NEWARK, U.S.A. and NANJING, China, Aug 8, 2024 — The Partner of Biosion Inc. (Biosion) , OBI Pharma (4174.TWO), announced that received the notification letter today from US FDA, stating that the request for Orphan Drug Designation of OBI-992 TROP2 ADC for the treatment of gastric cancer, including gastroesophageal junction cancer, has been approved.
Heidi Wang, Ph.D, OBI Pharma’s Chief Executive Officer pointed out, the U.S. FDA grants Orphan Drug Designation to drugs that have the potential to treat rare diseases to encourage the industry to develop new treatment options for these diseases. In the United States, a rare disease is defined as any condition that affects fewer than 200,000 patients.After granting Orphan Drug Designation, the US FDA will offer companies or drug developers incentives such as more assistance and marketing exclusivity.
OBI-992 is an ADC independently developed by OBI and targeting TROP2. In June, OBI launched a phase I/II clinical trial in the United States, recruiting patients with advanced solid tumors, including gastric cancer (GC) and other potential cancers. The objectives of the trial are 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. “We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. “
About OBI-992（BSI-992）
OBI-992（BSI-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, 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.
About Biosion
Biosion is a global, clinical-stage biotechnology company committed to developing breakthrough antibody-based therapies to improve patient outcomes with immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform. Biosion has 8 global partnerships with 7 clinical stage assets including monoclonal antibody, bispecific antibody and antibody drug conjugates. Biosion has operations in the US, China and Australia. For more information, please visit www.Biosion.com.
BIOSION ALL RIGHTS RESERVED.
NEWARK, U.S.A. and NANJING, China, Aug 8, 2024 — The Partner of Biosion Inc. (Biosion) , OBI Pharma (4174.TWO), announced that received the notification letter today from US FDA, stating that the request for Orphan Drug Designation of OBI-992 TROP2 ADC for the treatment of gastric cancer, including gastroesophageal junction cancer, has been approved.
Heidi Wang, Ph.D, OBI Pharma’s Chief Executive Officer pointed out, the U.S. FDA grants Orphan Drug Designation to drugs that have the potential to treat rare diseases to encourage the industry to develop new treatment options for these diseases. In the United States, a rare disease is defined as any condition that affects fewer than 200,000 patients.After granting Orphan Drug Designation, the US FDA will offer companies or drug developers incentives such as more assistance and marketing exclusivity.
OBI-992 is an ADC independently developed by OBI and targeting TROP2. In June, OBI launched a phase I/II clinical trial in the United States, recruiting patients with advanced solid tumors, including gastric cancer (GC) and other potential cancers. The objectives of the trial are 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. “We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. “
About OBI-992（BSI-992）
OBI-992（BSI-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, 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.
About Biosion
Biosion is a global, clinical-stage biotechnology company committed to developing breakthrough antibody-based therapies to improve patient outcomes with immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform. Biosion has 8 global partnerships with 7 clinical stage assets including monoclonal antibody, bispecific antibody and antibody drug conjugates. Biosion has operations in the US, China and Australia. For more information, please visit www.Biosion.com.
BIOSION ALL RIGHTS RESERVED.