Porton Advanced and BRL Medicine Build Strategic Partnership to Accelerate Commercialization of CGT

 

On September 13th, 2023, Porton Advanced Solutions (Porton Advanced) announced a strategic partnership with BRL Medicine Inc. (BRL Medicine). This collaboration will enhance the CGT pipelines from BRL Medicine from clinical trials to further expedite the commercialization of innovative therapies.

BRL Medicine, with its strong gene editing technology, robust R&D capabilities, and prospective pipelines, has been devoted to the realm of CGT for years and has achieved significant progress. Multiple pipelines of the company have entered the IND application stage, with three core ones already receiving China IND approval. The gene therapy product, BRL-101, was developed using the in-house ModiHSC® hematopoietic stem cell platform. Whereas, the CAR-T product, BRL-201, was developed using the in-house non-viral site-specific integration CAR-T platform (Quikin CART®). Notably, both have shown impressive results in clinical trials, gaining recognition from prestigious international academic journals like Nature and Nature Medicine.

Porton Advanced, on the other hand, has built an end-to-end gene and cell engineering CDMO service platform with proven experience in plasmids, cell engineering, gene therapy, oncolytic viruses, mRNA therapy, and bacterial therapy. Through this strategic partnership, the two companies will work together to accelerate the commercialization of gene and cell engineering drugs, making innovative treatments accessible to a wider range of patients.

Dr. Zheng Biao, CEO of BRL Medicine, expressed his enthusiasm for the strategic collaboration with Porton Advanced, an international leader in the CGT field with a strong track record. BRL Medicine currently has three new drugs approved for China IND and is in the midst of rapid product commercialization, and high capacity demand. Dr. Zheng hopes that this diversified collaboration will expedite the clinical translation and implementation of multiple innovative drugs benefiting patients worldwide who suffer from genetic diseases, malignant tumors, and autoimmune disorders. Furthermore, he believes that this partnership will contribute to the flourishing development of China’s pharmaceutical industry.

Dr. Wang Yangzhou, CEO of Porton Advanced, also expressed his excitement about the profound partnership with BRL Medicine. Recognizing BRL Medicine’s robust technological platform, sustained innovation capabilities, and remarkable results achieved in multiple R&D pipelines, Dr. Wang anticipates that Porton Advanced’s end-to-end gene and cell engineering CDMO platform will support BRL Medicine in accelerating clinical trials and future commercial production of cell engineering products to introduce more innovative drugs that are safer, more effective, and more accessible. Dr. Wang hopes that through their joint efforts, they can contribute to the advancement of China’s CGT field, ensuring the timely availability of quality drugs to the general public.

About BRL Medicine

At BRL Medicine Inc., we aim to become the world’s leading Cellular & Gene pharmaceutical company in the era of new commercial civilization, with the mission of “Through innovation led by gene editing, develop breakthrough human therapeutics and benefit the whole world”. With its independent R&D center and the “Shanghai Research Center for Gene Editing and Cell Engineering”, jointly established by BRL Medicine and university, BRL Medicine has obtained more than 100 patent achievements, and initiated 5 Investigator-Initiated clinical Trials (IIT) in 8 leading hospitals in China, with many pipeline projects have entered into IND application stage. Among them, gene editing projects for β-thalassemia, PD1 knockout non-viral targeted integration CAR-T and UCART have achieved excellent clinical results and have published several academic papers in famous academic journals such as Nature, Nature Medicine and Nature biotechnology. BRL Medicine has built five technology platforms with independent intellectual property rights, including The Gene Editing Technology Innovation Platform, Hematopoietic Stem Cell Platform, The Quikin CAR-T Platform, Universal Cell Platform and Enhanced T Cell Platforms, and has a 7000 square meter GMP pilot plant and an operating team of nearly 200 people, which strongly guarantees the rapid transformation and application of innovative research. BRL Medicine continuously promotes rapid update and iteration of R&D products through patient needs and clinical feedback. Driven by the era of new commercial civilization, BRL Medicine holds an open, shared, and win-win attitude, and works with global innovative biomedical ecological chain companies to accelerate the transformation and implementation of innovative drugs, so as to benefit global patients with genetic diseases and malignant tumors!

About Porton Advanced

Porton Advanced is a subsidiary of the globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363), founded in 2018. Located in Suzhou, China, Porton Advanced offers a cGMP-compliant manufacturing platform for plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy, enabling different development stages for global companies.

