Laekna Therapeutics has dosed the first two subjects in the US and China, respectively, in a Phase Ib/III clinical trial of afuresertib plus fulvestrant in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients.

Subject enrolment was initiated at the same time at the Piedmont Cancer Institute in the US and Tianjin Medical University Cancer Institute & Hospital in China.

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Afuresertib is an investigational inhibitor of AKT kinase, while fulvestrant is an estrogen receptor antagonist.

The company obtained worldwide exclusive rights to afuresertib from Novartis. 

The trial will analyse the safety and efficacy of afuresertib plus fulvestrant combination in HR+/HER2- breast cancer patients, who have failed one to two lines of treatments with CDK4/6 inhibitors, endocrine, or chemotherapy.

The company anticipates expanding the trial to various several other sites soon. 

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Laekna Therapeutics chief medical officer Dr Yong Yue said: “Our team has been working closely with the investigators to overcome obstacles and dose the first patients both in the US and China according to schedule, which demonstrated Laekna’s robust global clinical development capabilities. 

“Our next step is to expedite simultaneous global development of afuresertib plus fulvestrant to bring hope to patients who have developed treatment resistance.”

The company will commence a Phase III worldwide pivotal trial after a manageable safety profile of afuresertib plus fulvestrant combination therapy is demonstrated in the Phase Ib trial. 

The latest development comes after the company raised Series D funds worth $61m.

CS Capital led the funding round with Worldstar and Infinity Capital offering support. 

The proceeds from the financing round will be utilised to expedite the clinical development of the company product candidates, LAE002 and LAE001.