Rugocrixan (KAND567)

Rugocrixan is the company’s most advanced drug candidate, with three completed Phase II studies.

The project was acquired in 2016 from AstraZeneca, at which time it was in the preclinical phase. Since then, Novakand Pharma has gained new insights into how the compound works against cancer, patented new chemistry, and advanced the project into clinical development, including six Phase I and II clinical trials. In total, more than 170 trial participants and patients have been treated with rugocrixan.

KANDOVA

KANDOVA is a recently completed combined Phase Ib/IIa study of rugocrixan in ovarian cancer patients with relapse following carboplatin treatment. In the study, all participants received active treatment; that is, no study participant received a placebo. A total of 18 patients were enrolled in the study and evaluated for the study’s primary endpoints—safety and tolerability. Of these, 15 participants completed at least two treatment cycles, which was a requirement for being considered evaluable for the study’s secondary endpoint—antitumor activity. Study participants were followed up for a maximum of six treatment cycles.

“The study shows that KAND567 is well tolerated in the studied patient group with advanced ovarian cancer. The fact that the study includes relatively few patients limits the ability to assess antitumor activity, but from a predictive biomarker perspective, I find it interesting that the proportion of patients with a partial response or stable disease is so much higher among patients with high CX3CR1 levels in the tumor prior to the start of treatment,” says the study’s principal investigator, Hanna Dahlstrand, senior physician and associate professor at Karolinska University Hospital in Solna.

In June 2025, the company reported positive overall results from the study:

• The primary endpoints wereas met —to define the recommended dose and to evaluate safety and tolerability.

• The secondary objective was also met —to demonstrate signs of antitumor activity from treatment with KAND567 in combination with carboplatin.

• Disease progression, assessed in accordance with the definitions in RECIST 1.1 and GCIG, showed that the proportion of patients with a partial reduction in tumor burden or stable disease was 73% at week 12 and 53% at week 18 (N=15).

• In-depth exploratory analyses of tumor biopsies from study participants (N=15) showed that high levels of the fractalkine receptor CX3CR1 in cancer cells prior to the start of treatment were associated with partial tumor reduction or stable disease in 75% of evaluable participants, according to RECIST 1.1 and GCIG. In contrast, low CX3CR1 levels were associated with stable disease in 43% (no cases of partial tumor reduction).

• Further exploratory analyses of tumor biopsies (N=7) from study participants for whom biopsies could be obtained both before the start of treatment and after 8 weeks of treatment showed an average reduction in tumor burden of 29%*. For study participants with partial tumor burden reduction or stable disease according to RECIST 1.1 and GCIG, increased DNA damage in cancer cells was also observed, which is consistent with KAND567’s expected mechanism of action for its antitumor effect.

* Measured as the percentage of cancer cells in the biopsy after 8 weeks of treatment compared to the biopsy taken before the start of treatment.[

FRACTAL

FRACTAL is a completed Phase IIa clinical trial of rugocrixan in patients with acute myocardial infarction (STEMI) undergoing angioplasty. The study was a randomized, two-arm, double-blind, placebo-controlled, multicenter trial with the primary objective of evaluating safety and tolerability and the secondary objective of assessing signals of cardioprotective effects. Both of these objectives were met.

The Fractal study showed signs of a positive effect of rugocrixan on the heart, as evidenced by a lower incidence of thrombosis and reduced myocardial bleeding. The study also showed, based on analyses of gene and protein regulation in blood cells, that rugocrixan affects a type of immune cell involved in both the development of resistance and the risk of thrombosis in cancer patients. Thus, the Fractal study provides important information that can guide Novakand’s continued efforts against cancer with rugocrixan and fosrugocrixan.