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DelMar Pharmaceuticals to Present Updated Phase I/II Clinical Data on VAL-083 in the Treatment of Refractory Glioblastoma Multiforme at GBM2015: 2nd International Symposium on Clinical and Basic Investigation in Glioblastoma

On July 9, 2015 DelMar Pharmaceuticals reported that the Company will be presenting updated clinical data on its lead product candidate, VAL-083, from its Phase I/II clinical trial in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer (Press release, DelMar Pharmaceuticals, JUL 9, 2015, View Source [SID:1234506194]).

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DelMar’s abstract entitled, "Update on Phase 1/2 study of VAL-083 (dianhydrogalactitol) in patients with recurrent malignant glioma," will be presented during a poster session at GBM2015, II International Symposium on Clinical and Basic Investigation in Glioblastoma, being held September 9 – 12, 2015, in Toledo, Spain.

In spite of recent advances in cancer care, GBM continues to be the most common and malignant primary brain tumor in adults carrying a dismal prognosis with less than 15 months median survival. The symposium is designed with a focus on clinical and basic research in this devastating disease.

DelMar recently presented interim data from the trial at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar’s multicenter Phase I/II clinical study with VAL-083 is ongoing in patients with recurrent GBM. Eligible GBM patients must have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). (ClinicalTrials.gov Identifier NCT01478178). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).

Cancer Research UK and Cancer Research Technology announce partnership with Monopar Therapeutics to develop new oncology compound

On July 9, 2015 Cancer Research UK and Cancer Research Technology (CRT) reported they have reached an agreement with Monopar Therapeutics LLC, an emerging biopharmaceutical company focused on developing orphan oncology compounds*, to take forward Monopar’s experimental antibody treatment HuATN-658 into clinical trials in cancer patients with advanced solid tumours (Press release, Cancer Research Technology, JUL 9, 2015, View Source [SID1234523204]).

HuATN-658 is an antibody that targets the cell surface protein uPAR, which is found in high levels in some of the most deadly cancers.

Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will finance and complete preclinical development of HuATN-658 and conduct a Phase 1 clinical trial in cancer patients. Although drug efficacy will be monitored, the trial’s main objective will be to evaluate the safety of the antibody.

The trial will be managed and run by the CDD through the Experimental Cancer Medicine Centre (ECMC) network, a UK-wide initiative funded by Cancer Research UK and the UK’s four Health Departments.

Upon completion of the clinical trial, Monopar has the right to acquire the clinical trial data. If Monopar declines the option, CRT may continue the development and commercialisation of HuATN-658 in exchange for a share to Monopar of any future revenues from the drug.

Dr Chandler D. Robinson, co-founder and CEO of Monopar Therapeutics, said: "While these are still the early days of the company, we have created a very strong team and development strategy.

"HuATN-658, our lead compound, was discovered by our chief scientific officer, Dr Andrew Mazar, one of the world’s experts on the uPAR pathway.

"The development partnership with Cancer Research UK allows Monopar to leverage a strong platform for the clinical advancement of this compound as it brings long established clinical, regulatory, and manufacturing expertise and resources that would be difficult for an emerging company to amass quickly."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said, "We’re excited to be working with Monopar Therapeutics to take this promising new treatment a step further on its journey towards the clinic. The collaboration forms part of our Clinical Development Partnerships scheme, which aims to help progress promising treatments from drug company pipelines and bring them into early phase trials sooner. Thanks to this, six new treatments are now in clinical trials that may otherwise never have moved beyond the lab."

Globavir Exclusively Licenses Oncology Program to Sorrento Therapeutics

On July 9, 2015 Globavir Biosciences, Inc., a specialty biotechnology company developing small molecule drugs to treat cancer and infectious diseases, and Sorrento Therapeutics, Inc. (NASDAQ: SRNE), an oncology company developing new treatments for cancer and associated pain, reported that the companies have entered into an agreement under which Globavir exclusively licensed its novel oncology compound, BC001, to Sorrento Therapeutics (Press release, Globavir, JUL 9, 2015, View Source [SID1234519506]).

"Our agreement with Sorrento Therapeutics represents the first oncology partnership for Globavir," said Dr. Shalabh Gupta, Globavir’s president and CEO. "Sorrento has a strong background in oncology and proven experience in clinical development advancing drugs to commercial stage. We are excited about the potential of BC001 as a new therapeutic option for patients affected with cancer and look forward to leveraging our computational Globavir Drug Discovery Platform (GDDP) to generate additional oncology compounds in the future."

About the partnership:
Under the terms of the agreement, Sorrento Therapeutics will be responsible for the development and commercialization of BC001 for the treatment of solid tumors. Full details of the partnership were not disclosed, but Sorrento Therapeutics participated as an equity investor in Globavir’s previous round of financing, and under the terms of partnership Globavir is entitled to $80 million in regulatory and sales milestones in addition to multi-tiered royalty payments on global net sales.

