JAB-3312

BEIJING and SHANGHAI and BOSTON, April 30, 2024 /PRNewswire/ -- Jacobio Pharma (1167.HK) announced that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO Plenary Series, which was held online. Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214). The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month DOR rates were 73.6% and 56.6%, respectively. Safety data showed that glecirasib has a manageable safety profile. No grade 5 treatment related adverse event (TRAE) was observed, and only 5.0% of patients discontinued the treatment due to TRAEs. Gleciasib has a favorable gastrointestinal (GI) profile compared to other KRAS G12C inhibitors. "If glecirasib can match or even bypass current efficacy data with an overall improved side effect profile, this agent would be an attractive treatment option." commented Julia Rotow, MD, of the Dana-Farber Cancer Institute, who critiqued the glecirasib findings. She said that the unique toxicity profile of glecirasib may offer the potential for combination with agents that cannot be readily combined with other existing KRAS G12C inhibitors due to overlapping toxicities. "The trend in the treatment of lung cancer is to reduce the use of chemotherapy. Currently, for lung cancer patients harboring the KRAS G12C mutation who fail first-line treatment, chemotherapy such as docetaxel is the main second-line treatment in China. The ORR is 14%, mPFS is 3.0 months, and OS is 9.1 months. Existing clinical data show that glecirasib is more effective and safer than chemotherapy and is expected to bring more treatment options to patients." Said Prof. Yuankai Shi. About Glecirasib Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China. 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 signalling 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. Please visit for more information SOURCE Jacobio Pharma

BEIJING, SHANGHAI and BOSTON, March 28, 2024 Jacobio/PRNewswire/ -- Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: "In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of 'drugging the undruggable'. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to be submitted in the first half of 2024. This marks that Jacobio will enter into the commercial stage." Development of core clinical stage products KRAS G12C inhibitor Glecirasib (JAB-21822) Non-small cell lung cancer (NSCLC) The patient enrollment for pivotal trial of glecirasib monotherapy in ≥2L NSCLC patients harboring KRAS G12C mutation was completed. The NDA application is expected to be submitted to CDE (Center for drug evaluation, NMPA) in Q2 2024 as planned. 1L NSCLC is in combination with SHP2 inhibitor JAB-3312. The phase III registrational trial was approved by CDE. Pancreatic cancer (PDAC) The pivotal trial of glecirasib monotherapy in ≥2L PDAC patients was activated in China. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) GI Annual Meeting. The cORR was 41.9% (13/31) and the DCR was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months. Colorectal cancer (CRC) The clinical results of glecirasib monotherapy and glecirasib combined with cetuximab in advanced colorectal cancer were presented at the Second JCA- AACR Precision Medicine International Conference. Phase III pivotal trial design of glecirasib monotherapy or glecirasib in combination with cetuximab is expected to be approved by CDE in Q2 2024. Multi-tumors basket Multi-tumors basket includes biliary tract cancer, gastric cancer, small bowel cancer, appendices cancer, etc. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) GI Annual Meeting. The cORR was 57.9%（11/19), DCR was 84.2%（16/19), mPFS was 7.0 months. A phase II single arm pivotal trial is under communication with CDE. SHP2 inhibitor JAB-3312 The Phase III pivotal trial of JAB-3312 in combination with glecirasib to treat 1L NSCLC patients has been approved by CDE, and this study in China is expected to initiated in Q3 2024. JAB-3312 is the very first SHP2 inhibitor entering a phase III registrational trial worldwide. The clinical data of glecirasib in combination with JAB-3312 was published at the 2023 European Society for Medical Oncology Congress (ESMO 2023). Glecirasib (800mg once daily) + JAB-3312 2mg (once daily for 1 week on, then 1 week off) dosage yielded ORR of 86.7% (13/15) and DCR of 100% (15/15). Long term safety and efficacy data have submitted to the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Development of other clinical products 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. The preclinical study of JAB-2485 was presented at the 2023 AACR. 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. We are optimizing the clinical development strategy for PARP7 inhibitor JAB-26766, GUE (glutamine-utilizing enzyme) inhibitor JAB-24114, and LIF mAb JAB-BX300 considering the current treatment landscape and our resources available. Development of other pre-clinical products KRASmulti inhibitor JAB-23E73: The IND application is expected to be submitted in Q2 2024. Clinical candidate for HER2-STING iADC JAB-BX400 is expected to be nominated in the second half of 2024. As of December 31, 2023, Jacobio owned 340 patents or patent applications that are filed globally, of which 82 patents have been issued or allowed in major markets globally. During the performance period, Jacobio raised HKD159 million through public placing, and obtained RMB150 million from Beijing E-town Capital. As of December 31, 2023, Jacobio has RMB 1.2 billion cash and cash equivalent, providing sufficient cash reserves for R&D investment in the next 30-36 months. Jacobio repurchased and canceled 1.807 million shares, continuing to increase shareholder value. Conference Call Information Jacobio Pharma will hold a live conference call at 10:30 AM March 29 2024 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