A Randomized Phase 1/2 Trial Evaluating the Addition of Tolinapant to Weekly Paclitaxel With or Without Bevacizumab in Patients With Recurrent Epithelial Ovarian Cancer

This phase I/II trial tests the safety, best dose and effectiveness of adding tolinapant (ASTX660) to paclitaxel with or without bevacizumab in treating patients with ovarian cancer that has come back after a period of improvement (recurrent). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, that promote the growth of tumor cells and increase resistance to chemotherapy. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of tumor cells. Adding ASTX660 to paclitaxel with or without bevacizumab may be safe, tolerable and/or effective in treating patients with recurrent ovarian cancer.

Start Date31 Oct 2025

Sponsor / Collaborator

National Cancer Institute

NCT06590558

/ WithdrawnPhase 1IIT

Phase I/Ib Study of Eribulin in Combination With ASTX660 (Tolinapant) in Metastatic Triple Negative Breast Cancer (TNBC)

This phase I/Ib trial tests the safety, side effects, best dose, and effectiveness of ASTX660 (tolinapant) in combination with eribulin mesylate (eribulin) in treating patients with triple negative breast cancer that cannot be removed by surgery (unresectable) or that has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, needed for tumor cell survival. Chemotherapy drugs, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tolinapant in combination with eribulin may be safe, tolerable, and/or effective in treating patients with unresectable, locally advanced, or metastatic triple negative breast cancer.

Start Date04 Aug 2025

Sponsor / Collaborator

National Cancer Institute

ISRCTN11197711

/ SuspendedPhase 1IIT

ASTFOX : A Phase I study of IAP antagonist, ASTX660 (tolinapant), in combination with standard of care FOLFOX chemotherapy in metastatic colorectal cancer

Start Date17 Jul 2024

Sponsor / Collaborator

NHS Greater Glasgow & Clyde

[+1]

100 Clinical Results associated with Tolinapant

100 Translational Medicine associated with Tolinapant

100 Patents (Medical) associated with Tolinapant

Literatures (Medical) associated with Tolinapant

01 Dec 2025·Blood Research

Translational investigation of tolinapant (ASTX660) in acute myeloid leukemia by integrating clinical, bioinformatic and pharmacological approaches

Letter

Author: Nogueira, Frederico Lisboa ; Lima, Keli ; Reis-Silva, Catarina Sofia Mateus ; de Cássia Cavaglieri, Rita ; Costa-Lotufo, Leticia Veras ; Rego, Eduardo Magalhães ; Machado-Neto, João Agostinho

15 Jul 2025·CLINICAL CANCER RESEARCH

Early-Phase Trial of IAP Antagonist Tolinapant and Definitive Radiation in Cisplatin-Ineligible Patients with Advanced Head and Neck Cancer

Article

Author: McDonald, Mark W. ; Saba, Nabil F. ; Shin, Dong M. ; Kaka, Azeem S. ; Patel, Mihir R. ; Schmitt, Nicole C. ; Bates, James E. ; Steuer, Conor E. ; Steininger, Madison ; Stokes, William A. ; Gross, Jennifer H. ; Rudra, Soumon ; Remick, Jill ; Kinney, Brendan L.C. ; Switchenko, Jeffrey ; Oyewole, Mosope

Abstract:

Purpose::

Tolinapant is an inhibitor of apoptosis protein antagonist that enhances apoptotic pathways. In preclinical studies, tolinapant + radiotherapy (RT) enhances antitumor immunity. We conducted an open-label, single-arm trial to evaluate the safety and feasibility of concurrent tolinapant and RT in cisplatin-ineligible patients with head and neck squamous cell carcinoma.

Patients and Methods::

Eligible patients had locally/locoregionally advanced head and neck squamous cell carcinoma, were human papillomavirus positive or negative, and were cisplatin ineligible. RT was delivered via intensity-modulated RT or proton therapy to a total of 70 Gy (35 fractions). Tolinapant was given every other week during RT at 180 mg/day with option to de-escalate to 90 mg for toxicity. Blood samples for research were collected at baseline and during RT.

