A Phase 1/1b Single Arm Safety Lead in Study of Leronlimab (CCR5 Blockade) With Hepatic Arterial Infusion Pump Therapy Delivering Floxuridine (FUDR) and Concurrent Systemic Therapy in Colorectal Cancer Liver Metastases Patients (CHAMP)

This phase I/Ib trial tests the effect of leronlimab in combination with hepatic arterial infusion (HAI) floxuridine (FUDR)and standard of care (SOC) systemic therapy in treating patients with colorectal cancer that has spread from where it first started to the liver (metastatic). Leronlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets, such as CCR5 which is expressed on T cells (a type of immune cell), which may cause the body to make an immune response (antigens) and may also improve the effectiveness of treatment. HAI delivers chemotherapy, such as floxuridine, directly to the liver. Catheters are put into an artery in the groin that leads directly to the liver and drugs are given through the catheters. Floxuridine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of tumor cells in your body. HAI can deliver floxuridine at up to 300 times the concentrations that can be given through the vein. Systemic therapy is treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body. Giving leronlimab in combination with HAI floxuridine and SOC systemic therapy may be safe, tolerable, and/or safe in treating colorectal cancer patients with liver metastases.

开始日期2027-05-06

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07553338

/ Recruiting临床2期IIT

Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer's Disease

The present study will administer the drug leronlimab to 20 participants who are above 50 years old with Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of cancer, its safety and tolerability in AD will be tested for the first time. The main purpose of this study is to learn:
1. Is this drug safe for participants with AD and MCI due to AD?
2. Does leronlimab change levels of brain inflammation?
The results of this study could lead to future studies with more participants that will test whether leronlimab may slow or prevent the decline in thinking abilities and brain function in this group of participants. Using leronlimab for Alzheimer's disease is experimental, which means that the Food and Drug Administration (FDA) has not approved leronlimab for this purpose.
Participants will be asked to take leronlimab once a week for 12 weeks in our clinic or in their own home. Participants will also be asked to complete the below procedures before and after taking leronlimab for 12 weeks:
1. Undergo 2 types of brain scans, Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
2. Visit our clinic for routine lab work, an electrocardiogram (ECG), and a physical exam.
3. Donate blood so the researchers can better understand how leronlimab affects levels of inflammation and proteins related to AD in the blood.
4. Undergo a series of tests and questionnaires that test thinking abilities.
5. Have weekly phone calls with researchers to let them know if there are side effects while taking this drug.

开始日期2026-04-30

申办/合作机构

Weill Medical College of Cornell University

NCT06699836

/ Active, not recruiting临床2期

A Phase Two Study Evaluating Two Doses of Leronlimab (PRO 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, mCRC who have progressed on prior treatment, with optional open label leronlimab plus pembrolizumab cohort for participants who have documented disease progression during the initial treatment period of the study and who continue to meet the initial inclusion and exclusion criteria.
The main questions this study aims to answer are:
1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in participants with MSS, mCRC who have progressed on prior treatment before participating in the study.
2. In participants who have documented progressive disease during the initial treatment period of the study, what is the objective response rate when leronlimab is administered in combination with pembrolizumab.
3. Is leronlimab safe and well tolerated when used in combination with trifluridine and tipiracil+ bevacizumab or in combination with pembrolizumab.

开始日期2025-06-16

申办/合作机构

CytoDyn, Inc.

[+1]

100 项与 Leronlimab 相关的临床结果

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100 项与 Leronlimab 相关的转化医学

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100 项与 Leronlimab 相关的专利（医药）

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项与 Leronlimab 相关的文献（医药）

2026-09-29·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

A push–pull gut–brain signal regulates flexible learning in Caenorhabditis elegans

Article

作者: Zhang, Ke ; Sun, Yinghao ; Jia, Huixia ; Yang, Yu ; Yang, Wenxing ; Liu, He ; Qin, Ruixue ; Liu, Hanzhang ; Jiang, Chunhuan ; Li, Honggang ; Di, Zengru ; Zhu, Ying ; Dong, Nan

Animals must flexibly adjust their learning strategies to cope with changing environmental threats. In Caenorhabditis elegans , exposure to the pathogenic bacterium Pseudomonas aeruginosa (PA14) induces aversive learning, and we uncover that the shape of learning curves varies with the virulence of the pathogen. This flexibility is governed by a gut-to-brain neuropeptide signaling pathway that modulates learning dynamics in response to internal physiological state. PA14 exposure upregulates the intestinal neuropeptide FLP-18, which acts on two antagonistic receptors, NPR-5 and NPR-6, in the ADF sensory neurons. NPR-5 promotes ADF activity and accelerates learning, whereas NPR-6 dampens ADF responses and slows learning. Through behavioral assays, calcium imaging, and genetic perturbations, we show that the dynamic balance between these receptor pathways tunes ADF activity and learning progression according to pathogen virulence. Finally, we develop a mathematical model incorporating pathogen intake, FLP-18 dynamics, receptor interactions, and ADF activity, which quantitatively captures the modulation of learning behavior across virulence levels. Together, our findings reveal a push–pull signaling mechanism within the gut–brain axis that translates internal state into flexible behavioral adaptation.

2026-08-01·Cell Chemical Biology

An ER stress-responsive RNA rheostat for programmable gene and mRNA therapies

Article

作者: Sanchez, Eliya B ; Asokan, Aravind ; Humkey, Matthew C ; Potter, Sofia K ; Pessoa, Cleiton T ; Webb, Gabriela M ; Ogurlu, Roza ; Wu, Helen L ; Fergione, Sophia M ; Rosales, Alan ; Sacha, Jonah B ; Vincent, Heather A ; Yudistyra, Vivian ; Hull, Joshua A

Therapeutic protein overexpression can overwhelm endoplasmic reticulum (ER) folding capacity, trigger unfolded protein response (UPR) signaling, and compromise the safety of gene and mRNA therapies. Here, we engineer stress-responsive RNA rheostats that couple transgene expression to endogenous ER stress sensing. Short RNA elements derived from X-box-binding protein 1 (XBP1) mRNA undergo inositol-requiring enzyme 1α (IRE1α)-dependent splicing under ER stress, inducing a frameshift that attenuates downstream protein expression. XBP1 switches function across DNA and mRNA delivery platforms and regulate the expression of fluorescent reporters, coagulation factor VIII, and Leronlimab, a therapeutic anti-CCR5 monoclonal antibody. Switch activation reduces ER stress markers while preserving expression under homeostatic conditions. We further demonstrate the regulation of Leronlimab expression in vivo using recombinant adeno-associated virus vectors. Together, these findings establish programmable RNA feedback control as a strategy for linking cellular proteostasis to therapeutic protein expression and improving the safety of gene and mRNA therapies.

2026-07-01·BIOCHIMIE

Effects of head group substitution on large antiviral polyamide-DNA binding kinetics

Article

作者: Fisher, Chris ; Koeller, Kevin J ; Song, Yang ; Niederschulte, Jacquelyn ; Edwards, Terri G ; Dupureur, Cynthia M ; Bashkin, James K ; Harris, G Davis

