NewCo+1! Akesobio Partners with K2 Therapeutics to Advance Global Clinical Development and Commercialization of ACR246

Under the agreement, K2 Therapeutics has obtained exclusive global rights to develop and commercialize ACR246. In addition to an upfront cash payment in US dollars, Aikeresi will receive corresponding equity consideration in the asset company, up to $730 million in R&D and sales milestone payments, and tiered royalties on global net sales at high single- to double-digit percentages.

ACR246 is a first-in-class antibody-drug conjugate (ADC) targeting the 5T4 antigen. Currently, Aikeresi is conducting Phase I/IIa clinical trials of ACR246 in China; K2 Therapeutics expects to initiate its global Phase Ib clinical trial in 2027.

Dr. Miao Zhenwei, Chairman of Aikeresi, stated, “This collaboration marks a significant step toward fully unlocking the potential of ACR246. ACR246 is our potential best-in-class anti-5T4 antibody-drug conjugate (ADC), with the prospect of becoming the first to market globally. By partnering with K2 Therapeutics, part of the MPM BioImpact ecosystem, we will leverage global operational scale, mature clinical development capabilities, and extensive commercialization expertise to facilitate the efficient, compliant, and steady advancement of this pipeline program, ultimately benefiting patients worldwide.”

ACR246 is the world’s first anti-5T4 ADC product with a TOP1 inhibitor as its cytotoxic payload to enter clinical development, holding dual potential as best-in-class and the first of its kind to achieve global market approval.

5T4 is an oncofetal antigen highly expressed in various solid tumors (such as non-small cell lung cancer, breast cancer, ovarian cancer, head and neck cancer, gastric cancer, colorectal cancer, etc.) and cancer stem cells. It is closely associated with tumor invasion, metastasis, and drug resistance, making it an ideal therapeutic target.

ACR246 utilizes an innovative TOP1 inhibitor as its toxin payload, offering a more potent bystander effect and enhanced cytotoxicity against heterogeneous tumors compared to traditional tubulin inhibitors, with the potential to overcome the efficacy bottlenecks of current ADCs.

With its triple design of precise targeting, high-potency payload, and controlled release, ACR246 has demonstrated an excellent therapeutic window and safety profile in preclinical studies, offering new hope for patients.

Since completing the first-in-human dosing in October 2024, ACR246’s Phase I clinical trial (0.6 mg/kg–4.5 mg/kg) has yielded impressive clinical data, with early signs of dual excellence in both safety and efficacy.

This transaction adopts the NewCo model. Under the agreement, K2 Therapeutics will be responsible for the global development and commercialization of ACR246. In addition to receiving an upfront cash payment in US dollars, Aikerais will receive corresponding equity consideration in the asset company, up to $730 million in R&D and sales milestone payments, as well as tiered royalties on global sales. This collaboration combines Aikerais’s technical expertise with K2 Therapeutics’ global clinical development and commercialization capabilities, thereby more efficiently advancing the project’s R&D progress.

NewCo Capital served as the lead coordinator and exclusive financial advisor for this transaction. Li Rui, Partner at NewCo Capital, stated, “ADC pipelines have currently become highly sought-after M&A targets in overseas capital markets, and high-quality domestic ADC assets of the same category have also become key focuses for leading overseas funds. We believe this transaction will serve as an important benchmark for the global expansion of Chinese ADC pipelines.”

This collaboration between Aikereisi and K2 Therapeutics will ensure that the ACR246 project receives independent, efficient, and international operational support, accelerating dual regulatory submissions in China and the United States (IND/BLA), the layout of global multi-regional clinical trials (MRCT), and commercialization readiness, with the aim of bringing this innovative drug with first-in-class potential to cancer patients worldwide as soon as possible.

Furthermore, a collaboration for another bispecific antibody ADC project was also included under the same agreement on similar terms.

K2 Therapeutics is a biotechnology company dedicated to making a profound global impact, renowned for its “borderless” R&D model and its experienced drug development team. The company focuses on identifying biomedical assets with the greatest innovative potential worldwide and transforming these cutting-edge achievements into high-quality innovative drugs through a standardized development system led by senior drug R&D experts. K2 Therapeutics aims to build a product pipeline centered on high-potential first-in-class and best-in-class assets, delivering therapies with significant clinical value to patients worldwide.

MPM BioImpact is a world-leading biotechnology investment firm with over 30 years of specialized experience, dedicated to incubating and investing in innovative enterprises to deliver transformative therapies for patients. The company brings together an exceptional team of seasoned investment professionals, entrepreneurs, advisors, and leading scientists, enabling the efficient translation of cutting-edge scientific discoveries into breakthrough drugs and potential therapies. With assets under management exceeding $3.5 billion, its investment portfolio spans early-stage venture capital funds, private and public impact funds, and publicly traded equity funds.

NewCo Capital (Niukou Capital) was co-founded by senior investment bankers, business development (BD) experts, and scientists with extensive experience in the innovative drug sector. It is a professional collaborative platform that centers on resource connectivity and enhances asset value through transaction facilitation. The firm focuses on incubating high-quality domestic biotech assets into NewCos and fostering overseas BD collaborations, covering the full spectrum of innovative drug assets from the preclinical candidate (PCC) stage to Phase I clinical trials. To date, it has successfully launched two offshore NewCo incubation projects with investments from renowned domestic and international funds.

Aikeresi is a clinical-stage company specializing in bioconjugation technology and drug development, with a focus on precision treatments for cancer and other diseases with unmet clinical needs. The company has independently developed two major technology platforms, ADC and AXC, which include highly active payload drugs (PHAPs) with independent intellectual property rights.™), cleavable flexible linkers (CLEFS™), and multi-functional site-specific quantitative conjugation technology (MuSC™) enable rapid translation from antibodies to ADC candidates, facilitating the development of First-in-Class (FIC) and First-in-Generation (FIG) ADC products.

The company’s founders and team have dedicated over 20 years to the field of antibody-drug conjugate (ADC) therapeutics, accumulating extensive experience in successful ADC drug development and product commercialization. Leveraging their proprietary technology platform, they have established a pipeline of 10 first-in-class (FIC) and fast-follow-in-class (FIG) products. Among these, ADC2122 has completed Phase I clinical trials; ACR246 is entering Phase Ib/IIa trials; and ACR335 and ACR317 are in late-stage preclinical studies, approaching Investigational New Drug (IND) application submission.

AikruiSi welcomes investors and industry partners to engage in exchanges and collaboration, jointly advancing the development of innovative ADC drugs.