A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases

To explore the Efficacy and Safety of Tislelizumab combined with fruquintinib and Chidamide in the treatment of unresectable or advanced microsatellite stabilized (MSS/pMMR) colorectal cancer with liver metastases

Start Date01 Jun 2024

Sponsor / Collaborator

Fujian Cancer Hospital

NCT06386302 / Not yet recruitingNot ApplicableIIT

A Multicenter, Randomized, Controlled Clinical Trial of Chidamide Combined With Venetoclax and Azacitidine in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Not Suitable for Intensive Chemotherapy

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.

Start Date30 May 2024

Sponsor / Collaborator-

NCT06393361 / Not yet recruitingPhase 2IIT

A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti-PD-1 Antibody in PD-1 Inhibitor Failed Patients With Classical Hodgkin Lymphoma.

The issue of therapy after PD-1 inhibitor failure is unresolved in classic Hodgkin lymphoma. Preliminary clinical observations have shown that patients might benefit from Chidamide+Decitabine plus anti-PD-1 antibody. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 and the standard of care, which includes anti-PD-1 antibody, in patients with classical Hodgkin lymphoma who have experienced failure with PD-1 inhibitor. The primary objective of the study is to evaluate the 12-month progression-free survival rates.

Start Date15 May 2024

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

100 Clinical Results associated with Chidamide

100 Translational Medicine associated with Chidamide

100 Patents (Medical) associated with Chidamide

333

Literatures (Medical) associated with Chidamide

01 May 2024·International Immunopharmacology

Combination of chidamide and PD-1 blockade in Refractory/Relapsed aggressive large B-cell lymphomas with high risk of failing CAR-T therapy

Article

Author: Xiao, Min ; Han, Zhiqiang ; Wang, Zhenhao ; Zheng, Miao ; Yang, Zhuming ; Xu, Hao ; Cao, Yang ; Hong, Zhenya ; Zhang, Yicheng ; Mei, Yu ; Huang, Liang

BACKGROUNDRefractoriness and relapse after chimeric antigen receptor T-cell therapy have emerged as major challenges for immunotherapy of aggressive large B-cell lymphoma. Thus far, there is no consensus on how to address treatment failure and whether to administer maintenance therapy following CAR-T cell therapy.METHODSFrom August 2017 through November 2022, 52 patients with refractory/relapsed aggressive LBCL who had a high risk of resistance to CAR-T cell therapy were given chidamide in combination with a PD-1 inhibitor as maintenance therapy following either CAR19/22 T-cell cocktail therapy or CAR19/22 T-cell cocktail therapy plus autologous stem cell transplantation (ASCT). Another 52 aggressive LBCL patients who had comparable baseline characteristics and received similar therapeutic regimens but did not receive any interventions following CAR-T cell therapy or CAR-T cell therapy plus ASCT were regarded as the control group to evaluate the efficacy and safety of the combination of chidamide and a PD-1 inhibitor.RESULTSAmong the 52 patients who received chidamide and a PD-1 inhibitor as maintenance therapy, with a median follow-up of 26.5 months (range: 1.1-53.8), neither the median progression-free survival (PFS) nor overall survival (OS) was reached, and the expected 2-year OS and PFS rates were 89 % and 77 %, respectively, which were superior to those of the control group (p < 0.001). Long-term chidamide administration and a specific genetic subtype of EZB were strongly associated with a better response after chidamide plus PD-1 blockade therapy. Additionally, long-term chidamide administration was significantly associated with prolonged persistence and reactivation of CD19-directed CAR-T cells in the peripheral blood. Adverse effects (AEs) were moderate and reversible, and no treatment-related deaths occurred.CONCLUSIONOur results indicate that the combination of chidamide and PD-1 blockade as maintenance therapy could improve the outcomes of aggressive LBCL patients at high risk of failing CAR-T cell therapy.

10 Apr 2024·Zhonghua yi xue yi chuan xue za zhi = Zhonghua yixue yichuanxue zazhi = Chinese journal of medical genetics

[Study of a patient with Myelodysplastic/myeloproliferative neoplasm with co-morbid neutrophilia and a novel NCOR1::GLYR1 fusion gene].

