gontivimab (ALX-0171) / Sanofi - LARVOL DELTA

Systematic Review of the Efficacy and Safety of RSV-Specific Monoclonal Antibodies and Antivirals in Development. (PubMed, Rev Med Virol) - "Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab-YTE, nirsevimab, ALX-0171, suptavumab, clesrovimab) and 12 AV therapies (ALN-RSV01, RSV604, presatovir, MDT-637, lumicitabine, IFN-α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP-938). Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development. TRIAL REGISTRATION: PROSPERO registration: CRD42022376633."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNA1

Neutrophils in respiratory syncytial virus infection: from harmful effects to therapeutic opportunities. (PubMed, Br J Pharmacol) - "Although antiviral drugs are obvious candidates to treat viral illness, and some have shown antiviral effects in humans, antivirals such as GS-5806, ALX-0171, ALS-8176 did not yet meet their expectations. It is unclear how these cells contribute to antiviral defense or whether they contribute to lung pathology. This article discusses the protective and harmful roles of neutrophils during RSV infection and provides an overview of mechanisms by which neutrophil function could be targeted to prevent tissue injury and preserve homeostasis."

Journal • Review • Immune Modulation • Immunology • Infectious Disease • Inflammation

Nebulised ALX-0171 for respiratory syncytial virus lower respiratory tract infection in hospitalised children: a double-blind, randomised, placebo-controlled, phase 2b trial. (PubMed, Lancet Respir Med) - P2 | "Antivirals against RSV might be unable to improve clinical course once RSV lower respiratory tract infection is established. Future studies of RSV antivirals should focus on earlier intervention and more precise measurement of objective outcomes before the onset of significant lower respiratory tract inflammation."

Clinical • Journal • P2b data • Immunology • Infectious Disease • Inflammation • Pediatrics • Respiratory Diseases

Respire: Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (clinicaltrials.gov) - P2; N=180; Completed; Sponsor: Ablynx; Active, not recruiting ➔ Completed

Trial completion • Biosimilar

Comparative therapeutic potential of ALX-0171 and palivizumab against RSV clinical isolate infection of well-differentiated primary pediatric bronchial epithelial cell cultures. (PubMed, Antimicrob Agents Chemother) - "The data indicate a clear disparity between viable virus neutralisation and GC viral load, the latter of which does not discriminate between viable and neutralised RSV. This study validates the RSV/WD-PBEC model for the pre-clinical evaluation of RSV antivirals."

Journal

Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Ablynx; N=75 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal

"Sanofi $SAN $SNY piepline additions & removals IN: CD38+atezo in solid tumors (didn't work w/ Darzalex+atezo...) & CD38+cemi in NHL, BCMAxCD3 bispec in RRMM, "cytokine mRNA" in melanoma, RIPK1 in ALS & AD... OUT: cemi+ipi in NSCLC 1L, ALX0171 in RSV, LAG3, CTLA-4,..." (@BiotechRadar)

"Now $SNY highlighting Sobi-partnered SP0232 in RSV - why they dropped the Ablynx project ALX0171? See today's earlier story by @JacobPlieth https://t.co/3YWmUV7iW3" (@ByMadeleineA)

Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2; N=75; Not yet recruiting; Sponsor: Ablynx; Initiation date: Jun 2018 ➔ Feb 2019

Clinical • Trial initiation date