C3b

NovelMed Commences Phase II Trial for Anti-Bb Antibody (NM8074) in Treatment-Naïve PNH Patients: A Glimpse into the PNH Study Progress

Retrieved on: 
Monday, October 30, 2023
FDA, CP, PNH, Hemolysis, C3b, LDH, Intravascular hemolysis, Phase, Phase II, EVH, Lactate dehydrogenase, RBC, Risk, Paroxysmal nocturnal hemoglobinuria, AP, Safety, IVH, Therapy, Patient, Infection, PRBC, Pharmaceutical industry, Haptoglobin, Hemoglobin, Reticulocyte

Regulatory approval for the Phase II trial in treatment-naïve PNH patients was granted based on the safety and tolerance demonstrated in the previous Phase I clinical trial involving healthy subjects.

Key Points: 
  • Regulatory approval for the Phase II trial in treatment-naïve PNH patients was granted based on the safety and tolerance demonstrated in the previous Phase I clinical trial involving healthy subjects.
  • CLEVELAND, Oct. 30, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics is excited to announce the commencement of its Phase II clinical trial targeting treatment-naïve Paroxysmal Nocturnal Hemoglobinuria (PNH) patients with its groundbreaking anti-Bb antibody, NM8074.
  • This open-label, multi-dose, and multi-center study aims to assess the safety and efficacy of NM8074 in PNH patient population.
  • The Phase II study is divided into two cohorts, featuring a biweekly dosing schedule spanning a 3-month assessment period.

NovelMed Phase I Clinical Trial Shows Inhibition of the Alternative Pathway and Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody NM3086 for PNH Patients

Retrieved on: 
Monday, June 5, 2023
C3b, PD, C5a, Serum, Receptor (biochemistry), IVH, Pathology, CP, Pharmacokinetics, AP, Intravascular hemolysis, EVH, C3a, Disorder, Trial of the century, MAC, Clinical trial, Paroxysmal nocturnal hemoglobinuria, Patient, Anemia, PNH, Complement factor B, FDA, Therapy, ADA, Safety, Vaccine, News, Hydraulic machinery, Pharmaceutical industry

Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.

Key Points: 
  • Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.
  • Correspondingly, the classical pathway (CP) remained unaffected, suggesting that NM3086 selectively blocks the AP while maintaining the host defense.
  • The duration of AP-C3b inhibition followed the AP inhibition profile very closely in a dose dependent manner.
  • CLEVELAND, June 05, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. announced today topline results from First-in-Human Phase I clinical trial of its complement blocker monoclonal anti-Properdin antibody, known as NM3086.

Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients (Rare Disease)

Retrieved on: 
Monday, January 30, 2023
Disease, AP, Food, Patient, BB, Efficacy, Acquisition, Thrombotic microangiopathy, Safety, CP, Phase, Complement, Hemolysis, Partnership, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Ahus, Anemia, C3b, Inflammation, Pharmaceutical industry, Eculizumab, Adult

CLEVELAND, Jan. 30, 2023 (GLOBE NEWSWIRE) -- NovelMed announced today that the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational drug NM8074 to initiate an efficacy trial in patients with aHUS in coming months. NovelMed is advancing its anti-Bb antibody (NM8074) to treat patients with evidence of treatment-related resistance or complement-mediated relapses in aHUS, a rare disease with unmet need. NovelMed is a clinical-stage biopharma company focused on the development of humanized monoclonal antibody treatments for several complement-mediated disorders.

Key Points: 
  • NovelMed is advancing its anti-Bb antibody (NM8074) to treat patients with evidence of treatment-related resistance or complement-mediated relapses in aHUS, a rare disease with unmet need.
  • NovelMed is a clinical-stage biopharma company focused on the development of humanized monoclonal antibody treatments for several complement-mediated disorders.
  • NM8074 has recently completed a Phase I trial in healthy volunteers with no safety concerns.
  • NM8074 blocks the AP-mediated formation of C3b, an important molecule responsible for incurable anemia seen in both Soliris and Ultomiris treated patients.

