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  • ||||||||||  OBI-833 / OBI Pharma
    Journal:  Enhanced Antitumor Immunity of a Globo H-Based Vaccine Enabled by the Combination Adjuvants of 3D-MPL and QS-21. (Pubmed Central) -  Dec 16, 2024   
    The results revealed that Globo H-CRM197 conjugate adjuvanted with QS-21 and 3D-MPL elicited robust IgG2a and IgG3 antibody responses and Th1 cellular immunity in mice. Moreover, antibodies induced by this formulation effectively bound to Globo H-positive MCF-7 cancer cells and exhibited superior complement-dependent cytotoxicity and antibody-dependent cellular phagocytosis, holding promise for further development of effective anticancer vaccines.
  • ||||||||||  OBI-3424 / OBI Pharma
    Journal, BRCA Biomarker:  Enhanced pharmacological activities of AKR1C3-activated prodrug AST-3424 in cancer cells with defective DNA repair. (Pubmed Central) -  Nov 20, 2024   
    The results showed that AST-3424 exhibited enhanced in vitro cytotoxicity and superior and durable in vivo anti-tumor effects in cells deficient of DNA repair protein BRCA2. In summary, we report here that when DNA repair capacity is reduced, the in vitro and in vivo activity of AST-3424 can be further enhanced, thus providing supporting evidence for the further evaluation of AST-3424 in the clinic.
  • ||||||||||  adagloxad simolenin (OBI 822) / OBI Pharma, OBI-833 / OBI Pharma
    Potential role and prognostic value of Globo-H in lung cancer. () -  Apr 24, 2024 - Abstract #ASCO2024ASCO_6657;    
    In addition, the level of GH is positively correlated with levels of EGFR and EGFR-related signaling proteins in vitro. Expression of GH can induce the expression of EGFR and vice versa in LC cells.
  • ||||||||||  OBI-3424 / OBI Pharma
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors (clinicaltrials.gov) -  Apr 18, 2024   
    P1/2,  N=68, Terminated, 
    The phase II dose expansion phase of AST-3424 monotherapy is ongoing in subjects diagnosed as advanced HCC and with high AKR1C3 expression. N=104 --> 68 | Trial completion date: Dec 2024 --> Mar 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Feb 2024; Little evidence of clinical activity in tumor types enrolled
  • ||||||||||  OBI-992 / OBI Pharma
    In vitro characterization of a novel TROP2-targeting antibody-drug conjugate OBI-992 (Section 21) -  Mar 5, 2024 - Abstract #AACR2024AACR_5298;    
    This study aims to investigate the characteristics of a novel TROP2 antibody (R4702) and its ADC OBI-992, which is derived from the conjugation of R4702 with a TOP1 inhibitor exatecan.METHODSClinical study: Prognostic roles of TROP2 and TOP1 in patients were accessed through the "Kaplan-Meier plotter" database from more than 1055 colon cancer patients.In vitro study: An ELISA study was conducted to investigate the binding epitope of R4702...Finally, a synergistic effect of OBI-992 and PARP inhibitors (talazoparib, rucaparib, niraparib, and olaparib) on the enhancement of cancer cell killing and DNA damage was observed.CONCLUSIONHigh expression of both TROP2 and TOP1 is associated with poor survival in patients with colon cancer...Exatecan and exatecan-conjugated ADC OBI-992 showed high cytotoxic activities. Combination of OBI-992 with PARP inhibitors have potential in TROP2-expressing malignancies.
  • ||||||||||  OBI-999 / OBI Pharma
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  Phase 1/2 Study of OBI-999 in Patients with Advanced Solid Tumors (clinicaltrials.gov) -  Jan 5, 2024   
    P1/2,  N=44, Terminated, 
    Active, not recruiting --> Recruiting N=185 --> 44 | Trial completion date: Dec 2025 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Oct 2023; Has not shown its expected therapeutic potential for the enrolled patients in this trial
  • ||||||||||  OBI-999 / OBI Pharma
    Trial completion date, Trial primary completion date, Metastases:  Phase 1/2 Study of OBI-999 in Patients with Advanced Solid Tumors (clinicaltrials.gov) -  Nov 3, 2023   
    P1/2,  N=185, Recruiting, 
    N=185 --> 44 | Trial completion date: Dec 2025 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Oct 2023; Has not shown its expected therapeutic potential for the enrolled patients in this trial Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Nov 2023 --> Nov 2025
  • ||||||||||  adagloxad simolenin (OBI 822) / OBI Pharma
    Journal:  Heat-shock protein 90? protects NME1 against degradation and suppresses metastasis of breast cancer. (Pubmed Central) -  Sep 21, 2023   
    Three additional patients will be enrolled at dose level 3 after the study is reopened with a protocol amendment to relocate the MRD testing lab. These 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.
