Autoantibody

Gracell Biotechnologies Initiates Investigational Study Evaluating GC012F for Treatment of Refractory Systemic Lupus Erythematosus (SLE)

Retrieved on: 
Monday, May 15, 2023
Tissue, IIT, CD19, CRS, Bone marrow, Cancer, End organ damage, Quality of life, SLE, Cytokine release syndrome, Patient, Graceling, SAN, B cell, Immune system, Autoimmune disease, Disease, RRMM, Death, IND, ORR, BCMA, Autoantibody, Pharmaceutical industry, Vaccine

SAN DIEGO, Calif., SUZHOU and SHANGHAI, China, May 15, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer and autoimmune diseases, today announced the initiation of an investigator-initiated trial (IIT) in China of GC012F, the Company's autologous FasTCAR therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, for the treatment of refractory SLE.

Key Points: 
  • "Our lead candidate GC012F leverages several next-generation CAR-T technologies including CD19/BCMA dual-targeting and the FasTCAR next-day manufacturing.
  • "Patients with refractory SLE have limited options to treat their wide-ranging and often debilitating symptoms.
  • As such, there is urgent, high unmet medical need for more effective – and even curative – therapies, particularly to help manage refractory SLE.
  • [3]
    Gracell's GC012F represents a novel approach entering human study for refractory SLE and pioneers the use of CD19/BCMA dual-targeting CAR-T in autoimmune disease.

MARAbio Systems, Inc. Appoints Dr. Michael Paul to Serve as Company's Chief Executive Officer

Retrieved on: 
Monday, April 17, 2023
Transfer, MIND, Grey Literature International Steering Committee, Business development, Vice, Pregnancy, University of California, Davis, University, Therapy, Business, Woman, SALT, Lineagen, MARA, Organization, Biochemistry, Incidence, Molecular biology, Shire (pharmaceutical company), Committee, Ernst & Young Entrepreneur of the Year Award, Acquisition, UC, Physician, Risk, Child, Medicine, Spectrum, FDA, Autoantibody, Medical device, Vaccine, Birth control, Pharmaceutical industry, Health care

SALT LAKE CITY, April 17, 2023 /PRNewswire/ -- MARAbio Systems (MARAbio), a precision medicine biotechnology company, has appointed Dr. Michael Paul to serve as the company's CEO. Dr. Paul has more than 25 years of life-sciences industry experience, including leading a number of organizations from formation to strategic exit. MARAbio's technology enables the earliest detection for risk of developing a specific subtype of autism through a simple blood test in the mother, either prior to pregnancy or after the child is born. Dr. Paul succeeds Dr. James Woody, who will continue to serve as Vice Chairman of the Board of Directors.

Key Points: 
  • SALT LAKE CITY, April 17, 2023 /PRNewswire/ -- MARAbio Systems (MARAbio), a precision medicine biotechnology company, has appointed Dr. Michael Paul to serve as the company's CEO.
  • Dr. Paul has more than 25 years of life-sciences industry experience, including leading a number of organizations from formation to strategic exit.
  • Dr. Paul succeeds Dr. James Woody, who will continue to serve as Vice Chairman of the Board of Directors.
  • Dr. Paul is Chief Executive Officer for MARAbio.

Devic's Syndrome Treatment Global Market Report 2022: Soliris (Eculizumab) to Foster Growth in the Sector - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 22, 2023
Health, Pharmaceutical, Complement component 5, Neuron, Syndrome, C5a, Spinal cord, Neuromyelitis optica spectrum disorder, National Multiple Sclerosis Society, MedImmune, Chugai Pharmaceutical Co., Woman, NMOSD, CNS, Plasma protein binding, Protein, Patient, Immune system, Optic nerve, Alexion, Diagnosis, Rare, Death, Autoantibody, Pharmaceutical industry, Eculizumab

Soliris works by specifically preventing activation of particular proteins in the complement system (C5a and C5b), which play a role in the treatment of Devic s syndrome.

Key Points: 
  • Soliris works by specifically preventing activation of particular proteins in the complement system (C5a and C5b), which play a role in the treatment of Devic s syndrome.
  • Patients suffering with Devic's syndrome possess AQP4 antibody-positive, the body s immune system can turn against itself to produce autoantibodies against AQP4.
  • There are three promising molecules in Devic s syndrome treatment pipeline such as Satralizumab - Phase 3 (Hoffmann-La Roche/ Chugai Pharmaceutical), MEDI-551- Phase 2/3 (MedImmune LLC), and RC18 - Phase 3 (RemeGen, Ltd.).
  • According to National Multiple Sclerosis Society, there are around 4,000 people suffering with Devic's syndrome in the United States with majority of women population.

