China CDE awarded Jacobio’s KRAS G12C-Inhibitor JAB-21822 Breakthrough Therapy designations

BEIJING, SHANGHAI and BOSTON, Dec. 15, 2022 /PRNewswire/ — Jacobio Pharma (1167. HK) has announced that JAB-21822, a Company-developed KRAS G12C inhibit, was given breakthrough therapy designations by The Center for Drug Evaluation (CDE), of the National Medical Products Administration. JAB-21822 was awarded this designation based on its solid clinical efficacy as well as safety data. It will speed up the registration of the program to the health authority, and enable patients to access it sooner.

In December, the Phase II pivotal clinical trial for JAB-21822 in humans was approved China On September 5, 2022. This multi-center, single arm, open-label, multi-center study will evaluate JAB-21822’s safety and efficacy as a single agent to treat NSCLC patients suffering from KRAS G12C.

JAB-21822 could be the best-in-class program to block KRAS G12C inhibitions. Preliminary phase I clinical data from the American Society of Clinical Oncology 2022 Annual Meeting show that the drug is effective as of April 1, 2022A total of 72 patients were enrolled with advanced solid tumors. 32 NSCLC patients carrying the KRAS G12C mutation were evaluated for efficacy. The overall response rate (ORR), was 56.3% (18/32) while the disease control rate was 90.6% (29/32).

JAB-21822 is safe and has very few treatment-related adverse events (TRAE). There were 72 cases of diarrhea (4/72) and 6.9% (5/72) among the patients. No gastrointestinal disorder greater than grade 2 was seen.

JAB-21822 currently has clinical trials in both monotherapy and combination therapy. China, The United States EuropeIncluding the monotherapy to NSCLC patients suffering from KRAS G12C mutations, pancreatic ductal cancer and colorectal carcinoma; the combination therapy using EGFR monoclonal anti-cancer treatment; and the combination of therapy with inhouse SHP2 JAB-33112 inhibitor to treat NSCLC patients

CDE’s Breakthrough Therapie Designation

CDE’s Breakthrough Therapy Designation is intended to accelerate the clinical development and clinical evaluation of new drugs that offer significant clinical benefits. Breakthrough therapy is a treatment that provides effective treatment for serious, life-threatening conditions. It must also demonstrate significant improvement over existing therapies. The CDE says that the breakthrough therapy designation allows for CDE guidance and discussion regarding clinical trials and strategy development, as well as priority review.

About JAB-21822

JAB-21822 was an oral, small-molecule KRAS G12C inhibitor that the Company independently developed. A number of Phase I/II clinical studies have been initiated by the Company. China, The United States Europe Patients with KRAS G12C mutations and advanced solid tumors. Includes pivotal clinical trial to treat NSCLC ChinaMonotherapy for STK11 comutated NSCLC in front-line settings; combination therapy SHP2 Cetuximab, anti-PD-1 monoclonal anti-PD-1 antibody inhibitor JAB-33112 and JAB-33112.

Jacobio Pharma

Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people’s health. Our pipeline focuses on novel molecular targets for six major signalling pathways, including KRAS, immune checkpoints and tumor metabolism, P53 and RB, as well as MYC. We want our key projects to rank among the top 3 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

Forward-looking statements in this news release could contain statements that involve significant risks and uncertainties. These forward-looking statements can be identified using the words “anticipate”, believe”, estimate”, “estimate”,” expect”, “intend”, and similar expressions as they relate with the Company. These forward-looking statements will not be regularly updated by the Company.

These forward-looking statements reflect the current beliefs, assumptions and expectations of the Company regarding future events. These statements cannot be relied upon as a guarantee of future developments. There are risks, uncertainties, and other factors that are outside the Company’s control. Some of these factors are hard to predict. Therefore, future developments and changes that may occur in our business, the Company’s competitive environment and other factors could lead to actual results being materially different from the forward-looking information. China.

The Company, its Directors and employees assume no obligation to update or correct forward-looking statements on this site. They also assume no liability if any forward-looking statement does not materialize.

 

Download multimedia from original content:https://www.prnewswire.com/news-releases/jacobios-kras-g12c-inhibitor-jab-21822-was-granted-breakthrough-therapy-designations-by-china-cde-301704804.html

SOURCE Jacobio Pharma