To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.

Start Date10 Jun 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07535632

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study on the Efficacy of Stereotactic Body Radiation Therapy Sequential Combined With Bevacizumab and Trifluridine/Tipiracil in the Treatment of Recurrent Metastatic Colorectal Cancer(BEST)

This phase II trial studies how well stereotactic body radiotherapy (SBRT) followed by a combination of an immune checkpoint inhibitor (sintilimab), bevacizumab, and trifluridine/tipiracil (TAS-102) works as third-line treatment for patients with recurrent or metastatic colorectal cancer (mCRC) that has progressed after at least two prior lines of systemic therapy.
The study will enroll 58 participants at Zhongshan Hospital, Fudan University. Participants will be randomly assigned (1:1) to either the experimental group or the control group. Those in the experimental group will receive SBRT to lung or liver metastases, followed one week later by sintilimab (200 mg every 2 weeks), bevacizumab (5 mg/kg every 2 weeks), and TAS-102 (35 mg/m² twice daily on days 1-5 every 2 weeks). Those in the control group will receive the investigator's choice of standard third-line therapy (such as TAS-102 alone or with bevacizumab, regorafenib, or fruquintinib).
The main purpose is to see whether the new combination extends the time without the cancer growing or spreading (progression-free survival, PFS). Other goals include measuring overall survival, tumor response rates, local control of treated tumors, abscopal (out-of-field) effects, safety, quality of life, and exploring biomarkers that might predict treatment response.
The study is expected to take 24 months to complete (12 months for enrollment and 12 months for follow-up). Results will help determine if adding SBRT and immunotherapy to standard chemotherapy and anti-angiogenic therapy is a beneficial option for patients with refractory mCRC.

Start Date01 Jun 2026

Sponsor / Collaborator

Zhongshan Hospital Fudan University

[+1]

NCT07525206

/ Not yet recruitingPhase 3

An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.
In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Start Date07 May 2026

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Tipiracil Hydrochloride/Trifluridine

100 Translational Medicine associated with Tipiracil Hydrochloride/Trifluridine

100 Patents (Medical) associated with Tipiracil Hydrochloride/Trifluridine

430

Literatures (Medical) associated with Tipiracil Hydrochloride/Trifluridine

01 Mar 2026·Immuno-oncology technology

Refractory microsatellite-stable metastatic colorectal cancer: a comparison between botensilimab + balstilimab and current standard of care

Article

Author: Picone, V ; Bengala, E ; Santini, D

Background:

The combination of botensilimab + balstilimab demonstrated promising clinical activity in heavily pre-treated patients with microsatellite-stable metastatic colorectal cancer (mCRC) in a recently published phase I study (NCT03860272).

Patients and methods:

Our objective was to derive overall survival (OS), progression-free survival (PFS) and safety data from the trials of reference of the current standard of care for refractory mCRC and from the above-mentioned study, and to compare them. After a systematic search of PubMed, we selected four studies (SUNLIGHT, FRESCO-2, RECOURSE, CORRECT). Individual patient OS and PFS data were extracted from Kaplan-Meier curves and more frequent toxic effect rates were collected.

Results:

Immunotherapy showed higher efficacy in terms of median OS both compared with trifluridine-tipiracil plus bevacizumab [hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.44-0.89] and to later lines of treatment: fruquintinib, regorafenib, and trifluridine-tipiracil alone. These results were confirmed by median PFS comparison of all the therapies except for the trifluridine-tipiracil + bevacizumab combination (HR 0.46, 95% CI 0.35-0.61 in favor of trifluridine-tipiracil + bevacizumab). As for treatment-related adverse events the most frequent with immunotherapy were fatigue and diarrhea. The other regimens were associated with hematologic toxic effects, nausea, hypertension, and dermatological toxicity.

Conclusion:

These findings suggest that the immunotherapy combination appears to be a potential option for patients with refractory mCRC while being associated with a completely different toxicity profile. However, confirmation of its efficacy awaits the results of randomized studies. Better comprehension of disease characteristics related to treatment response, such as metastatic sites and molecular biology, is warranted for patient selection.

