FX.co ★ Sonnet BioTherapeutics Announces Positive Topline Safety Data Of SON-1010 At Highest Dose, Stock Up

Sonnet BioTherapeutics Holdings, Inc. (SONN) announced on Monday the results from its Phase 1 SB101 clinical trial, focusing on the highest evaluated dose of SON-1010. This trial involved adult patients with advanced solid tumors and received evaluation from the Safety Review Committee.

The SB101 trial is characterized by its open-label and adaptive-design approach, primarily aimed at assessing the safety and tolerability of SON-1010, in addition to determining its maximum tolerated dose (MTD).

The trial concluded that the MTD for SON-1010 is 1200 ng/kg. Notably, there was no occurrence of dose-limiting toxicity or cytokine release syndrome across all dose levels.

During the study, it was observed that 10 out of 21 participants receiving monotherapy maintained stable disease four months after starting treatment. This included one individual who achieved a partial response at the MTD, witnessing a 45% reduction in tumor size.

Commenting on these findings, CEO Pankaj Mohan stated, "The safety of this extended pharmacokinetic version of IL-12 has been as anticipated, with comparisons to healthy volunteer dosing showing strong evidence of targeted tumor response in humans."

The CEO further added, "This trial has successfully established the MTD. We will continue monitoring the patients currently under treatment to evaluate long-term safety and tumor response. Sonnet is actively exploring partnership opportunities to facilitate the advanced development stages of SON-1010."

Following this announcement, Sonnet's stock soared by 52.9%, reaching $3.20 on the Nasdaq.