Article

Author: Cheng, Yu ; Lei, Yutian ; Zhao, Xiaoli ; Wang, Shuai ; Zhao, Huihui ; Li, Jianyong ; Zhu, Yu

OBJECTIVETo explore the genetic background for a patient with refractory myelodysplastic/myeloproliferative neoplasm (MDS/MPN) with co-morbid neutrophilia patient.METHODSA MDS/MPN patient who was admitted to the First Affiliated Hospital of Nanjing Medical University in May 2021 was selected as the study subject. RNA sequencing was carried out to identify fusion genes in his peripheral blood mononuclear cells. Fusion gene sequence was searched through transcriptome-wide analysis with a STAR-fusion procedure. The novel fusion genes were verified by quantitative real-time PCR and Sanger sequencing.RESULTSThe patient, a 67-year-old male, had progressive thrombocytopenia. Based on the morphological and molecular examinations, he was diagnosed as MDS/MPN with co-morbid neutropenia, and was treated with demethylating agents and Bcl-2 inhibitors. Seventeen months after the diagnosis, he had progressed to AML. A novel fusion gene NCOR1::GLYR1 was identified by RNA-sequencing in his peripheral blood sample, which was verified by quantitative real-time PCR and Sanger sequencing. The patient had attained morphological remission after a DCAG regimen (a combinatory chemotherapy of decitabine, cytarabine, aclarubicin and granulocyte colony-stimulating factors) plus Chidamide treatment. A significant decrease in the NCOR1::GLYR1 expression was revealed by quantitative real-time PCR at post-chemotherapy evaluation.CONCLUSIONNCOR1::GLYR1 gene is considered as the pathogenic factor for the MDS/MPN patient with neutropenia.

02 Apr 2024·Molecular Cancer Therapeutics

ADCT-602, a Novel PBD Dimer–containing Antibody–Drug Conjugate for Treating CD22-positive Hematologic Malignancies

Article

Author: Corbett, Simon ; Tarantelli, Chiara ; Sachini, Nikoleta ; Zammarchi, Francesca ; Golino, Gaetanina ; Santos, Kathleen ; Tyrer, Peter ; van Berkel, Patrick H ; Spriano, Filippo ; Hartley, John A ; Gaudio, Eugenio ; Cascione, Luciano ; Bertelli, Francois ; Janghra, Narinder ; Idusogie, Esohe ; Bertoni, Francesco ; Chivers, Simon ; Havenith, Karin E

AbstractRelapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and lymphomas have poor patient outcomes; novel therapies are needed. CD22 is an attractive target for antibody–drug conjugates (ADCs), being highly expressed in R/R B-ALL with rapid internalization kinetics. ADCT-602 is a novel CD22-targeting ADC, consisting of humanized mAb hLL2-C220, site specifically conjugated to the pyrrolobenzodiazepine dimer–based payload tesirine. In preclinical studies, ADCT-602 demonstrated potent, specific cytotoxicity in CD22-positive lymphomas and leukemias. ADCT-602 was specifically bound, internalized, and trafficked to lysosomes in CD22-positive tumor cells; after cytotoxin release, DNA interstrand crosslink formation persisted for 48 hours. In the presence of CD22-positive tumor cells, ADCT-602 caused bystander killing of CD22-negative tumor cells. A single ADCT-602 dose led to potent, dose-dependent, in vivo antitumor activity in subcutaneous and disseminated human lymphoma/leukemia models. Pharmacokinetic analyses (rat and cynomolgus monkey) showed excellent stability and tolerability of ADCT-602. Cynomolgus monkey B cells were efficiently depleted from circulation after one dose. Gene signature association analysis revealed IRAK1 as a potential marker for ADCT-602 resistance. Combining ADCT-602 + pacritinib was beneficial in ADCT-602–resistant cells. Chidamide increased CD22 expression on B-cell tumor surfaces, increasing ADCT-602 activity. These data support clinical testing of ADCT-602 in R/R B-ALL (NCT03698552) and CD22-positive hematologic cancers.