CANbridge Pharmaceuticals Granted Orphan Drug Designation for CAN 106 for the Treatment of Myasthenia Gravis

Retrieved on: 
Wednesday, November 16, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, FDA, Pompe, Weakness, Spinal muscular atrophy, Muscle contraction, Paroxysmal nocturnal hemoglobinuria, American Society of Gene and Cell Therapy, Acetylcholine, C5a, European Society for Medical Oncology, Glycogen storage disease, Ventilation, Glycogen storage disease type II, Neuromuscular disease, Degenerative disease, WuXi Biologics, University of Massachusetts, Patient, US, C3b, European Society of Gene and Cell Therapy, Muscle, Cell, C3a, SMA, Hospital, Glioblastoma, Research, MAC, Safety, Woman, Hunter syndrome, Drug, C3, Myasthenia gravis, Disease, Complement component 5, US FDA, Gene, C5, Congress, PNH, University, Haemophilia, Society, Fabry disease, Orphan, Pharmaceutical industry, Vaccine

Orphan Drug Designation for CAN106 in MG is both a validation of CANbridge innovation and a major milestone as our first US FDA regulatory designation, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.

Key Points: 
  • Orphan Drug Designation for CAN106 in MG is both a validation of CANbridge innovation and a major milestone as our first US FDA regulatory designation, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.
  • We continue to advance our global development strategy for CAN106 and look forward to developing CAN106 for myasthenia gravis and other complement-mediated diseases.
  • CAN106 is a clinical-stage investigational novel, long-acting recombinant humanized monoclonal antibody that binds to and neutralizes C5, a key component of the complement system.
  • CAN106 acts downstream of C3 in the complement pathway, preserving the generation of C3a and C3b, which are important for innate immunity.

Kira Pharmaceuticals Presents Complete Data from Phase 1 SYNERGY-1 Trial of KP104 at American Society for Nephrology Kidney Week 2022

Retrieved on: 
Thursday, November 3, 2022
Hemolysis, FDA, PNH, Medicine, CEO, Health, ASN, Doctor of Philosophy, Society, MD, Patient, C3b, C5, Paroxysmal nocturnal hemoglobinuria, Half-life, Biomarker, Microangiopathy, RBC, SC, Poster, AP, IgA nephropathy, American Society of Nephrology, University of South Australia, MAD, PD, Immunoglobulin A, Multimedia, University, Blood, Time-invariant system, Conditional sentence, TP, Pharmaceutical industry

CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ -- Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, today presented complete first-in-human data from its SYNERGY-1 trial of KP104 at the American Society of Nephrology (ASN) Kidney Week 2022 in Orlando, FL. KP104 is a first-in-class bifunctional biologic engineered to selectively target the alternative and terminal complement pathways.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ --Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, today presented complete first-in-human data from its SYNERGY-1 trial of KP104 at the American Society of Nephrology (ASN) Kidney Week 2022 in Orlando, FL.
  • KP104 is a first-in-class bifunctional biologic engineered to selectively target the alternative and terminal complement pathways.
  • Biomarker assay also included a rabbit red blood cell (RBC) hemolysis assay which measures the combined inhibitory effect of KP104 on AP and TP.
  • This dual-target mechanism of action uniquely positions KP104 to address complement-mediated diseases and potentially provide greater benefits than single-target complement agents.

Alternative Pathway Blocker Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Efficacy Trial in C3 Glomerulopathy (C3G) Patients

Retrieved on: 
Monday, August 15, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Serum, C5-convertase, Inflammation, Properdin, Population, Classical complement pathway, C3b, Disease, Hemolysis, EGFR, USD, Proteinuria, Patient, Therapy, Company, Acquisition, Partnership, AP, Infection, Kidney, MAC, Membranoproliferative glomerulonephritis, Time, BB, CP, Food, MPGN, DDD, Pharmaceutical industry, Vaccine, Eculizumab, C3, C5

CLEVELAND, Aug. 15, 2022 /PRNewswire/ -- NovelMed Therapeutics is a clinical-stage biopharmaceutical company focused on the development of targeted therapies for complement-mediated rare diseases. The Company announced today that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational drug NM8074 to initiate an Efficacy trial in patients with C3G in the First Quarter of 2023. NM8074 has recently completed a Phase I trial in forty (40) healthy volunteers with no safety concerns. 

