Iksuda Therapeutics Deepens Clinical Pipeline Through Licensing Agreement for Her2 Antibody Drug Conjugate Programme From LegoChem Biosciences

US phase 1 study expected to begin H1 2022; asset generated impressive preclinical results,

Global (excluding Greater China and South Korea) development and commercialisation deal recognises the Iksuda team’s world-class reputation in the antibody drug conjugate field

NEWCASTLE, England--(BUSINESS WIRE)--Iksuda Therapeutics (Iksuda), the developer of a new generation of antibody drug conjugates (ADCs) with raised therapeutic index, today announced further expansion of its differentiated ADC pipeline through a license and commercialisation agreement with LegoChem Biosciences (LCB), a Korean biopharmaceutical company focused on the development of next-generation novel therapeutics utilising its proprietary medicinal drug discovery technologies.

The agreement provides Iksuda with exclusive world-wide rights (excluding Greater China and South Korea) to LCB’s Her2 ADC programme, LCB14. The agreement includes development, regulatory and commercial milestone payments to LCB contingent on successful achievement of certain milestones as well as royalties on commercial sales.

Iksuda anticipates that LCB14, now designated IKS014, will enter a phase 1 clinical trial programme in the US during Q3 2022.

LCB14 is under license from LCB to Fosun Pharma for Greater China where it is designated FS-1502. Fosun is currently conducting a phase 1 clinical trial in China in patients with breast cancer.

This agreement with LCB allows Iksuda to further expand its clinical development pipeline. The Company’s IKS03 programme, a best-in-class CD19-targeting ADC, is also expected to enter phase 1 clinical trials in H1 2022.

Iksuda is also rapidly expanding its pre-clinical pipeline. These assets centre on delivering ADCs with raised therapeutic index through both improved safety and efficacy, conferred by tumour activated, prodrug payloads in combination with stable conjugation technologies, including its proprietary novel PermaLink^® platform.

Iksuda announced the completion of its Series A financing round in June 2021, co-led by Celltrion Inc and Mirae Asset Capital, further recognising the Company’s expertise in ADCs and underpinning its commitment to targeting the treatment of cancers with currently limited treatment options.¹

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:
“This agreement further demonstrates Iksuda’s commitment to the development of differentiated ADCs that will potentially bring benefit to patients living with cancer. Importantly, it is also further recognition of the unmatched expertise of our team.

“We continue to focus on delivering our strategy of driving potentially valuable therapies through the clinic for cancer indications with high burden and for where there are limited treatment options. Our wholly-owned pipeline is supplemented with in-licensed assets where we been able leverage our expertise to recognise promising opportunities from others to partner and then develop further, utilising our armoury of [proprietary] payload and conjugation platforms where necessary.”

Dr. Young-Lag Cho, Chief Development Officer and VP of LegoChem Biosciences, said:
“Iksuda is the best partner for the expedited development of HER2 ADC. Learning from Iksuda’s world class expertise and experience on ADC development by jointly conducting phase 1 trial in US will strengthen our internal development capabilities while accelerating advancement of our other ADC programs.”

Yong-Zu Kim, CEO, LegoChem Biosciences, commented: “Recognising Iksuda’s depth of knowledge within the field of ADCs we are pleased to once again expand our relationship and our continued efforts to develop a broad pipeline of pre-clinical and clinical opportunities.”

1. Press release: Iksuda Therapeutics closes $47 million financing round (07 June 2021)

ENDS

About Iksuda Therapeutics: www.iksuda.com
Iksuda Therapeutics is a UK-based biotechnology company focussed on the development of a new generation antibody drug conjugates (ADCs) targeting difficult-to-treat haematological and solid tumours. Iksuda’s pipeline of ADCs is centred on a portfolio of non-prodrug/prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries including its proprietary PermaLink^® platform. The Company’s ADCs portfolio is designed to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer.

About IKS014
IKS014 is a potential best-in-class HER2-targeting ADC. In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with significantly higher HNSTD vs other HER2-directed drugs. A phase 1a clinical trial is nearing completion in China, with phase1b in HER2-positive breast cancer patients planned to start soon. Phase 2 trials in HER2-positive gastric cancer patients are planned for 2022.

About IKS03
IKS03 is a best-in-class CD19-targeting ADC delivering a tumour-activated prodrug pyrrolobenzodiazepine (PBD) which was licensed from LegoChem Biosciences (https://iksuda.com/2020/05/licensing-agreement-with-legochem-biosciences/). Preclinical testing demonstrates best-in-class efficacy (vs in-clinic and marketed CD19-targeted therapies) in in vivo xenograft models and significantly raised maximum tolerated dose (MTD) in non-human primate disease models, demonstrating its potential to be the leading anti-CD19 therapy in B-cell cancers. IND is planned for Q2 2022, with initial phase 1 patient data anticipated Q3 2022.

About LegoChem Biosciences
LegoChem Biosciences (KOSDAQ: 141080) is a biopharmaceutical company focused on the development of next-generation novel therapeutics utilising its proprietary medicinal drug discovery technology legochemistry™ and ADC platform technology conjuall™. Since its foundation in 2006, LegoChem Biosciences has focused on the research and development of antibody-drug-conjugates, antibiotics, anticoagulants and anticancer therapeutics based on its proprietary platform technologies.

For further information please contact:

Iksuda Therapeutics
Dave Simpson, Chief Executive Officer
Tel: +44 (0) 191 6031680
Email info@iksuda.com

FTI Consulting (Financial Media and IR)
Simon Conway / Rob Winder
Tel: +44 (0) 020 3727 1000
Iksuda@fticonsulting.com