Autoimmune disease

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

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목요일, 4월 4, 2024
Logic, LN, Transplant, Medical College of Wisconsin, Rachel Haurwitz, Infection, Lupus, Risk, Medical college, Patient, Inflammation, Tissue, Autoimmune disease, Standard of care, Doctor of Philosophy, MD, Autoantibody, IND, Congress, HLA, Reindeer, Antibody, CRISPR, Safety, Immune system, Fatigue, FDA, Lupus nephritis, Autoimmunity, Bone marrow, ERL, Medicine, CD19, Food, PD-1, Pharmaceutical industry

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

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목요일, 4월 4, 2024
Rituximab, Multiple sclerosis, ALS, Insulin, Patient, Warsaw Stock Exchange, GMP, PTG, Therapy, Marketing, Autoimmune disease, PD-1, Pharmaceutical industry

This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.

Key Points: 
  • This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.
  • PolTREG CEO Piotr Trzonkowski, who co-authored the peer-reviewed study, said: “This peer-reviewed scientific publication adds to our growing excitement about the potential of polyclonal Treg therapies.
  • We have treated over 100 patients with our cell therapy at our facility over the last 17 years.
  • Having a biomarker of efficacy, like PD-1+ T-cells, could facilitate doctors’ ability to monitor their patients’ responses to therapy.

GRI Bio Reports Full Year 2023 Financial Results and Provides Corporate Update

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월요일, 4월 1, 2024
Research, Conference, Lupus, Inflammation, Patient, Food and Drug Administration, CTA, Doctor of Philosophy, SLE, Insurance, GRI, IPF, Fibrosis, Oxygen, Immune system, Injury, NKT, Food, Movement, Lupus nephritis, Autoimmune disease, Natural killer T cell, Medication, Pharmaceutical industry

LA JOLLA, CA, April 01, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported its financial results for the fiscal year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream.
  • GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells.
  • Research and development expenses were $3.2 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively.
  • General and administrative expenses were $8.2 million and $2.0 million for the years ended December 31, 2023 and 2022, respectively.

Shattuck Labs Announces Participation in Upcoming 23rd Annual Needham Virtual Healthcare Conference

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월요일, 4월 1, 2024
Webcast, Patient, Conference, Cancer, Autoimmune disease

AUSTIN, TX & DURHAM, NC, April 01, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced that company management will participate in the 23rd Annual Needham Virtual Healthcare Conference being held virtually from April 8-11, 2024.

Key Points: 
  • AUSTIN, TX & DURHAM, NC, April 01, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced that company management will participate in the 23rd Annual Needham Virtual Healthcare Conference being held virtually from April 8-11, 2024.
  • Format: Fireside chat with covering analyst Gil Blum, Ph.D.
    A live webcast of the presentation will be available on the Investors section of the Company’s website.
  • A replay of the webcast will be archived for up to 90 days following the presentation date.

Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases

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목요일, 3월 28, 2024
Mustang, Rheumatoid arthritis, Rituximab, Chronic lymphocytic leukemia, Patient, DSM-IV codes, CD20, Cancer, Translation, NHL, B cell, Clinical trial, Society, Waldenström macroglobulinemia, Hematology, Health, Lymphoma, Waldenström, Autoimmune disease, Pharmaceutical industry

WORCESTER, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.

Key Points: 
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
  • Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
  • “MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases.
  • Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis.

