Mundipharma EDO Gmbh Announces FDA Investigational New Drug Approval Of Its First Anti-Cancer Compound, EDO-S101, For The Treatment Of Patients With Relapsed/Refractory Haematologic Malignancies And Solid Tumours
BASEL, Switzerland, July 31, 2015 /PRNewswire/ --
First in human clinical trials to commence Q3 2015
Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration ("FDA") has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.
(Logo: http://photos.prnewswire.com/prnh/20150731/252073LOGO )
(Logo: http://photos.prnewswire.com/prnh/20150731/252074LOGO )
EDO-S101 is a first in class fusion molecule that combines the DNA damaging effect of bendamustine with the pan-histone deacetylase inhibitor (HDACi) vorinostat, with the aim of increasing the efficacy of the alkylator through the HDACi-mediated chromatin relaxation.
It is anticipated that EDO-S101 may have significant activity in various haematological malignancies and solid tumours and may have the potential to break through resistance towards other conventional chemotherapy.
Alkylating agents have demonstrated strong activity in a wide range of cancers and have been a mainstay of anti-tumour therapy for decades. In several malignancies alkylating agents are still considered standard of care. Bendamustine, the latest introduction, has demonstrated good efficacy and tolerability in a number of haematological malignancies.
Thomas Mehrling, MD, Ph.D, Managing Director of Mundipharma EDO, stated that this is a significant milestone for the company. "With this IND approval, Mundipharma EDO has transitioned from a pre-clinical company to a company in clinical stage in about two years. This successful IND represents the culmination of a focused and rigorous development program aimed at providing proof of efficacy and safety in animals to support human clinical trials of EDO-S101. Preparations are underway to start the first in human clinical trial in patients with relapsed-refractory haematologic malignances in quarter 3 2015."
The primary goal of this first clinical trial is to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile. This information will be used to establish the dose of EDO-S101 to be used in subsequent Phase 1b and Phase 2 trials. A further objective will be to evaluate gene expression profiles correlated with response or resistance to EDO-S101, in order to better characterize its future applications.
A phase 1 trial in solid tumors will be developed once the dose escalation part of the first in human study has been completed.
About the disease
Despite recent improvements in the treatments of hematological malignancies, patients who have relapse or refractory disease remain a clinical challenge due to limited effective treatment options.
Almost all patients with multiple myeloma (MM) who survive initial treatment will eventually relapse and will require further therapy. Patient survival rate is up to 5 years.[1]
Relapse in Hodgkin Lymphoma 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.[2]
Prognosis in peripheral T-cell lymphoma (PTCL) is very poor with the response rate to available treatments falling between 25 and 27%. Patients experience repeated treatment failures until drug resistance or death; 5-year survival is 20-30%.[3]
Patients with acute myeloid leukemia (AML) fail to achieve remission, or relapse because of chemotherapy drug resistance that can be present at the time of diagnosis or is induced by treatment. The majority of relapses occur within 2 years of initial treatment and only 24% of patients survive 5 years or more after they are diagnosed.[4]
NOTES FOR EDITORS
Mundipharma EDO GmbH ("EDO")
EDO is developing early stage assets in oncology for the Mundipharma network of independent associated companies and is committed to increasing the treatment options available for cancer patients, improving their quality of life through the early development of small molecules and biologics. EDO is currently investigating a new chemotherapy agent for haematological malignancies and solid tumours, and an antibody-drug conjugate for the treatment of ovarian cancer.
The company has utilised its worldwide clinical connections and partners to successfully license-in and develop competitively differentiated preclinical stage programs for a portfolio of biologic and small molecules in 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.
EDO's demonstrated capability in early development, as well as its diverse pipeline, uniquely positions the company to develop multiple commercial opportunities for different therapeutic indications. EDOs' experienced management and scientific team, a broad network of scientific and clinical experts and partners around the world, are key drivers of the company's success to-date.
For further information on Mundipharma's network of independent associated companies please visit http://www.mundipharma.com
For information on Mundipharma EDO please visit http://www.mundipharma-edo.com
References
SEER Stat Fact Sheets: Myeloma Myeloma, S.S.F.S
Connors J. M. Hodgkin lymphoma: special challenges and solutions Hematol Oncol 2015; 33: 21-24
Moskowitz A. J. How I treat the peripheral T cell lymphomas Blood 2014;123(17)
American Cancer Society: Cancer Facts and Figures 2014. Atlanta, Ga: American Cancer Society, 2014. Online: http://www.cancer.gov/policies/linking
For enquiries:
Dr. Thomas Mehrling M.D., Ph.D., Managing Director
Mundipharma EDO GmbH
Tel: +41-798-701948
thomas.mehrling@mundipharma-edo.com
or
Media contact:
Clare Lucker, Director
Makara Health Communications
Tel: +44-(0)797-969-4931
clare@makarahealth.com
Spokesperson available:
Dr. Thomas Mehrling M.D., Ph.D., Managing Director, Mundipharma EDO GmbH
SOURCE Mundipharma EDO GmbH
Help employers find you! Check out all the jobs and post your resume.
