 |
1 Disease |  |
2 Trials |
|
2 Trials |  |
136 News |  |
| «1234» |
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] SUTIMLIMAB, A TARGETED COMPLEMENT C1S INHIBITOR, IMPROVES QUALITY OF LIFE (QOL) IN PATIENTS WITH COLD AGGLUTININ DISEASE (CAD): RESULTS FROM THE RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 CADENZA STUDY () - May 13, 2021 - Abstract #EHA2021EHA_652;
P3
Improvements in some other PROs were also observed. In addition to the single-arm CARDINAL study, these PBO-controlled results support targeting the classical pathway via C1s inhibition in CAD.
- | sutimlimab (BIVV009) / Sanofi
Journal: Sutimlimab in Cold Agglutinin Disease. (Pubmed Central) - Apr 23, 2021
P3
In patients with cold agglutinin disease who received sutimlimab, selective upstream inhibition of activity in the classic complement pathway rapidly halted hemolysis, increased hemoglobin levels, and reduced fatigue. (Funded by Sanofi; CARDINAL ClinicalTrials.gov number, NCT03347396.).
- ||| Enjaymo (sutimlimab) / Sanofi
Trial completion: TNT009-01: Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders (clinicaltrials.gov) - Apr 8, 2021
P1, N=122, Completed, Sponsor: Bioverativ, a Sanofi company
(Funded by Sanofi; CARDINAL ClinicalTrials.gov number, NCT03347396.). Active, not recruiting --> Completed
- || Enjaymo (sutimlimab) / Sanofi
Trial completion: A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - Mar 4, 2021
P1, N=12, Completed, Sponsor: Bioverativ, a Sanofi company
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Journal: Antibodies to watch in 2020. (Pubmed Central) - Jan 9, 2021
P3
Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.
- || Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: New Insights in Autoimmune Hemolytic Anemia: From Pathogenesis to Therapy Stage 1. (Pubmed Central) - Dec 3, 2020
Several new drugs are under development including B-cell directed therapies (ibrutinib, venetoclax, parsaclisib) and inhibitors of complement (sutimlimab, pegcetacoplan), spleen tyrosine kinases (fostamatinib), or neonatal Fc receptor. Here, a comprehensive review of the main clinical characteristics, diagnosis, and pathogenic mechanisms of AIHA are provided, along with classic and new therapeutic approaches.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] SUTIMLIMAB, A COMPLEMENT C1S INHIBITOR, IMPROVES QUALITY OF LIFE IN PATIENTS WITH COLD AGGLUTININ DISEASE: PATIENT-REPORTED OUTCOMES RESULTS OF THE PHASE 3 CARDINAL STUDY () - Nov 26, 2020 - Abstract #HEMO2020HEMO_94;
P3
Treatment with sutimlimab, an inhibitor of complement C1s, resulted in rapid, clinically meaningful improvements in all PRO measures evaluated, further supporting the effectiveness of targeting the CP in the management of patients with this condition. Data first presented at EHA 2020, 11th-21st June 2020.
- |||| sutimlimab (BIVV009) / Sanofi
Sanofi's hopes for rare blood disease candidate sutimlimab on hold after FDA blasts 3rd-party manufacturer https://t.co/gWQGSyv7xk (Twitter) - Nov 17, 2020
- ||| sutimlimab (BIVV009) / Sanofi
Clinical: $SNY receives CRL for Sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease. (Twitter) - Nov 16, 2020
- | sutimlimab (BIVV009) / Sanofi
A CRL for sutimlimab is @sanofi 's Friday 13th bad luck charm https://t.co/XmrVte1CS4 (Twitter) - Nov 14, 2020
- || sutimlimab (BIVV009) / Sanofi
CRL for $SNY sutimlimab (ex Bioverativ). Earlier take from #ASH19 @ByAmyBrown https://t.co/t822zbUpFj (Twitter) - Nov 14, 2020
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Effect of Sutimlimab Treatment on Healthcare Resource Utilization in Patients with Cold Agglutinin Disease (Channel 17 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3153;
P3
Sutimlimab treatment demonstrates substantial reductions in hospitalizations and blood transfusions. This results in a reduced HCRU impact and decreases the associated burden for hospitals, patients and payers.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Interim Results of the Phase 3 Cardinal Study Long-Term Follow-up (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_2137;
P3
Conclusions The 1-year interim follow-up results of the Phase 3 Cardinal study show that sutimlimab, a first-in-class selective CP inhibitor, has a sustained treatment effect in CAD; via long-term complement inhibition, sutimlimab maintains both Hb levels >11 g/dL and improved FACIT-F, with no new safety concerns identified. These positive results support sutimlimab use as an effective and well-tolerated long-term therapy for the management of chronic primary CAD.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Sutimlimab, a Complement C1s Inhibitor, Improves Quality of Life in Patients with Cold Agglutinin Disease: Patient-Reported Outcomes Results of the Phase 3 Cardinal Study (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1721;
P3
Conclusions The Phase 3 Cardinal study demonstrated that, in addition to the degree of anemia, CP activation with subsequent hemolysis plays a critical role as a driver of fatigue symptoms and poor QoL in patients with CAD. Treatment with sutimlimab, an inhibitor of complement C1s, resulted in rapid, clinically meaningful improvements in all PRO measures evaluated, further supporting the effectiveness of targeting the CP in the management of patients with this condition.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Inflammation and Fatigue in Patients with Cold Agglutinin Disease (CAD): Analysis from the Phase 3 Cardinal Study (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1714;
P3
Improved FACIT-F scores are concurrent with sutimlimab treatment and inhibition of the CP. Concurrent inverse changes were noted between select inflammatory cytokines and improvements in patients’ fatigue, suggesting complement-mediated inflammation may additionally contribute to manifestation of fatigue in patients with CAD.
