Silence Therapteutics inks deal with Takeda after decent year
Silence Therapeutics
535.00p
16:34 29/11/21
Serious disease therapeutics developer Silence Therapeutics updated the market on the year ended 31 December on Tuesday, reporting that it has entered into a technology evaluation agreement with Takeda to explore the potential of using its platform to generate siRNA molecules against a novel, undisclosed target discovered by Takeda.
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The AIM-traded firm said Takeda would provide Silence with a single-digit million dollar amount of research funding.
It said the two companies had further agreed to negotiate the terms of a license agreement, should the initial evaluation study prove successful.
Looking at its development activities, Silence said it was “encouraged” by the growing prominence of RNAi technology, as evidenced by the approval of Alnylam's ‘Givosiran’, and a number of significant partnerships and transactions in the RNAi space, including agreements between Dicerna Pharmaceuticals and Novo Nordisk, the $9.7bn acquisition of the Medicines Company by Novartis, and its own collaboration with Mallinckrodt Pharmaceuticals to develop and commercialise RNAi therapeutics for complement-mediated diseases.
The board said the firm was continuing to explore multiple opportunities to create shareholder value through significant partnerships with large and established pharmaceutical companies that would leverage its proprietary GalNAc-siRNA platform.
It added that, given the increased focus on the United States, the company was planning to establish a subsidiary in the US during 2020.
On the subject of its pipeline and clinical development, Silence said it was progressing ‘SLN124’, its wholly-owned lead candidate, towards the clinic.
Patients were currently being screened for a phase 1b first-in-human study, with six sites already open in the UK, Bulgaria and Turkey.
The primary objective of the study was to determine the safety and tolerability of SLN124 for the treatment of non-transfusion dependent β-thalassemia and myelodysplastic syndrome (MDS).
Following a recent protocol revision, the first patient was expected to be dosed in the first quarter of 2020, and the firm said it was on track to report interim results in the second half.
SLN124 had been granted ‘orphan drug designation’ by the European Medicines Agency (EMA), which the directors said highlighted the potential that the product had to “transform the lives” of patients.
Looking at SLN360, its wholly-owned pre-clinical candidate for the potential treatment of cardiovascular disease, the company said it had made “significant” progress with investigational new drug (IND) enabling studies and was still expecting to file an IND and clinical trial authorisation (CTA) application in the second half of 2020.
A recent pre-IND meeting was held with the US Food and Drug Administration (FDA) in December, and Silence said it was “looking forward” to progressing the candidate towards the clinic in 2020.
SLN500, which was being developed in partnership with Mallinckrodt for the treatment of complement-mediated diseases, Silence said it expected to nominate a lead candidate from the programme in the first half of 2020 and to file an IND/CTA application in 2021.
The partnership with Mallinckrodt was still progressing according to plan, the board reported, with one milestone payment having already been received and the possibility of further options being exercised in 2020 as part of the license and collaboration agreement signed in July.
On the corporate front, the company noted that it made several high-profile appointments during 2019 including Dr. Rob Quinn as chief financial officer, Dr Giles Campion as head of research and Development and chief medical officer, Dr Barbara Ruskin as general counsel, Dr John Strafford as head of business development, and Jorgen Wittendorff as head of manufacturing.
Executive chairman Iain Ross was leading the company on an interim basis following David Horn Solomon's resignation in December as chief executive officer, and the board said a search for a new CEO had begun.
The firm said it was currently in discussion with several “world-leading” scientists and clinicians to form a scientific advisory board, which would be led by Sir Gordon Duff, who previously served as chair of the UK's Commission on Human Medicines, chair of the Biotechnology and Biological Sciences Research Council, and chair of the Medicines and Healthcare Products Regulatory Agency.
Silence Therapeutics reported an unaudited cash balance as at 31 December of £33.5m, which it said provided it with sufficient cash to fund operations under its current business plan into the second half of 2021.
“The company has made substantive progress in 2019, cementing its reputation as a leading participant in the burgeoning field of RNAi therapeutics, securing a major deal with Mallinckrodt Pharmaceuticals,” said Iain Ross.
“We are in our most robust health now, both financially and operationally, and today's agreement with Takeda represents further validation of our technology and capabilities.
“In 2020, Silence will look to continue leveraging its expertise to advance its pipeline of new medicines through the clinic to show safety, tolerability and efficacy for patients.”
Ross said that in addition, it would continue to explore multiple opportunities to create shareholder value through significant partnerships that would leverage the company's proprietary GalNAc-siRNA platform.
“With our increased US focus, the board has taken the decision to establish a US subsidiary in the coming year to improve the company's visibility and capture value for shareholders by more actively participating in the rapidly expanding field and the world's most significant healthcare market.”
Silence said it would announce its audited results for the year ended 31 December in April..
At 1529 GMT, shares in Silence Therapeutics were up 9.88% at 356p.