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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September 18, 2024
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-35570 |
|
20-2932652 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
100
Overlook Center, Suite 102
Princeton,
New Jersey |
|
08540 |
| (Address
of principal executive office) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (609) 375-2227
Not
Applicable
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
Stock, $0.0001 par value per share |
|
SONN |
|
The
Nasdaq Capital Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD.
On
September 18, 2024, Sonnet BioTherapeutics Holdings, Inc. (the “Company”) issued a press release announcing the completion
of enrollment and initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid
tumors.
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 Securities and Exchange Commission
(the “SEC”), and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed
to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be
expressly set forth by a specific reference in such filing.
Item
8.01 Other Events.
On September 18, 2024, the Company announced
the completion of enrollment and initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 in adult patients with advanced
solid tumors. The Company expects to report topline data from this study in Q4 2024.
SB101
is the Company’s open-label, adaptive-design dose-escalation study to assess the safety, tolerability, and PK/PD of SON-1010 administered
to patients with advanced solid tumors. The study enrolled 24 subjects. Primary outcome measures for the study are to evaluate the safety
and tolerability of SON-1010 and establish the maximum tolerated dose (MTD) of SON-1010.
SON-1010
is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using the Company’s Fully
Human Albumin Binding (FHAB®) platform, which extends the half-life and activity of the IL-12 component due to binding native albumin
in the serum and targets the tumor microenvironment (TME) by strongly binding gp60 and Secreted Protein Acidic and Rich in Cysteine (SPARC).
As previously
announced, the safety of SON-1010 was reviewed by the Safety Review Committee at each step during dose escalation. The trial uses a ‘desensitizing’
first dose to take advantage of the known tachyphylaxis with rhIL-12, which minimizes toxicity and allows higher maintenance doses. No
dose-limiting toxicities have occurred to date. The safety and toxicity profile that has developed is typical for a Phase 1 oncology
trial, with the majority of adverse events (AEs) being reported as mild. All have been transient, with no evidence of cytokine release
syndrome.
As
previously announced, one patient with progressive endometrial sarcoma receiving SON-1010 monotherapy in SB101 had stable disease (SD)
for almost 2 years before progressing - her ascites had resolved and tumors had shrunk at one point but she never reached a partial response
(PR) by Response Evaluation Criteria in Solid Tumors (RECIST) rules. Cytokine analysis following each dose in that study revealed controlled
and prolonged induction of interferon gamma (IFNγ) that peaked at 24 to 48 hours and returned to baseline within 2 to 4 weeks.
A small increase in IL-10 was observed with each dose as expected in response to IFNγ. There was either a minimal or no signal
for IL-1β, IL-6, IL-8, and TNFα, and there was no indication of any potential for cytokine release syndrome (CRS) at these
doses.
Forward-Looking
Statements
This
Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Exchange Act and Private Securities Litigation Reform Act, as amended, including those relating to the outcome
of the Company’s clinical trials, the Company’s cash runway, the Company’s product development, clinical and regulatory
timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential
growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These
statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the negatives of those terms. These statements
relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors
which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the
SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date
of this Current Report. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
SONNET
BIOTHERAPEUTICS HOLDINGS, INC. |
| |
|
|
| Date:
September 18, 2024 |
By: |
/s/
Pankaj Mohan, Ph.D. |
| |
Name: |
Pankaj
Mohan, Ph.D. |
| |
Title: |
Chief
Executive Officer |
Exhibit 99.1
CONFIDENTIAL
DRAFT NOT FOR IMMEDIATE RELEASE
Sonnet
BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment
of Solid Tumors
SON-1010
is a targeted immune activation cancer therapy designed to turn ‘cold’ tumors ‘hot’
Topline
safety data of SB101 Phase 1 study expected by Q4 2024
PRINCETON,
NJ / GlobeNewswire / September 18, 2024 / Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”)
(NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced the completion of enrollment and
initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors.
The Company expects to report topline data from this study in Q4 2024.
Pankaj
Mohan, Founder and Chief Executive Officer of Sonnet commented, “This milestone is an important step forward in our development
program for SON-1010 as a monotherapy. We are encouraged by the data seen to date demonstrating safety and tolerability being well within
expected levels. We are hopeful that we will continue to see extended PK/PD, tumor targeting and clinical activity during treatment.