- sutimlimab (BIVV009) / Sanofi, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Long-Term Safety and Efficacy of Sutimlimab in Patients with Chronic Immune Thrombocytopenia (Channel 17 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1567;
This is continued clinical evidence that the complement pathway plays a role in thrombocytopenia in a subset of patients with ITP. These sustained responses suggest ≥1 additional pathophysiologic explanation for the clinical heterogeneity of ITP and provide a strong platform for continued evaluation of CP inhibition in ITP treatment.
- || Enjaymo (sutimlimab) / Sanofi
Enrollment closed: TNT009-01: Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders (clinicaltrials.gov) - Oct 28, 2020
P1, N=122, Active, not recruiting, Sponsor: Bioverativ, a Sanofi company
These sustained responses suggest ≥1 additional pathophysiologic explanation for the clinical heterogeneity of ITP and provide a strong platform for continued evaluation of CP inhibition in ITP treatment. Recruiting --> Active, not recruiting
- || Enjaymo (sutimlimab) / Sanofi
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - Oct 28, 2020
P1, N=12, Active, not recruiting, Sponsor: Bioverativ, a Sanofi company
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Apr 2021 | Trial primary completion date: May 2022 --> Apr 2021
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] The Complement C1s Inhibitor Sutimlimab Improves Quality of Life in Patients with Cold Agglutinin Disease: Patient-Reported Results from the Phase 3 Cardinal Study (Abstract video presentations) - Sep 3, 2020 - Abstract #DGHO2020DGHO_1580;
P3
The Phase 3 Cardinal study demonstrated that CP activation with subsequent hemolysis plays a critical role as a driver of fatigue symptoms and poor QoL in patients with CAD. Treatment with sutimlimab resulted in rapid improvements in fatigue measurement and QoL endpoints.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Results of the phase 3 cardinal study: Inhibition of complement factor C1s with sutimlimab in patients with cold agglutinin disease (CAD) (Abstract video presentations) - Sep 3, 2020 - Abstract #DGHO2020DGHO_1575;
In the Phase 3 Cardinal study, sutimlimab treatment rapidly and sustainably improved hemolysis and QOL in patients with CAD. Thus, CP inhibition represents a novel, effective therapeutic approach for the management of CAD.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Results of the phase 3 cardinal study: Inhibition of complement factor C1s with sutimlimab in patients with cold agglutinin disease (CAD) (Samarkand) - Sep 3, 2020 - Abstract #DGHO2020DGHO_1137;
In the Phase 3 Cardinal study, sutimlimab treatment rapidly and sustainably improved hemolysis and QOL in patients with CAD. Thus, CP inhibition represents a novel, effective therapeutic approach for the management of CAD.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] The Complement C1s Inhibitor Sutimlimab Improves Quality of Life in Patients with Cold Agglutinin Disease: Patient-Reported Results from the Phase 3 Cardinal Study (Abstract video presentations) - Sep 3, 2020 - Abstract #DGHO2020DGHO_929;
P3
The Phase 3 Cardinal study demonstrated that CP activation with subsequent hemolysis plays a critical role as a driver of fatigue symptoms and poor QoL in patients with CAD. Treatment with sutimlimab resulted in rapid improvements in fatigue measurement and QoL endpoints.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Results of the phase 3 cardinal study: Inhibition of complement factor C1s with sutimlimab in patients with cold agglutinin disease (CAD) (Abstract video presentations) - Sep 3, 2020 - Abstract #DGHO2020DGHO_924;