Enable Biosciences Announces Relaunch of Website for Early Detection of Type 1 Diabetes

Retrieved on: 
Tuesday, March 21, 2023
Carolyn Bertozzi, JDRF, Teplizumab, T1D, Research, MD, SAN, Immune system, Autoimmune disease, Sanofi, Health, Autoantibody, Disease, Pharmaceutical industry, Vaccine

SOUTH SAN FRANCISCO, Calif., March 21, 2023 /PRNewswire/ -- Enable Biosciences, a biotechnology company dedicated to developing innovative diagnostics, announced the relaunch of its website, type1testing.enablebiosciences.com , which offers an at-home testing kit for the early detection of type 1 diabetes.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 21, 2023 /PRNewswire/ -- Enable Biosciences, a biotechnology company dedicated to developing innovative diagnostics, announced the relaunch of its website, type1testing.enablebiosciences.com , which offers an at-home testing kit for the early detection of type 1 diabetes.
  • Type 1 diabetes is an autoimmune disease affecting over 1.6 million people in the United States.
  • The relaunch of the site coincides with the approval of a new therapy for type 1 diabetes.
  • The Enable Biosciences website is now live and accepting orders for the early detection testing kit.

Cabaletta Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 16, 2023
Cancer, Research, Conference, Autoimmunity, University, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cyclophosphamide, Partnership, CAR, SLE, Maintenance, University of Pennsylvania, Lancet, Patient, Autoimmune disease, MG, Autoantibody, Investment, CD19, FDA, Disease, Nature Biotechnology, Immunoglobulin therapy, Clinical trial, Immune system, Investigational New Drug, MuSK protein, Coronavirus Scientific Advisory Board, Food, Drug discovery, IND, Syndrome, Recurrence, Pharmaceutical industry, Cryptocurrency, Cabaletta

PHILADELPHIA, March 16, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

Key Points: 
  • We believe the tolerability data reported by IASO in these patients support clinical development in patients with autoimmune diseases.
  • These data were developed through a sponsored research agreement between Cabaletta Bio and University of Pennsylvania professor Aimee Payne, M.D., Ph.D., Cabaletta Bio co-founder and Scientific Advisory Board co-chair.
  • As of December 31, 2022, Cabaletta had cash, cash equivalents and investments of $106.5 million, compared to $122.2 million as of December 31, 2021.
  • The Company expects that its cash, cash equivalents and investments as of December 31, 2022, will enable it to fund its operating plan into the first quarter of 2025.

Researchers from Rowan University and Durin Technologies announce highly accurate blood test for Alzheimer's Disease

Retrieved on: 
Wednesday, March 8, 2023
Journal, Research, Ageing, Biomarker, Disease, Rowan-Virtua School of Osteopathic Medicine, Patient, Parkinson, Autoantibody, Pathology, Study Group, Osteopathic medicine in the United States, AD, American Journal of Alzheimer's Disease & Other Dementias, New Jersey Institute of Technology, Medical imaging, Alzheimer's disease, Geriatrics

STRATFORD, N.J., March 8, 2023 /PRNewswire/ -- A team of researchers from Rowan-Virtua School of Osteopathic Medicine (Rowan-Virtua SOM) and Durin Technologies, Inc., have announced the results of a newly-designed blood test that can detect the presence of Alzheimer's disease-related pathology up to 10 years before symptoms arise with a nearly 97 percent accuracy rate. Their findings appear online ahead of press in the Journal of Alzheimer's Disease.

Key Points: 
  • Their findings appear online ahead of press in the Journal of Alzheimer's Disease .
  • The study involved 328 blood samples with the goal of determining if a test that monitors a small number of a patient's autoantibodies can detect Alzheimer's disease (AD)-related pathology at pre-symptomatic, prodromal (i.e., mild cognitive impairment), and mild-moderate stages of the disease.
  • "To our knowledge, this is the first blood test to accurately detect Alzheimer's-related pathology several years before either clinical symptoms or more expensive and invasive tests can identify the disease."
  • For a number of reasons, the test has significant potential to impact effective treatments for Alzheimer's disease.