Results::

Ten patients were enrolled. Treatment was well tolerated, with the most common adverse events similar to standard chemoRT (radiodermatitis, fatigue, dysphagia, pain, dysgeusia, and dry mouth). All patients completed treatment, and tolinapant dose de-escalation was not required. One patient experienced brief treatment interruptions due to severe dysphagia. Two patients developed distant metastases after treatment. Another patient developed second and third tumors outside the radiation field after treatment and was treated surgically. At a median follow-up of 13.8 months, the remaining 7 (70%) patients remained free of disease. Blood samples showed a burst of activated (CD38+HLA-DR+) CD8+ T lymphocytes in 40% of patients.

Conclusions::

Tolinapant + RT is well tolerated and induced proliferation of activated T cells in a subset of patients. Larger prospective studies are needed to better assess efficacy.

01 May 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

The IAP antagonist tolinapant enhances the anti-tumor activity of cell therapies

Article

Author: Kogue, Yosuke ; Matsuyama, Hironori ; Akamine, Hiroki ; Sudo, Toshiki ; Sone, Masayuki ; Sims, Martin J ; Ward, George ; Tazuru, Keisuke ; Smyth, Tomoko

Various gene-modified cell therapies have been investigated in clinical trials, among which chimeric antigen receptor (CAR)-T cell therapy has been approved for the treatment of B cell tumors and has shown remarkable therapeutic effects. However, challenges, such as, cancer recurrence and manufacturing issues remain. To overcome such limitations, we investigated whether combining CAR-T cells with tolinapant, an inhibitor of apoptosis proteins (IAP) antagonist with immunomodulatory activity, could enhance the anti-tumor effect. Tolinapant induced cancer cell death in the presence of TNF-α. Tumor killing by CAR-T, TCR-T or CÊNK cells was enhanced by tolinapant in vitro in a TNF-α-dependent manner. TNF-α secreted from CAR-T cells, in the presence of tolinapant, also induced cell death of antigen-negative cancer cells not in cell-cell contact with CAR-T cells. Addition of tolinapant potentiated efficacy of not only two different CAR-T, but also TCR-T and CAR-NK cells in vivo. Tolinapant treatment led to faster expansion of stimulated CAR-T cells in vitro and in vivo. Our study suggests that the combination of tolinapant improves the efficacy of cell-based cancer therapies by inducing both cancer cell death and CAR-T cell proliferation. This combination therapy may overcome the current limitations of cell-based therapies and enhance their anti-cancer effect.

News (Medical) associated with Tolinapant

13 Nov 2025

·www.prnewswire.com

Taiho Oncology Announces 14 Presentations, Including Six Oral Presentations, at the 67th American Society of Hematology Annual Meeting and Exposition