Hairpin polyamides are pyrrole-based polymers that bind in the minor groove of DNA with remarkable affinity and specificity. While the natural product netropsin that inspired PA design features a terminal guanidinium group, few studies have examined how the head groups affect PA-DNA binding behavior and biological activity. Here the effects of two headgroup substitutions on DNA binding and antiviral behavior are explored with two large (14- and 20-ring) hairpin polyamides. To complete two sets of three polyamides, the syntheses of two, 20-ring hairpin polyamides with N-terminal cationic substitutions (guanidinium (Guan) and tetramethyl guanidine (TMG)) are reported. Using a fluorescence binding assay, some small differences in binding affinity toward a small DNA hairpin are observed for the PA14 series, with head-group substitution weakening low-nM binding by at least several-fold. DNA binding kinetics for head group-substituted PA14 exhibit biphasic traces. The head groups have no effect on a diffusion-controlled binding event, but result in a newly observed, concentration-independent slower phase. In contrast, head group substitutions significantly weaken DNA binding for PA20, and in the case of PA20-Guan, by 1000-fold. Head group substitution results in a faster first binding event for PA20, and a newly detected, second, slower binding event. Head group substitutions do not significantly alter dissociation decay constants for the PA14 series, with little effect across the PA20 series. Perturbations in pM to low nM PA-DNA binding affinities have little to no impact on μM IC₅₀ and IC₉₀ values. However there is a positive correlation between long residence times and antiviral behavior.

210

项与 Leronlimab 相关的新闻（医药）

2026-10-19

·BioSpace

CytoDyn Appoints Robert E. Hoffman as Chief Executive Officer

Dr. Jacob Lalezari to remain with Company in scientific innovation and discovery role VANCOUVER, Washington, Oct. 19, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple solid-tumor oncology indications, including colorectal cancer (mCRC) and metastatic triple-negative breast cancer (mTNBC), today announced the appointment of Robert E. Hoffman as Chief Executive Officer, effective October 20, 2026. Mr. Hoffman takes over in place of Dr. Jacob Lalezari, who had served as Chief Executive Officer since November 2023. Dr. Lalezari will remain with CytoDyn as Head of Research and Translational Sciences, where he will focus on identifying and advancing new opportunities for leronlimab in solid-tumor oncology. The leadership transition comes as CytoDyn prepares for its next phase of clinical development, with a focus on advancing its oncology pipeline, pursuing regulatory milestones and exploring potential strategic partnerships. “Robert’s expertise is aligned with what’s next for CytoDyn as we look to 2027 as a year of clinical results, regulatory progress, and renewed partnering opportunities,” said Dr. Lalezari. “While our team executes the business plan to build on the very promising results from the CLOVER study, I will focus on identifying new opportunities for possible pursuits in solid-tumor oncology.” “We are entering a transformational period for the Company, with opportunities to build on the scientific and clinical progress achieved in recent years,” said Mr. Hoffman. “Jay has played an instrumental role in advancing the Company and helping establish a clearer path forward for leronlimab. I am grateful for his leadership and look forward to continuing to work closely with him as we focus on clinical execution, financial discipline and positioning CytoDyn for its next stage of growth.” The Board of Directors appointed Mr. Hoffman as Chief Executive Officer in consultation with Dr. Lalezari, who supports the transition and intends to continue to support the Company’s scientific efforts. In addition to assuming the CEO role, Mr. Hoffman will continue to serve as the principal accounting officer of the Company. About Robert E. Hoffman The Board of Directors appointed Robert E. Hoffman as the Company’s Chief Executive Officer, effective October 20, 2026. Mr. Hoffman first joined CytoDyn on May 15, 2025, originally serving as its Chief Financial Officer. Mr. Hoffman is an industry veteran with decades of financial and leadership experience, having served in a number of biotech executive and board roles. Most recently, he was the President, CEO, interim Chief Financial Officer and Chairperson of the board of directors of Kintara Therapeutics, Inc. Prior to that, he served as Chief Financial Officer and Senior Vice President of Heron Therapeutics, Inc., Chief Financial Officer and Executive Vice President of Innovus Pharmaceuticals, Inc. and Chief Financial Officer of AnaptysBio, Inc. Mr. Hoffman started his career at Arena Pharmaceuticals, Inc., rising through the ranks to Senior Vice President, Finance and Chief Financial Officer. Mr. Hoffman currently serves on the board of directors of TuHURA Biosciences and Fibrobiologics, Inc., and has previously served as a director of several public and private life sciences companies, including Esperion Therapeutics, Inc., ASLAN Pharmaceuticals Limited, Saniona AB, Kura Oncology, Inc., CombiMatrix Corporation, MabVax Therapeutics Holdings, Inc. and Aravive, Inc. Mr. Hoffman is a former member of the steering committee of the Association of Bioscience Financial Officers. He also formerly served as a director and President of the San Diego Chapter of Financial Executives International and was an advisor to the Financial Accounting Standards Board from 2010 to 2020. Mr. Hoffman holds a B.B.A. from St. Bonaventure University. About CytoDyn CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide. For more information, please visit and follow us on LinkedIn . Note Regarding Forward-Looking Statements This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2026, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law. Corporate Contact CytoDyn Inc. ir@cytodyn.com Media Contacts David Schull or Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC CytoDyn@russopartnersllc.com

