Medicilon Assisted DAC Biotechnology's Fourth ADC Drug DXC007 Getting Approved for Clinical Use

2022-01-24

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On December 28, 2021, Hangzhou DAC Biotechnology Co., Ltd. (DAC Biotech) DXC007 project was successfully approved for clinical trials. The drug is indicated for the most common acute leukemia in adults-relapsed/refractory acute myeloid leukemia (AML).

DXC007 is the fourth ADC drug approved for clinical use by DAC Biotech, and it is also the fourth ADC drug that Shanghai Medicilon Inc. (Medicilon) to help DAC Biotech successfully getting approval. In the long-term collaboration, Medicilon’s scientific research team has continuously communicated with DAC Biotech, and created a tailor-made non-clinical trial program for DAC Biotech to meet their clinical needs of the ADC projects with higher quality and efficient R&D services.

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17 Product Pipelines in 9 Years

DAC Bioteech Focuses on ADC Drug R&D

Since its establishment at the end of 2012, DAC Biotech has been deeply involved in the ADC field for 9 years. At present, DAC Biotech has 17 product pipelines, and its indications include solid tumors such as breast cancer, non-small cell lung cancer, gastric cancer, urothelial cancer, pancreatic cancer, and a variety of hematomas.

In June 2021, DAC Biotech successfully declared the first ADC drug targeting Muc1 in China. (In the development of this drug, Medicilon provided pre-clinical research services including efficacy, pharmacokinetics, and safety evaluation).

In September 2021, DAC Biotech's DX126-262 launched a phase II clinical trial. It is expected that in the year 2022, DAC Biotech will continue to apply for IND for a number of ADC drugs.

After nearly 9 years of research and development, DAC Biotech has established a complete ADC technology platform and has 29 international PCT applications. DAC Biotech, who has taken every step of the way solidly and steadily, and spared no effort to save more lives, has become a leader in the world's ADC field.

Medicilon ADC Pre-clinical R&D Platform

Refining Experience and Starting Again

Under the guidance of the concept of win-win collaboration, Medicilon and DAC Biotech have reached a long-term strategic partnership, which has successfully assisted DAC Biotech's 4 ADC new drugs to be approved for clinical use, and has multiple ADC projects under development.

In the R&D of DXC007, Medicilon provided services including pharmacokinetics, safety evaluation and SEND conversion, which helped the project successfully obtain clinical approval. In the pharmacokinetic test, Medicilon provided a variety of high-quality test methods and reliable high-quality test data for various ADC component analytes of DXC007. In the safety evaluation test, the Toxicology Research Department of Medicilon followed the ICH guidelines S6 and S9, combined with the specific conditions of the DXC007 project, customized a personalized safety evaluation plan, and provided a safety evaluation service in compliance with international GLP standards such as NMPA and FDA.

❖ SEND Format Conversion Platform

Medicilon's preclinical pharmacology and toxicology research team is equipped with a professional send format conversion team, and has established a send data conversion platform that is fully mature in terms of software, technology, specification and quality, so as to realize accurate data conversion and provide a good environment for electronic data submission. In 2020 alone, it has helped customers complete 14 send data conversion projects, of which 3 new drug projects have obtained clinical licenses from FDA.

Time after time for the perfect collaboration, time after time for strategic synergy, complementary advantages, and overcome difficulties, Medicilon and DAC Biotech not only successfully promoted every ADC new drug to the clinic, but also achieved the Medicilon’s antibody drug conjugate (ADC) pre-clinical R&D platform. These precious R&D experiences have far-reaching enlightening effects on advancing the preclinical and high-quality R&D of ADC drugs in China.

After years of development, ADC drugs have gradually matured and continued to iterate, but more new concepts of ADC technology still need clinical verification. In the future, Medicilon looks forward to helping more self-developed best-in-class and first-in-class ADC drugs enter the clinic and market as soon as possible, opening doors of hope for cancer patients worldwide.

Up to now, Medicilon has undertaken more than 100 IND application biopharmaceutical projects, including monoclonal antibodies, double antibodies, polyclonal antibodies, ADCs, viral vaccines and fusion proteins. As of May 2022, Medicilon has successfully helped 10 ADC drugs to be approved for clinical trails, and has multiple ADC projects under development. Medicilon has in-depth exchanges with customers in the formulation of the preclinical integrated research plan of ADC. The backbone of scientific research combines the characteristics of each case with years of practical experience and technical accumulation, and carefully submits high-quality experimental plans and results to customers.

About DAC Biotech

DAC Biotech is an innovative biopharmaceutical company dedicated to the R&D, production and commercialization of antibody-conjugated drugs (ADC) for tumors. "Let original medicines benefit the world" is DAC Biotech’s mission.

After nearly 9 years of research and development, DAC Biotech has become the world leader in the field of ADC drugs. DAC Biotech has an ADC drug creation platform with independent intellectual property rights, about 50 types of intelligent connectors, and more than 100 type of anti-tumor cytotoxic molecules in 5 categories. DAC Biotech has 27 world intellectual property PCT invention patents, has applied for more than 300 invention patents all over the world, and 21 patents have been granted in the United States.

The new-generation ADC drug DX126-262 (for the treatment of Her2-positive solid tumors) developed by DAC Biotech is currently undergoing phase I clinical trials in the Cancer Hospital of Fudan University. Phased reports showed that the drug showed obvious tumor-killing effects, and good effectiveness data was obtained. In terms of safety, DX126-262 drug has low toxicity and is well tolerated by patients. At the same time, phase II clinical trials of the drug for multiple diseases have been launched and the clinical trial application in the United States has also been approved by the FDA.

The second drug, DAC-002 (for Trop2-positive solid tumors), collabrated by DAC Biotech and Junshi Biosciences, is conducting phase I clinical trials in Shanghai Pulmonary Hospital, Peking University Cancer Hospital and Cancer Hospital of Fudan University. The third Muc1-ADC drug DXC005 (treatment of colorectal cancer, pancreatic cancer, etc.) and the fourth ADC drug DXC007 (treatment of AML and other hematomas) have obtained the clinical approval and will be enrolled in the first patient in the near future. The following three innovative solid tumor ADC drugs DXC004, DXC009, and DXC008 are undergoing or will be undergoing safety reviews and will apply for IND this year.

About Medicilon

Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.

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