Six oral presentations will detail new data on the outcomes of all-oral regimens containing azacitidine and cedazuridine or decitabine and cedazuridine in patients with myelodysplastic syndromes, chronic myelomonocytic leukemia or acute myeloid leukemia PRINCETON, N.J., Nov. 13, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced the presentation of new data from 14 studies across company-sponsored and company-funded externally led studies at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, to be held Dec. 6-9, 2025, in Orlando, Florida. Taiho Oncology will share findings from clinical trials in two oral presentations and evidence from real-world studies in two online abstracts. The oral presentations will highlight results from the Phase 2 part of ASTX030-01, a randomized, open-label, crossover trial comparing oral combination of azacitidine and cedazuridine to subcutaneous azacitidine and the Phase 2 portion of the Phase 1/2 trial ASTX727-03 of low-dose versus standard-dose oral decitabine and cedazuridine in patients with lower-risk myelodysplastic syndromes (MDS). The two online posters will present real-world data on U.S. adults with acute myeloid leukemia (AML), describing treatment patterns and outcomes with hypomethylating agent (HMA) plus venetoclax, and evaluating the time burden of initiating parenteral HMA-based therapy in routine practice. Additionally, 10 presentations – including four oral presentations – led by independent investigators will feature data from Taiho-funded investigator-initiated or collaborative studies. These presentations will highlight: Results from a UK multicenter Phase 2 randomized trial comparing ASTX727 with hydroxycarbamide or best supportive care in advanced MDS/ myeloproliferative neoplasm (MPN). Data from a Phase 2 study evaluating the all-oral combination of ASTX727, venetoclax and revumenib in newly diagnosed AML patients with NPM1m, KMT2Ar or NUP98r AML mutations. Results of a Phase 1/2 clinical trial of the combination of oral decitabine/cedazuridine with the venetoclax in patients with untreated high-risk MDS and chronic myeloid leukemia (CMML). Safety and efficacy results from a Phase 1/2 trial evaluating an all-oral combination of ASTX727, venetoclax and gilteritinib in both relapsed refractory and newly diagnosed FLT3-mutated AML, high-risk MDS or MPN. "As the leader of oral HMA development, we're excited that these data will be featured in six oral presentations at the ASH Annual Meeting," said Harold Keer, MD, PhD, Taiho Oncology Chief Medical Officer. "These data highlight our increasing understanding of novel oral regimens in hematology. We are invested in developing treatments that have the potential to improve flexibility and lower the treatment burden for patients, and collaborating with leading institutions, evidenced by our continued support of independent clinical research to advance cancer care. We look forward to participating in the essential scientific exchange that contributes to progress in hematology at the ASH Annual Meeting." Data being presented by Taiho Oncology and its partners at the 2025 ASH Annual Meeting and Exposition include: Company-Sponsored Studies Oral Presentations Title: A phase 2 dose confirmation trial of oral ASTX030, a combination of oral azacitidine with cedazuridine among patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia Abstract Number: 491 Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Moving the Needle Through Novel Approaches in MDS and CMML Session Date: Dec . 7, 2025 Session Time: 9:30 a.m. to 11a.m. Presentation Time: 10:15 to 10:30 a.m. Location: OCCC - Valencia Room W415D Presenter: Guillermo Garcia-Manero, MD Title: Low-dose oral decitabine and cedazuridine among patients with low-risk myelodysplastic syndromes Abstract Number: 790 Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Treatment Advances in Lower risk Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms Session Date: Dec . 