Widow spiders are spread worldwide, and their bite induces severe envenomation symptoms that can lead to a complex syndrome known as latrodectism and death in severe cases. The only available specific treatment consists of polyclonal antibodies derived from horse plasma obtained by hyperimmunization with black widow spider venom. However, this process is slow, dangerous, and implies the continuous use of large domestic animals (mainly horses) in the manufacturing process. Venom unavailability is a significant supply chain bottleneck in antivenom manufacture, which imposes a very high product cost. Also, the efficacy of this horse-derived product suffers from batch-to-batch variation, resulting in variable efficacy profiles for different batches. Finally, the non-human nature of the horse-derived antibodies may provoke severe adverse immunological reactions. The high prevalence of adverse reactions severely limits its use, and antivenom use is thus reserved for only the most extreme cases, while not being administered at all to the many patients with asthma, atopy, or other allergy-related conditions.
In this project, we are developing a recombinant antivenom based on a single broadly-neutralizing fully human monoclonal antibody that can neutralize the toxic effects of widow spider bites. According to WHO nomenclature, this antibody will be called Latrotoxumab, and it will be safer to administer, more efficacious, as well as cost-competitive with existing antivenoms. In this ERC PoC project, which is based on results obtained in the ERC StG project MABSTER (grant number 850974), we will explore the commercial potential of Latrotoxumab and lay the first foundation for a spin-off company (Fang Pharma) by securing in vivo PoC, securing IPR, developing a regulatory, manufacturing, and clinical trial plan, and preparing a fully-flexed business plan, incl. market, pricing, and SWOT analyses, identification of business growth opportunities (partners and investors), and exit strategy.
Beyond Latrotoxumab, the this proof-of-concept project, and the establishment of Fang Pharma, is paving the way for developing and commercializing other recombinant antivenoms for other life-threatening venomous animals like funnel-web spiders, recluse spiders, or even scorpions and snakes.
