A Phase 2, Randomized, Open Label Study to Evaluate Efficacy, Safety, and Tolerability of CA102N Combined With Trifluridine/Tipiracil (TAS-102) Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer (mCRC) Who Failed the Standard Treatment

HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).

Start Date01 Dec 2027

Sponsor / Collaborator

Holy Stone Healthcare Co., Ltd.

NCT07649655

/ RecruitingPhase 1

A Phase Ib, Open-Label Study of EMB-01 in Combination With Chemotherapy in Patients With Unresectable or Metastatic Colorectal Cancer

This is an open-label, multicenter, Phase Ib trial designed to evaluate the safety, tolerability, and preliminary efficacy of EMB-01 in combination with chemotherapy in patients with unresectable or metastatic colorectal cancer (CRC), and to determine the recommended Phase II combination dose (RP2CD). The study consists of a dose escalation phase followed by a dose expansion phase. Approximately 30 patients are planned to be enrolled in each combination treatment group across both phases, with a maximum total enrollment of approximately 120 patients.

Start Date30 Sep 2026

Sponsor / Collaborator

EpimAb Biotherapeutics, Inc.

NCT07861360

/ Active, not recruitingNot ApplicableIIT

Emulation of the SUNLIGHT (NCT04737187) Trial Using Specialty Oncology Electronic Health Records Databases

This observational study uses existing U.S. specialty oncology electronic health records to emulate the SUNLIGHT trial. It compares survival among adults with metastatic colorectal cancer who began trifluridine-tipiracil plus bevacizumab or trifluridine-tipiracil alone after prior systemic treatment. Treatment was chosen during routine care; the study did not assign treatment. The main outcome is time to death from any cause. Investigators will compare the real-world estimate with the published estimate from the randomized SUNLIGHT trial.

Start Date24 Sep 2026

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

100 Clinical Results associated with Tipiracil Hydrochloride/Trifluridine

100 Translational Medicine associated with Tipiracil Hydrochloride/Trifluridine

100 Patents (Medical) associated with Tipiracil Hydrochloride/Trifluridine

425

Literatures (Medical) associated with Tipiracil Hydrochloride/Trifluridine

01 Nov 2026·ANTI-CANCER DRUGS

Prolonged multimodal disease control with trifluridine/tipiracil plus bevacizumab in KRAS-mutant metastatic rectal cancer: a case report

Article

Author: Alkan, Onur ; Nazli, İsmail ; Başgöze, Ahmet

Refractory metastatic colorectal cancer (mCRC) management is further complicated when fluoropyrimidine-based therapy is contraindicated, leaving few systemic options. We present a 57-year-old man with KRAS G13D-mutant, liver-dominant metastatic rectal adenocarcinoma and recurrent fluoropyrimidine-associated coronary vasospasm precluding 5-fluorouracil and capecitabine. After multimodal first-line therapy and regorafenib, trifluridine/tipiracil (TAS-102) plus bevacizumab was initiated and integrated with liver-directed treatments for oligoprogressive disease. This combined strategy achieved approximately 16.6 months of disease control, substantially exceeding the median progression-free survival reported in the SUNLIGHT trial, with manageable hematological toxicity and preserved performance status. This case highlights the value of TAS-102 plus bevacizumab combined with focal liver-directed therapy as a feasible long-term strategy for selected patients with oligoprogressive mCRC when fluoropyrimidines cannot be used.

01 Sep 2026·ESMO Gastrointestinal Oncology

The Danish randomized trial of trifluridine–tipiracil and bevacizumab in metastatic colorectal cancer: final survival and post hoc neutropenia and quality-of-life analyses

Article

Author: Qvortrup, C ; Pfeiffer, P ; Zitnjak, D ; Tarpgaard, L S ; Winther, S B ; Brink, C ; Poulsen, L Ø ; Kreiberg, K B ; Yilmaz, M N

Background:

In 2020, we published the first randomized trial demonstrating the efficacy of trifluridine-tipiracil (FTD-TPI) with bevacizumab compared with FTD-TPI monotherapy in chemorefractory metastatic colorectal cancer. This study aims to: (i) analyze final survival data, (ii) perform post hoc analyses of the prognostic role of chemotherapy-induced neutropenia (CIN), and (iii) assess time to deterioration of performance status (PS) as a measure associated with quality of life in post hoc analyses.

Materials and methods:

The Kaplan-Meier method and Cox proportional hazards models were used to analyze final survival data for all 93 patients included in the trial. CIN was modeled as a time-varying covariate.