24 Feb 2026·NEJM evidence

Trifluridine–Tipiracil with and without Bevacizumab in Colorectal Cancer

Article

Author: Cann, Christopher G. ; Khan, Nadeem ; Nusrat, Maliha ; Penney, Kathryn L. ; Zhao, Ruizhi ; Wang, Yuexi ; Salimi, Tehseen

BACKGROUND:

In the phase 3 SUNLIGHT trial (Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients), trifluridine-tipiracil+bevacizumab (FTD-TPI+bev) improved the overall survival of patients with metastatic colorectal cancer (mCRC) compared with trifluridine-tipiracil (FTD-TPI) monotherapy. We investigated the real-world outcomes of FTD-TPI+bev compared with FTD-TPI for patients with mCRC.

METHODS:

We analyzed U.S.-based electronic medical records and claims in the ConcertAI RWD360 dataset. Adults with mCRC were grouped by first exposure to FTD-TPI versus FTD-TPI+bev. Propensity score matching was used to balance the cohorts based on patient characteristics. Kaplan-Meier analyses were used to describe the real-world overall survival (rwOS, the primary outcome), time to treatment discontinuation (rwTTD), and time to next treatment or death (rwTTNTD).

RESULTS:

This cohort included 3151 patients treated with FTD-TPI and 529 patients treated with FTD-TPI+bev. After propensity score matching, 472 patients were included in each cohort with balanced patient characteristics. The median rwOS was 8.9 months (95% confidence interval [CI], 7.8 to 10.1) for FTD-TPI+bev and 5.8 months (95% CI, 4.9 to 6.7) for FTD-TPI (P<0.001). The median rwTTD was 3.5 months (95% CI, 3.2 to 3.8) in the FTD-TPI+bev group and 2.2 months (95% CI, 1.9 to 2.5) in the FTD-TPI group. The median rwTTNTD among the FTD-TPI+bev group was 4.9 months (95% CI, 4.5 to 5.4) and in the FTD-TPI group it was 3.5 months (95% CI, 3.1 to 3.7).

CONCLUSIONS:

This U.S.-based real-world observational study found that FTD-TPI+bev was associated with longer rwOS compared with FTD-TPI in patients with mCRC. These findings align with the results of the SUNLIGHT clinical trial. (Funded by Taiho Oncology, Inc. and others.).

05 Feb 2026·ONCOLOGIST

Third-line treatment decision-making for metastatic colorectal cancer: a cross-sectional survey of US community physicians

Article

Author: Khan, Nadeem ; Salimi, Tehseen ; Cann, Christopher ; Zhao, Sophia ; O’Donnell, Malinda ; Taylor, Melina

Abstract:

Background:

Colorectal cancer (CRC) is the second leading cause of cancer-related death worldwide, with increasing incidence in the US. Improvements in disease management and the increasing incidence of patients with metastatic CRC (mCRC) at younger ages has resulted in more patients being treated in the third-line setting. Treatment has evolved beyond chemotherapy with the approval of newer agents, but there is no consensus on the optimized choice or sequencing post second-line treatment. Identification of the drivers of treatment decisions may provide evidence to guide decision-making, ensuring that patients receive optimal care. The objective of this study was to evaluate treatment preferences and prescribing patterns for third-line mCRC among community-based physicians.

Methods:

This study surveyed community-based physicians in the US who were actively treating patients with mCRC.

Results:

Overall survival (OS) and impacts to patient quality of life (QoL) were primary considerations for any third-line treatment for mCRC. Physicians considered OS and progression-free survival (PFS) as extremely important factors when making third-line treatment decisions. Most physicians selected trifluridine-tipiracil (FTD-TPI) combined with bevacizumab as their first treatment choice for third-line mCRC (60%), compared to regorafenib (12%), FTD-TPI monotherapy (8%), capecitabine (8%), and fruquintinib (6%). Physicians identified fatigue, neutropenia, and hand-foot syndrome as the most challenging adverse events (AEs) to manage, while hand-foot syndrome and allergic reactions were AEs that would most likely lead physicians to discontinue treatment.

Conclusion:

These findings highlight the third-line treatment preferences and prescribing patterns of community-based physicians who are actively treating patients with mCRC.

