On December 4, 2013 3-V Biosciences reported the recent initiation of a Phase 1 clinical study of TVB-2640 in patients with advanced solid tumors (Press release 3-V Biosciences, DEC 4, 2013, View Source [SID:1234500430]). TVB-2640 is an oral, proprietary fatty acid synthase (FASN) inhibitor being evaluated for the treatment of solid tumors. FASN is an enzyme responsible for the synthesis of palmitic acid and has a key role in tumor metabolism, lipid signaling and tumor cell survival.
The Phase 1 open-label, dose-escalation trial will enroll patients with advanced solid tumors whose cancer has become refractory to standard therapy, and for whom no useful treatment exists. Patients will receive TVB-2640 once daily for 21 days. The primary endpoint for the Phase 1 study is the identification of any dose-limiting toxicities and the establishment of a maximum- tolerated dose (MTD) for oral TVB-2640. Secondary and exploratory endpoints include safety, pharmacokinetics, and initial signs of efficacy and evidence of FASN biomarker activity.
FASN over-expression is associated with aggressive disease and poor prognosis in a number of cancers. In a series of preclinical studies, 3-V’s FASN inhibitors demonstrated potent activity against multiple tumor types, including breast, lung, pancreatic, ovarian and colon cancers. FASN inhibition reduced cell proliferation and induced apoptosis (cell death) in a dose-dependent manner and single-agent FASN inhibition both blocked tumor growth and resulted in significant tumor regression in patient-derived xenografts. In addition, 3-V has demonstrated potential synergy of its FASN inhibitors with cytotoxic agents.

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(Press release, Flag Therapeutics, DEC 4, 2013, View Source [SID:1234503449])

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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, JHL Biotech, DEC 3, 2013, View Source [SID:1234503387])

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

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