高管变更

2026-10-18

·BioSpace

ESMO 2026 Presentations Deepen the Evidence Base for Natera’s Oncology Portfolio and Leadership in Ultrasensitive MRD Technology

Natera and its collaborators will present 20 abstracts, including 4 rapid oral presentations Signatera ™ Genome with Phased and Structural Variants, which has achieved detection below 1 part per 10 million and an LOD95 of 1 part per million, will be featured in Natera’s ESMO program AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that 20 abstracts featuring its technology will be presented at the 2026 European Society for Medical Oncology (ESMO) Annual Congress, taking place October 23–26 in Madrid, Spain. New evidence highlights the power of Natera’s latest ultrasensitive molecular residual disease (MRD) technology, Signatera Genome with Phased and Structural Variants, which has demonstrated an industry-leading analytical limit of detection (LOD95) below 1 part per million (ppm), and detection observed significantly below 1 part per 10 million. 1 Spanning tumor types and treatment modalities, multiple ESMO presentations will show that serial ctDNA testing provides meaningful clinical benefit: ICONIC trial in gastroesophageal cancer (abstract 2901P): Among patients treated with perioperative chemotherapy and immunotherapy, MRD clearance during neoadjuvant therapy was strongly associated with a lower risk of recurrence and a favorable pathologic response. Signatera Genome with Phased and Structural Variants detected all evaluable recurrences during surveillance, with a >7.3 month median lead time over standard imaging. SAGITTARIUS trial in colon cancer (abstract 808P): In this phase III trial, post-operative patients were randomized to a physician-choice adjuvant treatment plan prior to receiving MRD results to assess impact. The analysis showed that Signatera results influenced a change to providers’ pre-planned treatment for one in three patients, of which 87% were treatment de-escalated based on MRD negativity. Colorectal/Breast cancer (abstract 4258P): In a retrospective analysis of surveillance monitoring of stage I-III breast and colorectal cancer survivors, serial Signatera negativity was associated with an extremely low 2-year recurrence risk, which may help refine risk stratification and inform eligibility for solid organ transplant earlier than current methodologies. Breast cancer (abstract 1770RO): In HER2+ metastatic breast cancer, an analysis of exceptional responders on anti-HER2 therapy showed 81% with sustained MRD-negativity during serial monitoring, supporting the potential for Signatera-guided de-escalation. MDT-Bridge trial in non-small cell lung cancer (NSCLC) (abstract LBA62) : This phase II trial evaluated MRD clearance from baseline to pre-surgery/pre-CRT using the Clarity ™ assay with phased variant technology. MRD-guided reflex to liquid CGP drives actionable treatment decisions (abstract 4260P) : In a cohort of 50 patients across 10 tumor types, Signatera, complemented by reflex to blood-based comprehensive genomic profiling (liquid CGP), identified clinically relevant biomarkers in 18 patients, including ESR1, BRAF, FGFR3, and BRCA2 . “We are pleased to share data at ESMO that highlights our expanding diagnostics portfolio, which includes the newest version of our ultrasensitive Signatera Genome test,” said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection, Natera. “The incorporation of phased and structural variants results in the ability to detect ctDNA significantly below 1 part per 10 million and takes MRD sensitivity into a range we haven’t seen before.” The 2026 ESMO program featuring Natera’s technologies includes: October 23, 2026, 15:15 CET | Abstract 4258P Presenter: Hideaki Bando, M.D., Ph.D. Poster: Circulating tumor DNA (ctDNA)-informed risk prediction in breast (BC) and colorectal cancer (CRC) patients (pts): implications for solid organ transplant (SOT) October 23, 2026, 15:15 CET | Abstract 4265P Presenter: Luca Lazzari, Ph.D. Poster: Genomic alterations and association with post-surgery circulating tumor DNA status in early-stage colon cancer October 23, 2026, 15:15 CET | Abstract 4764P Presenter: Yousef Zakharia, M.D. Poster: Outcomes in patients with muscle-invasive bladder cancer