(Press release, TNI BioTech, DEC 3, 2013, View Source [SID:1234507311])

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On December 3, 2014 Kancera reported the discovery of a new class of compounds that inhibits the epigenetic enzyme histone deacetylase 6 (HDAC6) and thereby controls the activity of the cancer cell genes (Press release Kancera, DEC 3, 2013, View Source;releaseID=835081 [SID:1234500120]). Severe side effects, due to poor selectivity, have limited the clinical use of HDAC inhibitors in the treatment of cancer, despite their promising treatment efficacy. For this reason, the pharmaceutical industry is now looking for HDAC inhibitors displaying a higher level of selectivity within this family of enzymes. Kancera´s discovery of selective HDAC6 inhibitors may provide a solution to how physicians could take advantage of HDAC inhibitors in the treatment of cancer without causing the patient severe side effects.

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There are currently two HDAC inhibitors on the market for the treatment of various forms of T-cell lymphoma. These inhibitors are active against several members of the HDAC family of enzymes leading to side effects including severe nausea and potentially an increased cardiovascular risk. Selective inhibition of HDAC6 is expected to reduce these side effects, while activity against cancer cells is maintained.

Kancera´s unexpected discovery of such selective HDAC6 inhibitors is the result of an incidental finding made following an EU-funded project against epigenetic targets for the treatment of parasitic diseases. Laboratory tests have shown that Kancera’s inhibitors display a higher level of selectivity against the HDAC6 enzyme as compared to a competing inhibitor, ACY-1215. Kancera´s HDAC6 inhibitors have furthermore been shown to be able to kill cancer cells in vitro.

ACY-1215, developed by the Boston-based company Acetylon Pharmaceuticals, is currently in early clinical trials ( Phase 1b) for the treatment of multiple myeloma. In July 2013 it was announced that Celgene for a $100 million upfront cash payment received an option to acquire Acetylon Pharmaceuticals with ACY -1215 as their main asset.

Kancera now intends to file patent applications for these inhibitors and to further evaluate the potential of them in the treatment of cancer, including multiple myeloma.

(Press release, ImmunoCellular Therapeutics, DEC 3, 2013, View Source [SID:1234506425])

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On December 2, 2013 Sareum Holdings reported that it has signed a co-development agreement with Hebei Medical University Biomedical Engineering Center ("HMUBEC") to advance its Aurora+FLT3 cancer programme (Press release Sareum, DEC 2, 2013, View Source;year=2013 [SID:1234501235]).

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Under the terms of the agreement HMUBEC has been granted exclusive rights to carry out pre-clinical and clinical studies within Greater China* to obtain approval for sales in that territory. Sareum will receive a significant milestone payment once a product receives authorisation for marketing, and up to 15% of operating profit from sales generated in Greater China.

HMUBEC will be required to disclose and exclusively licence to Sareum all pre-clinical and clinical data it generates in the course of the development collaboration in order to facilitate Sareum’s own development and commercialisation activities. This would include conducting any further studies required for authorisation for clinical trials in the rest of the world as well as out-licensing and supporting applications for marketing authorisations outside Greater China. HMUBEC will be entitled to receive up to 10% of operating profit Sareum receives from any licence agreement or sales made outside Greater China, dependent on the stage at which Sareum out-licences data generated by HMUBEC to a third party.

HMUBEC is an independent research centre operating within Hebei Medical University Science & Technology General Company (HMUSTGC). Its capabilities include GLP† compliant laboratories, CGMP compliant manufacturing capabilities and well-established sales distribution channels in Greater China. HMUSTGC has successfully developed more than 85 therapeutic products and medical devices for the Chinese market since its formation in 1992.

Aurora+FLT3 kinase inhibitors have the potential to treat acute myeloid leukaemia (AML, the most common form of adult leukaemia) and various other forms of cancer. Aurora kinase is involved in the control of mitosis (cell division), and FLT3 kinase over-activation is the most common mutation in AML. The pre-clinical development candidate that has been licenced by Sareum to HMUBEC has showed particular promise against a range of haematological cancer models including AML and Acute Lymphoblastic Leukaemia (ALL) with an encouraging early safety profile and positive ADME (absorption, distribution, metabolism, excretion) properties.

On December 2, 2013 Celldex Therapeutics announced that it has launched a randomized study (METRIC) of Glembatumumab vedotin (CDX-011) in patients with metastatic triple negative breast cancers that over-express glycoprotein NMB (gpNMB) (Press release Celldex Therapeutics, DEC 2, 2013, View Source [SID:1234500219]). Initial sites are now open to screen patients in the United States. Additional sites in the United States and in Canada and Australia will open in early 2014. The study is expected to include up to 100 sites and will enroll approximately 300 patients.
The company also plan to further expand the clinical development program for Glembatumumab vedotin in 2014 by initiating additional studies in other cancers known to express gpNMB including melanoma and squamous cell lung cancer.
The METRIC study is a pivotal, open-label, prospectively controlled, randomized study of Glembatumumab vedotin in patients with metastatic gpNMB-expressing triple-negative breast cancer. Eligible patients must have received no more than 1 prior line of chemotherapy for advanced disease and therapy must have included a taxane and anthracycline. Patients will be randomized (2:1) to receive Glembatumumab vedotin or capecitabine. Study treatment will continue until disease progression or intolerance with tumor assessments performed at six week intervals for six months and nine week intervals thereafter. The primary objective is to evaluate the anti-cancer activity of Glembatumumab vedotin as measured by the objective response rate (ORR) and duration of progression-free survival (PFS). The study is designed to enable Celldex to apply for registration with positive results for either endpoint. Secondary endpoints include duration of response, overall survival, safety and tolerability. The Company will also assess improvements in quality of life and/or cancer-related pain as exploratory endpoints.
Patients will be stratified as follows:
* No prior chemotherapy for advanced disease vs. 1 prior line of chemotherapy for advanced disease
* "Resistant" to anthracycline therapy (i.e., progression-free interval of ≤ 6 months after completing treatment) vs. "Exposed" to anthracycline therapy (i.e., progression-free interval of > 6 months after completing treatment)
Clinical Data Supporting Glembatumumab vedotin in Triple Negative Breast Cancer
In the Phase 2 EMERGE study, final data supported an overall survival benefit in specific sub-groups of breast cancer patients with tumors that over-express gpNMB. Treatment of patients with both triple negative breast cancer and over-expression of gpNMB showed a high overall response rate (ORR) of 33% (n=12) when treated with Glembatumumab vedotin. In comparison, no responses (n=4) were seen in patients with both triple negative breast cancer and over-expression of gpNMB with standard chemotherapies. In this same patient population, the median overall survival (OS) for patients treated with Glembatumumab vedotin was 10 months vs. 5.5 months (p= 0.003) and progression free survival (PFS) was 3 months for the Glembatumumab vedotin arm vs. 1.5 months for the control arm (p=0.008), respectively. The most common adverse event was rash.

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