Porton Advanced operates on a “Customer First” approach to Gene and Cell Therapeutics (GCT) manufacturing, anchored by its core principles of “Compliance, Expertise, and Open Collaboration”. The company operates to rigorous, internationally harmonized Quality Management and IP protection standards, bringing innovative manufacturing solutions to the complex challenges in the GCT space.

Porton Advanced and Bennu Biotherapeutics Announced a Strategic Partnership to Accelerate Cell Engineering Development for Solid Tumors

SUZHOU, China, March 13, 2023 /PRNewswire/ — On March 7th, 2023, Suzhou Porton Advanced Solutions Ltd. (Porton Advanced) and Bennu Biotherapeutics (Bennubio) announced a strategic partnership to advance CGT R&D pipelines. The partnership aims to accelerate the development of T-cell therapies for tumors and autoimmune diseases.

As an end-to-end gene and cell engineering service CDMO, Porton Advanced provides comprehensive solutions covering plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy. Bennu Biotherapeutics is focused on developing T-cell therapies to address T-cell exhaustion, offering TIL, TCR-T, and Treg therapy for solid tumors and autoimmune diseases. Under this strategic agreement, Porton Advanced will provide CDMO services for multiple pipelines for gene and cell engineering, including plasmids, virus, TIL, TCR-T, and Treg, to Bennu Biotherapeutics.

“We are pleased to collaborate with Bennu Biotherapeutics, which focuses on the development of innovative therapies for tumors and autoimmune diseases. Through our end-to-end CGT CDMO, Porton Advanced aims to help Bennu Biotherapeutics develop multiple pipelines for cell engineering products, accelerate the development of innovative drugs such as TIL, and bring these beneficial drugs to market as soon as possible,” said Dr. Yangzhou Wang, CEO of Proton Advanced.

Ms. Zhao Ping, Co-founder and CEO of Bennu Biotherapeutics, said, “We can advance our process development and production by utilizing the advanced process development technologies provided by Porton Advanced. Through this strategic cooperation, we can accelerate the development of our process development platforms, enhancing our strength and market competitiveness. Both companies will continue to explore and innovate, giving full play to their advantages and making the biotechnology industry prosper in rapid development.”

About Bennu Biotherapeutics

Bennu Biotherapeutics is dedicated to transforming scientific achievements and developing innovative therapies for cancer and autoimmune diseases. Its innovative technology platform and gene editing methods aim to alleviate T-cell exhaustion, increase T cell durability and functionality by overcoming the inhibitory effect of the tumor microenvironment, and provide patients with a better prognosis.

About Porton Advanced

Porton Advanced is a subsidiary of globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363), founded in 2018. Located in Suzhou, China, Porton Advanced offers a cGMP-compliant manufacturing platform for plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy, enabling different development stages for global companies.

Porton Advanced operates on a “Customer First” approach to Gene and Cell Therapeutics (GCT) manufacturing, anchored by its core principles of “Compliance, Expertise, and Open Collaboration.” The company operates to rigorous, internationally harmonized Quality Management and IP protection standards, bringing innovative manufacturing solutions to the complex challenges in the GCT space.

Porton Advanced Collaborates with DanausGT to Accelerate the Development of Gene and Cell Engineering

SUZHOU,China, March 2, 2023 /PRNewswire/ — Porton Advanced Solutions Ltd. (Porton Advanced) and DanausGT Biotechnology Co., Ltd. (DanausGT) announced on February 27, 2023, a strategic collaboration in gene and cell engineering pipelines to expedite the development of innovative therapeutics.

As an end-to-end gene and cell engineering service provider, Porton Advanced CDMO offers comprehensive solutions covering plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy. On the other hand, DanausGT focuses on researching, developing, and producing new anti-cancer drugs and rare diseases with gene editing technology. DanausGT has established multiple R&D pipelines, and Porton Advanced will offer gene and cell engineering CDMO solutions to DanausGT, including plasmid, virus, and cell engineering products.

“We are excited to partner with DanausGT as their proprietary CRISPR/AAV technology is widely recognized. Their seven research pipelines are highly competitive, covering all the stages from pre-clinical to Clinical Phase I. Through our end-to-end gene and cell engineering CDMO, we hope to help DanausGT achieve IND approval for multiple pipelines and advance the development pipeline from domestic and overseas into the clinical stage. This collaboration will accelerate the development of innovative CGT therapeutics,” said Dr. Wang Yangzhou, CEO of Porton Advanced.

