Date: 2017-07-06

Type of information: Granting of a patent

Product name: GMI-1271 - E-selectin antagonist

Compound: E-selectin antagonist

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism: E-selectin antagonist. GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with acute myeloid leukemia cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug's potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy.

Company: GlycoMimetics (USA - MD)

Disease: acute myeloid leukemia

Latest news: • On May 25, 2017, GlycoMimetics announced that the European Commission, based on a favorable recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products, has granted orphan designation for GMI-1271 , for the treatment of acute myeloid leukemia (AML). This E-selectin antagonist is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. • On May 17, 2017, GlycoMimetics announced that the FDA has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to GMI-1271. • On June 13 ,2016, GlycoMimetics announced that it received Fast Track designation from the FDA for its novel E-selectin antagonist GMI-1271 for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and elderly patients aged 60 years or older with AML. • On May 13 ,2015, the FDA has granted orphan drug designation for E-selectin antagonist for the treatment of acute myeloid leukemia. GlycoMimetics is currently recruiting patients in a Phase 1/2, open-label multicenter study designed to evaluate the safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in adult patients with AML; a Phase 1 study in healthy volunteers was completed last year.

Patents: • On July 6, 2017, GlycoMimetics announced that the European Patent Office has issued an "intention to grant" letter for European Patent Application Number EP12813711.1, titled "E-Selectin Antagonist Compounds, Compositions, and Methods of Use. With the issuance of patents in the U.S. and Europe , GlycoMimetics will have claims directed at GMI-1271 extending at least until 2032. • On May 31, 2015, GlycoMimetics announced that the U.S. Patent and Trademark Office has issued a composition of matter patent (No. 9,109,002), entitled "E-Selectin Antagonist Compounds, Compositions and Methods of Use," which provides coverage for the chemical structure of GlycoMimetics' clinical product candidate GMI-1271. Based upon data from preclinical studies, GMI-1271 has the potential to synergize with chemotherapy to improve cancer cell killing. It may also address both metastasis (cancer's spread) and complications of chemotherapy including neutropenia and mucositis. Applications are pending for patents outside of the United States.

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA: 2015-05-13

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes