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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): December 9, 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
December 9, 2024, Sonnet BioTherapeutics Holdings, Inc. (the “Company”) issued a press release announcing topline safety
data following successful completion of SON-1010 monotherapy dose escalation in Phase 1 SB101 trial.
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
December 9, 2024, the Company announced topline safety data following successful completion of SON-1010 monotherapy dose
escalation in Phase 1 SB101 trial. The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg, without dose-limiting
toxicity or evidence of cytokine release syndrome at any dose level. Stable disease (SD) at four months post-initiation of dosing
was seen in 10 of 21 (48%) evaluable monotherapy patients, and importantly included one patient dosed at the MTD who had a partial
response (PR) by RESIST criteria (a 45% decrease from baseline). Together, these data suggest clinical benefit when SON-1010 is
administered as a monotherapy.
The
results of SON-1010 at the highest dose have been formally evaluated by the Safety Review Committee in the Phase 1 SB101 clinical trial
of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. SB101 is the Company’s open-label, adaptive-design dose-escalation
study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 administered to patients with
advanced solid tumors. The study has enrolled 24 subjects to date. Primary outcome measures for the study were to evaluate the safety
and tolerability of SON-1010 and establish the MTD.
SON-1010
is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using genetic fusion to the Company’s
Fully Human Albumin Binding (FHAB®) platform, which extends the half-life and bioactivity of the IL-12 component due to binding
native albumin in the serum and also targets the tumor microenvironment (TME) by strong binding to gp60 and Secreted Protein Acidic and
Rich in Cysteine (SPARC).
All
enrolled patients have had advanced solid tumors. The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to
enhance the assessment of PK and PD at the MTD. The SB101 trial employed a ‘desensitizing’ first dose of 300 ng/kg to take
advantage of the known tachyphylaxis with rhIL-12, with the intention of minimizing toxicity and allowing for higher maintenance doses.
No dose-limiting toxicities or related serious adverse events (SAE) 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 AEs seen to date have
been transient, with no evidence of cytokine release syndrome. Of the 24 patients dosed to date, 17 (71%) had SD at the first follow-up
CT, 12 of whom were progressing at study entry. 10 of 21 patients (48%) remained stable at four months, suggesting SON-1010 clinical
benefit, and one of those patients, who has clear cell sarcoma, had a PR with a 45% reduction in tumor size by RESIST criteria. As previously
disclosed, one patient with endometrial sarcoma who was progressing at study entry had evidence of improvement after 11 months, with
smaller tumors and complete resolution of ascites. This patient later progressed at 23 months and started chemotherapy.
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:
December 9, 2024 |
By: |
/s/
Pankaj Mohan, Ph.D. |
| |
Name: |
Pankaj
Mohan, Ph.D. |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Sonnet
BioTherapeutics Announces Topline Safety Data Following Successful Completion of SON-1010 Monotherapy Dose Escalation in Phase 1 SB101
Trial
The
maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg, without dose-limiting toxicity or evidence of cytokine release syndrome
at any dose level
Stable
disease (SD) at four months post-initiation of dosing was seen in 10 of 21 (48%) evaluable monotherapy patients, and importantly included
one patient dosed at the MTD who had a partial response (PR) by RESIST criteria (a 45% decrease from baseline)
Together,
these data suggest clinical benefit when SON-1010 is administered as a monotherapy
Sonnet
management discusses what this data means in a Virtual Investor “What This Means” segment; access here
PRINCETON,
NJ, December 9, 2024 (GLOBE NEWSWIRE) — Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the “Company” or “Sonnet”),
a clinical-stage company developing targeted immunotherapeutic drugs, announced today that the results of SON-1010 at the highest dose
have been formally evaluated by the Safety Review Committee in the Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in
adult patients with advanced solid tumors. SB101 is the Company’s open-label, adaptive-design dose-escalation study to assess the
safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 administered to patients with advanced solid tumors.
The study has enrolled 24 subjects to date. Primary outcome measures for the study were to evaluate the safety and tolerability of SON-1010
and establish the MTD. Additionally, the Company announced the release of a “What This Means” segment to discuss the data
which is now available here.
SON-1010
is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using genetic fusion to Sonnet’s
Fully Human Albumin Binding (FHAB®) platform, which extends the half-life and bioactivity of the IL-12 component
due to binding native albumin in the serum and also targets the tumor microenvironment (TME) by strong binding to gp60 and Secreted Protein
Acidic and Rich in Cysteine (SPARC).
“We
are encouraged by this topline safety data generated to date in our Phase 1 study. Given the history of safety concerns with rhIL-12
in its first human trials over 25 years ago, it is exciting to see higher doses of SON-1010 demonstrating minimal toxicity, which is
likely due to its unique biodistribution and albumin binding profile, with delivery to and retention in the tumor microenvironment,”
said Richard Kenney, M.D., Sonnet’s Chief Medical Officer. “We may finally be able to realize the promising antitumor effect
that has been associated with this cytokine in preclinical models for decades. The IFNγ response, which is considered to be important
for anti-tumor control, has been robust but controlled with a much longer return to baseline. While the clinical benefit we have been
seeing during dose escalation has been reassuring, the PR at the highest dose is particularly important, as this suggests that there
may be a synergistic effect in combination with checkpoint inhibitors and/or chemotherapy.”
All
enrolled patients have had advanced solid tumors. The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to
enhance the assessment of PK and PD at the MTD. The SB101 trial employed a ‘desensitizing’ first dose of 300 ng/kg to take
advantage of the known tachyphylaxis with rhIL-12, with the intention of minimizing toxicity and allowing for higher maintenance doses.
No dose-limiting toxicities or related serious adverse events (SAE) 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 AEs seen to date have
been transient, with no evidence of cytokine release syndrome. Of the 24 patients dosed to date, 17 (71%) had SD at the first follow-up
CT, 12 of whom were progressing at study entry. 10 of the 21 evaluable patients (48%) remained stable at four months, suggesting
SON-1010 clinical benefit, and one of those patients in the highest dose cohort, who has clear cell sarcoma, had a PR with a 45%
reduction in tumor size by RESIST criteria. As previously disclosed, one patient in the first dose cohort with endometrial sarcoma
who was progressing at study entry had evidence of improvement after 11 months, with smaller tumors and complete resolution of ascites.
This patient later progressed at 23 months and started chemotherapy.
“This topline safety data release on our lead program is a significant milestone
for Sonnet’s clinical development.
We have now successfully completed dose escalation
in our first trial with SON-1010 and are pleased to see a partial response in one patient at the highest dose, in addition to clinical
benefit in almost half of the evaluable patients,” said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer. “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. 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.”
For
more information about the Phase 1 SB101 trial in adult patients with advanced solid tumors visit www.clinicaltrials.com and reference
identifier NCT05352750.
SON-1010
is also being evaluated in a Phase 1b/2a dose-escalation and proof-of-concept study (SB221) in combination with SON-1010 and atezolizumab
(in collaboration with Genentech, a member of the Roche Group), which is focused on platinum-resistant ovarian cancer (PROC) (NCT05756907).
Enrollment remains ongoing and an update on safety at the MTD in that trial is expected in Q1 2025.
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 Phase 1 SB101 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
PK, 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. In October 2024, Sonnet announced an India license agreement with Alkem Laboratories, Inc. who
will assume responsibility for advancing development of the SON-080 program into a Phase 2 study in DPN.
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
908-824-0775
SONN@jtcir.com
v3.24.3
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