Jacobio Pharma Announces 2023 Annual Results
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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.
- 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 firstSHP2 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 2024European 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
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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
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