8, 2025 Session Time: 10:30 a.m. to 12 p.m. Presentation Time: 11:15 to 11:30 a.m. Location: OCCC - Valencia Room W415A Presenter: Guillermo Garcia-Manero, MD Online Abstracts Title: Time burden of treatment with parenteral HMAs in combination with venetoclax among patients with newly diagnosed AML Abstract Number: 6990 Lead Author: Amer Zeidan, MD Title: Real-World Characteristics, Treatment Modifications, and Outcomes for AML Patients Receiving HMAs + Venetoclax (1L) Abstract Number: 8176 Lead Author: Amer Zeidan, MD Company-Funded Externally Led Studies Oral Presentations Title: Phase II Study of the All-Oral Combination of Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE) in Newly Diagnosed AML Abstract Number: 47 Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Frontline treatment with intensive or lower-intensity regimens Session Date: Dec . 6, 2025 Session Time: 9:30 to 11 a.m. Presentation Time: 10:30 to 10:45 a.m. Location: OCCC - Valencia Room W415A Presenter: Wei-Ying Jen, BM BCh, FRCPath Title: Oral decitabine/cedazuridine in combination with venetoclax in treatment-naïve high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia: Updates of a Phase 1/2 clinical trial Abstract Number: 237 Session Name: 637 . Myelodysplastic Syndromes : Clinical and Epidemiological: Treatment Advances in Higher Risk Myelodysplastic Syndromes Session Date: Dec . 6, 2025 Session Time: 2 to 3:30 p.m. Presentation Time: 2:30 to 2:45 p.m. Location: OCCC - Chapin Theater W415BC Presenter: Alex Bataller, MD, PhD Title: ASTX727 delivers superior response rates and associated survival benefit versus hydroxycarbamide/best supportive care in CMML and other MDS/MPN overlap syndromes: First results from the Phase 2 UK multicenter randomized ammo trial Abstract Number: 488 Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Moving the Needle Through Novel Approaches in MDS and CMML Session Date: Dec. 7, 2025 Session Time: 9:30 to 11 a.m. Presentation Time: 10:45 to 11 a.m. Location: OCCC - Valencia Room W415D Presenter: Daniel H. Wiseman, MB, ChB, PhD Title: Phase I/II Study of Decitabine/Cedazuridine (ASXT727), Venetoclax, and Gilteritinib for Patients with FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Abstract Number: 997 Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Frontline treatment with intensive or lower-intensity regimens Session Date: Dec . 8, 2025 Session Time: 4:30 to 6 p.m. Presentation Time: 4:30 to 4:45 p.m. Location: OCCC - Chapin Theater W320 Presenter: Roberta S. Azevedo, MD Poster Presentations Title: Translational Investigation of Tolinapant (ASTX660) in Acute Myeloid Leukemia Using Integrated Clinical, Bioinformatic, and Pharmacological Approaches Abstract Number: 2552 Session Name: 802. Chemical Biology and Experimental Therapeutics: Poster I Session Date: Dec. 6, 2025 Session Time: 5:30 to 7:30 p.m. Location: OCCC - West Halls B3-B4 Title: A Randomized Phase II Trial of ASTX727 and Venetoclax With or Without Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy (MM1OA-S03) Abstract Number: 3466 Session Name: 617 . Acute Myeloid Leukemias: Commercially Available Therapies: Poster II Session Date: Dec. 7, 2025 Session Time: 6 to 8 p.m. Location: OCCC - West Halls B3-B4 Title: Trial in progress: A Phase I Study Evaluating the Safety of cirtuvivint (CIRT) as Monotherapy and in Combination with ASTX727 in Patients with MDS and AML Abstract Number: 3431 Session Name: 616 . Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II Session Date: Dec. 7, 2025 Session Time: 6 to 8 p.m. Location: OCCC - West Halls B3-B4 Title: Trial in Progress - A Randomized Study of ASTX727 With or Without Ladademstat in Accelerated/Blast-Phase Myeloproliferative Neoplasms Abstract Number: 3827 Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II Session Date: Dec. 7, 2025 Session Time: 6 to 8 p.m. Location: OCCC - West Halls B3-B4 Title: A Comparison of Overall Survival and Quality of Life in MDS Patients Treated with Azacitidine vs Decitabine: A Propensity-Matched Registry Study Abstract Number: 3862 Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II Session Date: Dec. 7, 2025 Session Time: 6 to 8 p.m. Location: OCCC - West Halls B3-B4 Title: A Multiarm Phase 1b Study of Personalized Oral Maintenance Therapy with Decitabine/Cedazuridine (ASTX727) Plus Physician's Choice of Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib in Acute Myeloid Leukemia Abstract Number: 5228 Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster III Session Date: Dec. 8, 2025 Session Time: 6 to 8 p.m. Location: OCCC - West Halls B3-B4 About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Taiho Pharmaceutical Co., Ltd. Taiho Oncology Contact: Leigh Labrie (609) 664-9878 [email protected] SOURCE Taiho Oncology 21% more press release views with Request a Demo

