100% CBR! FDA Granted ODD to Biostar Pharma's Utidelone Capsule (UTD2) for the Treatment of Gastric Cancer

SAN FRANCISCO, March 21, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their key pipeline product UTD2 (utidelone capsule) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of gastric cancer.

An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval.

Utidelone is the only approved innovative microtubule inhibitor developed using synthetic biology technology. It has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, high oral bioavailability, better safety profile with very low hematologic toxicity, not susceptible to P-glycoprotein and effective against multidrug-resistant tumors, and capability of crossing the blood-brain barrier for brain tumor treatment. In addition, its environmental-friendly fermentation production process also contrasts with paclitaxel.

Development of oral formulation of microtubule inhibitors has been challenging due to susceptibility to P-glycoprotein-mediated efflux and low bioavailability. Oral taxanes such as Tesetaxel^® and Oraxol^® all failed in clinical trials because of safety problems, suggesting a huge unmet medical need. So far there is no approved oral microtubule inhibitors in the US and Europe. Biostar successfully developed utidelone capsule leveraging on its proprietary technology platform. Utidelone capsule has many advantages including improved administration convenience, enhanced patient compliance, reduced treatment cost, facilitation of long-term therapy and promotion of combination therapy.

Gastric cancer, despite its low prevalence in the US, is an extremely serious global health problem due to its highly invasive and heterogeneous nature. In 2022, about 810,000 gastric cancer patients died worldwide, ranking fourth in the global mortality rate of malignant tumors ^[1]. In the U.S., according to the American Cancer Center, 26,890 new cases and 10,880 deaths of gastric cancer are expected in 2024. In addition, the five-year survival rate of gastric cancer in the U.S. is only 31.1%, indicating poor prognosis. Chemotherapy is the cornerstone therapy for gastric cancer and is widely used for major subtypes and various treatment lines. Chemotherapy combined with PD-1 has gradually become the first choice for the first-line treatment of advanced gastric cancer.

The FDA granted ODD to UTD2 based on the promising data of a two-stage, multi-center phase 2 clinical study. For the first stage which has been completed, 15 advanced gastric cancer patients who received utidelone monotherapy were evaluated for efficacy with an outcome of 3 PR (partial response) and 5 SD (stable disease). For the second stage, 11 patients with metastatic and/or unresectable HER2 negative gastric cancer who received the first-line treatment of utidelone plus sintilimab and oxaliplatin completed tumor assessment with an outcome of 8 PR and 3 SD, showing 100% clinical benefit rate (CBR)!

Currently utidelone capsule's clinical studies are underway both in the U.S. and China. The preliminary data showed high bioavailability of 57% with low effective dose, wide therapeutic window, and a good safety profile. Biostar Pharma believes that utidelone capsule will show huge application potential and market space with its promising clinical performance and other advantages.

^{[1] Source: Frost & Sullivan Analysis}

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 [email protected] on partnering with us.

SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.