Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Randomization of Oral β-glucan, for High-Risk Neuroblastoma

The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.

Start Date21 Sep 2023

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

CTR20211603 / RecruitingPhase 3

GLORIA研究：一项抗Globo-H疫苗Adagloxad Simolenin (OBI-822) /OBI-821治疗高危早期-Globo H-阳性的三阴性乳腺癌患者的III期、随机、开放性研究

[Translation] GLORIA study: A phase III, randomized, open-label study of the anti-Globo-H vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in patients with high-risk early-stage Globo H-positive triple-negative breast cancer

主要目的确定研究人群中adagloxad simolenin (OBI-822)/OBI-821治疗对IDFS改善的影响。次要目的研究的次要目的是： 1. 确定研究人群中adagloxad simolenin (OBI-822)/OBI-821治疗对以下方面的影响： a. 总生存期（OS） b. 生活质量（QoL） c. 无乳腺癌间期（BCFI） d. 无远处转移间期（DDFS） 2. 确定研究人群中adagloxad simolenin (OBI-822)/OBI-821的安全性和耐受性。探索性目的探索性目的如下： 1. 探索adagloxad simolenin （OBI-822）/OBI-821抗Globo H抗体应答、IDFS以及OS之间的相关性 2. 评价Globo H肿瘤表达对IDFS和OS的影响 3. 识别可预测adagloxad simolenin（OBI-822）/OBI-821治疗结局的患者基线特征和人口统计学特征 4. 探索基线特征（包括肿瘤病理、分子和免疫特征）和肿瘤表达水平之间的相关性

[Translation]

Primary Objective To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improvement of IDFS in the study population. Secondary Objectives The secondary objectives of the study are: 1. To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on the following aspects in the study population: a. Overall survival (OS) b. Quality of life (QoL) c. Breast cancer free interval (BCFI) d. Distant metastasis free interval (DDFS) 2. To determine the safety and tolerability of adagloxad simolenin (OBI-822)/OBI-821 in the study population. Exploratory objectives The exploratory objectives are as follows: 1. To explore the correlation between adagloxad simolenin (OBI-822)/OBI-821 anti-Globo H antibody response, IDFS, and OS 2. To evaluate the impact of Globo H tumor expression on IDFS and OS 3. To identify patient baseline and demographic characteristics that may predict adagloxad simolenin (OBI-822)/OBI-821 treatment outcomes 4. To explore the correlation between baseline characteristics (including tumor pathology, molecular and immune characteristics) and tumor expression levels

Start Date07 Dec 2021

Sponsor / Collaborator

Zuellig Pharma China

[+3]

NCT03562637 / RecruitingPhase 3

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer

The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

Start Date05 Dec 2018

Sponsor / Collaborator

OBI Pharma, Inc.

100 Clinical Results associated with Adagloxad simolenin

100 Translational Medicine associated with Adagloxad simolenin

100 Patents (Medical) associated with Adagloxad simolenin

Literatures (Medical) associated with Adagloxad simolenin

09 Nov 2023·British Journal of Cancer

Heat-shock protein 90α protects NME1 against degradation and suppresses metastasis of breast cancer

Article

Author: Yin, Yongmei ; Wang, Xun ; Fu, Ziyi ; Meng, Yao ; Zhao, Guomeng ; Mao, Jinlei ; Wang, Xindong ; Li, Jinyao ; Yu, Liting ; Zhang, Yanchao ; Guo, Changying

BACKGROUNDNME1 has been exploited as a potential translational target for decades. Substantial efforts have been made to upregulate the expression of NME1 and restore its anti-metastasis function in metastatic cancer.METHODSCycloheximide (CHX) chase assay was used to measure the steady-state protein stability of NME1 and HSP90α. The NME1-associating proteins were identified by immunoprecipitation combined with mass spectrometric analysis. Gene knockdown and overexpression were employed to examine the impact of HSP90AA1 on intracellular NME1 degradation. The motility and invasiveness of breast cancer cells were examined in vitro using wound healing and transwell invasion assays. The orthotopic spontaneous metastasis and intra-venous experimental metastasis assays were used to test the formation of metastasis in vivo, respectively.RESULTSHSP90α interacts with NME1 and increases NME1 lifetime by impeding its ubiquitin-proteasome-mediated degradation. HSP90α overexpression significantly inhibits the metastatic potential of breast cancer cells in vitro and in vivo. A novel cell-permeable peptide, OPT22 successfully mimics the HSP90α function and prolongs the life span of endogenous NME1, resulting in reduced metastasis of breast cancer.CONCLUSIONThese results not only reveal a new mechanism of NME1 degradation but also pave the way for the development of new and effective approaches to metastatic cancer therapy.

