HONG
KONG, GERMANTOWN, Md.
and SUZHOU, China,
June 28,
2024 /PRNewswire/ -- Sirnaomics Ltd. (the
"Company", together with its subsidiaries, the
"Group" or "Sirnaomics"; stock code: 2257), a leading
biopharmaceutical company engaging in discovery and
development of advanced RNAi therapeutics, today announced that the
Group has completed STP707 Phase I clinical study with strong
safety profile and stable disease activity for treatment of
pancreatic cancer patients. This is a dose escalation study
conducted in 11 oncology clinics in the U.S. The study
involved six cohorts, consisting of 50 patients with various
cancers, of which 11 had pancreatic cancer.
In an earlier news release from the Company in August 2023, the Group noted completion of all
dosing regimens for its Phase I study of STP707 for the treatment
of multiple solid tumors. This basket study has enrolled
patients suffering from various types of late-stage cancers
and failing after multiple rounds of treatments. The study is to
evaluate the safety, tolerability and anti-tumor activity of
the Group's siRNA (small interfering RNA) drug candidate,
STP707, through intravenous infusion (IV) with six cohorts of
escalating doses. Patients including pancreatic, colorectal,
liver, melanoma and other cancers, with advanced/ metastatic
or surgically unresectable solid tumors, refractory to standard
therapy, were recruited. Six dose levels (3mg, 6mg, 12mg, 24mg,
36mg and 48mg) were explored in ascending doses. Patients received
IV infusion on Day 1, 8, 15 and 22 of a 28-days cycle.
11 pancreatic patients (five males and six females, average age
64 years) were enrolled in the study. Patients were heavily
pre-treated and received, on average, three lines of
therapy prior to enrollment in the study (including
Gemcitabine, Paclitaxel and Folfirinox). The preliminary
results indicated that the mean treatment cycles completed was
three cycles (average 12 doses). The average days for stable
disease for all 11 patients with STP707 treatment was 92
days, while 31 days for the 12mg group, 65 days for 24mg group
and 112 days for 48mg group, including one patient ongoing at
281 days. No treatment related adverse events (TRAE) were
reported for the 11 patients, except for one patient with a Grade 2
infusion reaction. Non-treatment related adverse events were
secondary to their advanced metastatic disease including
intestinal obstruction, abdominal distention, gastrointestinal
obstruction, embolism, gastrointestinal hemorrhage, tumor
pain, hypoxia and dyspnea.
The maximum tolerated dose of STP707 for all 50 late-stage
cancer patients was not reached even at 48mg dosage level.
STP707 was very well-tolerated in a heavily pretreated cancer
patient population. The 11 pancreatic subset of patients showed low
toxicity and relatively long stable disease at various dosages
(106, 281 and 302 days), and warrants further study with
STP707 alone or in combination with immune check point
inhibitors, given the preclinical documented ability of STP707
to recruit T-cells to the tumor microenvironment (TME). This
is the first time a polypeptide nanoparticle-based siRNA cancer
therapeutic has demonstrated early positive safety and efficacy
results for the treatment of late-stage pancreatic cancer
patients.
"We are very excited to see STP707, our leading siRNA drug
product for the treatment of heavily pre-treated pancreatic
cancer (one of the deadliest tumor types), shows these strong
results upon intravenous administration. This is a very promising
result for RNAibased cancer therapeutics for the treatment of
metastasized tumors." said Dr. Patrick
Lu, Ph.D., Founder, Chairman of the Board,
Executive Director, President and Chief
Executive Officer of Sirnaomics. "The strong safety
profile, long-lasting stable disease efficacy
and dose-dependent antitumor activity of this intravenously
administered STP707 formulation, present a potential novel cancer
therapeutic, either as a single drug or in combination with immune
check point inhibitor drugs."
For more information about Sirnaomics' clinical trials please
visit ClinicalTrials.gov (Identifier NCT05037149) and the Company's
website at www.sirnaomics.com.
About STP707
STP707 is composed of two siRNA oligonucleotides, targeting
TGF-β1 and COX-2 mRNA respectively, formulated in
nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H)
peptide as the carrier. The specific carrier peptide is distinct
from the carrier used in Sirnaomics' STP705 product. Each
individual siRNA was demonstrated to inhibit the expression of
their target mRNAs and combining the two siRNA's produces a
synergistic effect that diminishes pro-inflammatory factors.
Over-expression of TGF-β1 and COX-2 have been
well-characterized in playing key regulatory roles in
tumorigenesis. In preclinical studies with STP707, IV
administration resulted in knock-down of TGF-β1 and COX-2 gene
expressions in various organs including liver, lung and xenograft
tumor. In addition, in preclinical models STP707 had shown
strong antitumor activity in various solid tumor types. Using
a mouse liver orthotopic tumor model, a combination regimen of
STP707 with an immune checkpoint antibody has demonstrated a
potent antitumor activity.
About Sirnaomics
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 Asia and the United States. Based on its proprietary
delivery technologies: Polypeptide Nanoparticle Formulation
and the 2nd generation of GalNAc conjugates, the Group has
established an enriched drug candidate pipeline. Sirnaomics is
advancing RNAi therapeutics for oncology application with
multiple successes of its clinical programs for STP705 and
STP707. STP122G represents the first drug candidate of
GalAhead™ technology entering clinical development. With the
establishment of the Group's manufacturing facility,
Sirnaomics currently is undergoing a transition from a biotech
company to a biopharma corporation. Learn more at:
www.sirnaomics.com.
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SOURCE Sirnaomics