China’s MediLink Therapeutics has confirmed that YL201, developed using the company’s first proprietary antibody-drug conjugate (ADC) technology platform, has been cleared on its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its Phase I first-in-human study.
YL201 uses a novel “TMALIN” (Tumor Microenvironment Activable Linker) ADC technology developed at MediLink Therapeutics which focuses on the tumor microenvironment (TME) which has a decisive role in tumor differentiation, epigenetics, dissemination, and immune evasion.
The technology is designed to resolve potential ADC resistance and stability issues and generates homogeneous DAR8 ADC products with potential to resolve drug resistance issues of current ADC products.
Preclinical data demonstrated great efficacy of YL201 in various in vivo tumor models, including non-small cell lung cancer, prostate cancer and esophageal squamous cell carcinoma. Furthermore, in non-human primates YL201 has shown good tolerability. The clearance of our first IND marks an important milestone for MediLink and brings novel treatment opportunity of this conjugate drug to global cancer patients.
The drug will be investigated in a phase 1 multi centre, nonrandomized, open-label, first-in-human study in China and the United States. The study will evaluate the safety, tolerability, pharmacokinetics, and efficacy in patients with advanced solid tumors.
Earlier this year MediLink Therapeutics, established in 2020 by BioBAY and an experienced team with innovative ADC expertise and management skill, announced completion of a US $ 70 million Series B financing. This round was led by LYFE Capital and Qiming Venture Partners, and co-invested by Legend Capital, Loyal Valley Capital and Highlight Capital (HLC), etc. The new funding will support clinical development of MediLink’s new generation ADC pipeline, as well as early discovery and development of novel conjugated drugs.
“Over the past year, MediLink Therapeutics has focused on the development of the latest generation ADC technology platform,” noted Tongtong Xue, Ph.D., Founder and Chief Executive Officer of MediLink, who, previously was a general manager of Kelun-Biotech where he led a team of over 1,000 scientists.
“ADC will play a very important role in the future treatment of cancers. The advancement in new-generation linkers and toxins has expanded the application of ADCs. MediLink Therapeutics has rich experience and great capacity in developing ADCs with competitive technology for developing new-generation ADCs. It has made remarkable progress in all aspects and demonstrated efficient teamwork based on a tacit understanding between the team members,” Said Xie Ronggang, partner at Loyal Valley Capital.
“We are glad to work together with such an outstanding team to seek solutions that can relieve patients from pains relying on innovation and sciences. Loyal Valley Capital will give MediLink Therapeutics long-term support to help it become a world-leading ADC technology platform company,” Ronggang concluded.
In addition to YL201 MediLink has developed 6 additional ADCs which are all in preclinical development.
A Study of YL201 in Patients With Advanced Solid Tumors – NCT05434234
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