Search Results for “immune” – Page 60 – media

Sanofi’s amlitelimab shows promise in phase 2b atopic dermatitis trial

Sanofi has announced positive results from a phase 2b trial of amlitelimab in adults with moderate-to-severe cases of atopic dermatitis, one of the most common inflammatory skin diseases. Typically referred to as eczema, atopic dermatitis affects an estimated 16.5 million adults in the US, with nearly 40% affected by moderate-to-severe cases. The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck. Sanofi’s amlitelimab is an investigational anti-OX40-ligand monoclonal antibody that is designed to rebalance the immune system by blocking inappropriate activation and proliferation of pro-inflammatory effector T cells and promoting expansion of anti-inflammatory regulatory T cells. The company says the candidate “has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders”, including moderate-to-severe atopic dermatitis and asthma. The dose-ranging STREAM-AD study has been evaluating amlitelimab in adult patients ...
- Source: drugdu
- 190
- June 30, 2023
Sanofi’s $1.4B Bet Pays Off with Promising Phase II Eczema Data

By Tristan Manalac https://www.biospace.com/ Pictured: Atopic dermatitis patient scratches their arm/iStock The company announced Tuesday that topline data from the Phase IIb STREAM-AD trial showed that Sanofi’s investigational antibody amlitelimab met the study’s primary outcome and strongly eased symptoms in patients with moderate-to-severe atopic dermatitis. After 16 weeks of treatment, patients in the amlitelimab group saw significant improvements in their average Eczema Area and Severity Index (EASI) scores compared to placebo. Amlitelimab retained its statistical edge over the placebo across all four studied doses. Sanofi’s candidate also cleared the study’s key secondary endpoints, including biomarker measurements, which suggested that amlitelimab had therapeutic effects on both type 2 and non-type 2 inflammatory pathways, according to the company’s news release. Improvements in primary and secondary measures persisted through 24 weeks of follow-up. These Phase IIb results support amlitelimab’s mechanism of action and indicate that “targeting OX40-Ligand has the potential to provide a ...
- Source: drugdu
- 159
- June 29, 2023
Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

Pfizer’s Litfulo (ritlecitinib) has been approved by the US Food and Drug Administration (FDA) as the first treatment option for patients aged 12 years and older with severe alopecia areata. Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body. The condition can develop at any age, with nearly 20% of patients diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, is thought to work by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata. Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options ...
- Source: drugdu
- 120
- June 29, 2023
Global study shows loneliness can shorten life spans

There is an epidemic of loneliness and isolation today, and the consequences can be deadly, researchers say. Folks who reported that they were socially isolated or felt lonely were more likely to die early from all causes including cancer, according to a sweeping review of 90 studies that included more than 2.2 million people from around the globe. Exactly how loneliness or social isolation affects a person’s health and well-being is not fully understood, but many theories exist, the researchers reported. People who are socially isolated or lonely may be less likely to eat a healthy diet and get regular exercise and more likely to smoke and consume alcohol. In addition, social isolation is linked to inflammation and weakened immune systems. People who are socially isolated may be less likely to receive medical care due to their smaller social networks. Social isolation and loneliness are not one and the same, ...
- Source: drugdu
- 105
- June 28, 2023
Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
- Source: drugdu
- 108
- June 27, 2023
Empress Therapeutics emerges with $50m to fund small molecule development

Life sciences venture capital firm Flagship Pioneering has unveiled Empress Therapeutics, a small molecule drug development startup. The Moderna-backed venture fund has launched Empress with a $50m investment. This will support development of its proprietary Chemilogics platform and drug discovery pipeline. So far, Empress claims to have generated 15 drug leads across multiple indications. These span multiple structural classes and target several classes of proteins, including cytokines, enzymes, G protein-coupled receptors (GPCRs), and ion channels. With this pipeline, Empress hopes to address unmet clinical needs in immune and inflammatory conditions, and metabolic, neurologic, oncologic, and pain disorders. The company expects to file multiple IND applications in these areas over the next couple of years. Empress benefits from a wealth of clinical data, and recent advances in genomics, artificial intelligence (AI) and synthetic biology. This allows the company’s platform to read genetic code and use biosynthetic instructions to find, make and ...
- Source: drugdu
- 122
- June 23, 2023
Tessa Therapeutics Hodgkin’s Lymphoma CAR-T therapy shows promising Phase I data

