Intensity Therapeutics’ stock has risen nearly 400% after its oncology candidate showed high overall survival (OS) and disease control.
In the Phase I/II trial (NCT03058289), INT230-6 showed a disease control rate of 75% in adult patients with metastatic disease in more than 20 cancers, including pancreatic, breast, and sarcoma.
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Median OS (mOS) was 11.9 months, compared to a historical mOS of four to seven months. In the metastatic sarcoma population specifically, the median overall survival was 21.3 months.
In exploratory analysis in patients treated at a dose that was greater than 40% of total tumour burden (TTB), the disease control rate was 83.3% compared to 50% of patients treated with less than 40% of their TTB. This improvement was also notable in mOS, which was 18.7 months compared to 3.1 months in the two cohorts, respectively.
USC Norris’ clinical research associate director Dr Anthony El-Khoueiry said: “Uninjected tumours shrinking from a locally administered therapy, referred to as abscopal effects, are generally rare for local therapies. Yet, an abscopal effect was observed in at least 20% of 48 patients who received drug volumes above 40% of their tumour burden.
“In addition, in 13 of 14 matched pair biopsy slides, a notable increase in activated CD4+ and CD8+ T cells was observed in the tumour microenvironment in response to INT230-6 treatment. The abscopal effects and immune cell infiltration observed in this study highlight this intertumoral therapy’s potential to drive both a local and systemic anti-cancer activity.”
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By GlobalDataIntensity’s stock jumped 394.4% when the data was released, from a 29 October close of $0.27 to $1.32 at market close on 30 October. The company has a market cap of $64.8m.
No dose-limiting toxicities were reported, with seven patients suffering a Grade 3 treatment-related adverse event (TEAE) and no patients suffering a Grade 4 or 5 TEAE.
Intensity has already initiated Phase III trials of the candidate, including the INVINCIBLE-3 trial in sarcoma (NCT06263231). There is also a planned Phase III study in triple-negative breast cancer (TNBC).
In the sarcoma space, Inhibrix Biosciences recently posted a win with its targeted therapy ozekibart, which led to a 61% stock rise.
INT230-6 is a fixed dose combination of two chemotherapies, cisplatin and vinblastine sulphate, which elicits cytotoxic effects by interfering with mitosis to inhibit DNA synthesis.
