JAB-2485 / Jacobio Pharma - LARVOL DELTA

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2024 ➔ Aug 2026

Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Jacobio Pharma Announces 2024 Annual Results (PRNewswire) - "JAB-2485: A Phase I/IIa global trial of JAB-2485 is ongoing in the U.S. and China; Dose escalation phase is expected to be completed in the first half of 2025."

Trial status • Solid Tumor

A phase I/IIa trial of Aurora-A inhibitor (JAB-2485) in adult patients with advanced solid tumors (ESMO 2024) - P1/2 | "The secondary endpoints include pharmacokinetics, overall response rate, time to, and duration, of response. Exploratory endpoints include correlative pharmacodynamic markers.Enrollment in this trial started in January 2023 in the US and April 2024 in China."

Clinical • Metastases • P1/2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • ARID1A • AURKB

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

JAB-2485: A potent, highly selective small-molecule Aurora kinase A inhibitor that targets cell division (AACR 2023) - P1/2 | "Taken together, preclinical results provide robust evidence supporting further evaluation of JAB-2485 both as a single agent and in combinations for treatment of various types of cancers. A Phase 1/2a clinical trial of evaluating JAB-2485 in adult patients with advanced solid tumors is enrolling patients in the US (NCT05490472)."

Breast Cancer • CNS Tumor • Lung Cancer • Neuroblastoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • AURKA • AURKB • CASP3 • CASP7

Jacobio Pharma to Present Data of Three Preclinical Studies at the 2023 AACR Annual Meeting (PRNewswire) - "Jacobin Pharma...announced that the company will present the results of three preclinical studies of KRASmulti inhibitor JAB-23425, CD73-STING iADC JAB-X1800, and Aurora kinase A inhibitor JAB-2485 in form of the abstract during the American Association for Cancer Research (AACR) Annual Meeting 2023 (the 'AACR 2023') from April 14 to 19, 2023....JAB-23425 has significant antitumor effect on cancer models with multiple KRAS mutations (such as G12D, G12V, and G13D) and amplification of wild type KRAS, and has no inhibitory effect on KRAS-independent cells."

Preclinical • Oncology • Solid Tumor

"#Jacobio Completes First Patient Dosage of #AuroraAInhibitor #JAB2485 in U.S https://t.co/Kb7SohbMK8" (@1stOncology)

Clinical

Jacobio Completes First Patient Dosage of Aurora A Inhibitor JAB-2485 in U.S (PRNewswire) - "Jacobio Pharma...announced it has completed the first patient dosage of its in-house R&D drug candidate Aurora A Inhibitor JAB-2485 in a Phase I/IIa clinical trial for advanced solid tumour patients in U.S. JAB-2485 is a highly selective small molecule Aurora A inhibitor....Jacobio's self-developed JAB-2485 is the third Aurora A inhibitor entered into clinical stage in the United States. This clinical trial will be completed independently by the clinical team of Jacobio, marking the further improvement of Jacobio's global R&D capability."

Trial status • Oncology • Solid Tumor

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2022 ➔ Dec 2022

Enrollment open • Metastases • Trial initiation date • Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

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-2485 Activity in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=102 | Not yet recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd.

New P1/2 trial • Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Jacobio Receives IND Approval for Aurora A Inhibitor JAB-2485 from FDA (PRNewswire) - "Jacobio's self-developed global first-in-class drug Aurora A inhibitor JAB-2485 received IND (Investigational New Drug) from the FDA (Food and Drug Administration) in US. Jacobio plans to initiate a Phase I/IIa clinical trial in patients with advanced solid tumors in the US. JAB-2485 is a highly selective small molecule Aurora A inhibitor. JAB-2485 can inhibit Aurora A activity at the cellular level, induce apoptosis and inhibit tumor growth."

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

"#Jacobio Receives #IND Approval for #AuroraA #Inhibitor #JAB2485 from #FDA https://t.co/tMU6fKO6i1" (@1stOncology)

FDA event