Clinical-stage cell therapy company Tessa Therapeutics have announced positive safety and efficacy data from the trial (NCT04288726 of TT11X, its off-the-shelf CD30.CAR-modified EBVST (Epstein Barr Virus Specific T Cells) therapy in patients with relapsed or refractory (R/R) Hodgkin lymphoma. In tandem with Baylor College of Medicine, Tessa enrolled 18 patients with R/R Hodgkin’s Lymphoma in the trial, all of whom had been heavily pre-treated. Patients were administered with TT11X across four dosing levels, resulting in an overall response rate (ORR) of 78%. Higher doses produced improved clinical response, and no dose-limiting toxicities were observed. Treatment works by utilising highly specialised T-cells able to recognize and kill infected cells, whilst activating the body’s immune system to produce a coordinated response. The company claimed that early trials have demonstrated a strong safety profile and efficacy. TT11X is the lead allogenic cell therapy in Tessa’s planned pipeline of treatments built with its CD30.CAR ...
- Source: drugdu
- 170
- June 20, 2023
Race for universal flu vaccine ramps up as Osivax kicks off Phase IIa trial

France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836. The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs). The developer has tested OVX836 in four completed clinical trials. In a company statement announcing the latest trial kick-off, Osivax said a recently completed separate Phase IIa trial demonstrated that the candidate in combination with QIVs had a good safety profile with no impairment of immune response by the QIVs. The aim of the latest ongoing trial is to evaluate the vaccine in a larger and more diverse population. The company aims to enrol more than 500 participants aged 18-60 across multiple clinical sites in Australia. The OVX836 vaccine targets nucleoprotein – a conserved internal antigen. Internal antigens, unlike surface antigens, have a lower probability of ...
- Source: drugdu
- 103
- June 20, 2023
Scientists develop universal donor stem cell therapy to treat degenerative brain diseases in a preclinical study

Scientists at City of Hope have developed universal donor stem cells that could one day provide lifesaving therapy to children with lethal brain conditions, such as Canavan disease, as well as to people with other degenerative diseases, such as Alzheimer’s and multiple sclerosis. The study was recently published in Advanced Science. “The off-the-shelf approach City of Hope is taking can easily be extended to improve the quality of life of cancer patients who are experiencing cognitive impairment or impaired motor function as a side effect of chemotherapy or radiation,” said Yanhong Shi, Ph.D., chair of the Department of Neurodegenerative Diseases and the Herbert Horvitz Professor in Neuroscience at Beckman Research Institute of City of Hope. Shi has been working on this research for 12 years. This is the first time stem cells have been engineered to become universal donors for cell therapy targeting diseases of the central nervous system, Shi ...
- Source: drugdu
- 139
- June 17, 2023
Valneva Reports Strong Phase III Chikungunya Vaccine Data After Merck’s Exit from Race

By Tristan Manalac Pictured: Syringe pulling vaccine from a vial / Adobe Stock, weyo Data from a Phase III study showed Valneva’s chikungunya vaccine candidate VLA1553 can elicit a strong immune response and could be an effective protective option against the mosquito-borne disease caused by the chikungunya virus, the French company announced Tuesday. This news follows a February 2023 report from Fierce Biotech revealing that Merck had dropped out of the chikungunya race. Citing a company spokesperson, Fierce noted that the decision to discontinue the chikungunya program was part of the company’s “routine pipeline prioritization.” Published Monday in the medical journal The Lancet, Valneva’s double-blinded and randomized Phase III study enrolled more than 4,100 participants who were given either VLA1553 or placebo. In the per-protocol analysis, the investigational shot induced neutralizing antibody titers above the protective threshold in 263 of 266 participants with evaluable findings. This corresponded to a 28-day ...
- Source: drugdu
- 117
- June 15, 2023

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