- The study involved end-stage oncology patients with no other
suitable treatment options.
- In this Phase Ib study, Pidnarulex (CX-5461) demonstrated
acceptable clinical tolerability and showed preliminary signs of
efficacy, even in patients who had previously failed treatment with
PARP inhibitors.
- Out of 15 patients who were evaluable for drug response, 40%
achieved clinical benefit, with stable disease (SD) being the best
therapeutic response observed.
TAIPEI and SAN
DIEGO, Sept. 8, 2024 /PRNewswire/ -- Senhwa
Biosciences, Inc. (TPEx: 6492), a drug development company
dedicated to developing first-in-class therapeutics for oncology,
rare diseases, and infectious diseases, announced the presentation
of a poster abstract of its investigational drug, Pidnarulex, at
the 2024 European Society for Medical Oncology (ESMO) Congress. The
abstract highlights Pidnarulex's demonstrated efficacy in treating
various solid tumors harbouring BRCA1/2 or PALB2 gene defects. This
significant milestone underscores the promising potential of
Pidnarulex in the realm of precision medicine.
The findings, presented both on-site and online via the ESMO
platform, involve patients with advanced-stage cancer who have
undergone multiple prior treatments. Notably, a portion of the
patients have achieved stable disease and are continuing to
receive Pidnarulex as part of the ongoing clinical trial. This
development marks a remarkable achievement for both Senhwa
Biosciences and the collaborating Canadian and the US clinical
team, reinforcing the drug's relevance in the evolving landscape of
targeted cancer therapies.
The title of the poster abstract is "Phase 1b expansion study of CX-5461 in patients with
solid tumours and BRCA2 and/or PALB2 mutation." The full
abstract content has been published on the ESMO website at
00:05 CEST on September 9, 2024, at the following link:
https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation/list?q=631p.
The trial report indicates that the preliminary results from Senhwa
Biosciences' clinical trials of Pidnarulex, conducted in
Canada and the USA, shows that out of the first 28 enrolled
patients, 22 completed at least one cycle of treatment and were
evaluated for dose-limiting toxicity (DLT). The patients had
previously undergone multiple lines of cancer treatment, with a
median of 6 lines (ranging from 2 to 10 lines) of prior therapy,
including 77% of patients who had received platinum-based
chemotherapy, 41% of patients who had been treated with
bevacizumab, and 86% of patients who had previously received PARP
inhibitors without success. These were end-stage oncology patients
with no other suitable treatment options. The median number of
Pidnarulex treatments received by the patients was 4 doses (ranging
from 2 to 36 doses).
### Trial Results:
Among the 15 patients who were evaluable for drug response, 40%
achieved clinical benefit, with stable disease (SD) being the best
therapeutic response. Among these stable disease patients, there
were 5 ovarian cancer patients, including 3 with BRCA1 somatic
mutations, 1 with a BRCA1 germline mutation, and 1 with HRD-related
gene mutations. All 5 patients had previously failed platinum
chemotherapy and PARP inhibitor treatments, with 2 of them
maintaining stable disease for at least 6 months following
Pidnarulex treatment, offering renewed hope for advanced-stage
ovarian cancer patients.
### Trial Objectives:
This clinical trial is designed as an open-label, multicenter,
multinational study, divided into the Main Study Cohort and the
Exploratory Cohort. It aimed to recruit patients with BRCA2 and/or
PALB2 gene deficiencies from various tumor types (pancreatic
cancer, ovarian cancer, prostate cancer, and breast cancer), as
well as ovarian cancer patients with BRCA1 deficiencies and/or
other HRD-related homologous recombination defects. The primary
goal of the trial was to determine the recommended Phase II trial
dose for patients with specific genetic deficiencies, while
secondary endpoints include evaluating the safety, tolerability,
and antitumor activity of Pidnarulex (CX-5461).
### Trial Conclusion:
This Phase Ib study demonstrated that CX-5461 exhibit acceptable
clinical tolerability and shows preliminary signs of activity, even
in patients who had previously failed treatment with PARP
inhibitors. Photosensitivity was found to be manageable through
preventive measures.
Currently, several PARP inhibitors have been approved by the FDA
for the treatment of pancreatic, breast, ovarian, and prostate
cancers with BRCA1/2 gene deficiencies. In addition to BRCA1/2, the
PALB2 mutated gene represents a critical factor in in
triple-negative breast cancer, ranking the third most significant
gene associated with this subtype. Moreover, mutations in the PALB2
gene are also associated with a higher risk of developing ovarian
and pancreatic cancers, further underscoring its importance in
oncology.
Senhwa's Pidnarulex is a next-generation novel DDR drug with the
potential to be developed as a rescue medication for patients who
have developed resistance to PARP inhibitors. In preclinical
studies, Pidnarulex has also demonstrated the ability to modulate
tumor microenvironment, thereby enhancing sensitivity and efficacy
of immunotherapy, including anti-PD-1 and anti-PD-L1. Senhwa looks
forward to combining Pidnarulex with immunotherapy drugs such as
Keytruda, which has been approved in the
United States for the treatment of over 30 types of cancer.
In 2023, Keytruda achieved global sales exceeding $25 billion, making it the highest-grossing drug
worldwide. However, immunotherapy has its limitations, with only
20% of patients experiencing significant effects. If Pidnarulex can
enhance the efficacy of immunotherapeutic agents, it is expected to
provide new options for future treatment plans.
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SOURCE Senhwa Biosciences, Inc.