Report confirms robust survival in late stage melanoma patients
SCIB1 Phase 2 combination study on track; IND expected to be filed in H1 2017
Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces that the Clinical Study Report (CSR) on the SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma has been completed on schedule.
The Clinical Study Report includes safety, immunology and clinical data from all patients with Stage 3/4 melanoma up to 29 October 2015, the date of the last patient’s final dose in the main study. The main
conclusions of the CSR are:
Updated survival and disease recurrence data are as follows:
The Clinical Study Report will support the Company’s Investigational New Drug (IND) Application for SCIB1 which is anticipated to be filed with Food and Drug Administration (FDA) in H1 2017 subject to the outcome
of the pre-IND meeting planned for Q1 2017. Scancell is expecting to conduct a Phase 2 checkpoint inhibitor combination study with SCIB1 in melanoma in 2017, led by Principal Investigator Dr Keith Flaherty,
Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School. A key objective of this important study will be to evaluate safety and
response rates in melanoma patients administered SCIB1 in addition to a checkpoint inhibitor compared to the checkpoint inhibitor alone.
Dr Richard Goodfellow, CEO of Scancell, said: “We are pleased that the Clinical Study Report on our SCIB1 Phase 1/2 clinical trial in patients with melanoma has now been finalised, and will be able to support our US
IND submission. We are very encouraged by the compelling survival data generated in this study which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with
resected tumours and receiving 2/4 mg doses of drug. This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients.
“We continue to expect to file our IND for SCIB1 in the first half of 2017, and to start our US clinical study of SCIB1 in combination with a checkpoint inhibitor next year. We look forward to updating the market further on these plans in due course.”
For Further Information:
Dr John Chiplin, Executive Chairman
Dr Richard Goodfellow, CEO
Scancell Holdings Plc
+1 858 900 2646
+44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance)
Tom Salvesen (Corporate Broking)
Panmure Gordon & Co
+44 (0) 20 7886 2500
+44 (0) 20 7886 2500
Mo Noonan/Simon Conway
+44 (0) 20 3727 1000
Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour
load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.
Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.
Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer
survival times than when either treatment was used alone. Experimental data suggests that the high avidity T cells induced by ImmunoBody vaccines increase expression of PDL-1 on the tumour cell surface, thereby
making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody induces a powerful memory
response. Such an effect has not been observed with checkpoint inhibitors.
Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could
play a major role in the development of safe and effective cancer immunotherapies in the future.
Holloway says generating clinical data's a big focus for them in the near-term.
''Over the next two years we expect to see clinical readouts from two of our programmes - SCIB1 and Modi-1''.
''We'll be extending our pipeline particularly around Moditope with the Modi-3 programme, if we're successful with the grand challenge''.
''Then it's around looking at technical partnerships that will allow us to de-risk our developments''.
Thu, 15 Feb 2018 12:38:00
Dutch group ISA Pharmaceutical will incorporate its Amplivant technology into Modi-1, the first cancer treatment candidate being developed on the platform
Thu, 15 Feb 2018 15:00:00
Immuno-therapy SCIB1, which is expected to progress into Phase II clinical trials in the second-half of the year, was the focus of a peer-reviewed paper in OncoImmunology
Mon, 12 Feb 2018 11:50:00