Item 7.01. Regulation FD.
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The information in this Current Report on Form 8-K under Item 7.01, including
the information contained in Exhibit 99.1, is being furnished to the
Item 8.01. Other Events.
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Of the 15 patients from the first five cohorts of SB101 evaluable for follow-up at this latest cutoff, 9 had stable disease at the first follow-up scan, 4 of which were already progressing at study entry. At four months follow-up, 5 of 14 patients remained stable at the second scan, suggesting clinical benefit of SON-1010 in 36% of patients. The very first patient dosed, with an aggressive endometrial sarcoma, had target tumor shrinkage with complete resolution of ascites at one point and has been clinically stable for nearly a year. Dosing in the first 3 cohorts was performed every 4 weeks, but is now being done every 3 weeks in the new cohorts to enhance safety at higher doses.
SON-1010 has been safe and tolerable at all doses tested to date. Adverse events have generally been mild/moderate and transient in nature, with no study discontinuations for safety reasons. In addition, adverse effects have been less numerous and less intense with subsequent doses. The geomean half-life (t½) of SON-1010 was 113 hours in SB101 and 122 hours in SB102, compared to 12 hours for recombinant IL-12 observed in prior studies. Comparison of the PK curves between the two studies suggests that SON-1010 may be targeting tumors, as it was designed to do. Cytokine analysis following each dose revealed controlled and prolonged induction of interferon gamma (IFN?) that peaked at 24 to 48 hours and returned to baseline after 2 to 4 weeks. A small increase in IL-10 was observed with each dose as expected in response to IFN?. There was either a minimal or no signal for IL-1?, IL-6, IL-8, and TNF? and no indication of any potential for cytokine release syndrome (CRS) at these doses.
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Item 9.01. Financial Statements and Exhibits.
(d) The following exhibit is furnished with this report:
Exhibit No. Description 99.1 Press Release issued bySonnet BioTherapeutics Holdings, Inc. , datedApril 18, 2023 . 99.2 Presentation bySonnet BioTherapeutics Holdings, Inc. , datedApril 18, 2023 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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