Search Results for “immune” – Page 37 – media

Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
- 151
- March 5, 2024
‘Top-down’ treatment strategy dramatically improves outcomes for Crohn’s patients

Researchers from the University of Cambridge have revealed a ‘top-down’ treatment strategy involving Janssen’s Remicade (infliximab) straight after diagnosis significantly improved outcomes for patients with Crohn’s disease. Affecting around one in 350 people in the UK, Crohn’s disease is a life-long condition caused by inflammation of the digestive tract, which can lead to flares of inflammation and progressive bowel disease damage as the condition worsens. Sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with support from the National Institute for Health and Care Research (NIHR), the PROFILE trial recruited 386 Crohn’s disease patients from 40 hospitals across the UK. Despite the biomarker not proving useful in selecting treatments for individual patients, patients were randomly assigned to one of two treatment groups, which were given a different treatment strategy: ‘accelerated step-up’ or ‘top-down’. The accelerated step-up group treatment approach involved patients starting Remicade if their disease ...
- Source: drugdu
- 136
- March 2, 2024
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA

Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA)，bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
- Source: drugdu
- 139
- March 2, 2024
AstraZeneca’s “CD19/CD3 dual antibody” receives clinical approval in China

According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
- Source: drugdu
- 98
- March 2, 2024
Hengrui Pharmaceuticals’ PD-L1 Inhibitor Adebelizumab Combined with HER2 ADC SHR-A1811 Approved for Breast Cancer Clinical Treatment

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved by the State Drug Administration, which authorizes the company to carry out the clinical trial of adelberizumab in combination with SHR-A1811 for the treatment of breast cancer. According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is the most common malignant tumor in women. Statistics show that in 2020, there were about 2.26 million newly diagnosed cases of female breast cancer and 685,000 deaths worldwide, ranking first in female malignant tumor morbidity and mortality. The incidence and mortality rates of breast cancer worldwide vary according to regional distribution. In China, the 2020 China Cancer data show that the incidence rate of breast ...
- Source: drugdu
- 137
- February 29, 2024
Qyuns Therapeutics passed the IPO hearing on the Main Board of the Hong Kong Stock Exchange

According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon. It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases. According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, ...
- Source: drugdu
- 100
- February 28, 2024
TransThera initiates IND-Enabling studies for TT-02332, a novel, highly potent and CNS-penetrating NLRP3 inhibitor

NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ — TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLRP3 inflammasome inhibitor. The NLRP3 inflammasome is a pivotal component of the human innate immune system. Aberrant activation of NLRP3 is strongly linked with a variety of inflammatory disorders, including obesity, neurodegenerative diseases, NASH, inflammatory bowel disease (IBD), dermatitis, and atherosclerosis. “Immuno-inflammation is one of TransThera’s key therapeutic areas of interest. Over the past three years, we have achieved breakthroughs with the NLRP3 inhibitor program.” said Jennifer Sheng, Vice President of Biology at TransThera. “Our clinical candidate compound TT-02332 is a highly potent NLRP3 inhibitor that has shown promising efficacy in a number of disease-relevant in vivo animal models. The compound exhibits desirable pharmacokinetic/ pharmacodynamic (PK/PD) properties, suitable for once-daily dosing. TT-02332 demonstrates an ...
- Source: drugdu
- 140
- February 28, 2024
Simple Blood Test Quickly and Accurately Diagnoses Potentially Life-Threatening Inflammatory Disease

Sarcoidosis, a chronic inflammatory condition characterized by small lumps known as granulomas in the lungs and other organs, remains a medical mystery with its exact cause yet to be understood. Current theories suggest it might be an immune disorder triggered by specific antigens, usually foreign substances that provoke an immune response. Diagnosing sarcoidosis is currently a complex process that typically involves tissue removal and testing, accompanied by additional screenings to exclude other conditions like tuberculosis or lung cancer. Now, researchers have developed a tool that uses a simple blood test to rapidly and inexpensively diagnose sarcoidosis, potentially reducing the need for more invasive diagnostic techniques presently used to detect the disease. In a research project supported by the National Institutes of Health (NIH, Bethesda, MD, USA), researchers at Wayne State University (Detroit, MI, USA) set out to identify antigens and determine which might be linked to sarcoidosis. They collected lung ...
- Source: drugdu
- 197
- February 26, 2024
State-Of-The Art Techniques to Probe Bacterial Cause Of Deadly Strep A Infections

Annually, a staggering half a million people, including numerous children and young individuals, succumb to serious infections caused by the group A streptococcal (Strep A) bacteria globally. Strep A is highly transmissible and spreads from person to person mostly via the respiratory route from sore throats. Strep A is typically known for causing sore throats and skin infections in younger children. However, both groups are very susceptible to the invasive form of the infection. In rare cases, it can lead to more severe conditions like sepsis and toxic shock if the bacteria invade the bloodstream or tissue. A particularly alarming consequence of repeated Strep A infections is the autoimmune-induced damage to heart valves, termed rheumatic heart disease (RHD). RHD affects approximately 50 million people worldwide, predominantly in middle- and low-income countries. Currently, there is no vaccine available for Strep A. The development of immunity to Strep A over time, including ...
- Source: drugdu
- 162
- February 26, 2024
Zhuohe Pharmaceutical’s “Category 1.1 innovative traditional Chinese medicine” was approved for marketing

On February 21, the National Medical Product Administration approved the marketing application pf the innovative traditional Chinese medicine Category 1.1 drug Jiuwei Cough Oral Liquid applied by Zhuohe Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Zhuohe Pharmaceutical”). According to the NMPA official website, a randomized, double-blind, placebo and active drug parallel controlled multi-center clinical trial has been conducted. The results show that in terms of the main efficacy indicators: cough disappearance rate and cough disappearance time the test group is better than the placebo group and non-inferior to the positive drug group. This medicine is used for relieving lungs and cough, acute tracheobronchitis and cough that belongs to wind-heat syndrome according to traditional Chinese medicine. The launch of this drug provides more treatment option for patients with acute tracheobronchitis cough. Anti-rheumatic, anti-tumor… According to Zhuohe Pharmaceutical’s public information, the company has professional R&D and innovation capabilities in multiple disciplines ...
- Source: drugdu
- 149
- February 26, 2024

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