FDA Approved Utidelone Injectable (UTD1) Phase 2/3 Multi-National Clinical Trial for Non-Small Cell Lung Cancer

SAN FRANCISCO,June 15,2023 -- Biostar Pharma,Inc. (hereinafter referred to as "Biostar"),the US subsidiary of Beijing Biostar Pharmaceuticals Co.,Ltd. which is a synthetic biology driven biopharma company focusing on the discovery,development and commercialization of innovative oncology drugs,is pleased to announce that,after having in-depth discussions with the FDA throughpre-IND meetings,the FDA has approved the IND of a phase 2/3 clinical trial with seamless protocol design for the company's core product utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Designated as BG01-2202,this trial is a multi-national,phase 2/3,open-label,randomized,controlled clinical study of utidelone injectable (UTD1) versus docetaxel. The study is going to be conducted at about 50 sites in about 10 countries and regions across US,Europe and Asia -Pacific. About 760 patients are planned to be enrolled,90 for phase 2 with ORR (objective response rate) as the primary endpoint and 670 for phase 3 with OS (overall survival) as the primary endpoint and PFS (progression free survival),ORR,etc. as the secondary endpoints.

Dr. Li Tang,Chairman of Biostar Pharma commented: "This is an important milestone for global development of utidelone injectable -- an innovative anti-cancer drug and new generation epothilone analogue. We are fully committed to advancing this pivotal multi-national study and also willing to partner with global pharmaceutical companies to bring this product to market around the world to benefit more patients".

This study was warranted by a previous open-label,multi-center phase 2 trial conducted in China (NCT03693547) of utidelone as single-agent to treat patients with advanced NSCLC who had received at least two prior systemic regimens including platinum-containing chemotherapy or targeted therapy,which demonstrated promising clinical efficacy and manageable safety profile with outcomes of 19.0% ORR,81.0% DCR (disease control rate),4.37 months of median PFS and 71% of 12-month OS rate. The median OS was not reached by the cut-off date. The results were selected by 2022 ELCC (European Lung Cancer Congress) as poster presentation. A phase 3 study to evaluate utidelone versus docetaxel in locally advanced or metastatic NSCLC patients that have failed chemotherapy with a platinum-containing regimen has also been initiated and being in progress now in China.

Unmet Medical Need

Lung cancer remains the leading cause of cancer death worldwide [1]. NSCLC accounts for about 85% of lung cancer cases [2,3] and more than 75% of patients with lung cancer are diagnosed with locally advanced or stage IV disease [4]. Although currently targeted therapies and/or immunotherapies are commonly used for advanced NSCLC,limitations are obvious. Many patients either do not have a targetable driver gene alteration or are not suitable for immunotherapy [5,6]. Besides,acquired resistance to targeted- and immune-therapy is a substantial problem. In this case,chemotherapy,such as platinum- and taxane-based regimens,remains the fundamental treatment. However,acquired resistance to standard chemotherapies still presents challenges,which may limit their efficacy [7,8]. There is a huge unmet clinical need for alternative chemotherapeutic agents that can overcome,or are less susceptible to,drug resistance and have clinical efficacy in heavily pretreated patients.

About Utidelone

Being derived from Biostar's synthetic biology technology platform,utidelone is a genetically engineered best-in-class epothilone analog,which is a class of microtubule-targeting agent that has differential mechanisms of action from taxanes and is developed to overcome drug resistance. Utidelone injectable has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies,utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features,such as overcoming taxane-resistant,low hematological toxicity suitable for longer term exposure,ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. Relevant study results were twice selected for oral presentations at ASCO annual meetings and invited to publish in Lancet Oncology and Annals of Oncology.

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.

References

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[2] Howlader N,Forjaz G,Mooradian MJ,Meza R,Kong CY,Cronin KA,et al. The effect of advances in lung-cancer treatment on population mortality. N Engl J Med. 2020;383:640-649. https://doi.org/10.1056/NEJMoa1916623.

[3] American Cancer Society. About lung cancer. 2022. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00.pdf. Accessed March 2023.

[4] Surveillance,Epidemiology,and End Results. SEER registry data,2011 to 2017. Available at: https://seer.cancer.gov/statfacts/html/lungb.html. Accessed March 2023.

[5]NCCN. Clinical practice guidelines in oncology. Non-small cell lung cancer. V2.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed March 2023.

[6] Chinese Association for Clinical Oncologists,Medical Oncology Branch of Chinese International Exchange and Promotion Association for Medical and Healthcare. Clinical practice guideline for stage IV primary lung cancer in China (2023 edition) [In Chinese]. Chin J Oncol. 2023 Jan;45(1):1-30. https://doi.org/10.3760/cma.j.cn112152-20221009-00687.

[7]Hardin E,Shum E,Singh AP,Perez-Soler R and Cheng H. Emerging treatment using tubulin inhibitors in advanced non-small cell lung cancer. Expert Opin Pharmacother. 2017 May;18(7):701-716. https://doi.org/10.1080/14656566.2017.1316374.

[8]Sève P and Dumontet C. Chemoresistance in non-small cell lung cancer. Curr Med Chem Anticancer Agents. 2005 Jan;5(1):73-88.