[Translation] A clinical study to evaluate the safety, tolerability, pharmacokinetics, efficacy and correlation with AKR1C3 enzyme expression of AST-3424 in the treatment of patients with malignant tumors

主要目的：根据受试者的客观缓解率（ORR），疾病控制率（DCR），缓解持续时间（DOR）和无进展生存期（PFS）, 初步评估AST-3424单药治疗HCC等恶性肿瘤的疗效。次要目的：评估单药治疗肝细胞癌等恶性肿瘤的安全性和耐受性，探讨肿瘤组织经免疫组织化学确定的AKR1C3表达与疗效之间的关系。探索性目的：评估受试者接受单药治疗后的疼痛缓解程度及止痛药使用变化。

[Translation]

Primary purpose: To preliminarily evaluate the efficacy of AST-3424 monotherapy for HCC and other malignant tumors based on the objective response rate (ORR), disease control rate (DCR), duration of response (DOR) and progression-free survival (PFS) of the subjects. Secondary purpose: To evaluate the safety and tolerability of monotherapy for malignant tumors such as hepatocellular carcinoma, and to explore the relationship between AKR1C3 expression in tumor tissues determined by immunohistochemistry and efficacy. Exploratory purpose: To evaluate the degree of pain relief and changes in the use of analgesics after monotherapy in subjects.

Start Date23 Jun 2022

Sponsor / Collaborator

Ascentawits Pharmaceuticals Ltd.Startup

CTR20201908

/ RecruitingPhase 1

评价AST-3424 治疗复发或难治性急性淋巴细胞白血病患者的安全性、耐受性、药代动力学、初步疗效以及疗效与AKR1C3 酶表达相关性的临床研究

[Translation] A clinical study to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy, and correlation between efficacy and AKR1C3 enzyme expression of AST-3424 in the treatment of patients with relapsed or refractory acute lymphoblastic leukemia

主要目的：评估AST-3424静脉给药的安全性和耐受性；评估AST-3424及其代谢产物的药代动力学特征；评估ALL受试者接受AST-3424单药治疗的给药方案；次要目的：初步评估AST-3424单药治疗复发或难治性ALL的血液学缓解情况，判定标准为ORR= CR+PR（其中CR包括CR和CRi）；评估患者的总生存期（OS）；评估患者的无进展生存期（PFS）（PFS定义为从首次用药开始到疾病进展或任何原因导致的死亡的时间）；评估CR/CRi患者的微小残存病变（MRD）的阴性率（MRD阴性定义为流式细胞术检测< 0.01%）；评估CR/CRi患者微小残存病变（MRD）首次达到阴性的时间；评估CR/CRi患者MRD阴性持续的时间（从达到CR/CRi后MRD首次评估阴性到MRD转为阳性或CR/CRi后复发的最早日期时间）；探讨患者外周血和骨髓中经PCR-荧光探针法确定的AKR1C3酶的表达与疗效之间的关系。探索性目的：探索DNA损伤修复相关基因突变的表达。

[Translation]

Primary objectives: To evaluate the safety and tolerability of intravenous administration of AST-3424; To evaluate the pharmacokinetic characteristics of AST-3424 and its metabolites; To evaluate the dosing regimen of AST-3424 monotherapy in ALL subjects; Secondary objectives: To preliminarily evaluate the hematological remission of AST-3424 monotherapy in relapsed or refractory ALL, with the criteria of ORR = CR + PR (CR includes CR and CRi); To evaluate the overall survival (OS) of patients; To evaluate the progression-free survival (PFS) of patients (PFS is defined as the time from the first medication to disease progression or death from any cause); To evaluate the negative rate of minimal residual disease (MRD) in patients with CR/CRi (MRD negative is defined as flow cytometry detection < 0.01%); To evaluate the time when minimal residual disease (MRD) in patients with CR/CRi first reaches negative; To evaluate the duration of MRD negativity in patients with CR/CRi (from the first negative MRD assessment after reaching CR/CRi to the earliest date of MRD conversion to positive or relapse after CR/CRi); To explore the relationship between the expression of AKR1C3 enzyme in the peripheral blood and bone marrow of patients determined by PCR-fluorescent probe method and the therapeutic effect. Exploratory purpose: To explore the expression of gene mutations related to DNA damage repair.

Start Date06 Apr 2021

Sponsor / Collaborator

Ascentawits Pharmaceuticals Ltd.Startup

NCT04315324

/ RecruitingPhase 2IIT

A Phase II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)

This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.

