EnGeneIC will grant ImmunityBio an exclusive, worldwide licence for development through to commercialization of its EnGeneIC Dream Vector (EDV) in combination with its anti-cancer drugs and COVID-19 vaccine. As part of the deal, ImmunityBio will build manufacturing facilities for EnGeneIC in US and South Africa.
The COVID-19 vaccine is already in clinical trials: with early results indicating that the antibodies generated can neutralize COVID-19 and variants including Delta. EnGeneIC also believe the vaccine will be effective against mutants, as well as having the logistical advantages of one year of shelf-life and room temperature storage.
The EDV tech also ‘targets and effectively kills cancer cells with minimal toxicity, while stimulating an anti-tumour immune response’. It is in Phase 1 and IIa trials in patients with advanced pancreatic cancer.
Nanocell tech
Founded in 2001, Sydney-based EnGeneIC's EDVs are non-living nanocells originally developed for oncology applications.
A single 400nm EDV can be packed with up to 1 million molecules of an anticancer drug such as Doxorubicin or the extremely potent derivative of nemorubicin, PNU159682, which is unable to be used systemically as a clinical chemotherapeutic due to its severe toxicity.
Meanwhile, regulatory genetic molecules (siRNA/miRNA) can be loaded in therapeutically significant concentrations.
The EDV is coated with a bispecific antibody, which attaches through antibody-antigen interaction to the EDV at one end and has specificity to cancer cells on the other end. The tumor targeting antibody can be changed depending on the type of cancer.
For the COVID-19 vaccine, EDVs are used to carry the COVID-19 spike protein. The vaccine entered a Phase 1 trial in Melbourne in September.
One of the points of difference of EDVs is that they could be used with vulnerable cancer patients or vulnerable populations for COVID-19 vaccination.
“In cancer trials, dosing with EDVs has resulted in physiological levels of Type 1 and Type II interferon stimulation, and activation and proliferation of white blood cells (WBCs) has been measured, including CD8+ T cells, macrophages, NK cells, and dendritic cells. The same proven approach has potential in vulnerable COVID-19 patients and indeed in most future viral pandemics for the target population,” says the company.
Joint focus on oncology and infectious diseases
ImmunityBio’s founder and executive chairman Dr. Patrick Soon-Shiong invented the world’s first protein nanparticle drug, Abraxane (used in the treatment of pancreatic cancer); before founding ImmunityBio in 2014 to create innovative immunotherapies in oncology and infectious diseases.
It now has more than 40 Phase 1,2 or 3 clinical trials in development across 19 indications in solid and liquid cancers and infectious diseases.
Soon-Shiong, the billionaire businessman, doctor and scientist who owns the Los Angeles Times and has a large interest in Zoom, said ImmunityBio and EnGeneIC share the same focus areas.
“It was so exciting and refreshing to find a company and its founders, who believe like we do in the power of the immune system to fight cancer and infectious diseases such as COVID,” he said. “Drs Jennifer MacDiarmid and Himanshu Brahmbhatt [EnGeneIC’s joint CEOs] have dedicated their careers to bringing this vision to fruition and we are honoured to partner with EnGeneIC to transform how these life threatening diseases are treated. A critical element of the platform is the ability to democratize this technology across the globe and bring much needed 21st century care to the under developed world.”
Developing, manufacturing and commercializing EDV
EnGeneIC’s deal with ImmunityBio is reportedly the largest in Australian biotech history. EnGeneIC will grant ImmunityBio an exclusive, worldwide licence to develop, manufacture and commercialize EDV in combination with its anti-cancer drugs and COVID-19 vaccine.
EnGeneIC will also receive upfront payments and fees for future cancer programs.
ImmunityBio will build EDV manufacturing facilities in the USA and South Africa, and cover costs associated with clinical trials and regulatory approvals.
The companies have agreed to a 50:50 split on net profit from worldwide sales of EDV-based therapeutics.