Candidate: rCIG (recombinant anti-coronavirus 19 hyperimmune gammaglobulin)

Category: ANTIBODY

Type: Recombinant polyclonal antibody therapy designed to provide passive immunity to COVID-19 patients. GIGA-2050 encompasses the full diversity of anti-coronavirus antibodies captured from the convalescent serum of 16 exceptional responders to COVID-19.

According to GigaGen, GIGA-2050 consists of more than 12,000 antibodies that have shown strong neutralizing activity against natural SARS CoV-2 variants in laboratory studies, including the Delta variant and other variants.

2021 Status: First Patient Dosed—GigaGen, a subsidiary of Grifols, said August 11 that the first patient had been dosed in its Phase I trial (NCT04883138) of GIGA-2050, the company’s recombinant hyperimmune polyclonal antibody drug designed to provide passive immunity to COVID-19 patients.

The Phase I single ascending dose trial is designed to assess the safety and tolerability of GIGA-2050 in up to 18 hospitalized patients with confirmed COVID-19. Participants will be divided into three cohorts who will receive a single intravenous (IV) infusion dose of GIGA-2050 at 5mg, 15mg or 50 mg (or as determined by the safety review committee) per kg of body weight, respectively. Participants will be followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit at day 56.

2020 Status: GigaGen on March 30 disclosed its effort to deveop rCIG, an intravenous therapy designed to reproduce whole antibody repertoires of recovered COVID-19 patients, including high concentrations of antibodies that target and prevent further replication of the COVID-19 virus. GigaGen uses its single-cell technology to capture and recreate complete libraries of antibodies from COVID-19 convalescent patients that can directly translate into antibody therapies—a method the company says is much more scalable than plasma from recovered COVID-19 patient donors since one person’s B cell repertoire can be used to generate a drug that treats millions of patients.

Other advantages cited by GigaGen include a decreased risk of contamination, greater batch to batch consistency, and “hundreds-fold” higher potency than plasma-derived equivalents, which may yield better clinical outcomes.

GigaGen is recruiting patients who have recovered from COVID-19 to donate blood for the development of rCIG. The company has signed a collaboration agreement with plasma collector/manufacturer Access Biologicals to expedite patient identification and assist with sample collection. GigaGen added that it will continue talks with the FDA toward expediting development.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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