HDAC1 inhibitors(Histone deacetylase 1 inhibitors), HDAC2 inhibitors(Histone deacetylase 2 inhibitors), HDAC3 inhibitors(Histone deacetylase 3 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersNervous System Diseases+ [3]

Active Indication

Metastatic Colorectal CarcinomaMicrosatellite instability-high colorectal cancerBrain Cancer+ [5]

Inactive Indication

Advanced Malignant Solid Neoplasm

Originator Organization

National Taiwan University

Active Organization

AnBogen Therapeutics, Inc.

Taipei Medical University

Formosa Pharmaceuticals, Inc.

Inactive Organization

Taipei Medical University Hospital

National Taiwan University

License Organization

Formosa Pharmaceuticals, Inc.

BeOne Medicines Ltd.

AnBogen Therapeutics, Inc.

+ [1]

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Clinical Trials associated with Imofinostat

NCT07244705

/ RecruitingPhase 1/2

An Open-label, Multicenter, Phase 1/2 Study Exploring the Safety and Efficacy of ABT-301 in Combination With Tislelizumab and Bevacizumab in Participants With Proficient Mismatch Repair (pMMR)/Non-Microsatellite Instability-High (Non-MSI-H) Locally Advanced or Metastatic Colorectal Cancer (mCRC)

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab 200 mg IV infusion and bevacizumab 7.5 mg/kg IV infusion Q3W, in participants with pMMR/non-MSI-H colorectal cancer (CRC). It will also determine the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301.
Participants will receive ABT-301 administered once daily (QD ±3 hours) or twice daily (Q12H ±3 hours, at least 9 hours apart) with water in 21-day treatment cycles. Tislelizumab 200 mg IV and bevacizumab 7.5 mg/kg IV Q3W will be given in both parts of the study.

Start Date01 Nov 2025

Sponsor / Collaborator

AnBogen Therapeutics, Inc.

[+1]

NCT02350868

/ CompletedPhase 1IIT

A Phase 1, First-In-Human, Dose-Seeking Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered MPT0E028 in Subjects With Advanced Solid Malignancies Without Standard Treatment

The Dose Escalation Phase will determine the MTD of MPT0E028 and evaluate its safety and tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation Phase will be a cohort expansion at or below the MTD (i.e., an RP2D) of MPT0E028.

Start Date24 Apr 2015

Sponsor / Collaborator

Taipei Medical University

100 Clinical Results associated with Imofinostat

100 Translational Medicine associated with Imofinostat

100 Patents (Medical) associated with Imofinostat

Literatures (Medical) associated with Imofinostat

01 Aug 2024·EUROPEAN JOURNAL OF PHARMACOLOGY

MPT0E028, a novel pan-HDAC inhibitor, prevents pulmonary fibrosis through inhibition of TGF-β-induced CTGF expression in human lung fibroblasts: Involvement of MKP-1 activation

Article

Author: Chien-Huang Lin ; Fara Silvia Yuliani ; Chia-Hao Liu ; Wun-Hao Cheng ; Jing-Ping Liou ; Bing-Chang Chen ; Hung-Sheng Hua ; Hong-Sheng Lee

Histone deacetylase (HDAC) inhibitors are potential candidates for treating pulmonary fibrosis. MPT0E028, a novel pan-HDAC inhibitor, has been reported to exhibit antitumor activity in several cancer cell lines. In this study, we investigated the mechanism underlying the inhibitory effects of MPT0E028 on the expression of fibrogenic proteins in human lung fibroblasts (WI-38). Our results revealed that MPT0E028 inhibited transforming growth factor-β (TGF-β)-, thrombin-, and endothelin 1-induced connective tissue growth factor (CTGF) expression in a concentration-dependent manner. In addition, MPT0E028 suppressed TGF-β-stimulated expression of fibronectin, collagen I, and α-smooth muscle actin (α-SMA). Furthermore, MPT0E028 inhibited the TGF-β-induced phosphorylation of c-Jun N-terminal kinase (JNK), p38, and extracellular signal-regulated kinase (ERK). MPT0E028 reduced the increase in SMAD3 and c-Jun phosphorylation, and SMAD3-and activator protein-1 (AP-1)-luciferase activities under TGF-β stimulation. Transfection with mitogen-activated protein kinase phosphatase-1 (MKP-1) siRNA reversed the suppressive effects of MPT0E028 on TGF-β-induced increases in CTGF expression; JNK, p38, and ERK phosphorylation; and SMAD3 and AP-1 activation. Moreover, MPT0E028 increased MKP-1 acetylation and activity in WI-38 cells. Pretreatment with MPT0E028 reduced the fibrosis score and fibronectin, collagen, and α-SMA expression in bleomycin-induced pulmonary fibrosis mice. In conclusion, MPT0E028 induced MKP-1 acetylation and activation, which in turn inhibited TGF-β-stimulated JNK, p38, and ERK phosphorylation; SMAD3 and AP-1 activation; and subsequent CTGF expression in human lung fibroblasts. Thus, MPT0E028 may be a potential drug for treating pulmonary fibrosis.