Start Date08 Feb 2021

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with AST-3424

100 Translational Medicine associated with AST-3424

100 Patents (Medical) associated with AST-3424

Literatures (Medical) associated with AST-3424

01 Aug 2023·British journal of cancer

Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, and clinical activity of OBI-3424 in patients with advanced or metastatic solid tumors.

Article

Author: Hsu, Pei ; Pearce, Tillman E. ; Wesolowski, Robert ; Verschraegen, Claire F. ; Shia, Chi-Sheng ; Tsimberidou, Apostolia Maria

BACKGROUND:

Report of a Phase 1 dose-escalation study of OBI-3424 monotherapy in patients with advanced solid tumors (NCT03592264).

METHODS:

A classic 3 + 3 design was used to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of OBI-3424 administered intravenously, as a single agent, at doses of 1, 2, 4, 6, 8, or 12 mg/m² (days 1 and 8 of a 21-day cycle, Schedule A) or 8, 10, 12, or 14 mg/m² (day 1 of a 21-day cycle, Schedule B).

RESULTS:

Dose-limiting hematologic toxicities at 12 mg/m² in Schedule A led to dose and schedule modifications (Schedule B). In Schedule B, maximum tolerated dose was not reached at the maximum dose tested (14 mg/m²). Grade ≥3 anemia was noted in 3/6 patients treated at 14 mg/m²; the RP2D was 12 mg/m² (Schedule B). Grade ≥3 treatment-emergent adverse events were experienced by 19/39 (49%) and included anemia (41%) and thrombocytopenia (26%); three patients experienced serious treatment-emergent adverse events (grade ≥3 anemia and thrombocytopenia). One patient had a partial response and 21/33 (64%) had stable disease.

CONCLUSIONS:

The RP2D is 12 mg/m² once every 3 weeks. OBI-3424 was well tolerated; dose-dependent, noncumulative thrombocytopenia and anemia were dose-limiting.

01 Jun 2023·Journal of pharmacological sciences

A novel AKR1C3 specific prodrug AST-3424 and its combination therapy in hepatocellular carcinoma

Article

Author: Qin, Shukui ; Zheng, Xia ; Xun, Chen ; Zhang, Yu

OBJECTIVE:

AST-3424 is a novel specific aldo-keto reductase 1C3 (AKR1C3) prodrug that releases a DNA alkylating reagent upon reduction by AKR1C3. This study aimed to evaluate the efficacy and safety of AST-3424 in patient-derived tumor xenograft (PDTX) model and orthotopic model against hepatocellular carcinoma (HCC).

MATERIALS AND METHOD:

PDTX models derived from three HCC patients and orthotopic mice models using HepG2 cells were developed. The mice were treated with AST-3424 alone or combined with other drugs (oxaliplatin, apatinib, sorafenib and elemene in PDTX models, oxaliplatin and 5- fluorouracil in orthotopic models). The tumor volume and weight, as well as the mice weight were assessed. The liver tumor and transplanted tumor were removed for histological, immunohistochemical and Western blot detection in orthotopic model experiments.

RESULTS:

AST-3424 could inhibit tumor growth in HCC PDTX models and orthotopic models, with no difference in safety compared with other marketed drugs, and the drug combination did not increase toxicity. The inhibitory effect of combination treatment was more obvious than which used alone. The reduction of AKR1C3 expression was negatively correlated with AST-3424 dose.

CONCLUSION:

AST-3424 had a promising effect against HCC in PDTX model and orthotopic model with good safety. It could promote the sensitivity of other drugs without increasing toxicity. Clinical trials are warranted to further certify its antitumor effect and safety.

01 Jan 2023·American journal of cancer research

Erratum: A novel selective AKR1C3-activated prodrug AST-3424/OBI-3424 exhibits broad anti-tumor activity.

Author: Wang, Chun-Chung ; Qi, Tianyang ; Meng, Fanying ; Jung, Donald ; Hsu, Ren-Yu ; Duan, Jianxin ; Hsieh, Yin-Cheng ; Li, Wan-Fen ; Shia, Chi-Sheng

[This corrects the article on p. 3645 in vol. 11, PMID: 34354865.].

