OBI-833 / OBI Pharma - LARVOL DELTA

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: OBI Pharma, Inc | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • EGFR

Enhanced Antitumor Immunity of a Globo H-Based Vaccine Enabled by the Combination Adjuvants of 3D-MPL and QS-21. (PubMed, Angew Chem Int Ed Engl) - "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."

Journal • Oncology

Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Chang Gung Memorial Hospital

IO biomarker • Metastases • New P1 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Potential role and prognostic value of Globo-H in lung cancer. (ASCO 2024) - "Clinical trials have been conducted to evaluate the efficacy of anti-GH vaccine Adagloxad Simolenin/OBI-821 (in Ph 3) and OBI-833/OBI-821 (in Ph 2) in cancer patients. GH expression was associated with the worse survival of LC patients in clinical setting. 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."

IO biomarker • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCND1

Positive associations of active immune therapy OBI-833/OBI-821 induced immune responses with clinical outcomes in patients with non-small cell lung cancer. (ASCO 2024) - "OBI-833 can elicit beneficial immune responses in NSCLC patients. Both GH IgM and GH IgG may contribute to the isPFS and TR of the subjects. Further development of OBI-833 in EGFR-mutated NSCLC patients phase II trial is ongoing."

Clinical • Clinical data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • IFNG

OBI ANNOUNCES THE TERMINATION OF LICENSE AGREEMENT WITH ODEON FOR THE RIGHTS OF OBI-999 AND OBI-833 IN CHINA, HONG KONG AND MACAU (OBI Pharma Press Release) - "On 2022/2/22, OBI Pharma entered into a license agreement with Odeon Therapeutic...for the exclusive rights of OBI-999 and OBI-833 in China, Hong Kong and Macau, including the first right of negotiation for OBI-888 in China with a period of two years....Reason for termination: OBI has rebuilt its pipeline as a measure to the recent development of cancer therapy. Take OBI-888 as example, as the antibody drug yield rate was reduced during scale-up production, the manufacturing costs increase dramatically for commercial viability. Therefore, OBI resolved to discontinue its Phase II enrollment in 2022. Also, considering that OBI-999 has not shown its expected therapeutic potential for the enrolled patients in its clinical trial during past two years, OBI determined to stop further enrollment of patients in this Phase II trial and will focus existing resources on other ADC drugs in our pipeline."

Licensing / partnership • Trial termination • Oncology • Solid Tumor

Focus stocks: Haoding’s multiple R&D new drugs are advancing in clinical trials, and the first interim analysis of OBI 822/821 Phase III is positive [Google translation] (stock.yahoo) - "...Yesterday (31st), it announced its new active immune drug OBI-822/821 as an adjuvant treatment for post-surgery surgery A phase III clinical trial for patients with early-stage, Globo H-positive, high-risk triple-negative breast cancer received a positive response from the Data and Safety Monitoring Board (DSMB) for the first (75 cases) interim analysis of this clinical trial (113 cases will be reviewed after receipt of 113 cases) Conducting the second interim analysis), it is recommended that the trial continue; this will add points to Haoding's chance of success."

DSMB • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

To Evaluate OBI-833/OBI-821 in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer for Recurrence (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: National Taiwan University Hospital

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastrointestinal Cancer • Oncology

Globo H-targeted CAR T cell cancer immunotherapy (AACR 2023) - "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...As a result, development of CAR T targeting GH may offer a novel anticancer therapeutic agent.Aim: The aim of this study was to develop a CAR T cell therapy targeted against Globo H (obi-R007) using lentivirus-mediated genetic engineering with a proprietary Globo H-specific antibody... 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."

CAR T-Cell Therapy • IO biomarker • Breast Cancer • Colon Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD69 • GZMB • IFNG • IL2 • IL2RA • LAG3 • PD-1

[VIRTUAL] A phase I cohort expansion trial of OBI833 in nonsmall cell lung cancer patients (ESMO Asia 2020) - P1 | "Eleven patients were treated with a 1st or 2nd-generation EGFR TKI and OBI-833, one patient with ceritinib plus OBI-833, and two patients with OBI-833 monotherapy. Further development of OBI-833 in EGFR-mutated NSCLC patients to assess the potential benefits of combination therapy of OBI-833 with TKIs is ongoing. OBI Pharma."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatitis • Solid Tumor • EGFR • TMB

[VIRTUAL] A phase I cohort expansion trial of OBI833 in nonsmall cell lung cancer patients (ESMO Asia 2020) - P1 | "Eleven patients were treated with a 1st or 2nd-generation EGFR TKI and OBI-833, one patient with ceritinib plus OBI-833, and two patients with OBI-833 monotherapy. Further development of OBI-833 in EGFR-mutated NSCLC patients to assess the potential benefits of combination therapy of OBI-833 with TKIs is ongoing. OBI Pharma."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatitis • Solid Tumor • EGFR • TMB

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: OBI Pharma, Inc | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • EGFR

To Evaluate OBI-833/OBI-821 in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer for Recurrence (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: National Taiwan University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastrointestinal Cancer • Oncology

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: OBI Pharma, Inc

Combination therapy • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • EGFR

OBI Pharma Announces Poster Presentations at the 2022 ASCO Annual Meeting for Adagloxad Simolenin, OBI-999, OBI-3424, and Exhibition Booth (GlobeNewswire) - "OBI Pharma, Inc...announced that data highlighting ongoing clinical studies targeting Globo H and AKR1C3 in different tumor types will be presented at the American Society of Clinical Oncology (ASCO) meeting from June 3–7, 2022 in Chicago, IL (USA). These studies will be presented by the lead investigators of OBI Pharma’s first-in-class anti-Globo H cancer vaccine (Adagloxad Simolenin) and Antibody Drug Conjugate (OBI-999), and AKR1C3 targeting prodrug (OBI-3424)."

