JAB-8263

BEIJING, SHANGHAI and BOSTON, Aug. 30, 2023 /PRNewswire/ -- 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 (KRASmulti 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-30300 (P53 Y220C corrector): JAB-30300 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 About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform. SOURCE Jacobio Pharma

BEIJING, SHANGHAI and BOSTON, March 22, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK) announced its 2022 annual results. R&D investment was RMB530 million, showing an increase of 26% compared with 2021. The revenue was RMB95.7 million, which was generated from an out-licensing deal. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: "Jacobio's business made satisfying progress in 2022, although all biotechnology companies had to deal with challenges created by a bleak macroeconomic environment. We continue to accelerate clinical projects and expand pipelines through in-house R&D. The previous hard work is about to enter the harvest period. Next, we will focus on the two major R&D areas of targeted therapy and iADC, and further implement the strategy of 'aiming the global market and the key projects are among the top three in the world'." Development of core clinical stage products KRAS G12C inhibitor Glecirasib (JAB-21822) Monotherapies - The pivotal trial in patients with NSCLC harboring KRAS G12C mutation was approved by the CDE in September 2022. The NDA application is expected to be submitted in 2023 Q4. - In December 2022, Glecirasib has been granted BTD (Breakthrough Designation) for the second line and above treatment of advanced or metastatic NSCLC patients with KRAS G12C mutation by the CDE. - Jacobio has received the IND approval of Glecirasib monotherapy for a Phase I/IIa trial in first line NSCLC patients who have KRAS G12C and STK-11 co-mutation and the first patient was dosed in August 2022. - In patients with CRC, PDAC and other solid tumors treated with Glecirasib monotherapy, promising efficacy signals were observed. The potential global development plan in other solid tumors will be discussed with China and U.S. regulatory authorities. In combination with EGFR mAb - In China, the enrollment of the Phase I/IIa trial of Glecirasib in combination with an anti-EGFR antibody cetuximab in patients with CRC was completed in February 2023. Pivotal trial is expected to be initiated in 2023 Q4 in China. - In October 2022, Jacobio has entered into a clinical trial collaboration agreement with Merck on clinical study of Glecirasib in combination with Merck's Erbitux® (cetuximab). Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement. SHP2 inhibitors: JAB-3312 & JAB-3068 In combination with KRAS G12C inhibitor - In China, the Phase I/IIa clinical trial of JAB-3312 in combination with our KRAS G12C inhibitor Glecirasib to treat KRAS G12C naïve and resistant patients is actively recruiting. - Jacobio has completed the global first dose of Phase II clinical trial for the combination of JAB-3312 and a KRAS G12C inhibitor Sotorasib. - The results of JAB-3312 in combination with Glecirasib in pre-clinical cancer models were presented in a poster session in 2022 ESMO Asia Congress. Development of other products - 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-2485 (Aurora A inhibitor): In China, the IND application for a Phase I/IIa trial was approved by the CDE in October 2022. The first patient was dosed in January 2023 in the U.S. This is the first global trial fully managed by Jacobio's internal clinical team, which demonstrates our global clinical development capabilities. - 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. Jacobio has entered into a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA to evaluate the combination of Jacobio's CD73 mAb JAB-BX102 in combination with Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). - JAB-24114 (GUE inhibitor): The IND application was approved by China CDE in March 2023. - Jacobio has submitted the IND applications of JAB-BX300 (LIF mAb) to the NMPA in January 2023. - The IND applications of JAB-23400 (KRASmulti inhibitor), JAB-30300 (P53 Y220C corrector) and JAB-26766 (PARP7 inhibitor) will be submitted this year. - Candidate of JAB-X1800, Jacobio's in-house CD73-STING iADC, was nominated in the first quarter of 2023. Data publication plan in 2023 - AACR 2023 (accepted): The preclinical studies of KRASmulti inhibitor JAB-23425, CD73-STING iADC JAB-X1800, and Aurora kinase A inhibitor JAB-2485. - ASCO 2023 (submitted): The clinical data of Glecirasib in combination with Cetuximab in patients with CRC. - ESMO 2023 (planed): The clinical data of SHP2 inhibitor JAB-3312 in combination with Glecirasib. - 2023 H2-2024 H1 (planed): Glecirasib monotherapy in PDAC and other solid tumors - expect to read out preliminary data for this study. In 2022, Jacobio owned 280 patents or patent applications that are filed globally, the number increased 60% compared with 2021. The new R&D headquarters in Beijing will be officially used in May 2023, with a total area of 22,000 square meters. In March 2023, Jacobio was selected as the first batch of transferred Hong Kong Listed company under the Shanghai-Hong Kong Stock connect. Jacobio is able to continuously invest in its pipelines with cash reserve. As of December 31, 2022, Jacobio has 1.3 billion yuan cash and cash equivalent. In February 2023, Jacobio raised HKD159 million through public placing. Conference Call Information Jacobio Pharma will hold a live conference call at 9:00 AM March 23 2023 Beijing time. Participants please register in advance through About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to the Company, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment, and political, economic, legal and social conditions in China. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Jacobio Pharma