with divergent differentiation or histologic subtypes from NIAGARA October 23, 2026, 15:15 CET | Abstract 3633P Presenter: Nicholas Bingham, BS Poster: Utility of circulating tumor DNA in patients with renal cell carcinoma at increased risk of recurrence after resection October 23, 2026, 16:15 CET | Abstract 542RO Presenter: Yukinori Ozaki, M.D., Ph.D. Rapid Oral: Prognostic impact of postoperative ctDNA surveillance on relapse-free survival and molecular lead time in high-risk breast cancer: JCOG1204A1 October 23, 2026, 15:15 CET | Abstract 4462P Presenter: Benjamin O. Herzberg, M.D. Poster: Genomic landscape of the SKI Complex in a large multi-cancer cohort of 260,000 tumors October 23, 2026, 15:15 CET | Abstract 4276P Presenter: Nicholas Hornstein, M.D., Ph.D. Poster: Quantification of circulating tumor DNA (ctDNA) in patients using a multi-cancer, methylation-based assay for tissue-free treatment response monitoring (tf-TRM) October 23, 2026, 15:15 CET | Abstract 4260P Presenter: Jason A. Mouabbi, M.D. Poster: Clinical utility of reflex liquid comprehensive genomic profiling (LCGP) to complement tumor-informed circulating tumor DNA (ctDNA) monitoring in solid tumors October 23, 2026, 15:15 CET | Abstract 4417P Presenter: Fizza Mughal, Ph.D. Poster: Plasma whole-exome sequencing (pWES) reveals somatic landscape and clonal dynamics in metastatic urothelial carcinoma October 24, 2026, 10:15 CET | Abstract 4741RO Presenter: Matthew D. Galsky, M.D. Rapid Oral: Exploratory analysis of molecular subtypes and association with treatment outcomes in patients (pts) with muscle-invasive bladder cancer (MIBC) from NIAGARA October 24, 2026, 12:00 CET | Abstract 574P Presenter: Adrianne L. Rolfes, M.D. Poster: Neoadjuvant anti-PD1 without chemotherapy in early-stage luminal B breast cancer October 24, 2026, 12:00 CET | Abstract 583P Presenter: Teck Long King Poster: ≥4 positive nodes identify a population enriched for ctDNA-guided adjuvant treatment escalation in ER+/HER2- early breast cancer October 25, 2026, 12:00 CET | Abstract 808P Presenter: Vicente Alonso-Orduna, M.D. Poster: ctDNA negativity influences adjuvant treatment decisions: a paired counterfactual analysis from the SAGITTARIUS trial October 25, 2026 | Abstract 870eP Presenter: Carlo Federici, Ph.D. e-Poster: Cost-effectiveness of a dynamic ctDNA-guided adjuvant strategy in stage II-III colon cancer, A SAGITTARIUS model-based analysis October 25, 2026, 12:00 CET | Abstract 810P Presenter: Stefano Tamberi, M.D., Ph.D. Poster: ctDNA-guided adjuvant trials may miss the molecular residual disease (MRD) window: evidence of early attrition during trial allocation October 25, 2026, 12:00 CET | Abstract 820P Presenter: Benjamin Weinberg, M.D. Poster: Leronlimab (LRM) in combination with trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) in metastatic colorectal cancer (mCRC): The phase 2 CLOVER study October 25, 2026, 12:00 CET | Abstract 3542P Presenter: Torben Van Zijp Poster: Organ preservation in rectal cancer after neoadjuvant radiotherapy, bevacizumab and atezolizumab: Translational analysis from the TARZAN study October 25, 2026, 12:00 CET | Abstract 2901P Presenter: Marco Gerlinger, M.D., FRCP Poster: Clinical performance of the Signatera Genome assay in patients with localized gastroesophageal adenocarcinomas (GEA) treated with peri-operative FLOT and immunotherapy: ICONIC trial October 26, 2026, 10:15 CET | Abstract 1770RO Presenter: Kazuki Nozawa, M.D. Rapid Oral: Ultra-sensitive MRD assessment in long-term complete responders to anti-HER2 therapy in HER2-positive metastatic breast cancer: Initial results from HER2-CR study October 26, 2026, 10:15 CET | Abstract LBA62 Presenter: Jonathan Spicer, M.D., Ph.D. Rapid Oral: ctDNA clearance (CL) during neoadjuvant treatment (neoadj Tx) and its association with outcomes in patients (pts) with resectable/borderline resectable stage IIB–IIIB NSCLC from MDT-BRIDGE References William B, Galanina N, Iqbal M, et al. ctDNA-Based MRD as a Dynamic Biomarker for Monitoring Treatment Response and Relapse in Lymphoma. SOHO 2026 Annual Meeting, Houston, TX, September 9-12, 2026. About Natera Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at and . Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

