Scancell Holdings Plc (LON:SCLP) expects to submit an investigational new drug (IND) application for its SCIB1 skin cancer drug candidate in the first half of 2018.
The immune-oncology specialist said in its interim results statement that patient enrolment for the SCIB1 Phase 2 checkpoint inhibitor combination study for patients with advanced melanoma is planned to start in the second half of the year, subject to receiving sufficient funding.
READ: Scancell poised for “significant” year with its immuno-oncology portfolio
Following the pre-IND meeting in 2017, the US Food and Drug Administration (FDA) suggested that technical data from Ichor's new TriGrid 2.0 clinical device should be submitted 30-60 days prior to Scancell's own FDA submission; Ichor expects to make its Master File submission any week now.
Scancell is also close to initiating GMP (good manufacturing practice) manufacture of Modi-1, the lead product from its Moditope platform, for the planned Phase 1/2 clinical trial in triple negative breast cancer, ovarian cancer and sarcoma, which is planned to start in the first half of 2019 and will continue to advance Modi-2 in preparation for clinical trials in other solid tumours resistant to checkpoint inhibitor therapy.
READ: Scancell Holdings raises £5mln as the pace of clinical work quickens
Financial results for the six months to the end of October showed losses widened slightly to £2.02mln from £1.72mln the year before, as development expenditure increased.
The group also saw an increase in administrative expenditure, largely due to a significant increase in patent costs as the company continues to protect and extend its intellectual property portfolio.
Scancell ended the reporting period with a cash balance of £5.0mln, up from £2.7mln at the beginning of the period, after it raised £4.7mln through a placing of shares in May.
READ: Scancell inks research collaboration deal with European biopharma BioNTech
"Our lead ImmunoBody, SCIB1, continues to demonstrate remarkable survival data,” said Dr Cliff Holloway, Scancell’s newly installed chief executive officer.
Referring to the group’s recently signed collaboration deals with BioNTech and Cancer Research UK, Holloway said the deals provided the first external validation of Scancell’s ImmunoBody and Moditope immunotherapy platforms.
READ: Scancell soars as it confirms Cancer Research UK to fund and sponsor SCIB2 clinical trial
“Cancer Research UK's world-renowned expertise will be invaluable as SCIB2 is progressed into Phase 1/2 clinical trials, and we are excited to be working with BioNTech in one of the most promising areas of cancer immunotherapy: the development of T cell receptor therapeutics,” Holloway said.