01 Dec 2020·BMC pharmacology & toxicologyQ4 · MEDICINE

Investigating the potential effects of selective histone deacetylase 6 inhibitor ACY1215 on infarct size in rats with cardiac ischemia-reperfusion injury

Q4 · MEDICINE

ArticleOA

Author: Lin, Chao-Feng ; Lin, Tony Eight ; HuangFu, Wei-Chun ; Pan, Shiow-Lin ; Huang, Han-Li ; Hsu, Kai-Cheng

Abstract:

Background:

Despite the fact that histone deacetylase (HDAC) inhibitors have been tested to treat various cardiovascular diseases, the effects of selective HDAC6 inhibitor ACY1215 on infarct size during cardiac ischemia-reperfusion (IR) injury still remain unknown. In the present study we aimed to investigate the effects of ACY1215 on infarct size in rats with cardiac IR injury, as well as to examine the association between HDAC6 inhibitors and the gene expression of hypoxia inducible factor-1α (HIF-1α), a key regulator of cellular responses to hypoxia.

Methods:

By using computational analysis of high-throughput expression profiling dataset, the association between HDAC inhibitors (pan-HDAC inhibitors panobinostat and vorinostat, and HDAC6 inhibitor ISOX) and their effects on HIF-1α gene-expression were evaluated. The male Wistar rats treated with ligation of left coronary artery followed by reperfusion were used as a cardiac IR model. ACY1215 (50 mg/kg), pan-HDAC inhibitor MPT0E028 (25 mg/kg), and vehicle were intraperitoneally injected within 5 min before reperfusion. The infarct size in rat myocardium was determined by 2,3,5-triphenyltetrazolium chloride staining. The serum levels of transforming growth factor-β (TGF-β) and C-reactive protein (CRP) were also determined.

Results:

The high-throughput gene expression assay showed that treatment of ISOX was associated with a more decreased gene expression of HIF-1α than that of panobinostat and vorinostat. Compared to control rats, ACY1215-treated rats had a smaller infarct size (49.75 ± 9.36% vs. 19.22 ± 1.70%, p < 0.05), while MPT0E028-treated rats had a similar infarct size to control rats. ACY-1215- and MPT0E028-treated rats had a trend in decreased serum TGF-β levels, but not statistically significant. ACY1215-treated rats also had higher serum CRP levels compared to control rats (641.6 μg/mL vs. 961.37 ± 64.94 μg/mL, p < 0.05).

Conclusions:

Our research indicated that HDAC6 inhibition by ACY1215 might reduce infarct size in rats with cardiac IR injury possibly through modulating HIF-1α expression. TGF-β and CRP should be useful biomarkers to monitor the use of ACY1215 in cardiac IR injury.

01 Dec 2019·Clinical epigeneticsQ2 · MEDICINE

Combination treatment strategy for pancreatic cancer involving the novel HDAC inhibitor MPT0E028 with a MEK inhibitor beyond K-Ras status

Q2 · MEDICINE

ArticleOA

Author: Chen, Yi-Ying ; Tu, Huang-Ju ; Chang, Li-Hsun ; Lai, Mei-Jung ; Pan, Shiow-Lin ; Teng, Che-Ming ; Liou, Jing-Ping ; Chang, Chao-Di ; Chao, Min-Wu

BACKGROUND:

Oncogenic K-Ras signaling highly relies on the canonical Ras/MEK/ERK pathway to contribute to pancreatic cancer progression. However, numerous efforts of MEK inhibitors have failed to provide an optimal antitumor effect for pancreatic cancer in practice. The aim of the present work was to develop a more efficacious therapeutic intervention for MEK inhibitors through combination with histone deacetylase (HDAC) inhibitor MPT0E028.

METHODS:

The effects of combined therapy on cell viability, apoptosis, protein, and RNA expressions were determined by MTT assay, flow cytometry, western blotting, and quantitative PCR analysis. The AsPC-1 xenograft was used to assess antitumor effects in vivo.

