Focuses on the Consolidation for Leading Projects
Accelerates Clinical Trials for Core Products STP705, STP707
and STP122G
HONG
KONG, Germantown, Md. and
SUZHOU, China, March 28,
2024 /PRNewswire/ -- Sirnaomics Ltd. (the
"Company"; together with its subsidiaries, "Sirnaomics" or
the "Group"; stock code: 2257), a leading biopharmaceutical
company engaged in the discovery and development of advanced RNAi
therapeutics, has announced its audited annual results for the year
ended 31 December 2023 (the
"Year").
In order to ensure sufficient cash runway in the face of global
macroeconomic uncertainty, the Group has undergone three rounds of
restructuring. It has also prioritized the allocation of resources
to programs that have the significant potential to advance the
development of its core products. The Group's loss for the Year
narrowed by 12.7% to US$84.99
million, demonstrating the effectiveness of these
initiatives.
Clinical trials progress smoothly with orderly development of
multiple product pipelines
During the Year, Sirnaomics
continued to advance a prioritized product pipeline, conducting
five siRNA clinical trials in the U.S. for its lead clinical drug
candidates STP705 and STP707, and STP122G, in addition to RV-1730
and RV-1770, the mRNA vaccine programs that received
Investigational New Drug Application (IND) approval from the Food
and Drug Administration (FDA) sponsored by RNAimmune, its
non-wholly owned subsidiary.
STP705
STP705 for the treatment of squamous
cell carcinoma in situ (isSCC) has advanced into late-stage
clinical development. The Group is in active communication with the
U.S. FDA to seek further guidance on late-stage clinical
development. After discussing the Phase IIa and Phase IIb results
with the U.S. FDA in an End-of-Phase II meeting, the Group was well
positioned to advance STP705 into clinical studies for the
treatment of isSCC. The Group have now proposed a well-designed
Phase II/III study to serve as a pivotal trial to achieve alignment
with the U.S. FDA and expects to provide an update to the FDA in
the second quarter of 2024.
The Phase II clinical study of STP705 for the treatment of basal
cell carcinoma (BCC) was fully completed in 2023. The final data
readout showed very favorable efficacy with no systemic
drug-related adverse events (AEs) and serious adverse events
(SAEs), further validating the broad potential of this drug
candidate for the treatment of non-melanoma skin cancers and
beyond. The Group will hold the End-of-Phase II meeting with the
U.S. FDA to obtain guidance on the future path forward for the
late-stage development of STP705 for the treatment of BCC. Based on
the previous experience with isSCC, the Group expects communication
with the FDA to be smooth and efficient.
The Group completed the Phase I study of STP705 for focal fat
reduction in the fourth quarter 2023. The positive results and
the histological observations provide preliminary evidence that
STP705 may become a best-in-class drug candidate for focal fat
reduction and is worthy of further investigation. This will better
inform later stage development of this asset in the medical
aesthetics category.
STP707
The dose escalation for the Phase I
clinical study of STP707 for the treatment of multiple solid tumors
was completed in August 2023. Based
on preliminary efficacy observations, 74% of evaluable patients
demonstrated a best response of stable disease according to
Response Evaluation Criteria in Solid Tumors. The results of this
Phase I basket clinical study are encouraging for a potential
combination study with immune checkpoint inhibitor drugs. The Group
looks forward to further clinical trials with STP707, which has the
potential to address the unmet needs of patients with refractory
solid tumors such as pancreatic and other cancers.
STP122G
STP122G, a treatment for coagulation
disorders, is currently undergoing a Phase I clinical study in
volunteers, with the first cohort completed and active dosing
monitoring in the second cohort. This study marks the first
time Sirnaomics has applied its proprietary GalNAc RNAi
platform technology, GalAhead™, to one of its siRNA-based
candidates and conducted a trial in a patient population with a
high unmet need for anticoagulation but low bleeding incidence. By
targeting Factor XI (FXI), the Group has the potential to address
multiple conditions requiring anticoagulation, including atrial
fibrillation, pulmonary embolism, deep vein thrombosis, and deep
venous thrombosis prophylaxis for surgical procedures.
Other product pipelines
Two products of RNAimmune, Sirnaomics's non-wholly owned
subsidiary specializing in the discovery and development of
mRNA-based therapeutics and vaccines, received regulatory clearance
on its IND from the U.S. FDA in December
2023 and April 2023,
respectively. RNAimmune has initiated two Phase I clinical trials
for RV-1770, an mRNA vaccine targeting the human respiratory
syncytial virus, and RV-1730, a SARS-CoV-2 vaccine booster
candidate.
The Group expects to file a U.S. IND for STP125G and STP144G
from the GalAhead™ delivery platform in 2025.
Commencement of production at Guangzhou facility to meet clinical
needs
With the production of the full GMP batch of STP707
for human injection in the first quarter of 2023, the Guangzhou facility is expected to begin full
GMP-compliant manufacturing of the Group's pipeline products,
including formulation, filling and finishing for both liquid and
solid dose production, testing and release. During the Year, the
Guangzhou facility also completed
the expansion of the filling line capacity to include liquid dose
filling in 2R vials in order to support the Group's GalAhead™
platform.
Following the second full year of successful operation of the
Guangzhou Fill and Finish (F&F) Facility, which was established
in December 2021, the facility
continues to support the optimization of the Group's clinical
supply strategy in Asia by
adapting production to its current needs. The expected annual
capacity of around 50,000 vials of lyophilized solid dose and
150,000 to 200,000 vials of liquid dose for human injectables dose
capacity is sufficient to support all of the Group's currently
planned clinical trials and future clinical developments.
Dr. Patrick Lu, Founder,
Chairman of the Board, Executive Director, President and Chief
Executive Officer of Sirnaomics, said, "During the
Year, we undertook a restructuring of our Group's operations and
expanded cash flow through various measures, enabling us to
proactively respond to the challenges of the macroeconomic
environment while further enhancing operational efficiency, better
aligning resources with our strategic objectives and further
developing our core products. With the top priority of
commercializing STP705 for the treatment of isSCC, we are moving
full speed ahead with late-stage clinical studies and have begun to
explore potential partnerships. We have also started to explore the
application of STP705 in the medical aesthetic industry. As with
the first GalAhead™ mxRNA candidate, STP122G, which was
successfully advanced to the clinical stage, based on the Company's
unique and innovative delivery platform technology, we will advance
more promising first-in-class preclinical assets into clinical
stage, such as STP125G for the treatment of familial
hypertriglyceridemia. Our other core product, STP707, and our
exclusive targeted PNP delivery have demonstrated their potential
to treat a variety of solid tumors, especially for pancreatic
cancer, and will set us apart from other RNA players globally.
Going forward, we will continue to focus on creating healthier and
better lives for patients while also creating value for our
shareholders, customers and stakeholders."
About Sirnaomics Ltd. (Stock Code: 2257)
Sirnaomics is
an RNA therapeutics biopharmaceutical company with product
candidates in preclinical and clinical stages that focuses on the
discovery and development of innovative drugs for indications with
medical needs and large market opportunities. Sirnaomics is the
first clinical-stage RNA therapeutics company to have a strong
presence in both China and
the United States, and also the
first company to achieve positive Phase II clinical outcomes in
oncology for an RNAi therapeutic for its core product, STP705.
Learn more at www.sirnaomics.com.
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SOURCE Sirnaomics