Phase 2ASHClinical ResultPhase 1Cell Therapy

09 Mar 2023

·www.businesswire.com

Cutaneous T-Cell Lymphoma - Pipeline Insight, 2022 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Cutaneous T-Cell Lymphoma - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering. This "Cutaneous T-Cell Lymphoma - Pipeline Insight, 2022" report provides comprehensive insights about 25+ companies and 27+ pipeline drugs in Cutaneous T-Cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage Cutaneous T-Cell Lymphoma Understanding Cutaneous T-Cell Lymphoma: Overview Cutaneous T-cell lymphoma (CTCL) is a rare type of blood cancer. It begins in a type of white blood cell called the T-lymphocyte (T-cell). T-cells help prevent infections and other diseases. As odd as it sounds, most T-cells are found in our skin. That's because our skin is the first line of defense against disease. The surface of an adult's skin contains about 20 billion T-cells. That's nearly twice as many T-cells as found in other parts of the body. There are many types of CTCL. More than half the people who develop CTCL will have one of the following types: Mycosis fungoides or Sezary syndrome. Mycosis fungoides is the most common type of CTCL. This type tends to worsen very slowly. It can stay in its earliest stage, which often looks like rash, for years. In this stage, the cancer is often difficult to diagnose because it tends to looks like eczema or psoriasis. These conditions are much more common than CTCL. Sezary syndrome is more aggressive. It can also look like eczema. Some people develop red and swollen skin over much of their body. Their skin may feel hot, sore, and extremely itchy. Because CTCL is rare and often looks like eczema or another common skin disease, it can take time to get the diagnosis. Some people who have CTCL are referred to a dermatologist because it's thought that they have a stubborn case of eczema or psoriasis. This report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cutaneous T-Cell Lymphoma pipeline landscape is provided which includes the disease overview and Cutaneous T-Cell Lymphoma treatment guidelines. The assessment part of the report embraces, in depth Cutaneous T-Cell Lymphoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Cutaneous T-Cell Lymphoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Cutaneous T-Cell Lymphoma Emerging Drugs Chapters This segment of the Cutaneous T-Cell Lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Cutaneous T-Cell Lymphoma Emerging Drugs SGX301: Soligenix SGX301 is a novel first-in-class photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. HyBryte (synthetic hypericin or SGX301) may provide a safer, more convenient alternative. It is a topical ointment which is applied to the lesions and then activated by safe visible fluorescent light. HyBryte is being tested as a photodynamic light therapy with an enhanced safety profile and a treatment regimen that may be completed in as little as 6 weeks. Its pivotal Phase III clinical study (the "FLASH" study) for CTCL has completed enrollment showing a statistically significant outcome after 6 weeks treatment (p=0.04) with continued improvement to 40% response rate after 12 weeks treatment (p< 0.0001). Lacutamab : Innate Pharma Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 90% of patients with certain aggressive CTCL subtypes, in particular, Sezary syndrome. It is currently being evaluated in Phase II stage of development. BNZ-1: Bioniz BNZ-1 is a selective inhibitor of three members of the IL-2 family: IL-2, IL-9, and IL-15. The profile of BNZ-1 is promising as a long-term therapy capable of transforming the standard of care in CTCL as data implicates the dysregulation of IL-2/IL-9/IL-15 as responsible for disease pathology. Bioniz conducted a Phase I/II study in CTCL, in which BNZ-1 exhibited a substantial improvement in safety and efficacy relative to standard of care. BNZ-1 has orphan drug designation in US and EU. In February 2022, Equillium, Inc. announced that it has acquired Bioniz Therapeutics, Inc., a privately held clinical-stage biotechnology company. Bioniz developed its novel structured-domain peptides, including BNZ-1 and BNZ-2, entirely in-house from its proprietary product discovery platform. BNZ-1 is Phase II/III ready in CTCL with open U.S. INDs for each indication and has orphan designation for CTCL in the U.S. and Europe. Cutaneous T-Cell Lymphoma: Therapeutic Assessment This segment of the report provides insights about the different Cutaneous T-Cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Cutaneous T-Cell Lymphoma There are approx. 25+ key companies which are developing the therapies for Cutaneous T-Cell Lymphoma. The companies which have their Cutaneous T-Cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Soligenix Phases The report covers around 27+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Cutaneous T-Cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Molecule Type Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Cutaneous T-Cell Lymphoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cutaneous T-Cell Lymphoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Cutaneous T-Cell Lymphoma drugs. Cutaneous T-Cell Lymphoma Report Insights Cutaneous T-Cell Lymphoma Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Cutaneous T-Cell Lymphoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Soligenix Elorac Innate Pharma Viridian Therapeutics Sorrento Therapeutics Bio-Path Holdings Legend Biotech Genzada Pharmaceuticals VidacPharma Bioniz Therapeutics Otsuka Pharmaceutical Hoffmann-La Roche BioInvent International AB Scopus BioPharma Codiak BioSciences Merck Sharp & Dohme LLC Otsuka Pharmaceutical Co., Ltd. Myeloid Therapeutics Jiangsu Simcere Pharmaceutical miRagen Therapeutics Kymera Therapeutics Citius Pharmaceuticals 4SC Equillium Key Products SGX301 BNZ-1 Lacutamab ExoIL-12 BP1002 MRG-106 BBI-3000 WP1220 Tucidinostat IPH4102 Resiquimod VDA-1102 Resminostat Pembrolizumab ASTX660 KT-333 MT-101 SIM1811-03 Cobomarsen LB1901 EQ101 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/uspzvl About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Orphan DrugPhase 3

