**Chinese Biopharmaceuticals: Ushering in a New Era in Nasopharyngeal Carcinoma Treatment, EBV-Specific CAR-T Injection Approved for Phase II Clinical Trials in the US and China**

**Chinese Biopharmaceuticals: Ushering in a New Era in Nasopharyngeal Carcinoma Treatment, EBV-Specific CAR-T Injection Approved for Phase II Clinical Trials in the US and China**

Nasopharyngeal Carcinoma

#Nasopharyngeal #Carcinoma #BRG01 #CART #EBVspecific

Biosyngen has announced a milestone achievement: the company’s independently developed BRG01 injection (EBV-specific CAR-T) has received formal written approval from the U.S. Food and Drug Administration (FDA) to conduct pivotal Phase II clinical trials for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma patients. This is the world’s first original cell drug for solid tumors approved in both the US and China to enter Phase II trials, bringing hope and breakthroughs to the field of solid tumor treatment.

Previously reported, the Center for Drug Evaluation (CDE) of the National Medical Products Administration has agreed to conduct pivotal Phase II clinical trials of BRG01 injection (EBV-specific CAR-T). Patients for the BRG01 US-China Phase I clinical trials completed enrollment by the end of January this year, and all trial participants have received BRG01 reinfusion treatment. The Phase I registered clinical trial of BRG01 has successfully completed DLT (dose-limiting toxicity) observation and efficacy evaluation in 9 patients, all of whom were advanced nasopharyngeal carcinoma patients who had failed at least one treatment, including PD-1 antibody immune checkpoint inhibitors.

The data shows that BRG01 has demonstrated excellent safety and preliminary efficacy: in PET-CT scans, 75% of high-dose patients experienced a local reduction in tumor lesions and a decrease in metabolic activity, with some patients achieving 100% complete remission of tumor lesions. Additionally, BRG01 also demonstrated excellent anti-EB virus efficacy, with a significant reduction of EB virus load in the peripheral blood of patients after reinfusion to normal levels.

These data not only highlight the potential of BRG01 in tumor treatment but also demonstrate its dual advantages in antiviral therapy, laying a solid foundation for future clinical applications. This is believed to be the key reason for the FDA’s approval of BRG01 to enter Phase II clinical trials.

The FDA’s approval not only highly recognizes the preliminary research results of BRG01 injection but also fully affirms Biosyngen’s innovative capabilities and research and development strength in the field of cellular immunotherapy. Biosyngen will take this as an opportunity to accelerate the clinical research process of BRG01 injection, striving to achieve the commercialization of this therapy as soon as possible to bring benefits to nasopharyngeal carcinoma patients worldwide.

Biosyngen’s layout in the field of solid tumor cell therapy goes far beyond this. The company has become a biotech enterprise with three major cellular therapies for both solid and hematological tumors: CAR-T, TCR-T, and TIL. The product pipelines have completed dual submissions and approvals in both the US and China, and the indications for the latter two include a variety of solid tumors such as lung and liver cancer.

🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China  for preliminary evaluation!

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com

#Biosyngen #CAR_T #CancerTreatment #NasopharyngealCarcinoma #FDAApproval #ClinicalTrials #MedicalBreakthrough #BiotechInnovation #CancerResearch #Immunotherapy #HealthcareInnovation #CancerHope #SolidTumors #GlobalHealth #CancerCare

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8 months ago CAR-T

AACR 2024/Breakthrough in Treating Recurrent or Metastatic Nasopharyngeal Carcinoma by Chinese Medical Team

AACR 2024/Breakthrough in Treating Recurrent or Metastatic Nasopharyngeal Carcinoma by Chinese Medical Team

AACR 2024

We’re thrilled to share groundbreaking updates from the 2024 American Association for Cancer Research (AACR) Annual Meeting!

China’s innovative pharmaceuticals are making waves in early clinical trials, hinting at promising breakthroughs in cancer treatment!

At the forefront is the remarkable research on Treprilimumab, a monoclonal antibody, showcased by Prof. Ma Haiqiang and his team from Sun Yat-sen University Cancer Center.

Their pioneering work focuses on advancing treatments for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), a challenging form of cancer.

Treprilimumab, administered subcutaneously, has shown remarkable safety and preliminary efficacy when combined with Gemcitabine and Cisplatin (GP), earning FDA approval in October 2023 for first-line therapy in RM-NPC.

The team initiated the first human clinical trial to assess Treprilimumab’s pharmacokinetics in RM-NPC, aiming to establish optimal subcutaneous dosing regimens for future trials.

The study enrolled RM-NPC patients, confirmed histologically, and previously untreated systemically. Patients received Treprilimumab SC at 240mg Q3W, 360mg Q3W, or 480mg Q6W, in combination with GP for up to 6 cycles, followed by Treprilimumab SC monotherapy until disease progression, intolerable toxicity, or completion of 2 years of treatment. Tumor response was assessed by RECISTv1.1 criteria, with primary endpoints focusing on pharmacokinetics and secondary endpoints including safety, efficacy, and immunogenicity.

From November 24, 2022, to November 20, 2023, 38 patients were enrolled, with a median follow-up of 6.8 months. The median age was 49, with 73.7% male. Pharmacokinetic analysis revealed comparable exposure between Treprilimumab 360mg Q3W SC and 240mg Q3W IV in the first cycle. Overall response rates (ORR) were 100%, 92.3%, and 92.3% for the 240mg, 360mg, and 480mg groups, respectively. By November 20, 2023, 71.1% of patients experienced sustained remission, with no new safety concerns. Grade ≥3 adverse events (AEs) occurred in 76.3% of patients, with no fatalities. Immune-related AEs were reported in 36.8% of patients, with one case of grade ≥3.

These groundbreaking findings demonstrate comparable safety and clinical efficacy between Treprilimumab SC and IV formulations when combined with GP in treating RM-NPC patients. The exposure of Treprilimumab 360mg Q3W SC mirrors that of 240mg Q3W IV. Excitingly, Treprilimumab SC formulations are slated for Phase III clinical development, promising hope for enhanced cancer therapies!

Stay tuned for more updates on this game-changing research!

To assess whether the condition is suitable for Chinese Top level therapy, you can submit pathology reports, treatment history, and discharge summaries to the Medical Department of <Advanced Medicine in China> for preliminary evaluation!

WhatsApp: 137 1795 9070

Email: doctor.huang@globecancer.com

#AACR2024 #CancerResearch #InnovationInMedicine