First in human clinical trials to commence Q3 2015
Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration ("FDA") has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.
(Logo: http://photos.prnewswire.com/prnh/20150731/252073LOGO )
(Logo: http://photos.prnewswire.com/prnh/20150731/252074LOGO )
EDO-S101 is a first in class fusion molecule that combines the DNA damaging effect of bendamustine with the pan-histone deacetylase inhibitor (HDACi) vorinostat, with the aim of increasing the efficacy of the alkylator through the HDACi-mediated chromatin relaxation.
It is anticipated that EDO-S101 may have significant activity in various haematological malignancies and solid tumours and may have the potential to break through resistance towards other conventional chemotherapy.
Alkylating agents have demonstrated strong activity in a wide range of cancers and have been a mainstay of anti-tumour therapy for decades. In several malignancies alkylating agents are still considered standard of care. Bendamustine, the latest introduction, has demonstrated good efficacy and tolerability in a number of haematological malignancies.
Thomas Mehrling, MD, Ph.D, Managing Director of Mundipharma EDO, stated that this is a significant milestone for the company. "With this IND approval, Mundipharma EDO has transitioned from a pre-clinical company to a company in clinical stage in about two years. This successful IND represents the culmination of a focused and rigorous development program aimed at providing proof of efficacy and safety in animals to support human clinical trials of EDO-S101. Preparations are underway to start the first in human clinical trial in patients with relapsed-refractory haematologic malignances in quarter 3 2015."
The primary goal of this first clinical trial is to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile. This information will be used to establish the dose of EDO-S101 to be used in subsequent Phase 1b and Phase 2 trials. A further objective will be to evaluate gene expression profiles correlated with response or resistance to EDO-S101, in order to better characterize its future applications.
A phase 1 trial in solid tumors will be developed once the dose escalation part of the first in human study has been completed.
About the disease
Despite recent improvements in the treatments of hematological malignancies, patients who have relapse or refractory disease remain a clinical challenge due to limited effective treatment options.
Almost all patients with multiple myeloma (MM) who survive initial treatment will eventually relapse and will require further therapy. Patient survival rate is up to 5 years.[1]
Relapse in Hodgkin Lymphoma 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.[2]
Prognosis in peripheral T-cell lymphoma (PTCL) is very poor with the response rate to available treatments falling between 25 and 27%. Patients experience repeated treatment failures until drug resistance or death; 5-year survival is 20-30%.[3]
Patients with acute myeloid leukemia (AML) fail to achieve remission, or relapse because of chemotherapy drug resistance that can be present at the time of diagnosis or is induced by treatment. The majority of relapses occur within 2 years of initial treatment and only 24% of patients survive 5 years or more after they are diagnosed.[4]
NOTES FOR EDITORS
Mundipharma EDO GmbH ("EDO")
EDO is developing early stage assets in oncology for the Mundipharma network of independent associated companies and is committed to increasing the treatment options available for cancer patients, improving their quality of life through the early development of small molecules and biologics. EDO is currently investigating a new chemotherapy agent for haematological malignancies and solid tumours, and an antibody-drug conjugate for the treatment of ovarian cancer.
The company has utilised its worldwide clinical connections and partners to successfully license-in and develop competitively differentiated preclinical stage programs for a portfolio of biologic and small molecules in 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.
EDO's demonstrated capability in early development, as well as its diverse pipeline, uniquely positions the company to develop multiple commercial opportunities for different therapeutic indications. EDOs' experienced management and scientific team, a broad network of scientific and clinical experts and partners around the world, are key drivers of the company's success to-date.
For further information on Mundipharma's network of independent associated companies please visit http://www.mundipharma.com
For information on Mundipharma EDO please visit http://www.mundipharma-edo.com
References
SEER Stat Fact Sheets: Myeloma Myeloma, S.S.F.S
Connors J. M. Hodgkin lymphoma: special challenges and solutions Hematol Oncol 2015; 33: 21-24
Moskowitz A. J. How I treat the peripheral T cell lymphomas Blood 2014;123(17)
American Cancer Society: Cancer Facts and Figures 2014. Atlanta, Ga: American Cancer Society, 2014. Online: http://www.cancer.gov/policies/linking
For enquiries:
Dr. Thomas Mehrling M.D., Ph.D., Managing Director
Mundipharma EDO GmbH
Tel: +41-798-701948
thomas.mehrling@mundipharma-edo.com
or
Media contact:
Clare Lucker, Director
Makara Health Communications
Tel: +44-(0)797-969-4931
clare@makarahealth.com
Spokesperson available:
Dr. Thomas Mehrling M.D., Ph.D., Managing Director, Mundipharma EDO GmbH
SOURCE Mundipharma EDO GmbH
Help employers find you! Check out all the jobs and post your resume.