites and investigators not historically preferred, designing trials for a minimum of burden on research sites and patients and, perhaps most importantly, moving more studies into community-based research settings."
CTO 2.0 now includes a range of features: (1) clinical depth and tools, such as line of therapy assessments, Kaplan-Meier survival curves, and cox-proportional hazard assessments that guide alternative designs with the largest underlying research dataset for oncology; (2) data integrating electronic medical-derived, medical claims, and social determinants of health; (3) site- and investigator-level information on current and previous clinical trials derived from public and private sources; and (4) operational trial metrics and site profile information to highlight performance and capabilities.
The solution's foundation is a study digitization layer that can handle any depth of inclusion and exclusion (I/E) criteria. Protocols can be assessed relative to standard-of-care in different settings and in different time periods, all the way down to the individual event or clinical activity level. There are APIs for integrating past study protocols from any legacy systems of records. Optimizer and recommendations engines can provide study-level optimizations and semi-automate site selection. Additional APIs can integrate past site survey data and investigator databases as a means of simplifying and unifying what are often non-integrated solutions within the clinical analytics and clinical operations organization. The SaaS technology will support researchers and clinicians in selecting the most appropriate sites for clinical trials, balancing potential patients available and previous trial performances at those sites to give the highest likelihood of success for a clinical trial. In assurance that trials can be conducted across settings and utilize the latest digital trial solutions that support direct EMR to EDC, CTO 2.0 leverages the latest clinical informatics integrations and data standards to ensure research can be conducted at scale and meeting, or exceeding, enhanced standards of care.
"In the past, clinicians used previously published protocols and recently approved studies in the same disease to inform trial designs for new studies," said Ronan Brown, ConcertAI's Chief Operating Officer. "Now that is changing. We'll now see greater reliance on large scale, multi-sourced, clinical datasets that have low latency, reflecting the latest treatments, supporting new designs, lower site burden, greater, diversity, and expanded views of relevant sites. It's a significant step forward in clinical trial planning and operations."
About ConcertAI
ConcertAI is a leader in Real-World Evidence (RWE) and AI technology solutions for life sciences and healthcare. Our mission is to accelerate insights and outcomes for patients through leading real-world data, AI technologies, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies.
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