On Rare Disease Day 2023 RemeGen Highlights Its Social Responsibility and Rare Disease Advocacy

Retrieved on: 
Tuesday, February 28, 2023
ODD, Speech, Rare, Diagnosis, Policy, Colon, Claudin, Stomach, Pancreatic cancer, Center for Drug Evaluation and Research, Permeability, MG, Research, Social responsibility, FDA, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Autoantibody, Liver, Myasthenia gravis, CDE, US Food Sovereignty Alliance, GMG, Neuromuscular junction, United, ADC, Breast, Food, Cancer, US, Pharmaceutical industry

YANTAI, China, Feb. 27, 2023 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, continues to strengthen its social responsibility and rare disease advocacy in unison with Rare Disease Day 2023's message of continuing to increase visibility and generate change for the millions of people globally living with a rare disease, their families and carers.

Key Points: 
  • YANTAI, China, Feb. 27, 2023 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, continues to strengthen its social responsibility and rare disease advocacy in unison with Rare Disease Day 2023's message of continuing to increase visibility and generate change for the millions of people globally living with a rare disease, their families and carers.
  • RemeGen takes immense pride in observing this special day and will be there to help and support all those living with rare diseases."
  • Rare Disease Day is a global movement focused on rare diseases that pushes for equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease.
  • Orphan drugs, also known as rare disease drugs, are used for the prevention, treatment, and diagnosis of rare diseases.

Zenas BioPharma Announces First Patient Dosed in Phase 3 Clinical Study of Obexelimab for the Treatment of Immunoglobulin G4-Related Disease (IgG4-RD)

Retrieved on: 
Wednesday, January 11, 2023
Degenerative disease, IgG4-related disease, Death, Safety, Zenas, Patient, CD19, INDIGO, End organ damage, Autoantibody, Pharmaceutical industry, Vaccine

WALTHAM, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced that the first patient has been dosed in the INDIGO Phase 3 registrational study of obexelimab. The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare. Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.

Key Points: 
  • The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare.
  • Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.
  • “There are no currently approved treatments for patients living with IgG4-RD.
  • Based upon the promising data from a Phase 2 study of obexelimab in IgG4-RD patients, we are excited to continue to evaluate the potential of obexelimab in the INDIGO study.”

SAB Biotherapeutics Novel DiversitAb™ Platform Proven to Develop Anti-idiotype Antibodies to Help Treat Autoimmune Diseases

Retrieved on: 
Thursday, January 5, 2023
Autoimmune disease, ASX, MD, Research, Rheumatoid arthritis, Immunotherapy, Tissue, Autoantibody, CSL, Degenerative disease, Lupus, Aplastic anemia, Autoimmune hepatitis, SLE, Antibody, NMO, Autoimmunity, Spectrum disorder, Vaccine

Autoantibodies are immune system proteins that can mistakenly target the body’s own organs and tissues.

Key Points: 
  • Autoantibodies are immune system proteins that can mistakenly target the body’s own organs and tissues.
  • Autoantibodies can target almost every part of the body and are found in a wide range of autoimmune diseases, such as lupus, autoimmune hepatitis, aplastic anemia, and rheumatoid arthritis among many others.
  • “The unique capabilities of our transchromosomic cows and DiversitAb™ platform continue to prove the power of polyclonals to address complex and very difficult to treat autoimmune diseases.”
    Anti-idiotypic polyclonal antibodies are highly specialized antibodies that bind to other antibodies specifically “bad acting” antibodies associated with many autoimmune diseases such as type 1 diabetes, NMO or systemic lupus erythematosus (SLE).
  • “Often, multiple autoantibodies are responsible for an autoimmune response, and our DiversitAb™ platform has proven its ability to create an ‘antidote’ antibody treatment that can "disarm” those harmful autoantibodies without a broad immunosuppressive effect — having implications across a wide variety of autoimmune diseases.”

Sengenics Broadens Its Systems Serology Tools to Enable the Detection of a Wider Range of Autoantibody Biomarkers

Retrieved on: 
Wednesday, November 30, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Autoimmune disease, Degenerative disease, Infection, Autoantibody, Cancer, KREX, Biomarker, Immunoglobulin A, Disease, Immunoglobulin G, Precision medicine, Medical imaging

The new Dual-Color Assays accelerate the pace and expand the biological space in the quest to discover new autoantibody biomarkers.

Key Points: 
  • The new Dual-Color Assays accelerate the pace and expand the biological space in the quest to discover new autoantibody biomarkers.
  • The Dual-Color IgG/IgA Assays enable the simultaneous and sensitive detection of IgG and IgA autoantibodies with exquisite specificity from very low sample volume input.
  • The Dual Color IgG/IgA Assay Services expands Sengenics systems serology tools enabling a deeper dive into the humoral immune response.
  • Our solutions enable the discovery and validation of autoantibody biomarker signatures for patient stratification, therapeutic response prediction and development of companion diagnostics.