Syndax Pharmaceuticals Inc. (SNDX), a clinical-stage biopharmaceutical company developing cancer therapies, has a number of data readouts lined up for this year. The Company’s stock has gained nearly 28 percent in just 5 trading days.
— The lead product candidate is Entinostat, an oral histone deacetylase (HDAC) inhibitor, which is being developed for advanced hormone receptor-positive breast cancer and for multiple solid tumors.
The most advanced clinical trial is E2112, a phase III registration trial of Entinostat plus *Exemestane in HR+, HER2- breast cancer, which is focused on overall survival. *Exemestane is an approved drug for breast cancer.
— SNDX-5613, an oral nuclear protein menin inhibitor, being developed for the treatment of MLL-rearranged (MLL-r) acute leukemias, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). There are FDA-approved therapies targeting MLLr or NPM1 acute leukemias.
A phase I/II clinical trial of SNDX-5613 in patients with relapsed/refractory (R/R) acute leukemias, dubbed AUGMENT-101, was initiated as recently as November 2019.
— Axatilamab, formerly known as SNDX-6352, a monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages, is being developed for the treatment of Chronic Graft Versus Host Disease.
SNDX-6352 is under a phase I/II trial for the treatment of Chronic Graft Versus Host Disease.
The Company sees a blockbuster market potential for Entinostat and SNDX-5613.
** The final overall survival analysis of E2112 – the phase III registration trial of Entinostat plus Exemestane in HR+, HER2- breast cancer, is expected in the second quarter. If the overall survival assessment turns positive, the Company plans to file for full regulatory approval of Entinostat in the U.S. for the treatment of breast cancer.
** The initial clinical data from AUGMENT-101, the phase I/II clinical trial of SNDX-5613 in patients with relapsed/refractory (R/R) acute leukemias, is anticipated to be presented at a medical conference in the fourth quarter of 2020.
** Results from the phase I/II trial of SNDX-6352 for the treatment of Chronic Graft Versus Host Disease are also expected in the fourth quarter of this year.
As of December 31, 2019, Syndax had cash, cash equivalents and short-term investments of $59.8 million.
In January of this year, the Company raised $35 million in an equity offering involving premier life sciences investors including BVF, Boxer Capital and AI Life Sciences.
Last month, the Company entered into an agreement with Hercules Capital, Inc. (HTGC) for a term loan of up to $30.0 million.
SNDX touched a new 52-week high of $12.16 in intraday trading yesterday (Mar.5, 2020) before closing at $12.
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