Specialist drug developer Sareum Holdings (AIM:SAR) has issued final results for the year ended 30 June 2021 including reporting on progress with its R&D pipeline.
It is being closely watched by investors as it works on its SDC-1801 treatment for autoimmune diseases and severe COVID. The company said this morning that it was nearing completion of the pre-clinical phase of SDC-1801.Sareum is a specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of autoimmune diseases and cancer. Sareum aims to generate value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.
Sareum is advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases, including the ‘cytokine storm’ immune system overreaction to Covid-19 and other viral infections, (SDC-1801) and cancer immunotherapy (SDC-1802).
Development of an improved drug product is underway for the first clinical studies and the decision has been made to develop a potentially higher value capsule formulation rather than orally dosed solutions or suspensions. This stage is expected to continue during H1 2022.
Sareum also said that consultants have been appointed to assist in developing a plan for initial clinical studies. An Exploratory Clinical Trial Application is now expected to be filed mid-2022 owing to the additional time needed to manufacture a capsule drug product, and subject to the completion of final toxicity and safety studies. First clinical studies are expected to begin shortly thereafter, subject to drug product supply, as well as gaining the needed approvals and funding.
“We are close to completing the preclinical development of SDC-1801 with the aim of starting the clinical development of this novel compound in the second half of 2022,” explained Dr Tim Mitchell, CEO of Sareum. “This is clearly a very important milestone for the company. In addition, the early preclinical results we have seen with SDC-1801 in our Covid-19 programme suggest that it may have potential to address the hyper-inflammatory response that some patients experience, and we are looking at the next steps to advance development in this indication. We are particularly pleased to have raised substantial additional funding that will be deployed to advance these programmes into clinical development and build a robust data package that will add momentum to our ongoing partnering activities for these exciting and differentiated assets.”
Further progress on Chk1 cancer inhibitor
On the cancer front, Sareum reported that its licensing partner Sierra Oncology is continuing to explore options for continuing development and that the company has amended the licensing agreement for its SRA737 selective Chk1 inhibitor for cancer.
Chk1 targets cancer cell replication and DNA damage repair mechanisms. The Preliminary Phase 2 and comprehensive preclinical data suggest SRA737 may have broad application in combination with other oncology and immune-oncology drugs in genetically defined patients.
SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed by the CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra continues to explore options that would enable the development of SRA737 to advance.
Last year Sierra and the CRT Pioneer Fund amended the licensing agreement for the cancer treatment, including a revised milestone schedule that includes a $2m payment upon the dosing of the first patient in the next clinical trial, and slightly reduced outstanding milestones payable by Sierra – reduced from $319m to $290m.
“The possibility that clinical combination studies of SRA737 could be initiated by Sierra in the first half of 2022 is very encouraging and would represent a significant advance in the development of the SRA737 programme,” said Dr Mitchell. “We look forward to further updates on the clinical development of this candidate as the programme progresses.”
On the financial front, Sareum reported that it had raised £2.37m before expenses in June 2021 through two subscriptions by a high net worth individual. Cash in the bank at the end of June was £2.7m. The company took a loss on ordinary activities – after taxation – of £1.5m versus a loss of £0.99m in 2020. Sareum said this reflects tha increased R&D expenditure required for preclinical development.
