Sonnet BioTherapeutics Announces Publication Detailing the Discovery and Development of SON-1010, an Albumin-Binding IL-12 Fusion Protein, Demonstrating Its Mechanism of Action
04 Dicembre 2024 - 3:20PM
Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet”)
(NASDAQ: SONN), a clinical-stage company developing innovative
targeted immunotherapeutic drugs, today announced the publication
of extensive discovery, development and preclinical data on
SON-1010 demonstrating its mechanism of action in Frontiers in
Immunology. SON-1010, Sonnet’s lead proprietary drug candidate,
combines the Company’s fully human albumin-binding (FHAB®)
construct with a native single-chain IL-12 sequence to simplify
delivery of the cytokine systemically. The paper entitled,
“SON-1010: An Albumin-binding IL-12 Fusion Protein with Improved
Cytokine Half-life Targets Tumors and Enhances Therapeutic
Efficacy,” details the identification of single-chain variable
fragments (scFv) from a human phage display library that bound
human, mouse, and cynomolgus macaque serum albumin, both at
physiologic and acidic conditions. The composition of matter patent
claims on the FHAB domain and SON-1010 fusion protein have been
issued in a number of major markets, including but not limited to
the U.S., China, Japan, Russia and New Zealand, and expire between
2038 and 2039. Additionally, the Company announced the release of a
“What This Means” segment to discuss the publication which is now
available here.The extensive discovery program included putting the
scFv domains through a series of steps to identify strongly binding
molecules that bind tightly over a 5.8 to 7.2 pH range and do not
interfere with the normal physiology of albumin to bind the
neonatal Fc receptor (FcRn). This resulted in having prolonged
half-life in serum and binding to SPARC/GP60, which allows albumin
to target the tumor microenvironment (TME). A final molecule was
selected and a single mutation was introduced that minimizes the
potential for immunogenicity. This FHAB domain was characterized,
and manufacturing processes were developed to prepare Sonnet’s
first drug candidate for the clinic. Once identified, the murine
form of mIL12-FHAB was shown to be much more efficient at blocking
tumor growth compared to murine IL-12, while stimulating
significant and prolonged IFNγ production with minimal
toxicity. Biodistribution studies in mice confirmed tumor delivery
and toxicological studies in non-human primates allowed the
initiation of the clinical trials.“We are pleased to share these
findings, which is the first time we have fully described the
extensive research that was required to discover and develop our
signature FHAB platform,” said Pankaj Mohan, Ph.D., Founder and CEO
of Sonnet. “This work lays the foundation for all of the products
on our platform that are designed to safely extend the half-life of
cytokines and deliver them to the tumor, where they can convert the
immunological response from ‘cold’ to ‘hot’ and potentially realize
the promise of immunotherapy.”“IL-12 and related compounds have
been extensively studied in cancer and immunotherapy indications.
However, recombinant interleukins have had limited clinical success
owing to their short circulating half-life, inefficient TME
targeting, and requirement for frequent dosing, often leading to
substantial systemic toxicities,” added John Cini, Ph.D. Co-Founder
and CSO of Sonnet. “We believe we have addressed these issues with
our discovered platform, having utilized a molecule that can be
applied in any solid tumor type that concentrates albumin, such as
sarcoma, gynecologic, and gastrointestinal cancers. We intend to
explore new compounds as well, as funds become available.”
The Company is currently conducting a Phase 1
clinical trial of SON-1010 (IL12-FHAB) as a monotherapy in adult
patients with advanced solid tumors (SB101; NCT05352750). The
Company expects to report safety data from this study in Q4 2024.
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).
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. 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, LLCJenene
Thomas908-824-0775SONN@jtcir.com
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