RESULTS:

The co-administration of MPT0E028 and MEK inhibitor yielded synergistic effects on cell viability suppression both in K-Ras mutated and wild-type pancreatic cancer cells and also markedly triggered cell apoptosis. Surprisingly, ERK and epidermal growth factor receptor (EGFR) were activated by the long-term and low-concentration treatment of MPT0E028 or another HDAC inhibitor alone. Whereas, the pharmacological attenuation of ERK signaling dramatically abolished the MPTE028-induced p-ERK and EGFR expression. Overexpression of HDAC4, HDAC6, and MEK, respectively, reversed the cell death induced by the combined treatment. Finally, the combined treatment decreased the tumor volume in an AsPC-1 xenograft model compared to each individual treatment alone.

CONCLUSIONS:

The synergistic anti-survival effect of the combination was suggested to occur via compensation of the MEK inhibitor for activated ERK. Our results indicate that this combination strategy could benefit patients with pancreatic cancer beyond K-Ras status.

News (Medical) associated with Imofinostat

13 Apr 2026

·www.prnewswire.com

AnBogen Therapeutics to Present Dual Breakthroughs for Imofinostat (ABT-301) at AACR 2026: Addressing Immunotherapy Barriers in CRC and Chemo-resistance in Pancreatic Cancer

TAIPEI, April 13, 2026 /PRNewswire/ -- AnBogen Therapeutics, a clinical-stage biotechnology company focused on precision oncology, today announced that two key research abstracts regarding its lead compound, Imofinostat (ABT-301), have been selected for poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting. The data demonstrate ABT-301's superior performance in enhancing immunotherapy for colorectal cancer (CRC) and reveal a novel mechanism for overcoming chemotherapy resistance in pancreatic cancer. AnBogen will present these breakthroughs during the session "PO.ET09.01 - Epigenetic Modulators 1" on Tuesday, April 21, 2026, from 9:00 AM to 12:00 PM (Local Time) in San Diego. 1. Strengthening Immune Response: New Evidence in Colorectal Cancer (CRC) Abstract Title: Imofinostat in combination with immune checkpoint inhibitors enhances anti-tumor activity in colorectal cancer Abstract Number: 4496 (Section 14, Poster 15) Key Breakthrough: Preclinical data confirms that Imofinostat, acting as an HDAC inhibitor, effectively modulates the tumor microenvironment (TME). By synergizing with immune checkpoint inhibitors and anti-angiogenic agents, it converts "cold tumors" into "hot tumors," significantly enhancing the immune system's ability to recognize and eliminate cancer cells. This provides a robust scientific foundation for AnBogen's ongoing global clinical trials. 2. Breaking the Defense: Targeting the HDAC3-NRF2 Pathway in Pancreatic Cancer Abstract Title: Imofinostat enhances chemotherapy response in KRAS-mutant pancreatic ductal adenocarcinoma (PDAC) by targeting the HDAC3-NRF2 pathway Abstract Number: 4497 (Section 14, Poster 16) Key Breakthrough: For highly challenging KRAS-mutant pancreatic cancer, the study reveals that Imofinostat precisely regulates the HDAC3-NRF2 signaling pathway—a key driver of chemo-resistance. By intervening in this pathway, Imofinostat significantly boosts tumor sensitivity to chemotherapy, offering a promising new therapeutic strategy for patients with this aggressive malignancy. Triple Combination Strategy for Advanced CRC Based on the strong scientific evidence presented at AACR, AnBogen is actively advancing a Phase 1/2 global multi-center clinical trial (NCT07244705) for Imofinostat in combination with Tislelizumab (an anti-PD-1 monoclonal antibody provided by BeOne Medicines under a clinical drug supply agreement) and an anti-angiogenic agent for advanced CRC. This triple combination strategy leverages ABT-301's capacity to reshape the tumor microenvironment and lift immune suppression, which in turn unlocks the therapeutic potential of the PD-1 inhibitor. Through a synergistic interplay with anti-angiogenic agents, the treatment collectively promotes the normalization of tumor vasculature and optimization of the microenvironment. This integrated action effectively dismantles drug delivery barriers, allowing immune cells to penetrate deeper into the tumor core for maximum anti-cancer synergy. "The two abstracts presented at AACR this year represent international academic recognition of ABT-301's innovative mechanism," said John Hsu, CEO of AnBogen Therapeutics. "We are accelerating the translation of these findings into clinical results. Furthermore, our recent successful Series B funding and upcoming plans for an Emerging Stock Market listing will provide the resources needed to drive our trials forward and address significant unmet medical needs." About Imofinostat (ABT-301) Imofinostat is a small-molecule Histone Deacetylase inhibitor (HDACi). It reactivates tumor suppressor genes silenced by cancer cells, inducing apoptosis and inhibiting tumor growth. In Phase 1 monotherapy trials, ABT-301 demonstrated excellent safety and competitive advantages across various solid tumors. Currently, a global multi-center Phase 1/2 clinical trial (NCT07244705) is underway to evaluate the safety and efficacy of Imofinostat in combination with Tevimbra® (Tislelizumab) and Bevacizumab. This study focuses on patients with proficient mismatch repair (pMMR) or non-high microsatellite instability (Non-MSI-H) metastatic colorectal cancer (mCRC). About AnBogen Therapeutics AnBogen Therapeutics is a clinical-stage biotech company dedicated to developing innovative precision oncology therapies. By transforming high-value scientific discoveries into clinical proof-of-concept, AnBogen aims to provide next-generation treatment options for cancer patients worldwide. SOURCE Anbogen Therapeutics 21% more press release views with Request a Demo

