An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation

This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Start Date07 Aug 2024

Sponsor / Collaborator

Shanghai Allist Pharmaceuticals Co., Ltd.

NCT05288205

/ RecruitingPhase 1/2

A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Start Date14 Apr 2022

Sponsor / Collaborator

Shanghai Allist Pharmaceuticals Co., Ltd.

CTR20212254

/ RecruitingPhase 1/2

一项评价基于JAB-3312的联合治疗在成人晚期实体瘤受试者中的安全性、耐受性、药代动力学和初步抗肿瘤活性的1/2a期、多中心、开放性临床研究

[Translation] A Phase 1/2a, multicenter, open-label clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of JAB-3312-based combination therapy in adult subjects with advanced solid tumors

（剂量递增）主要目的：评估JAB-3312联合帕博利珠单抗、binimetinib、sotorasib或奥希替尼在晚期实体瘤受试者中的安全性和耐受性，并确定其RP2D。次要目的：根据RECIST v1.1评估联合用药的初步有效性及联合用药时JAB-3312的PK特征。（剂量扩展）主要目的：根据RECIST v1.1评估联合用药在特定实体瘤类型中的初步有效性。次要目的：评估联合用药的安全性和耐受性。

[Translation]

(Dose escalation) Primary objective: To evaluate the safety and tolerability of JAB-3312 in combination with pembrolizumab, binimetinib, sotorasib, or osimertinib in subjects with advanced solid tumors and to determine its RP2D. Secondary objective: To evaluate the preliminary efficacy of the combination and the PK characteristics of JAB-3312 in combination according to RECIST v1.1. (Dose expansion) Primary objective: To evaluate the preliminary efficacy of the combination in specific solid tumor types according to RECIST v1.1. Secondary objective: To evaluate the safety and tolerability of the combination.

Start Date24 Feb 2022

Sponsor / Collaborator

Beijing Jiakesi New Drug Development Co. Ltd.

100 Clinical Results associated with Sitneprotafib

100 Translational Medicine associated with Sitneprotafib

100 Patents (Medical) associated with Sitneprotafib

Literatures (Medical) associated with Sitneprotafib

15 Jul 2025·CLINICAL CANCER RESEARCH

JAB-3312, a Potent Allosteric SHP2 Inhibitor That Enhances the Efficacy of RTK/RAS/MAPK and PD-1 Blockade Therapies

Article

Author: Leventakos, Konstantinos ; Kang, Di ; Ding, Yuli ; Ma, Wen Wee ; Bi, Chao ; Lin, Yiwei ; Ma, Cunbo ; Morgensztern, Daniel ; Yan, Man ; Wang, Yanping ; Wang, Yinxiang ; Sun, Xin ; Wang, Peng ; Xiong, Jing

Abstract:

Purpose::

Recent advances have seen the development of targeted therapeutics against the receptor tyrosine kinase (RTK)/RAS/MAPK pathway, which, when aberrantly activated, drives the malignant transformation of many cancer indications. However, the efficacy of inhibitors targeting single molecules is dampened by pathway feedback activation and acquired drug resistance. We seek to evaluate the application of JAB-3312 (sitneprotafib), a potent inhibitor of SHP2, in RTK/RAS/MAPK pathway–targeted combination therapies. Furthermore, SHP2 plays a vital role in PD-1–mediated immunosuppression. The rational combination of JAB-3312 with PD-1 blocking therapies is also explored.

Experimental Design::

Biochemical and cellular assays were applied to evaluate the potency of JAB-3312 in SHP2 inhibition. Tumor cell lines and cell line– and patient-derived xenografts were used to test different combinations of JAB-3312 with KRASG12C, MEK, EGFR, and PD-1 inhibitors.

