Biotechnology

Calliditas is seeing encouraging results from a head and neck cancer trial

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Calliditas Therapeutics AB has announced interim data from a phase 2 proof-of-concept trial in patients with head and neck squamous cell carcinoma (SCCHN) with its principal NOX 1 and 4 inhibitor product candidate, Satanaxib.

This analysis reflects the early encouraging clinical progression-free survival (PFS) results and supports the anti-fibrotic mode of action of Satanaxib.

The basis for the analysis consisted of a data set of 20 patients with recurrent or metastatic SCCHN, of which 16 patients had evaluable tumor size and PFS-related outcome. Twelve patients had pre- and post-treatment tumor biopsies that could be evaluated for biomarker analysis, which included transcriptomics analysis and also evaluated pathology markers such as SMA, Foxp3 regulatory T cells and PDL-1 CPS. Because of the small sample size and heterogeneity of the patient population, any conclusions from interim analyzes should be treated with caution.

Path affected

Transcriptomic analysis showed that the top two pathways affected by treatment were fibrosis-associated signaling pathways (idiopathic pulmonary fibrosis signaling pathway and hepatic/hepatic fibrosis stellate cell activation pathway), providing support for a putative mode of action related to modulation of (myofibroblastic) fibroblast activation. , as well as ongoing clinical programs.

Pathological analysis showed preliminary evidence of increased immunological activity in the tumors of patients treated with Satanaxib, with favorable changes in Foxp3 and PDL-1 CPS. Because baseline SMA rates were unequal between groups, and tumor biopsy samples were generally small, it was not possible to draw conclusions regarding the impact of Satanaxib on SMA reduction.

In terms of PFS, seven of the 16 patients evaluated were progress-free with stable disease or partial response, six of whom were in the satanaxib arm and one in the placebo arm. Six of the seven patients were still on study drug at the time the data were read with the longest reported drug period of 21 weeks, related to patients in the satanaxib group.

“Based on the encouraging clinical and transcriptomic results, the data clearly support continuation of the trial, which will read tumor size and progression-free survival in the full trial population next year. Also, it is interesting that the transcriptomic results clearly show a beneficial impact on two fibrosis-associated signaling pathways, which supports the considered mode of action as well as our pipeline program. We are very excited about the potential of Satanaxib in disease areas where there are currently limited treatment options,” said CEO Renée Aguiar-Lucander.

“We are pleased with these encouraging interim data in a patient population requiring effective adjunctive treatment, and look forward to completing this study in collaboration with our excellent site and investigators,” said CMO Richard Philipson.

Trail details

This trial is a phase 2 randomized, placebo-controlled, double-blind, proof-of-concept study investigating the effects of Satanaxib 800 mg twice daily along with pembrolizumab 200 mg IV, given every three weeks (standard accepted treatment regimen for SCCHN), in at least 50 patients with moderate or high density CAF tumors.

Tumor biopsies were taken before randomization and again after at least nine weeks of treatment. Treatment will continue until unacceptable toxicity or tumor development. The study is expected to read final data in 2024.

Earlier this year, the company announced positive topline results from a global, randomized, double-blind, placebo-controlled phase 3 clinical trial investigating the effects of Nefecon (TARPEYO/Kinpeygo delayed-release capsules (budesonide) versus placebo in patients with primary IgA nephropathy.

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