Avalo Acquires Anti-IL-1β mAb and Announces Private Placement Financing of up to $185 Million

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수요일, 3월 27, 2024
Eli Lilly, Disease, Half-life, Partnership, Patient, Sale, Acquisition, Inflammation, Therapy, OrbiMed, Hidradenitis suppurativa, Probability, Autoimmune disease

Executed private placement financing of up to $185 million, including initial upfront investment of $115.6 million; expected to extend cash runway into 2027

Key Points: 
  • Executed private placement financing of up to $185 million, including initial upfront investment of $115.6 million; expected to extend cash runway into 2027
    Webcast to be held tomorrow, March 28, 2024 at 8:30 a.m. E.T.
  • The private placement will provide up to $185 million in gross proceeds, including an initial gross upfront investment of $115.6 million.
  • After deducting estimated transaction costs from both the private placement financing and the acquisition of AlmataBio, Avalo expects net upfront proceeds to be approximately $105 million.
  • The private placement is expected to close on March 28, 2024, subject to the satisfaction of customary closing conditions.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

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화요일, 3월 26, 2024
Diagnosis, Blood pressure, Efgartigimod alfa, System, Urination, Urinary tract infection, MHLW, Chest pain, Rituximab, Allergy, Disease, Infection, Risk, Headache, Patient, Sore throat, IWG, History, ITP, Chills, Quality of life, Cough, Euronext, Rash, Respiratory tract infection, Splenectomy, Medicine, Skin, Fever, Antibody, Wheeze, Back pain, Shivering, Safety, Pain, Fatigue, Phlegm, Swelling, Food, Autoimmune disease, Nursing

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

Zura Bio Announces Robert Lisicki as CEO and Director

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월요일, 4월 8, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Partnership, Drug development, Multimedia, Autoimmunity, Autoimmune disease, Inflammation, Management

Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”) a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that Robert Lisicki has assumed the role of Chief Executive Officer and a Director of the Board at Zura Bio.

Key Points: 
  • Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”) a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that Robert Lisicki has assumed the role of Chief Executive Officer and a Director of the Board at Zura Bio.
  • The Company previously announced Mr. Lisicki's appointment and the commencement of a seamless transition process with Founding CEO, Dr. Someit Sidhu.
  • "With a successful track record in strategy, commercial operations, and drug development, Robert is well suited to establish Zura Bio as a leading immunology company.
  • On behalf of the board, I would like to welcome Robert,” stated Amit Munshi, Chairman of Zura Bio Board of Directors.

Nkarta Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

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목요일, 3월 21, 2024
Research, Conference, Cy, AML, Patient, SAN, Lymphoma, Cytopenia, Cytarabine, European Hematology Association, G&A, SLE, NHL, Clinical trial, Investment, Society, Safety, Depreciation, NK, Autoimmune disease, Pharmaceutical industry

Research and development (R&D) expenses were $96.8 million for the full year 2023 and $23.3 million for the fourth quarter of 2023.

Key Points: 
  • Research and development (R&D) expenses were $96.8 million for the full year 2023 and $23.3 million for the fourth quarter of 2023.
  • Non-cash stock-based compensation expense included in R&D expense was $8.0 million for the full year 2023 and $1.7 million for the fourth quarter of 2023.
  • General and administrative (G&A) expenses were $34.9 million for the full year 2023 and $7.9 million for the fourth quarter of 2023.
  • Net loss was $27.8 million, or $0.57 per basic and diluted share, for the fourth quarter of 2023.

Cabaletta Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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목요일, 3월 21, 2024
Research, MPV, IIM, MuSK protein, Toxicity, Conference, Disease, Dermatomyositis, Juvenile dermatomyositis, Federation, Patient, NOL, Observation, CRS, SLE, Health Canada, IND, Immunoglobulin therapy, Pemphigus, Investment, Investigational New Drug, Myopathy, Systemic scleroderma, Marketing, FDA, Clinical trial, Cytokine release syndrome, Cyclophosphamide, CD19, Food, Autoimmune disease, Pharmaceutical industry

In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.

Key Points: 
  • In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.
  • In November 2023, Cabaletta announced that its IND application for CABA-201 was allowed to proceed by the FDA for the Phase 1/2 RESET-MG trial.
  • Cabaletta anticipates reporting initial clinical data from the Phase 1/2 RESET-MG trial in the second half of 2024.
  • As of December 31, 2023, Cabaletta had cash, cash equivalents and short-term investments of $241.2 million, compared to $106.5 million as of December 31, 2022.