Results:

Progression-free survival was 4.6 months [95% confidence interval (CI) 3.7-6.5] with FTD-TPI plus bevacizumab versus 2.4 months (95% CI 1.8-3.6) with FTD-TPI; hazard ratio (HR) 0.47 (95% CI 0.31-0.73). Overall survival was 10.0 months (95% CI 8.1-12.7) with FTD-TPI plus bevacizumab versus 6.0 months (95% CI 5.5-7.9) with FTD-TPI; HR 0.55 (95% CI 0.36-0.84). CIN was associated with reduced hazard of progression; HR 0.32 (95% CI 0.15-0.70) for FTD-TPI and HR 0.22 (95% CI 0.10-0.52) for FTD-TPI plus bevacizumab. CIN was also associated with reduced hazard of death: HR 0.62 (95% CI 0.39-0.97) for FTD-TPI and HR 0.64 (95% CI 0.35-1.17) for FTD-TPI plus bevacizumab. Patients receiving FTD-TPI plus bevacizumab had longer time to PS worsening to ≥2: HR 0.39 (95% CI 0.25-0.61).

Conclusions:

Our findings support the superiority of FTD-TPI plus bevacizumab over FTD-TPI in prolonging survival and maintaining PS. CIN was associated with improved survival outcomes.

01 Jul 2026·NATURE MEDICINE

Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial

Article

Author: Aleshin, Alexey ; Rabinowitz, Matthew ; Yamazaki, Kentaro ; Komatsu, Yoshito ; Yeh, Kun-Huei ; Kotaka, Masahito ; Sato, Akihiro ; Takemasa, Ichiro ; Sharma, Shruti ; Oki, Eiji ; Liang, Yi-Hsin ; Watanabe, Jun ; Kato, Takeshi ; Kotani, Daisuke ; Watsuji, Yuko ; Bando, Hideaki ; Aushev, Vasily N ; Jurdi, Adham ; Manaka, Dai ; Nakamura, Yoshiaki ; Taniguchi, Hiroya ; Liu, Minetta C ; Hirata, Keiji ; Shiozawa, Manabu ; Takahashi, Masanobu ; Fukui, Makoto ; Kanazawa, Akiyoshi ; Yoshino, Takayuki ; Matsuhashi, Nobuhisa ; Miyamoto, Yuji ; Misumi, Toshihiro ; Shi, Qian ; Yamamoto, Yuko ; Takahashi, Yusuke

Tumor-informed circulating tumor DNA (ctDNA) enables detection of molecular residual disease (MRD) after curative resection of colorectal cancer (CRC), but whether early intervention improves outcomes remains uncertain. ALTAIR was a randomized, double-blind, phase 3 trial embedded in the CIRCULATE-Japan platform evaluating a post-adjuvant ctDNA surveillance strategy with treatment initiation upon molecular recurrence. Patients with resected stage 0-IV CRC who became ctDNA positive after completion of standard-of-care therapy and had no radiological evidence of disease were randomly assigned (1:1) to receive trifluridine/tipiracil (FTD/TPI) or placebo for 6 months. The primary endpoint was investigator-assessed disease-free survival (DFS). Between July 2020 and June 2023, 243 patients were randomized to FTD/TPI (n = 122) or placebo (n = 121). Median DFS was 9.30 months with FTD/TPI and 5.55 months with placebo (hazard ratio = 0.79, 95% confidence interval: 0.60-1.05, P = 0.107), and the primary endpoint was not met. FTD/TPI increased grade 3 or higher hematologic adverse events (73.0% versus 3.3%) without new safety signals. These findings indicate that post-adjuvant intervention with FTD/TPI did not significantly improve DFS in ctDNA-positive patients without radiological disease. ClinicalTrials.gov identifier: NCT04457297 .

158

News (Medical) associated with Tipiracil Hydrochloride/Trifluridine

14 Oct 2026

·www.globenewswire.com

Oncolytics Biotech® Provides Update on GOBLET Study Clinical Data and Final PanCAN Grant Payment

