GIGA-2050 / Grifols - LARVOL DELTA

A Potent Recombinant Polyclonal Antibody Therapeutic for Protection Against New SARS-CoV-2 Variants of Concern. (PubMed, J Infect Dis) - "Omicron-specific antibody sequences were enriched from yeast expressing rCIG-scFv antibodies and exhibited increased binding and neutralization to omicron BA.2 while maintaining binding and neutralization to the ancestral strain. Polyclonal antibody libraries such as rCIG can be utilized to develop antibody therapeutics against present and future SARS-CoV-2 threats."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

GMP Manufacturing and IND-Enabling Studies of a Recombinant Hyperimmune Globulin Targeting SARS-CoV-2. (PubMed, Pathogens) - "These results supported a successful investigational new drug application for GIGA-2050. This study demonstrates that a new class of drugs, recombinant hyperimmune globulins, can be manufactured consistently at the clinical scale and presents a new approach to treating infectious diseases that targets multiple epitopes of a virus."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients (clinicaltrials.gov) - P1; N=3; Terminated; Sponsor: GigaGen, Inc.; N=18 ➔ 3; Trial completion date: Aug 2021 ➔ Jan 2022; Recruiting ➔ Terminated; Trial primary completion date: Aug 2021 ➔ Jan 2022; Study stopped for commercial reasons.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: GigaGen, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: GigaGen, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Grifols reinforces its innovation strategy after completing the acquisition of GigaGen to boost a novel method to generate a wide range of immunoglobulins (PRNewswire) - "Grifols...announced the closing of its agreement with GigaGen Inc. to acquire its remaining 56% share capital for USD 80 million....GigaGen brings a diversified pipeline of recombinant polyclonal antibodies, including GIGA-2050, a recombinant hyperimmune immunoglobulin for the treatment of COVID-19, which is expected to be evaluated in a Phase 1 trial in the U.S. in spring 2021 after the recent approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial, which will be the first-in-human study...will assess the safety and tolerability of a single dose of GIGA-2050 in up to 18 hospitalized patients with confirmed COVID-19."

IND • M&A • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Newly added product (GlobeNewswire) - Preclinical, Novel Coronavirus Disease

Pipeline update