Lupus

Cabaletta Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 9, 2023
SLE, GMG, FDA, Systemic scleroderma, Research, CAR, CART, Report, American College, IND, Syndrome, Cyclophosphamide, MPV, MuSK protein, Dermatomyositis, Food, Nidec ASI, Myositis, Oxford, CD19, Molecular Therapy, Pemphigus, Good manufacturing practice, MG, Lupus, Conference, University, DM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Maintenance, American College of Rheumatology, Development, Wuxi, San Diego Convention Center, Disease, Scleroderma, Immunoglobulin therapy, GMP, Autoimmunity, Investment, Patient, ACR, Investigational New Drug, Pharmaceutical industry, Vaccine, Nightclub, Cryptocurrency, Cabaletta, Limited

PHILADELPHIA, Nov. 09, 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 third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • In November 2023, Cabaletta announced the Company’s fourth IND application for CABA-201 was cleared by the FDA for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG).
  • Cabaletta will present new preclinical data for CABA-201 in a poster presentation and Cabaletta Bio Scientific Advisory Board members Carl June, M.D., and Georg Schett, M.D.
  • Cabaletta plans to participate in the following upcoming investor conferences:
    Stifel 2023 Healthcare Conference, which is being held from November 14-15, 2023 in New York, NY.
  • As of September 30, 2023, Cabaletta had cash, cash equivalents and short-term investments of $164.4 million, compared to $106.5 million as of December 31, 2022.

Spherix Global Insights Amplifies the Lupus Patient Voice, Highlighting the Lengthy and Challenging Journey to Diagnosis and Treatment

Retrieved on: 
Wednesday, November 8, 2023
SLE, Steroid, Arthralgia, Patient, Lupus nephritis, Education, Social media, Rash, History, Human, Rheumatology, Prevalence, Skin, Rheumatoid arthritis, Kidney, Research, Migraine, Disease, Internet, Aurinia, Hypertension, Special, Stiffness, Joint, Swelling, Human voice, Irritation, Safety, Diagnosis, Fatigue, Nursing, Lupus

Upon consulting healthcare professionals, a substantial portion faced prolonged diagnostic journeys, enduring over a year to receive an accurate diagnosis.

Key Points: 
  • Upon consulting healthcare professionals, a substantial portion faced prolonged diagnostic journeys, enduring over a year to receive an accurate diagnosis.
  • Indeed, SLE patients commonly experience a myriad of concurrent health conditions, with approximately one-fifth officially diagnosed with lupus nephritis.
  • Notwithstanding this yearning for more information, the Lupus patient community remains remarkably self-empowered, often relying on personal research for insights into their condition.
  • Patient Voice Dynamix™ is an independent service that explores the voice of the patient as they progress through their disease and treatment journeys.

Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, November 8, 2023
Food, Multiple myeloma, CXCR2, Enrollment, B-cell lymphoma, Lupus, SITC, Cetuximab, Annual general meeting, Rituximab, SLE, CAR, Hyperbaric treatment schedules, GAAP, Graft-versus-host disease, Safety, Cancer, Therapy, Ono Pharmaceutical, Investment, Patient, IPSC, Society for Immunotherapy of Cancer, Chronic lymphocytic leukemia, Research, Immunotherapy, TRAC, CD16, NK, Clinical trial, Multiplexing, BCL, Acute leukemia, CRS, Cell, FDA, Trastuzumab, IND, ONO, ADR, HER2, Neoplasm, Protocol, Lupus Research Alliance, Destiny, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, Tumor microenvironment, BCMA, Vaccine, Pharmaceutical industry, Autoimmunity

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • FT522 is the Company’s off-the-shelf, multiplexed-engineered natural killer (NK) cell product candidate that incorporates five synthetic controls of cell function.
  • In addition, as of September 30, 2023, cash receivables from the Company’s collaboration with ONO were $1.5 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of September 30, 2023.
  • ET to review financial and operating results for the quarter ended September 30, 2023.