Key Points: 
  • The Company announced todaythat the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational drug NM8074 to initiate an Efficacy trial in patients with C3G in the First Quarter of 2023.
  • Further, NM8074 also blocks the formation of these proteases by impairing the amplification loop of the AP.
  • Interestingly, NM8074 does not block the classical pathway (CP) which is critical for host defense against infections.
  • Our goal is to develop an alternative pathway specific drug that can treat a multitude of rare diseases and provide patients with low-cost treatment.

First Patient Dosed in CAN106 Phase 1b/2 Trial for Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Retrieved on: 
Monday, March 28, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Kidney, Cell, Thrombosis, Heart, MPS II, University of Massachusetts Medical School, University, MAC, Death, 2-Bromo-LSD, Glioblastoma, Degenerative disease, Patient, Pulmonary hypertension, GBM, Peking Union Medical College Hospital, Research, WuXi Biologics, Incidence, C3a, PNH, Hemolysis, PHN, Paroxysmal nocturnal hemoglobinuria, Hunter syndrome, Administration, CEO, C3, Anemia, MPS, C5, Safety, C5a, Steroid, Diagnosis, Glycogen storage disease, C3b, University of Massachusetts, Disorder, CH50, Complement component 5, Lists of diseases, Paroxysmal attack, Medicine, Fatigue, Protein, Spiroplasma mirum, Ravulizumab, Haemophilia, Pharmaceutical industry, Vaccine, Fine chemical, Hematology, CAN106, PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH), CANBRIDGE PHARMACEUTICALS INC.

CAN106 was previously shown to be safe and well-tolerated, with dose-dependent and linear pharmacokinetic exposure, in a study of healthy volunteers in Singapore.

Key Points: 
  • CAN106 was previously shown to be safe and well-tolerated, with dose-dependent and linear pharmacokinetic exposure, in a study of healthy volunteers in Singapore.
  • Based on these results, Chinas National Medical Products Administration approved the CAN106 Phase 1b/2 trial for the treatment of patients with PNH.
  • CAN106 is a novel, long-acting recombinant human monoclonal antibody that binds to and neutralizes C5, a key component of the complement system.
  • Paroxysmal nocturnal hemoglobinuria (PNH) belongs to a group of fatal and rare disorders that occur when the complement system is dysregulated.

CANbridge Reports Positive Top-Line CAN106 Phase 1 Data

Retrieved on: 
Monday, February 7, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PNH, Disorder, MPS II, Single, C5, Immune system, IND, MPS, Ravulizumab, Investigational New Drug, Safety, Anemia, 2-Bromo-LSD, Glioblastoma, Steroid, Hemolysis, Glycogen storage disease, Cell, Blood, SAD, WuXi Biologics, Complement component 5, Paroxysmal nocturnal hemoglobinuria, Research, C3, Șaeș, Haematopoietic system, Haemophilia, C3b, Pulmonary hypertension, Incidence, Paroxysmal attack, Patient, Kidney, Heart, University of Massachusetts, Diagnosis, Hunter syndrome, Protein, University, PHN, PK, GBM, Thrombosis, Lists of diseases, CEO, C5a, Spiroplasma mirum, Death, C3a, MAC, CH50, PD, University of Massachusetts Medical School, Partnership, Degenerative disease, Fatigue, Vaccine, Pharmaceutical industry, Palladium, Fine chemical, Pharmacokinetics, the Study, CAN106, Paroxysmal Nocturnal Hemoglobinuria (PNH), CANbridge Pharmaceuticals Inc., THE STUDY, CAN106, PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH), CANBRIDGE PHARMACEUTICALS INC.