Completion of enrollment earlier this year and expected final PanCAN grant payment this quarter mark successful completion of a key phase of Cohort 5 Final Cohort 4 results expected in Q4 2026; initial Cohort 5 results expected in the first half of 2027 The Company will use the clinical data to focus and guide its strategy to combine pelareorep with a checkpoint inhibitor in gastrointestinal and additional tumors SAN DIEGO, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced an update regarding the status of its GOBLET Phase 1/2 study, including timing for the release of certain clinical data. It also declared that it will receive the final payment under its grant from the Pancreatic Cancer Action Network (“PanCAN”) later this quarter, following the completion of certain activities in Cohort 5 of the study. Patients remain on treatment and in follow-up in two GOBLET cohorts. Cohort 4 is evaluating pelareorep with atezolizumab in patients with second-line and later squamous cell anal carcinoma, while Cohort 5 is evaluating pelareorep-based therapy in combination with chemotherapy with and without atezolizumab in patients with first-line metastatic pancreatic ductal adenocarcinoma (“PDAC”). Oncolytics expects to report final results from Cohort 4 in the fourth quarter of 2026. Initial results from Cohort 5 are expected in the first half of 2027, but could be extended as multiple patients continue treatment and follow-up. “We are incredibly grateful to PanCAN for its support of GOBLET Cohort 5 and, more broadly, for the extraordinary work the organization does every day on behalf of patients and families affected by pancreatic cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “PanCAN has played an important role in advancing pancreatic cancer research by bringing together patients, researchers, clinicians, and industry around the shared goal of developing better treatments for this devastating disease. We are proud to have worked with PanCAN through GOBLET and deeply appreciate the organization’s support as we complete this phase of the study and continue following patients in our anal and pancreatic cancer cohorts.” The GOBLET study has played an important role in the clinical development of pelareorep by evaluating its potential across multiple gastrointestinal cancers in combination with a checkpoint inhibitor and generating clinical and translational data that have informed the Company’s ongoing development strategy. With enrollment now complete, Oncolytics is winding down the broader GOBLET study infrastructure while continuing treatment and follow-up of remaining patients and preparing for upcoming clinical data readouts from the remaining cohorts. Notably, each cohort that enrolled the required number of patients met its pre-specified success criteria for efficacy. “The efficacy data from Cohort 5, including overall survival and duration of response, continue to mature, and we will provide an update to investors and stakeholders as soon as possible,” said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. “In parallel, we continue to monitor patients in Cohort 4 and are happy to report that median overall survival exceeds our expectations. The full data set is still being processed, and we anticipate sharing more details before the end of the year.” About GOBLET The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH (“AIO”). The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment cohorts: Pelareorep in combination with atezolizumab (Tecentriq®), gemcitabine, and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients;Pelareorep in combination with atezolizumab in first-line MSI (microsatellite instability)-high metastatic colorectal cancer patients;Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patientsPelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients; andPelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. About AIOAIO emerged from the study center of the medical oncology working group within the German Cancer Society. AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About PelareorepPelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types. About Oncolytics Biotech Inc.Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically inactive tumors to active through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the U.S. Food and Drug Administration for colorectal, anal, and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. Forward-looking statementsThis press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the timing, continued treatment and follow-up of patients, and results of Cohorts 4 and 5 of the GOBLET study; the winding down of the broader GOBLET study infrastructure; the potential clinical benefits of pelareorep; timing of final payment under the PanCAN grant; the continued clinical development of pelareorep; statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the anticipated timelines and expected outcomes for current and future studies; the Company’s belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers, including colorectal cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon PattonDirector of IR & Communicationjpatton@oncolytics.com

ImmunotherapyFast TrackClinical ResultPhase 2

14 Oct 2026

·www.biospace.com

Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib for Use as a First-line Treatment Option for Unresectable or Metastatic Hepatocellular Carcinoma

