{"id":5400,"date":"2024-07-05T15:56:22","date_gmt":"2024-07-05T08:56:22","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=5400"},"modified":"2024-07-05T15:56:22","modified_gmt":"2024-07-05T08:56:22","slug":"biostar-pharma-announces-fda-clearance-of-the-ind-application-for-a-phase-2-study-of-utidelone-injection-utd1-in-her2-breast-cancer-brain-metastasis","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=5400","title":{"rendered":"Biostar Pharma Announces FDA Clearance of the IND Application for a Phase 2 Study of Utidelone Injection (UTD1) in HER2- Breast Cancer Brain Metastasis"},"content":{"rendered":"

SAN FRANCISCO<\/span><\/span>, July 5, 2024<\/span><\/span> \/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.<\/p>\n

Depending on the molecular classification of breast cancer, approximately 20~50% of\u00a0metastatic breast cancer patients develop\u00a0brain 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]<\/p>\n

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.<\/p>\n

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.<\/p>\n

Utidelone has been granted an “orphan drug designation” by the US FDA for the treatment of BCBM in Mar 2024<\/span>. 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.\u00a0<\/p>\n

About BG01-2402 Study<\/p>\n

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.<\/p>\n

\n

Reference:<\/span><\/p>\n

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\u201356 (2017).<\/span><\/p>\n

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<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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<\/span><\/p>\n

9. Die\u0301ras 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\u201307-PD13-07<\/span><\/p>\n<\/div>\n

About Beijing Biostar Pharmaceuticals Co., Ltd.<\/p>\n

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<\/a>\u00a0or by contacting our business development team at bd@biostar-pharma.com<\/a>\u00a0on partnering with us.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

SAN FRANCISCO<\/span><\/span>, July 5, 2024<\/span><\/span> \/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.<\/p>\n

Depending on the molecular classification of breast cancer, approximately 20~50% of\u00a0metastatic breast cancer patients develop\u00a0brain 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]<\/p>\n

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.<\/p>\n

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.<\/p>\n

Utidelone has been granted an “orphan drug designation” by the US FDA for the treatment of BCBM in Mar 2024<\/span>. 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.\u00a0<\/p>\n

About BG01-2402 Study<\/p>\n

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.<\/p>\n

\n

Reference:<\/span><\/p>\n

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\u201356 (2017).<\/span><\/p>\n

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<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

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<\/span><\/p>\n

9. Die\u0301ras 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\u201307-PD13-07<\/span><\/p>\n<\/div>\n

About Beijing Biostar Pharmaceuticals Co., Ltd.<\/p>\n

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<\/a>\u00a0or by contacting our business development team at bd@biostar-pharma.com<\/a>\u00a0on partnering with us.<\/p>\n

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