Stapokibart

CHENGDU, China , Aug. 27, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced its interim results for the first half of 2024, along with a corporate update. Rapid development of our pipeline products Stapokibart (CM310) (IL-4Rα antibody) In June 2024, the long-term efficacy and safety data from the Phase III clinical trial of Stapokibart injection for the treatment of moderate-to-severe AD were presented by way of oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. The study showed that at week 52, the rates of achieving EASI-75 and EASI-90 for the Stapokibart group was 92.5% and 77.1%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline was 67.3%. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. In terms of safety, Stapokibart was safe and well-tolerated after 52 weeks of administration, with safety profiles consistent with those observed at week 16 and no new safety signals identified. Advanced and completed the 52-week treatment and safety follow-up of the Phase III clinical study of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in the first half of 2024. In June 2024, the new drug application of Stapokibart injection for the treatment of CRSwNP was accepted by the NMPA and granted priority review. Advanced and completed the unblinding of data and the statistical analysis of the Phase III clinical study of Stapokibart injection for the treatment of seasonal allergic rhinitis (SAR) in the first half of 2024, with the clinical data meeting the primary endpoints. In April 2024, the new drug application of Stapokibart injection for the treatment of SAR was accepted by the NMPA. Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in adolescent subjects with moderate-to-severe AD in February 2024. Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in prurigo nodularis subjects in May 2024. Our partner CSPC initiated the critical Phase II/III clinical study for the treatment of moderate-to-severe asthma and moderate-to-severe COPD. CMG901/AZD0901 (Claudin 18.2 ADC) As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901 (AZD0901) for the treatment of advanced solid tumors. Among these, an international multi-center Phase III study comparing CMG901 (AZD0901) monotherapy versus investigator's choice as second-line or later-line treatment in patients with advanced or metastatic gastric and gastroesophageal junction (G/GEJ) cancer expressing Claudin 18.2 was publicly announced on the drug clinical trial registration and information publicity platform in March 2024. The first patient has received the initial dose in April 2024. In June 2024, the latest data from a Phase I clinical study of CMG901 (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. The study results indicated that as of February 2024, among 89 evaluable patients with Claudin 18.2-high expressing (defined as Claudin 18.2 membrane intensity ≥2+ in ≥20% of tumor cells) G/GEJ cancer in three cohorts, confirmed objective response rate (ORR) and confirmed disease control rate (DCR) were 35% and 70%, respectively. In the 2.2 mg/kg dose group, the confirmed ORR was 48%. The median progression free survival (mPFS) for all 93 patients with Claudin 18.2-high expressing G/GEJ cancer was 4.8 months, and the median overall survival (mOS) was 11.8 months. CM313 (CD38 antibody) Continued to advance a multi-center, open-label, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM313 injection in patients with RRMM, lymphoma, and other hematological malignancies. Continuously proceeded with a randomized, double-blinded, placebo-controlled, dose-escalation, multiple-dose Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with SLE. In June 2024, a research paper titled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" was published in The New England Journal of Medicine. This is an investigator-initiated, single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of CM313 in adult patients with primary immune thrombocytopenia. The results showed that 95.5% of patients (21/22) achieved a platelet count of ≥50 × 109/L within 8 weeks upon the first acceptance of CM313 infusion, with a median cumulative duration for a platelet count of ≥50 × 109/L of 23 weeks (interquartile range: 17-24). Additionally, the durable platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6% (14/22). In June 2024, we have submitted an IND application to further assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313 in patients with primary immune thrombocytopenia. CM326 (TSLP antibody) In May 2024, we initiated a randomized, double-blinded, placebo-parallel Phase II clinical study to evaluate the efficacy and safety of CM326 in patients with CRSwNP, further exploring the optimal dosage. Our partner CSPC initiated the Phase II clinical study for the treatment of moderate-to-severe asthma. CM355/ICP-B02 (CD20xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical trial in the first half of 2024 to assess the safety, tolerability, pharmacokinetics, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin's lymphoma (NHL). As of the date of this announcement, dose escalation of the intravenous infusion formulation (IV) was completed and the subcutaneous formulation (SC) is in the process of patient evaluation. