Jacobio Pharma Announces 2022 Annual Results

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 (KRAS^multi 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 KRAS^multi 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 https://goldmansachs.zoom.us/webinar/register/WN_MTI5cNcKQP6-ysfAaabm7w

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