143

News (Medical) associated with Tipiracil Hydrochloride/Trifluridine

01 May 2026

·allsci.com

AbbVie Q1’26 Earnings Call: Skyrizi combo doubles remission rates in refractory Crohn’s

During AbbVie’s Q1 2026 earnings conference call, held April 29, 2026, executives discussed the decision to accelerate Phase III development of the Skyrizi (risankizumab) plus ABBV-382 combination in inflammatory bowel disease after interim data showed double the endoscopic remission rate of either monotherapy in a highly refractory Crohn’s disease population. The company has also pulled forward its obesity Phase II program and signaled an earlier-than-expected regulatory submission for etentamig in multiple myeloma. Key Strategic Signals Skyrizi + ABBV-382 Combination: Interim data from AbbVie’s Crohn’s disease platform study showed the combination of Skyrizi (risankizumab) and ABBV-382, an anti-alpha 4 beta 7 antibody, achieved approximately 42% endoscopic remission at week 24 in a population where 82% had failed prior advanced therapies — double the rate observed with either monotherapy. Chief Scientific Officer Roopal Thakkar said the company observed a non-flat exposure-response relationship for ABBV-382, meaning patients with higher drug exposures fared better, and that a Phase IIb study initiating this summer will test a higher dose of ABBV-382 in combination with Skyrizi. AbbVie said it is simultaneously evaluating Phase III acceleration options and will evaluate Skyrizi in combination with ABBV-382 and separately with its extended half-life TL1A antibody, with ulcerative colitis (UC) included alongside Crohn’s disease. The Skyrizi plus lutikizumab cohort within the same platform study was discontinued after failing to differentiate meaningfully from Skyrizi monotherapy. Etentamig regulatory timeline advanced: AbbVie said it now expects to submit etentamig, its B-cell maturation antigen (BCMA) bispecific antibody, for regulatory review by the end of 2026 — earlier than previously guided. The Phase III monotherapy trial in third-line-plus multiple myeloma is tracking ahead of schedule, with a response rate readout anticipated in the third quarter of 2026 and the potential for a concurrent interim progression-free survival (PFS) analysis. If that interim PFS analysis is positive, AbbVie said regulatory submissions would follow in the same year. Thakkar also said plans are underway for a Phase III study evaluating etentamig in combination with pomalidomide in second-line-plus patients, including those previously exposed or refractory to anti-CD38 antibodies or who have lost response to a BCMA-directed CAR-T or antibody-drug conjugate (ADC). ABBV-295 obesity program accelerated: ABBV-295, a long-acting amylin analog with a half-life of approximately 270 hours, produced approximately 10% weight loss after 12 weeks in a multiple ascending dose study conducted predominantly in male, non-obese participants with a mean body mass index of approximately 29. AbbVie said the Phase II program has been pulled forward to the third quarter of 2026, with interim Phase I data in obese patients expected later this year. Thakkar noted the molecule signals through both amylin and calcitonin receptors, and said the pharmacodynamic profile supports potential monthly dosing in the maintenance setting, drawing an analogy to Skyrizi’s durable efficacy beyond its 28-day half-life. AbbVie also flagged active interest in external business development to complement ABBV-295 with additional obesity mechanisms, including oral agents and assets that preserve lean muscle mass. Analyst Pressure Points IBD combination positioning and competitive durability: JPMorgan analyst Christopher Schott pressed management on where the Skyrizi plus ABBV-382 combination fits in the treatment sequence — specifically whether it would be a second-line option post-Skyrizi or could reach the frontline. Thakkar said AbbVie does not intend to restrict the combination to refractory patients, noting that the platform study already enrolled patients who had previously received Skyrizi, vedolizumab, and Rinvoq (upadacitinib), and that frontline IBD use is commercially and clinically relevant given the risk of irreversible gut damage with uncontrolled inflammation. Schott also asked more broadly about AbbVie’s ability to sustain its immunology competitive position given increasing pipeline activity across the sector. Chief Executive Officer Robert Michael pointed to recent business development transactions — including Capstan Therapeutics for in vivo CAR-T B-cell depletion, Nimble Therapeutics for oral peptides, and additions of TL1A and IRAK4 mechanisms — as evidence that AbbVie is building depth beyond Skyrizi and Rinvoq for the next decade. RemeGen PD-1/VEGF bispecific differentiation: Deutsche Bank analyst James Shin pressed Thakkar on how RC-148, the PD-1/VEGF bispecific antibody acquired through the RemeGen agreement, can differentiate given its later entry into a field already occupied by established competitors. Thakkar said AbbVie’s strategy is not to develop RC-148 as a standalone asset but to deploy it as a combination partner for Temab-A, the company’s c-MET ADC, across colorectal, lung, and ovarian cancers — framing the asset’s value as contingent on ADC combinations rather than monotherapy positioning. Forward-Looking Catalysts Q3 2026 — etentamig Phase III response rate readout: The Phase III trial evaluating etentamig monotherapy in third-line-plus multiple myeloma is expected to deliver a response rate readout in the third quarter of 2026, with a potential concurrent interim PFS analysis. AbbVie said a positive interim PFS result would trigger regulatory submissions by year-end, making this the most time-sensitive oncology catalyst on the company’s near-term calendar. The trial’s ahead-of-schedule pace reduces execution risk on that timeline. H2 2027 readout for Temab-A colorectal cancer Phase III: Following AbbVie’s decision to pivot the next-generation c-Met directed ADC telisotuzumab adizutecan (Temab-A) colorectal cancer pivotal strategy from c-MET-selected monotherapy to an all-comers combination with bevacizumab, the company said it expects an initial data readout from the Phase III trial in the second half of 2027. The strategic rationale cited was a 30% objective response rate and 97% confirmed disease control rate for Temab-A plus bevacizumab versus 0% and 70%, respectively, for Lonsurf (trifluridine/tipiracil) plus bevacizumab as the comparator, with responses observed regardless of c-MET expression level. AbbVie also said Temab-A received its first breakthrough therapy designation as a monotherapy in second-line-plus EGFR wild-type non-squamous non-small cell lung cancer (NSCLC), with a Phase III trial in that setting in planning. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 2Phase 3Clinical ResultBreakthrough TherapyPhase 1

