Humabs BioMed Seeking Clinical Development Partner For ‘Natural Selection’ MAbs
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis and MedImmune have over the past several months also started clinical studies of antibodies licensed from the Swiss biotech, which derives its products from patients with highly effective immune responses.
The private Swiss biotech Humabs BioMed SA has become profitable because of its licensing deals and now wants to take its monoclonal antibody products into clinical development in partnership with a co-developer, says company CEO Alcide Barberis.
Because of the revenues generated from licensing products to other companies, Humabs has sufficient funding to take one or two projects into clinical development with a co-development partner. “We have already had some interesting contacts that we are evaluating,” Barberis said.
However, the company is unlikely to contemplate taking a drug all the way to market on its own.
Humabs has a large pipeline of preclinical projects that include programs licensed from Switzerland’s Institute for Research in Biomedicine (IRB), projects generated from its own internal research and other compounds already licensed to collaborators. The programs include MAbs against respiratory syncytial virus, Staphylococcus aureus infection, rabies, Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), dengue and ebola.
Humabs is currently focused on infectious diseases, but also has selected antibodies against inflammatory disorders and cancer for its pipeline.
‘Natural Selection’ Approach To Product Discovery
Humabs was set up in 2004 as a spin out from the IRB, based on the work of IRB researcher and company co-founder Antonio Lanzavecchia, Barberis explained in an interview.
Humabs takes a “natural selection” approach to identifying new products by isolating antibodies from patients who have developed strong immune responses to disease and using them as a template for novel products.
Two of Humabs’ big pharma partners have been unveiled over the past several months – Novartis AG and MedImmune LLC – and it has two other undisclosed big pharma partners exploiting its technology involving the identification and cloning of MAbs derived from “winning” antibodies that have helped patients overcome serious infections and other conditions.
Novartis signed a licensing agreement with Humabs in 2009, and earlier this month revealed it had started Phase II clinical studies in the U.S. and Germany with a potential human anti-cytomegalovirus MAb that used Humabs’ proprietary Cellclone technology. The trial initiation triggered a milestone payment to Humabs.
And in April 2015, MedImmune reported the start of a Phase I clinical study with MED18852, an antibody isolated from human memory B cells using Cellclone technology that has potential in the treatment of influenza A. MED18852 binds to a novel site in the hemagglutinin stem region shared by all 18 influenza A virus subtypes.
Although the idea of isolating antibodies directly from patients recovering from serious disease and using them to derive MAb products is not new, “the devil is in the details,” Barberis said. “You have to be systematic and well organized.” You also have to have access to patients that are donors for this “natural selection” approach.
Once isolated, Humabs’ proprietary and IP-protected methods of immortalizing and cloning immune B cells and plasma cells come into play. This is combined with its method of selecting antigen-binding antibodies that actually neutralize infectious agents or kill tumor cells. “Only a handful of antibodies out of a huge number of antigen-binding MAbs have functional activity,” he noted.
The process selects for clinical efficacy and is relatively fast compared with other methods of antibody development, taking just several months to come up with a candidate.
There are only a few other companies that are potential competitors in this space, including AIMM Therapeutics BV in the Netherlands (Also see "Epidemiology First: MedImmune Moving Ahead With Preventive Antibodies, But Needs More HAP Data" - Pink Sheet, 25 Sep, 2014.). Theraclone Sciences Inc. in Seattle has also isolated antibodies that have been effective in combatting disease (Also see "Financings Of The Fortnight And The Never-Ending Venture Round" - Pink Sheet, 21 Feb, 2014.).
Humabs’ board includes former Chiron Corp. (now part of Novartis) co-founder, chairman and Humabs majority shareholder William Rutter; Jakob Nuesch, former head of research at Ciba Pharmaceuticals (also now part of Novartis); and Thomas Hecht, former vice-president of marketing at Amgen Inc. in Europe.