Sareum Regulatory News (SAR)

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Sareum Holdings PLC

("Sareum" or the "Company")

Sareum notes Sierra Oncology has reported its Second Quarter 2019 Results and Published its Form 10-Q with the US SEC

Sareum Holdings PLC, the specialist small molecule drug development business notes that Sierra Oncology ("Sierra"), the licence holder advancing clinical cancer candidate SRA737, has announced its financial and operational results for the second quarter 2019 ended 30 June 2019. The status and recent progress made on the development of SRA737, a novel Chk1 inhibitor, is summarised in an excerpt from the statement below.

At the 2019 ASCO Annual meeting, Sierra reported preliminary efficacy and safety data from two ongoing clinical trials evaluating SRA737 across multiple indications, as monotherapy and when potentiated by non-cytotoxic low-dose gemcitabine (LDG). SRA737 demonstrated notable anti-cancer activity in multiple indications including a 30% Overall Response Rate in evaluable patients with anogenital cancer treated with SRA737+LDG, an indication for which the second-line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, evaluable RAS wild-type subjects whose tumours harboured FA/BRCA gene network mutations displayed favourable outcomes across multiple indications, with an Overall Response Rate of 25%.

During the second quarter, Sierra announced plans to prioritise its resources on the development of its lead candidate momelotinib and that it has launched a campaign exploring non-dilutive strategic options to support the future continued development of its portfolio of DNA Damage Response (DDR) assets, which includes SRA737.

In its Form 10-Q, filed with the US Securities and Exchange Commission (SEC) today, Sierra noted further information relating to the milestone payment schedule (of which Sareum is eligible to receive 27.5%) resulting from the future development of SRA737:

Additional milestone payments of up to an aggregate of $319.5 million may become payable to CPF upon the achievement of certain developmental, regulatory and commercial milestones, including a milestone payment of $7.5 million upon the dosing of the first patient in the first Phase 1 trial of SRA737 in the United States, and a payment of $12.0 million upon the dosing of the first patient of a randomized Phase 2 trial of SRA737. In the event that the milestone payment for Phase 2 becomes due, but no milestone payment for Phase 1 has been paid, then the milestone payment for Phase 1 will become due and payable contemporaneously with the payment for the Phase 2 milestone for an aggregate payment of $19.5 million.

Sierra also noted:

There can be no assurance that we will successfully obtain non-dilutive development support or obtain the funding or support necessary to advance SRA737 or SRA141 or obtain such funding or support on commercially reasonable terms. If we are unable to obtain such funding or support, we may need to cease development of these product candidates.

If we are unable to renegotiate these milestone payments or raise additional capital, our ability to continue developing SRA737 may be adversely affected.

Additionally, our current license agreements impose, and any future licenses we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement, and other obligations on us. For example, we are required to use commercially reasonable efforts to develop and commercialize licensed products.

If we breach any of these obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology. We may also be required to negotiate to return our licensed intellectual property related to SRA737 to CPF if we cease or scale back development and commercialization of SRA737 for oncology-related indications.

The full announcement from Sierra Oncology can be found by clicking here and the Form 10-Q can be accessed here.

For further information, please contact: 

Notes for editors: 

Sareum is a specialist drug development company delivering targeted small molecule therapeutics, to improve the treatment of cancer and autoimmune disease. The Company generates value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Sareum's leading clinical-stage programme, SRA737, a novel Checkpoint kinase 1 (Chk1) inhibitor licensed to NASDAQ-listed Sierra Oncology, is in Phase 2 clinical trials targeting multiple advanced cancers. The key role of Chk1 in cancer cell replication and DNA damage repair suggests that SRA737 may have broad application as a targeted therapy 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, London, UK in collaboration with Sareum, and with funding from Cancer Research UK. SRA737 was licensed to Sierra Oncology for up to $328.5 million plus royalties by Sareum's co-investment partner, CRT Pioneer Fund. Sareum is eligible to receive up to $88 million in milestone payments, plus sales royalties as SRA737 advances.

Notable highlights from the Phase 1/2 preliminary results reported by Sierra at ASCO (June 2019) were:

SRA737 + low dose gemcitabine (LDG) combination

·; Striking anti-tumour activity was observed in patients with anogenital cancer, including examples where metastatic disease was cleared from liver and lung.

·; Tumour size decreased by more than a third in 30% of the evaluable anogenital cancer patients and a further 30% had durable stable disease.

·; Sierra outlined a potential route to market for SRA737+LDG in anogenital cancer via a registration-intent Phase 2 trial.

SAR737 monotherapy

High-grade serous ovarian cancers (HGSOC) appeared to be the most sensitive tumour to SRA737, with the disease being controlled (stable disease) in 54% of evaluable patients.

Sareum is also advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) /Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases (SDC-1801) and cancers (SDC-1802). TYK2 and JAK1 have roles in pro-inflammatory responses in autoimmune diseases (e.g. psoriasis, rheumatoid arthritis, inflammatory bowel diseases and lupus) and tumour cell proliferation in certain cancers (e.g. T-cell acute lymphoblastic leukaemia and some solid tumours). The Company is targeting first human clinical trials in each indication in 2020.

The Company also has an Aurora+FLT3 inhibitor targeting haematological cancers, which is at the preclinical development stage.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit www.sareum.co.uk

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