Harbour BioMed (HBM), a US-China-Netherlands biopharma, has out-licensed its fully human SARS-CoV-2 neutralizing antibody, 47D11, to AbbVie (NYSE: ABBV). The candidate is expected to prevent and treat the disease. HBM developed 47D11 together with Utrecht University in the Netherlands. AbbVie has started a Phase I clinical trial of the antibody in the US among patients with COVID-19, which it will expand into Europe. Financial details of the agreement were not disclosed.

AbbVie will conduct the clinical development of the product, and if it is successful, it will manufacture and commercialize the product around the globe. The company will pay HBM and Utrecht University a one-time license fee, payments upon achievement of certain development, regulatory, and sales-based milestones, and tiered royalties on commercial net sales.

HBM said the antibody targets a specific conserved region of the SARS-CoV-2 spike protein. It expects the candidate will treat cases of the existing pandemic, as well as future mutants of the virus. 

The Phase I trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. Specifically, it is being examined in adults who are hospitalized with COVID-19.

"The rapid progress we have made to date is a credit to the outstanding research by our teams and university partners, the strength of HBM's fully human antibody discovery platform and AbbVie's world leading expertise in antibody and antiviral drug development," said Dr. Jingsong Wang, principal founder, executive director, chairman and CEO of HBM. "With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic."

In August, HBM, Utrecht University and the Erasmus Medical Center announced they would collaborate with Viroclinics-DDL and Kiadis Pharma to develop a combination of a monoclonal antibody (mAb) and Natural Killer (NK) cells to treat COVID-19. The collaboration was meant to leverage Kiadis’ K-NK cell therapy platform.

In the past, COVID-19 has been shown to break down NK cell immunity. Patients with a severe case of the disease often lack functional NK cells. The fully human, non-blocking antibody, 49F1, targets a specific region of the SARS-CoV-2 spike protein. It has also shown that it has strong binding affinity to both SARS-CoV-2 and a second coronavirus in vitro. HBM and AbbVie expect the candidate to eliminate the SARS-CoV-2 virus and virally infected cells by K-NK cells.

HBM currently has more than 30 programs in its pipeline, including an anti-CD73 monoclonal antibody and a bi-specific anti-BCMAxCD3 mAb. Its drug discovery operations are in Rotterdam.

See our other articles on HBM and AbbVie.

Disclosure: none.