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, and the anti-tumor activity of CM336 in RRMM. CM350 (GPC3xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM350 in patients with advanced solid tumors. CM369/ICP-B05 (CCR8 antibody) Continuously proceeded with a Phase I clinical study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL. CM383 (Aβ protofibrils antibody) Initiated a Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single dose-escalation administration of CM383 in healthy subjects. The enrollment of the first subject was completed in June 2024. CM380 (GPRC5DxCD3 bispecific antibody) Submitted IND application, and planned to conduct a multi-center, open-label Phase I/II clinical study for evaluation of CM380 in treatment of patients with relapsed or refractory multiple myeloma. Financial and Business Highlights Actively carry out the out-licensing collaboration In July 2024, Chengdu Keymed and Belenos entered into an out-license agreement, which grants Belenos an exclusive right to develop, manufacture and commercialize the Group's drug candidates, CM512 and CM536, globally excluding the Greater China region. In return, Chengdu Keymed shall receive an upfront and nearterm payment of US$15 million, and iBridge HK Holdings Limited, a wholly-owned subsidiary of the Group, shall receive approximately 30.01% of the equity interest in Belenos as consideration. Subject to achievement of certain development, regulatory and commercial milestones, Chengdu Keymed may also receive additional payments of up to US$170 million. Chengdu Keymed is also entitled to receive tiered royalties from Belenos on net sales for a specified period of time commencing after the first commercial sale of CM512 and CM536. Expand manufacturing capacity and efficiently prepare for commercialization We continue to recruit talents to meet the growing needs of commercialization, research and development, clinical, production and operation of the Company. We further expanded our cGMP-compliant manufacturing capacity, efficiently prepared for the company to become a commercial organization. As of the date of this announcement, the production capacity of our production base has reached 18,600 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Financial highlights As of June 30, 2024, the Company held cash (including bank wealth management products) of RMB 2.58 billion. R&D expenses of the Group increased by RMB 81 million to RMB 331 million, from RMB 250 million for the six months ended June 30, 2023. During the Reporting Period, the Group's revenue amounted to RMB 54.6 million, mainly consisted of the 1st milestone revenue from AZ on the CMG901 license transaction. SOURCE Keymed

CHENGDU, China, June 2, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced the long-term efficacy and safety data of a Phase III clinical trial of stapokibart injection in patients with moderate-to-severe atopic dermatitis (AD) has been released by way of oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. The data of long-term treatment with stapokibart demonstrated sustained efficacy and favorable safety profile in adult patients with moderate-to-severe AD, and no new safety signals were observed. This multicenter, randomized, double-blind, placebo-controlled phase III trial was designed to assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of stapokibart in patients with moderate-to-severe AD. A total of 476 patients entered the maintenance treatment period, with 238 in each group. At week 52, EASI-75 was achieved in 92.5% of patients continuing stapokibart and 88.7% of those switching from placebo to stapokibart, IGA score of 0/1 with a ≥2-point reduction was achieved in 67.3% and 64.2%, respectively; a ≥4-point reduction in weekly average of daily PP-NRS was achieved in 67.3% and 60.5%, respectively. Long-term treatment with stapokibart continuously improved AD symptoms and quality of life of patients with moderate-to-severe AD. Only 1 patient (0.9%) relapsed during the maintenance period. In terms of safety, stapokibart was well-tolerated, and its safety profile over 52 weeks was consistent with the initial 16-week double-blind period, with no new safety signals identified. During the double-blind treatment period, a total of 500 adult patients with moderate-to-severe AD were randomized 1:1 to receive stapokibart 300 mg (loading dose: 600 mg) or placebo every 2 weeks for 16 weeks. In the subsequent 36- week maintenance treatment period, patients in the stapokibart group continued the same dose, and patients switching from placebo to stapokibart received stapokibart 300 mg (loading dose: 600 mg) every 2 weeks. Concomitant use of topical medications for AD treatment was permitted during the maintenance treatment period. The co-primary endpoints of this trial were the proportions of patients achieving ≥75% improvement from baseline in Eczema Area and Severity Index score (EASI-75) and an Investigator's Global Assessment (IGA) score of 0/1 with a ≥2 point reduction from baseline at week 16. Other efficacy indicators included EASI score, IGA score, and Peak Pruritus Numerical Rating Scale (PP-NRS), etc. About Stapokibart Stapokibart (CM310) is a highly efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and is the first domestically manufactured IL-4Rα antibody drug receiving clinical trial approval from the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two key cytokines that trigger type 2 inflammation. Stapokibart has shown a good safety profile and encouraging efficacy in a number of previous clinical trials, and its new drug application for the treatment of moderate-to-severe atopic dermatitis in adults was accepted by the NMPA and granted priority review on December 7, 2023. About Keymed Biosciences Inc. Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies. For more information, please visit . SOURCE Keymed