4SC provides Q1 2018 update
Planegg-Martinsried, Germany, 26 April 2018 – 4SC AG (4SC, FSE Prime Standard: VSC) today published the Q1 Announcement 2018 as of 31 March 2018 that presents all material developments in Q1 2018 and provides the Company’s current outlook. The full communication is available for download on 4SC’s website.
Jason Loveridge, Ph.D., CEO of 4SC, commented: “After last year’s strategic refocusing and subsequent financing round the company is well resourced to further advance our drug candidates in clinical development and toward market approval. In the first quarter we made excellent progress and have already achieved several of our stated goals for 2018. We remain committed to ensuring continued progress of our core drug candidates and to achieve our remaining goals for 2018.”
Key highlights in Q1 2018 and beyond
- The Data Safety Monitoring Board, an independent committee of clinical and drug safety experts, evaluated data from the first 50 patients treated in the RESMAIN study of resminostat in CTCL and observed no safety issues. The committee recommended continuation without modification of the study protocol.
- Yakult Honsha, 4SC’s development partner in Japan, joined the RESMAIN study – triggering a milestone payment to 4SC.
- Yakult Honsha initiated a Phase II study of resminostat in biliary tract cancer in Japan.
- 4SC presented a poster on preclinical data supporting multiple combinations of 4SC-202 and checkpoint inhibitors in cancer therapy at the AACR Annual Meeting.
- 4SC was granted composition of matter patents in further geographic regions for a group of molecules including 4SC‑208. The patents now not only provide 4SC with market exclusivity until 2033 in the U.S. but also in China, Japan, Singapore, Australia and New Zealand.
Business outlook
- Continue enrolling patients in the pivotal RESMAIN study of resminostat in CTCL, with top-line data expected in 2019.
- Final results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.
- Top-line results from the first cohorts of patients in the Phase Ib/II study SENSITIZE of 4SC‑202 in combination with pembrolizumab in melanoma to be available in H2 2018. Study expected to complete in H1 2019.
- Phase II study EMERGE of 4SC-202 in combination with avelumab in gastrointestinal tumors to start in H1 2018. Safety data is expected in H2 2018 and top-line results in H2 2019.
- Generate a further out-licensing deal for a non-core asset.
- Continue evaluating potential partnering opportunities with pharmaceutical and biotech companies to progress the clinical development of 4SC’s core pipeline assets.
Development of cash balance in Q1 2018 and financial forecast
As of 31 March 2018, 4SC holds cash balance/funds of €35,891 thousand as compared to €41,327 thousand as of 31 December 2017. The monthly use of cash from operations was within the range forecasted for 2018 amounting to €1,812 thousand on average in the first quarter of 2018 (Q1 2017: €1,293 thousand). The increase of the monthly use of cash and the decrease in cash balance/funds in Q1 2018 was mainly driven by costs for the ongoing clinical studies RESMAIN and SENSITIZE. The Management Board of 4SC confirms that the funds should be sufficient to finance 4SC into 2020.
Conference Call
4SC will not hold a telephone conference along with today’s Q1 Announcement 2018. According to 4SC’s policy, the Company will only hold conference calls when there is significant or material newsflow.
About 4SC
4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. Such drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies and provide a better quality of life.
4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises three key drug candidates in various stages of preclinical and clinical development: resminostat, 4SC-202 and 4SC-208.
4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.
4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 47 employees as of 31 March 2018 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).
About resminostat
Resminostat is orally administered and potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body’s immune response to cancer.
Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC and a Phase II study in biliary tract cancer by 4SC’s development partner Yakult Honsha in Japan. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).
About 4SC-202
4SC-202 is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. 4SC‑202 also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.
4SC‑202 has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).
In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating 4SC-202’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of 4SC-202 in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of 4SC-202 in combination with the anti-PD-L1 checkpoint inhibitor avelumab, which will be conducted by an academic partner in gastrointestinal cancers, is expected to start soon.
As soon as results from the aforementioned trials will be available, 4SC plans to advance 4SC-202 into a pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel cell carcinoma (MCC).
About 4SC-208
Data from several preclinical studies in well recognized in vivo models has established the efficacy of 4SC-208 in inhibiting the Hedgehog/GLI signaling. Inhibition of this signaling pathway is emerging 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 all target the pathway upstream of the transcription factor GLI, whereas 4SC‑208 inhibits several kinases associated with 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 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.
Forward-looking information
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.