22 Apr 2026

·www.globenewswire.com

CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer at AACR Annual Meeting 2026

Ongoing Phase 2 study in metastatic colorectal cancer (mCRC) demonstrates early clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, supporting CCR5 as a therapeutic target VANCOUVER, Washington, April 22, 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 indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“mCRC”), today announced that new clinical data from its ongoing Phase 2 study in metastatic colorectal cancer (mCRC) were presented at the AACR Annual Meeting 2026, taking place April 17–22, 2026, at the San Diego Convention Center. The presentation highlighted findings supporting CCR5 inhibition with leronlimab as a strategy to modulate the tumor microenvironment, enhance immune engagement, and improve outcomes in metastatic colorectal cancer (mCRC), particularly in combination with standard-of-care therapies. Metastatic colorectal cancer remains a significant clinical challenge, particularly in patients with refractory disease who have progressed on multiple prior lines of therapy. While standard regimens such as TAS-102 in combination with bevacizumab provide modest benefit, treatment resistance and immune evasion continue to limit durable responses. Results presented at AACR demonstrate that CCR5 inhibition with leronlimab may enhance anti-tumor activity by modulating the tumor microenvironment and improving immune engagement. “Preliminary results from our ongoing Phase 2 study suggest that CCR5 inhibition with leronlimab may enhance both biomarker and clinical responses in heavily pretreated mCRC patients,” said Pashtoon M. Kasi, M.D., M.S., Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. “Real-time assessment of novel liquid biopsy biomarkers, including circulating tumor cells, circulating tumor DNA, and cancer-associated macrophage-like cells in blood, along with integrated evaluation of tumor tissue and the tumor microenvironment, is providing insights that conventional imaging and traditional assessment methods cannot capture.” Key findings from the ongoing Phase 2 mCRC study include: Among pre-screened patients with evaluable samples (N=33), CCR5 expression was detected in 100% of cases, supporting its potential as a therapeutic target in mCRC.Early clinical and biomarker responses were observed, including rapid and substantial reductions in circulating tumor DNA (ctDNA), with median declines of approximately 70% by week 2 across evaluable patients (N=19).The combination regimen has been well tolerated, with no leronlimab-related dose-limiting toxicities (DLTs) observed, and escalation to 700 mg dosing underway.The study continues to enroll toward full enrollment, reflecting significant unmet need in previously treated mCRC. “Building on the translational and clinical data presented earlier in the week in mTNBC, these findings further support CCR5 as a key regulator of the tumor microenvironment across solid tumors,” said Jacob P. Lalezari, M.D., Chief Executive Officer of CytoDyn. “The early biomarker and clinical signals observed in our ongoing Phase 2 mCRC study reinforce the potential of leronlimab-based combination approaches to enhance immune engagement and address resistance in heavily pretreated patients.” The poster presentation titled “Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer” was presented by Dr. Kasi on April 21, 2026, from 2:00 p.m. – 5:00 p.m. PT (Poster #6466). A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section. 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 StatementsThis 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, 2025, 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

