SinoMab BioScience preclinical results of SM17 on atopic dermatitis (AD) published on International Scientific Journal Allergy
HONG KONG, Apr 16, 2024 – (ACN Newswire) – SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialisation of therapeutics for the treatment of immunological diseases, is pleased to announce that the preclinical works of SM17, a humanised IgG4 monoclonal antibody against IL-17RB, is published on Allergy, an official journal of the European Academy of Allergy and Clinical Immunology (EAACI), on 9 April, 2024. This article compared the efficacy of SM17 in alleviating symptoms of atopic dermatitis (AD) with that of FDA approved JAK1 inhibitor in a preclinical setting (animal data), and confirmed that animals treated with SM17 exhibited a similar, if not better, therapeutic responses than those treated with the FDA approved JAK1 inhibitor. The publication in this international, peer-reviewed and well-cited journal Allergy establishes the scientific validity of SM17 on the treatment of AD, and highlights the potential of SM17 as a revolutionary product in this field.
SM17 is a novel, first-in-class (FIC) IgG4 monoclonal antibody targeting IL-17RB (also known as interleukin 25 (IL-25) receptor) with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological and autoimmune disorders. In Phase I clinical trials (NCT05332834) performed in the US, SM17 showed a good safety profile with no drug-related serious adverse event (SAE) reported, demonstrating superiority over other JAK1 inhibitor in safety and tolerability.
AD is a chronic inflammatory skin disease that is characterised by intense itching and recurrent blisters. AD patients are known to have low treatment satisfaction and there exists a huge unmet medical need for a safer and more efficacious treatment option. AD is driven by Th2 immunity where IL-25 is one of the key mediators that drives the whole cascade of events leading to ILC2 and Th2 cell activation, resulting in inflammatory skin swelling, itching, skin irritation and other symptoms characteristic of AD. The Company has developed SM17, a IgG4 monoclonal antibody, that targets a co-receptor for IL-25 (also known as IL-17RB), with the purpose of blocking the early (upstream) events induced by IL-25, in the hope of achieving a differentiating treatment modality for AD that is fast-acting, efficacious and safe. Current products in the market are either fast-acting and efficacious but with safety concerns (JAK1 inhibitor) or relatively slow to respond and less efficacious yet with better safety profile (anti-IL-4Ra antibody). The Allergy article and the results of the US Phase I study scientifically validated the favourable efficacies and good safety profile of SM17 for treating AD.
In addition to AD, SM17 is found to exhibit therapeutic potentials for treating asthma, idiopathic pulmonary fibrosis and other type 2 immunological disorders. Studies to explore the therapeutic potential of these indications are on-going.
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “SinoMab focuses on the development of innovative products through scientific excellence, with the goal of identifying differentiating products that address immunological diseases of unmet medical needs. We are pleased that evidence demonstrating the advantageous therapeutic potential of SM17 for treating AD is scientifically confirmed and endorsed by being published on the renowned peer-reviewed journal Allergy. The global market size for AD is estimated to reach US 27.68 billion by 2030, according to a new report by Grand View Research, Inc. Currently, the two most prescribed products for AD are the FDA approved anti-IL-4Ra antibody and JAK1 inhibitor. Studies indicated that JAK1 inhibitor is comparatively faster acting and achieving better response than anti-IL-4Ra antibody. However, JAK1 inhibitor has a black box warning, making anti-IL-4Ra antibody more receptive in the medical community due to its better safety profile. Our results indicated that SM17 appeared to have the best of both worlds: SM17 is comparable to (if not better than) JAK1 inhibitor in “time to response (anti-itching)”(unpublished data), and “therapeutic efficacies” in a preclinical model, as illustrated in the Allergy article, and comparable to (if not better than) anti-IL-4Ra antibody in tolerability and safety as demonstrated in our US Phase I study. SM17 is an innovative product with differentiating therapeutic and safety properties that compete favourably with existing treatment options. The preclinical results will be confirmed in human in a proof of concept clinical trial in AD patients that was initiated in April 2024.”
