David Oxley: Reframing Curative-Intent Immunotherapy Through the Lens of SITC25 at JPM26

David Oxley, CEO of Vaccinogen and Member Board of Directors at Caladrix, shared a post on LinkedIn:

“As the industry prepares for JPM Week, a defining theme has emerged from the scientific discussions at SITC25: durable disease control in solid tumors will come from strategies that intervene early, target heterogeneous residual disease, and leverage biologically privileged treatment windows, not from escalating interventions in metastatic settings.

This shift represents one of the most meaningful realignments in oncology strategy in more than a decade, and few programs embody this transition more concretely than OncoVAX.

A First-in-Class Approach That Was Ahead of Its Time

OncoVAX, Vaccinogen’s autologous tumor-derived immunotherapy, demonstrated what modern tumor biology is only now fully explaining. In a randomized Phase III trial in resected Stage II colon cancer, OncoVAX:

1. Reduced recurrence from one in three patients to one in nine;
2. Produced a recurrence-free survival plateau extending beyond fifteen years; and
3. Delivered this benefit specifically in microsatellite-stable disease, which is one of the most challenging early-stage populations

These durable outcomes, leveraged with advanced tools to interrogate minimal residual disease, neoantigen breadth, immune surveillance, and postoperative biology, underpin an FDA SPA and Fast Track Pivot trial poised to kick off.

SITC25 and the Emergence of the Curative Window

SITC25 sharpened a concept that has enormous implications for early-stage oncology development: the immediate postoperative period is a biologically distinct curative window.

During this interval:

• tumor burden is at its lowest
• innate immune activation is naturally heightened
• the full neoantigen repertoire of the tumor is still synchronized with residual micrometastatic disease.

Intervening at this moment gives the immune system a tractable target; one that becomes far more elusive once metastatic progression and clonal diversification accelerate. OncoVAX was designed precisely for this early-stage window, long before the industry had the vocabulary or analytic tools to describe it.

Why Antigenic Breadth Matters

One of the persistent challenges in solid-tumor oncology is the heterogeneity of tumors. Most targeted agents address a single pathway or epitope, leaving other subclones unaffected. OncoVAX, by contrast, presents the complete antigenic breadthof the patient’s own tumor:

1. capturing the whole neoantigen landscape
2. engaging immune recognition across all relevant subclones
3. offering a mechanism capable of suppressing or eliminating heterogeneous minimal residual disease

This is not theoretical. The long-term recurrence-free plateau observed in select patients demonstrates that when timing and antigenic completeness are aligned, recurrence is not inevitable.

A Modern Development Pathway for a Curative-Intent Therapy
Vaccinogen has now modernized every element of the registration-enabling pivotal trial:

1. A validated commercial-scale cGMP manufacturing capability in place; and
2. A contemporized regulatory strategy.

This positions OncoVAX as a first-in-class immunotherapy specifically engineered for early-stage solid tumors, the space where durable benefit is most biologically achievable.

A Forward-Looking Model for Global Partners
For global partners evaluating the evolving 2026 landscape, from MRD-guided trial designs, earlier lines of IO intervention, and renewed enthusiasm for curative-intent strategies, we believe OncoVAX offers both historical precedent and strategic differentiation.

Its long-term clinical outcomes are rooted in decades of data, while its biological rationale aligns directly with the scientific momentum from SITC25 and is being highlighted at JPM26. When antigenic breadth and timing converge with the biology of immune dominance, durable remission becomes a real, actionable possibility.

Takeaways:

As JPM Week approaches, OncoVAX stands at the intersection of:

• proven long-term benefit
• cutting-edge understanding of postoperative tumor biology
• renewed investor and scientific focus on curative-intent immunotherapy.

OncoVAX stands as both precedent and guidepost: evidence that durable outcomes in early-stage solid tumors depend more on targeting heterogeneous residual disease at the only moment when it can be eliminated.

David Oxley | Frederick, Maryland”

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