22 Apr 2026

·www.biospace.com

CytoDyn Completes Enrollment in Phase 2 Metastatic Colorectal Cancer Study

Enrollment concludes with just over 60 patients participating across seven clinical sites located throughout the United States VANCOUVER, Washington, April 21, 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 indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“mCRC”),” today announced the completion of enrollment in its Phase 2 clinical study (ClinicalTrials.gov Identifier: NCT06699836 ) evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – C CR5-targeting L eronlimab With O ral Chemotherapy and V EGF-inhibitor E nriched R egimen. The open-label, randomized, two-arm, multi-center study is evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients who have progressed following prior standard therapies. With enrollment now complete, CytoDyn will advance the study through treatment and follow-up, with resulting data expected to inform the program’s development strategy and potential next steps. “Completing enrollment in this Phase 2 study marks an important milestone for CytoDyn and for the continued development of leronlimab in oncology,” said Dr. Jacob Lalezari, Chief Executive Officer of CytoDyn. “We are grateful to the patients, investigators, and clinical sites whose commitment made completion of enrollment possible and look forward to evaluating the study results.” “CLOVER is designed to prospectively assess the activity of leronlimab in combination with an established regimen in a difficult to treat and highly refractory patient population with microsatellite stable (MSS) metastatic colorectal cancer, ” said Pashtoon M. Kasi, M.D., M.S., Principal Investigator of the study and Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. “With enrollment now complete, the study is well positioned to generate meaningful insights in this patient population with a high unmet need.” The CLOVER study builds on emerging clinical and translational findings from CytoDyn’s ongoing Phase 2 mCRC program, including data being presented at the AACR Annual Meeting 2026. Preliminary results demonstrated early signals of clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, including rapid reductions in circulating tumor DNA and modulation of immune-related markers. These findings support further evaluation of CCR5 inhibition as a strategy to enhance anti-tumor activity in metastatic colorectal cancer. Leronlimab is a monoclonal antibody targeting CCR5, a receptor involved in immune cell trafficking and tumor biology. By blocking CCR5, leronlimab may help modulate the tumor microenvironment and enhance the activity of existing therapies in difficult-to-treat cancers. CytoDyn plans to share topline data from the study as they become available. About the Phase 2 mCRC Study (NCT06699836) This Phase 2 clinical study is an open-label, randomized, two-arm, multi-center study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – C CR5-targeting L eronlimab With O ral Chemotherapy and V EGF-inhibitor E nriched R egimen. Approximately 60 patients were enrolled and randomized 1:1 to receive either 350 mg or 700 mg of leronlimab in combination with standard-of-care therapy. Eligible participants are adults with histologically confirmed mCRC who have progressed following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, where appropriate, anti-EGFR therapy. The primary endpoint of the study is objective response rate (ORR), as defined by RECIST v1.1 criteria. Secondary endpoints include safety and tolerability, duration of response, and overall survival. Patients will be followed for up to 12 months. 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, 2025, 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 2Clinical ResultAACR

100 Deals associated with Tipiracil Hydrochloride/Trifluridine

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

R&D Status

Approved

10 top approved records.

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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.

