Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 31, 2021

Antengene starts eltanexor dosing in myelodysplastic syndrome trial

Apart from MDS, eltanexor is being analysed as an advanced solid tumour treatment in China.

Antengene has dosed the first subject in a Phase I/II HATCH trial of eltanexor (ATG-016) for treating patients with intermediate and higher-risk myelodysplastic syndrome (MDS) in China.

A selective inhibitor of nuclear export compound, eltanexor stimulates apoptosis in tumour cells by hindering nuclear export protein XPO1.

The single-arm, open-label HATCH trial will assess the safety and efficacy of eltanexor as a single agent in MDS patients who had failed hypomethylating agent (HMA) based treatments.

According to results from a Phase I/II clinical trial in increased-risk MDS patients who are refractory to HMAs, eltanexor provided an objective response rate (ORR) of 35%, with all of them achieving bone marrow complete response.

Furthermore, eltanexor was found to have favourable safety and tolerability profile in the trial.

Apart from MDS, eltanexor is being analysed for treating advanced solid tumour patients in China.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

Antengene founder, chairman and CEO Dr Jay Mei said: “We are encouraged by the dosing of the first MDS patient in the HATCH trial, as it marks the beginning of the clinical development of our second SINE compound.

“Eltanexor was found to be safe and well-tolerated in preclinical studies and showed potent anti-cancer activity in xenograft models, and demonstrated preliminary clinical efficacy and well-tolerated safety profile in patients with high-risk MDS.”

MDS is a malignancy that develops in the bone marrow hemopoietic stem cells and its incidence rises drastically with age.

The median overall survivals (OS) of intermediate, high, and very high-risk MDS patients are 3, 1.6, and 0.8 years, respectively. They are also at an increased risk of advancing to acute myeloid leukaemia.

HMAs such as azacytidine and decitabine are used as standard of care therapies for MDS but they do not eliminate neoplastic clones and cause a response in nearly 50% of MDS patients, Antengene noted.

In addition, MDS patients who are refractory to HMA-based treatments have a reduced prognosis, fewer options for follow-up therapies and a median OS of just four to six months.

In November last year, Antengene announced plans to begin the Phase I/II clinical trial of eltanexor monotherapy in patients with intermediate and higher-risk MDS.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy