Nephritis

OncoOne Announces Formation of Clinical Advisory Board to Support Development of ON104 for Chronic Inflammatory Diseases

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Tuesday, March 12, 2024
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OncoOne , a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104.

Key Points: 
  • OncoOne , a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104.
  • ON104 is a monoclonal antibody targeting the oxidized isoform of the macrophage migration inhibitory factor (oxMIF) for the treatment of chronic inflammatory diseases.
  • His research focuses on arthritis and other inflammatory rheumatic diseases, precision medicine, and the management of complex diseases.
  • Dr. Freissmuth is an inaugural member of OncoOne’s scientific advisory board, where he continues to support the development of the company’s pipeline of biotherapeutics.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024
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Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

Lupus Research Alliance Announces Recipients of the Lupus Mechanisms and Targets Award

Retrieved on: 
Wednesday, February 28, 2024
LRA, Engineering, Chronic kidney disease, LMTA, Immune system, Infection, Thrombus, Inflammation, Physician, Kidney disease, Quality of life, Lupus Research Alliance, Colchicine, Lupus, Nephritis, NETS, CD19, Skin, Cell, UV, Risk, Autoantibody, APS, Bacteria, Death, Agent handling, Mortal Kombat, Fibrosis, Clinical trial, Gene, Survival, Disease, Antiphospholipid syndrome, Kidney, SLE, S100A4, Research, DNA, Kidney failure, Vaccine

NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).

Key Points: 
  • NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).
  • The development of targeted treatments is hindered by an incomplete understanding of lupus and its devastating complications.
  • These seven talented investigators will identify targets for new treatments and test novel therapeutic avenues to revolutionize the field and improve the lives of individuals with lupus.
  • Surgical biopsies of the kidneys are often needed to diagnose lupus nephritis (LN), kidney inflammation caused by lupus that can result in severe and sometimes life-threatening organ damage.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Retrieved on: 
Friday, January 12, 2024
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Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Key Points: 
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
  • The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.
  • In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303).

Exagen Inc. and Johns Hopkins University Announce License Agreement for Novel Patented Lupus Nephritis Biomarkers

Retrieved on: 
Thursday, November 9, 2023
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SAN DIEGO, California, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, and Johns Hopkins University jointly announced today the execution of an exclusive license agreement.

Key Points: 
  • SAN DIEGO, California, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, and Johns Hopkins University jointly announced today the execution of an exclusive license agreement.
  • Exagen will focus on the development of novel patented biomarkers for therapeutic management of patients with lupus nephritis.
  • Exagen intends to develop the novel biomarkers into assays to aid diagnostic and treatment decisions by providing unique clinical insight into a specific patient’s lupus nephritis in a non-invasive manner.
  • “We are very excited to accelerate the development of these highly innovative biomarkers for lupus nephritis patient management.

Alentis Therapeutics Doses First ANCA-Associated Vasculitis Rapidly Progressive Glomerulonephritis Patient in Phase 2 Clinical Trial of Lixudebart (ALE.F02)

Retrieved on: 
Tuesday, December 5, 2023
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The randomized, double-blind, placebo-controlled Phase 2 study ( NCT06047171 ) of lixudebart evaluates the drug’s safety, tolerability, pharmacokinetics, and how well it protects against the loss of kidney function.

Key Points: 
  • The randomized, double-blind, placebo-controlled Phase 2 study ( NCT06047171 ) of lixudebart evaluates the drug’s safety, tolerability, pharmacokinetics, and how well it protects against the loss of kidney function.
  • The study plans to recruit patients with Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis with Rapidly Progressive Glomerulonephritis (RPGN).
  • This disease typically causes a rapid and dramatic loss of kidney function and can result in kidney loss with patients requiring dialysis or a transplant.
  • It is the second clinical trial investigating lixudebart in patients after the initiation of a clinical study in advanced liver fibrosis patients earlier this year,” said Dr. Luigi Manenti, Chief Medical Officer of Alentis.

Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan

Retrieved on: 
Monday, November 13, 2023
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Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN).
  • LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys.
  • Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
  • As part of the agreement, Aurinia is eligible to receive a payment of $10 million upon approval in Japan along with low double-digit royalties on net sales once launched.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

Retrieved on: 
Wednesday, November 1, 2023
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Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

Key Points: 
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles.
  • There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%).

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery

Retrieved on: 
Tuesday, October 17, 2023
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With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.

Key Points: 
  • With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
  • The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine.
  • Adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single agent adjuvant treatment, were generally similar to those occurring in patients across tumor types receiving KEYTRUDA in combination with chemotherapy.
  • Eighty-one percent of patients in the KEYTRUDA in combination with platinum-containing chemotherapy arm had definitive surgery compared to 76% of patients in the placebo in combination with platinum-containing chemotherapy arm.

Spherix Introduces Patient Chart Dynamix™, an Enhanced Independent Pharmaceutical Market Research Chart Audit

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Tuesday, September 26, 2023
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Exton, PA, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Spherix Global Insights, a trusted leader in pharmaceutical market research, is delighted to announce the launch of its latest product, Patient Chart Dynamix™.

Key Points: 
  • Exton, PA, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Spherix Global Insights, a trusted leader in pharmaceutical market research, is delighted to announce the launch of its latest product, Patient Chart Dynamix™.
  • Patient Chart Dynamix utilizes a trusted and thorough approach to gather and analyze data from prescriber-provided electronic medical records and patient charts.
  • Discover Hidden Patient Insights: Patient Chart Dynamix™ uncovers valuable insights relevant to unique patients that traditional diagnosis codes can't capture.
  • Patient Chart Dynamix™ is a testament to Spherix's commitment to innovation and excellence in pharmaceutical market research.