06 May 2021

·www.globenewswire.com

T-cell Leukemia Pipeline: Comprehensive Analysis of 15+ Key

Los Angeles, USA, May 05, 2021 (GLOBE NEWSWIRE) -- T-cell Leukemia Pipeline: Comprehensive Analysis of 15+ Key Players and 15+ Key Therapies Out of all T-cell Leukemia pipeline therapies, HBI-8000 is set to capture the maximum patient pool owing to its immunomodulatory function. DelveInsight’s ‘T-cell Leukemia Pipeline Insights’ report provides a holistic view of the pipeline therapies that are under development in pre-clinical as well as clinical stages of development, and growth prospects across the T-cell Leukemia domain. Some of the key highlights of the T-cell Leukemia Pipeline report: Got queries? Want to know more? Request for Sample @ T-cell Leukemia Emerging Therapies and Forecast The report lays down a complete coverage of the therapeutics by development stage, product type, and route of administration, molecule type, and MOA type for T-cell Leukemia across the complete product development cycle, including all clinical and non-clinical stages. The T-cell Leukemia pipeline report puts on the table business opportunities, threats, prospective collaborations, strong competitors, growth strategies, and failed as well as discontinued drugs. T-cell Leukemia Pipeline Drugs Request for Sample to know more @ T-cell Leukemia Pipeline Analysis, Key Companies and Futuristic Trends T-cell Leukemia Therapeutic Assessment The T-cell Leukemia Pipeline report proffers exhaustive insights into active pipeline assets segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Get in touch with our Business executive for Rich and Deep Market Assessment and Consulting Solutions Scope of the Report Coverage: GlobalKey Players: Daiichi Sankyo; Bioniz; Otsuka Pharmaceutical; Seagen /Takeda; HUYA Bioscience; iCell Gene Therapeutics; Gracell Biotechnology; Ascentage Pharma Group; Celgene Corporation; Shorla Pharma; AVM Biotechnology; Expression Therapeutics; miRagen Therapeutics, and others.Key T-cell Leukemia Pipeline Therapies: Valemetostat; BNZ-1; ASTX 660; Brentuximab vedotin; HBI-8000; CD4CAR; CD7 UCAR-T cells; APG-115; Romidepsin; SH-111; Cobomarsen; AVM-0703, and others. Reach out @ T-cell Leukemia Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ T-cell Leukemia Emerging Therapies Browse through Related Reports CAR T-Cell Therapy for Acute Lymphoblastic LeukemiaDelveInsight’s “CAR T-Cell Therapy for Acute Lymphoblastic Leukemia (ALL)- Market Insights and Market Forecast- 2030” report. CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Pipeline DelveInsight’s, “CAR T-Cell Therapy for Acute Lymphoblastic Leukemia - Pipeline Insight, 2021,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in CAR T-Cell Therapy for Acute Lymphoblastic Leukemia pipeline landscape. Adult T Cell Leukemia Lymphoma MarketDelveInsight's "Adult T-Cell Leukemia-Lymphoma - Market Insights, Epidemiology, and Market Forecast-2030" report. Acute Myeloid Leukemia MarketDelveInsight's "Acute Myeloid Leukemia (AML) Market Insights, Epidemiology, and Market Forecast-2030" report. B-Cell Chronic Lymphocytic Leukemia MarketDelveInsight's "B-Cell Chronic Lymphocytic Leukemia - Market Insights, Epidemiology, and Market Forecast-2030" report. Hairy Cell Leukemia Market Insight Epidemiology and Market ForecastDelveInsight's 'Hairy Cell Leukemia (HCL)- Market Insights, Epidemiology and Market Forecast-2028' report. Bowens Disease MarketDelveInsight's "Bowen's Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Buergers Disease MarketDelveInsight's "Buerger’s Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Brucellosis MarketDelveInsight's "Brucellosis - Market Insights, Epidemiology, and Market Forecast-2030" report. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

Cell TherapyCollaborate

100 Deals associated with Tolinapant

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Recurrent cutaneous T-cell lymphoma	Phase 2	Japan	Otsuka Pharmaceutical Co., Ltd.	14 Jul 2020
Cutaneous T-Cell Lymphoma	Phase 2	Italy	Astex Pharmaceuticals, Inc.	15 May 2020
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	Italy	Astex Pharmaceuticals, Inc.	15 May 2020
Advanced cancer	Phase 2	United States	Taiho Oncology, Inc.	01 Dec 2017
Advanced cancer	Phase 2	Canada	Taiho Oncology, Inc.	01 Dec 2017
Advanced cancer	Phase 2	Italy	Taiho Oncology, Inc.	01 Dec 2017
Advanced cancer	Phase 2	Spain	Taiho Oncology, Inc.	01 Dec 2017
Advanced cancer	Phase 2	United Kingdom	Taiho Oncology, Inc.	01 Dec 2017
Head and Neck Neoplasms	Phase 2	United States	Taiho Oncology, Inc.	01 Dec 2017
Head and Neck Neoplasms	Phase 2	Canada	Taiho Oncology, Inc.	01 Dec 2017