In the Phase 3 Cardinal study, sutimlimab treatment rapidly and sustainably improved hemolysis and QOL in patients with CAD. Thus, CP inhibition represents a novel, effective therapeutic approach for the management of CAD.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] The Complement C1s Inhibitor Sutimlimab Improves Quality of Life in Patients with Cold Agglutinin Disease: Patient-Reported Results from the Phase 3 Cardinal Study (Abstract video presentations) - Sep 3, 2020 - Abstract #DGHO2020DGHO_89;
P3
The Phase 3 Cardinal study demonstrated that CP activation with subsequent hemolysis plays a critical role as a driver of fatigue symptoms and poor QoL in patients with CAD. Treatment with sutimlimab resulted in rapid improvements in fatigue measurement and QoL endpoints.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] Results of the phase 3 cardinal study: Inhibition of complement factor C1s with sutimlimab in patients with cold agglutinin disease (CAD) (Abstract video presentations) - Sep 3, 2020 - Abstract #DGHO2020DGHO_84;
In the Phase 3 Cardinal study, sutimlimab treatment rapidly and sustainably improved hemolysis and QOL in patients with CAD. Thus, CP inhibition represents a novel, effective therapeutic approach for the management of CAD.
- || sutimlimab (BIVV009) / Sanofi
Clinical, Journal: Serum complement levels in immune thrombocytopenia: Characterization and relation to clinical features. (Pubmed Central) - Jul 21, 2020
Complement levels are reduced in one-third of patients with ITP and are associated with more severe disease. Additional study is needed to evaluate if hypocomplementemia is predictive of response to emerging complement-directed therapies.
- | sutimlimab (BIVV009) / Sanofi
Journal: Specific inhibition of the classical complement pathway prevents C3 deposition along the dermal-epidermal junction in bullous pemphigoid. (Pubmed Central) - Jun 8, 2020
P1
One serious adverse event (i.e. fatal cardiac decompensation) occurred at the end of the post-treatment observation period in an 84-year-old patient with a history of diabetes and heart failure, but was deemed unlikely to be related to the study drug. This trial provides the first results with a complement-targeting therapy in BP, to our knowledge, and supports further studies on BIVV009's efficacy and safety in this population.
- | Enjaymo (sutimlimab) / Sanofi
Trial completion date, Trial primary completion date: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) (clinicaltrials.gov) - Jun 2, 2020
P3, N=20, Active, not recruiting, Sponsor: Bioverativ, a Sanofi company
This trial provides the first results with a complement-targeting therapy in BP, to our knowledge, and supports further studies on BIVV009's efficacy and safety in this population. Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Sep 2021
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] INHIBITION OF THE CLASSICAL COMPLEMENT PATHWAY WITH SUTIMLIMAB IN PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WITHOUT ADEQUATE RESPONSE TO TWO OR MORE PRIOR THERAPIES () - May 16, 2020 - Abstract #EHA2020EHA_1740;
Thrombocytopenia reoccurred upon sutimlimab discontinuation and resolved with re-treatment. These findings support a role for the activation of the CP as a mechanism of thrombocytopenia in ITP and provide rationale for the continued evaluation of CP inhibition as a novel therapeutic option.
- sutimlimab (BIVV009) / Sanofi
[VIRTUAL] SUTIMLIMAB, A COMPLEMENT C1S INHIBITOR, IMPROVES QUALITY OF LIFE IN PATIENTS WITH COLD AGGLUTININ DISEASE: PATIENT-REPORTED OUTCOMES RESULTS OF THE PHASE 3 CARDINAL STUDY () - May 16, 2020 - Abstract #EHA2020EHA_553;
P3
Conclusion The Phase 3 Cardinal study demonstrated that, in addition to the degree of anemia, CP activation with subsequent hemolysis plays a critical role as a driver of fatigue symptoms and poor QoL in patients with CAD. Treatment with sutimlimab, an inhibitor of complement C1s, resulted in rapid, clinically meaningful improvements in all PRO measures evaluated, further supporting the effectiveness of targeting the CP in the management of patients with this condition.