“We are pleased to establish strategic cooperation with Porton Advanced. I believe this partnership will expedite the development of innovative gene cell engineering. We are looking forward to collaborating in more fields,” said Dr. Wang Haifeng, founder, and CEO of DanausGT.

During the signing ceremony, Professor Jose Carlos Segovia, co-founder and CSO of DanausGT, presented a lecture entitled “Ex Vivo Gene Editing as a Definitive Cure for Hemolytic Anemias” and introduced the latest research progress of DanausGT. “We make gene editing technology and cell engineering to treat various diseases and work on therapy development for patient-centered care and clinical value. We look forward to collaborating with Porton Advanced to bring innovative biopharmaceuticals to patients earlier and deliver innovative values to society and the industry,” Professor Segovia said.

About DanausGT

DanausGT Biotechnology Co., Ltd. (DanausGT) is a biotechnology company that specializes in gene editing technology and cell engineering for the treatment of various diseases. Using its proprietary CRISPR/AAV technology, DanausGT can achieve precise gene replacement and gene insertion with a cDNA fragment smaller than 10,000 bp, without off-target effects or cancer risk. The editing efficiency can reach 80%. DanausGT has several projects in various stages from preclinical to clinical phase one. Its pyruvate kinase deficiency pipeline CG001 obtained EMA orphan drug qualification in March 2022 and is expected to complete the IND application in Europe and America in mid-2023.

DanausGT’s precision gene replacement technology is applied in the treatment of blood diseases, nerve-related diseases, cancer, and skin diseases. The company has six major pipelines that cover blood diseases, skin diseases, and liver-related diseases. Several of these pipelines have obtained orphan drug designation in Europe and America.

About Porton Advanced

Porton Advanced is a subsidiary of the globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363) and was founded in 2018. Located in Suzhou, China, Porton Advanced offers a cGMP-compliant manufacturing platform for plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy. The platform enables different development stages for global companies.

Porton Advanced operates on a “Customer First” approach to Gene and Cell Therapeutics (GCT) manufacturing. It is anchored by the company’s core principles of “Compliance, Expertise, and Open Collaboration”. Porton Advanced operates to rigorous, internationally harmonized Quality Management and IP protection standards, bringing innovative manufacturing solutions to the complex challenges in the GCT space.

Porton Advanced and Yinjia Biosciences Partner to Enhance CDMO Technology Platform

SUZHOU, China, Feb. 24, 2023 /PRNewswire/ — On February 20, 2023, Porton Advanced Solutions Ltd. (Porton Advanced) and Yinjia (Shanghai) Biosciences Co., Ltd. (Yinjia Biosciences) announced a strategic partnership in developing core protein raw materials for CGT (CGT) and test reagent products for quality control and evaluation systems to accelerate the development and commercialization of CGT.

Porton Advanced CDMO offers end-to-end gene and cell engineering services covering plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy. Yinjia Biosciences focuses on high-quality core protein raw materials and also offers companion diagnostics products for innovative adjuvant therapies. Yinjia Biosciences will provide Porton Advanced with high-quality core protein raw materials and testing reagent products for quality control and evaluation systems. Porton Advanced will continue to advance its technology and capabilities to accelerate the development of CGT to meet clinical needs and empower global partners.

“We are glad to establish a strategic partnership with Yinjia Biosciences. Yinjia Biosciences has a strong R&D and advanced platform for high-quality protein and rich industrialization experience in core protein raw materials and testing reagents. This strategic partnership will strengthen Porton Advanced’s CGT CDMO and accelerate the development of innovative CGT therapeutics to deliver life-changing benefits to patients,” said Dr. Wang Yangzhou, CEO of Porton Advanced.

“Porton Advanced has a proven track record in both product quality and market penetration and plays an important role in the CGT space. We are excited to partner with Porton Advanced to apply our products in other areas, and create new possibilities for us to meet more client needs,” said Dr. Wu Yifei, Chairman and CEO of Yinjia Biosciences.

About Yinjia Biosciences

Founded in November 2020, Yinjia Biosciences has built R&D and industrialization foundations in Shanghai, Beijing, and Suzhou, and has completed three rounds of financing. Yinjia Biosciences has successfully developed about 100 kinds of high-quality proteins, covering p frontier fields such as cell engineering, mRNA vaccine and closed-loop RNA, new drug R&D, molecular diagnostics, and companion diagnostics for new tumor drugs. Yinjia Biosciences has also developed testing reagents for personalized therapies guidance (companion and auxiliary diagnostics), and quality control.

