By treating patients before their tumors are surgically removed, Infinitopes can analyze the resected tissue. This provides direct evidence of CD8 T cell infiltration in response to the vaccine—a powerful, mechanistic proof-point that is impossible for competitors testing in later-stage patients.
The most common investor misconception is that cancer vaccines have "never worked." The key rebuttal is that past failures targeted generic, shared antigens. The new generation of vaccines is fundamentally different, targeting specific mutations unique to each patient's tumor, which changes the entire paradigm.
Instead of focusing solely on T-cells, Create's platform first targets myeloid cells, which constitute up to 60% of some solid tumors. Programming these cells transforms the tumor microenvironment, enabling a 5-10x influx of CD8 T-cells. This overcomes a key barrier for T-cell therapies in solid tumors.
Even though companies like Moderna (mRNA) and Transgene (viral vector) use different platforms, positive results from any of them help validate the entire individualized neoantigen approach for investors and clinicians. The massive unmet medical need ensures the market is large enough to support multiple successful players.
While personalized cancer vaccines require extracting and processing a patient's tumor, Create Medicines' in vivo approach is entirely off-the-shelf. By delivering the programming directly into the body, they enable the patient's own immune system to do the complex, personalized work of attacking the cancer itself.
Developers often test novel agents in late-line settings because the control arm is weaker, increasing the statistical chance of success. However, this strategy may doom effective immunotherapies by testing them in biologically hostile, resistant tumors, masking their true potential.
Standard cancer surgery often removes lymph nodes—the factories producing immune cells. Administering immunotherapy *before* this destructive process is critical. It arms the immune system while it is still intact and capable of mounting a powerful, targeted response against the tumor.
To demonstrate its drug could overcome resistance, Actuate designed a trial where patients who had already failed a specific chemotherapy were given the exact same regimen again, but this time with Actuate's drug added. The resulting increased efficacy across eight different cancers provided powerful, direct proof of the drug's mechanism.
Infinitopes' platform uses immunopeptidomics to directly measure peptides on a tumor's surface. This contrasts with competitors like Moderna and BioNTech, who rely on computational predictions from DNA sequencing. This "measure, don't predict" approach aims for more reliable identification of potent immune targets.
Unconventionally, Infinitopes' first-in-human trial targets neoadjuvant patients (newly diagnosed, pre-surgery). This provides cleaner efficacy signals compared to trials in heavily pre-treated patients and enables unique analysis of resected tumors to prove the vaccine's mechanism, a key differentiator from competitors.
The platform doesn't just transport a drug. The T-cells themselves populate the tumor microenvironment, which is naturally 'cold' (lacking immune cells) in glioblastoma. This increases inflammatory activity, making the tumor more susceptible to the delivered therapeutic payload.