  • ||||||||||  OBI-3424 / OBI Pharma
    The essential role of DNA repair in the pharmacological activities of AST-3424 () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_1656;    
    Conclusions DNA repair plays an essential role in AST-3424-mediated in vitro biological activities and in vivo anti-tumor activity. The preclinical data presented in this study support a new approach for cancer treatment.
  • ||||||||||  OBI-3424 / OBI Pharma
    Trial completion date, Trial primary completion date, Metastases:  A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors (clinicaltrials.gov) -  Apr 13, 2023   
    P1/2,  N=104, Recruiting, 
    OBI-3424 was well tolerated; dose-dependent, noncumulative thrombocytopenia and anemia were dose-limiting. Trial completion date: Apr 2024 --> Dec 2024 | Trial primary completion date: Feb 2024 --> Dec 2024
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), OBI-999 / OBI Pharma
    OBI-999, an anti-Globo H antibody drug conjugate, exhibits synergistic anti-tumor effect in combination with pembrolizumab (Section 7; Poster Board #7) -  Mar 14, 2023 - Abstract #AACR2023AACR_8912;    
    P1/2
    These synergistic effects may be attributed to the ability of OBI-999 to induce ICD, as demonstrated by the release of DAMPs in vitro and tumor-specific immunity in vivo, suggesting that OBI-999 can create a tumor microenvironment that enhances the function of pembrolizumab. The results suggest that combination therapy with OBI-999 and immune checkpoint inhibitors is warranted in human clinical studies.
  • ||||||||||  adagloxad simolenin (OBI 822) / OBI Pharma, OBI-888 / OBI Pharma, OBI-833 / OBI Pharma
    Globo H-targeted CAR T cell cancer immunotherapy (Section 23; Poster Board #4) -  Mar 14, 2023 - Abstract #AACR2023AACR_6268;    
    Clinical studies with the Globo H vaccines (OBI-822 and OBI-833) and the humanized anti-Globo H antibody (OBI-888) demonstrating an excellent safety profile. In conclusion, our in vitro and in vivo pharmacology and preliminary toxicology studies support clinical development of Globo H CAR T immunotherapy for patients with cancer.
  • ||||||||||  adagloxad simolenin (OBI 822) / OBI Pharma
    P3 data, Review, Journal:  GLORIA: phase III, open-label study of adagloxad simolenin/OBI-821 in patients with high-risk triple-negative breast cancer. (Pubmed Central) -  Oct 22, 2022   
    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.
  • ||||||||||  OBI-3424 / OBI Pharma
    Trial completion date, Trial primary completion date, Metastases:  A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors (clinicaltrials.gov) -  Oct 19, 2022   
    P1/2,  N=104, Recruiting, 
    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. Trial completion date: Mar 2023 --> Apr 2024 | Trial primary completion date: Jan 2023 --> Feb 2024
  • ||||||||||  OBI-3424 / OBI Pharma
    Preclinical, Journal, Combination therapy, Monotherapy, PARP Biomarker:  The In-Vitro Antitumor Effects of AST-3424 Monotherapy and Combination Therapy With Oxaliplatin or 5-Fluorouracil in Primary Liver Cancer. (Pubmed Central) -  Aug 10, 2022   
    AST-3424 is a prodrug of a potent nitrogen mustard, which targets the tumor by its specific and selective mode of activation and results in the concentration of the drug in the tumor and plays a higher intensity of antitumor effect with reduced side effects...The inhibition of AST-3424 was significantly higher than OXA, 5-Fu, Sor (sorafenib), and Apa (apatinib) in both HCC cells...The in-vitro studies revealed that AST-3424 in combination with both OXA and 5-Fu showed an increased antitumor effect, and the combination with OXA resulted in a synergistic effect. Together with the in-vitro results, additional in-vitro and in-vivo studies are warranted to further certify its antitumor effects and explore more potential antitumor mechanisms.
  • ||||||||||  OBI-888 / OBI Pharma
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (clinicaltrials.gov) -  Jul 8, 2022   
    P1/2,  N=54, Terminated, 
    Together with the in-vitro results, additional in-vitro and in-vivo studies are warranted to further certify its antitumor effects and explore more potential antitumor mechanisms. N=168 --> 54 | Trial completion date: Dec 2022 --> Apr 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2022 --> Apr 2022; OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients
  • ||||||||||  OBI-999 / OBI Pharma
    Preclinical, Journal, IO biomarker:  Pre-clinical Studies of OBI-999: a Novel Globo H-Targeting Antibody-Drug Conjugate. (Pubmed Central) -  Jan 27, 2022   
    P1/2
    The highest nonseverely toxic dose in cynomolgus monkeys is 10 mg/kg determined by a 3-week repeated-dose toxicology study demonstrating an acceptable safety margin. Taken together, these results support further clinical development of OBI-999, which is currently in a Phase 1/2 clinical study in multiple solid tumors (NCT04084366).