Intensity Therapeutics (INTS.US), a biopharmaceutical company with a market capitalization of approximately $13 million, saw its stock price surge by nearly 395% after announcing the results of its Phase 1/2 clinical trial of INT230-6, a candidate drug for metastatic or refractory cancer, on Thursday (October 30).

Regarding the mechanism of action and clinical data highlights of the candidate drug INT230-6, the drug achieves diffusion and penetration of the cytotoxic drugs cisplatin and vinblastine sulfate through direct intratumoral injection. Simultaneously, the drug also contains a cell penetration enhancement molecule (“SHAO”) that can bind to these two chemotherapy drugs.

The company stated that the trial results showed an increase in the number of activated CD4+ T cells and CD8+ T cells in the tumor microenvironment. Regarding key clinical trial data, a total of 64 patients participated, representing more than 20 different cancer types, and all patients had received extensive prior treatment (i.e., disease progression or intolerance after multiple lines of therapy). The disease control rate was 75%.

The median overall survival (mOS) for the overall patient population was 11.9 months; the median mOS for the metastatic sarcoma subgroup was 21.3 months.

Regarding safety data, no grade 4 or 5 treatment-related adverse events (the most severe level) were reported, and only 7 patients reported grade 3 adverse events; furthermore, no dose-limiting toxicities were observed in the trial.

“Clearly, the market has reacted positively to these data and results… This shows us that this area of ​​research (solid tumor treatment) – and hopefully our research in particular – resonates with many people,” said Lewis Bender, CEO and founder of the company. “These early data demonstrate the potential of a new cancer treatment approach that we hope will benefit many more patients.”

Regarding collaborative research progress, Intensity Therapeutics has partnered with Merck (MRK.US) and Bristol-Myers Squibb (BMY.US) to explore combination therapies of INT230-6 with Keytruda (pembrolizumab) and Yervoy (ipilimumab), respectively.

The company will hold a conference call at 9:00 a.m. Eastern Time on October 31 to discuss the results of this clinical trial. The results have been published in the academic journal eBioMedicine.