11 July 2017
Scancell Holdings Plc
("Scancell" or the "Company")
Continued progress on SCIB1 - eight patients reach 5 year survival milestone
US IND on schedule for submission in 3Q17; New batch of SCIB1 for planned US CI combination study successfully manufactured
Most resected Stage III and IV melanoma patients from the SCIB1 Phase 1/2 clinical trial remain alive and without disease recurrence
ImmunoBody patent approved in all major markets
Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, today provides an update on SCIB1, the lead programme from the Company's ImmunoBody® platform, and its future plans for a US clinical trial in malignant melanoma.
Dr Richard Goodfellow, CEO of Scancell, said: "We are pleased to report that most patients with resected disease enrolled in the SCIB1 clinical trial are still alive and without disease recurrence, including the majority of patients who were previously undergoing continuation treatment. As previously announced, our next study, which will be in the US, will assess the potential for an increase in response rate in patients with malignant melanoma when treated with SCIB1 and a checkpoint inhibitor. We remain on track to submit the IND for this study in 3Q17.
Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School, commented: "Despite the plethora of combination regimens under evaluation in melanoma, we believe that the SCIB1 / Checkpoint Inhibitor combination represents a novel, rational and safe approach that offers considerable clinical potential in a disease that still has significant medical need."
SCIB1 Survival Update
As of July 2017, SCIB1 continues to deliver strong survival data:
· Overall, 18 of 20 stage III/IV melanoma patients with resected disease remain alive with survival well beyond the established norms †
· Of the 16 resected patients who received 2-4mg doses of SCIB1, only six patients have had recurrence of their disease and of whom, only two have died. The median observation time for this group of patients is now 4.75 years, with seven patients surviving for more than 5 years since starting treatment and only three having evidence of disease recurrence during that period. *
· One patient with unresected disease has also survived for more than 5 years since starting treatment with SCIB1, despite disease progression.*
· Two of four resected patients who received 8 mg doses of SCIB1 have experienced disease recurrence although none have died.* The median observation time for this group of patients is 28 months
*All patients who relapsed went on to receive additional therapies for their melanoma
† Recurrence-free survival at 3 years in 951 resected stage III patients was 46.5% on ipilimumab and 34.8% on placebo (Eggermont et al Lancet Oncol 2015 May;16 (5):522-30) versus 69% at 3 years in 16 resected stage III/IV patients treated with SCIB1.
SCIB1 drug product manufacture and US IND
The new batch of SCIB1 has been manufactured successfully and will be released for clinical use in 3Q17. Following the pre-IND meeting held with the FDA in February 2017, we remain on track to submit the IND for a Phase 2 SCIB1/CI combination study in 3Q17.
SCIB1 continuation treatment
Of the eight patients who were previously receiving long term continuation treatment until this was suspended in June 2016, three have experienced a recurrence of their melanoma. The other five patients remain disease-free. Following a review with our clinical investigators it has been decided not to continue the SCIB1 long term continuation treatment in the five remaining disease-free patients. These patients have received between six and 17 doses of SCIB1 prior to a dosing holiday of more than 15 months. The company believes that the effects of any further dosing would therefore be difficult to interpret and to justify to the regulatory authorities.
ImmunoBody patent
As previously reported, a patent for its DNA ImmunoBody® technology has now been granted in Europe. This patent will extend global coverage of Scancell's intellectual property with counterparts already granted in the United States, Australia and Japan.
Investor Events
Proactive One2One Forum, 13 July 2017 - Dr Richard Goodfellow
The event will commence at 6.00pm at the Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair. Attendance is free. Proactive Investors One2One Forums have rapidly gained global recognition for companies to present to an audience of astute high net worth investors, fund managers, private client brokers and analysts. See Proactive Investors website for more details: http://www.proactiveinvestors.co.uk/register/event_details/106
The Company will provide a corporate presentation and will provide an update on its immunotherapy platform technologies:
· ImmunoBody® - Best-in-class DNA vaccine technology for use in combination with checkpoint inhibitors or as monotherapy for patients with resected disease
· Moditope® - Novel immunotherapy that destroys tumours and extends survival without the need for checkpoint inhibition
For Further Information:
Scancell Holdings Plc
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) Maisie Atkinson (Sales) |
Panmure Gordon & Co |
+44 (0) 20 7886 2500 +44 (0) 20 7886 2905 |
|
|
|
Mo Noonan/Simon Conway |
FTI Consulting |
+44 (0) 20 3727 1000 |
About Scancell
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 T-lymphocyte 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.