News (Medical) associated with Chidamide

30 Apr 2024

·www.prnewswire.com

National Medical Products Administration (NMPA) Approves Chipscreen Bioscience's Chidamide (Epidaza) combined with R-CHOP for the treatment of diffuse large B-cell lymphoma

SHENZHEN, China, April 30, 2024 /PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company's lead innovative product Chidamide (Epidaza®) , an oral subtype-selective histone deacetylase (HDAC) inhibitor, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), has been officially approved by the National Medical Products Administration (NMPA) for treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) with positive MYC and BCL2 expression. Up to now, Chidamide has been approved for multiple indications globally. (For more information, please review the global commercialization situation). Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma, with approximately 30000 new cases occurring annually in China. Clinical diagnosis and treatment guidelines and consensus both domestically and internationally recommend the R-CHOP regimen as the standard first-line treatment for DLBCL. However, about one-third or more of patients in the overall population still experience ineffective or early recurrence of first-line R-CHOP treatment. Meanwhile, approximately 30% of patients with DLBCL exhibit simultaneous overexpression of MYC/BCL2 protein (referred to as "double expression" lymphoma, DEL), and their efficacy and prognosis after R-CHOP treatment are significantly lower than those of non double expression patients. Therefore, how to combine new drugs based on R-CHOP regimen to provide a more effective and safer treatment to our patients is a significant unmet medical need. The approval of this new indication is based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial DEB trial (NCT04231448). The DEB trial is the first Phase III registered clinical study in the world as first line treatment of MYC/BCL2 dual expression diffuse large B-cell lymphoma. This trial is to evaluate the efficacy and safety of Chidamide combined with R-CHOP compared to R-CHOP in primary treatment and MYC/BCL2 dual expression DLBCL subjects. Based on the interim analysis conducted by the Independent Data Monitoring Committee (iDMC), the efficacy and safety indicators set by the protocol were achieved. Compared with the R-CHOP regimen, the Chidamide combination regimen significantly improved the complete response rate (CRR) of the study's key secondary endpoint, and the study's primary endpoint, event free survival (EFS), also showed a clear trend of benefit. The experimental safety profile is consistent with known risks, and no new significant safety signals were found. The results of the interim analysis of the DEB Phase III study were selected as the Late breaking Abstract (LBA) for the American Society of Clinical Oncology (ASCO) Annual Meeting on April 24, 2024. Dr. Xianping Lu, Chairman and General Manager of Chipscreen Biosciences, stated, "The classic R-CHOP regimen has been used as a first-line treatment for diffuse large B-cell lymphoma (DLBCL) for nearly 20 years, but its therapeutic effect is not satisfactory in populations with dual expression of BCL2 and MYC proteins. The combination of Chidamide and R-CHOP is the world's first phase 3 registered clinical study that focuses on first line therapy of dual expressed DLBCL, and also the world's first R-CHOP improvement study with significant benefits in complete remission rate. We believe that the approval of the new indication will bring new hope and better survival benefits to patients." About Chidamide (Epidaza®) Chidamide (Tucidinostat, Trade name: Epidaza®), a Class 1.1 innovative drug, is a novel molecular entity with global patent protection and the first marketed product developed independently by Chipscreen Biosciences. The first original chemical new drug approved in China, Chidamide is also the first oral subtype-selective histone deacetylase (HDAC) inhibitor in the world, Since its approval in China in December 2014 for the treatment of peripheral T-cell lymphoma, Chidamide has achieved significant commercialization worldwide and continuously explored new indications. Global commercialization situation: In December 2014, Chidamide was approved for use in patients with recurrent or refractory peripheral T-cell lymphoma (PTCL) in China; In November 2019, Chidamide was approved to combine aromatase inhibitors to treat locally advanced or metastatic breast cancer patients with estrogen receptor positive, human epidermal growth factor receptor-2 negative, postmenopausal, and endocrine therapy relapse or progress in China; In June 2021, Chidamide was approved for monotherapy in the treatment of recurrent or refractory (R/R) adult T-cell leukemia (ATL) in Japan; In December 2021, Chidamide was approved for monotherapy for recurrent or refractory (R/R) peripheral T-cell lymphoma (PTCL) in Japan; In March 2023, Chidamide was approved to be used for postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor positive, type II human epidermal growth factor receptor (HER2) negative, and relapse or worsen after endocrine therapy (in combination with exemestane) in Taiwan, China; In April 30, 2024, Chidamide was approved to use in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) for previously untreated diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression in China. Global exploration of other indications: In addition to ongoing global multicenter phase III clinical trial for the first-line treatment of melanoma in comniation with Opdivo, Chidamide is also conducting multiple clinical trials in China and internationally in combination with different anti-tumor immunotherapies. In November 2023, the Phase II clinical trial of the first-line treatment of non-small cell lung cancer with Chidamide combined with Tislelizumab was completed and enrolled. On March 4, 2024, Professor Ruihua Xu and Professor Feng Wang from the Cancer Prevention and Treatment Center of Sun Yat sen University led the research on CAPAbility-01, which was published on the world's top academic journal Nature Medicine (IF=82.9). As one of the most valuable sub journals under Nature, the publication of Nature Medicine reflects the academic authority's recognition of CAPAbility-01 research. This study indicates that for patients with microsatellite stable/mismatched repair function intact (MSS/pMMR) type metastatic colorectal cancer (mCRC), a three drug regimen led by Chidamide (Chidamide+sintilimab antibody+bevacizumab) for third line and above treatment, with an 18 week PFS rate of 64.0%, an ORR of 44.0%, and a median PFS of 7.3 months, is considered a promising treatment option for MSS/pMMR advanced CRC patients. On April 24, 2024, an abstract entitled "Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study" was selected the American Society of Clinical Oncology (ASCO) LBA list for the 2024 ASCO, which submitted by Professor Weili Zhao's team from Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide. With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, we have marketed two drugs for threeindications in Mainland China, two indications in Japan, and one indication in Taiwan, China. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 660 invention patents in China and worldwide, with over 180 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Phase 3Drug ApprovalPhase 2Clinical ResultImmunotherapy