About SinoMab BioScience Limited
SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company’s flagship product SM03 (Suciraslimab) is a potential global first-in-class mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer’s disease, systemic lupus erythematosus (SLE), pemphigus, multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), asthma, and other diseases with major unmet clinical needs.
About Allergy
Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI), aims to advance, impact and communicate all aspects of the discipline of Allergy/Immunology including educational, basic, translational and clinical research and maintain contact between basic and clinical Allergy/Immunology.
Allergy is an international journal with contributors and readers from all countries. Allergy publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors and correspondences.
For more information about SM17, please read the published article on Allergy.
Link http://doi.org/10.1111/all.16120
This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact:
Financial PR (HK) Limited
|
Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Amy Yang |
||
|
Email: |
sinomab@financialpr.hk |
|
|
Tel: |
(852) 2610 0846 |
Fax: (852) 2610 0842 |
Topic: Press release summary
SinoMab Announces that IND Application of SM17 for the Treatment of Asthma was Approved by NAMP
A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases- SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), is pleased to announce that the Investigational New Drug (“IND”) application, for the treatment of patients with asthma for the Company’s First-in-Class (FIC) therapeutic product SM17, was approved by the National Medical Products Administration of China (the “NMPA”) on 11 August 2023. The Company plans to conduct a Phase I clinical study in China soon to investigate the safety profile of SM17 in Chinese population and to initiate the clinical development program of SM17 for the treatment of allergic diseases.
SM17 is a novel, first-in-class, humanized, IgG4-k monoclonal antibody which is capable of modulating Type II allergic reaction by targeting the receptor of a critical “alarmin” molecule interleukin 25 (IL-25). SM17 could suppress Th2 immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s), and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by IL-25, and suppressing the release of the downstream Th2 cytokines such asIL-4, IL-5 and IL-13. IL-25 is a critical cytokine classified as “alarmin”, which has shown to be implicated in the pathogenesis of multiple airway viral responses and allergic diseases, such as asthma. Patients with severe, uncontrolled asthma are at risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality and morbidity, diminished quality of life and increased health expenditures.
Meanwhile, the Company is also advancing the Phase I clinical study of SM17 in the U.S. at full speed. Based on the current progress, the Company expects to complete the Phase I clinical study by the end of this year, half a year ahead of the anticipated completion date. As early as March 2022, SM17’s IND application for the treatment of asthma was approved by the U.S. Food and Drug Administration (“FDA”), and the first healthy subject had been successfully dosed in a Phase I clinical First-in-Human(FIH) clinical trial in June 2022. As of today, none of the subjects reported a serious adverse event.
As a new pathway for asthma treatment, therapy targeting the upstream mediators of the Th2 inflammatory cascade pathway, such as “alarmin”, is expected to have a broad effect on airway inflammation. This is expected to lead to more effective control of asthma symptoms and an improvement in disease conditions compared to existing therapies. This has also been validated in the clinical trial of SM17.
The potential first-in-target antibody of SM17 has demonstrated the potential efficacy for multiple indications, including asthma and IPF (Idiopathic Pulmonary Fibrosis). The above unique mechanism enables SM17 to cover more diversified indications, which can not only target indications with huge market size such as asthma and atopic dermatitis, but also treat diseases with high mortality rate such as IPF, and continuously expand its indication coverage. Compared with other currently approved therapeutic antibody drugs targeting ILC2s downstream pathway, SM17 has a differentiated advantage at the source.
As one of the global pandemics, asthma has caused social problems, with huge and urgent medical needs that cannot be ignored. The number of asthma patients worldwide is increasing year by year, and a large patient base is in urgent need of effective therapeutic drugs to alleviate unmet medical needs. According to the Frost & Sullivan Report, the number of asthma patients worldwide is expected to increase to approximately 860 million in 2030, of which the number of asthma patients in China will increase to 78.1 million which is higher than the global growth rate. The Company expects that targeting upstream mediators of the Th2 inflammatory cascade, such as the receptor for IL-25, will have a broad effect on airway inflammation, which is expected to provide a new therapeutic channel with efficacy and safety for asthma diseases and bring relief and treatment to asthma patients.
