Investment in R&D increased 26.3% to RMB 221 million. Recorded revenue was RMB 54.7 million.

Global development of KRAS G12C inhibitor and other clinical stage drug candidates accelerated.

Development started in new pre-clinical stage drug candidates, such as iADC (immunostimulatory antibody-drug conjugate), P53, and PARP7.

BEIJING, SHANGHAI and BOSTON, Aug. 23, 2022 -- Jacobio Pharma (1167.HK), an innovative novel drug developer focused on undruggable targets, released 2022 interim results, business updates and expected milestones. During H1 2022, investment in R&D increased 26.3% year-on-year to RMB 221 million. Revenue generated from Jacobio's out licensing deal with AbbVie for SHP2 inhibitors was RMB 54.7 million, in line with the same period a year earlier.

"We accelerated our clinical stage programs in the first half of 2022. Through the period, our SHP2 inhibitors completed a number of first dosages of combination therapies. Also, preliminary Phase I data for the KRAS G12C inhibitor JAB-21822 was reported at the 2022 ASCO Annual Meeting. Expanding our reach and capabilities, we started a clinical trial in Europe for the first time and expanded our ongoing trials in China and the U.S.," said Dr. WANG Yinxiang, Chairman and CEO of Jacobio.

"Meanwhile, to fulfil our strategic goal of ensuring our 'key programs are among the top three worldwide and capture the global market', we continued developing pre-clinical programs to expand our pipeline, such as our KRAS related pipeline including KRAS^multi and KRAS G12D. We also continued developing several new drugs, including iADC (immunostimulatory antibody-drug conjugate) programs, P53 inhibitor, PARP7 inhibitor, and others," said Dr. WANG.

Development progress of core pipeline products:

SHP2 inhibitors: JAB-3312 & JAB-3068

In combination with KRAS G12C inhibitor

• Global: A dose escalation study was completed in July 2022 for JAB-3312 in combination with Sotorasib to treat KRAS G12C treatment naïve NSCLC patients.

• China: First dosing in a study of the combination therapy of JAB-3312 and JAB-21822 was completed in May 2022 and a Phase I dose escalation study is ongoing. Partial response (PR) was observed in the first NSCLC patient enrolled at the first dose level.

In combination with EGFR inhibitor

• A dose escalation trial for JAB-3312 in combination with an EGFR inhibitor is ongoing. Early clinical response with confirmed PR was observed in one EGFR inhibitor resistant NSCLC patient.

In combination with anti-PD-1 antibody

• Dose exploration studies are being carried out in China and the U.S. and an early clinical response was observed in patients with certain tumor types.

Monotherapies

• Monotherapy studies for both JAB-3312 and JAB-3068 have identified the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D).

KRAS G12C inhibitor JAB-21822

Monotherapies

• Phase I preliminary clinical data of the JAB-21822 monotherapy trial in China was reported at the 2022 ASCO Annual Meeting in June 2022. The overall response rate (ORR) is 56.3% (18/32) and the disease control rate (DCR) is 90.6% (29/32). 

• A pivotal trial in patients with NSCLC harboring the KRAS G12C mutation is expected to start in H2 2022 in China. 

• First patient is expected to be enrolled in September 2022 in China for monotherapy in NSCLC patients with KRAS G12C and STK-11 co-mutation.

• The first patient in Europe was enrolled in May 2022 as part of a global trial. Jacobio has enrolled patients with pancreatic ductal adenocarcinoma cancer and colorectal cancer and a dose expansion study will be initiated in H2 2022.

In combination with anti-EGFR antibody

• The first patient in the dose expansion study for colorectal cancer was enrolled in July 2022.

In combination with JAB-3312 

• China: First dose was completed in China in May 2022 for the combination therapy with JAB-3312 and a dose escalation study is ongoing. PR was observed in the first NSCLC patient enrolled at the first dose level.

Development progress of other products:

• JAB-8263 (BET inhibitor): A Phase I dose escalation study was initiated in China and the U.S. The recommended Phase II dose (RP2D) is expected to be determined in Q4 2022.

• JAB-2485 (Aurora A inhibitor): A Phase I/IIa investigational new drug (IND) approval was received in the U.S. in January 2022. The first patient in the U.S. is expected to be enrolled in Q4 2022. An IND application was submitted in China in August 2022.

• JAB-BX102 (CD73 inhibitor): A Phase I/IIa study for advanced solid tumors was approved in China in March 2022. First patient enrolment is expected in Q3 2022. A Phase I/IIa clinical trial in the U.S. was approved in October 2021, once the Phase I dose escalation stage is completed, patients will participate in a Phase IIa dose expansion for which they will receive the combination of JAB-BX102 and Pembrolizumab.

During the period, Jacobio continued to leverage its strength in small-molecule drug discovery and development to design iADC programs with the potential to address the challenges of both the toxicity caused by the conventional ADCs and low response rates in current immune-checkpoint inhibitors (ICIs) therapy. Jacobio is currently developing HER2 STING iADC JAB-BX400 and CD73-STING iADC JAB-X1800. IND applications for these two programs are expected to be submitted in 2024.

Jacobio continued to develop new drugs on KRAS signalling pathway. Among its pre-clinical assets, Jacobio has the oral KRAS^multi inhibitor JAB-23400; the KRAS G12D inhibitor JAB-22000; and JAB-BX300 that is a large molecule program on the RAS pathway. Meanwhile, Jacobio is developing the P53 Y220C inhibitor JAB-30355, the PARP7 inhibitor JAB-26766, and the small molecule program JAB-24144 on the tumor metabolic pathway.

As of June 30, 2022, Jacobio owned 228 patents or patent applications filed globally. The number of global employees increased to 285 during the period as of the same date.

Jacobio's investment in R&D has been growing rapidly and the bank balance, bank credit and the cash income generated from the out-licensing deal ensures a cash runway of 24 to 30 months.

Conference Call Information

Jacobio will host a live conference call on August 24, 2022, at 9:00 a.m. (UTC +8). Participants must register in advance of the conference call. Registration Link: https://goldmansachs.zoom.us/webinar/register/WN_ZD3M5pvPRlmaY19zMIHa1w

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