01 Nov 2022·Future Oncology

GLORIA: phase III, Open-Label Study of Adagloxad Simolenin/OBI-821 in Patients with High-Risk Triple-Negative Breast Cancer

Review

Author: Rugo, Hope S ; Nanda, Rita ; Cabrera, Paula ; Melisko, Michelle ; Rapoport, Bernardo L ; Cortes, Javier ; Pieńkowski, Tadeusz ; Schwab, Richard ; Kim, Sung-Bae ; Barrios, Carlos H ; Xu, Binghe ; Huang, Chiun-Sheng

Triple-negative breast cancer (TNBC) has the highest rate of distant metastasis and poorest overall survival among breast cancer subtypes. In a phase II study, adagloxad simolenin (AdaSim), a synthetic Globo H conjugate vaccine administered with adjuvant OBI-821, was shown to induce IgM and IgG anti-Globo H humoral responses in patients with metastatic breast cancer overexpressing the glycosphingolipid Globo H. GLORIA is an ongoing phase III, randomized, open-label clinical trial to evaluate the safety and efficacy of AdaSim and the quality of life (QoL) of patients receiving AdaSim plus standard of care (SOC) versus SOC alone in high-risk, early-stage TNBC. The primary end point is invasive progression-free survival; secondary end points include overall survival, QoL, breast cancer-free interval, distant disease-free survival, safety, and tolerability.

01 Jun 2022·Journal for ImmunoTherapy of Cancer

The clinical relevance of humoral immune responses to Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 and expression of Globo H in metastatic breast cancer

Article

Author: Yu, Alice L ; Ueng, Shir-Hwa ; Lin, Yung-Chang ; Chen, Mu-Yi ; Lin, Chun-Yen ; Campbell, Michael J ; Rugo, Hope S ; Huang, Chiun-Sheng ; Chen, I-Ju ; Chen, Shin-Cheh ; Hung, Jung-Tung

An international randomized phase II trial of Globo H (GH) vaccine, adagloxad simolenin/OBI-821 in 349 patients with metastatic breast cancer showed longer progression-free survival (PFS) in vaccinated patients who developed anti-Globo H (anti-GH) IgG than those who did not and the placebo group. The impacts of anti-GH IgM and GH expression on peak anti-GH IgG and clinical outcome were further evaluated. The titers of anti-GH IgG and IgM were determined by ELISA. GH expression in tumor was examined by immunohistochemical staining. Immunophenotyping was conducted by flow cytometry. Adagloxad simolenin elicited anti-GH IgM which peaked at titers ≥1:80 between weeks 5 and 13. The mean anti-GH IgG titer peaked at week 41 and decreased thereafter on the completion of vaccination. One log increase in peak IgM was associated with 10.6% decrease in the HR of disease progression (HR: 0.894, 95% CI: 0.833 to 0.960, p=0.0019). Patients with anti-GH IgM ≥1:320 within first 4 weeks after vaccination had significantly higher maximum anti-GH IgM (p<0.0001) and IgG titers (p<0.0001) than those with <1:320. Moreover, the median PFS appears to be longer for patients with anti-GH IgM ≥1:320 within first 4 weeks than those with anti-GH IgM titer <1:320 (11.1 vs 7.3 months, p=0.164), but not statistically significant. Among patients with H score ≥80 for GH expression by immunohistochemistry, the vaccination group (n=42) seemed to have better PFS than the placebo group (n=23) (HR=0.59; 95% CI: 0.32 to 1.10, p=0.10), but the difference did not reach statistical significance. In addition, peak levels of anti-GH IgM were higher in patients who had lower percentage of activated regulatory T cells (Treg cells; CD4+CD45RA-Foxp3high) at baseline than those who had higher activated Treg cells (p=0.042). This study demonstrates that adagloxad simolenin induced both IgG and IgM antibodies against GH. Anti-GH IgM ≥1:320 within first 4 weeks or low activated Treg cells at baseline may help to select patients who are likely to produce a higher level of GH-specific IgM and IgG in the future.