About Porton Advanced

Founded in 2018 and located in Suzhou, China, Porton Advanced is a subsidiary of the globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363). Porton Advanced offers global services, a cGMP-compliant manufacturing platform, plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy from pre-clinical to commercialization.

Porton Advanced’s “Customer First” approach to Gene and Cell Therapeutics (GCT) manufacturing is anchored by our core principles of “Compliance, Expertise, and Open Collaboration”. Operating to rigorous, internationally harmonized Quality Management and IP protection standards, Porton Advanced is bringing innovative manufacturing solutions to the complex challenges in the GCT space.

Porton Advanced announced strategic cooperation with KAEDI to accelerate the R&D and production of CAR-T drugs

Dr. Hongjiu Dai, Chairman and CEO of KAEDI, said: “We are very pleased to have a strategic cooperation with Portonbio.

On May 31, 2021, Porton Biologics Ltd. (hereinafter referred to as Portonbio) announced a strategic cooperation with Nanjing KAEDI Biotech, Inc. (hereinafter referred to as KAEDI). Portonbio will offer CMC services for KAEDI’s CAR-T cell therapies with its end-to-end CDMO platform for CGT to help accelerate their development process.

According to the agreement, Portonbio, as an exclusive CDMO partner, will provide KAEDI with CMC services for multiple CAR-T projects, including the process development and manufacturing of plasmids, viral vectors and CAR-T cells and IND filling (CMC part) support services. The indication of the first project of our collaboration, KD-025 CAR-T, is liver cancer and glioma. The results of its preclinical research have been published in the leading international journal of tumor immunotherapy and ASCO (American Society of Clinical Oncology). At present, a multi-center clinical trial of KD-025 CAR-T POC is being carried out and a number of cases of clinical infusion have been completed with no obvious toxicities and side effects being observed. At the same time, the product is being applied for IND at home and abroad.

KAEDI has successfully developed a pipeline of several CAR-T new drug candidates for malignant solid tumors. We believe that Portonbio’s excellent technical team and professional CDMO platform can help KAEDI quickly and efficiently promote the drug candidates in our pipeline and accelerate the development process of our cell engineering drugs.”

“We are very honored to contribute to KAEDI’s innovative research in the field of cell engineering”, said Mr. Nianfeng Ju, Chairman and CEO of Portonbio, “Portonbio has established an integrated CDMO service platform for plasmids, viral vectors and cell engineering products, and has an experienced expert team and unique technical advantages. We hope to accelerate the marketing process of KAEDI CAR-T products through this cooperation, jointly promote the breakthrough of cell engineering products in the field of solid tumor, and enable the patients’ early-access to the therapies.”

About KAEDI

KAEDI is a clinical stage biotech company. The company is committed to the research and development of new CAR-T CGT drugs for malignant solid tumors. Relying on the company’s advanced synthetic biology technology platform KD SmCAR™, KAEDI has successfully developed several R&D pipelines of CAR-T first-in-class drugs for malignant solid tumors, including the second generation of CAR-T, dual-targeted fourth generation CAR-T and allogeneic CAR-T, which have applied for dozens of patents at home and abroad and eight authorized.

Preclinical research results of KD-025 CAR-T products targeting NKG2DL for liver cancer and glioma were published in Journal for ImmunoTherapy of Cancer, Cancer Immunology Research and ASCO. At present, a multi-center clinical trial of KD-025 CAR-T POC is being carried out, and a number of cases of clinical infusion have been completed with no obvious toxicities and side effects being observed. At the same time, the product is being applied for IND at home and abroad. http://www.cartbiomed.com/china/

About Portonbio

Founded in 2018 and located in Suzhou, China, Porton Biologics Ltd. (Portonbio) is a subsidiary of the globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363). Portonbio offers global biotech companies a seamlessly integrated, cGMP-compliant manufacturing platform spanning plasmids, viral vectors and cell therapeutics to enable early to late-phase clinical trials and full commercial production.

Featuring a world-class senior management team with global experience, Portonbio’s “Customer First” approach to Gene and Cell Therapeutics (GCT) manufacturing is anchored by our core principles of “Compliance, Expertise and Open Collaboration”. Operating to rigorous, internationally harmonized Quality Management and IP protection standards, Portonbio is bringing innovative and highly flexible development and manufacturing solutions to the complex challenges in the GCT space – ultimately enabling the public’s early access to good medicines.

