Mundipharma EDO GmbH initiates expansion phase of first-in-human trial to investigate use of tinostamustine in rare and difficult-to-treat blood cancers

 

Basel, Switzerland, 5 March 2019 – Mundipharma EDO GmbH, part of the Mundipharma global network of independent associated companies, today announced that the first patient has been enrolled in the expansion stage of a Phase I/II clinical trial of tinostamustine in patients with relapsed/refractory (R/R) haematological malignancies in the US and Europe which they are conducting in conjunction with Imbrium Therapeutics L.P., an operating subsidiary of Purdue Pharma L.P.

Following the successful completion of the dose-escalation phase to determine the safety, tolerability and recommended Phase II dose, the expansion stage seeks to establish the ORR, DR and safety of five cohorts of patients with R/R cancer, specifically: multiple myeloma (MM), Hodgkin lymphoma (HL), peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and T-cell prolymphocytic leukaemia (T-PLL). Each study arm will run separately, with results announced as they become available.1

Tinostamustine is an alkylating deacetylase inhibiting molecule that, in preclinical studies, has been shown to improve drug access to the DNA strands within cancer cells, break them and counteract damage repair.2-4Preclinical studies suggest that these complementary and simultaneous modes of action have the potential to overcome resistance.4,5

Lead study investigator Dr Owen O’Connor, Columbia University Medical Center, commented: “Initial results in the dose-escalation phase of the study have been promising and our aim now is to establish the efficacy and safety of the treatment in cancer types for patients with very limited treatment options, either because their cancer is rare or is not responding to other treatments.”

Dr Thomas Mehrling, CEO of Mundipharma EDO added: “This is an important milestone for both Mundipharma EDO and tinostamustine. Our focus as a company is on areas where we can bring benefit to cancer patients with significant unmet need and we, in conjunction with Imbrium Therapeutics, are excited to progress this compound.”

To find out more about this study or the Mundipharma EDO oncology clinical trials programme visit: www.edoncology.com/clinical-trials.

 

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Notes to editors:

About Mundipharma EDO

Mundipharma EDO is partof 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 treatments to patients as rapidly as possible.

For more information please visit: www.edoncology.com.

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 treatments for oncology chemotherapeutics, 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 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.

For more information please visit: www.mundipharma.com.

About the study1

This Phase I multi-centre study has demonstrated the safety and tolerability of intravenous tinostamustine in patients with R/R haematological malignancies for which there are no available therapies as part of the Stage 1 dose-escalation phase. The second stage of the study will involve expansion into five cohorts. Patient cohorts will include R/R MM; HL; PTCL; CTCL; and T-PLL. Patients enrolled will be treated at the recommended Phase II dose based on the results of Stage 1. Endpoints for Stage 2 include ORR, clinical benefit rate by cohort, safety of selected doses, time to overall response, time to complete response, DR, progression-free survival and overall survival. Please refer to www.clinicaltrials.gov for additional details.

For further information please contact:

 

Tiffany Fretwell

Communications Lead, Mundipharma

[email protected]

+44 (0) 1223 393 361

 

Helen Rae

Makara Health

[email protected]

Tel: +44 (0) 23 81 247 327

 

 

References:

  1. Study of EDO-S101, A First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Haematological Malignancies. clinicaltrials.gov
  2. López-Iglesias AA. The Alkylating Histone Deacetylase Inhibitor Fusion Molecule Edo-S101 Displays Full Bi-Functional Properties in Preclinical Models of Hematological Malignancies. Blood2014; 124: (21). https://ash.confex.com/ash/2014/webprogram/Paper72121.html
  3. López-Iglesias AA. Preclinical antimyeloma activity of EDO-S101 (bendamustine-vorinostat fusion molecule) through DNA-damaging and HDACi effects. 15thInternational Myeloma Workshop. 23−26 September 2015. Rome, Italy.
  4. Di Filippi R, et al. The First-In-Class Alkylating Histone Deacetylase Inhibitor (HDACi) Fusion Molecule EDO-S101 Exerts Potent Preclinical Activity Against Tumor Cells of Hodgkin Lymphoma (HL) Including Bendamustine Resistant Clones. 57thAnnual Meeting and Exposition of the American Society of Hematology (ASH). 6 December 2015.
  5. Yan S, et al. Synergistic inhibition of tumor growth and overcoming chemo-resistance by simultaneously targeting key components in DNA damage/repair, epigenetic, and putative cancer stem cell signaling pathways using novel dual-functional DNA-alkylating/HDAC inhibitor and tumor suppressor gene nanoparticles in lung cancer. Cancer Research2012;72(Suppl 1): Abstract 2741.