Results::

JAB-3312 produced potent in vitro inhibition of SHP2 activity and downstream ERK phosphorylation, with IC50 values of 1.44 nmol/L and 0.68 to 4.84 nmol/L, respectively. When used in combination, JAB-3312 significantly increased the antitumor activity of the KRASG12C inhibitor glecirasib in naïve and resistant models. The combination of JAB-3312 with MEK inhibitors significantly delayed RTK signaling reactivation and enhanced tumor growth inhibition in KRAS-mutated cancer models. The JAB-3312–osimertinib combination exhibited great efficacy in osimertinib-resistant non–small cell lung cancer models. Additionally, JAB-3312 enhanced the efficacy of PD-1 blockade therapies by promoting an antitumor microenvironment. Representative cases of patients who responded to the combination therapies from two ongoing clinical trials (NCT05288205 and NCT04720976) were reported.

Conclusions::

JAB-3312 in combination with RTK/RAS/MAPK or PD-1 blockade therapies is a promising strategy that warrants further clinical investigation.

01 May 2025·Cancer research communications

Glecirasib, a Potent and Selective Covalent KRAS G12C Inhibitor Exhibiting Synergism with Cetuximab or SHP2 Inhibitor JAB-3312

Article

Author: Yang, Guiqun ; He, Xueting ; Wang, Yanping ; Wang, Yinxiang ; Li, Sujing ; Li, Amin ; Kang, Di ; Lin, Yiwei ; Liu, Dan ; Sun, Xin ; Wang, Peng ; Liu, Xiaoyu

Abstract:

Clinical studies have demonstrated the antitumor efficacy of covalent KRAS G12C inhibitors in treating advanced/metastatic cancers. In the current study, we report the preclinical characteristics of a specific KRAS p.G12C covalent inhibitor, glecirasib. Glecirasib exhibited high potency against KRAS G12C, along with a high level of selectivity over wild-type KRAS, HRAS, and NRAS in biochemical assays. On the cellular level, it substantially reduced downstream ERK and AKT phosphorylation, inhibited the viability of cancer cells harboring the KRAS p.G12C mutation, and demonstrated high selectivity over non-KRAS p.G12C cancer cells. Glecirasib could effectively inhibit HRAS G12C, NRAS G12C, and several G12C-inclusive KRAS double mutants that showed resistance to adagrasib. In vivo research suggested that once-daily dosing of glecirasib can robustly inhibit ERK phosphorylation for at least 24 hours and induced tumor regression in several xenograft models, including the NCI-H1373–luciferase intracranial model. Glecirasib in combination with cetuximab or JAB-3312 (sitneprotafib, a clinical-stage SHP2 inhibitor developed by Jacobio Pharma) significantly enhanced antitumor activity both in vitro and in vivo. Collectively, these results suggest that glecirasib is a potent and selective covalent inhibitor of KRAS G12C, shows potent antitumor activity as monotherapy, and synergizes with either EGFR blockade or SHP2 inhibition. A new drug application for glecirasib has been submitted in China, seeking approval for the treatment of non–small cell lung cancer, supported by a pivotal phase II single-arm study (NCT05009329). Additionally, glecirasib is being explored in clinical trials in combination with cetuximab (phase II, NCT05194995) and JAB-3312 (phase III, NCT06416410).

Significance::

Glecirasib potently and selectively inhibits KRAS G12C and reduces ERK and AKT phosphorylation in KRAS G12C–mutant cancer cells, further inducing cell-cycle arrest and apoptosis. Glecirasib monotherapy leads to tumor regression in KRAS G12C–mutant animal models and shows synergistic effects with cetuximab or JAB-3312 (sitneprotafib).

22 Aug 2024·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of JAB-3312, a Potent SHP2 Allosteric Inhibitor for Cancer Treatment

Article

Author: Kang, Di ; Xu, Zilong ; Wu, Xinping ; Wang, Yanping ; Zhang, Lei ; Gao, Panliang ; Wang, Yinxiang ; Zhang, Wei ; Long, Wei ; Ma, Cunbo ; Cai, Yang ; Han, Huifeng

As an oncogenic phosphatase, SHP2 acts as a converging node in the RTK-RAS-MAPK signaling pathway in cancer cells and suppresses antitumor immunity by passing signals downstream of PD-1. Here, we utilized the extra druggable pocket outside the previously identified SHP2 allosteric tunnel site by the (6,5 fused), 6 spirocyclic system. The optimized compound, JAB-3312, exhibited a SHP2 binding K_d of 0.37 nM, SHP2 enzymatic IC₅₀ of 1.9 nM, KYSE-520 antiproliferative IC₅₀ of 7.4 nM and p-ERK inhibitory IC₅₀ of 0.23 nM. For JAB-3312, an oral dose of 1.0 mg/kg QD was sufficient to achieve 95% TGI in KYSE-520 xenograft model of mouse. JAB-3312 was well-tolerated in animal models, and a close correlation was observed between the plasma concentration of JAB-3312 and the p-ERK inhibition in tumors. Currently, JAB-3312 is undergoing clinical trials as a potential anticancer agent.