- || Enjaymo (sutimlimab) / Sanofi
Enrollment closed: Cadenza: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (clinicaltrials.gov) - Apr 24, 2020
P3, N=40, Active, not recruiting, Sponsor: Bioverativ, a Sanofi company
Treatment with sutimlimab, an inhibitor of complement C1s, resulted in rapid, clinically meaningful improvements in all PRO measures evaluated, further supporting the effectiveness of targeting the CP in the management of patients with this condition. Recruiting --> Active, not recruiting
- | sutimlimab (BIVV009) / Sanofi
Sutimlimab effectief bij patiënten met koudeagglutinatieziekte https://t.co/6kOpyxcwVS #ASH2019 (Twitter) - Dec 11, 2019
- | Enjaymo (sutimlimab) / Sanofi
Trial completion date, Trial primary completion date: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) (clinicaltrials.gov) - Nov 29, 2019
P3, N=20, Active, not recruiting, Sponsor: Bioverativ Therapeutics Inc.
Recruiting --> Active, not recruiting Trial completion date: Jun 2020 --> Sep 2020 | Trial primary completion date: Jun 2020 --> Sep 2020
- | Enjaymo (sutimlimab) / Sanofi
Trial completion date, Trial primary completion date: Cadenza: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (clinicaltrials.gov) - Nov 29, 2019
P3, N=40, Recruiting, Sponsor: Bioverativ Therapeutics Inc.
Trial completion date: Jun 2020 --> Sep 2020 | Trial primary completion date: Jun 2020 --> Sep 2020 Trial completion date: Oct 2020 --> Nov 2021 | Trial primary completion date: Oct 2020 --> Nov 2021
- | Enjaymo (sutimlimab) / Sanofi
Trial completion date, Trial primary completion date: A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - Nov 26, 2019
P1, N=16, Recruiting, Sponsor: Bioverativ, a Sanofi company
Trial completion date: Oct 2020 --> Nov 2021 | Trial primary completion date: Oct 2020 --> Nov 2021 Trial completion date: Feb 2021 --> May 2022 | Trial primary completion date: Feb 2021 --> May 2022
- sutimlimab (BIVV009) / Sanofi
Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Results from the Phase 3 Cardinal Study (Hall D, Level 2 (Orange County Convention Center)) - Nov 21, 2019 - Abstract #ASH2019ASH_6614;
P3
Conclusions The Phase 3 Cardinal study shows that sutimlimab, a first-in-class selective inhibitor of the CP, has a rapid and sustained treatment effect in CAD by preventing hemolysis, significantly increasing Hb, and improving QOL (FACIT-F) . These results demonstrate that targeting the CP represents a novel, effective therapeutic approach for the management of CAD and indicate that sutimlimab has the potential to change treatment practices for patients with this condition.
- || Late-breaking abstract: #ASH19 late breakers out with four Ph3 data https://t.co/flyuEk5DOc $AMGN Blinatumomab https://t.co/pzogHxYjht $JNJ Daratumumab https://t.co/ENWRK5MlYv $SNY Sutimlimab https://t.co/5m45Fqqbrr $CELG CC-486 https://t.co/nlFEv1JcZM (Twitter) - Nov 21, 2019
- || sutimlimab (BIVV009) / Sanofi
P1 data, Journal: Inhibition of complement C1s improves severe hemolytic anemia in cold agglutinin disease: a first-in-human trial. (Pubmed Central) - Nov 14, 2019
P1
In conclusion, sutimlimab was safe, well tolerated, and rapidly stopped C1s complement-mediated hemolysis in patients with cold agglutinin disease significantly increasing hemoglobin levels and precluding the need for transfusions. This trial was registered at https://clinicaltrials.gov/ as #NCT02502903.
- || sutimlimab (BIVV009) / Sanofi
Clinical, P1 data, Journal: Anti-C1s Monoclonal Antibody BIVV009 in Late Antibody-Mediated Kidney Allograft Rejection - Results from a First-in-Patient Phase 1 Trial. (Pubmed Central) - Nov 11, 2019
This initial trial provides a valuable basis for future studies designed to clarify the therapeutic value of CP blockade in transplantation. ClinicalTrials.
- sutimlimab (BIVV009) / Sanofi
Inhibition of the Classical Pathway of Complement with Sutimlimab in Chronic Immune Thrombocytopenic Purpura Patients without Adequate Response to Two or More Prior Therapies (W307, Level 3 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_6562;
This is the first clinical evidence that the CP plays a role in thrombocytopenia in a subset of patients with ITP . These responses suggest at least 1 additional pathophysiologic explanation for the clinical heterogeneity of ITP, and provide a strong rationale for continued evaluation of CP inhibition in ITP treatment.