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “SM17’s IND application for the treatment of asthma has been approved three months after it was accepted by the NMPA, which demonstrates that the efficient execution of the Company’s new drug R&D program is well recognized by the NMPA, and also fully reflects the huge potential of SM17 in unmet medical needs for asthma treatment. We are confident in the huge clinical development and commercialization prospects of SM17, and will accelerate the progress of clinical trials and strive to achieve commercial business as soon as possible in the future. At the same time, we continue to expand the scope of indications so that new treatment options can benefit more Chinese patients in the future. The Company will continue to focus on autoimmune diseases, and spare no effort to provide more effective treatment options for Chinese and global patients with abundant technical reserves and strong innovation capabilities.”
About SinoMab BioScience Limited
SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer’s disease, systemic lupus erythematosus (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact:
Financial PR (HK) Limited
Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Willa Xue
Email: sinomab@financialpr.hk
Tel: (852) 2610 0846
Fax: (852) 2610 0842
Topic: Press release summary
SinoMab Submits another IND Application for SM17 for the Treatment of Atopic Dermatitis, Which was Accepted by NMPA CDE
A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases – SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), is pleased to announce that an Investigational New Drug application (“IND”) for SM17, a humanised anti-IL-17RB monoclonal antibody for injection, for atopic dermatitis (“AD”) , has been filed with and accepted by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration of China (“NMPA”). The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of AD.
SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB, which is a global first-in-class monoclonal antibody drug targeting IL-17BR with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological disorders. The IND is mainly for the treatment of AD, and the Company will initiate a Phase I clinical study in China upon approval of the present IND.
SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s) and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as “alarmin”, which has shown to be implicated in the pathogenesis of autoimmune and inflammatory skin diseases, especially for AD. Around the globe, about one-fifth of the population were affected by AD at a certain stage of life, especially during the period of children. The condition is extremely volatile and can be difficult to be totally cured. It significantly reduces the quality of life of patients, and requires highly effective products to make up for unmet medical needs.
As a long-standing chronic disease, new cases of AD are growing rapidly in China with broad market potential. According to Frost & Sullivan, there were approximately 65.7 million AD patients in China in 2019 and is expected to grow to 81.7 million in 2030, and 30% of which will be moderate-to-severe patients. China’s AD medicine market was US$600 million in 2019, and is expected to grow to US$1.5 billion in 2024, and is expected to increase to US$4.3 billion in 2030, indicating a considerable market size. We expect that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB, will have a broad effect on skin inflammation. Coupled with the vast market potential of AD market and the lack of effective treatment methods, it is believed that the research and development of its treatment has market potential.
The Company is also committed to advancing multiple indications studies for SM17, laying a foundation for proof of concept and drug launches. In the United States, as early as March 2022, SM17’s IND application for the treatment of asthma was approved by the U.S. Food and Drug Administration (“FDA”), and the first healthy subject had been successfully dosed in a Phase I clinical First-in-Human(“FIH”) clinical trial in June 2022. Since then, none of the subjects reported a serious adverse event. At present, we are in full steam ahead to accelerate the progress of our clinical study, and expect the Phase I clinical study can be completed by the end of this year, six months ahead of the original anticipated completion date. In China, in addition to the acceptance of the application of SM17 for the treatment of AD, the new drug application for the treatment of asthma was also accepted by NMPA CDE on May 19 this year. If approved, the phase I clinical trial will be accelerated.
