Typically, the starting dose in a Phase 1 trial is too low to show efficacy. For CDR Life, observing immunological activity and biomarker improvement in their very first patient was a rare and remarkable event that provided the first tangible sign their scientific platform could become a real therapeutic.

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.

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.

Despite pancreatic cancer being notoriously difficult, Actuate prioritized it as a lead indication for strategic reasons. Strong preclinical data allowed the company to bypass later-line trials and move directly into a first-line setting, a 'leapfrog' maneuver that significantly accelerates the drug's overall development and regulatory path.

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.

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.

Rather than expecting cell therapies (CAR-T, TIL) to eradicate every cancer cell, Dr. Radvanyi reframes them as powerful adjuvants. Their role is to inflict initial damage, kill tumor cells, and release antigens, creating an opportunity to prime a broader, secondary immune response with other modalities like vaccines or checkpoint inhibitors.