Artiva Biotherapeutics Receives Immunology Innovation of the Year in the 2023 BioTech Breakthrough Awards Program

Retrieved on: 
Wednesday, November 8, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, SLE, Lupus nephritis, IND, CD16, CD20, Northwest Biotherapeutics, GVHD, Neurotoxicity, ADCC, NK, Cancer, Cytokine release syndrome, Rituximab, Immunotherapy, Autoimmune disease, Safety, Hospital, Patient, Lupus, Vaccine

This year’s program attracted more than 1,500 nominations from over 12 different countries throughout the world.

Key Points: 
  • This year’s program attracted more than 1,500 nominations from over 12 different countries throughout the world.
  • Seminal clinical data with autologous CAR-T cells suggests that deep B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis.
  • “The use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects.
  • “We’re pleased to recognize Artiva with ‘Immunology Innovation of the Year’ for their pipeline of off-the-shelf, allogeneic NK cell therapies that have the potential to be safe and immediately accessible to patients in need,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards.

LAPIX Therapeutics Inc. Announces First Subjects Dosed in its First-in-Human Clinical Study of its Treg-expanding Tim3/4 Agonist LPX-TI641 to Treat Multiple Sclerosis and other Autoimmune Conditions

Retrieved on: 
Tuesday, November 7, 2023
Immune tolerance, Autoimmunity, Multiple sclerosis, LPX, Rheumatoid arthritis, TIM, Volunteering, Pharmacokinetics, Immune system, Safety, Therapy, Patient, MS, Lupus, Pharmaceutical industry, Vaccine

LPX-TI641 is a novel, and proprietary first-in-class orally bioavailable small molecule designed as a T cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptor agonist.

Key Points: 
  • LPX-TI641 is a novel, and proprietary first-in-class orally bioavailable small molecule designed as a T cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptor agonist.
  • LPX-TI641 restores the balance of regulatory immune cells (T- and B-regs) to autoreactive T-cells reestablishing immune tolerance.
  • It is being developed for the treatment of Multiple Sclerosis (MS) and potentially other autoimmune diseases such as rheumatoid arthritis and lupus.
  • The study is a randomized, double-blind, placebo-controlled study in healthy adult volunteers to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 after single ascending oral doses.

Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Health, Science, Research, Clinical Trials, Patient, Lupus nephritis, Week, American College, CNI, EGFR, Human, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., TAC, AURORA, Safety, University of California, CSA, VCS, Lupus, Society, Mouse, Acute kidney injury, Ciclosporin, Division, Clinical trial, Efficacy, Physiology, Biopsy, MMF, University, Tacrolimus, Glucocorticoid, ACR, Conditional sentence, Proteinuria, Lithium toxicity, Pharmaceutical industry, Rheumatology, Black, ALMS, Aurinia, Medicine, UPCR, LN

Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.

Key Points: 
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.
  • In AURORA 1, patients received LUPKYNIS® 23.7 mg BID in combination with MMF (target dose 2 g/day) and oral glucocorticoids (starting dose of 25 mg/day tapered to 2.5 mg/day by Week 16).
  • The data showed an improved safety profile over the first six months of treatment with LUPKYNIS® in combination with low-dose glucocorticoids and lower-dose MMF without compromising efficacy.
  • Additional data assessed the disposition of cyclosporine (CSA), tacrolimus (TAC), and voclosporin (VCS) in mouse kidneys relative to its systemic drug exposure.

Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, C-reactive protein, Headache, American College, TAK, MDA, PGA, MD, Research and development, Skin, Inflammation, AM, Ulcerative colitis, Psoriasis Area and Severity Index, Rash, MACR, Lower respiratory tract infection, Lupus, Common, American College of Rheumatology, Body surface area, Safety, Patient, ACR, BSA, Abstract, PASI, TYK2, Pharmaceutical industry, Copper, Takeda, Psoriasis

These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.

Key Points: 
  • These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.
  • There was no clinically significant difference in adverse event rates between doses of TAK-279.
  • “We are also advancing the development of TAK-279 in Crohn’s disease, ulcerative colitis and systemic lupus erythematosus and exploring a range of other potential indications.
  • These opportunities are being explored in parallel with the psoriasis and psoriatic arthritis programs.”