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04362007 (CTgov)	Phase 1/2	Recurrent cutaneous T-cell lymphoma	8	ASTX660 (Cohort 1)	wtasdllxuz = qhvzegrkcs cdqlsxqwcu (xbaoirgmgz, wmqpnpgejx - jvjdmsjjgg) View more	-	25 Feb 2026
				ASTX660 (Cohort 2)	aygajjpxud(vuihkwslwj) = iuwgyftwyo ymcckkhcsq View more
NCT05245682 (Early-phase trial of IAP antagonist tolinapant and definitive radiation in cisplatin-ineligible patients with previously untreated, locally advanced head and neck cancer, AACR2025)	Early Phase 1	Head and Neck Neoplasms HPV positive \| HPV-negative	19	Tolinapant	nwyrwvjciq(cjwofvslth) = 90% uidpnqsffy (haechnhncd ) View more	Positive	28 Apr 2025
				IAP antagonist tolinapant (Definitive Radiation)
NCT05245682 (Early-phase trial of IAP antagonist tolinapant and definitive radiation in cisplatin-ineligible patients with previously untreated, locally advanced head and neck cancer, CTgov)	Early Phase 1	Squamous Cell Carcinoma of the Oropharynx \| Nasopharyngeal Squamous Cell Carcinoma \| Locally Advanced Head and Neck Squamous Cell Carcinoma ... View more	10	Radiation Therapy+Tolinapant	jkhxkalfxa = uhnjwlflck joeybkwyus (uiohpszlou, oinhemdiyt - qatkoslhlp) View more	-	17 Mar 2025
NCT05082259 (AACR2024) Manual	Phase 1	Neoplasms	22	ASTX660 + pembrolizumab	pithvvgduz(kuarjpyefa) = None cwpsrpatbr (oggkplnkyb ) View more	Positive	08 Apr 2024
NCT02503423 (AACR2022)	Phase 1/2	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	230	Tolinapant	abtmgghnka(laqenydwzv) = pxxhjwpmvk ecbtzemigt (kzvnuqpcbm ) View more	-	15 Jun 2022
				ABT199	abtmgghnka(laqenydwzv) = jfmeebhnoh ecbtzemigt (kzvnuqpcbm )
NCT02503423 (ASCO2022)	Phase 2	T-Cell Lymphoma	230	Tolinapant	kuwapfwagq(tlxdbkldse) = weoqljlmim mflnwexbyv (wnijxxvouz, 1)	-	02 Jun 2022
NCT02503423 (EHA2022) Manual	Phase 2	Peripheral T-Cell Lymphoma \| Cutaneous T-Cell Lymphoma	149	tolinapant 180 mg (PTCL)	berzxxkhfs(cxaxkhblwr) = wmecbgxyle loykvdgxyp (yefeyxepad ) View more	Positive	12 May 2022
				tolinapant 180 mg (CTCL)	berzxxkhfs(cxaxkhblwr) = psawxiulvq loykvdgxyp (yefeyxepad ) View more
NCT02503423 (EHA2022)	Phase 2	T-Cell Lymphoma	230	Azacytidine	dqywhwfhtx(rhrazwtqpe) = ysvidegxca utfizwyjqk (vvyemsfbkt )	-	12 May 2022
				Decitabine	dqywhwfhtx(rhrazwtqpe) = ibhklhxhsl utfizwyjqk (vvyemsfbkt )
NCT02503423 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Neoplasms \| Lymphoma	45	ASTX660	mflipfygpv(vlbrstdcgb) = 3 pts at 270 mg/day and 1 pt at 210 mg/day brmywsdhwc (cmfkzdgibj ) View more	Positive	15 Jun 2020
NCT02503423 (AACR2019) Manual	Phase 2	Solid tumor \| Lymphoma	107	ASTX660	dsozilffbw(xinyvpxkog) = lldogkskfk suwnygiuna (szfgqnwqqc ) View more	Positive	01 Dec 2019

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