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4SC AG was granted a fundamental composition of matter patent for 4SC-208 for the US
Patent provides United States (US) market exclusivity until 2033
Formal preclinical testing of 4SC-208 has already started and is expected to be completed in 2018 followed immediately thereafter by a Phase I/II clinical study
4SC AG (4SC, FSE Prime Standard: VSC) today announced the issuance of US patent No. 9,580,438 by the United States Patent and Trademark Office (USPTO). The patent covers the composition of matter of a group of molecules including 4SC-208, an orally-available hedgehog/GLI signaling inhibitor in formal preclinical testing for the treatment of Hedgehog-driven cancers. The patent provides 4SC with US market exclusivity until 2033.
The hedgehog/GLI signaling pathway is critical for the growth and proliferation of cancer stem cells. To date, drug development has focused on targeting the pathway upstream of the transcription factor GLI mainly at the level of the cell surface receptor SMO. However, occurrence of resistance to SMO inhibition is quite common - either via mutations of the SMO receptor itself or by activating alternative pathways negating the impact of SMO inhibition. 4SC-208 targets two novel kinases whose role as key regulators of GLI was discovered by 4SC. In this way, 4SC-208 directly acts at the level of GLI and is thus potentially able to avoid the tumor recurrence and relapse observed in response to currently available inhibitors.
"4SC-208 is one of our three core assets, along with resminostat and 4SC-202, that are the focus for development at 4SC," said Jason Loveridge, Ph.D., CEO of 4SC. "This patent is a key component of our IP portfolio and successfully secures our position in the field of treatment of hedgehog-driven cancers. We have already started the formal preclinical testing for 4SC-208 and expect it to be completed in 2018, after which we plan to initiate a Phase I/II clinical study. Cancer indications that are particularly promising are those where resistance to therapies targeting the Hedgehog/GLI pathway are emerging, such as in basal cell carcinoma, a kind of skin cancer."
Data from several preclinical in vivo models has established the efficacy of 4SC-208 in inhibiting the Hedgehog/GLI signaling. Inhibition of this signaling pathway has emerged as a highly effective strategy in obstructing the tumorigenic capacity of cancer stem cells, as well as tumor development, proliferation and survival.
Available inhibitors of Hedgehog signaling target the pathway upstream of the transcription factor GLI, whereas 4SC-208 inhibits at the level of GLI and is thus potentially able to avoid the tumor recurrence and relapse observed in response to currently available inhibitors.
4SC believes that 4SC-208 is a promising drug candidate and expects it to complete formal preclinical testing in 2018 and to enter into a Phase I/II clinical study immediately thereafter. Cancer indications that are particularly promising are those where resistance to therapies targeting the Hedgehog/GLI pathway are emerging, such as in basal cell carcinoma.
About cancer stem cells
Cancer stem cells, like somatic stem cells, are multi-potent; they are able to self-renew and to generate more differentiated bulk tumor cells. They are also the ʻrootsʼ of the tumor, assuring its sustained growth. If disseminated, they cause metastasis and lead to new tumor lesions.
Cancer stem cells are often resistant to chemo- and radiotherapy and even after section, circulating cancer stem cells are often left behind. The result is a lifelong risk of tumor re-initiation and metastasis. So in order to achieve sustained remission, cancer stem cells must be completely eliminated.
4SC believes that 4SC-208 is a promising drug candidate in the field of cancer stem cells and intends to advance the compound into clinical studies in relevant cancer indications.
Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC's control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
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