Lupus

Cartesian Therapeutics Highlights Progress and 2024 Strategic Priorities Across Innovative Pipeline of mRNA Cell Therapies for Autoimmunity

Retrieved on: 
Monday, January 8, 2024
Lancet Neurology, RNA, Food, Autoantibody, Autoimmune disease, Risk, IND, Messenger, FDA, Cytokine release syndrome, The Lancet, SLE, Fatigue, Multiple myeloma, BCMA, Muscle weakness, Therapy, Pharmacokinetics, Lupus, Neurotoxicity, Transfection, Myasthenia gravis, Patient, Safety, Autoimmunity, Vaccine

The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion.

Key Points: 
  • The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion.
  • Cartesian’s proprietary technology platform, RNA Armory®, is designed to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, including autologous, allogeneic, and in situ transfection.
  • Descartes-08 is an autologous anti-B cell maturation antigen (BCMA) mRNA CAR-T.
  • Cartesian continues to anticipate the initiation of Phase 2 basket studies in additional autoimmune indications in the second half of 2024.

Cartesian Therapeutics Announces Positive Long-Term Follow-Up Data from Phase 2a Study of Lead mRNA Cell Therapy Candidate Descartes-08 in Patients with Myasthenia Gravis

Retrieved on: 
Monday, January 8, 2024
Lancet Neurology, Patient, Quality of life, Acetylcholine receptor, Peer review, Food, Autoimmune disease, Risk, IND, Messenger, Cytokine release syndrome, The Lancet, Data, Fatigue, Lupus, BCMA, Muscle weakness, Orphan, Therapy, Clinical trial, Investigational New Drug, Quality, Pharmacokinetics, Neurotoxicity, Manuscript, Month, MedRxiv, Autoimmunity, Pharmaceutical industry

GAITHERSBURG, Md., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), (“the Company”) a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, today announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.

Key Points: 
  • The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.
  • Descartes-08, Cartesian’s lead mRNA cell therapy candidate and a potential first-in-class mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T), is an autologous anti-B-cell maturation antigen (BCMA) mRNA CAR-T.
  • “Notably, most patients maintained robust, clinically meaningful improvements across all four standard MG severity scores approximately 10 months after the last infusion.
  • Enrollment is ongoing in a Phase 2b randomized, double-blind, placebo-controlled trial (NCT04146051) in patients with MG. Topline results are expected in mid-2024.

Zura Bio Continues to Strengthen Leadership with Appointment of Robert Lisicki as President and Kiran Nistala as CMO

Retrieved on: 
Monday, January 8, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Marketing, Arena, Pfizer, Autoimmune disease, GSK plc, Dermatology, Multimedia, Johnson & Johnson, Amgen, AstraZeneca, Child, Rheumatology, Arena Pharmaceuticals, Protocol, Trust, Lupus, CCO, University, Wellcome Trust, Doctor of Philosophy, Therapy, Senior, State, University College London, Great Ormond Street Hospital, Inflammation, Myositis, MBBS, Regeneron Pharmaceuticals, Growth, Mergers and acquisitions, Patient, State university system, Economics, Scleroderma, Management

Mr. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company.

Key Points: 
  • Mr. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company.
  • Mr. Lisicki and Dr. Nistala have successfully worked on or led in the development of multiple drugs within the auto-immune therapeutic area.
  • These executives position Zura Bio to deliver on the promise of their innovative medicines for patients in need of better clinical outcomes.
  • View the full release here: https://www.businesswire.com/news/home/20240108851979/en/
    “I am very pleased to welcome Rob and Kiran to Zura Bio as members of the Executive Team.

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

R&D Day Highlights Kymera’s Immunology Strategy and Emerging Pipeline of Novel, First-in-Class Oral Degraders Addressing Multiple Highly Prevalent Immuno-inflammatory Diseases

Retrieved on: 
Thursday, January 4, 2024
Janus, Atopic dermatitis, Receptor (biochemistry), Sanofi, Janus kinase, Hidradenitis suppurativa, Eosinophilic esophagitis, Autoimmunity, Inflammatory bowel disease, HS, Inflammation, Lupus, Blood, TLR, Therapy, Clinical trial, Asthma, JAK, Dupilumab, Roflumilast, Polyp (medicine), TPD, Webcast, Patient, Psoriasis, TYK2, STAT6, Skin, Sinusitis, Pharmaceutical industry

As part of its strategy, Kymera is unveiling two new programs that each have the potential to address multiple immune-mediated diseases, each with considerable market potential.

Key Points: 
  • As part of its strategy, Kymera is unveiling two new programs that each have the potential to address multiple immune-mediated diseases, each with considerable market potential.
  • Kymera will share its immunology strategy, including market insights, program updates, new preclinical data and development timelines, at its virtual R&D Day this morning.
  • In addition, at low oral doses, KT-621 demonstrated near full in vivo STAT6 degradation and was well-tolerated in multiple preclinical toxicity studies.
  • Kymera will host a webcast to discuss its emerging immunology pipeline from 10:00 a.m. – 12:00 p.m.

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, MRI, INN, Contraindication, AZA, Axial spondyloarthritis, Rash, Tissue, ACR20, Heart, Cancer, Inflammation, Red, Disease-modifying antirheumatic drug, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, Adolescence, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Ageing, Nonsteroidal anti-inflammatory drug, Blood, Safety, Heart failure, CRP, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Select, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Child, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, MRI, INN, Risk, Contraindication, AZA, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Disease-modifying antirheumatic drug, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Ageing, Blood, Safety, Heart failure, CRP, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Medicine, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Date of authorisation: 26/07/2018, Revision: 14, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Contraindication, AZA, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, Psoriasis, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Medicine, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Date of authorisation: 26/07/2018, Revision: 14, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hyrimoz, adalimumab, Date of authorisation: 26/07/2018, Revision: 14, Status: Authorised

Gracell Biotechnologies to be acquired by AstraZeneca, furthering cell therapy ambition across oncology and autoimmune diseases

Retrieved on: 
Tuesday, December 26, 2023
ADS, CVR, AstraZeneca, LLP, Acquisition, AllBright Law Offices, SLE, Centerview Partners, Maples Group, Multiple myeloma, BCMA, Cancer, Lupus, Harney Westwood & Riegels, Investment, Patient, CD19, Bone marrow, VWAP, Cooley LLP, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 26, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative cell therapies for the treatment of cancer and autoimmune diseases, today announced it has entered into a definitive agreement to be acquired by AstraZeneca.

Key Points: 
  • Autologous CAR-T is a type of cell therapy created by reprogramming a patient’s immune T cells to target disease-causing cells, and the manufacturing process for this type of treatment is complex and time-consuming.
  • Gracell’s FasTCAR next-day manufacturing platform significantly shortens manufacturing time, enhances T cell fitness and will potentially improve the effectiveness of autologous CAR-T treatment in patients.
  • AllBright Law Offices is acting as PRC legal advisor to Gracell, and Harney Westwood & Riegels is acting as Cayman Islands legal advisor to Gracell.
  • RuiMin is acting as PRC legal advisor to AstraZeneca, and Maples Group is acting as Cayman Islands legal advisor to AstraZeneca.