Cleave Therapeutics Announces Acquisition of Clinical and Preclinical Assets

Cleave Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced that CASI Pharmaceuticals (NASDAQ: CASI) has acquired the global rights to the company's clinical asset, CB-5339, and Eikon Therapeutics has acquired rights to the company's pre-clinical assets. CASI Pharmaceuticals is a global biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products. Eikon Therapeutics is a clinical-stage company working to advance breakthrough therapeutics through the purposeful integration of engineering and science.

"Both CASI and Eikon have unique capabilities and the expertise to continue advancing Cleave programs for patients with unmet needs in cancer and other indications," said Amy Burroughs, president and chief executive officer of Cleave Therapeutics. "The robust scientific and clinical insights the Cleave team has generated over the past decade will inform future development across multiple novel targets and disease areas. I would like to thank the many patients, investigators, site staff, scientists, advisors, partners, investors and employees for their contributions."

CB-5339 is an oral, second-generation, small molecule valosin-containing protein (VCP)/p97 inhibitor, designed to disrupt protein homeostasis, DNA damage response and other cellular stress pathways. In a Phase 1 clinical trial in patients with acute myeloid leukemia and myelodysplastic syndrome, the drug was well tolerated in 55 patients and demonstrated signs of clinical activity. Two patients remain on CB-5339 under compassionate use protocols at two leading US cancer centers.

The CASI global rights agreement follows a 2021 transaction between the parties in which CASI licensed rights to CB-5339 in Greater China. CASI announced Clinical Trial Application approval in China for patients with multiple myeloma in early 2023.

"Cleave's extensive clinical and preclinical work has shown CB-5339's significant potential to address treatment gaps in hematological malignancies," said Wei-Wu He, PhD, CASI's chairman and chief executive officer. "CB-5339 is a complementary addition to our portfolio of approved and investigational therapies in oncology, including EVOMELA^® (melphalan for injection) which is approved in China in the multiple myeloma treatment setting. We are thrilled to add CB-5339 to our portfolio of global assets in oncology."

In a separate transaction, Eikon Therapeutics acquired Cleave's preclinical assets, including a large chemical library spanning multiple targets in the AAA (ATPases Associated with diverse cellular Activities) family of ATPases. "Eikon has proprietary technology that will permit us to expand Cleave's work as a means of addressing novel, high-potential targets," said Roger M. Perlmutter, MD, PhD, Eikon's chairman and chief executive officer. "We have the team and the resources to develop medicines from the preclinical stage through regulatory approval, and to enable broad patient access."

About Cleave Therapeutics

Cleave was founded in 2011 with scientific co-founders Raymond Deshaies, PhD, Seth Cohen, PhD, and Francesco Parlati, PhD. The company has focused on novel biological mechanisms and pathways in the AAA (ATPases Associated with diverse cellular Activities) family of ATPases to address unmet needs in oncology and neurodegeneration. Cleave investors include 5AM Ventures, Bristol-Myers Squibb, Orbimed, U.S. Venture Partners, Arcus Ventures, Astellas Venture Management, and Osage University Partners.