Kimia Therapeutics, Inc. (Kimia), a biotechnology company advancing small-molecule medicines in oncology and immunology with its integrated ATLAS discovery platform, today announced a clinical collaboration agreement with CStone Pharmaceuticals (CStone, HKEX: 2616). Under the agreement, CStone will advance Kimia’s lead oncology asset, KT-721, a novel small-molecule therapy targeting pathways critical for tumor cell survival, into Phase 1 clinical development. The collaboration marks Kimia’s transition to a clinical-stage company, with first patient dosing expected in early 2027.

CStone will lead the Phase 1 study in mainland China and Australia, applying its oncology clinical development and regulatory capabilities. The study includes dose-escalation and expansion components. It will evaluate KT-721 in biomarker-selected patient populations as an initial proof of concept, to define safety, pharmacokinetics, pharmacodynamics and early activity. Under the agreement, Kimia will reimburse CStone for the applicable clinical development costs, and CStone is eligible to receive milestone payments plus royalties on global net sales of the asset. Kimia is responsible for drug supply, CMC, scientific guidance and regulatory oversight, and retains full global rights to the asset.

Kimia’s lead asset, KT-721, was discovered using Kimia’s discovery platform integrating generative AI and medicinal chemistry. “Generative AI played a key role in the discovery of KT-721 inspiring novel paths of experimentation that led to a breakthrough for the program. This discovery was leveraged using clever medicinal chemistry resulting in a highly potent and selective molecule”, said Stig K. Hansen, co-founder, President and CEO of Kimia. “Entering the clinic is a defining milestone for Kimia. It marks our rapid evolution into a clinical-stage company and is an important validation of our drug discovery strategy. CStone’s expertise and capabilities in oncology clinical development will be valuable as we aim to quickly evaluate KT-721 in Phase 1 proof-of-concept studies in biomarker-selected patient populations.”

“We are pleased to collaborate with Kimia to advance this innovative oncology asset,” said Dr. Jason Yang, Chief Executive Officer, President of R&D and Executive Director of CStone. “This collaboration connects Kimia’s innovative platform with a clear path to efficient and robust clinical development to bring potential new therapies to patients faster.”

The lead asset is the first of a growing pipeline of potential first- and best-in-class small-molecule medicines in oncology and immunology discovered at Kimia. Additional programs are advancing through discovery and preclinical development.

About Kimia Therapeutics

Kimia is a drug discovery company applying high-throughput precision chemistry in combination with AI to identify novel therapies for the treatment of cancer and autoimmune diseases. Kimia’s proprietary ATLAS (AcTive Learning with Automated Synthesis and screening) platform combines machine learning-guided molecular design with high-throughput nanogram-scale synthesis and direct-to-biology screening in iterative experimental cycles.

ATLAS operates over reaction-defined chemical spaces of hundreds of millions of molecules, enabling Kimia’s drug hunters and agentic design systems to select, synthesize, and screen thousands of compounds per cycle to broadly explore chemical space while progressively focusing on molecules with the properties required for therapeutic development.

Kimia is building a pipeline of potential first- and best-in class drugs, with its lead oncology program, KT-721, entering clinical development in the first quarter of 2027.

For more information, visit www.kimiatx.com.

About CStone Pharmaceuticals

CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas. Dedicated to addressing patients’ unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched four innovative drugs and secured approvals for 21 new drug applications covering nine indications. The Company’s pipeline comprises 13 innovative drug candidates, including potential first-in-class or best-in-class antibody-drug conjugates (ADCs) and mono-/multi-specific antibodies across oncology, immunology and inflammation.

CStone has an experienced management team with comprehensive capabilities spanning the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development and commercialization.

For more information about CStone, please visit www.cstonepharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements regarding the anticipated timing of advancement of Kimia’s lead asset into clinical development, including the expected initiation of clinical activities in the first quarter of 2027; the potential of Kimia’s product candidates and discovery programs; and the capabilities and potential of the ATLAS platform. Words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These statements are based on Kimia’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to preclinical and clinical development, regulatory review and approval, manufacturing, the sufficiency of capital resources and other factors inherent in drug discovery and development. Kimia’s product candidates are investigational and have not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Forward-looking statements speak only as of the date of this release, and Kimia undertakes no obligation to update them except as required by law.

Media gallery

About The Author
Business Wire