Combination achieved mOS of 23.8 months in patients with unresectable or metastatic HCC FORT LEE, N.J., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients with cancer, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment option for unresectable or metastatic hepatocellular carcinoma (uHCC). In July 2026, the FDA issued a Complete Response Letter (CRL) for a previous NDA submitted in January 2026. Following work with the FDA and its partner, Hengrui Pharma, Elevar resubmitted the NDA on October 9, 2026, in response to the CRL. “Our Elevar team has remained steadfast in our commitment to bring a novel combination therapy for uHCC to patients and healthcare providers, as uHCC remains an area of significant unmet medical need,” said Dong-Gun Kim, chief executive officer of Elevar Therapeutics. “Following submission of our response to the Complete Response Letter (CRL), we look forward to continued engagement with the FDA as it reviews the NDA for this combination therapy, which demonstrated positive overall survival and progression-free survival results and a manageable safety pro the CARES-310 study.” The NDA is based on the global Phase 3 CARES-310 study, in which first-line camrelizumab plus rivoceranib combination therapy achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months (HR = 0.64, 95% CI 0.52 - 0.79, P< 0.0001). Results observed across multiple patient subgroups were generally consistent. In December 2025, the final analysis was published in The Lancet Oncology , a leading international medical journal. In addition, prior to regulatory approval, the combination regimen was included as a first-line treatment option for advanced HCC in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines in recognition of the treatment’s clinical relevance. For more information about the combination of camrelizumab and rivoceranib, visit ElevarTX.com . About Hepatocellular Carcinoma Hepatocellular carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society. About Rivoceranib Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf ® ). Rivoceranib, under the name apatinib (Aitan ® ), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety pro other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma, is the license-holder of rivoceranib in the Chinese territory. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid cancers. Camrelizumab is developed by Hengrui Pharma. Under the brand name AiRuiKa ® , Camrelizumab is currently approved for 10 indications in China, covering lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and cervical cancer. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab in combination with rivoceranib for HCC for commercialization from Hengrui Pharma worldwide excluding Greater China and South Korea. About Elevar Therapeutics Elevar Therapeutics, Inc., is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for cancer patients. A subsidiary of HLB Co., Ltd. based in Fort Lee, New Jersey, Elevar’s expertise is rooted in oncology and grounded in compassion. Our team of experienced scientists and industry leaders is highly focused on identifying and developing medicines for complex yet under-treated health conditions, with a shared goal of making a meaningful difference in the lives of patients. For more information, follow us on LinkedIn and X or visit ElevarTX.com . Media Contact: Mason Levinson mlevinson@rosecomm.com Cell: (908) 358-4826

Phase 3Orphan DrugImmunotherapyNDAClinical Result

08 Oct 2026

·www.biospace.com

CytoDyn to Present Updated Data from Phase 2 CLOVER Clinical Study at ESMO Congress 2026

VANCOUVER, Washington, Oct. 08, 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 that updated clinical data from its ongoing Phase 2 CLOVER study (ClinicalTrials.gov Identifier: NCT06699836 ), evaluating leronlimab in combination with trifluridine and tipiracil (“TAS-102”) plus bevacizumab in patients with previously treated mCRC, will be presented at the ESMO Congress 2026, taking place October 23–27, 2026, in Madrid, Spain. Details of the poster presentation are as follows: Abstract title: Leronlimab (LRM) in combination with trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) in metastatic colorectal cancer (mCRC): The phase 2 CLOVER study Presenter: Benjamin Weinberg, M.D., Associate Professor at Georgetown University Date and Time: Sunday, October 25, 2026, 12:00-12:45 p.m. CET (local time) Poster ID: 820P Location: Poster Area, Hall 5, IFEMA Madrid “We are excited to present updated findings from the CLOVER study at ESMO and share additional clinical and translational insights from our metastatic colorectal cancer program,” said Jacob P. Lalezari, M.D., Chief Executive Officer of CytoDyn. “These data will contribute to our understanding of CCR5 biology in colorectal cancer and help inform the continued development of leronlimab in combination with established therapies for patients with difficult-to-treat disease.” A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section, shortly after the presentation date. About the European Society for Medical Oncology (ESMO) Congress 2026 The ESMO Congress 2026, taking place October 23–27, 2026, in Madrid, Spain, is a leading global oncology meeting bringing together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from around the world. The Congress provides a global platform for advances in oncology research, clinical practice and patient care, featuring new scientific data, educational programming, networking opportunities and innovation across the oncology community. For more information, visit esmo.org . 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

Phase 2ASCO

100 Deals associated with Tipiracil Hydrochloride/Trifluridine

External Link

KEGG	Wiki	ATC	Drug Bank
D10526	Tipiracil Hydrochloride/Trifluridine	L01BC	DB08937