21 Mar 2024

·www.biospace.com

Muscular Dystrophy Association’s Funding of Foundational Research Leads to New FDA Approved Treatment Duvyzat (givinostat) for Duchenne Muscular Dystrophy

New York, March 21, 2024 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association’s funding of foundational research leads to new drug approval by the US Food and Drug Administration (FDA) of Duvyzat (givinostat), a histone deacetylase (HDAC) inhibitor to treat children and adolescents living with Duchenne muscular dystrophy (DMD). This drug changes gene expression in cells by altering the three-dimensional folding of DNA and has shown that it can slow DMD progression. Duvyzat (givinostat) will be made available in the United States by ITF Therapeutics. Results from a phase 3 clinical trial of Duvyzat (givinostat) recently published in The Lancet demonstrated a significantly smaller decline in stair climbing ability in treated patients compared to a placebo control group. "The approval of Duvyzat (givinostat) provides another significant treatment option for people living with Duchenne muscular dystrophy,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA. “As more drugs are approved for DMD we look forward to understanding if and how they might be used in combination.” Pier Lorenzo Puri’s group based at Sanford Burnham Prebys Medical Discovery Institute in San Diego performed the studies that led to the discovery of HDAC inhibitors (HDACi) for treatment of DMD since 2004. These studies were performed in close collaboration with the lab Puri led in Rome in Scientific Park of Castel Romano (2002-2007) and at Fondazione Santa Lucia (2008-2018). “Muscular Dystrophy Association’s funding was fundamental for the discovery of HDACi in the treatment of Duchenne muscular dystrophy. We are grateful to MDA to have enabled studies that support the important pre-clinical evidence that HDACi exerted beneficial effects in the mouse model of DMD. These studies provided the initial experimental evidence that led me to contact Italfarmaco to test givinostat, as a HDACi that was already in clinical trial for other diseases and could have been easily repurposed for DMD,” said Pier Lorenzo Puri, M.D., Sanford Burnham Prebys Medical Discovery Institute. For decades, MDA has awarded many research grants to fund investigators worldwide and their promising early-stage science. These grants support the foundational discoveries that enable future clinical translation, such as with Duvyzat (givinostat). “Since the way Duvyzat (givinostat) works is different from other treatments for Duchenne muscular dystrophy, the combination of this new drug with other therapies may further improve the lives of our patients living with Duchenne muscular dystrophy,” said Barry Byrne, M.D., Ph.D., Chief Medical Advisor, MDA and the Associate Chair of Pediatrics and Director of the Powell Gene Therapy Center at the University of Florida. “We’re excited to celebrate this additional treatment option for people living with Duchenne muscular dystrophy. This approval demonstrates the FDA’s understanding of the importance of slowing disease progression in diseases like Duchenne, and how meaningful that is to the community. We are proud to partner with the FDA to help speed the approval of new therapies that slow disease progression and ensure the voice of patients and their families is heard,” said Paul Melmeyer, Vice President, Public Policy and Advocacy, MDA. “Being part of the Muscular Dystrophy Association is everything. From the MDA Care Center Network and Resource Center to the industry development, educational resources, and advocacy and so much more, because of MDA when people are diagnosed, they have such a wide range of resources. When my son Conner was diagnosed nine years ago, there were 10 drugs in the pipeline for DMD and steroids possibly if you chose to do that -- and really not much else. With this new FDA approval, it's amazing because of the MDA, they've funded the seed research, for a lot of the drugs that are