Recently, Hangzhou Adcoris Biopharmaceutical Co., Ltd. and international biopharmaceutical company K2 Therapeutics reached a global exclusive strategic cooperation on the First in class ADC candidate drug ACR246, accelerating the international clinical development and commercial layout of this innovative targeted solid tumor product. As a long-term intellectual property service partner of Aikeisi, MeritsIP sincerely congratulates Aikeisi on achieving this important milestone!

According to the cooperation agreement signed by both parties, K2 Therapeutics will obtain exclusive global rights for the development and commercialization of ACR246, and will be fully responsible for the global clinical promotion, registration application, and market promotion of the drug. As a return on investment, iCruisi will receive a cash down payment in US dollars, corresponding equity consideration for the asset company, and up to $730 million in R&D and sales milestone payments. At the same time, it will enjoy the highest double-digit percentage of global sales revenue, achieving a win-win situation for both technological value and business benefits.

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1、 ACR246: The world’s first anti-5T4 TOP1 inhibitor ADC to enter clinical stage

As the core target of this collaboration, ACR246 is a first in class ADC drug targeting the 5T4 antigen, and is currently the world’s first anti-5T4 ADC product to enter the clinical stage with TOP1 inhibitors as cytotoxic payloads. It has the best in class potential and can effectively fill the technical gap in the field of solid tumor treatment. As a carcinoembryonic protein, 5T4 is highly expressed in a variety of solid tumors and cancer initiating cells, such as non-small cell lung cancer, breast cancer, ovarian cancer, head and neck cancer, gastric cancer, colorectal cancer, etc. It is closely related to tumor invasion, metastasis and drug resistance, and is an ideal target for precise tumor treatment.

In terms of technical design, ACR246 adopts a triple innovative architecture of “precise targeting+efficient payload+controllable release”:

Precise targeting: Specific recognition and binding to 5T4 positive tumor cells, reducing damage to normal cells

Efficient payload: Compared to traditional microtubule inhibitors, the innovative TOP1 inhibitor has a stronger bystander effect and can effectively kill heterogeneous tumor lesions

Controlled release: Optimized cleavable linkers achieve controlled drug release, increase drug concentration at the tumor site, and ensure treatment safety

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2、 Preliminary validation of clinical data, global multicenter clinical trials are about to commence

Clinical data shows that the safety and efficacy of ACR246 have been preliminarily validated. Since the first human administration was completed in October 2024, the Phase I clinical trial (dose range 0.6mg/kg-4.5mg/kg) has progressed smoothly, and the patients who have been administered have good tolerance without dose limiting toxicity. At the same time, some patients have shown clear signs of tumor shrinkage, laying a solid foundation for subsequent clinical progress. At present, Aikosi is advancing the Phase I/IIa clinical trials of ACR246 in China, and K2 Therapeutics is expected to launch its global Phase Ib clinical trials in 2027, accelerating the layout and commercialization preparation of Sino US dual reporting (IND/BLA) and global multi center clinical trials (MRCT).

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3、 NewCo model goes global, domestic ADC adds another benchmark

This cooperation adopts the NewCo model. Aikosi will leverage the global operational scale, clinical development capabilities, and commercial expertise of the MPM BioImpact ecosystem under K2 Therapeutics to accelerate the global research and development process of ACR246.

Dr. Miao Zhenwei, Chairman of iCruisi, said, “This cooperation is an important step towards fully unleashing the full potential of ACR246. ACR246 is a potential best in class anti-5T4 ADC drug that is expected to be globally launched. Relying on K2 Therapeutics, we will receive global operational support to assist in the efficient and compliant advancement of this pipeline, benefiting patients worldwide. ”

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4、 About Aikruisi

As a domestic clinical stage bio coupling technology and drug research and development enterprise, Aikeisi focuses on precise treatment of tumors and other clinically unmet diseases. It has independently developed two core technology platforms, ADC and AXC, and possesses high activity loaded drugs (PHAPsTM), cleavable flexible linkers (CLEFSTM), and multifunctional fixed-point quantitative coupling technology (MuSCTM) with independent intellectual property rights. It can quickly achieve the conversion from antibodies to ADC candidate drugs. Currently, it has established 10 first of its kind (FIC) and intergenerational first of its kind (FIG) product pipelines, with outstanding research and development capabilities. Relying on the deep cooperation with Aikeisi, Zhizhongde provides full chain professional services such as patent mining, layout, and examination response. Zhizhongde also offers full chain professional services including patent mining, domestic and international patent layout, examination response, infringement risk assessment, and technical barrier construction.

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5、 Summary

The strategic cooperation between Aikosi and K2 Therapeutics not only demonstrates the technological strength and international recognition of domestic innovative drugs, but also provides useful reference for the global transformation of innovative achievements of domestic biotech enterprises. In the future, Aikosi will continue to deepen global industrial cooperation and accelerate the clinical development and commercialization of core pipelines such as ACR246;

 

MeritsIP will continue to leverage its professional advantages and provide highly adaptable and professional intellectual property services to its cooperative clients, including Aikeisi, to safeguard enterprise innovation and long-term stable development, and assist in the high-quality upgrading of China’s biopharmaceutical industry.

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