100% Objective Response Rate! BonYao Bio's BRL-201 Delivers a Breakthrough in CAR-T Therapy

May 30, 2024 07:20 CST Updated 07:20

BRL Medicine

Cell and Gene Therapy Drug Developer

May 30, 2024

eMedClub News

On May 29, BRL Medicine Inc. (hereinafter referred to as "BRL Medicine"), a company focusing on gene and cell therapy, announced that the research results of its "Targeted CD19 Non-viral PD1 Site-specific Integration CAR-T Cell Injection" (Pipeline Code: BRL-201) will be presented for the first time in2024 ASCO ConferencePublic debut.

▲ The abstract of BRL-201 study has been released on the ASCO official website (Abstract ID: 7031).

BRL-201 is a CAR-T product developed using BRL Medicine's self-developed non-viral targeted integration CAR-T platform (Quikin CART® platform), and it is alsoWorld's First Targeted CD19 Non-Viral PD1-CAR-T Product, Indications: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL).

Non-viral Targeted Integration CAR-T Platform (Quikin CART) Utilizes CRISPR Gene Editing Technology to Achieve Gene Knockout and Targeted Stable Integration of CAR Components.Quikin CAR-T has the advantages of a simple process, short preparation time, and high product uniformity, and also avoids the tumorigenic risk caused by random integration.The PD1-CD19-CART product developed by this platform has the dual advantages of PD1 gene knockout and stable, uniform CAR expression.This platform can also be used for the preparation of multiple immune checkpoint knockout-enhanced CAR-T cells, rapid production of universal CAR-T cells, and development of dynamically regulated safe CAR-T products, providing strong technical support for future CAR-T cell engineering.

▲ Quikin CART® Platform Mechanism

100% Objective Response Rate!

BRL-201Brings New Surprises to the CAR-T Field

eMedClub

The latest clinical data of BRL-201 in IIT research will be announced at this ASCO. The research results show that a total of 21 patients received BRL-201 treatment, with an objective response rate (ORR) as high as100%, with a complete response rate (CR) reaching85.7%。

While achieving significant efficacy,Not caused in any patientCytokine release syndrome or neurotoxicity above grade 2. To date, the world's first patient to receive BRL-201 treatment from BRL Medicine has been cancer-free for over three years. This study demonstrates the excellent clinical safety and efficacy of the BRL-201 product, which can be said to beWorldwide so farHigh Remission Rate and Low Toxicity in CAR-T Cell Therapy for Refractory and Relapsed LymphomaBest Clinical Outcomes。

In addition, the research results of this product were published on August 31, 2022, in an international top-tier academic journal.NaturePublished on.

Four Major Advantages

eMedClub

01 Low cost, can benefit more patients

BRL-201 utilizes the 2020 Nobel Prize-winning CRISPR/Cas9 gene editing technology to precisely edit the PD1 site in T lymphocytes and insert a CAR molecule targeting CD19 in tumor cells, all without the use of viral vectors. The non-viral production process significantly reduces the high costs associated with using viral vectors and simplifies the complex manufacturing process.

02 Fast preparation, suitable for patients with rapid progressionPatient

BRL-201 is produced using a non-viral method, with a simple process that requires only one step to simultaneously achieve sustained CAR expression and regulation of endogenous genes in T cells. This significantly shortens the entire CAR-T production time, with a minimum of 3 days required for completion, greatly enhancing production capacity and enabling timely treatment for patients with rapidly progressing tumors.

03 Safer, ensuring product uniformity

Non-viral targeted integration allows each CAR sequence to be precisely inserted into a specific site of the genome, avoiding the oncogenic risks caused by random insertion, and maximizing the safety and efficacy of CAR-T products.

04 MoreEffective, Breaking the Shackles of Recurrence and Refractoriness

Clinical Research Results of BRL-201 Demonstrate Outstanding Clinical Efficacy, Representing the Best Clinical Outcomes in Global CAR-T Cell Therapy for Refractory and Relapsed Lymphoma to Date, with High Remission Rates and Low Toxicity. The Objective Response Rate (ORR) Reached 100%, and the Complete Response Rate (CR) Achieved 85.7%. Patients Showed Significantly Greater Long-Term Benefits Compared to Existing Similar Viral CAR-T Products. As of January 10, 2024, the Median Progression-Free Survival (mPFS) Reached 19.5 Months. Single-Cell Sequencing Results Indicate a High Proportion of Memory T Cells in the BRL-201 Cell Product, Exhibiting Stronger Anti-Tumor Immune Function, and the Infused CAR-T Cells Possess Long-Term Persistence.

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