Stamford, CT (Press Release) – Imbrium Therapeutics L.P., a clin­i­cal-stage bio­pharma­ceu­tical com­pany and operating sub­sid­i­ary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced that they have enrolled the first patient in the expansion stage of a Phase 1/2 clin­i­cal trial of tino­sta­mus­tine, an inves­ti­ga­tional treat­ment, in patients with re­lapsed refractory (R/R) hema­to­logic malig­nan­cies in the U.S. and Europe.

Following a dose escalation trial to estab­lish­ tolerability, this expansion phase seeks to in­ves­ti­gate the over­all response rate, duration of response and safety of five cohorts of patients with R/R cancers, in­­clud­ing: multiple myeloma, Hodgkin lym­phoma, periph­eral T-cell lym­phoma, cutaneous T-cell lym­phoma and T-cell prolymphocytic leukemia. Each study arm will run separately, with results to be submitted for upcoming medical meetings.

“The initiation of the expansion arms of this Phase 1/2 trial is a sig­nif­i­cant step for our work in on­col­ogy as we pursue im­por­tant treat­ment options for people living with these types of dev­as­tat­ing cancers,” said Paul Medeiros, pres­i­dent of Imbrium Therapeutics. “We look forward to con­tinue build­ing on the foundation of safety data generated in the dose-escalation portion of the trial as we ad­vance the devel­op­ment of tino­sta­mus­tine as a poten­tial ther­apy for people with limited treat­ment options.”

Craig Landau, MD, pres­i­dent and CEO, Purdue Pharma L.P., added, “This mile­stone underscores our con­tinued commitment to im­prov­ing the lives of patients with cancer and leveraging our capabilities in science and medicine to develop more effective ther­a­pies. We are creating a strong pipe­line of poten­tial medicines to help us achieve this mission.”

In addi­tion to tino­sta­mus­tine, Imbrium’s clin­i­cal stage on­col­ogy portfolio in­cludes etoposide toniribate, a novel prodrug with a target cell-activated topoisomerase inhibitor. Imbrium is cur­rently col­lab­o­rating in research for four drug can­di­dates across 14 dif­fer­en­t cancer types. Research on these com­pounds is being ad­vanced on behalf of Imbrium by Mundipharma EDO.

“We are excited to see the first patient enrolled in the tino­sta­mus­tine expansion study in patients with hema­to­logic malig­nan­cies, a group of dif­fi­cult-to-treat cancers,” said John Renger, PhD, vice pres­i­dent, Head of Research & Development and Regulatory Affairs, Imbrium Therapeutics. “Pre­clinical data suggest tino­sta­mus­tine’s dual mech­a­nisms of action may im­prove access to the DNA strands within cancer cells, both through breaking the strands and also coun­ter­acting the cancer cells’ attempt to repair the DNA damage.”

Imbrium Therapeutics, in col­lab­o­ration with Mundipharma EDO GmbH, ex­pec­ts to con­tinue enrollment in the Phase 1/2 trial. To learn more about the trial, please visit clin­i­caltrials.gov.

About Hematologic Malignancies

Hematologic malig­nan­cies are forms of cancer in the cells of blood-forming tissue or in the cells of the immune system. Examples of hema­to­logic cancer are acute and chronic leukemias, lym­phomas, multiple myeloma and myelo­dys­plastic syn­dromes. In most blood cancers, the normal blood cell devel­op­ment process is interrupted by uncontrolled growth of an ab­nor­mal type of blood cell. These can­cer­ous cells prevent the blood from per­forming many of its functions.¹

About Tino­sta­mus­tine

Tino­sta­mus­tine is an alkylating deacetylase inhibiting molecule (AK-DACi) in devel­op­ment for a range of rare or dif­fi­cult-to-treat blood cancers and solid tumors. It is a multi-action ther­apy and is cur­rently in Phase 1 clin­i­cal trials. Pre-clinical studies with tino­sta­mus­tine as mono­therapy have shown response, in myeloid and lymphoid malig­nan­cies and solid tumors.

About Imbrium Therapeutics L.P.

Imbrium is a clin­i­cal-stage bio­pharma­ceu­tical com­pany dedicated to ad­vanc­ing medical science through the devel­op­ment of im­por­tant new pharmacologic and biologic thera­peutics. We are pursuing on­col­ogy chemotherapeutics, treat­ments for disorders of the central nervous system, and non-opioid ap­proaches to the man­agement of pain. As an operating sub­sid­i­ary of Purdue Pharma L.P., Imbrium strives to develop and bring to market new medicines that serve the unmet needs of patients, physicians and health systems world­wide. We have built a robust and di­vers­i­fied pipe­line of inves­ti­ga­tional drug can­di­dates, and we actively col­lab­o­rate with industry and academic partners to identify and ad­vance future impactful medicines. For more in­for­ma­tion, please visit www.imbriumthera.com.

About Mundipharma EDO

Mundipharma EDO is part of the Mundipharma global network of privately-owned independent asso­ci­ated com­pa­nies, which operate in over 120 countries world­wide. We develop treat­ments for patients around the world with rare or R/R cancer, investigating smart ap­proaches to new cancer treat­ments from concept through to clin­i­cal devel­op­ment and regu­la­tory approval. We operate a lean, agile research and devel­op­ment model, empowering the team to form conclusions and make quick de­ci­sions with the aim of getting new ther­a­pies to patients as rapidly as possible. For more in­for­ma­tion please visit: www.edoncology.com.

About the Mundipharma Network

Mundipharma is a global network of privately-owned independent asso­ci­ated com­pa­nies whose pur­pose is to move medicine forward. With a high per­forming and learning organization that strives for inno­va­tion and commercial excellence through part­ner­ships, we suc­cess­fully transformed and di­vers­i­fied our European portfolio of medicines to create value for patients, payers and wider health­care systems across im­por­tant thera­peutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

This release discusses inves­ti­ga­tional uses of an agent in devel­op­ment and is not intended to convey conclusions about efficacy or safety. There is no guar­an­tee that such an inves­ti­ga­tional agent will suc­cess­fully com­plete clin­i­cal devel­op­ment or gain health authority approval.

References

1. American Society of Hematology. Blood Cancers. Accessed February 28, 2019. Retrieved from https://www.hematology.org/Patients/Cancers/.

Source: Imbrium Therapeutics.