WALTHAM, Mass.—Thermo Fisher Scientific and BioNTech have teamed up in a four-year, nonexclusive licensing agreement centered on the supply of critical raw materials for manufacturing immunotherapy vaccine candidates. Per the terms of the deal, Thermo Fisher will provide BioNTech with nucleotides, enzymes and other raw materials necessary for BioNTech's messenger RNA (mRNA) manufacturing platform. This agreement also provides BioNTech with rights to apply Thermo Fisher's technologies in conjunction with its clinical and commercial manufacturing processes. Specific financial details were not disclosed.
"Our portfolio of molecular biology products is now enabling development and commercialization of multiple individualized therapies and other advanced medicines, and we continue to expand our capabilities to meet increasing demand," commented Gianluca Pettiti, president, biosciences, Thermo Fisher Scientific. "We share BioNTech's commitment to deliver life-saving therapies to patients faster, and we look forward to supporting them through clinical trials and post-approval production."
BioNTech is advancing three “therapeutic platforms using mRNA technologies for pharmacologically optimized protein-coding RNA for targeted in-vivo delivery,” the company explains on its website, one of which is geared toward cancer immunotherapies.
Within that indication, BioNTech is advancing its IVAC (Individualized Vaccines Against Cancer) approach. The IVAC platform combines the company's RNA technologies and tumor-specific information to generate personalized immunotherapies. IVAC WAREHOUSE uses RNA-based vaccines “that target shared tumor-associated antigens. The antigens that are included in a warehouse are carefully selected based on their selective expression in a certain tumor entity and their ability to induce antigen-specific immune responses. Tumor material of a patient is profiled by RT-qPCR, and based on the results, the most suitable RNAs are selected from the pre-manufactured IVAC WAREHOUSE. The patient is then treated with an individualized vaccine that best matches the antigen profile,” BioNTech explains.
Also in this platform is IVAC MUTANOME, which targets unique tumor antigens resulting from tumor-specific mutations. “The IVAC MUTANOME vaccine is produced de novo based on a patient‘s mutation profile,” according to the company. “The IVAC MUTANOME process starts with sequencing the patient’s healthy and cancerous tissue using state-of-the-art next-generation sequencing technologies. A proprietary algorithm compares the sequences in healthy and cancerous tissue and produces a catalogue of all tumor mutations—the tumor mutanome, which is specific for each patient.”
"The relationship with Thermo Fisher Scientific secures our access to customized material essential for the manufacturing and commercialization of our RNA-based product candidates," Dr. Ugur Sahin, co-founder and CEO of BioNTech, said in a press release. "In addition, as a life-science services leader, Thermo Fisher can also deliver reagents at the scale needed to expand our manufacturing capacities."
Beyond what is covered under the new agreement, BioNTech is also developing two other platforms, one of which is aimed at vaccines for infectious diseases. As the company explains on its website, “Previous epidemics have taught us that emerging viruses can quickly cause a global calamity. Conventional vaccines are usually based on inactivated or engineered viruses often require seasonal and accurate selection of specific viral strains and cannot be produced fast enough to stop a rapidly spreading pandemic. As globalization reaches remote locations, new vaccine approaches are urgently needed to respond quickly to new epidemic threats. To meet this challenge, we are developing an innovative self-amplifying RNA-based Ribological RNA Amplicon vaccine Platform against Infectious Diseases (A.I.R.--Amplified Immune Response) that has the potential to deliver millions of doses of prophylactic vaccines for a given viral threat within the shortest time possible.”
BioNTech is advancing a platform based on its mRNA technologies for protein replacement, as well.