Adagloxad simolenin

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

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