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2-positive gastric cancer	South Korea	Jeil Pharmaceutical Co., Ltd.	17 Oct 2019
Metastatic Gastric Carcinoma	Australia	Servier Laboratories (Australia) Pty Ltd.	23 May 2017
Metastatic Gastroesophageal Junction Adenocarcinoma	Australia	Servier Laboratories (Australia) Pty Ltd.	23 May 2017
Gastroesophageal junction adenocarcinoma	European Union	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Iceland	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Liechtenstein	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Norway	Les Laboratoires Servier SAS	25 Apr 2016
Metastatic Colorectal Carcinoma	United States	Taiho Oncology, Inc.	22 Sep 2015
Colorectal Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014
Stomach Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	United States	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Japan	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Belgium	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Denmark	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Finland	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Hungary	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
Adenocarcinoma of large intestine	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025
Dihydropyrimidine Dehydrogenase Deficiency	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025
Gastrooesophageal junction cancer	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025
Rectal Cancer	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_GI2026 \| ESMO_GCC2026	Not Applicable	Metastatic Colorectal Carcinoma Third line	142	Trifluridine tipiracil + bevacizumab (FTD-TPI/Bev)	spjyfkuipl(fmnllynmym) = 9.86% pyzibsmhnv (fcpwaehdba ) View more	Positive	02 Jul 2026
RETRIEVE (ESMO_GI2026)	Phase 2	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma Last line	111	FTD/TPI + Ramucirumab	syrshbffrr(itsezzxhce) = ECOG PS 1 (vs 0) was associated with poorer OS (HR 1.454, 95% CI 1.044–2.027, P = 0.025). ogpyskiwfh (suohokalnf ) View more	Positive	02 Jul 2026
				FTD/TPI
ReTrITA (ESMO_GI2026)	Not Applicable	Metastatic Colorectal Carcinoma	1,156	Trifluridine/tipiracil (T) + Regorafenib (R)	toibhrkgro(egajmhlspy) = gmezxfxpin oyzhnlwcsr (aidfijhwuh ) View more	Positive	02 Jul 2026
				Regorafenib (R) + Trifluridine/tipiracil (T)	toibhrkgro(egajmhlspy) = rbuzwepyhe oyzhnlwcsr (aidfijhwuh ) View more
ESMO_GI2026	Not Applicable	Metastatic Gastric Carcinoma	90	Trifluridine/tipiracil (FTD/TPI)	rsrynzhsfp(aogedhdbwu) = vhndlsjzkr fyahwsrzng (gnmxvwhzwo ) View more	Positive	02 Jul 2026
				Oxaliplatin retreatment (FOLFOX or XELOX)	rsrynzhsfp(aogedhdbwu) = zdzqwcfdlm fyahwsrzng (gnmxvwhzwo ) View more
ESMO_GI2026	Not Applicable	Metastatic Colorectal Carcinoma KRASG12	317	FTD/TPI alone	yaqbyospqc(cqekotuuxh) = culvzctjhf kewfykcybm (pfxxpmuwad ) View more	Positive	02 Jul 2026
				FTD/TPI + bevacizumab	yaqbyospqc(cqekotuuxh) = jmgplnjryo kewfykcybm (pfxxpmuwad ) View more
ESMO_GI2026	Not Applicable	Metastatic Colorectal Carcinoma KRAS \| NRAS \| BRAF ... View more	100	Trifluridine/tipiracil plus bevacizumab	kvfihhdzyb(kmqujpsmab) = qejqoglhzd jatdpyapjg (xwitsrdxng, 4.1 - 6.0) View more	Positive	02 Jul 2026
ESMO_GI2026	Not Applicable	Metastatic Colorectal Carcinoma	71	Trifluridine/tipiracil + bevacizumab	sexeotgrkc(uvqkjizaaq) = cxtjcqfrsz mapyhsubgh (jqnquqizrv, 2.8 - 6.5) View more	Positive	02 Jul 2026
NCT07381764 (ROMANCE, ESMO_GI2026)	Phase 2	Metastatic Colorectal Carcinoma Third line RAS/BRAF wild-type \| pMMR	150	Irinotecan plus cetuximab	gwgypbqsah(meywrkvlvh) = iywgdvwgol bdlxonlzsd (twtmnfipok ) View more	Positive	02 Jul 2026
				trifluridine/tipiracil plus bevacizumab	gwgypbqsah(meywrkvlvh) = pcilsigkmw bdlxonlzsd (twtmnfipok )
NCT04457297 (ALTAIR, Pubmed \| Nat Med)	Phase 3	Colorectal Cancer ctDNA positive	243	Trifluridine/tipiracil (FTD/TPI)	elcpinnmrs(wunpatvuoz) = ubcrxqiyaz twginzejsp (mxumpawzsj ) View more	Negative	08 Jun 2026
				Placebo	elcpinnmrs(wunpatvuoz) = nvowfpdglr twginzejsp (mxumpawzsj ) View more
NCT04104139 (FIERCE, Pubmed \| Clin Colorectal Cancer)	Phase 1	Rectal Cancer Neoadjuvant	18	Trifluridine/Tipiracil	rczhmxjlhl(hokzkrichg) = fzqpvjcebe giscyijxtg (rbieqhhrjv ) View more	Positive	01 Jun 2026

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