Kelun-Biotech and Ellipses Pharma Announce a Licensing Agreement for A400

Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. and UK company Ellipses Pharma Ltd. Announce a Licensing Agreement for Innovative Small Molecule Cancer Therapeutics

Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (hereinafter referred to as “Kelun-Biotech”), a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as “Company” or “Kelun Pharma”), signed a licensing agreement with UK company Ellipses Pharma Ltd. (hereinafter referred to as “Ellipses”) in March 2021. Kelun-Biotech granted Ellipses an exclusive license for an innovative small molecule targeted kinase inhibitor (hereinafter referred to as “A400”), in certain territories including the US and Europe under undisclosed financial terms. Kelun-Biotech retains certain rights in Greater China and part of the Asia-Pacific region including South Korea, Singapore, and Malaysia. Each party will perform development and commercial activities in their own respective territories and agree on certain data sharing to support global development.

About A400

A400 is a selective and targeted small molecule RET kinase inhibitor with intellectual property rights developed by Kelun-Biotech. The IND application of A400 was submitted to NMPA in March 2021. A series of international patent applications have been filed. Professor Yilong Wu, a leader in the field of lung cancer in China, will serve as Principal Investigator in registrational clinical trials in China. In preclinical studies, A400 demonstrated favorable kinase inhibitory activities with selectivity in-vitro and in-vivo, advantages in animal blood/brain exposure, and efficacy on several drug resistance mutations reported clinically. A400 has the potential to overcome clinically significant drug resistance mutations and provide improved clinical outcomes for brain metastases.

Dr. Rajan Jethwa, CEO of Ellipses Pharma, said:
"RET fusion-positive NSCLC and RET-mutated thyroid cancers are an area of high unmet need. We congratulate Kelun-Biotech for their success in discovering A400 and efficiently developing it thus far. Ellipses is excited to in-license this novel RET inhibitor for onward development through the clinic and we look forward to continue building a long-term partnership with Kelun- Biotech, working collaboratively to advance this promising new therapy to patients in the clinic."

Dr. Junyou Ge, COO of Kelun-Biotech, commented:
"Kelun-Biotech is committed to developing innovative drugs with differentiations and advantages for unmet medical needs. As a drug candidate in our cancer precision medicine pipeline, A400 showed a significant therapeutic potential for tumors with RET oncogene mutation/fusion and is expected to bring clinical benefits to patients. We are happy to establish a licensing partnership with Ellipses, a company focused on developing high quality oncology medicines that have the potential to change the standard of care to address unmet need. The collaboration will speed up the overseas development, registration, and commercialization of A400. Meanwhile, Kelun-Biotech will accelerate the development in China and Southeast Asian countries, and work with our partner to promote the global development and commercialization of A400 to benefit more cancer patients around the world."

Professor Yilong Wu of Guangdong Provincial People's Hospital said:
"RET gene fusion is a key driver for the growth and proliferation of many solid tumors, and about 2% of NSCLC patients have RET gene fusion mutation. NSCLC patients with RET fusion gene mutation have higher malignancy, more rapid disease progression, higher recurrence, and shorter survival. In the past, no particularly effective treatment was available for this group of patients. Traditional chemotherapy is the main treatment for these patients, but the efficacy is poor. Therefore, new therapeutics and treatment regimens with better efficacy and safety are in urgent need. As a pan-tumor small molecule kinase inhibitor selectively targeting RET, A400 showed favorable anti-tumor activity and safety in the preclinical development. Compared with other drugs in the same category in the global market, A400 demonstrated the differentiated advantages of overcoming drug resistance and increased brain penetration, which will potentially benefit patients with drug resistance and brain metastases. We look forward to launching clinical trials in China as soon as possible to benefit Chinese cancer patients with the corresponding gene mutations. In parallel, the collaboration between Kelun-Bioteh and Ellipses will help A400 enter the global market and bring new treatment options to patients worldwide."

About Kelun-Biotech

Founded in 2016, Kelun-Biotech focuses on the development of innovative small molecules and biologics and has established a comprehensive R&D pipeline. Currently, the pipeline includes 38 innovative small molecules and 47 biologics (including cell therapies), among which 13 programs are in clinical trials.

About Ellipses

Ellipses Pharma is an international drug development company, focused exclusively on the development of innovative cancer medicines and treatments. Headquartered in London, Ellipses is run by a world-class leadership team, leveraging the expertise of the world’s largest cancer-focused key opinion leader group to oversee a rapidly growing pipeline of high-quality clinical oncology opportunities. Its worldwide reach and asset-focused approach transform the clinical trial process to make the very best drugs and therapies available to patients with cancer at unprecedented speed. For more information, please visit https://ellipses.life/

Business Development, KLUS Pharma
Business Development, Kelun-Biotech

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