SAN
FRANCISCO, July 5, 2024 /PRNewswire/ -- Biostar
Pharma, Inc., the U.S. subsidiary of Beijing Biostar
Pharmaceuticals Co., Ltd. (Biostar), which is a synthetic
biology-driven biopharma company focusing on the development and
commercialization of innovative oncology drugs, announced today
that their core pipeline product Utidelone Injection (UTD1) had
been granted to conduct a phase 2 study (BG01-2402) for HER2-
breast cancer brain metastasis (BCBM) by the US FDA.
Depending on the molecular classification of breast cancer,
approximately 20~50% of metastatic breast cancer patients
develop brain metastases.[1] The current standard
of care for BCBM is primarily local treatment with surgery and
radiation therapy, supplemented by drug therapy. Due to blood-brain
barrier (BBB) and blood-tumor barrier (BTB), many drugs that are
effective for extracranial metastasis of breast cancer have very
limited intracranial permeability, leading to poor prognosis for
BCBM patients, especially with HER2- BCBM.[2-3] The mPFS
for HR+/HER2- BCBM is about 4-6 months,[4-8] while the
mFPS for TNBC brain metastasis is only 2.8
months.[9]
In recent years, multiple small-molecule TKIs and ADC drugs have
brought survival benefits to HER2+ BCBM patients. However, there is
still a lack of drug treatment regimens with proven efficacy for
HER2- BCBM, and no drug has been approved for HER2- BCBM worldwide,
suggesting a significant unmet medical need.
Utidelone can penetrate BBB due to its unique physicochemical
characteristics and insusceptibility to P-glycoprotein-mediated
efflux, which has been confirmed by preclinical drug tissue
distribution studies and several clinical trials. A phase 2 study
of utidelone in combination with bevacizumab for the treatment of
HER2- BCBM presented at the ASCO 2024 demonstrated efficacy
outcomes of 42.6% of CNS-ORR, 7.7 months of mPFS, and 74.4% of
12-month OS rate with total 47 eligible patients being enrolled.
The efficacy was even better in HR-/HER2- subgroup, showing 55% of
CNS-ORR and 8.4 months of mPFS. The safety was manageable with
majority of the AEs being Grade 1~2, suggesting a promising
efficacy and manageable safety profile of utidelone for HER2- BCBM,
and the potential of utidelone to become a new treatment option in
the space.
Utidelone has been granted an "orphan drug designation" by the
US FDA for the treatment of BCBM in Mar
2024. Biostar then filed an IND application for this phase 2
study for HER2- BCBM. The US FDA clearance of the application marks
an important milestone of Biostar's globalization development
strategy.
About BG01-2402 Study
BG01-2402 study refers to "A Pivotal Phase II Clinical Trial of
Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative
Breast Cancer Patients with Brain Metastases". The purpose of the
study is to evaluate the intracranial and systemic efficacy of
Utidelone Injection in combination with capecitabine in HER2- BCBM
patients. This study follows a Simon's 2-stage design, and is
planned to be conducted at 10-15 sites in the US with enrollment
target of 120 patients. The primary endpoint is CNS-ORR; the
secondary endpoints include PFS, DOR and OS, etc.
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Reference:
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1. Lin, N. U., Gaspar,
L. E. & Soffietti, R. Breast cancer in the central nervous
system: multidisciplinary considerations and management. Am. Soc.
Clin. Oncol. Educ. Book 37, 45–56 (2017).
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2. Arvanitis, Costas D
et al. "The blood-brain barrier and blood-tumour barrier in brain
tumours and metastases." Nature reviews. Cancer vol. 20, 1 (2020):
26-41. doi:10.1038/s41568-019-0205-x
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3. Darlix A, Louvel G,
et al. Impact of breast cancer molecular subtypes on the incidence,
kinetics and prognosis of central nervous system metastases in a
large multicentre real-life cohort. Br J Cancer. 2019 Dec; 121(12):
991-1000.
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4. Leone, J.P. Emblem,
K.E et al. Phase II trial of carboplatin and bevacizumab in
patients with breast cancer brain metastases. Breast Cancer Res.
2020, 22, 131.
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5. Chen X, Bai X, et
al. The anti-tumor efficiency of low-dose apatinib-based
chemotherapy in pretreated HER2-negative breast cancer with brain
metastases. Ann Med. 2023 Dec; 55(1): 2218647.
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6. Tolaney SM, Sahebjam
S, et al. A Phase II Study of Abemaciclib in Patients with Brain
Metastases Secondary to Hormone Receptor-Positive Breast Cancer.
Clin Cancer Res. 2020 Oct 15; 26(20): 5310-5319.
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7. Mosele F, Deluche E,
Lusque A, et al. Trastuzumab deruxtecan in metastatic breast cancer
with variable HER2 expression: the phase 2 DAISY trial. Nat Med.
2023; 29(8): 2110-2120.
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8. Nadia Harbeck, et
al. Trastuzumab deruxtecan vs treatment of physician's choice in
patients with HER2-low unresectable and/or metastatic breast
cancer: Subgroup analyses from DESTINY-Breast04. 2022 SABCS.
P1-11-01
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9. Diéras V, Weaver R,
et al. Abstract Pd13-07: Subgroup analysis of patients with brain
metastases from the phase 3 ascent study of sacituzumab govitecan
versus chemotherapy in metastatic triple-negative breast cancer.
Cancer Res (2021)81 (4_Supplement): PD13–07-PD13-07
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About Beijing Biostar Pharmaceuticals Co., Ltd.
Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated
biopharma company focusing on the development of first- and
best-in-class innovative anti-cancer drugs with independent
intellectual property through state-of-the-art technology platforms
of combinatorial biosynthesis, microbial fermentation production
and microbial drug formulation development. With an insight-driven
strategy, experienced R&D teams, cGMP-compliant manufacturing
facility and domestic commercialization capability, the company
have built a balanced product pipeline, covering both lead product
life-cycle expansion and early-stage projects development. Further
information can be found on the company's website
http://www.biostar-pharm.com/en or by contacting our business
development team at bd@biostar-pharma.com on partnering with
us.
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SOURCE Biostar Pharma, Inc.