ImmunotherapyPhase 1AACRASCO

04 Aug 2025

·www.prnewswire.com

Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal Cancer

TAIPEI, Aug. 4, 2025 /PRNewswire/ -- Anbogen Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, enabling the initiation of a Phase 1/2 clinical trial in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). This open-label, multi-center international study plans to enroll 66 patients with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC to evaluate the safety and preliminary efficacy of the triplet therapy. Enrollment is planned in Taiwan and Australia. Tislelizumab, a PD-1 monoclonal antibody, used in this trial is provided by BeOne Medicines (formerly known as BeiGene). Further details on this collaboration were disclosed by Anbogen in a press release dated September 27, 2024. ABT-301 is an oral HDAC1/2/3 inhibitor. Preclinical studies have shown that it promotes CD8+ cytotoxic T cell infiltration and activity, enhances antigen presentation, and inhibits M-MDSCs cells, effectively modulating the tumor microenvironment and converting "cold tumors" into "hot tumors" to improve the efficacy of immune checkpoint inhibitors. ABT-301 also exhibits pro-apoptotic, anti-angiogenic, and tumor metabolic regulation effects. As a single-molecule, multi-modality anti-cancer agent, ABT-301 aims to enhance tumor treatment when combined with the two antibody drugs. Notably, in a previous Phase 1 monotherapy clinical trial involving 23 participants, ABT-301 did not exhibit neutropenia or cardiac toxicity, which are commonly observed in other HDAC inhibitors—further supporting its suitability for use in combination immunotherapy. Approximately 95% of mCRC patients are pMMR or non-MSI-H types—commonly referred to as "cold tumors"—which respond poorly to current immunotherapies. Only around 5% of patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) "hot tumors" typically benefit from immune checkpoint inhibitors. According to GlobalData, an estimated 370,000 new pMMR/non-MSI-H patients in second-line or later settings are diagnosed annually across the U.S., China, Japan, and the top five European markets (UK, France, Germany, Spain, and Italy), representing a potential market size of USD $9 billion. Anbogen stated that the FDA's IND approval marks a key milestone in the development of ABT-301, demonstrating the safety profile of the triplet therapy and advancing it into clinical stages. The company emphasized that the study targets the majority of patients (over 90%) with poor responses to immunotherapy, aiming to provide a novel treatment option and address this unmet clinical need. Looking ahead, Anbogen will continue to advance the clinical development of ABT-301 while pursuing global licensing and strategic partnerships to accelerate commercialization and market entry. The company is also launching its Series B fundraising to attract strategic partners committed to advancing innovative cancer therapies and global expansion. About Anbogen Therapeutics Anbogen Therapeutics is a clinical-stage biotechnology company committed to developing precision oncology therapies that improve the lives of cancer patients worldwide. The company currently has two core assets: ABT-301, a HDAC1/2/3 inhibitor with immune-modulating capabilities, enhances the tumor microenvironment and boosts immune responses. It significantly improves the efficacy of immune checkpoint inhibitors (ICIs) in metastatic colorectal cancer (mCRC), offering a new treatment pathway for the majority of patients who do not benefit from ICIs. ABT-501 is a novel Peptide Drug Conjugate (PDC) that targets LHRH-receptor tumors using a proprietary delivery system. It has shown strong efficacy and safety in triple-negative breast cancer models, with potential for broader cancer applications. For more information, please visit Anbogen's official website at . SOURCE Anbogen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyINDPhase 1