News (Medical) associated with Sitneprotafib

29 Aug 2025

·www.prnewswire.com

Jacobio Pharma Announces 2025 Interim Results

BEIJING and SHANGHAI and BOSTON, Aug. 29, 2025 /PRNewswire/ -- Jacobio Pharma (1167.HK) today announced its interim results for the six months ended June 30, 2025. During the reporting period, the Company achieved revenue of RMB45.7 million, representing a 100% increase compared with the same period in 2024. Research and development (R&D) expenses amounted to RMB93.2 million. The net loss for the first half of 2025 was RMB59.0 million, narrowing by 65.1% compared with the same period in 2024. As of June 30, 2025, Jacobio maintained cash and bank balances, and investments in capital protected structure deposits, totaling RMB1,07billion, along with RMB270 million bank credit available which provides sufficient and stable liquidity to support our R&D activities. Dr. Yinxiang Wang, Chairman and Chief Executive Officer of Jacobio, said: "In the first half of 2025, we reached an important milestone with the approval and launch of Glecirasib in China. Through our collaboration with business partners, we significantly alleviated the pressure of R&D investment, enabling the Company to focus resources on advancing our pan-KRAS inhibitor and ADC pipeline. Looking forward, we remain committed to a transformative innovation strategy, working hand in hand with global partners to accelerate the development of breakthrough therapies and deliver benefits to more cancer patients." Accelerated Progress in Core Programs JAB-23E73 (pan-KRAS inhibitor): The dose-escalation portion of the phase I trials are onging in China and the U.S, respectively. Safety profile: low incidence of skin toxicity (rash observed in 10%, all Grade 1) no Grade ≥3 liver toxicity reported to date. Favorable PK with predicted exposure. Multiple partial responses have been observed to date. Preclinical data to be presented at the AACR-NCI-EORTC International Conference in October 2025. Phase I results readout expected in the first half of 2026. JAB-BX600 (First-in-class EGFR-KRAS G12Di ADC): This program uses a highly potent KRAS G12D inhibitor as the payload. The candidate demonstrates picomolar (pM)-level cellular activity, compared with nanomolar (nM) typically achieved by oral small molecules. Unlike oral small molecules usually achieve tumor drug concentrations 1–10x higher than plasma levels, the JAB-BX 600 delivers a KRAS G12D inhibitor at 1,000 x higher in tumor, resulting in a substantially wider therapeutic window. The KRAS G12D inhibitor and EGFR antibody have synergistic effect and durable anti-tumor activity. IND submission planned for the second half of 2026. Glecirasib (JAB-21822, KRAS G12C inhibitor): Approved by China's NMPA in May 2025 for ≥2L KRAS G12C mutant NSCLC, successfully launched in China. Triggered a RMB50 million milestone payment in addition to the RMB200 million upfront received in 2024. The full second-line NSCLC dataset has been published in Nature Medicine (Impact Factor: 50). Phase I/II data for the combination with SHP2 inhibitor has been accepted by a top-tier academic journal, with publication expected in H2 2025. Sitneprotafib (JAB-3312, SHP2 inhibitor): Ongoing Phase III registration trial in combination with Glecirasib as first-line NSCLC treatment in China. Translational research published in Clinical Cancer Research (Impact Factor: 10.2), demonstrating significant synergy with Glecirasib. JAB-BX467 (HER2-STING iADC): A HER2-targeted ADC carrying a STING agonist, designed to convert "cold tumors" into "hot tumors" and address the 70% of patients unresponsive to PD-1 inhibitors. Currently in IND-enabling stage, with IND filing planned for H2 2026. SOURCE Jacobio Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Financial StatementINDPhase 3

