31 December 2018
2018 Operational Update
Oxfordshire, UK, 31 December 2018 – Karus Therapeutics Ltd (‘Karus’), a leader in the design and development of innovative medicines with breakthrough potential in the treatment of cancer, provides an update on its clinical, preclinical, financing and operational progress in 2018.
Toward the end of 2018, and in tandem with additional equity funding, Karus strengthened its leadership team with the appointment of Tim Edwards as Executive Chairman. Tim brings a wealth of management and advisory experience in the biopharmaceutical industry. Dr Stephen Shuttleworth continues as Chief Operating Officer, Chief Scientific Officer and Director of the Board.
As well as his role at Karus, Tim is Chair of Storm Therapeutics Limited, a spin-out from the Gurdon Institute Cambridge, pioneering the development of small molecule drugs that target RNA-modifying enzymes, and a Director of Ervaxx Limited, a privately-held company developing cancer vaccines based on insights into tumour-specific endogenous retroviral sequences, and until July 2018 was a Governing Board member of InnovateUK.
Commenting on his appointment and reflecting on 2018, Tim Edwards, Executive Chairman said: “With two assets in the clinic and, additionally, an industry-leading R&D programme in development on non-hydroxamate HDAC6-targeted small molecules, it is an important time to be joining Karus as we decide on the strategic path for the Company and the clinical path for our programmes. I look forward to working closely with Steve and the rest of the Karus team to drive the Company through its next phase of development towards our goal of delivering innovative cancer therapeutics.”
Clinical Progress with KA2237 and KA2507
Karus has a strategic collaboration with The University of Texas MD Anderson Cancer Center. The collaboration is focused on Karus’s orally-active small molecule cancer therapeutics, KA2237 and KA2507, both of which have progressed into Phase I clinical trials; these clinical studies have been designed to assess safety, tolerability, pharmacokinetic and pharmacodynamic profiles of both drugs. The PI3K-p110β/δ and HDAC6 mechanisms combine potential for direct tumour-targeting with immunotherapy. Whilst recruitment has been slower than anticipated on both clinical studies, encouraging progress has been made in both studies during 2018, which will has guided the company’s clinical strategy for 2019.
KA2237 is a selective, dual-PI3K-p110β/δ inhibitor that has potential to treat haematological and solid malignancies. The Phase I clinical study for KA2237 conducted at The University of Texas MD Anderson Cancer Center was designed to assess the safety of KA2237 alone in relapsed, treatment-resistant B cell lymphoma patients. Of the 13 subjects receiving a dose of KA2237 in the therapeutic window, 3 subjects gained a partial response and 4 achieved complete remission. The toxicity profile of KA2237 is favourable, and the study will be completed in 2019.
KA2507 is a highly-potent, selective and differentiated HDAC6 inhibitor which has potential for the treatment of both haematological malignancies and solid tumours. The Phase I dose escalation clinical study for KA2507 is an all-comer solid tumour study; to date, selective target engagement has been observed, with a favourable tolerability profile. Dose escalation is continuing, and the company plans to open a Phase II efficacy study for KA2507 in a specific solid tumour setting, in 2019.
Pipeline Expansion – Next-generation HDAC6 Inhibitors
Karus has designed and developed a follow-on series of differentiated, non hydroxamic acid HDAC6-targeted inhibitors, with potential to be explored in several indications; preclinical development candidates nomination is scheduled for 2019.
Reflecting the progress of its clinical and preclinical development programs, Karus was pleased to secured additional equity investment of £12m from existing investors in October. This will be used to support Phase II studies as well as the continuing development of next-generation HDAC6 inhibitors.
Throughout the year, Karus representatives attended the following scientific, investor and partnering conferences: J.P. Morgan Healthcare Conference, BioTrinity, AACR, ASCO, BIO International Convention, ELRIG Drug Discovery, BIA UK Bioscience Forum, NCRI Cancer Conference, BIO-Europe, EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, and Genesis.
For more information, please contact:
Sue Charles / Dr Christelle Kerouedan / Dr Katie Duffell
Tel: +44 (0)20 7457 2013
About Karus Therapeutics
Karus Therapeutics, based in Oxfordshire, UK, is a leader in the design and development of innovative cancer therapeutics. The Company’s orally-active, small molecule drugs combine targeted cancer cell activity with immunotherapy for the treatment of haematological and solid tumours. Karus has designed and developed its two lead therapeutic agents from research to early-stage clinical trials. The Company is privately-held and is supported by a world-leading syndicate of life science investors from the US and Europe: SV Health Investors, New Leaf Ventures, Novo A/S and IP Group. For further information please visit: www.karustherapeutics.co