Novimmune Explained

Novimmune is a privately held Swiss pharmaceutical development company focusing on monoclonal antibody therapies for treatment of immune-related diseases.^[1] The company was founded in 1998.^[2]

Novimmune has six publicly disclosed drug in their pipeline:

• NI-0101, an anti-TLR4 antibody being developed in partnership with Genentech. A phase I clinical trial was completed in 2014^[3] and phase II trials are expected to begin in early 2017.^[4]
• NI-0401, an anti-CD3ε antibody being developed in partnership with Tiziana Life Sciences. Phase II trials in patients with Crohn's disease and transplant rejection finished in 2008 and 2009, respectively.^[5]
• NI-0501, an anti-IFNγ antibody, is in development for hemophagocytic lymphohistiocytosis.^{[6] [7]} A phase II/III trial began in 2013 and is ongoing.^[8] The FDA awarded breakthrough status to the drug in 2016.^[9]
• NI-1401, an anti-IL17 drug being developed in partnership with Genentech for inflammatory and auto-immune diseases.^[10]
• NI-1701, an anti-CD47, anti-CD19 bispecific antibody in development for treatment of B-cell hematological cancers.
• NI-1801, an anti-CD47, anti-mesothelin bispecific antibody in the preclinical phase of development for treatment of solid tumors.^[11]

No drugs have been approved yet.

Notes and References

1. Web site: Novimmune's NI-0501 Granted Breakthrough Therapy Designation by US FDA for Treatment of Patients With Primary Hemophagocytic Lymphohistiocytosis (HLH) - FierceBiotech. www.fiercebiotech.com.
2. Web site: Novimmune SA: Private Company Information - Bloomberg. www.bloomberg.com.
3. Web site: First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers - Full Text View - ClinicalTrials.gov.
4. Web site: Pipeline - NI-0101 anti-TLR4. www.novimmune.com.
5. Web site: NI-0401 in Patients With Acute Renal Allograft Rejection - Full Text View - ClinicalTrials.gov.
6. Web site: Pipeline | NI-0501 anti-IFNγ . 2017-01-11 . https://web.archive.org/web/20170113153746/https://www.novimmune.com/en/pipeline/ni-0501-anti-ifngamma.html . 2017-01-13 . dead .
7. Web site: Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody - Full Text View - ClinicalTrials.gov.
8. Web site: A Study to Investigate the Safety and Efficacy of an Anti-IFNγ mAb in Children Affected by Primary Haemophagocytic Lymphohistiocytosis - Full Text View - ClinicalTrials.gov.
9. Web site: Emapalumab - NovImmune - AdisInsight. adisinsight.springer.com.
10. Web site: Pipeline - NI-1401 anti-IL17. www.novimmune.com.
11. Web site: Pipeline - NI-1801 anti-CD47/Mesothelin. www.novimmune.com.