Keymed Biosciences Announces Interim Results for First Half of 2024
PR Newswire
CHENGDU, China, Aug. 27, 2024
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-4R<ALPHA> 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 $(ORR.AU)$
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 (A<BETA> 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
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August 27, 2024 09:10 ET (13:10 GMT)
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