Immunoglobulin G

Orphan designation: humanised IgG1 monoclonal antibody against TfR1 conjugated to double stranded siRNA oligonucleotide against DUX4 mRNA via a non-cleavable linker treatment of facioscapulohumeral muscular dystrophy, 15/02/2023 Positive

Retrieved on: 
Saturday, January 20, 2024
COMP, Immunoglobulin G, DUX4, European Commission, Small RNA, Transferrin, EMA, Facioscapulohumeral muscular dystrophy, IRIS, Committee, Pharmaceutical industry

EU/3/23/2756 - orphan designation for treatment of facioscapulohumeral muscular dystrophy

Key Points: 
  • EU/3/23/2756 - orphan designation for treatment of facioscapulohumeral muscular dystrophy
    humanised IgG1 monoclonal antibody against TfR1 conjugated to double stranded siRNA oligonucleotide against DUX4 mRNA via a non-cleavable linker
    OrphanHuman
    MWB Consulting
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Cyrus Biotechnology to Present Its Novel IgG-degrading IdeS Enzyme Development Candidates for Autoimmune Indications at PepTalk Conference in San Diego

Retrieved on: 
Tuesday, January 16, 2024
Software, Biotechnology, Pharmaceutical, Health, Artificial Intelligence, Health Technology, Technology, Clinical Trials, Protein, Streptococcus pyogenes, Multimedia, Half-life, Immunoglobulin G, Autoimmune disease, WT, Disease, Rabbit, Antibody, MHC, Ides, Immunity, Guillain–Barré syndrome, Vaccine

The presentation will take place at the 23rd annual PepTalk conference in San Diego.

Key Points: 
  • The presentation will take place at the 23rd annual PepTalk conference in San Diego.
  • The IgG-degrading enzyme of S. pyogenes (IdeS) has been approved in wild type form for use in certain kidney transplantation recipients, where IgG depletion successfully mitigates host immunity against the transplant.
  • View the full release here: https://www.businesswire.com/news/home/20240116136157/en/
    Figure shows IgG levels after WT IdeS in diamonds and Cyrus’ candidates in squares and triangles.
  • Indications such as Guillain-Barre Syndrome, Autoimmune Immune Thrombocytopenia, Idiopathic Immune Myopathies, pemphigus vulgaris, and other diseases with a poor current standard of care are under consideration.

Adimab Announces Substantial Expansion of Research Campus

Retrieved on: 
Wednesday, January 10, 2024
Biotechnology, Health, Science, Pharmaceutical, Research, Engineering, Antibody, CD3, G protein-coupled receptor, TCR, Cytokine, Immunoglobulin G, HC, Spacecraft, CD28, Complex, GPCR, Protein, Eurosport 1, FC

Over the past seven years, Adimab has added more than 400 royalty bearing therapeutic programs.

Key Points: 
  • Over the past seven years, Adimab has added more than 400 royalty bearing therapeutic programs.
  • To accommodate this continual growth, Adimab has increased headcount by approximately 40% over the past three years.
  • “We have not expanded the footprint of our main research facility since initially occupying it in 2011,” explained Eric Krauland, President and Chief Scientific Officer of Adimab.
  • Antibodies from Adimab have exquisite specificity and are utilized as monospecific and multispecific therapies as well as CAR-Ts, ADCs, and other proteins.

Adimab Provides 2023 Update on Clinical Pipeline

Retrieved on: 
Tuesday, January 9, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Engineering, Antibody, CD3, G protein-coupled receptor, Cytokine, Immunoglobulin G, Partner, Sintilimab, HC, Spacecraft, CD28, Complex, Protein, BLA, Compugen, Eurosport 1, FC, Vaccine

This brings the total number of Adimab partner programs that have entered the clinic to 74.

Key Points: 
  • This brings the total number of Adimab partner programs that have entered the clinic to 74.
  • Two additional products were approved and another BLA was filed in 2023.
  • “We are thrilled to have 12 new clinical programs initiated in 2023, especially given the constrained financial market that has impacted so many biotech companies over the past few years,” said Philip T. Chase, Chief Executive Officer of Adimab.
  • For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that allow for discovery against membrane-obligate proteins in their native state.

Adimab Provides Year-End Update on 2023 Partnership Activities

Retrieved on: 
Monday, January 8, 2024
Biotechnology, Pharmaceutical, Health, Moonlight, Transfer, Cytokine, CD28, Partnership, Protein, Eurosport 1, Johnson & Johnson, Janssen Pharmaceuticals, Antibody, Spacecraft, FC, Engineering, Therapy, Complex, Åbogen, HC, Bill, Discovery, Immunoglobulin G, G protein-coupled receptor, CD3

Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that it entered into partnership agreements with 10 new companies in 2023.

