Hva kan vi forvente fra genomisk rapport?

The most optimistic expectations from the genomic response of VP-315 stem from its novel mechanism of action and the promising results observed in Phase 2 clinical trials for basal cell carcinoma (BCC).

Mechanism of Action:
VP-315 is an investigational oncolytic peptide immunotherapy that is directly injected into tumor lesions. It works by:
* Lysis of tumor cells: VP-315 disrupts the intracellular organelles of cancer cells, leading to their death.
* Release of tumor antigens: The destruction of tumor cells releases a broad spectrum of tumor-specific antigens.
* Induction of T-cell response: These released antigens trigger a T-cell-mediated immune response, where the body's immune system recognizes and attacks the remaining cancer cells.
Optimistic Expectations Based on Phase 2 Results:
Data presented at the 2025 Winter Clinical Dermatology Conference highlighted encouraging outcomes from the Phase 2 study of VP-315 in patients with BCC. These results, while preliminary, suggest the potential for significant benefit:
* High Objective Response Rate (ORR): A post-hoc analysis showed a 97% Calculated ORR. This means that 97% of patients experienced at least a 30% reduction in tumor size along with a partial or complete response and no disease progression. This is a very high response rate for a cancer treatment.
* Significant Histological Clearance: Approximately 51% of treated tumors achieved complete histological clearance, meaning no residual cancer cells were found after treatment.
* Tumor Size Reduction in Remaining Cases: Patients who did not achieve complete clearance still experienced a substantial average tumor size reduction of 71%.
* Favorable Safety Profile: The treatment was well-tolerated, with no Treatment Related Serious Adverse Events reported. Most adverse events were mild to moderate cutaneous reactions.

Genomic Response Expectations:
While the presented data focuses on tumor response and safety, the anticipated genomic and T-cell response data, expected in the first quarter of 2025, could further bolster optimism. Positive findings in this area could indicate:
* Strong Immunogenic Cell Death: Genomic analysis might confirm that VP-315 effectively induces immunogenic cell death, which is crucial for triggering a robust anti-tumor immune response.
* Activation of Specific T-cell Subtypes: The data could reveal the types of T-cells activated by VP-315, potentially identifying those associated with long-term tumor control.
* Absence of Resistance Mechanisms: Genomic analysis might show that the treated tumors did not develop resistance mechanisms against VP-315.
* Potential for Combination Therapies: Understanding the genomic response could pave the way for combining VP-315 with other therapies, such as checkpoint inhibitors, to further enhance efficacy.

Overall Optimistic Outlook:
The current data suggests that VP-315 has the potential to be a highly effective non-surgical treatment option for basal cell carcinoma. The optimistic expectation is that the upcoming genomic data will further elucidate the mechanism of action, confirm the induction of a strong and specific immune response, and potentially identify biomarkers that could predict treatment response. This could solidify VP-315's position as a first-line therapy, offering a less invasive and potentially curative option for a large number of patients with BCC.