JAB-8263 / Jacobio Pharma - LARVOL DELTA

Preliminary Results of Patients with Myelofibrosis (MF) from a Phase I Trial of Jab-8263, a Potent BET Inhibitor (ASH 2024) - P1/2 | "Promising efficacy signals were observed in patients previously treated with JAK inhibitors. The safety, efficacy (SVR 35 and TSS50) and PK data will be available at the presentation."

Clinical • P1 data • Hematological Malignancies • Myelofibrosis • Oncology • Solid Tumor • JAK2

Jacobio Pharma Announces 2024 Annual Results (PRNewswire) - "JAB-8263: The dose escalation for JAB-8263 in solid tumors and hematologic malignancy were completed in the U.S. and China, respectively. The RP2D (phase II recommended doses) was obtained. Dose expansion in patients with myelofibrosis is ongoing."

Trial status • Myelofibrosis • Solid Tumor

Jacobio Pharma Presented preliminary Data on BET Inhibitor for Myelofibrosis at 2024 ASH (PRNewswire) - P1/2a | N=152 | NCT04686682 | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | "The data showed that JAB-8263 was well tolerated with Recommended Phase 2 Dose (RP2D) being 0.3mg QD....As of the data cutoff date of Oct 17, 2024, 16 patients with intermediate-/high-risk MF have been enrolled, and 13 patients have undergone at least one post-treatment efficacy assessment. All patients showed a mean SVR-19.95%at week 24 and -26.16% at best response. Two patients achieved ≥35% SVR, and an SVR of -34.9% was observed in one patient. Six of ten (60%) patients experienced a ≥50% reduction in TSS at week 24. The best response of SVR in 2 of 8 patients (JAK inhibitors-treated) was -41.2% and -34.9%, respectively. At week 24, 3 of 6 (50%) patients (JAK inhibitors-treated) achieved TSS50."

P1 data • Myelofibrosis

JACOS-B (01167) will present clinical data of BET inhibitor JAB-8263 at the 66th Annual Meeting of the American Society of Hematology in 2024 [Google translation] (Sina Corp) - "JACOB...announced that the company will present clinical data of BET inhibitor JAB-8263 at the 66th American Society of Hematology (ASH) Annual Meeting in 2024. The ASH Annual Meeting will be held in San Diego, USA from December 7 to 10, 2024."

Clinical data • Oncology

JAB-8263, A POTENT BET INHIBITOR, IN MYELOFIBROSIS AND OTHER ADVANCED MYELOID NEOPLASMS: RESULTS FROM A PHASE 1/2A STUDY (EHA 2024) - P1/2 | "The preliminary results indicate that JAB-8263 is well tolerated in patients and has clinical activity in MFpatients. The spleen size reduction and symptomatic improvement were observed. JAB-8263 will be furtherexplored in MF."

Metastases • P1/2 data • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelofibrosis • Oncology • Solid Tumor

Preclinical Evaluation of JAB-2485, a Potent AURKA Inhibitor with High Selectivity and Favorable Pharmacokinetic Properties. (PubMed, ACS Omega) - P1/2 | "Furthermore, JAB-2485 exhibited robust in vivo antitumor activity both as monotherapy and in combination with chemotherapies or the bromodomain inhibitor JAB-8263 in xenograft models of various cancer types. Together, these encouraging preclinical data provide a strong basis for safety and efficacy evaluations of JAB-2485 in the clinical setting."

Journal • PK/PD data • Preclinical • Breast Cancer • CNS Tumor • Lung Cancer • Neuroblastoma • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • AURKA • AURKB

Jacobio Pharma Announces 2023 Annual Results (PRNewswire) - "P53 Y220C activator JAB-30355: The IND has been approved by U.S. FDA (Food and Drug Administration), and phase I clinical trial is expected to be initiated in the second half of 2024. Preclinical data will be presented at the AACR Annual Meeting 2024; BET inhibitor JAB-8263: A Phase II trial of JAB-8263 monotherapy or combination therapies is planned to be initiated in the second half of 2024. Clinical data will be published at the 2024 European Hematology Association (EHA) Congress; Aurora A inhibitor JAB-2485: RP2D is anticipated to be determined in Q2 2024."

New P1 trial • New P2 trial • P2 data • Preclinical • Trial status • Oncology

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 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

Potent bromodomain and extraterminal domain inhibitor JAB-8263 suppresses MYC expression and exerts anti-tumor activity in colorectal cancer models. (PubMed, World J Gastrointest Oncol) - "BET could be a potential effective drug target for suppressing CRC growth, and the BET inhibitor JAB-8263 can effectively suppress c-MYC expression and exert anti-tumor activity in CRC models."

Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • ANXA5 • CDKN1A • MYC

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

Metastases • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • 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

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Jan 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Jacobio Pharmaceuticals Announces 2021 Interim Results (PRNewswire) - "Jacobio Pharmaceuticals...announced its results for the first half of 2021. Investment in R&D for the clinical-stage biotech firm reached 175 million yuan (approx. US$27 million) for the half year, up 146 percent year-on-year. Driven by revenue generated from its overseas licensing deals, the company recorded revenue of 57.69 million yuan (approx. US$8.9 million) during the reporting period."

Commercial • Oncology

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors (clinicaltrials.gov) - P1/2; N=152; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors (clinicaltrials.gov) - P1/2; N=152; Not yet recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; N=60 ➔ 152

Clinical • Enrollment change • Acute Myelogenous Leukemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors (clinicaltrials.gov) - P1/2; N=60; Not yet recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Clinical • New P1/2 trial • Acute Myelogenous Leukemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor