JAB-BX102 / Jacobio Pharma - LARVOL DELTA

(1) INTERIM RESULTS ANNOUNCEMENT FOR THE SIX MONTHS ENDED JUNE 30, 2024; (2) RESIGNATION OF NON-EXECUTIVE DIRECTOR; AND 3) CHANGE IN THE COMPOSITION OF THE REMUNERATION COMMITTEE AND THE NOMINATION COMMITTEE (HKEXnews) - "JAB-BX102 (anti-CD73 humanized monoclonal antibody)...Dose escalation for a Phase I/IIa trial has been finished in China and dose expansion trial is being planned in China....Clinical candidate for JAB-BX400 is expected to be nominated in the second half of 2024."

Pipeline update • Trial status • Oncology • Solid Tumor

Jacobio Pharma Announces 2023 Annual Results (PRNewswire) - "Anti-CD73 humanized monoclonal antibody JAB-BX102: RP2D is anticipated to be determined in Q2 2024. The preclinical study of JAB-2485 was presented at the 2023 AACR; PARP7 inhibitor JAB-26766: Preclinical data will be presented at the AACR Annual Meeting 2024."

Preclinical • Trial status • Oncology • Solid Tumor

Jacobio Pharma Announces 2023 Interim Results (PRNewswire) - "Development of other clinical stage products: (i) JAB-8263 (BET inhibitor): A Phase I trial in solid tumors and hematological malignancies is ongoing in the U.S. and China simultaneously. Efficacy signals in hematological tumors have been observed. The recommended phase II dose (RP2D) is expected to be determined in the second half of 2023; (ii) JAB-BX102 (CD73 mAb): The Phase I/IIa dose expansion trial is ongoing and it is expected to receive the RP2D in the first half of 2024."

P1 data • Trial status • Hematological Malignancies • Oncology • Solid Tumor

Jacobio announces clinical collaboration to evaluate CD73 monoclonal antibody JAB-BX102 in combination with KEYTRUDA (pembrolizumab) for patients with cancer (PRNewswire) - "Jacobio Pharma (1167.HK) announced it has entered into a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA to evaluate the combination of Jacobio's CD73 monoclonal antibody JAB-BX102 in combination with Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The clinical study will evaluate the clinical effect of JAB-BX102 in combination with KEYTRUDA for the treatment of advanced solid tumors."

Licensing / partnership • Oncology • Solid Tumor

Jacobio Pharma Announces 2022 Annual Results (PRNewswire) - "JAB-8263 (BET inhibitor): The Phase I dose escalation portion in solid tumors and hematological malignancies is ongoing in the U.S. and China simultaneously. RP2D is expected to be determined in the second half of 2023....JAB-BX102 (CD73 mAb): The Phase I/IIa dose escalation or expansion trial for JAB-BX102 in advanced solid tumors was initiated in September 2022. RP2D is expected to be determined in the second half of 2024."

Trial status • Hematological Malignancies • Oncology • Solid Tumor

JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Solid Tumor

"#Jacobio Completes First Patient Dosage of #CD73mAb #JABBX102 in China https://t.co/l7AgdEho5G" (@1stOncology)

Clinical

Jacobio Completes First Patient Dosage of CD73 mAb JAB-BX102 in China (PRNewswire) - "Jacobio Pharma (1167.HK) announced it has completed first patient dosage of it's in-house R&D drug candidate CD73 monoclonal antibody JAB-BX102 in a Phase I/IIa clinical trial for advanced solid tumour patients. This is a phase I/IIa multi-center, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of anti-tumor activity of JAB-BX102 monotherapy and combination with Pembrolizumab in adult patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor

Jacobio Pharma Announces 2022 Interim Results (PRNewswire) - "Development progress of other products: (i) JAB-8263 (BET inhibitor): A Phase I dose escalation study was initiated in China and the U.S. The recommended Phase II dose (RP2D) will be determined in Q4 2022; (ii) JAB-2485 (Aurora A inhibitor): An IND application was submitted in China in August 2022; (iii) JAB-BX102 (CD73 inhibitor): A Phase I/IIa study for advanced solid tumors was approved in China in March 2022. First patient enrolment is expected in Q3 2022. A Phase I/IIa clinical trial in the U.S. was approved in October 2021, once the Phase I dose escalation stage is completed, patients will participate in a Phase IIa dose expansion for which they will receive the combination of JAB-BX102 and Pembrolizumab."

New trial • Trial status • Oncology • Solid Tumor

JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=62 | Not yet recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Initiation date: Mar 2022 ➔ Aug 2022

Monotherapy • Trial initiation date • Oncology • Solid Tumor

JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=62; Not yet recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Clinical • Monotherapy • New P1/2 trial • Oncology • Solid Tumor

GAX-B (01167.HK): CD73 monoclonal antibody JAB-BX102 clinical trial application approved by the US FDA [Google Translate] (jrj.com) - "JAX-B...announced that the company’s self-developed CD73 monoclonal antibody JAB-BX102 has received the U.S. Food and Drug Administration (FDA) New Drug Clinical Trial Approval Notice (IND) ). JAB-BX102 is the group's first macromolecular project to enter the clinical stage. The group will initiate a phase I/IIa clinical trial for patients with solid tumors in the United States....Preclinical data shows that JAB-BX102 has a dose-activity advantage and has the potential to benefit patients with solid tumors."

IND • New P1/2 trial • Preclinical • Oncology • Solid Tumor