临床结果临床2期临床3期ASCO会议

2026-10-15

·GlobeNewswire-Health Care

CytoDyn to Host Investor Webcast

VANCOUVER, Wash., Oct. 15, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple solid-tumor oncology indications, including colorectal cancer (“mCRC”) and metastatic triple-negative breast cancer (“mTNBC”), today announced it will host an investor webcast on October 19, 2026, at 1 p.m. PT, to provide a corporate and clinical update. The investor webcast will highlight CytoDyn’s latest scientific, clinical, operational, and financial progress, as well as calendar 2026 priorities and upcoming milestones. Dr. Jacob P. Lalezari, CEO of CytoDyn, will be joined by Robert E. Hoffman, CFO of CytoDyn, and Pashtoon M. Kasi, M.D., M.S., Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. Reny Aniline, Senior Director of BioPharma Business Development of Natera, Inc., will also participate in the webcast to discuss the recently announced strategic collaboration between Natera and CytoDyn, and to provide further context on the early ctDNA observations in CytoDyn’s CLOVER study. Date: Monday, October 19, 2026 Time: 1 p.m. PT Registration and Access Link This is a livestream presentation. Attendees are advised to log in ahead of the start time. The Company will host a live Q&A session during the webcast; questions may be submitted in advance to ir@cytodyn.com. Following the conclusion of the webcast, a replay will be available for approximately 30 days in the investor relations section of the Company’s website. About CytoDynCytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide. For more information, please visit www.cytodyn.com and follow us on LinkedIn. Note Regarding Forward-Looking Statements This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2026, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law. Corporate ContactCytoDyn Inc.ir@cytodyn.com Media ContactsDavid Schull or Ignacio Guerrero-Ros, Ph.D.Russo Partners, LLCCytoDyn@russopartnersllc.com

100 项与 Leronlimab 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11399	Leronlimab	-	DB05941

