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

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.

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.

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.