CAN106 was shown to be safe and well-tolerated with mostly mild or moderate adverse events and no drug-related serious adverse events (SAEs).

Key Points: 
  • CAN106 was shown to be safe and well-tolerated with mostly mild or moderate adverse events and no drug-related serious adverse events (SAEs).
  • CAN106 showed dose-dependent and linear pharmacokinetic exposure with low inter-subject variability and a terminal elimination half-life of approximately 32 days.
  • These results suggest complete functional blockade of terminal complement activity, and importantly, provide the first human data validating CAN106 as a potential treatment for complement-mediated diseases.
  • The objectives were to assess the safety and tolerability of single escalating doses of CAN106, to characterize the PK and PD profile of CAN106, and to evaluate the immunogenicity of CAN106.

NovelMed's Complement Alternative Pathway Specific Anti-Bb Antibody (NM8074) for Rare Diseases Achieves a Major Milestone

Retrieved on: 
Monday, January 31, 2022
AP, MAC, IND, Safety, Lists of diseases, Patient, Therapy, Pathology, Food, Infection, Conditional sentence, Hemolysis, BB, LDH, Thrombus, Inflammation, Properdin, CP, Pharmacokinetics, Serum, Disease, Complement component 5, C5a, Alternative-complement-pathway C3/C5 convertase, PNH, Paroxysmal nocturnal hemoglobinuria, C3b, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, C3a, Pharmaceutical industry, Vaccine, C5, C3, Pegcetacoplan, Eculizumab, Ravulizumab

Through its targeted specificity to the complement alternative pathway (AP), NM8074 is expected to improve upon current treatments such as Soliris, Ultomiris, and Empaveli, which are approved for treatment of a limited number of rare diseases.

Key Points: 
  • Through its targeted specificity to the complement alternative pathway (AP), NM8074 is expected to improve upon current treatments such as Soliris, Ultomiris, and Empaveli, which are approved for treatment of a limited number of rare diseases.
  • NM8074 selectively binds to complement alternative pathway specific protein Bb and inhibits the formation of C3a/C3b, C5a/C5b, and MAC, products that mediate inflammation and tissue damage in numerous diseases.
  • NM8074 carries a mechanistic advantage over current platforms because it targets the disease-specific complement alternative pathway (AP) without blocking the classical pathway (CP) required for host defense.
  • NovelMed is a clinical-stage biopharmaceutical company committed to innovating and developing biologics to treat rare diseases caused by the overactivation of the complement alternative pathway.

Catalyst Biosciences Announces CFI Variant Presentations at Two Upcoming Scientific Conferences

Retrieved on: 
Friday, October 29, 2021
Research, SAN, SQ, Complement component 4, Protease, CFI, Security (finance), U.S. Securities and Exchange Commission, Patient, NASDAQ, Disease, ASBMB, SEC, Risk, C3b, Precision medicine, Forward-looking statement, Company, Clinical trial, COVID-19, Coagulopathy, Biochemistry, Society, GLOBE, Mouse, Complement, American Society for Biochemistry and Molecular Biology, Animal, Pharmaceutical industry

Catalyst will provide an overview of the Companys ProTUNE platform, and its ability to engineer Complement Factor I (CFI) for potency and specificity in complement-mediated disorders.

Key Points: 
  • Catalyst will provide an overview of the Companys ProTUNE platform, and its ability to engineer Complement Factor I (CFI) for potency and specificity in complement-mediated disorders.
  • "We are excited that the ProTUNE platform and specifically the C3b/C4b degraders are demonstrating the potential to be used for precision medicine, in multiple complement-related indications, saidGrant Blouse, Ph.D., chief scientific officer of Catalyst.
  • Were looking forward to providing additional updates on our complement discovery programs as well as on CB 4332, our enhanced CFI protease for CFI deficiency expected to enter the clinic in 2022.
  • Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems.