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
https://s.comein.cn/AkyBh.
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.
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SOURCE Jacobio Pharma