- Rituxan (rituximab) / Roche, Biogen
Predictors of Response to Erythropoietin in Autoimmune Hemolytic Anemia (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_5223;
Predictors of response were severe anemia and low levels of endogenous EPO, as well as, shorter disease duration and a lower burden of previous treatments . These data suggest an early use of EPO in this setting in order to overcome inadequate bone marrow compensatory ability.
- sutimlimab (BIVV009) / Sanofi
Serum Complement Levels in Immune Thrombocytopenia: Characterization and Relation to Clinical Features (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1893;
We observed a relation between low C4 and more severe disease and low C3 and reduced platelet counts . Patients requiring treatment had significantly lower C4 and CH50 relative to those not requiring treatment, and splenectomized patients had significantly higher C3.
- | sutimlimab (BIVV009) / Sanofi
Preclinical, Journal: C1s Inhibition by BIVV009 (Sutimlimab) Prevents Complement-Enhanced Activation of Autoimmune Human B Cells In Vitro. (Pubmed Central) - Oct 27, 2019
Strikingly, CP antagonism suppressed human Ig-induced activation of B cells derived from patients with rheumatoid arthritis. These results suggest that clinical use of CP inhibitors in autoimmune patients may not only block complement-mediated tissue damage, but may also prevent the long-term activation of autoimmune B cells and the production of autoantibodies that contribute to the underlying pathologic condition of these diseases.
- sutimlimab (BIVV009) / Sanofi
Long-term inhibition of complement C1s in patients with cold agglutinin disease: results of a named patient program (M3) - Sep 30, 2019 - Abstract #DGHO2019DGHO_84;
C1s inhibition may be an effective therapeutic target for continuous treatment of CAD patients over time. Two ongoing phase 3 trials are further evaluating the use of sutimlimab in CAD.
- | Soliris (eculizumab) / Alexion Pharma
Review, Journal: Novel insights into the treatment of complement-mediated hemolytic anemias. (Pubmed Central) - Sep 17, 2019
Upstream complement modulation is currently being investigated and appears to be a highly promising therapy, and two such agents have entered phase II and III trials. Of these, the anti-C1s monoclonal antibody sutimlimab has shown favorable activity in CAD, while the anti-C3 cyclic peptide pegcetacoplan appears to be promising in PNH as well as CAD, and may also have a therapeutic potential in wAIHA.
- | sutimlimab (BIVV009) / Sanofi
Clinical, P1 data, Journal: A randomized, first-in-human, healthy volunteer trial of BIVV009, a humanized antibody for the specific inhibition of the classical complement pathway. (Pubmed Central) - Sep 11, 2019
BIVV009 exhibited a steep concentration-effect relationship with a Hill coefficient of 2.4, and an IC90 of 15.5 µg/mL. This study establishes the foundation for using BIVV009 as a highly selective inhibitor of the classical complement pathway in different diseases.
- | Rituxan (rituximab) / Roche, Biogen
Journal: Cold agglutinin disease: current challenges and future prospects. (Pubmed Central) - May 23, 2019
These achievements have raised new challenges and further prospects, which are discussed. Patients with CAD requiring therapy should be considered for clinical trials.
- | Campath (alemtuzumab) / Sanofi, Soliris (eculizumab) / Alexion Pharma, Rituxan (rituximab) / Roche, Biogen
Journal: Current and emerging treatment options for autoimmune hemolytic anemia. (Pubmed Central) - May 22, 2019
The latter may give hints for targeted therapies (either B or T cell directed) and for new immunomodulatory drugs. Future studies on the genomic landscape in AIHA will further help in designing the best choice, sequence and/or combination of targeted therapies.
- | Soliris (eculizumab) / Alexion Pharma
Journal: Novel Approaches to Block Complement. (Pubmed Central) - Apr 24, 2019
Moreover, modified apheresis techniques for preferential removal of macromolecules, including C1q, may allow for efficient complement depletion, in addition to antibody removal. The availability of effective strategies to interfere with the CP, as well as innovative approaches targeting other pathways, some of them already being tested in clinical trials, will help us figure out how complement contributes to acute and chronic graft injury, and hopefully provide us with new ways to more efficiently counteract rejection.
- | Rituxan (rituximab) / Roche, Biogen
Clinical, Journal: How I manage patients with cold agglutinin disease. (Pubmed Central) - Mar 29, 2019
Second-line options are rituximab-fludarabine in fit patients or, although less strongly documented, a bortezomib-based regimen. Therapies targeting the classical complement pathway are promising, and the complement C1s inhibitor, BIVV009, has shown favourable results in preliminary studies.