Beijing, Shanghai & Boston, Aug. 30, 2023 — Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, announced its 2023 interim results. During the period, the company recorded revenue of RMB 40.3 million even as it continued to accelerate multiple R&D projects. R&D investment increased by 5.5% to RMB 230 million.

“Jacobio has been continuously developing drugs for undruggable targets since its founding. We have developed more than 10 projects generated by our Induced Allosteric Drug Discovery Platform (IADDP) and iADC Platform. During the first half year of 2023, we remain committed to exploring the full potential of glecirasib and are pleased with the development program, expanding the pivotal trial from non-small cell lung cancer to pancreatic cancer, ” said Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma. “Following two rounds fundraising, we are well positioned to advance our pipeline.”

Development of core clinical stage products
KRAS G12C inhibitor glecirasib (JAB-21822)
- Non-small cell lung cancer (NSCLC): The pivotal trial has been initiated in more than 60 hospitals in China. Enrollment is expected to be completed in September 2023. The pre-NDA application will be submitted by the end of 2023 and an NDA is expected to be submitted in the first half of 2024. 
- Pancreatic cancer: Glecirasib has been granted Breakthrough Designation (BTD) for second-line or above pancreatic cancer patients with the KRAS G12C mutation. The pivotal trial has been approved in China. This is the  first approved global pivotal trial for pancreatic cancer with the KRAS G12C mutation. The pivotal site is expected to be activated in September 2023.
- Colorectal Cancer: The clinical results of glecirasib in combination with cetuximab to treat KRAS G12C mutant advanced CRC was released at the JCA- AACR Precision Medicine International Conference. The ORR is 62.8% (27/43) and DCR is 93% (40/43). The pivotal trial of this combination therapy is currently being discussed with the Centre for Drug Evaluation (CDE).

SHP2 inhibitors: JAB-3312
-    In combination with KRAS G12C inhibitor: JAB-3312 is currently enrolled in the Phase I/IIa clinical trial with glecirasib in China, with over 100 patients enrolled. The Phase IIa dose expansion trial of JAB-3312 in combination with sotorasib is ongoing in Europe and the U.S. The preliminary clinical results will be presented in the form of a Proffered Paper presentation at the 2023 European Society for Medical Oncology (ESMO) Congress in October 2023.
- In combination with other products: JAB-3312 is currently being used in combination with drugs such as osimertinib and PD-1 monoclonal antibody. Efficacy signals have been observed in specific tumor types.
- Monotherapies: JAB-3312 is a highly active second-generation SHP2 inhibitor, and the monotherapy phase I/IIa trial has been completed.

Development of other clinical stage products
- 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.
- JAB-2485 (Aurora A inhibitor): Preclinical data was released at the annual meeting of the American Association for Cancer Research (AACR) in April 2023. Phase I/IIa clinical trials are ongoing in the U.S. and China, and efficacy signals have been observed in the first dose group.
- 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. In March 2023, Jacobio entered into a clinical collaboration with Merck (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of Jacobio’s CD73 mAb JAB-BX102 with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). 
- JAB-26766 (PAPR7 inhibitor): A Phase I/IIa clinical trial was approved in China in June 2023, and it is currently being planned.
- JAB-24114 (GUE inhibitor): China’s CDE approved the IND application in March 2023. 
- JAB-BX300 (LIF mAb): China’s CDE approved the IND application in April 2023.

Development of pre-clinical stage products
- JAB-23400 (KRAS^multi inhibitor): Preclinical data was released at the annual meeting of the AACR in April 2023. The IND application is expected to be submitted in the first half of 2024.
- JAB-30355 (P53 Y220C corrector): JAB-30355 is an orally bioavailable small molecule activator for the treatment of patients with locally advanced or metastatic solid tumors harboring the P53 Y220C mutation. An IND application will be submitted in the second half of 2023.
- iADC projects: Relying on the iADC platform, Jacobio has developed JAB-BX400 (HER2 STING iADC) and JAB-X1800 (CD73 STING iADC). Preclinical studies have shown that JAB-BX400 is effective against DS8201 resistant tumor models, and the IND application will be submitted in 2024-2025. 

While accelerating the progress of R&D projects, Jacobio completed two rounds of financing during the period to maintain sufficient cash reserves to support R&D and company operations. As of June 30, 2023, Jacobio has RMB 1.3 billion in cash and cash equivalents.

Conference Call Information
Jacobio Pharma will hold a live conference call at 9:00 AM August 31 2023 Beijing time. Participants, please register in advance through https://goldmansachs.zoom.us/webinar/register/WN_jDcCDLTJTKGOD_bkRjodOg#...
 

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