The BioNTech Approach

How we enable our vision

We are focused on bringing cancer immunotherapy into the next generation. We believe that we can accomplish this by applying the following principles:

  • Exploiting the full potential of the immune system.
    Our broad pipeline includes mRNA-based immune activators, antigen-targeting T cells and antibodies, and defined immunomodulators of various immune cell mechanisms. This portfolio is designed to mirror the evolution of the immune system to rely on multiple complementary pathways.
  • Broadening the universe of patients benefiting from cancer immunotherapy.
    We discover and exploit novel targets and target combinations. Our aim is to extend the utility of immunotherapy to patient populations that are not currently amenable or do not benefit from the targets of current immunotherapies. One example are patients with low mutational load tumors, such as pancreatic and prostate cancer, which we address with tumor-associated antigens.
  • Improving the success rate.
    We engineer and develop highly potent drug candidates designed to avoid compromising precision for the specific target. We further augment activity and counteract resistance mechanisms by combining compounds with non-overlapping, synergistic mechanisms of action, such as combining our FixVac immunotherapy with our novel CAR T therapies.
  • Focusing on curative approaches.
    The root cause of recurrence or lack of tumor eradication is interindividual variability and cancer heterogeneity. Addressing this biological reality is one of the mandatory design aspects of the product candidates we develop. For example, each of our cancer immunotherapies incorporates multiple targets in order to account for this variability.

We have applied these four guiding principles to a broad suite of therapeutic platforms optimized for a distinct mode of action, high precision targeting, high potency and efficacy. We expect each platform to yield a pipeline of drug candidates for further development.

We focus on the patient to provide unique treatments

We believe that harnessing complementary, potentially synergistic modes of action increases the likelihood of therapeutic success, reduces the risk of emergence of secondary resistance mechanisms, and also unlocks a larger potential market. Critically, this approach allows us to pursue a technology agnostic approach, providing the most appropriate therapeutic platform or a combination thereof for the intended patient and purpose.

FROM PATIENT TO PATIENT-SPECIFIC CANCER TREATMENT

Our patient-centric model

Our computational approach to individualized immunotherapy

Bioinformatics are critical in the production of individualized therapies. We have accumulated a high level of experience in bioinformatics of mutation detection, cancer genomics and immunotherapy through our ongoing research and preclinical studies and clinical trials. Our validated patient-centric bioinformatic process, as illustrated below, allows the application of complex algorithms to the patient’s data in the context of drug manufacturing. Our bioinformatics processes are robust and scalable, incorporating our experience handling genomic data in a high throughput environment, as we target making on-demand production of individualized immunotherapies commercially viable.

OUR VALIDATED PATIENT-CENTRIC BIOINFORMATIC PROCESS

Our platforms leverage the following four drug classes:

We believe that the breadth of our technology is greater than the sum of its parts as it positions us to combine modes of action in a coordinated way to treat cancer in a more efficacious manner than current existing therapies. Our synergistic platform and manufacturing capabilities place us at the forefront of the paradigm shift towards individualized immunotherapies.

mRNA Therapeutics
We are utilizing messenger ribonucleic acid, or mRNA, to deliver genetic information to cells, where it is used to express proteins for therapeutic effect. We are developing a portfolio of immunotherapies that utilize four different mRNA formats and three different formulations to derive five distinct platforms for the treatment of cancer. Three of these platforms are currently in human testing:
  1. Our off-the-shelf shared antigen immunotherapy, or FixVac
  2. Our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
  3. Our intratumoral immunotherapy, in collaboration with Sanofi
  4. Our two platforms in which we use mRNA to express directly in the patient either (a) particular antibodies, or RiboMabs, or (b) specific cytokines, or RiboCytokines

In collaboration with Pfizer and Genevant, we are also leveraging our mRNA technology beyond oncology to treat influenza and rare diseases.

Engineered Cell Therapies
We are developing a range of novel cell therapies in which the patient’s T cells are modified to target cancer-specific antigens. These include two platforms for the treatment of solid tumors: chimeric antigen receptor or CAR T cells and T cell receptor or TCR programs. We are also combining our mRNA FixVac platform with our first CAR T product candidates to enhance the persistence of CAR-T cells in vivo.
Antibodies
We are developing, in collaboration with Genmab, next-generation bispecific antibodies that are designed to target immune checkpoints that modulate the patient’s immune response to cancer. We are also exploring additional targeted cancer antibody approaches utilizing our in-house and recently acquired antibody capabilities.
Small Molecule Immunomodulators
We use small molecules to augment the activity of other drug classes by inducing specific and discrete patterns of immunomodulation. We are developing a small molecule toll-like receptor 7 (TLR7) immunomodulator for the treatment of solid tumors.

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