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04109924 (TABAsCO, CTgov)	Phase 2	Recurrent Colon Cancer \| Rectal Adenocarcinoma \| Advanced Colorectal Adenocarcinoma ... View more	42	Trifluridine and Tipiracil Hydrochloride+Bevacizumab+Irinotecan	zcheralskx(nkgdobqlcb) = ojefydjsia mcaqovpxau (ymghytoeua, dlpskniecj - uvxnbukosv) View more	-	10 Feb 2026
NCT04457297 (ALTAIR \| ALTAIR Study, CTgov)	Phase 3	Adenocarcinoma of large intestine \| Colorectal Cancer \| Circulating Neoplastic Cells	243	trifluridine (Trifluridine and Tipiracil)	mxfboilzeq(yqikpoaojz) = ejuibziakv tsszkaamyr (gcjdhuanba, zukxiiciob - zwjvwkdxde) View more	-	21 Jan 2026
				Placebo (Placebo)	mxfboilzeq(yqikpoaojz) = dzlzavcgzf tsszkaamyr (gcjdhuanba, xrlukmprpl - gpkzdpxgew) View more
JPRN-jRCTs041220120 (RETRIEVE, ASCO_GI2026)	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma Third line	111	FTD/TPI plus RAM	xuybdduitd(pbvmlutrjy) = vtwjjtgmyf clnfahhedj (kiogtwwgvq ) View more	Negative	08 Jan 2026
				FTD/TPI	xuybdduitd(pbvmlutrjy) = gcqqfrfpxe clnfahhedj (kiogtwwgvq ) View more
SUNLIGHT (ASCO_GI2026)	-	Metastatic Colorectal Carcinoma	585	TAS-102 plus bevacizumab	mujiotoeuq(qaekzlfplk) = qbizuvsvyf jwjmvjyuso (souydmcgdq ) View more	Positive	08 Jan 2026
				TAS-102 alone	mujiotoeuq(qaekzlfplk) = zqqfdyfzvp jwjmvjyuso (souydmcgdq ) View more
JPRN-jRCTs041210105 (ASCO_GI2026)	Phase 2	Advanced gastric carcinoma Third line	32	Trifluridine/tipiracil plus Ramucirumab (Advanced Gastric Cancer)	safbetikcx(lzepmvwhvl) = taetyspojy ttsdhnwkwd (cbuwlfjzwj, 2.8 - 5.0) View more	Positive	08 Jan 2026
NCT04457297 (ALTAIR, ASCO_GI2026)	Phase 3	Colorectal Cancer ctDNA-positive	2,016	Trifluridine/tipiracil	lmuaeulhqd(gfixknpsou) = wtlexbwttg ovicxylvnt (xlpzhekiip ) View more	Positive	08 Jan 2026
NCT05970705 (FDZL-REGOT, ASCO_GI2026)	Phase 2	Metastatic Colorectal Carcinoma Third line	102	Regorafenib + Trifluridine/Tipiracil	grngdovrat(kckcogophd) = guzyderatv dlktwmclqm (vkeubaiiyu, 4.3 - 8.17) View more	Positive	08 Jan 2026
				Regorafenib	grngdovrat(kckcogophd) = roinxyecof dlktwmclqm (vkeubaiiyu, 2.1 - 3.47) View more
NCT05854498 (ASCO_GI2026)	Phase 2	Metastatic Colorectal Carcinoma KRAS	25	Nanoliposomal irinotecan + TAS102 + bevacizumab	eanhgrclmt(hsgiljwhqg) = inohgmjyoa uhubmtwlrq (pnclocigxx ) View more	Positive	08 Jan 2026
NCT05343013 (ASCO_GI2026)	Phase 2	Colorectal Cancer ctDNA	15	TAS-102 + Celecoxib	lthgycwpam(aypphgsgur) = dljfxdhsbf prxsggbvna (jsiipocahg ) View more	Positive	08 Jan 2026
SUNLIGHT (ASCO_GI2026)	Not Applicable	Metastatic Colorectal Carcinoma	1,672	Trifluridine/tipiracil + Bevacizumab	yrdyupduge(cdggqxawec): HR = 0.97, P-Value = 0.8 View more	Positive	08 Jan 2026
				Trifluridine/tipiracil

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