27 Sep 2024

·www.prnewswire.com

Anbogen Announces Drug Supply Collaboration with BeiGene to Evaluate Combination Therapy in Colorectal Cancer

TAIPEI, Sept. 27, 2024 /PRNewswire/ -- Anbogen, a clinical-stage biotech company, today announced a drug supply collaboration to evaluate the combination of Anbogen's HDAC inhibitor, ABT-301, with BeiGene's anti-PD-1 antibody tislelizumab, in patients with mismatch repair–proficient (pMMR) or microsatellite stable (MSS) metastatic colorectal cancer (mCRC) in a global Phase II trial. Under the terms of the agreement, BeiGene will supply tislelizumab to Anbogen for the study. In 2020, over 1.9 million new cases of colorectal cancer were diagnosed globally. Immune checkpoint inhibitors (ICIs) have emerged as a primary treatment for metastatic colorectal cancer (mCRC) with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). However, this innovative therapy benefits only a small fraction of patients, as less than 5% of mCRC cases exhibit dMMR/MSI-H. Consequently, there remains a significant unmet need for the 95% of patients with pMMR/MSS tumors, who do not respond to ICIs. ABT-301, a novel HDAC inhibitor, has shown promising safety and pharmacokinetic profiles in a prior Phase 1 study as a single agent. Preclinical studies indicate that ABT-301 enhances the effectiveness of anti-PD-1/anti-PD-L1 therapies by increasing CD8+ cytotoxic T cells and decreasing monocytic myeloid-derived suppressor cells within both the tumor and circulation, and inhibiting angiogenesis. These immune response enhancements may broaden the efficacy of ICIs in colorectal cancer patients. The upcoming Phase II study will investigate the effectiveness of treatment regimens combining ABT-301 and tislelizumab, with and without Bevacizumab, in pMMR/MSS mCRC patients with significant unmet needs. "We are excited to partner with BeiGene to investigate this promising combination therapy," said John Hsu, CEO of Anbogen. "ABT-301 has shown potential in preclinical studies, and we believe that combining it with tislelizumab could provide a new therapeutic option for patients with colorectal cancer." The clinical trial will be conducted in multiple centers and will evaluate the safety, tolerability, and preliminary efficacy of the combination therapy in patients with advanced MSS CRC. The study is expected to begin enrollment in the first quarter of 2025. About Anbogen Anbogen is a clinical-stage biotech company that completed a US$20M Series A in 2024. We are dedicated to developing precision anti-cancer drugs and are committed to R&D innovations to improve the lives of cancer patients around the world. The company was founded by Dr. Joe Shih in response to national science and technology policy. The team has years of experience in new drug development while working at the National Health Research Institutes and in the biopharma industry. Currently, there are two clinical-stage assets being developed. ABT-101 is being investigated in non-small cell lung cancer (NSCLC) patients who harbor HER2 exon20 insertion mutations, and ABT-301 and being investigated in pMMR/MSS mCRC patients in combination with anti-PD-1. For more information, please visit . SOURCE Anbogen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Phase 2License out/in

100 Deals associated with Imofinostat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	Australia	AnBogen Therapeutics, Inc.	01 Nov 2025
Metastatic Colorectal Carcinoma	Phase 2	Taiwan Province	AnBogen Therapeutics, Inc.	01 Nov 2025
Microsatellite instability-high colorectal cancer	Phase 2	Australia	AnBogen Therapeutics, Inc.	01 Nov 2025
Microsatellite instability-high colorectal cancer	Phase 2	Taiwan Province	AnBogen Therapeutics, Inc.	01 Nov 2025
Advanced Malignant Solid Neoplasm	Phase 1	Taiwan Province	Taipei Medical University	24 Apr 2015
Brain Cancer	Phase 1	Taiwan Province	AnBogen Therapeutics, Inc.	-
Idiopathic Pulmonary Fibrosis	Phase 1	Taiwan Province	Formosa Pharmaceuticals, Inc.	-
Neoplasms	Phase 1	-	Taipei Medical University Hospital	-
Neoplasms	Phase 1	-	National Taiwan University	-
Pancreatic Cancer	Phase 1	Taiwan Province	AnBogen Therapeutics, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02350868 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	23	ABT-301	hiqplkrrqs(qeiosibrxr) = pxceaqmkza cuevjzwhdq (pjziemdaaw ) View more	Positive	26 May 2023

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