19 Mar 2025

·www.prnewswire.com

Jacobio Pharma Announces 2024 Annual Results

BEIJING, SHANGHAI and BOSTON, March 19, 2025 /PRNewswire/ -- Jacobio Pharma (1167.HK) released its 2024 annual results, with revenue of RMB160 million, R&D expense of RMB330 million. Major operating and financing activities generated RMB320 million cash inflows. By the end of 2024, cash and bank balances and bank credit balances amounted to RMB1.45 billion. Jacobio also announced recent business progress and expected milestones. "2024 is a transforatmive year for Jacobio. We have submitted a New Drug Application (NDA) for the KRAS G12C inhibitor glecirasib and have licensed out the China rights of glecirasib and the SHP2 inhibitor sitneprotafib to our partner. This marks Jacobio's successful transformation from the early R&D stage to an innovation-driven value realization stage," said Dr.Yinxiang Wang, the Chairman and CEO of Jacobio Pharma. "Looking ahead to 2025, glecirasib is expected to receive the official approval for marking, which will continuously generate cash flow to invest in Jacobio' subsequent pipeline." Development of core clinical stage products Glecirasib (JAB-21822, KRAS G12C inhibitor) and sitneprotafib (JAB-3312, SHP2 inhibitor) The commercialization and further clinical development in China of glecirasib and sitneprotafib were licensed to Allist on August 30, 2024. Non-small cell lung cancer (NSCLC) The NDA application of glecirasib monotherapy in second-line and above NSCLC was submitted to the CDE (China Drug Evaluation Center) in May 2024 and the priority review designation was granted in the same month. Glecirasib is expected to be approved in the first half of 2025. The Phase III pivotal trial of glecirasib combined with sitneprotafib in front-line NSCLC enrolled the first patient in China on August 7, 2024. Multi-tumor basket The multi-tumor basket registration phase II trial of glecirasib for the treatment of pancreatic cancer, biliary tract cancer, gastric cancer, small bowel cancer, appendiceal cancer and other indications has been initiated in China. Glecirasib has received orphan drug designation (ODD) from FDA and EMA for pancreatic cancer. Colorectal cancer The Phase III trial of glecirasib mono or in combination with cetuximab in third line was approved by the CDE in May 2024 JAB-23E73 (pan-KRAS inhibitor) The IND (Investigational New Drug) applications were approved in China and the United States in September 2024 The first patient was enrolled in November 2024 The dose escalation phase is expected to be completed in the second half of 2025 JAB-30355 (p53 Y220C activator) The IND application of FIH (first-in-human) global trial of JAB-30355 was approved by the FDA in March 2024 and by the CDE in June 2024. The first patient was enrolled in July 2024 The dose escalation is expected to be completed in the second half of 2025 JAB-8263 (BET inhibitor) The dose escalation for JAB-8263 in solid tumors and hematologic malignancy were completed in the U.S. and China, respectively. The RP2D (phase II recommended doses) was obtained. Dose expansion in patients with myelofibrosis is ongoing. Solid tumor portion with specific biomarkers is being explored. . JAB-2485 (Aurora A inhibitor) A Phase I/IIa global trial of JAB-2485 is ongoing in the U.S. and China. Dose escalation phase is expected to be completed in the first half of 2025 The expansion of monotherapy and combination with chemotherapy are being planned. Development of pre-clinical pipelines JAB-BX467 (HER2-STING iADC) Clinical candidate of HER2-STING iADC has been nominated in the second half of 2024. The IND application is being planned to be submitted in 2026. JAB-BX600 (KRAS G12D ADC) The clinical candidate is expected to be nominated in the second half of 2025. As of December 31, 2024, Jacobio has filed more than 360 patent applications worldwide, including 126 authorized patents. Conference call information Jacobio Pharma will hold a conference call at 9:30 AM (Beijing time) on March 20, 2024. Participants, please register in advance through this link: About Jacobio Pharma Jacobio Pharma (1167.HK) is committed to providing breakthrough treatments for patients. With an induced allosteric drug discovery platform, the company's core projects focus on the KRAS pathway. The company envisions becoming a global leader in research and development, fostering strategic partnerships to drive innovation. Jacobio's R&D centers are located in Beijing, Shanghai (China), and Boston (USA). Clinical trials are conducted at over 180 sites in China, more than 30 sites in the USA, and over 10 sites across several European countries. For more information, please visit: SOURCE Jacobio Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2NDAPhase 3Orphan DrugDrug Approval