Lupus Foundation of America Research Accomplishments to be Presented at the 2023 American College of Rheumatology Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
SLE, Rheumatology, Patient, Lupus Foundation of America, American College, RAY, Social media, Burden, CLE, Fatigue, Medicine, History, Racism, Language, Human, Observational study, Mental health, RN, Lupus, Doctor of Philosophy, News, MBBS, Social, HES, The Digital Intervention, Quality of life, Education, LFA, American Indians, Lead, Alaska Natives, Skin, Delphi, SELF, Communication, Monash University, Pharmaceutical industry, Nursing, Research, Diagnosis

WASHINGTON, Nov. 7, 2023 /PRNewswire/ -- The American College of Rheumatology Convergence 2023 meeting will be held in San Diego, CA from November 10-15, 2023.

Key Points: 
  • WASHINGTON, Nov. 7, 2023 /PRNewswire/ -- The American College of Rheumatology Convergence 2023 meeting will be held in San Diego, CA from November 10-15, 2023.
  • "As exploration and understanding of lupus grows, the Lupus Foundation of America continues to lead, contribute and support many novel and exciting investigations that propel the field forward," said Joy Buie, PhD, MSCR, RN, Director of Research, Lupus Foundation of America.
  • Throughout the ACR Meeting, the Lupus Foundation of America will share updates on social media highlighting the innovative scientific initiatives and research studies presented, as well as breaking news.
  • Follow the Lupus Foundation of America for evolving conference hot topics and research highlights at LFA's Twitter , Facebook , LinkedIn .

Cabaletta Bio Receives FDA Clearance of CABA-201 IND Application for Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Monday, November 6, 2023
GMG, Steroid, FDA, IND, Respiratory failure, Food, Enzyme inhibitor, Myositis, MG, Lupus, Autoantibody, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Protein, Disease, Clinical trial, Acetylcholine receptor, Risk, Neurology, Neuromuscular junction, Autoimmune disease, Scleroderma, NMJ, Patient, Investigational New Drug, Rheumatology, Fatigue, Pharmaceutical industry

PHILADELPHIA, Nov. 06, 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 announced that the Company’s fourth Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel gMG cohorts based on autoantibody status – one cohort of six patients with acetylcholine receptor (AChR) antibody-positive gMG and a second cohort of six patients with AChR antibody-negative gMG. Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.

Key Points: 
  • Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.
  • The announcement of our fourth CABA-201 IND clearance is also our first IND clearance for the product candidate in a predominantly autoantibody mediated disease.
  • Generalized MG affects approximately 85% of the between 50,000 and 80,000 estimated MG patients in the United States.
  • Standard of care therapies include cholinesterase inhibitors, steroids, immunomodulators, and biologics, which often provide modest clinical effect and require chronic administration, increasing the risk of serious long-term side effects.

Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023

Retrieved on: 
Thursday, November 2, 2023
B-cell lymphoma, Rheumatoid arthritis, Mantle cell lymphoma, Symantec Endpoint Protection, Ulcerative colitis, Pulmonary embolism, Lupus, CET, Infection, SLE, RT, Bleeding, ORR, Safety, Patient, TYK2, Baltic, DLBCL, CR, Euronext, Galapagos NV, Failure mode and effects analysis, ASH, UK, Follicular lymphoma, Letter, CRS, Non-Hodgkin lymphoma, Survival, ET, Technology transfer, CRR, UC, CD19, Indolent lymphoma, CFO, Burn, Lymphoid leukemia, Pharmaceutical industry, Cryptocurrency, Vaccine, Uranium mining, Pamlab, Galápagos Islands, Dermatomyositis, Central Europe

Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).

Key Points: 
  • Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).
  • Overall, 11 of 13 patients responded to treatment (ORR of 85%) and 9 of 13 patients achieved a CRR (69%).
  • New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and poster presentation details below).
  • New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled in ATALANTA-1 will be presented at ASH (see ASH abstract and poster presentation details below).