Tedopi® Breakthrough: OSE Immunotherapeutics Poised to Redefine Oncology with Near-Term Catalysts

The oncology space is on the cusp of a paradigm shift, and OSE Immunotherapeutics (OSE:ENXTPA) is at the forefront with its groundbreaking cancer vaccine, Tedopi®. Recent clinical data from its Phase 2 pancreatic cancer trial and the ongoing Phase 3 NSCLC study have positioned the company as a leader in immuno-oncology, with catalysts that could unlock multi-billion-dollar markets. For investors, this is a rare opportunity to capitalize on a therapy that addresses critical unmet needs while leveraging a novel “pipeline in a product” platform. Let's dissect why Tedopi® is a buy now—and why the next 12–18 months could be transformative.

Pancreatic Cancer: A Survival Revolution

Pancreatic ductal adenocarcinoma (PDAC) is one of oncology's most lethal cancers, with a five-year survival rate of just 10%. Current treatments offer little hope for patients beyond surgery, which only 15–20% qualify for. Enter Tedopi®, which just delivered a 65% one-year survival rate in its Phase 2 TEDOPaM trial—more than double the pre-specified success threshold of 50%.

The trial's design was rigorous: Tedopi® combined with FOLFIRI chemotherapy in HLA-A2-positive patients who had stabilized after initial chemotherapy. Key takeaways:
- Median OS of 17 months in the control arm (FOLFIRI alone) defied expectations, suggesting improved patient selection or care.
- Two complete responses in the Tedopi® arm—none in the control—hint at durable antitumor activity.
- Minimal toxicity: Only 6% of serious adverse events were vaccine-related, underscoring its safety profile.

This isn't incremental progress—it's a new benchmark for maintenance therapy in PDAC. With 50% of pancreatic cancer patients being HLA-A2-positive, Tedopi® could redefine standards of care.

NSCLC Phase 3 Trial: The Next Big Catalyst

While pancreatic cancer data is compelling, the Phase 3 ARTEMIA trial in NSCLC is the catalyst investors should watch most closely. Enrolling 363 HLA-A2-positive patients with secondary resistance to checkpoint inhibitors, Tedopi® is pitted against docetaxel—a standard-of-care chemotherapy with limited efficacy.

Why this matters:
- A $10B+ opportunity: NSCLC is the most common lung cancer, with over 2 million patients globally. Those failing checkpoint inhibitors (like Keytruda) have few options.
- Mechanism-driven differentiation: Tedopi® targets p53 mutations (common in NSCLC) via HLA-A2-specific neo-epitopes. This bypasses resistance mechanisms that neuter checkpoint inhibitors.
- Fast-tracked path: If ARTEMIA hits its OS endpoint (expected in 2026), Tedopi® could secure accelerated approval, skipping a costly Phase 4 trial.

The stakes are high, but so is the potential: A successful readout could position Tedopi® as a $500M+ annual therapy in NSCLC alone.

The "Pipeline in a Product" Advantage

Tedopi® isn't just a single drug—it's a platform. Its 10 neo-epitopes (from five tumor antigens) are designed to activate T-cells across multiple cancer types. This “one vaccine, multiple targets” approach means OSE can expand Tedopi®'s reach without starting from scratch:

• Ovarian cancer (TEDOVA trial): Data expected in 2026.
• Combination therapies (CombiTED): Pairing with checkpoint inhibitors could boost response rates further.

This scalability reduces R&D risk and accelerates future approvals. Competitors chasing single-target therapies can't match this flexibility.

Valuation: A Stock on the Brink of a Breakout

OSE's current valuation of ~€300M seems disconnected from its potential. Consider:
- Pancreatic cancer: A $2B annual market if Tedopi® captures 30% of HLA-A2 patients.
- NSCLC: Potential peak sales of $750M+.

The stock has already risen ~30% YTD on PDAC data, but ARTEMIA's success could trigger a 5x–10x rerating. Even a modest 20% approval probability in NSCLC adds €200M to OSE's value—a 67% upside from current levels.

Risks? Yes. But the Reward Outweighs Them

• ARTEMIA trial failure: Possible, but early data from the ATALANTE-1 trial (which showed a 41% OS improvement in HLA-A2 patients) gives confidence.
• Regulatory hurdles: Tedopi®'s novel mechanism may face scrutiny, but the FDA's push for breakthrough therapies in oncology bodes well.
• Competition: Checkpoint inhibitors and targeted therapies (e.g., KRAS inhibitors) exist, but none address HLA-A2-driven immune evasion.

Investment Thesis: Act Before the Catalysts Strike

Tedopi® is no longer a “what-if” story—it's a proven survival game-changer in pancreatic cancer, with a clear path to NSCLC dominance. With two major readouts (TEDOVA in H2 2025, ARTEMIA in 2026) and a “pipeline in a product” moat, OSE is a high-conviction buy for growth investors.

Actionable Takeaway:
- Buy OSE now, targeting a 50–75% upside within 18 months.
- Set a stop-loss below the 2024 low (€2.50/share) to hedge trial risk.

The oncology world is watching. Don't miss the chance to board this rocket ship before lift-off.

This article is for informational purposes only. Always conduct your own research or consult a financial advisor before making investment decisions.