News (Medical) associated with Adagloxad simolenin

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

18 Mar 2024

·www.globenewswire.com

OBI Pharma Announces Poster Presentations at the AACR 2024 Annual Meeting for OBI-992 and GlycOBI™ ADC platform

Poster Presentations to highlight the latest research on OBI-992 (anti-TROP2 ADC) and OBI’s novel GlycOBI ADC platformTAIPEI, Taiwan, March 18, 2024 (GLOBE NEWSWIRE) -- OBI Pharma, Inc. (TPEx: 4174) today announced preclinical data for OBI-992, a potential best-in-class anti-TROP2 Antibody-Drug Conjugate (ADC). When evaluated against comparative TROP2 ADCs, OBI-992 demonstrated greater antitumor efficacy, superior PK/PD properties, and a favorable safety profile across various preclinical animal models. Additionally, preclinical data will be presented on the novel site-specific proprietary GlycOBI™ ADC platform, demonstrating improved in vivo efficacy and stability in animal model studies. These data will be presented at the American Association of Cancer Research (AACR) Annual Meeting from April 5 to 10, 2024 in San Diego, California (USA). “Our data suggest OBI-992 has the potential to become a best-in-class TROP2 ADC. OBI-992 binds to a TROP2 epitope that is distinct from that of datopotamab and sacituzumab. OBI-992 shows lower non-specific binding, which should lead to decreased off-target cytotoxicity compared to benchmark ADCs. OBI-992 demonstrated remarkable anti-tumor efficacy in several CDX and PDX models. In addition, OBI-992 showed excellent bystander effect and synergistic efficacy in combination with PARP inhibitors or anti-PD1 in animal models. OBI-992 was stable in circulation and well tolerated in cynomolgus monkeys, suggesting a good safety profile” said OBI’s Chief Scientific Officer, Ming-Tain Lai, Ph.D. “In addition, OBI developed a proprietary site-specific conjugation GlycOBI ADC platform to produce homogeneous ADCs. Preclinical studies demonstrated that the ADCs derived from GlycOBI platform showed better anti-tumor efficacy and PK profile. We are excited about the potential of applying this platform to generate novel ADCs to address unmet medical needs and provide cancer patients with better treatment options. These encouraging results warrant further clinical development.” Title: OBI-992, a novel TROP2 targeting antibody-drug conjugate, displayed excellent antitumor efficacy in various animal models 1 Authors*: Wan-Fen Li, Ming-Feng Chiang, Hao-Cheng Weng, Jhih-Jie Yang, Hsin-Shan Wu, Chun-Jung Lin, Ping-Tzu Chiu, and Ming-Tain LaiSession Title: Antibody-Drug Conjugates and Bispecific AntibodiesLocation: Poster Section 23Poster Board Number: 4Abstract Presentation Number: 1893Session Date and Time: Monday April 8, 2024. 9:00 AM - 12:30 PM Title: In vitro characterization of a novel TROP2-targeting antibody-drug conjugate OBI-992 2 Authors*: Tzer-Min Kuo, Ting-Yu Chang, Jye-Yu Huang, Wei-Chien Tang, Chun-Jung Lin, Yi-Chen Wu, Chi-Huan Lu, Hao-Cheng Weng, Yu-Jung Chen, Yu-Hsuan Tsao, Cheng-Yen Wei, Lifen Shen, Wan-Fen Li, and Ming-Tain LaiSession Title: Antibody-Drug ConjugatesLocation: Poster Section 21Poster Board Number: 11Abstract Presentation Number: 3130Session Date and Time: Monday April 8, 2024. 1:30 PM - 5:00 PM Title: Development of a novel site-specific ADC glycan platform with potential for improved in vivo efficacy and stability of the ADC in animal studies 3 Authors*: Teng-Yi Huang, Yin-Cheng Hsieh, Ka-Shu Fung, Yu-Chao Huang, Chi-Sheng Shia, Ming-Feng Chiang, Nan-Hsuan Wang, Wan-Fen Li, and Ming-Tain LaiSession Title: Antibody-Drug ConjugatesLocation: Poster Section 21Poster Board Number: 30Abstract Presentation Number: 3149Session Date and Time: Monday, April 8, 2024. 1:30 PM - 5:00 PM Title: OBI-992, a novel TROP2 targeting antibody drug conjugate demonstrates superior in vivo PK/PD properties and a favorable safety profile 4 Authors*: Chi-Sheng Shia, Shih-Ni Wen, Ren-Yu Hsu, Jyy-Shiuan Tu, Hui-Wen Chang, Wan-Fen Li, and Ming-Tain LaiSession Title: Pharmacology and PharmacogeneticsLocation: Poster Section 24Poster Board Number: 20Abstract Presentation Number: 7179Session Date and Time: Wednesday April 10, 2024. 9:00 AM - 12:30 PM * OBI Pharma, Inc., Taipei, Taiwan. 1, 2, 3, 4 : AACR Annual Meeting 2024 Abstracts online The e-posters will be available for browsing at the AACR Annual Meeting beginning at 12:00 PM ET on April 5, as well as on the OBI Pharma website (http://www.obipharma.com) beginning on April 11. About OBI-992 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, 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. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models. OBI-992 received US IND clearance in January 2024, Phase 1/2 efficacy and safety human studies are planned to commence early Q2, 2024. 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 GlycOBI™ OBI has developed a unique glycan ADC platform (GlycOBI™), which are in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in various Drug Antibody Ratio (DAR). Utilizing OBI’s proprietary enzymatic technology (EndoSymeOBI™), GlycOBI generates site-specific homogenous ADCs with an efficient and scalable process. The conjugation process of GlycOBI avoids disrupting the antibody structure and ensures the ADC has similar biophysical characteristics to the native antibody. Furthermore, OBI’s linker technology has improved conjugation efficiency of the payload and reduced aggregation propensity, and also expanded the half-life of the ADC products. GlycOBI has overcome the limitations of traditional ADCs and achieved better efficacy and stability in various in vivo tests. GlycOBI™ and EndoSymeOBI™ are trademarks of OBI Pharma. Inc. 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 pipelines, 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. 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, CBOOBI Pharma, Inc.1.619.537.7698 Ext. 102kpoulos@obipharmausa.com

