Immunoglobulin G

argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

Retrieved on: 
Wednesday, December 20, 2023
Biology, Patient, Efgartigimod alfa, Autoantibody, PV, Consistency, Literature, Pemphigus vulgaris, Conference call, Euronext, PD, Steroid, Pemphigus foliaceus, Growth, Safety, Immunoglobulin G

argenx will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications.

Key Points: 
  • argenx will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications.
  • “We are disappointed by today’s results, particularly for pemphigus patients who have seen little innovation in this treatment space,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • “We are grateful to the pemphigus community and all involved in the ADDRESS study, including patients, healthcare professionals, and our argenx teams,” continued Dr. Truyen.
  • Consistent pharmacodynamic (PD) effect of efgartigimod SC: Treatment with efgartigimod SC led to total immunoglobulin G (IgG) and desmoglein autoantibody (DSG-1 and DSG-3) reductions up to 75%.

Kineta Publishes Preclinical Data Demonstrating the Potential of Anti-VISTA Antibody KVA12123 as an Immunomodulatory Therapy for Cancer

Retrieved on: 
Wednesday, December 13, 2023
Immunotherapy, Tumor microenvironment, Arm, Cancer, Kineta, Pembrolizumab, VISTA, Patient, Safety, Immunoglobulin G, Vaccine

SEATTLE, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the peer-reviewed publication in Frontiers in Immunology of preclinical data highlighting the potential of KVA12123 as a new immunotherapy against poorly immunogenic tumors. The publication titled “A Highly Potent Anti-VISTA Antibody KVA12123 - A New Immune Checkpoint Inhibitor and a Promising Therapy Against Poorly Immunogenic Tumors”, reports on the development of KVA12123.

Key Points: 
  • The publication titled “ A Highly Potent Anti-VISTA Antibody KVA12123 - A New Immune Checkpoint Inhibitor and a Promising Therapy Against Poorly Immunogenic Tumors ”, reports on the development of KVA12123.
  • “This scientific article summarizes the extensive characterization and selection of our clinical candidate KVA12123 that targets VISTA, a strong driver of immune suppression in the tumor microenvironment,” said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta.
  • “The publication highlights the differentiating potency and safety characteristics of KVA12123 that guided its advancement into clinical development.
  • Additional clinical efficacy data in the monotherapy arm and initial combination data with pembrolizumab are anticipated in Q2 2024.

Kamada Announces its Largest Commercial Agreement; A Strategic Engagement with Kedrion for U.S. Distribution of KEDRAB® including $180 Million of Revenues Over First Four Years

Retrieved on: 
Wednesday, December 6, 2023
Marketing, KMDA, Partnership, Eastern Time Zone, FDA, International, Hospital, Growth, Internet, Patient, Immunoglobulin G, Pharmaceutical industry

Within the first four years of the eight-year term, which begins in January 2024, Kedrion will purchase minimum quantities of KEDRAB with revenues to Kamada of approximately $180 million.

Key Points: 
  • Within the first four years of the eight-year term, which begins in January 2024, Kedrion will purchase minimum quantities of KEDRAB with revenues to Kamada of approximately $180 million.
  • In addition, the parties will collaborate to expand distribution of Kedrion products by Kamada in Israel.
  • “We are thrilled to secure this strategic agreement with Kedrion as it represents our largest commercial agreement since Kamada's inception,” said Amir London, CEO of Kamada.
  • Kamada expects a substantial increase in sales of the product to Kedrion for full-year 2023.

Immunovant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential

Retrieved on: 
Tuesday, November 28, 2023
Pharmacokinetics, EST, Neonatal Fc receptor, Safety, Injection, Immunoglobulin G, Serum albumin, Vaccine

Four once-weekly SC injections of 600 mg IMVT-1402 reduced total IgG level by a mean of 74%, a potency that is similar to batoclimab at 680 mg that reduced IgG by 76% after 4 weekly doses.

Key Points: 
  • Four once-weekly SC injections of 600 mg IMVT-1402 reduced total IgG level by a mean of 74%, a potency that is similar to batoclimab at 680 mg that reduced IgG by 76% after 4 weekly doses.
  • In disease settings where batoclimab was administered continuously, a reduction of 80% was observed at steady state after about 6-8 weeks.
  • Across all doses evaluated, treatments with IMVT-1402 were generally well tolerated with only mild or moderate treatment-emergent adverse events observed.
  • Immunovant will host a conference call with accompanying slides and a simultaneous webcast today, November 28, 2023 at 8:00 a.m. EST to discuss the 600 mg multiple-ascending dose data.

Roivant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential

Retrieved on: 
Tuesday, November 28, 2023
Pharmacokinetics, EST, Neonatal Fc receptor, Safety, Injection, Immunoglobulin G, Serum albumin, Vaccine

Four once-weekly SC injections of 600 mg IMVT-1402 reduced total IgG level by a mean of 74%, a potency that is similar to batoclimab at 680 mg that reduced IgG by 76% after 4 weekly doses.

Key Points: 
  • Four once-weekly SC injections of 600 mg IMVT-1402 reduced total IgG level by a mean of 74%, a potency that is similar to batoclimab at 680 mg that reduced IgG by 76% after 4 weekly doses.
  • In disease settings where batoclimab was administered continuously, a reduction of 80% was observed at steady state after about 6-8 weeks.
  • Across all doses evaluated, treatments with IMVT-1402 were generally well tolerated with only mild or moderate treatment-emergent adverse events observed.
  • Immunovant will host a conference call with accompanying slides and a simultaneous webcast today, November 28, 2023 at 8:00 a.m. EST to discuss the 600 mg multiple-ascending dose data.

