On March 18, 2024 OBI Pharma, Inc. (TPEx: 4174) reported preclinical data for OBI-992, a potential best-in-class anti-TROP2 Antibody-Drug Conjugate (ADC) (Press release, OBI Pharma, MAR 18, 2024, View Source [SID1234641234]). 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.
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These data will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 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 Lai
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies
Location: Poster Section 23
Poster Board Number: 4
Abstract Presentation Number: 1893
Session 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 Lai
Session Title: Antibody-Drug Conjugates
Location: Poster Section 21
Poster Board Number: 11
Abstract Presentation Number: 3130
Session 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 Lai
Session Title: Antibody-Drug Conjugates
Location: Poster Section 21
Poster Board Number: 30
Abstract Presentation Number: 3149
Session 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 Lai
Session Title: Pharmacology and Pharmacogenetics
Location: Poster Section 24
Poster Board Number: 20
Abstract Presentation Number: 7179
Session Date and Time: Wednesday April 10, 2024. 9:00 AM – 12:30 PM
* OBI Pharma, Inc., Taipei, Taiwan.
1, 2, 3, 4 : AACR (Free AACR Whitepaper) Annual Meeting 2024 Abstracts online
The e-posters will be available for browsing at the AACR (Free AACR Whitepaper) Annual Meeting beginning at 12:00 PM ET on April 5, as well as on the OBI Pharma website (View Source) 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.