now in the pipeline or already approved. And parents have choices. It is more than fair to say that the Muscular Dystrophy Association has improved lives. My son is an example,” said Jessica Curran, MDA family member and mother of Conner who lives with Duchenne muscular dystrophy. About Duchenne muscular dystrophy (DMD) Duchenne muscular dystrophy (DMD) is a rare and progressive genetic muscle disease caused by the lack of a critical membrane-stabilizing protein called dystrophin, which results in muscle degeneration and weakness. DMD symptom onset is in early childhood, usually between ages 2 and 3. The disease primarily affects boys, but in rare cases it can affect girls. In Europe and North America, the prevalence of DMD is approximately 6 per 100,000 individuals. Doctors often diagnose the disease between ages 3 and 6 when children show early signs of significant muscle weakness, such as delayed ability to sit, stand, or walk and difficulties learning to speak. Over time, DMD becomes fatal as muscle degeneration disrupts lung and heart function. MDA’s Legacy in Duchenne Muscular Dystrophy Research Since our inception, MDA has invested over $229 million in research for Duchenne and Becker muscular dystrophy. The discovery of the dystrophin gene in the 1980s by MDA-funded research marked the beginning of our understanding of Duchenne and Becker muscular dystrophy. This discovery has been foundational in the development of treatments like Duvyzat (givinostat). For support and guidance, families and medical professionals in the neuromuscular community may contact the MDA Resource Center, ResourceCenter@mdausa.org. About Muscular Dystrophy Association Muscular Dystrophy Association (MDA) is the #1 voluntary health organization in the United States for people living with muscular dystrophy, ALS, and related neuromuscular diseases. For over 70 years, MDA has led the way in accelerating research, advancing care, and advocating for the support of our families. MDA's mission is to empower the people we serve to live longer, more independent lives. To learn more visit mda.org and follow MDA on Instagram, Facebook, X, Threads, TikTok, LinkedIn, and YouTube. Attachment New FDA Drug Approval for Duchenne Muscular Dystrophy Mary Fiance, Vice President, Strategic Communications Muscular Dystrophy Association press@mdausa.org

Phase 3Drug ApprovalClinical Result

18 Mar 2024

·www.fiercebiotech.com

Chinese biotech's MASH candidate reduces liver fat in phase 2 trial

Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin. Chipscreen Biosciences' metabolic dysfunction-associated steatohepatitis (MASH) candidate reduced patients' liver fat levels, adding further momentum to drugs aimed at the condition. The Shenzhen, China-based biotech says chiglitazar produced “significant and dose-dependent reductions” in liver fat content from baseline compared to placebo during a phase 2 study, according to a Monday press release. The company did not provide data to support the primary endpoint win and said more will be revealed at an upcoming conference or in a medical journal. Chipscreen also reported that patients given chiglitazar “showed significant or dose-dependent trend of improvements” on a number of secondary endpoints. As for safety, Chipscreen kept it short and sweet: “The overall safety is good.” Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin. The sampling of phase 2 data teased Monday comes days after Madrigal Pharmaceuticals scored the first-ever FDA approval to treat MASH, which has previously been known as non-alcoholic steatohepatitis (NASH). The much-hyped class of GLP-1 medications have also shown promise as potential MASH treatments. Chipscreen’s metabolic ambitions have grown in parallel with the biotech’s oncology work, centered on its epigenetic modulator, chidamide. The drug is approved in China as a treatment for peripheral T-cell lymphoma and breast cancer, with ongoing trials testing it in patients with diffuse large B cell lymphoma and non-small cell lung cancer.