07 Jan 2025

·www.prnewswire.com

The Registrational Clinical Data of Glecirasib was Published in Nature Medicine

BEIJING, SHANGHAI and BOSTON, Jan. 6, 2025 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets announced today that the data from a registrational clinical trial of its independently developed KRAS G12C inhibitor glecirasib has been published in Nature Medicine (impact factor 58.7). In the article, Jaocbio disclosed, for the first time, the complete dataset of glecirasib in KRAS G12C mutant non-small cell lung cancer patients in the second line or above setting. The pivotal phase II trial of glecirasib monotherapy demonstrated impressive efficacy, including the confirmed objective response rate of 47.9% (56/117), a median progression-free survival of 8.2 months, and a median overall survival of 13.6 months. Glecirasib has a manageable safety profile. Gleciasib has a favorable gastrointestinal safety profile compared with other KRAS G12C inhibitors. The new drug application of glecirasib is currently under evaluation by the Center for Drug Evaluation of the National Medical Products Administration of China, and has been granted Priority Review Designation. Dr. Yinxiang Wang, Chairman and CEO of Jacobio, said: "It's our great honor to present the data from our pivotal trial in such as prestigious journal as Nature Medicine. The development of KRAS-related inhibitors is still in the early stages. We will continue to explore registration clinical trials with our partners of glecirasib in combo with SHP2 inhibitor JAB-3312 for the treatment of first-line NSCLC and accelerate the development of our other RAS programs such as Pan-KRAS inhibitor." About Glecirasib Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of 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 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 us at SOURCE Jacobio Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugPhase 2Breakthrough TherapyClinical ResultPriority Review

100 Deals associated with Sitneprotafib

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	China	Shanghai Allist Pharmaceuticals Co., Ltd.	07 Aug 2024
Solid tumor	Phase 2	United States	AbbVie, Inc.	14 Jul 2022
Colorectal Cancer	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	14 Apr 2022
Pancreatic Ductal Carcinoma	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	14 Apr 2022
Esophageal Squamous Cell Carcinoma	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	30 Jan 2022
Squamous Cell Carcinoma of Head and Neck	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 2	United States	AbbVie, Inc.	23 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	United States	Shanghai Allist Pharmaceuticals Co., Ltd.	23 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	United States	AbbVie, Inc.	23 Mar 2021
Non-Small Cell Lung Cancer	Phase 2	United States	AbbVie, Inc.	23 Mar 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05288205 (ESMO2024) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C \| PD-L1	102	Glecirasib plus JAB-3312	jvhziojggn(ncgtaavecf) = nvaevmcvrr lsojwrwesb (gehmggwcft ) View more	Positive	14 Sep 2024
				Glecirasib plus JAB-3312 (PD-L1 TPS≥50%)	jvhziojggn(ncgtaavecf) = kwsvzjnwlr lsojwrwesb (gehmggwcft ) View more
NCT05288205 (ASCO2024) Manual	Phase 1/2	KRAS G12C mutation Solid Tumors KRAS G12C	179	Glecirasib 800 mg	rnritlvkbv(jysggptcqf) = yswrukmdaz kvpulvydae (wxorhdjpwb ) View more	Positive	24 May 2024
NCT05288205 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	KRAS G12C mutation Solid Tumors KRAS G12C	60	Glecirasib +JAB-3312	yytoawdjdt(vkaflmkedq) = khxglxcymd xaocuzbxbq (ocezwhojwt ) View more	Positive	22 Oct 2023
				Glecirasib +JAB-3312 (KRAS G12Ci naïve NSCLC)	sbujcqjbki(hmenpvsidh) = qejtyhmnit qwlejixrih (atbhkdiajw ) View more

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