Adimab Announces Successful Resolution of Lawsuit Brought Against LinkedUp Bioscience and Tianti Biotherapeutics

Retrieved on: 
Thursday, December 21, 2023
Professional Services, Health, Legal, Other Science, Science, Pharmaceutical, Biotechnology, Cytokine, CD28, Eurosport 1, Confidentiality, Antibody, Spacecraft, FC, Engineering, Complex, Medicine, HC, Immunoglobulin G, G protein-coupled receptor, CD3, Prejudice, Vaccine

In return for undisclosed consideration to Adimab, Adimab has withdrawn its claims that the LinkedUp parties misappropriated Adimab technology or breached any confidentiality agreement, and the LinkedUp parties shall have the unfettered right to continue using their technology as it exists today.

Key Points: 
  • In return for undisclosed consideration to Adimab, Adimab has withdrawn its claims that the LinkedUp parties misappropriated Adimab technology or breached any confidentiality agreement, and the LinkedUp parties shall have the unfettered right to continue using their technology as it exists today.
  • Similarly, LinkedUp and its related parties have withdrawn their counterclaims, including unfair and deceptive trade practices, intentional interference with business relationships, and infliction of emotional distress.
  • Our partners know that we bring unique technology and expertise to our efforts,” added Philip T. Chase, Chief Executive Officer of Adimab.
  • Bispecifics and T-cell engagers: Adimab has extensive bispecific and multispecific capabilities, including common light chain and fragment-based discovery and engineering.

ProMIS Neurosciences Announces Third Quarter 2023 Financial Results and Recent Highlights

Retrieved on: 
Tuesday, November 14, 2023
Acumen, Neurogranin, Research, Safety, Food, AAIC, Incidence, ALS, Immunoglobulin G, Translational neuroscience, PROMIS, CSF, Patient, MSA, Pharmacokinetics, ITN, Immunization, Therapy, Blood, Neuroscience, ARIA, PMN, Biomarker, Cerebrospinal fluid, Multiple system atrophy, Initiative, Lecanemab, Pharmaceutical industry, Cryptocurrency, Boston

CAMBRIDGE, Massachusetts, Nov. 14, 2023 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • “The third quarter was marked by significant progress across both our clinical and corporate initiatives,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences.
  • These results replicated biomarker findings from the CLARITY-AD trial of lecanemab, which also predominantly targets soluble amyloid beta oligomers.
  • In July 2023, the Company presented preclinical data from mouse vaccination studies at AAIC 2023.
  • Net loss was $2.4 million for the quarter ended September 30, 2023, compared to a net loss of $6.0 million for the same period in 2022.

IGM Biosciences Announces Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Myositis, CD38, Safety, Food, Treatment, Progression-free survival, Colorectal cancer, Acute myeloid leukemia, Myopathy, Bevacizumab, IND, Investment, Immunoglobulin G, Clinical trial, Net, Administration, Patient, Research, Lupus, Rheumatoid arthritis, FDA, Autoimmune disease, American College, G&A, Bispecific monoclonal antibody, FOLFIRI, SLE, Immunoglobulin M, GAAP, CD20, R, Antibody, Research and development, IGM, Azacitidine, Pharmaceutical industry, Vaccine, Sanofi

MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.
  • “During the third quarter, we continued to execute across our clinical development pipeline,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • Collaboration Revenue: For the third quarter of 2023, collaboration revenues were $0.5 million, compared to $0.3 million for the same period in 2022.
  • Research and Development (R&D) Expenses: For the third quarter of 2023, R&D expenses were $54.8 million, compared to $48.2 million for the same period in 2022.

Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance

Retrieved on: 
Monday, November 13, 2023
Sale, EBITDA, Three Months, Acquisition, Safety, CMV, International, Investment, S&M, SDF, Depreciation, Patient, DSMB, Internet, FDA, G&A, KMDA, Data monitoring committee, Eastern Time Zone, Availability, Innova (video game company), FIMI, Table, R, Growth, Nine Months, Coronavirus Scientific Advisory Board, TASE, Immunoglobulin G, Clothing, Pharmaceutical industry, Fine chemical, Security (finance), Video game, Reinsurance, Kamada

“Our future prospects were also recently further buoyed by the recent closing of our $60 million private placement with FIMI Opportunity Funds.

Key Points: 
  • “Our future prospects were also recently further buoyed by the recent closing of our $60 million private placement with FIMI Opportunity Funds.
  • Financial Highlights for the Three Months Ended September 30, 2023
    Total revenues were $37.9 million in the third quarter of 2023, an 18% increase from the $32.2 million recorded in the third quarter of 2022.
  • S&M costs, for the third quarter of 2023 and 2022, included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition.
  • Kamada continues to expect to generate fiscal year 2023 total revenues in the range of $138 million to $146 million.

Aulos Bioscience Advances AU-007 to Phase 2 Portion of Phase 1/2 Study Evaluating Computationally Designed IL-2 Antibody for Treatment of Solid Tumors

Retrieved on: 
Monday, December 18, 2023
Research, Technology, Clinical Trials, Health Technology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Artificial Intelligence, Renal cell carcinoma, Safety, Annual general meeting, Immunoglobulin G, Karen Teff, Clinical trial, Patient, Regulatory T cell, Kidney, Artificial intelligence, Immunotherapy, Interleukin, Neoplasm, RCC, CD25, Therapy, Melanoma, SITC, Eosinophil, Skin, Cell, NK, Pharmaceutical industry, Vaccine

AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.

Key Points: 
  • AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.
  • This is encouraging as the anti-tumor activity has been observed in heavily pre-treated patients whose tumors had progressed through checkpoint inhibitors.
  • Clinical data from the Phase 1/2 study were presented at the 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting in November.
  • Created by Biolojic Design, AU-007 is the first computationally designed monoclonal antibody to be tested in a clinical trial.