Sonnet BioTherapeutics Holdings, Inc. (SONN) on Monday announced results of SON-1010 at the highest dose, evaluated by the Safety Review Committee, in the Phase 1 SB101 clinical trial in adult patients with advanced solid tumors.
SB101 is the company's open-label, adaptive-design dose-escalation study with the primary outcome to evaluate the safety and tolerability of SON-1010 and establish its maximum tolerated dose or MTD.
The trial has set the MTD of SON-1010 at 1200 ng/kg, without dose-limiting toxicity or evidence of cytokine release syndrome at any dose level.
The company observed that 10 out of 21 monotherapy participants maintained stable disease at four-months post-initiation of dosing, which included one patient treated at MTD experiencing a partial response with 45 percent reduction in tumor size.
"Safety of this extended PK version of IL-12 has been within expected levels and the comparison with dosing in healthy volunteers provided strong evidence of tumor targeting in humans," said CEO Pankaj Mohan.
"We have used this trial to establish the MTD and will continue to follow the patients currently being treated to assess longer-term safety and tumor responses. Sonnet is currently seeking partnership opportunities to help support later stage development of SON-1010."
Currently, Sonnet's stock is climbing 52.9 percent, to $3.2 on the Nasdaq.
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