Keymed Biosciences | The Latest Results from the Phase Ia Clinical Study of CMG901 was presented at the 2023 ASCO GI CANCERS SYMPOSIUM

CHENGDU,China,Jan. 18,2023 -- Keymed Biosciences Inc. (Stock Code: 02162 HK) is pleased to announce that the latest data from the Phase Ia dose-escalation trial of CMG901 (Claudin 18.2 antibody drug conjugate),a novel drug candidate,for advanced solid tumors will be presented as a poster at the 2023 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (2023 ASCO GI).

Poster Title：A Phase 1a dose-escalation,multicenter trial of anti-claudin 18.2 antibody drug conjugate CMG901 in patients with resistant/ refractory solid tumors

Abstract #：352

Poster Bd #：E13

Abstract Presenter：Rui-hua Xu,Department of Medical Oncology,Sun Yat-sen University Cancer Center

This Phase Ia trial (NCT04805307) was designed to evaluate the safety,tolerability,pharmacokinetics,immunogenicity,and preliminary anti-tumor activity of CMG901 in patients with advanced solid tumors. During the dose-escalation phase,Claudin 18.2 expression was retrospectively tested by the central lab.

As of August 4,2022,totally 27 patients (13 gastric/gastroesophageal junction (gastric/GEJ) cancer and 14 pancreatic cancer patients) were enrolled in the Phase Ia clinical study of CMG901. The results showed that CMG901 was well-tolerated with a favorable safety profile. Drug-related grade ≥3 adverse events (AEs) occurred in 3/27 (11.1%) patients. No drug-related grade ≥4 AEs were reported. Patients received CMG901 at dose levels up to 3.4 mg/kg,and maximum tolerated dose (MTD) was not reached. One patient in the 2.2 mg/kg cohort developed a dose-limiting toxicity.

Preliminary efficacy results demonstrated that in the 8 Claudin 18.2-positive gastric/GEJ cancer patients receiving CMG901,objective response rate (ORR) and disease control rate (DCR) were 75.0% and 100%,respectively,with ORR of 100% in the 2.6,3.0,and 3.4 mg/kg cohorts. Median progression free survival (mPFS) and median overall survival (mOS) were not reached yet.

Efficacy of CMG901 in CLDN18.2-positive Gastric/GEJ Cancer (N=8)

ORR#

75.0% (6/8)

DCR*

100% (8/8)

Median PFS,day

NR&

Median OS,day

NR&

# Proportion with complete response (CR) + partial response(PR)

* Proportion with CR+PR+stable disease

&mPFS and mOS were not reached.

CMG901 showed a favorable safety and tolerability profile in this trial. CMG901 at doses of ≥1.8 mg/kg yielded encouraging anti-tumor activity in patients with Claudin 18.2-positive gastric/GEJ cancer.

ABOUT KYM901

KYM901 is a first-in-human Phase I trial evaluating the safety,and preliminary anti-tumor activity of CMG901 in patients with advanced solid tumors who had failed to respond to standard of care or had no available standard of care regimen. KYM901 comprises modified dose escalation part (Phase Ia) and dose-expansion part (Phase Ib). Patients enrolled in Phase Ia are not required to be positive for Claudin 18.2 expression,whereas Claudin 18.2 positivity tested by the central lab was required for patient entry into the Phase Ib trial.

ABOUT CMG901

CMG901,a novel recombinant humanized monoclonal antibody drug conjugate targeting Claudin 18.2,has been approved for clinical trials in both China and the United States. CMG901 consists of an anti-Claudin 18.2 monoclonal antibody,a protease-degradable linker,and a cytotoxic small molecule monomethyl auristatin E (MMAE). Enrollment of patients with solid tumors in Phase I dose-escalation trial of CMG901 was completed in the first half of 2022. Furthermore,Phase I dose-expansion trial of CMG901 in patients with solid tumors in China is simultaneously initiated since the second quarter of 2022.

About Keymed Biosciences

Keymed Biosciences Inc. (Stock Code: 02162 HK) focuses on the urgent unmet clinical needs,and is committed to providing high-quality,affordable,innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts from world-renowned universities who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. The core leadership team includes the inventors of the first PD-1 antibody drugs that were pioneered and approved in the United States and China. The Company was listed on the main board of Hong Kong Stock Exchange on July 8,2021.

For more information,please visit www.Keymedbio.com.

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