News (Medical) associated with AST-3424

01 Jan 2025

·www.globenewswire.com

OBI Pharma Enters Collaboration with GlyTech to Expand GlycOBI® Enabling Technologies Outreach in Japan and to Advance Glycan Production

Dec. 23, 2024 -- OBI Pharma, Inc. (OBI), a clinical-stage global oncology company specialized in the development of novel cancer therapies such as antibody-drug conjugates (ADC) and active immunotherapies (4174. TWO), and GlyTech, Inc. (GlyTech), a Japan manufacturer that focuses on glycan production and chemical glycosylation technologies, have entered into a Marketing Agreement and a Material Transfer Agreement. Under the terms of the Marketing Agreement, OBI grants GlyTech rights to market and promote OBI’s GlycOBI® ADC enabling technologies, powered by EndoSymeOBI®, to potential pharma and biotech partners in Japan. GlyTech will also be a key supplier of glycans in Japan. Under the terms of the Material Transfer Agreement, OBI will transfer some of its cutting-edge materials to GlyTech for research in advancing the efficient production of glycans for ADCs. Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, noted, “GlyTech has been one of our trusted suppliers for high quality glycans. We are excited to collaborate with GlyTech to broaden the reach of OBI’s novel GlycOBI® ADC enabling technologies with potential pharma and biotech partners in Japan. We also look forward to the collaborative research with GlyTech, which is part of our plan to ensure high quality, scalable glycan manufacturing and supply for ADCs.” Hiroaki Asai, President & CEO of GlyTech, added, “OBI Pharma's innovative GlycOBI® ADC technologies are testaments to their command of enzyme-based precision synthetic organic chemistry. GlyTech, Inc. is pleased to support the contribution of GlycOBI® ADC technologies to the world as a supplier of highly pure human glycans, a key material for this technology. We greatly look forward to OBI Pharma's continuing progress in new drug development.” OBI Pharma, Inc., is a clinical stage global oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. Using the company’s proprietary ADC enabling technologies, including but not limited to GlycOBI®, powered by EndoSymeOBI®, OBI has created its novel ADC pipeline, including OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. Additionally, the company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme that is highly expressed in tumors. Additional information can be found at www.obipharma.com. GlycOBI® and EndoSymeOBI® are registered trademarks of OBI Pharma, Inc. GlyTech, Inc. is headquartered in Kyoto, Japan and was established in 2012 as the only bio-venture company in the world capable of the commercial production of human-type glycans. Its current mission is to contribute to efforts enabling people to live healthier lives by supporting the development of advanced products and technologies that take advantage of glycans, proteins, nucleotides and other naturally occurring biochemicals. GlyTech’s technology platforms include the glycan-based enhancement of drugs of various modalities, brain drug delivery technology, and peptide binder discovery services. GlyTech’s own pipeline contains several assets that utilize glycans, and the company is conducting investigator-initiated clinical trials (P2a) for a glycosylated somatostatin with acromegaly as the target indication. The content above comes from the network. if any infringement, please contact us to modify.

License out/inImmunotherapyVaccineADC

13 Jun 2024

·pipelinereview.com

OBI Pharma Announces Phase 1/2 Study Initiation for OBI-992, a TROP2-Targeted Antibody-Drug Conjugate (ADC) for Cancer Therapy

Clinical trial to evaluate the safety and efficacy of OBI-992 in advanced solid tumors. TAIPEI, Taiwan I June 12, 2024 I OBI Pharma, a clinical-stage oncology company (4174.TWO), today announced the initiation of a Phase 1/2 clinical trial of OBI-992, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types. OBI plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and other potential cancers. The objective of the trial is to verify the safety, pharmacokinetics, and preliminary efficacy profile of OBI-992 in these patient populations. OBI Pharma’s Chief Medical Officer, M. Wayne Saville, M.D., noted, “Based on our preclinical data, OBI-992 has several important advantages over other TROP2 ADCs in development; including high serum stability, excellent bystander effect, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer 1 , 2 , 3 . We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. Leia Tsimberidou MD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study.” Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “We are excited to initiate this first in human study of OBI-992. This is an important company milestone and highlights our commitment to building and strengthening the novel OBI Pharma oncology pipeline. We thank the patients and the investigators for their efforts and dedication.” About OBI-992 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload (exatecan) proven to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, gastric, and other cancers, rendering it an ideal target for cancer therapy. OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. In preclinical animal models, OBI-992 demonstrated remarkable antitumor activity, improved pharmacokinetic characteristics, and a favorable safety profile relative to comparator ADCs. The TROP2 targeting antibody was in-licensed from Biosion, Inc. www.Biosion.com , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. About OBI Pharma OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. Using the company’s unique ADC platforms, including GlycOBI™, OBI created its novel ADC pipeline which includes OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at www.obipharma.com . GlycOBI™ is a trademark of OBI Pharma, Inc. 1 , 2 , 3 : AACR Annual Meeting 2024 Abstracts online. OBI Pharma, Inc. Taipei, Taiwan. https://www.obipharma.com/zh-hant/news-zh-hant/poster-presentations-at-the-aacr-2024-annual-meeting-for-obi-992-and-glycobi-adc-platform/ SOURCE: OBI Pharma

ImmunotherapyAACRADCVaccineIND

12 Jun 2024

·www.biospace.com

OBI Pharma Announces Phase 1/2 Study Initiation for OBI-992, a TROP2-Targeted Antibody-Drug Conjugate (ADC) for Cancer TherapyClinical trial to evaluate the safety and efficacy of OBI-992 in advanced solid tumors.