Porton Advanced and Sinorda Biomedicine Enter Strategic Collaboration to Accelerate Cell Engineering Development for Solid Tumors

22 April 2022 – Suzhou Porton Advanced Solutions Ltd. (‘Porton Advanced’) and Guizhou Sinorda Biomedicine Co. Ltd (‘Sinorda Biomedicine’) today announced a long-term strategic partnership in CGT R&D and platform development.

Porton Advanced offers an end-to-end gene and cell engineering CDMO service platform covering plasmids, cell engineering, gene therapy, oncolytic virus, mRNA therapy and Bacterial Therapy. With broad experience in domestic and international new drug filing, Sinorda Biomedicine focuses on the R&D of innovative drugs for digestive tract diseases, tumor immunotherapy and oncolytic virus therapy, and has several new drug projects in clinical stage. Its subsidiary, Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., provides pre-clinical and clinical research services for tumor immune pharmacology and efficacy.

Under the agreement, Porton Advanced will provide services to accelerate the development, production and registration of breakthrough cell therapies currently being developed by Sinorda Biomedicine, including its T-cell immunotherapy product for colorectal cancer, SND002  (Sentinel lymph node T cell) and other pipelines. Porton Advanced will also work with Sinorda Biomedicine to support its cell and gene therapeutic R&D and production.

SND002 (SLN-T) , the first collaborated project, received approval for the initiation of Phase II clinical trials in Europe. Previously, the product was also awarded for ‘the Breakthrough New Drugs ’ by the Chinese National Science and Technology Major Project. The launch of this critical first project allows the integration of resources and capabilities from both Porton Advanced and Sinorda and promises greater synergy to accelerate the clinical development and approval of Sinorda’s SLN-T program.

Dr. Yangzhou Wang, CEO of Proton Advanced, said, “Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end CGT CDMO platforms and quality systems can complement these capabilities and enhance Sinorda’s pipeline. Supporting Sinorda’s  development, production and regulatory filing  and accelerating  its cell engineering drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda  establish  advanced therapies  that benefit patients globally.”

Dr. Pingsheng Hu, founder of Sinorda Biomedicine, said, “The entering of the strategic collaboration between Sinorda and Porton Advanced is a significant milestone to speed up the clinical development of our novel immunotherapies for solid tumors. Sinorda has long-term experiences in clinical application of immunotherapy in solid tumors. In addition, Sinorda has rich resources in clinical research, in clinical bio-bank for real world data study with cutting edge technologies for evaluation of immunotherapy. Porton Advanced brings an integrated CDMO platform, innovative technologies and an international team, with experiences from R&D stage to market approval and commercial production. Those capabilities from both sides will bring great opportunities in future development, that will contribute to value creation in the long term for both companies.”

About Porton Advanced

Porton Advanced Solutions (Porton Advanced) is a Cell & Gene therapies (CGT) CDMO company, providing end-to-end process development (PD), analytical development (AD), GMP manufacturing and testing services to meet clients’ needs for their therapeutic products at the pre-clinical, clinical, and commercial stage. Our dedicated process development and analytical development teams have established not only robust platforms-based USP/DSP and GMP manufacturing capability and capacity, but also, proprietary technologies to further empower our clients’ successes. Our services include gene & cell engineering discovery research and technology licensing, process development and analytical development, testing, drug substances (DS) and drug products (DP), cGMP manufacturing across plasmids, cell engineering, gene therapy, virotherapy and mRNA-based therapeutic platforms.

About Sinorda Biomedicine

Guizhou Sinorda Biomedicine Co., Ltd. focuses on the development of innovative drugs and industrialization of tumor immunotherapy. As a pioneer in tumor immunotherapy with the ability to develop bio-innovative drugs, Sinorda boasts an experienced technical and management team, and rich experience in innovative drug development and international cooperation between China, the United States and Europe. The company owns a number of innovative drug product pipelines in the clinical stage, and has established extensive cooperation with domestic and foreign well-known pharmaceutical companies, R&D institutions, CROs, CMOs and government departments, building a new drug development system with shared resources, overlapping advantages and high competitiveness. The company will develop innovative drugs at low cost and high speed, and become an innovative drug company with the highest growth value in the industry.