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Regeneron has exclusive opportunity to connect large-scale genomic and proteomic data cohorts to TriNetX's industry-leading global network of electronic health record data
Collaboration will expand Regeneron's world-leading genomic and proteomic EHR-linked database
Growing database will continue to drive drug discovery and development and empower AI training algorithms to deliver digital health solutions of the future for consumers, patients and providers
TARRYTOWN, N.Y. and CAMBRIDGE, Mass., April 3, 2026 /PRNewswire/ -- TriNetX® and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a strategic collaboration to support Regeneron's capabilities in drug discovery and development, as well as new initiatives to deliver digital health solutions of the future for consumers, patients and providers. Regeneron gains the exclusive opportunity to connect large-scale genomic and proteomic data cohorts to TriNetX's industry-leading phenotypic data network of approximately 300 million de-identified and anonymized patients. This collaboration will enable expansion of Regeneron's world-leading genomic and proteomic Electronic Health Record (EHR)-linked database, a key driver of the company's industry-leading therapeutics pipeline.
Under the collaboration, TriNetX will provide Regeneron with secure, licensed access to TriNetX's current and future de-identified health data from approximately 300 million individuals (170 million of whom are in the United States), sourced directly from its global network of health system partners. With privacy-preserving methods, Regeneron will have the capability to match a portion of TriNetX's de-identified/anonymized data to genomic and proteomic data generated by the Regeneron Genetics Center® (RGC®). Such matching will be conducted in accordance with all applicable data privacy laws, including HIPAA and GDPR.
The RGC has developed high-throughput and cost-efficient DNA sequencing and proteomics approaches to build the world's largest database of EHR-linked sequencing and proteomics data, in collaboration with over 150 life sciences and healthcare collaborators around the world. The collaboration with TriNetX will help Regeneron dramatically expand this already world-leading dataset to continue to drive drug discovery and development, while also empowering artificial intelligence (AI) training algorithms to deliver digital health solutions of the future.
"We are delighted to work with Regeneron, and specifically the Regeneron Genetics Center team, to advance human health through the application of intelligence-driven information technology, powered by our trusted data," said Jeff Margolis, TriNetX Executive Chairman. "Our team is gratified to be selected by Regeneron to provide access to TriNetX's unique breadth and depth of research-ready data, across our extensive federated global network of academic medical centers and other leading healthcare research sites."
"This is a major milestone for the RGC and a powerful new pathway to achieve our core mission: building the world's largest and richest human health database to drive drug development and pioneer digital health solutions for consumers, patients and providers," said Aris Baras, M.D., Senior Vice President, Head of RGC and Co-head of Regeneron Genetic Medicines. "TriNetX has built a world-leading platform with a proven track record of enabling research at scale. The RGC has spent over a decade generating genomic and now proteomic data and integrating these molecular data with longitudinal health records at large-scale. Combining these platforms brings together powerful human health databases with analytical and AI capabilities to help discover and develop innovative medicines for devastating diseases and create digital health solutions that we hope will transform our ability to predict, prevent and manage disease."
"We are looking forward to working with the TriNetX team," said Andrew Deubler, Senior Vice President, RGC Chief Business and Administrative Officer. "Our RGC strategic investments catalyze innovation, driving advancements in cutting-edge technologies that accelerate drug discovery and development, as well as help us develop innovative digital health solutions. This deal represents the latest and one of our most significant collaborations, and we look forward to continuing to expand our network of top-tier partners as we pursue our mission."
As part of the collaboration, Regeneron will invest up to $200 million in TriNetX.
About TriNetX, LLC
TriNetX is the Global Truth Engine for Better Human Health™ that makes complex, real-world health data easy to use. Data is sourced directly from our growing global network of over 11,000 healthcare provider locations. TriNetX customers select the data source, types, and breadth of data they need; the data access methods they desire; and the types of software, human and machine intelligence they wish to apply – and combine these to solve their business objectives. Visit TriNetX at www.trinetx.com or follow TriNetX on LinkedIn to learn more.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook, YouTube or X.
About the Regeneron Genetics Center
The Regeneron Genetics Center® (RGC®) is a genomic research initiative and a wholly owned subsidiary of Regeneron. For over a decade, we have harnessed the power of human genetics to discover important new medicines, validate existing research programs and optimize clinical trials. We tap into our growing database of more than 3 million sequenced exomes and de-identified health information using proprietary data analytics, technology and human ingenuity to make meaningful biological discoveries at speed and scale. Our high-touch integrated model focuses on working closely with our collaborators to build a dataset with meaningful cohorts. We use innovative technologies, such as machine learning, to sequence exomes, align with health information and perform large-scale analyses to make meaningful associations between genes and diseases. We apply our insights to guide Regeneron's broader drug discovery and development efforts.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates"), research and clinical programs now underway or planned, and the use of human genetics in Regeneron's research programs; the likelihood, timing, and scope of achieving any of the anticipated milestones described in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (such as those that may result from Regeneron's collaboration with TriNetX discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron's pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) as well as the collaboration with TriNetX discussed in this press release, to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).
