Search Results for “immune” – Page 32 – media

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.Relapse is common in multiple myeloma, and when it happens, a drug that worked for a patient before might no longer help. Two cell therapies already approved for this cancer may now be used in earlier lines of treatment, a regulatory decision that brings additional choices for patients who have exhausted standard multiple myeloma treatment options. Multiple myeloma is a blood cancer that develops in the plasma cells in bone marrow. The expanded FDA approvals announced Friday cover Abecma, from Bristol Myers Squibb and 2seventy bio, and Carvykti, from Johnson & Johnson and Legend Biotech. Both products are CAR T-therapies made by engineering a patient’s own immune cells to go after BCMA, a protein ...
- Source: drugdu
- 97
- April 10, 2024
Hengrui Adebelizumab, SHR-A1811 Combination Chemotherapy for HER2 Expressing Adenocarcinoma of Gastric or Gastroesophageal Bundle Phase Ib/II Clinical Trial Approved

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. have received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which authorizes to conduct the Phase Ib/II clinical study of Adebelizumab Injection in combination with SHR-A1811 and chemotherapy for HER2-expressing advanced adenocarcinoma of the stomach or the gastroesophageal junction. In 2020, gastric cancer ranked 5th in global cancer incidence and 4th in mortality. Among them, 43.9% of new cases and 48.6% of deaths will occur in China, with 479,000 new cases and 374,000 deaths, both ranking third in China in terms of cancer incidence and mortality. Human Epidermal Growth Factor Receptor (HER2)-positive gastric cancer is a unique subtype of the disease, which requires different diagnostic and therapeutic strategies from HER2-negative gastric cancer. The global reported HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in ...
- Source: drugdu
- 164
- April 10, 2024
Touchlight joins forces with University of Liverpool for NSCLC vaccine

UK-based CDMO Touchlight has teamed up with the University of Liverpool, UK, to utilise its doggybone DNA (dbDNA) technology in for developing a personalised DNA vaccine for patients with non-small cell lung cancer (NSCLC), which will be assessed in a clinical trial. Touchlight’s dbDNA is a small, closed loop of DNA that is made in a lab using enzymes. This technique can speed up the drug development process by amplifying long and complex DNA sequences without traditional methods like bacterial fermentation. The term doggybone DNA refers to the structure of the synthesised DNA molecule, which resembles a bone with two loops at each end. The approach offers a way to make vaccines very quickly, especially for personalised treatments. In March 2023, Touchlight received a £14m ($17.7m) grant from the UK government for commercial scale manufacturing of the technology. A team at the University of Liverpool will use Touchlight’s dbDNA technology ...
- Source: drugdu
- 84
- April 9, 2024
AstraZeneca reports positive Phase III results for Imfinzi in small cell lung cancer

Though a recent Phase III trial failed to achieve its primary endpoint with Imfinzi (durvalumab) in a specific subset of non-small cell lung cancer (NSCLC), AstraZeneca has announced that another Phase III study evaluating the checkpoint inhibitor has demonstrated a survival benefit in patients with limited-state small cell lung cancer (LS-SCLC). As per the 5 April press release, Imfinzi monotherapy demonstrated statistically and clinically meaningful improvements across the study’s primary endpoints of overall survival (OS) and progression-free survival (PFS). Additionally, the safety profile of the Imfinzi remained consistent with previous findings. The randomised, double-blind, placebo-controlled Phase III ADRIATIC study (NCT03703297) is actively evaluating Imfinzi as both a monotherapy and as a combination therapy with AstraZeneca’s Imjudo (tremelimumab) for the treatment of patients with LS-SCLC who have not progressed following concurrent chemoradiotherapy (cCRT). The study enrolled a total of 730 patients who were randomly assigned to receive placebo or 1500mg Imfinzi, ...
- Source: drugdu
- 160
- April 9, 2024
Legend Biotech’s “CARVYKTI®” was approved for second-line indications in the United States

Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
- Source: drugdu
- 108
- April 8, 2024
RemeGen’s Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren’s Syndrome

YANTAI, China, April 3, 2024 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren’s syndrome (pSS). The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs. Primary Sjögren’s syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator ...
- Source: drugdu
- 129
- April 8, 2024
Poolbeg’s cytokine release syndrome drug shows potential

Data supports Poolbeg’s strategic expansion of POLB 001 Poolbeg – a company focused on innovative medicines – has announced promising in vivo results for POLB 001 in treating cancer immunotherapy-induced cytokine release syndrome (CRS). The drug showed efficacy in significantly reducing the condition in an animal model with CRS symptoms. The data further supports Poolbeg’s strategic expansion of the phase II-ready POLB 001 while the emerging results facilitate the expansion of patent applications for the therapy. As an oral therapy to prevent or treat CRS, POLB 001 has the potential to enable a broader use of cancer immunotherapies in an outpatient setting. Meanwhile, cancer immunotherapies are being developed through a considerable range of haematological malignancies, solid tumours and immune inflammatory diseases, which represents an even greater market opportunity. Due to the CRS risk – which can be life threatening – administration of cancer immunotherapies, such as bispecific antibodies, is currently ...
- Source: drugdu
- 103
- April 7, 2024
Xilio fires 21% of its workforce and reprioritises pipeline

XIlio Therapeutics has implemented cost-cutting measures which include a 21% workforce reduction and the termination of investments for developing one of its assets, XTX202, as a monotherapy. Xilio expects to incur one-time cost of approximately $1m for reducing its workforce by 15 employees. The company has reported $44.7m in cash reserves, which are expected to fund the company’s activities into Q2 2025. The Waltham, Massachusetts-based company’s market cap currently stands at $42.1m. Following the recent round of layoffs, Xilio joins a list of pharmaceutical companies including Atreca, Candel Therapeutics, Kinnate Bio, and NexImmune that have fired workers to funnel more money into their clinical development pipelines in the last few months. The company plans to not investigate XTX202, a tumour-activated beta-gamma biased interleukin (IL)-2, as a monotherapy and instead will explore partnerships to develop the therapy as a combination treatment. The therapy was evaluated in an open label Phase I/II ...
- Source: drugdu
- 77
- April 5, 2024
Cellenkos links with Mount Sinai to explore CK0804 for myelofibrosis

Cellenkos has signed a sponsored research agreement with the Icahn School of Medicine at Mount Sinai Hospital, New York, US, to investigate the use of CK0804, a T-regulatory cell therapy for myelofibrosis. The collaboration aims to explore the therapeutic potential of CK0804, an allogeneic, cord blood-derived T-regulatory cell product enriched with C-X-C chemokine receptor type 4. The research will be led by Ronald Hoffman, director of the Myeloproliferative Disorders Research Program at the Tisch Cancer Institute, Mount Sinai. CK0804 uses Cellenkos’ CRANE technology to create disease-specific cell therapy products. This approach allows CK0804 cells to preferentially target inflamed bone marrow. Cellenkos chief operating officer Tara Sadeghi stated: “We are very excited by our collaboration with Mount Sinai and eagerly anticipate gaining a deeper understanding of [how] mechanisms of CK0804 Tregs work in myelofibrosis, especially to decrease inflammation. “CK0804 is already in a Phase I clinical trial to examine its safety ...
- Source: drugdu
- 74
- April 5, 2024
FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

Don Tracy, Associate Editor Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis. Alexion, AstraZeneca Rare Disease announced that the FDA has approved Voydeya (danicopan) as an add-on therapy for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH), in combination with ravulizumab or eculizumab. According to the company, the medication treats patients with significant EVH despite receiving C5 inhibitor therapy. The approval was based on positive results from the Phase III ALPHA trial, which found that Voydeya improved hemoglobin levels while providing the benefit of avoiding transfusions after a primary 12-week period. Additionally, there was no significant increases reported related to safety concerns, with common adverse reactions including headache, nausea, arthralgia, and diarrhea.1 “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on ...
- Source: drugdu
- 89
- April 4, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.