Clinical data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

To Evaluate OBI-833/OBI-821 in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer for Recurrence (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: National Taiwan University Hospital

New P2 trial • Esophageal Cancer • Gastrointestinal Cancer • Oncology

OBI Pharma Enters License Agreement with Odeon Therapeutics for the Rights of OBI-999 and OBI-833 in China, Hong Kong and Macau (PRNewswire) - "OBI Pharma...and Odeon Therapeutics...have entered into an exclusive license agreement whereby OBI grants rights of OBI-999, a novel antibody-drug conjugate, and OBI-833, a therapeutic cancer vaccine, targeting the tumor antigen Globo H in China, Hong Kong and Macau to Odeon. Under the terms of the agreement, OBI will grant Odeon exclusive rights to develop, register and commercialize OBI-999 and OBI-833 for human cancer therapy in China, Hong Kong and Macao. Odeon will issue to OBI fully paid equity equivalent to US$ 12 million upon signing. OBI is eligible for development and commercialization milestones totaling up to US$ 188 million."

Licensing / partnership • Oncology

[VIRTUAL] OBI-833 was safe and immunogenic, without treatment:related SAEs, in a phase I dose-escalation trial (ESMO Asia 2020) - P1 | "Funding: OBI Pharma. Clinical trial identification: NCT02310464."

P1 data • Acute Kidney Injury • Breast Cancer • Cardiovascular • Colorectal Cancer • Dermatology • Gastrointestinal Cancer • Heart Failure • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Pruritus • Renal Disease • Respiratory Diseases • Solid Tumor

[VIRTUAL] A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients (ESMO Asia 2020) - P1 | "Eleven patients were treated with a 1st or 2nd-generation EGFR TKI and OBI-833, one patient with ceritinib plus OBI-833, and two patients with OBI-833 monotherapy. Funding: OBI Pharma. Clinical trial identification: NCT02310464."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatitis • Solid Tumor • EGFR • TMB

[VIRTUAL] Globo H expression in metastatic colorectal cancer (CRC). (ASCO 2021) - "An attractive therapeutic target, Globo H-targeted agents are being tested in early clinical trials (e.g., OBI-833, a Globo H antigen conjugated to a mutated diphtheria toxin with potential antineoplastic activities, and OBI-999, an antibody-drug conjugate (ADC) consisting of a Globo H monoclonal antibody with a synthetic antineoplastic agent) . The association with TMB-H, MSI-H, and PD-L1 status suggests that in some tumors Globo H may be a promising target for combination therapy with immune checkpoint inhibition . The association with different cell populations suggests manipulating the cellular balance in the TME as an approach to improve the efficacy of treatment . NK cell checkpoint inhibitors are in clinical trials and might be utilized in high Globo H cancers; treatments inducing DCs in tumors have been shown to enhance responses to BRAF and PD-L1 blockade and might be applicable in the context of Globo H immunotherapy to overcome Treg immune suppression ."

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Infectious Disease • Inflammation • Oncology • Solid Tumor • BRAF • CD4 • KRAS • MSI • MYC • RSPO3 • TMB

Hao Ding's new immune anti-cancer drug OBI-833 completes Phase I clinical population expansion trial [Google translation] - "Hao Ding...announced today that the company's new active immunization anti-cancer drug OBI-833 has completed the main indicators of 'safety' and 'immune antibody response' in the first phase of the cohort expansion test (cohort expansion phase) And the evaluation of the secondary indicators of 'tumor response', and plans to launch phase II clinical trials...Hao Ding's announcement pointed out that the second phase of clinical trials will be carried out next, which is expected to be completed in 2024."

New P2 trial • Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: OBI Pharma, Inc; Recruiting ➔ Completed

Clinical • Trial completion • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

OBI Pharma Announces Presentations at ESMO Asia 2020 Virtual Annual Meeting for OBI-833, a Novel Anti-Globo H Targeted Therapeutic Cancer Vaccine (PRNewswire) - “OBI Pharma, Inc…announced that data from the OBI-833 Phase 1 clinical study targeting the Globo H antigen in lung cancer will be presented at the European Society of Clinical Oncology Asia (ESMO Asia) 2020 Virtual Scientific Program from November 20-22, 2020. These results will be presented by the lead investigators of OBI Pharma's novel anti-Globo H therapeutic cancer vaccine, OBI-833.”

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: OBI Pharma, Inc; Trial completion date: Jul 2020 ➔ Mar 2021; Trial primary completion date: Jan 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • PD-L1

Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: OBI Pharma, Inc; Trial completion date: Dec 2019 ➔ Jul 2020; Trial primary completion date: Dec 2018 ➔ Jan 2020

Clinical • Trial completion date • Trial primary completion date