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that, “As a global first-in-class humanised IgG4-k monoclonal antibody targeting IL-17RB, SM17 has made good progress in several new drug research with the Company’s proactive progress. The acceptance of the new drug application for SM17 not only helps the Company to carry out the clinical research and development project for the treatment of AD in China, but also reflects the high efficiency of the research and development of new drugs. The Company is confident in the significant clinical trial and commercial development prospects of the new drug of SM17, and expects that the new treatment option will benefit more Chinese patients in the future, to jointly write a new chapter in the treatment of AD. In addition, the Company will continue to insist on independent innovation, strive to improve the research of new drugs, continuously expand the indication population, and provide more effective treatment solutions for patients in China and worldwide with no efforts, with an aim to become a global leader in innovative therapies for immunological diseases.”
About SinoMab BioScience Limited
SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer’s disease, systemic lupus erythematosus (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact:
Financial PR (HK) Limited
Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Cita Zhang / Ms. Willa Xue
Email: sinomab@financialpr.hk
Tel: (852) 2610 0846
Fax: (852) 2610 0842
Topic: Press release summary
SinoMab Announces IND Application of SM17 for the Treatment of Asthma was Accepted by NMPA CDE
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SinoMab Announces Appointment of Mr. Shanchun WANG as the President (China) of the Company
SinoMab BioScience Limited (“SinoMab” or the “Company”, together with its subsidiaries, the “Group”, stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, Mr. Shanchun WANG has been appointed as the President (China) of the Company. Mr. Wang will mainly be responsible for the China operation.
Mr. Shanchun WANG, served as the executive director of Sino Biopharmaceutical Limited (stock code: 1177) and the president of Chia Tai – Tianqing Pharmaceutical Group Co. Ltd., joined SinoMab lately as the President (China) of the Company. Mr. Shanchun WANG has rich experience and practical achievements in corporate strategic management, organizational management, innovation research and development and product commercialization. He is a specialist that granted the special government allowances of the State Council and awarded as a national model worker, a Jiangsu Province Technology Advanced Worker, a Jiangsu Province Model Labour, a winner of the Shanghai Technology Advancement First Honour Award, a Jiangsu Province Outstanding Entrepreneur, a Jiangsu Province Young and Middle-aged Expert with Outstanding Contribution, a Jiangsu Advanced Individual with Outstanding Contribution in Manufacture etc.
Mr. Shanchun WANG said that: “Under the leadership of Dr. Shui On LEUNG, SinoMab has gathered a very strong R&D force, forged a unique B-cell therapeutic platform, and prospectively launched a pipeline with a series of potential key products, with truly internationally recognized original innovation strength. At the same time, SinoMab’s dedication to the field of autoimmune diseases and its vision of growing into a global leader in novel treatments of immunological diseases is highly consistent with the development model of my service enterprises in the past, which is also an important reason why I chose to join SinoMab.”
Dr. Shui On LEUNG said that: “It is a great pleasure to have Mr. Shanchun WANG joining the Company. Our Group has been engaging extensively in the field of autoimmune disease and with the mission of growing into a global leader in the novel treatments of immunological diseases. We have a strong research and development capabilities. Leveraging on our Group’s B-cell therapeutic platform, Alarmins-pathway therapeutic platform and selective T-cell therapeutic platform, the Group has a strategic plan in expanding and diversifying our product pipeline. We believe that Mr. Wang’s rich experience in the pharmaceutical industry for more than 30 years, and as one of the leaders in the biotech industry in China, will help expediting the Company’s development from a global drug research and development enterprise to a biopharmaceutical company bearing commercialization capabilities and international perspective. Mr. Wang’s engagement as the President (China) of the Company while also subscribing shares of the Company also reflects the confidence and commitment of Mr. Wang and our senior management towards the long-term and sustainable growth of the Group, and the continuous support of our senior management will be beneficial to the long-term business development of the Group.”
The Company entered into a subscription agreement with Mr. Wang earlier. Pursuant to the subscription agreement, Mr. Shanchun WANG conditionally agreed to subscribe for and the Company conditionally agreed to allot and issue 14,340,000 subscription shares. This reflects his confidence and commitment towards the long-term and sustainable growth of the Group.
About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Topic: Press release summary
Ads