Drug ApprovalClinical ResultPhase 2

100 Deals associated with Chidamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Chidamide	L01XX	DB06334

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	24 Apr 2024
Adult T-Cell Leukemia-Lymphoma	JP	Meiji Seika Pharma Co., Ltd.	23 Jun 2021
Breast Cancer	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	20 Nov 2019
Peripheral T-Cell Lymphoma	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	23 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	-	Great Novel Therapeutics Biotech & Medicals Corp.	14 Jul 2018
HIV Infections	Phase 3	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	29 Nov 2016
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	01 Apr 2013
Melanoma	Phase 1	AU	HUYA Bioscience International LLC	18 Dec 2020
Breast Cancer	Phase 1	-	Great Novel Therapeutics Biotech & Medicals Corp.	14 Jul 2018
Cutaneous T-Cell Lymphoma	Preclinical	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	08 Feb 2010
Brain metastases	Discovery	AU	HUYA Bioscience International LLC	28 Jan 2021
Locally advanced breast cancer	Discovery	-	-	15 Dec 2007
Triple Negative Breast Cancer	Discovery	-	-	15 Dec 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02953652 (Pubmed) Manual	Phase 2	Peripheral T-Cell Lymphoma	55	tucidinostat	(yaeeyzzvbm) = vmuobvmokd hnbzohnqcc (jtxjehatuk, 30.9 - 61.0) View more	Positive	06 Oct 2022
NCT04724239 (CAPability-01, Literature) Manual	Phase 2	Colorectal Cancer \|	48	Sintilimab+Chidamide+Bevacizumab	(gmcbaycpkm) = vhglthjdlg wpyhposumx (yjhsrpfdik ) View more	Positive	04 Mar 2024
NCT04724239 (CAPability-01, Literature) Manual	Phase 2	Colorectal Cancer \|	48	Sintilimab+Chidamide	(gmcbaycpkm) = cnrghlniym wpyhposumx (yjhsrpfdik ) View more	Positive	04 Mar 2024
ChiCTR2000041542 (ESMO_IO2022) Manual	Phase 2	Non-Small Cell Lung Cancer First line PD-L1 expression positive	20	chidamide 20 mg+tislelizumab 200 mg	(ytmdbrzbmp) = iukrskasgm pfxpqedxyf (zeiplgkczr ) View more	Positive	08 Dec 2022
NCT02718066 (TN-Mel, SITC2020) Manual	Phase 1/2	Melanoma	49	nivolumab+HBI-8000	(cdpcgrqclh) = nafipsesnf pfysxrldqx (ezdswaeyjx ) View more	Positive	26 Nov 2020
NCT04022005 (ASH2020) Manual	Phase 2	Diffuse large B-cell lymphoma recurrent	25	R-GemOx+Chidamide	(faoziyfhzn) = alvhwbeego prqsjbiyfw (zoqgfrkfrr ) View more	Positive	05 Nov 2020
NCT04562311 (ASCO2023) Manual	Phase 2	Metastatic urothelial carcinoma	24	Chidamide 30 mg+Tislelizumab 200 mg	(nccphqtsji) = wepiafpcip hhebyeoybj (hmnpykqulb ) View more	Positive	26 May 2023
NCT02697552 (Pubmed) Manual	Phase 1	Non-Hodgkin Lymphoma	14	Chidamide	(lelbublbea) = two of six patients in the 40 mg BIW cohort had asymptomatic dose-limiting toxicitys. feridbuntb (dbkbecgish ) View more	Positive	02 Jun 2022
ESMO2023 Manual	Phase 2	Non-Small Cell Lung Cancer Consolidation	19	Tislelizumab 200 mg+Chidamide 30 mg	(rhetpcpoqt) = lmcfylkzrj srfetcxjuw (qajicngnsa ) View more	Positive	21 Oct 2023
NCT05400993 (ASCO2023) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR Positive \| HER2 Negative	35	chemotherapy+Chidamide	(gnksmnjepq) = xiaslautcp rwchslvuwc (bvqsffxvbu, 23.2 - 53.7) View more	Positive	31 May 2023
NCT04025931 (ASCO2023) Manual	Phase 2	Locally Advanced Soft Tissue Sarcoma	46	Toripalimab+Chidamide	(fqtqundhpu) = hdziohpxow ubiakqqfms (ntpcyuxviy ) View more	Positive	26 May 2023

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