Search Results for “immune” – Page 38 – media

Innovent and ImmVirX Enter into Clinical Trial Collaboration to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers

ROCKVILLE, M.D. and SUZHOU, China, February 21，2024 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that it has entered into a clinical trial collaboration and supply agreement with ImmVirX Pty Limited (“ImmVirX”) to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT® (sintilimab injection), the Chinese market-leading anti-PD-1 inhibitor. ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) of intratumoral IVX037 in Australia. Initial results from Part 1a of the trial indicate that multiple injections of IVX037 have been well tolerated and show early signs of inducing potentially beneficial inflammatory cytokines/chemokines, such as CXCL10, with antitumor activity observed in the injected lesions of some subjects. Part 1b of the trial, set to begin in mid-2024, evaluates the anticancer activity ...
- Source: drugdu
- 159
- February 26, 2024
Novel Immunoassays Enable Early Diagnosis of Antiphospholipid Syndrome

Antiphospholipid syndrome (APS) is an autoimmune disorder that typically presents as venous or arterial thrombosis and/or pregnancy loss. Diagnosing APS can be difficult as its symptoms often resemble those of other diseases. Prompt diagnosis is essential to avoid complications, unnecessary medical procedures, and escalating healthcare costs. Now, a new pair of reagents can enable early diagnosis of APS, one of the hard-to-diagnose autoimmune diseases. Werfen’s (Barcelona, Spain) Aptiva APS Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents are immunoassays that utilize Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. They serve as a diagnostic aid for both primary and secondary APS, in conjunction with other laboratory findings. The Aptiva system is a fully automated, multi-analyte system, representing the latest advancement in high throughput analyzers for autoimmunity and immunology laboratories. Utilizing ...
- Source: drugdu
- 92
- February 24, 2024
Bavarian Nordic Hones Infectious Disease Focus by Dropping Cancer Vaccine R&D

Bavarian Nordic will concentrate on its portfolio and pipeline of infectious diseases vaccines, including top seller Jynneos, approved for mpox and smallpox. The company only had one clinical-stage cancer vaccine program. By FRANK VINLUAN The mpox outbreak is a memory, but Bavarian Nordic, maker of the only FDA-approved vaccine for the pathogen behind this viral infection, turned skyrocketing demand for its product into record revenue. With that growth comes a need to focus, and the pure-play vaccines company is getting out of the business of developing vaccines for cancer. Bavarian Nordic’s lone cancer vaccine candidate, TAEK-VAC, had reached Phase 1 testing as a potential treatment for chordoma or HER2-positive breast cancer. But this program had also reached the point where further investment is needed, and Bavarian Nordic decided it needs to focus its R&D efforts on infectious disease, the Denmark-based company said Wednesday in its announcement of preliminary 2023 financial ...
- Source: drugdu
- 159
- February 23, 2024
Innovent Announces Primary Endpoint Met in the Phase 3 Clinical Trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in Treating Thyroid Eye Disease and Plans to Submit NDA to the NMPA

ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye ...
- Source: drugdu
- 181
- February 23, 2024
Pfizer’s Velsipity granted EC approval for ulcerative colitis in patients aged from 16 years

Pfizer’s S1P receptor modulator Velsipity (etrasimod) has been approved by the European Commission (EC) to treat moderately-to-severely active ulcerative colitis (UC) in patients aged 16 years and older. Those eligible for the drug, which is now the first and only oral advanced UC therapy approved in the EU for this patient population, will have had an inadequate response, lost response or been intolerant to conventional therapy or a biological agent. Affecting approximately 2.6 million people in Europe, UC is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as frequent diarrhoea, bowel urgency, rectal bleeding, abdominal pain, fatigue, fever and anaemia. The EC’s decision on Velsipity follows a recommendation from the European Medicines Agency’s human medicines committee in December and was supported by positive results from the late-stage ELEVATE UC registrational programme. The ELEVATE UC 52 and ELEVATE UC 12 studies, which evaluated Velsipity 2mg ...
- Source: drugdu
- 111
- February 23, 2024
Kangpu Biopharmaceuticals to Present Preclinical Efficacy Data of KPG-818 in Crohn’s Disease at the 19th Congress of ECCO (IND Application for Phase II in Progress)

HEFEI, China, Feb. 20, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced that a poster on preclinical efficacy data of KPG-818 in Crohn’s disease will be presented at the upcoming 19th Congress of European Crohn’s and Colitis Organisation (ECCO), taking place in Stockholm, Sweden, February 21-24, 2024. Poster Title: Therapeutic Effects of KPG-818 in a Trinitrobenzene Sulfonic Acid-Induced Mouse Crohn’s/Ulcerative Colitis Model Abstract Number: EC24-0844 Exhibition Zone: Poster Exhibition, Hall A Presentation Number: P131 Crohn’s disease is a chronic and difficult-to-treat autoimmune disorder. The current available therapeutic options for this condition are very limited, and there remain significant unmet medical needs. In preclinical studies, KPG-818 demonstrated potent therapeutic efficacy in mouse model of Crohn’s disease. KPG-818 significantly improved clinical symptoms, colorectitis, ulcers, and local immune ...
- Source: drugdu
- 121
- February 23, 2024
Adverse Event Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. By FRANK VINLUAN Rapt Therapeutics aim to bring patients oral alternatives to injectable or infused immunology medications has hit a setback. A Rapt drug candidate in mid-stage clinical development in atopic dermatitis and asthma has been placed under an FDA clinical hold after a serious adverse event reported in a study participant, the company announced Tuesday. The patient, a participant in the atopic dermatitis study, experienced liver failure. According to Rapt, the cause of the liver failure is unknown but has been characterized as potentially related to the company’s experimental drug, zelnecirnon. South San Francisco-based Rapt said the FDA verbally notified the ...
- Source: drugdu
- 157
- February 22, 2024
Recombinant Herpes Zoster Vaccine Independently Developed by Shanghai Institutes for Biological Products of China Receives Clinical Trial Approval Notice

On February 20, the recombinant herpes zoster vaccine, a Class I new drug independently developed by Shanghai Institutes for Biological Products of China, received a notice of approval for clinical trial from the State Drug Administration. Herpes zoster is a common viral infectious disease caused by the reactivation of varicella-zoster virus latent in the human sensory ganglia, with severe nerve pain and skin herpes as the main symptoms. According to relevant data, there are about 1.56 million new cases of herpes zoster in people aged 50 years and above every year in China. Herpes zoster and its complications seriously affect the work and life of patients. Vaccination against herpes zoster is an important measure for the prevention of herpes zoster and postherpetic neuralgia, but at present there are limited varieties of herpes zoster vaccine available in China. Shanghai Institutes for Biological Products (SIBI) has independently developed a recombinant herpes zoster ...
- Source: drugdu
- 89
- February 22, 2024
Hengrui Medical made a new breakthrough in the field of medical nuclide preparation and successfully prepared 64Cu in batch.

Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
- Source: drugdu
- 135
- February 22, 2024
FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight ...
- Source: drugdu
- 155
- February 21, 2024

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