CSL730 / CSL Behring, J&J - LARVOL DELTA

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=52 | Terminated | Sponsor: CSL Behring | Trial completion date: Dec 2024 ➔ Mar 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Mar 2023; Lack of clinical viability

Trial completion date • Trial primary completion date • Trial termination • Immunology

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: CSL Behring | Trial completion date: May 2023 ➔ Dec 2024 | Trial primary completion date: May 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Immunology

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: CSL Behring | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Immunology

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: CSL Behring | Trial completion date: Jul 2022 ➔ Dec 2022 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Immunology

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: CSL Behring; Trial completion date: Oct 2021 ➔ Jul 2022; Trial primary completion date: Oct 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Immunology

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: CSL Behring; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology

Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults (clinicaltrials.gov) - P1; N=26; Terminated; Sponsor: CSL Behring; N=66 ➔ 26; Active, not recruiting ➔ Terminated; The Sponsor decided to terminate this study in favor of development of subcutaneous administration.

Clinical • Enrollment change • Trial termination

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: CSL Behring

Clinical • New P1 trial • Immunology

"Die Gauß-Allianz ist auch dieses Jahr bei der #ISC18 dabei. Schauen Sie gern bei uns am Stand M-230 oder bei unseren Mitgliedern vorbei. @ISChpc" (@hpc_deutschland)

Cardiovascular

Identification of Mu opioid receptor in Melanoma (NCRI 2017) - "Taken together, our results confirm the presence of MOR and phosphorylated MOR in melanoma cells. Although, treatment with a MOR agonist and antagonist did not influence the proliferation of melanoma cells, we are currently investigating whether MOR downstream signalling is activated in melanoma. These data indicate that MOR expression is common in melanoma, highlighting the potential that opioid stimulation may influence tumour signalling cascades."

Melanoma

Momenta and CSL announce collaboration and license agreement to develop Fc multimer programs, including M230, a selective immunomodulator of Fc receptors (PipelineReview) - "Momenta Pharmaceuticals...and CSL Limited...today announced that they have entered into an exclusive research collaboration and worldwide license agreement to develop and commercialize...Momenta's M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic in 2017."

Licensing / partnership • Myasthenia Gravis

Next-generation Fc receptor-targeting biologics for autoimmune diseases. (PubMed, Autoimmun Rev) - "These include PF-06755347 (GL-2045), CSL730 (M230), CSL777 and Pan Fc Receptor Interacting Molecule (PRIM). Neonatal Fc receptor (FcRn)-targeting therapeutics block the FcRn receptor and are represented by candidate drugs such as the Fc fragment efgartigimod and the monoclonal antibodies rozanolixizumab (UCB7665), M281 and SYNT001. Finally, Fc and FcγR-targeting therapeutics, comprise molecules that target the Fc of IgG, such as the recombinant soluble FcγIIb receptor valziflocept (SM101/SHP652) and various monoclonal antibodies directed against the receptors...Although initial results are promising, further long-term data and a better understanding of the unique mechanisms of action of the different molecules are needed. The efficacy, safety, convenience of administration, duration of effects, and cost will all contribute to determining which of the molecules will be successful in the clinic."

Journal • Review

Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults (clinicaltrials.gov) - P1; N=66; Active, not recruiting; Sponsor: CSL Behring; Trial completion date: Sep 2019 ➔ May 2020; Trial primary completion date: Sep 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: CSL Behring; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open