TAIPEI, Taiwan, June 12, 2024 (GLOBE NEWSWIRE) -- OBI Pharma, a clinical-stage oncology company (4174.TWO), today announced the initiation of a Phase 1/2 clinical trial of OBI-992, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types. OBI plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and other potential cancers. The objective of the trial is to verify the safety, pharmacokinetics, and preliminary efficacy pro OBI-992 in these patient populations. OBI Pharma's Chief Medical Officer, M. Wayne Saville, M.D., noted, “Based on our preclinical data, OBI-992 has several important advantages over other TROP2 ADCs in development; including high serum stability, excellent bystander effect, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer 1, 2,3. We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. Leia Tsimberidou MD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study.” Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “We are excited to initiate this first in human study of OBI-992. This is an important company milestone and highlights our commitment to building and strengthening the novel OBI Pharma oncology pipeline. We thank the patients and the investigators for their efforts and dedication.” About OBI-992 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload (exatecan) proven to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, gastric, and other cancers, rendering it an ideal target for cancer therapy. OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. In preclinical animal models, OBI-992 demonstrated remarkable antitumor activity, improved pharmacokinetic characteristics, and a favorable safety pro to comparator ADCs. The TROP2 targeting antibody was in-licensed from Biosion, Inc. , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. About OBI Pharma OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. Using the company’s unique ADC platforms, including GlycOBI™, OBI created its novel ADC pipeline which includes OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at . GlycOBI™ is a trademark of OBI Pharma, Inc. 1, 2,3: AACR Annual Meeting 2024 Abstracts online. OBI Pharma, Inc. Taipei, Taiwan. Forward-Looking Statements Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau. COMPANY CONTACT: Kevin Poulos Chief Business Officer OBI Pharma, Inc. 1.619.537.7698 Ext. 102 kpoulos@obipharmausa.com 115011台北市南港区忠孝东路七段508号6楼 6F., No. 508, Sec 7, Zhongxiao E. R., Nangang Dist., Taipei 115011, Taiwan R.O.C. OBI PHARMA台灣浩鼎

ImmunotherapyAACR

100 Deals associated with AST-3424

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Bladder Cancer	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Colorectal Cancer	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Endometrial Carcinoma	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Esophageal Carcinoma	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Extranodal NK-T-Cell Lymphoma	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Hepatocellular Carcinoma	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
High Risk Myelodysplastic Syndrome	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Non-Small Cell Lung Cancer	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022
Peripheral T-Cell Lymphoma	Phase 2	CN	Ascentawits Pharmaceuticals Ltd.Startup	23 Jun 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06239155 (ASCO2024)	Phase 1	Advanced Malignant Solid Neoplasm AKR1C3 expression	21	AST-3424 8 mg/m2	pkaejfkcxq(wsblfjdrce) = deuajovjqz pujnpwodkt (wcxcftcuap ) View more	Positive	24 May 2024
NCT03592264 (Pubmed)	Phase 1	Metastatic Solid Tumor	39	OBI-3424	dvydnftpqn(llzkxnymbu) = xmecvmtmki zxsnlkunli (ljhkxcyvqc )	-	12 May 2023
NCT03592264 \| NCT04315324 (AACR2022)	Phase 1/2	Pancreatic adenocarcinoma \| HR-positive/HER2-low Solid Tumors \| Refractory T Acute Lymphoblastic Leukemia	-	OBI-3424	mkibtbvrdm(eyjptzfjii) = wqkgnjvsqt qrytlcchlf (yuwmuybpbf )	-	15 Jun 2022
NCT03592264 \| NCT04315324 (AACR2022)	Phase 1/2		-	Pembrolizumab	mkibtbvrdm(eyjptzfjii) = mbyprwylxz qrytlcchlf (yuwmuybpbf )	-	15 Jun 2022
NCT03592264 (ASCO2022)	Phase 1	Metastatic Solid Tumor	39	OBI-3424	eowhbiefjp(wgohgyqbyk) = alpoeghyjc hacdfvvcqp (ozspxmugbf ) View more	-	02 Jun 2022

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