Stamford, CT (Press Release) – Purdue Pharma L.P. today announced successful completion of a first-in-human Phase 1 dose escalation study of tino­sta­mus­tine in patients with re­lapsed or refractory hema­to­logical malig­nan­cies for which there are no avail­able ther­a­pies. The study eval­u­ated the safety and phar­ma­co­ki­netics, and sought to determine the maximum tolerated dose and inform a Phase 2 dose of tino­sta­mus­tine.¹

The multi-acting ther­apy can­di­date tino­sta­mus­tine, pre­vi­ously known as EDO-S101, is a novel and poten­tially first-in-class alkylating deacetylase inhibitor (AK-DACi) ther­apy being studied for its poten­tial to im­prove access to the DNA strands within cancer cells, break them, and coun­ter­act the cancer cells’ attempt to repair the DNA damage. It is in devel­op­ment for a range of rare or dif­fi­cult to treat blood cancers and solid tumors. Based on the results of this Phase I human trial, Purdue will sup­port ad­vancement of tino­sta­mus­tine into further clin­i­cal studies.

“We are pleased with the out­come of this promising early stage on­col­ogy pro­gram and we believe it has the poten­tial to make meaningful clin­i­cal con­tri­bu­tions in areas with sig­nif­i­cant unmet needs,” said Craig Landau, MD, pres­i­dent and CEO, Purdue Pharma. “In addi­tion to our estab­lish­ed commitments in on­col­ogy and neuroscience, we are actively seeking oppor­tu­ni­ties to col­lab­o­rate across a number of thera­peutic areas as part of our ongoing efforts to diversify our scientific research and bring ther­a­pies to market that may im­prove out­comes for patients.”

The reported completion of this study is the first clin­i­cal update since Purdue announced in November 2017 sig­nif­i­cant on­col­ogy-related investments to estab­lish­ a portfolio of drug can­di­dates with the poten­tial to deliver new cancer ther­a­pies, in areas of high unmet medical need, to physicians and patients. As part of these investments, Purdue is cur­rently sup­porting research for four drug can­di­dates across 14 dif­fer­en­t cancer types. Research on these com­pounds is being ad­vanced on behalf of Purdue by Mundipharma EDO.

In addi­tion to tino­sta­mus­tine, Purdue’s clin­i­cal stage on­col­ogy portfolio in­cludes etoposide toniribate, a novel target-activated topo­isom­er­ase inhibitor that delivers the chemo­ther­apy etoposide to tumors in an inactive form where it is ‘switched on’ by enzymes called carboxylesterases. Purdue also has two late pre-clinical stage anti­body-drug con­ju­gates, EDO-B776 and EDO-B278, in devel­op­ment. EDO-B776 is being studied for its poten­tial to target the cancer an­ti­gen 125 (CA-125) in ovarian cancer. EDO-B278, which targets human tissue factor, is in devel­op­ment for treat­ment of various solid tumors.

The de­ci­sion to move tino­sta­mus­tine into Phase 1 human trials was sup­ported by pre­clin­i­cal studies, which suggest that tino­sta­mus­tine may deliver both alkylat­ing activity and pan-histone deacetylase (HDAC) inhibition to im­prove access to the DNA strands within cancer cells, break them, and coun­ter­act the cancer cells’ attempt to repair the DNA damage.

Purdue will also con­tinue to selectively seek addi­tional on­col­ogy prod­uct assets through licensing and acquisition, and the com­pany will maintain a priority interest in can­di­dates with mech­a­nisms com­ple­men­tary to emerging immuno-oncology based treat­ment paradigms.

About Purdue Pharma

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of health­care professionals, patients, and care­givers. We were founded by physicians and we are cur­rently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to sup­porting national, regional and local col­lab­o­rations to drive inno­va­ts in patient care. Privately held, Purdue is pursuing a pipe­line of new medications and tech­nolo­gies through internal research & devel­op­ment and strategic industry part­ner­ships. For more in­for­ma­tion, please visit www.purduepharma.com.

About Mundipharma EDO

Mundipharma EDO is an on­col­ogy research com­pany devel­op­ing tino­sta­mus­tine for the US on behalf of Purdue Pharma. It is devel­op­ing ther­a­pies for patients around the world with rare, re­lapsed or refractory cancers, investigating smart ap­proaches to new cancer treat­ments from concept through to clin­i­cal devel­op­ment and regu­la­tory approval. The com­pany col­lab­o­rates with its world­wide network of clin­i­cal connections and ex­peri­enced partners to develop competitively dif­fer­en­ti­ated com­pounds suc­cess­fully for a range of cancer types. Mundipharma EDO is cur­rently recruiting patients for its on­col­ogy clin­i­cal trials pro­gram in hematology and solid tumors. To find out more please contact us at www.edoncology.com.

Reference

1. Information about the tinostamustine dose escalation study can be accessed at this link or ClinicalTrials.gov, identifier: NCT02576496.

Source: Purdue Pharma.