Regeneron
Media:
Ella Campbell
Email: ella.campbell@regeneron.com
Investors:
Vesna Tosic
Email: vesna.tosic@regeneron.com
TriNetX
Karen Tunks
Email: Karen.Tunks@TriNetX.com
SOURCE TriNetX, LLC.
Issued on behalf of GT Biopharma, Inc.
VANCOUVER, BC, Dec. 19, 2025 /CNW/ -- USA News Group News Commentary – The recent FDA approval in November of the first bispecific antibody combination for second-line blood cancer treatment marks the departure from traditional chemotherapy that oncologists have been anticipating for decades[1]. Engineered cell therapies and bispecific antibodies are now achieving response rates exceeding 90% in patients with relapsed and refractory hematologic malignancies, demonstrating the transformative power of immunotherapy in blood cancers[2]. These breakthroughs position companies like GT Biopharma, Inc. (NASDAQ: GTBP), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Genmab A/S (NASDAQ: GMAB), Autolus Therapeutics plc (NASDAQ: AUTL), and Lyell Immunopharma, Inc. (NASDAQ: LYEL).
Market forecasters project the CAR-T cell therapy market will surge from $3.87 billion in 2024 to $13.25 billion by 2030, driven by unprecedented efficacy in relapsed and refractory patient populations[3].
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, where patients now receive 10μg/kg/day dosing. The company specializes in developing next-generation immunotherapy treatments targeting some of the world's most resistant cancer types through its proprietary natural killer cell engager TriKE platform.
GT Biopharma's Phase 1 dose escalation trial evaluates GTB-3650 in patients facing relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These cancers represent exceptionally challenging cases where conventional treatments have either failed completely or provided only temporary benefit before disease returned.
The therapy harnesses the patient's natural killer cells, an immune cell type that instinctively identifies and eliminates abnormal cells, directing them to attack cancer specifically. Treatment delivery follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, with cycles continuing up to four months depending on individual patient response.
"We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026."
The six patients enrolled throughout Cohorts 1, 2, and 3 have completed GTB-3650 treatment successfully, establishing the therapy's safety profile across escalating dose concentrations. GT Biopharma indicates the current Cohort 4 dose of 10μg/kg/day represents a threshold where clinical efficacy becomes more likely, supported by encouraging immunological biomarker trends and zero dose-limiting toxicities across all completed cohorts.
The first-in-human Phase 1 protocol plans for approximately 14 patients distributed across seven cohorts, with each cohort enrolling two patients at progressively increasing doses starting from 1.25μg/kg/day in Cohort 1 and potentially reaching 100μg/kg/day in Cohort 7 if warranted. Following Cohort 4, three additional escalation levels remain: Cohort 5 testing 25μg/kg/day, Cohort 6 evaluating 50μg/kg/day, and Cohort 7 examining the maximum protocol dose of 100μg/kg/day. The company anticipates providing its next comprehensive trial update during first quarter 2026.
Beyond hematologic malignancies, GT Biopharma is advancing GTB-5550, targeting B7H3, a protein prevalent across multiple solid tumor categories including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. Regulatory submission to initiate GTB-5550 human trials is expected in late December 2025 or January 2026.
Designed as a subcutaneous injection, GTB-5550 offers the potential for eventual self-administration at home, significantly reducing patient burden.
Both therapeutic candidates leverage GT Biopharma's proprietary TriKE platform utilizing specialized antibody fragments initially discovered in camels and llamas. These molecules provide distinct advantages compared to traditional antibodies through their compact size and enhanced stability. GT Biopharma maintains exclusive worldwide licensing rights from the University of Minnesota for this technology.
CONTINUED… Read this and more news for GT Biopharma, Inc. at: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented data from the Phase 1/2 LINKER-MM4 trial showing Lynozyfic monotherapy achieved very good partial response or better of ≥70% across all three dose groups in newly diagnosed multiple myeloma patients despite limited follow-up. The first-ever BCMAxCD3 bispecific monotherapy trial in this setting demonstrated that 95% of evaluable responders achieved minimal residual disease negative status at 10⁻⁵ sensitivity.
"Lynozyfic monotherapy is already achieving MRD negativity rates comparable to quadruplet regimens but earlier in the treatment course, and these compelling results are expected to deepen with longer follow up," said Robert Orlowski, M.D., Ph.D., Deputy Chair, Professor of Medicine, and Director of Translational Myeloma Research in the Departments of Lymphoma/Myeloma and Experimental Therapeutics at The University of Texas MD Anderson Cancer Center and the lead investigator for the LINKER-MM4 trial. "These results underscore Lynozyfic's potential as a foundational component of frontline treatment regimens for multiple myeloma – or even a monotherapy regimen – for both transplant-eligible and transplant-ineligible patients."
The broad clinical development program includes ongoing Phase 2 expansion at the recommended 200mg dose and the LINKER-MM6 trial evaluating combination therapy in transplant-ineligible newly diagnosed patients. Regeneron will host a virtual Regeneron Roundtable investor event on December 10 to discuss its multiple myeloma development program.
Genmab A/S (NASDAQ: GMAB) announced new data from its Phase 1b/2 EPCORE CLL-1 trial demonstrating epcoritamab's effectiveness as both monotherapy and in combination regimens for patients with Richter transformation, a rare and aggressive evolution of chronic lymphocytic leukemia. In first-line monotherapy, patients achieved a 57% overall response rate with 52% complete response, while 95% of evaluable responders achieved minimal residual disease negative status across all dose groups.
"The results from these trials demonstrate the potential of epcoritamab as a monotherapy, and in combination, in patients with Richter transformation, a rare, often fatal, transformation of chronic lymphocytic leukemia into an aggressive lymphoma, mostly diffuse large B-cell lymphoma," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We are deeply committed to exploring epcoritamab as a potential core therapy across a range of B-cell malignancies, both as an initial treatment and as a later line of therapy."
Genmab continues expanding epcoritamab's development across hematologic malignancies through multiple ongoing Phase 3 trials in collaboration with AbbVie.
Autolus Therapeutics plc (NASDAQ: AUTL) presented initial clinical data from its CATULUS Phase 1 trial demonstrating obe-cel achieved a 95.5% overall response rate with 90.9% complete response in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The safety profile was consistent with the adult experience, showing low rates of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (both 8.7%), with 20 of 21 responding patients remaining in ongoing remission at data cutoff.
"Pediatric patients with r/r B-ALL have a poor prognosis, particularly those who relapse early," said Dr. Matthias Will, Chief Development Officer of Autolus. "We were pleased to share the first data from the Phase 1 CATULUS trial showing obe-cel can produce high remission rates in this pediatric patient population, including in patients with high-risk relapse and patients with primary CNS relapse. Consistent with our experience in the adult population, data show low rates of severe CRS and ICANS."
Autolus also presented post-hoc analyses from the FELIX pivotal trial demonstrating that CAR T-cell persistence at three months post-infusion may serve as a marker for predicting long-term outcomes in adult r/r B-ALL patients. Planning for the Phase 2 expansion of the CATULUS trial is underway to further explore obe-cel in pediatric relapsed/refractory B-ALL patients.
Lyell Immunopharma, Inc. (NASDAQ: LYEL) presented new clinical data from its ongoing trial of rondecabtagene autoleucel showing 93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with relapsed/refractory large B-cell lymphoma in the third-or-later-line setting at the 67th American Society of Hematology Annual Meeting. Patients evaluated in the second-line setting, comprised predominantly of those with primary refractory disease, achieved an 83% overall response rate and 61% complete response rate, with 70% of complete responders remaining in complete response at six months or longer.
"These data from the ongoing clinical trial showing high rates of durable complete responses along with a manageable safety profile in patients with high-risk large B-cell lymphoma represent the potential of ronde-cel to improve patient outcomes," said Sarah M. Larson, MD, Associate Professor at the David Geffen School of Medicine, University of California, Los Angeles. "The two pivotal trials underway, including the first-of-its kind head-to-head CAR T-cell trial, are expected to provide a comprehensive and robust evaluation of the potential for ronde-cel to demonstrate differentiated benefit over approved CD19 CAR T-cell therapies."
Ronde-cel demonstrated a manageable safety profile appropriate for outpatient administration with no high-grade cytokine release syndrome and five percent or less of patients experiencing Grade 3 or greater immune effector cell-associated neurotoxicity syndrome following dexamethasone prophylaxis. Lyell has initiated two pivotal clinical trials, PiNACLE-H2H, a Phase 3 head-to-head randomized controlled trial versus lisocabtagene maraleucel or axicabtagene ciloleucel in the second-line setting, and PiNACLE, a single-arm registration trial enrolling up to 120 patients in the third-or-later-line setting.
Article Sources: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/
CONTACT:
USA NEWS GROUP
info@usanewsgroup.com
(604) 265-2873
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