About the program:
BC001 is a new chemical entity discovered at The University of Southern California and originally licensed by Globavir. It represents an alternative and a superior approach to targeting angiogenesis, invasion and altered energy metabolism in cancers. BC001 targets hypoxia-inducible factors (HIF)-mediated signaling in a focal point of amplification in response (specifically HIF1a-p300 interaction, downstream of which multiple oncogenic targets are activated). It is known that traditional cancer therapies are often limited in their efficacy because they display toxicity to normal cells and can lead to drug-resistant tumors. Currently, there is no FDA-approved agent to target HIF.

About the compound:
Several companies are currently developing drugs that target traditional signaling and regulatory molecules such as Vascular Endothelial Growth Factors (VEGF), Platelet-Derived Growth Factors (PDGF) and Fibroblast Growth Factors (FGF), as well as transcription factors and receptor tyrosine kinases. BC001 is a different anti-angiogenic molecule, uniquely working by disrupting binding of a transcription factor to its co-factor and thereby controlling tumor growth. BC001 is therefore a highly differentiated compound with potential in oncology as well as outside the cancer setting for treating ophthalmological (macular) diseases and infectious diseases such as hepatitis B virus (HBV) and human papillomavirus (HPV).

Cancer Research UK and Cancer Research Technology announce partnership with Monopar Therapeutics to develop new oncology compound

On July 9, 2015 Cancer Research UK reported it and Cancer Research Technology (CRT) have reached agreement with Monopar Therapeutics LLC, an emerging biopharmaceutical company focused on developing orphan oncology compounds*, to take forward Monopar’s experimental antibody treatment HuATN-658 into clinical trials in cancer patients with advanced solid tumours (Press release, Cancer Research UK, JUL 9, 2015, View Source [SID:1234506202]).

"We’re excited to be working with Monopar Therapeutics to take this promising new treatment a step further on its journey towards the clinic." – Dr Nigel Blackburn

HuATN-658 is an antibody that targets the cell surface protein uPAR, which is found in high levels in some of the most deadly cancers.

Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will finance and complete preclinical development of HuATN-658 and conduct a Phase 1 clinical trial in cancer patients. Although drug efficacy will be monitored, the trial’s main objective will be to evaluate the safety of the antibody.

The trial will be managed and run by the CDD through the Experimental Cancer Medicine Centre (link is external)(ECMC) network, a UK-wide initiative funded by Cancer Research UK and the UK’s four Health Departments.

Upon completion of the clinical trial, Monopar has the right to acquire the clinical trial data. If Monopar declines the option, CRT may continue the development and commercialisation of HuATN-658 in exchange for a share to Monopar of any future revenues from the drug.

Dr Chandler D. Robinson, co-founder and CEO of Monopar Therapeutics, said: "While these are still the early days of the company, we have created a very strong team and development strategy.

"HuATN-658, our lead compound, was discovered by our chief scientific officer, Dr Andrew Mazar, one of the world’s experts on the uPAR pathway.

"The development partnership with Cancer Research UK allows Monopar to leverage a strong platform for the clinical advancement of this compound as it brings long established clinical, regulatory, and manufacturing expertise and resources that would be difficult for an emerging company to amass quickly."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said, "We’re excited to be working with Monopar Therapeutics to take this promising new treatment a step further on its journey towards the clinic. The collaboration forms part of our Clinical Development Partnerships scheme, which aims to help progress promising treatments from drug company pipelines and bring them into early phase trials sooner. Thanks to this, six new treatments are now in clinical trials that may otherwise never have moved beyond the lab."

Genmab Announces Completion of Rolling Submission of Biologics License Application for Daratumumab in Multiple Myeloma and Achievement of a USD 15 Million Milestone

On July 9, 2015 Genmab reported its licensing partner Janssen Biotech, Inc. has completed the rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab (Press release, Genmab, JUL 9, 2015, View Source [SID:1234506200]).

The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three prior lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In May, 2013, daratumumab was granted a Breakthrough Therapy Designation (BTD) in this population. The completion of the submission triggers a milestone payment of USD 15 million to Genmab from Janssen. The milestone was included in Genmab’s financial guidance for 2015, which was updated on May 20, 2015. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

A request for Priority Review has been submitted by Janssen with this BLA. The FDA will inform Janssen whether a Priority Review has been granted by calendar day 60 of their review starting today. If the FDA grants Priority Review the review period may not exceed 6 months from that date.

If daratumumab receives FDA approval, Genmab will receive a milestone payment from Janssen of USD 45 million associated with the first commercial sale of the product in the United States. However, it is not possible to precisely predict the timing of a potential marketing approval and first commercial sale; therefore, this milestone has not been included in the 2015 financial guidance at this time.

"The rapid completion of the BLA submission brings us a significant step closer to the potential regulatory approval of daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Daratumumab received Breakthrough Therapy Designation from the FDA for this indication for multiple myeloma patients who have no other treatment options available, and we are proud that our partner Janssen has completed the submission in record time."
The submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies have also been included in the BLA submission.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the United States (U.S.), following only leukemia and lymphoma.2 Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.3 Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About daratumumab
Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It induces rapid tumor cell death through diverse mechanisms of action. Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.