ImmunotherapyADCAACRIND

100 Deals associated with Adagloxad simolenin

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KEGG	Wiki	ATC	Drug Bank
D11205	-	-	DB16082

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Triple Negative Breast Cancer	Phase 3	US	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	AU	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	KR	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	UA	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	MX	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	ZA	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	PL	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	CN	OBI Pharma, Inc.	05 Dec 2018
Triple Negative Breast Cancer	Phase 3	HK	OBI Pharma, Inc.	05 Dec 2018
Breast Cancer	Phase 3	-	Memorial Sloan Kettering Cancer Center	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01516307 (Pubmed \| J Immunother Cancer)	Phase 2	Metastatic breast cancer	349	Adagloxad simolenin (AS/OBI-821)	(erfigjzzbu) = qkkmqmifug xqhksnflnj (bqghvjnpcy, 6.5 - 10.9)	Negative	01 Jul 2020
NCT01516307 (Pubmed \| J Immunother Cancer)	Phase 2	Metastatic breast cancer	349	Placebo	(erfigjzzbu) = qizlxticrz xqhksnflnj (bqghvjnpcy, 7.3 - 11.3)	Negative	01 Jul 2020
NCT03562637 (P163, SITC2018)	Phase 2	Metastatic breast cancer GH expression	349	Adagloxad simolenin (OBI-822/821)	ravnevfmnm(ejaaglcoeq) = gjfpesdxyg pzdfjjzved (xpotrdqvpy )	Positive	06 Nov 2018

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