Key Points: 
  • Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that it entered into partnership agreements with 10 new companies in 2023.
  • In addition, Adimab expanded its collaborations with nine partners, including Kelonia, Novo Nordisk, Santa Ana Bio, and Sensei Biotherapeutics, among others.
  • In 2023, Adimab and its partners initiated discovery on 56 new therapeutic programs, bringing the total number of royalty-bearing programs commenced to over 525.
  • The Adimab Platform is continuously developing and we offer our improvements to our Funded Discovery and Platform Transfer partners,” said Guy Van Meter, Chief Business Officer of Adimab.

Viridian Therapeutics to Present Key 2024 Corporate Priorities at J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, LDL, TED, Conference, IND, Autoimmunity, Half-life, Graves' ophthalmopathy, Trial of the century, Therapy, New Drug Application, Conditional sentence, Neonatal Fc receptor, Patient, Compensated emancipation, Safety, Employment, Immunoglobulin G, Pharmaceutical industry

As part of Viridian’s presentation at the J.P. Morgan Healthcare Conference, Mr. Mahoney will provide key updates on the company’s anti-insulin-like growth factor 1 receptor (IGF-1R) programs in thyroid eye disease (TED) and its programs targeting FcRn.

Key Points: 
  • As part of Viridian’s presentation at the J.P. Morgan Healthcare Conference, Mr. Mahoney will provide key updates on the company’s anti-insulin-like growth factor 1 receptor (IGF-1R) programs in thyroid eye disease (TED) and its programs targeting FcRn.
  • Viridian is currently evaluating VRDN-001 in two global Phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively.
  • The company expects to report THRIVE and THRIVE-2 data in the middle of 2024 and by year end 2024, respectively.
  • The Inducement Grant was granted as an inducement material to this individual entering into employment with Viridian in accordance with Nasdaq Listing Rule 5635(c)(4).

Hansa Biopharma provides update on business and key financials ahead of the JP Morgan Healthcare Conference

Retrieved on: 
Saturday, January 6, 2024
Marketing, Repeat, Conference, Partnership, Kidney transplantation, Trial of the century, Sarepta Therapeutics, DMD, Imlifidase, Growth, ANCA, Enzyme, Patient, Duchenne muscular dystrophy, Hansa, Immunoglobulin G, Neutron, Pharmaceutical industry

Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.

Key Points: 
  • Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.
  • We also continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge in the MENA region.
  • Management will be available for meetings in San Francisco during the J.P. Morgan Conference week, January 8-11, 2024.
  • Susan Noonan is coordinating the schedule on behalf of Hansa Biopharma and can be reached at [email protected] .

Hansa Biopharma provides update on business and key financials ahead of the JP Morgan Healthcare Conference

Retrieved on: 
Saturday, January 6, 2024
Marketing, Repeat, Conference, Partnership, Kidney transplantation, Trial of the century, Sarepta Therapeutics, DMD, Imlifidase, Growth, ANCA, Enzyme, Patient, Duchenne muscular dystrophy, Hansa, Immunoglobulin G, Neutron, Pharmaceutical industry

Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.

Key Points: 
  • Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities.
  • We also continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge in the MENA region.
  • Management will be available for meetings in San Francisco during the J.P. Morgan Conference week, January 8-11, 2024.
  • Susan Noonan is coordinating the schedule on behalf of Hansa Biopharma and can be reached at [email protected] .

Roivant Reports Positive Initial Phase 2 Results for Batoclimab in Graves’ Disease

Retrieved on: 
Wednesday, December 20, 2023
Patient, Hyperthyroidism, ATD, Injection, Safety, Immunoglobulin G, Pharmaceutical industry

This Phase 2 proof-of-concept trial is an open-label study to assess the safety and efficacy of batoclimab in Graves’ disease.

Key Points: 
  • This Phase 2 proof-of-concept trial is an open-label study to assess the safety and efficacy of batoclimab in Graves’ disease.
  • Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose.
  • A similar dose response was observed for anti-TSHR autoantibodies, with deeper reductions observed following treatment with 680 mg of SC batoclimab as compared to 340 mg of SC batoclimab.
  • Batoclimab was generally well tolerated with no new safety signals observed in the initial data set.

Immunovant Reports Positive Initial Phase 2 Results for Batoclimab in Graves’ Disease

Retrieved on: 
Wednesday, December 20, 2023
Patient, Hyperthyroidism, ATD, Injection, Safety, Immunoglobulin G, Pharmaceutical industry

This Phase 2 proof-of-concept trial is an open-label study to assess the safety and efficacy of batoclimab in Graves’ disease.

Key Points: 
  • This Phase 2 proof-of-concept trial is an open-label study to assess the safety and efficacy of batoclimab in Graves’ disease.
  • Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose.
  • A similar dose response was observed for anti-TSHR autoantibodies, with deeper reductions observed following treatment with 680 mg of SC batoclimab as compared to 340 mg of SC batoclimab.
  • Batoclimab was generally well tolerated with no new safety signals observed in the initial data set.