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	申请上市	美国	CytoDyn, Inc.	2021-11-01
新型冠状病毒感染	临床3期	美国	CytoDyn, Inc.	2020-08-05
阿尔茨海默症	临床2期	美国	Weill Medical College of Cornell University	2026-04-30
脑炎	临床2期	美国	Weill Medical College of Cornell University	2026-04-30
神经炎症	临床2期	美国	Weill Medical College of Cornell University	2026-04-30
错配修复功能正常的微卫星稳定型结肠癌	临床2期	美国	CytoDyn, Inc.	2025-06-16
转移性结直肠癌	临床2期	-	CytoDyn, Inc.	2022-09-20
转移性微卫星稳定结直肠癌	临床2期	-	CytoDyn, Inc.	2022-09-20
微卫星稳定型结直肠癌	临床2期	-	CytoDyn, Inc.	2022-09-20
新冠肺炎后遗症	临床2期	美国	CytoDyn, Inc.	2021-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03838367 (ASCO2026)	临床1/2期	转移性三阴性乳腺癌 C-C chemokine receptor 5 (CCR5) \| PD-L1 low/negative	28	Leronlimab plus physician’s choice combination therapy	選網醖繭顧製艱蓋觸顧(衊範鏇襯鑰餘壓餘築製) = 10.7% 醖鑰觸鬱觸窪蓋製壓鏇 (憲築鏇艱鑰衊範衊淵夢 ) 更多	积极	2026-05-29
NCT02859961 (CTgov)	临床2/3期	HIV感染	562	PRO 140 (Part 1 - 350 mg Weekly Injections of PRO 140, Group A)	蓋憲醖積襯膚鹹夢網鏇 = 廠簾糧築積獵餘憲築淵壓衊製淵襯窪構繭繭構 (鹹齋範構獵艱壓選鏇淵, 憲醖觸鹹衊顧選繭醖齋 ~ 壓糧網淵積艱襯憲鹹積) 更多	-	2026-03-04
				PRO 140 (Part 1 - 525 mg Weekly Injections of PRO 140, Group B)	蓋憲醖積襯膚鹹夢網鏇 = 餘簾糧顧壓製構遞壓夢壓衊製淵襯窪構繭繭構 (鹹齋範構獵艱壓選鏇淵, 膚遞選淵餘簾蓋願憲糧 ~ 築鹽膚夢築蓋簾鑰鹽製) 更多
NCT04504942 (Phase 2 single-arm basket study, CTgov)	临床2期	转移性实体瘤 \| 实体瘤	16	Leronlimab	襯網襯網鬱鬱鹹獵顧齋 = 醖遞糧鏇襯簾鬱繭築積願築構積鹹廠簾鏇築範 (鬱衊醖築築簾鏇積艱糧, 鹽繭廠範壓鑰淵繭願鏇 ~ 網膚鬱廠淵鹽製顧衊構) 更多	-	2026-01-23
NCT03838367 (SABCS2025)	临床1/2期	三阴性乳腺癌 PD-L1 \| PD-1 \| CCR5	28	Leronlimab ± immune checkpoint inhibitors (ICI) + various chemotherapies	製齋襯網製繭築鬱餘淵(糧構獵衊觸網築選顧齋) = 憲獵願積膚鬱憲顧壓築糧願網網鏇鑰壓選餘蓋 (鹹壓遞簾鏇鬱衊糧夢觸 ) 更多	积极	2025-12-12