We remain committed to bringing this trial to completion and we expect to report topline safety data in Q4 2024.”
SB101
is the Company’s open-label, adaptive-design dose-escalation study to assess the safety, tolerability, and PK/PD of SON-1010 administered
to patients with advanced solid tumors. The study enrolled 24 subjects. Primary outcome measures for the study are to evaluate the safety
and tolerability of SON-1010 and establish the maximum tolerated dose (MTD) of SON-1010.
SON-1010
is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using Sonnet’s Fully Human
Albumin Binding (FHAB®) platform, which extends the half-life and activity of the IL-12 component due to binding
native albumin in the serum and targets the tumor microenvironment (TME) by strongly binding gp60 and Secreted Protein Acidic and Rich
in Cysteine (SPARC).
As
previously announced, the safety of SON-1010 was reviewed by the Safety Review Committee at each step during dose escalation. The trial
uses a ‘desensitizing’ first dose to take advantage of the known tachyphylaxis with rhIL-12, which minimizes toxicity and
allows higher maintenance doses. No dose-limiting toxicities have occurred to date. The safety and toxicity profile that has developed
is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild. All have been transient, with
no evidence of cytokine release syndrome.
As
previously announced, one patient with progressive endometrial sarcoma receiving SON-1010 monotherapy in SB101 had stable disease (SD)
for almost 2 years before progressing - her ascites had resolved and tumors had shrunk at one point but she never reached a partial response
(PR) by Response Evaluation Criteria in Solid Tumors (RECIST) rules. Cytokine analysis following each dose in that study revealed controlled
and prolonged induction of interferon gamma (IFNγ) that peaked at 24 to 48 hours and returned to baseline within 2 to 4 weeks.
A small increase in IL-10 was observed with each dose as expected in response to IFNγ. There was either a minimal or no signal
for IL-1β, IL-6, IL-8, and TNFα, and there was no indication of any potential for cytokine release syndrome (CRS) at these
doses.
For
more information about the SB101 Phase 1 trial in adult patients with advanced solid tumors visit www.clinicaltrials.com and reference
identifier NCT05352750.
About
SON-1010
SON-1010
is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the
single-chain antibody fragment A10m3. This was selected to bind albumin both at normal pH, as well as at the acidic pH typically found
in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity
to improve the safety and efficacy profile of not only IL-12, but a variety of potent immunomodulators that can be linked using the platform.
Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME,
such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), several types of cancer such as non-small cell
lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1010
is designed to deliver IL-12 to local tumor tissue, turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which
activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.
About
the SB101 Phase 1 Trial
This
first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and is being
conducted at several sites across the United States. While the optimal dose is unknown at this stage, the potential to target tumors,
the extended PK mechanism, and our preclinical data suggest the therapeutic dose may be lower compared to native human IL-12. The study,
utilizing a standard 3+3 oncology design in at least five cohorts, should establish the MTD using subcutaneous injections of SON-1010
every 3 to 4 weeks. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure
pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity. This study will form the basis for potential combinations
with other types of immunotherapies and the future development of bispecific candidates using the FHAB platform.
About
Sonnet BioTherapeutics Holdings, Inc.
Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing
targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully
human single chain antibody fragment (scFv) that binds to and “hitch-hikes” on human serum albumin (HSA) for transport to
target tissues. Sonnet’s FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window
for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play
construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines.
Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of solid tumors and ovarian cancer.
SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary
Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of Platinum-Resistant
Ovarian Cancer (PROC). The Company is also evaluating its second program, SON-1210, an IL12-FHAB-IL15 for solid tumors, in
collaboration with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of
pancreatic cancer.
The
Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic
Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence
of a pro-inflammatory cytokine response. Sonnet is currently seeking partnership opportunities to support a Phase 2 trial.
Forward-Looking
Statements
This
press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the
outcome of the Company’s clinical trials, the Company’s cash runway, the Company’s product development, clinical and
regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies,
potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current
expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current
beliefs and assumptions.
These
statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may
cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed
or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities
and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak
only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether
as a result of new information, future events or otherwise.
Investor
Relations Contact:
JTC
Team, LLC
Jenene
Thomas
833-475-8247
SONN@jtcir.com
Source:
Sonnet BioTherapeutics Holdings, Inc.
Released
September 18, 2024
v3.24.3
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