Mundipharma EDO GmbH announces first-in-human clinical trial of its lead compound, EDO-S101 July 20, 2016

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Dr. Thomas Mehrling M.D., Ph.D., Chief Executive Officer, Mundipharma EDO GmbH

First-in-human clinical trial of its lead compound, EDO-S101

BASEL, SWITZERLAND – 31 May 2016:

Mundipharma EDO GmbH (Early Development in Oncology) has announced the initiation of a first-in-human clinical trial of its investigational drug candidate EDO-S101. A first in class, fusion molecule – S101 is currently being developed for the treatment of relapsed-refractory (RR) haematological malignances. This phase 1 study is designed to evaluate the safety and tolerability of ascending doses of EDO-S101 and will be conducted at several sites across the United States and Europe.

EDO-S101 is the first representative of the A-DAC principle, a new approach in chemotherapy that uses fusion technology to combine an alkylating agent with a pan-histone deacetylase inhibitor (HDAC) to simultaneously damage DNA and block damage repair. The combination of the two different modes of action has the potential to overcome resistance towards other conventional chemotherapies. EDO-S101 combines the active structures of bendamustine and vorinostat, two molecules that have been well established in the treatment of haematological malignancies, to produce a novel single agent with efficacy characteristics superior to those of the parent compounds given in combination.1,2

Dr. Thomas Mehrling, CEO, Mundipharma EDO GmbH commented: “Today EDO forges ahead with even greater momentum following this important milestone of a first-in-human trial. EDO-S101 is making significant progress in its clinical development journey and we are passionate about its potential to treat patients with relapsed-refractory haematological malignances, who are in dire need of new treatment options. The primary goal of this first clinical trial is to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile. These data will be used to establish the recommended dose which will then be further evaluated for safety and efficacy.”

Preclinical experiments demonstrated that EDO-S101 exerts significant activity against haematological malignancies including multiple myeloma (MM)1,3, acute myeloid leukemia (AML)1,4, mantle cell lymphoma (MCL)2, ABC type diffuse large B-Cell lymphoma (DLBCL)3 as well as hodgkin lymphoma (HL)3. In addition, the molecule is active in primary resistant cells as well as in cells that have acquired resistance.5

About Mundipharma EDO GmbH

Mundipharma EDO has collaborated with its worldwide clinical connections and partners to successfully license-in and develop competitively differentiated preclinical stage programmes for its compounds across a number of therapeutic areas and disease indications. EDO’s approach enables the design of highly selective inhibitors and targeted medicines, supporting the company’s strategy of ensuring cost-effective and safety-enhanced drug development. As a privately-funded company with strengths in rapid decision-making, commercial flexibility and excellent execution, EDO is an ideal partner for biotech companies.


For further information, please visit www.edoncology.com

For further information on Mundipharma’s network of independent associated companies, please visit www.mundipharma.com

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About the study

The Phase 1 multi-centre, clinical trial will assess the safety and tolerability of EDO-S101 administered intravenously once in a 28-day cycle. The study will enroll patients with relapsed refractory haematological malignancies for which there are no available therapies and it is designed as a two stage trial. The key objectives of stage one are to determine a maximum tolerated dose and pharmacokinetic profile, while in stage two the recommended dose will be further evaluated for safety and preliminary anti-tumor activity in selected haematological malignancies. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About relapsed refractory haematological malignancies

Despite recent improvements in the treatments of haematological malignancies, patients who have relapsed or refractory disease remain a clinical challenge due to limited effective treatment options.

For example, almost all patients with MM who survive initial treatment will eventually relapse and will require further therapy. The patient survival rate for MM up to five years is 48.5%.6

Relapse in HL occurs in a small proportion of patients; approximately 5% to 8% of those presenting with limited stage disease and 15% to 20% of those with advanced stage disease.7

In the majority of patients with AML who achieve a complete remission (CR), the leukaemia will recur within 3 years. In general, the prognosis of patients after relapse is poor and treatment options unsatisfactory.8

References

  1. López-Iglesias, A.A., The Alkylating Histone Deacetylase Inhibitor Fusion Molecule Edo-S101 Displays Full Bi-Functional Properties in Preclinical Models of Hematological Malignancies. Blood 2014 124 (21). https://ash.confex.com/ash/2014/webprogram/Paper72121.html
  2. López-Iglesias, A.A., preclinical antimyeloma activity of EDO-S101 (bendamustine-vorinostat fusion molecule) through DNA-damaging and HDACi effects. 15th International Myeloma Workshop. 23−26 September 2015. Rome, Italy.
  3. Kraus, M., EDO-S101, a New Alkylating Histone-Deacetylase Inhibitor (HDACi) Fusion Molecule, Has Superior Activity Against Myeloma and B Cell Lymphoma and Strong Synergy with Proteasome Inhibitors in Vitro. Blood 2014 124 (21). https://ash.confex.com/ash/2014/webprogram/Paper69945.html
  4. Mundipharma EDO GmbH Data on file.
  5. Chesi, M., Identification of Novel Therapeutic Targets in the Clinically Predictive Vk*MYC Mouse Model of Multiple Myeloma. Blood, 2014 124 (21). https://ash.confex.com/ash/2014/webprogram/Paper70113.html
  6. SEER Stat Fact Sheets: Multiple Myeloma, S.S.F.S
  7. Connors J. M. Hodgkin lymphoma: special challenges and solutions Hematol Oncol 2015;33:21–24.
  8. Döhner H. et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet Blood 2010;115:453-474.