NCT02990858 (CTgov)	临床2/3期	HIV感染	43	PRO 140 (leronlimab) (PRO 140)	淵衊鹽壓獵築鑰襯鬱顧(糧鹽範糧醖範鏇選鏇醖) = 齋繭艱廠蓋願製蓋襯餘顧遞醖鏇簾齋窪廠鑰壓 (鹹鹽積艱蓋構繭鑰顧壓, 1.11) 更多	-	2025-11-12
				PRO 140 (leronlimab) (PRO 140 350 mg)	鑰壓遞製製艱選衊餘願(範選簾鑰構繭築鑰積築) = 膚膚鹹網顧鏇壓夢觸鏇鹽襯餘製願範齋窪衊襯 (餘壓淵壓獵醖遞鹹範齋, 夢築願構蓋築觸鏇鹽襯 ~ 願築壓衊觸襯範憲衊夢) 更多
NCT05271370 (CTgov)	临床2/3期	HIV感染	56	PRO 140 350 (PRO 140 350 mg)	鹹蓋膚觸鑰餘糧壓餘積 = 鏇鏇遞淵醖糧選夢獵築淵鹹願顧齋鹹廠鏇窪鑰 (憲膚鑰構選構網膚鑰淵, 獵襯蓋遞鏇網構願廠夢 ~ 窪膚夢構蓋簾範獵構蓋) 更多	-	2025-10-30
				PRO 140 525 (PRO 140 525 mg)	鹹蓋膚觸鑰餘糧壓餘積 = 醖築繭簾鏇鹽鑰鬱積獵淵鹹願顧齋鹹廠鏇窪鑰 (憲膚鑰構選構網膚鑰淵, 壓構窪鏇選淵鏇廠膚艱 ~ 夢鏇鑰顧築製築膚糧鹹) 更多
NCT02355184 (CTgov)	临床2期	HIV感染	20	PRO 140	構構願鏇積獵顧襯獵簾(構齋淵艱鏇鏇夢鑰廠衊) = 願築築淵範齋窪壓觸獵顧鹽窪遞夢範簾餘衊膚 (鬱窪淵簾淵簾網顧憲願, 225.6) 更多	-	2025-10-07
NCT03902522 (CTgov)	临床2/3期	HIV感染	6	PRO 140	艱鹽壓繭鹹鑰製鬱觸構 = 窪鹽鑰選鹽夢鏇壓觸襯窪膚醖鑰餘廠鏇獵膚蓋 (鏇鹹壓衊鏇醖壓艱窪淵, 醖齋廠選鑰觸積構鹹膚 ~ 繭鹽遞衊醖鹽積顧糧鑰) 更多	-	2025-09-16
NCT03838367 (CTgov)	临床1/2期	三阴性乳腺癌	10	AUC 5 Carboplatin+leronlimab (Phase II- MTD to be Established for the Combination Treatment)	鹽範鬱艱衊蓋鹹淵鬱蓋(醖膚憲鬱壓膚鏇簾衊窪) = 艱壓鬱夢鬱積積鹹窪衊願繭壓憲簾艱顧餘積廠 (壓積艱網鹽夢獵遞餘觸, 糧鏇鹽齋衊鏇築襯醖醖 ~ 網膚築衊憲鬱積獵衊壓) 更多	-	2025-09-09
				AUC 5 Carboplatin+350 mg leronlimab (Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin)	廠觸範鬱憲鏇鹽鏇壓醖 = 鬱糧襯壓膚餘積願觸齋積鑰壓鹹淵蓋窪範淵艱 (夢積範構餘顧蓋齋範壓, 網製鑰蓋憲襯製選廠鏇 ~ 襯鹽窪憲顧觸鏇網鏇衊) 更多
NCT04347239 (CTgov)	临床2期	新型冠状病毒感染	484	Placebo (Placebo)	遞選夢齋齋簾製遞糧鹹 = 蓋淵醖齋憲觸觸膚簾壓選鹽獵蓋選憲獵選繭襯 (鏇繭網齋醖鏇遞窪餘繭, 鑰鬱膚繭衊獵願製餘餘 ~ 繭範餘顧醖壓築積積製) 更多	-	2025-08-27
				Leronlimab (700mg) (700mg Leronlimab)	遞選夢齋齋簾製遞糧鹹 = 糧餘遞鏇願壓廠衊餘選選鹽獵蓋選憲獵選繭襯 (鏇繭網齋醖鏇遞窪餘繭, 遞簾鑰鏇選鏇餘醖鹽窪 ~ 襯壓衊選齋遞鑰顧鬱製) 更多