Aslan Pharmaceuticals receives IND approval by Singapore’s Health Sciences Authority

ASLAN Pharmaceuticals, announced the approval of its investigational new drug (IND) application by Singapore’s Health Sciences Authority to initiate a phase 2 study of ASLAN003 for the treatment of acute myeloid leukaemia (AML)

ASLAN Pharmaceuticals, is a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types.

ASLAN003 is a highly potent, best-in-class, small molecule inhibitor of the human DiHydroOrotate DeHydrogenase (DHODH) enzyme.

Dr Bertil Lindmark, Chief Medical Officer of ASLAN Pharmaceuticals, said: “This important approval enables ASLAN to initiate the first study in AML, a disease with poor treatment outcomes and increasing prevalence, with a highly potent and selective DHODH inhibitor. Recent published findings have identified DHODH as a therapeutic target for AML and we look forward to initiating our study to investigate the potential of ASLAN003 as a novel treatment option.”1

AML is a rapidly progressing blood cancer that is characterised by the uncontrolled proliferation of immature blast cells in the bone marrow. The five-year cancer survival rate for AML patients is 26.9%.2 A majority of AML patients relapse or present with refractory disease and have overall poor prognosis.3

The phase 2 trial is a dose optimisation study and the primary outcome is to determine the optimum monotherapy dose of ASLAN003 including efficacy evaluated by Overall Complete Remission Rate (OCRR).

Earlier this year, ASLAN entered into a research and development collaboration with the Cancer Science Institute of Singapore (CSI) and the National University Cancer Institute, Singapore, to investigate the potential of ASLAN003 as a monotherapy and in combination with other targeted agents for haematological cancers.

A completed phase 1 trial showed that ASLAN003 has an excellent pharmacokinetic profile and was safe and well tolerated in healthy volunteers, which is more favourable compared to the reported side effect profiles of existing AML induction and maintenance chemotherapies.

References

  1. D. B. Sykes “Inhibition of Dihydroorotate Dehydrogenase Overcomes Differentiation Blockade in Acute Myeloid Leukemia,” 167(1), 171–186, (2016).
  2. National Cancer Institute
  3. J Szer, “The prevalent predicament of relapsed acute myeloid leukaemia”.

Companies