Sareum Holdings PLC (LON:SAR) has highlighted “good progress” on the development of its treatment candidates despite what it said was a “challenging period” for many people and firms during the coronavirus (COVID-19) pandemic.
In an update statement to be delivered at the company’s annual general meeting on Tuesday, Sareum's non-executive chairman Stephen Parker said the drug developer’s key focus remains on advancing the development of its two TYK2/JAK1 programmes, namely SDC-1801, targeting autoimmune diseases, and SDC-1802, targeting cancer.
READ: Sareum up as 'Nature' article identifies TYK2 as key causative genetic mechanism for coronavirus
For SDC-1801, Sareum said it has conducted and completed initial toxicology studies in rodents demonstrating “excellent tolerability” and established its manufacturing process. In recent months, the company also said it has developed a new formulation, specifically designed to deliver higher exposure levels of the molecule, which is now being tested in additional toxicology studies with a targeted completion date early in the new year.
Data from these studies will form part of a planned Clinical Trial Application (CTA), which the firm aims to submit in the first quarter of 2021, and if approved will allow the start of clinical studies with SDC-1801. Parker said this will “clearly be an important milestone” for the company.
Sareum also nopted that it has been granted £174,000 by UK Research & Innovation to investigate the therapeutic potential of SDC-1801 in severe phase COVID-19, a project which began immediately and is expected to take approximately six months to complete.
The company said its aim is to investigate whether treatment of cells infected with SARS-CoV-2, the virus that causes COVID-19, with SDC-1801 can block the overactive inflammatory response (known as a cytokine storm), which can become life-threatening for patients. It added that the scientific rationale for this project received a “significant boost” by data published last week in Nature of DNA studies from severe COVID-19 patients that indicated TYK2 to be a key gene involved in causing the cytokine storm that leads to the progression of severe disease in patients.
Sareum said the project will also investigate if treatment with SDC-1801 in disease models can re-establish protection against bacterial pneumonia following SARS-CoV-2 infection, and that positive results from these studies may also highlight the “broader potential for SDC-1801 as a treatment for severe and life-threatening inflammation that can occur with other viral infections”.
“We look forward to reporting the outcome of these initial studies in the second half of 2021”, the chairman said.
Regarding its second TYK2/JAK1 inhibitor candidate, SDC-1802, Sareum said formulation work for oral dosing was completed during the year and toxicology studies and further manufacturing work are continuing. During the year, the company said it presented new findings showing that SDC-1802, dosed orally as a monotherapy and in combination with chemotherapy, significantly reduced tumour growth in models of solid tumours and blood cancers. The firm said this added to growing evidence for the potential of SDC-1802 in cancer.
Looking at its licensed programmes, Sareum said in March it announced a global licensing deal for its FLT3+Aurora kinase inhibitor targeting blood cancers with a China-based specialty pharmaceutical company, and has received an upfront payment and is eligible to receive an additional £0.9mln dependent on certain milestones being achieved by January 2021. The company said it is also eligible to receive a further development-based milestone, and revenues upon the commercialisation of any products resulting from the agreement.
Meanwhile, the company said development of its licensed Chk1 inhibitor, SRA737, over the past 18 months has been “frustrating” due to the licence holder, Sierra Oncology Inc, putting further SRA737 development on hold while it explored options to fund this development.
In November, Sareum said Sierra and CRT Pioneer Fund LP (CPF) agreed an amendment to the licence agreement that reduces the aggregate outstanding milestones from up to US$319.5mln to up to US$290mln, including a milestone payment of US$2mln upon the dosing of the first patient in the next clinical trial of SRA737.
The company added that it continues to be eligible for 27.5% of the economics of the CRT licence agreement, as amended, and while the aggregate level of milestone payments is reduced, they were confident that the amendment will expedite the SRA737 programme.
“We continue to believe that, based on preclinical and early clinical data, SRA737 holds great promise for the treatment of cancer, particularly in combination with existing treatments. We will provide further updates on progress as and when Sierra makes further disclosures in relation to the development of SRA737”, Sareum said.
Turning to business development, the firm said it “continues to actively engage with potential partners with a view to securing commercial licences for its TYK2/JAK1 programme” while it reiterated its cash balance of £1.8mln at the end of its fiscal year to June 30 as well as a £1.02 fundraising which it said will enable it to progress its drug development programmes.
Looking ahead, Sareum said it “continues to actively monitor” its working capital position and has taken steps to maximise its cash runway and ensure its TYK2/JAK1 compounds are prioritised and adequately resourced.
“We now have the exciting prospect of submitting our first CTA for approval in the first quarter of 2021, a key step in allowing the first in human studies with SDC-1801 to begin”, Parker said.