Genexine Seals I-O Licensing Deal With I-Mab, Builds Momentum
Executive Summary
Genexine has reached a critical point in developing its immuno-oncology pipeline, firming up a $548m-plus licensing out pact for an asset with the Shanghai-based I-Mab Biopharma. The South Korean firm expects the deal to serve as a yardstick of ‘value determination’ in its future global transactions.
Genexine Inc. has licensed out its proprietary long-acting immuno-oncology drug HyLeukin to I-MAB Biopharma for $548m plus sales royalties, marking the South Korean biotech company's first immuno-oncology deal.
HyLeukin, also known as GX-I7, is an immuno-oncology agent comprising an optimally engineered Interleukin-7 (IL-7) molecule based on Genexine’s proprietary long-acting protein platform technology, focusing on cancer, infectious diseases and lymphopenia. IL-7 is known to be the critical factor of the immune system to increase the number and functionality of tumor-killing T cells. Clinical results showed that IL-7 has strong synergistic effects with other immuno-oncology drugs such as checkpoint inhibitors.
Phase I trials of HyLeukin are underway in Korea, and Genexine plans to initiate a Phase Ib trial in patients with solid tumors in Korea early next year. NeoImmuneTech (NIT), a US spin-off company of Genexine established three years ago, is preparing for various US clinical trials of HyLeukin, including glioblastoma, in 2018.
Under the agreement, I-Mab will provide a total of $548m, including $12m in upfront payment, in exchange for an exclusive license for development and commercialization rights of HyLeukin in greater China – Mainland China, Taiwan, Hong Kong and Macao - in the field of oncology. The deal amount includes potential milestone payments, Genexine said.
Genexine said HyLeukin has multiple indications, but it is progressing with cancer first, in line with keen global interest in immune-oncology. NIT is seeking partners for HyLeukin in the US and Europe.
MiraeAsset Daewoo said in a research note that Genexine could be re-evaluated as an immuno-oncology drug developer with the HyLeukin license deal. It is known as the only company that is developing IL-7 as an immuno-oncology drug.
Deal To Buoy Genexine’s China Entry, Base For Global Pacts
The latest deal is poised to further beef up Genexine's entry into the Chinese market and also provide an impetus for global licensing out deals for the asset.
The South Korean company has been making robust efforts to broaden its presence in Asia including China.
In 2015, it signed a licensing out agreement with Tasgen Bio-Tech Co. Ltd. , a subsidiary of China's Tasly Pharmaceutical Co. Ltd. and agreed to buy a 33.33% stake in Tasgen Bio-Tech to support the joint development of its biologics in China. (Also see "Genexine Seeks China Entry Through Multi-Biologic Tasly Tie-Up" - Scrip, 19 Oct, 2015.)
“China provides good opportunities to demonstrate efficacy of new immuno-oncology drugs in cancer patients, and I-MAB is the best partner to carry out these clinical trials at the global level. We believe this licensing partnership with I-Mab represents an important step in executing Genexine’s immuno-oncology development and will become a criterion of value determination in future global licensing deals," said Young Chul Sung, founder and CTO of Genexine.
According to Trialtrove data in November, China ranked eighth in terms of the number of immuno-oncology clinical trials being conducted, among the 25 countries where such trials are being done.
I-Mab Quickens Steps In Deal-Making
Meanwhile, the latest deal will speed up I-Mab's efforts to develop immuno-oncology drugs via partnerships. I-Mab Biopharma, which was established in 2017 through a merger of Third Venture Biopharma, an innovative antibody start-up, and Tasgen, a joint venture biotech by Tasly Pharmaceuticals, Genexine and C-Bridge Capital, is committed to developing innovative biologics in the areas of immuno-oncology and immuno-inflammation through internal R&D capabilities and global partnerships.
Earlier in December, I-Mab also reached a licensing agreement with MorphoSys AG to develop and commercialize MOR202 in China, Taiwan, Hong Kong and Macao. MOR202 is MorphoSys’s proprietary investigational antibody against CD38, for which a European Phase I/IIa clinical study in relapsed/refractory multiple myeloma has concluded recruitment.
“We are very excited to have brought our partnership with Genexine to a new level. This is a highlight of many on-going projects we have been collaborating with," said Jingwu Zang, founder and CEO of I-Mab Biopharma.
I-Mab plans to develop this clinical stage asset in China for cancer patients whose immune cells and functions are severely compromised.
“We hope to develop this investigational medicine, with first-in-class potential, in parallel with its global development. So, if proven safe and efficacious, patients in China can benefit from such a treatment in line with or even ahead of a global timeline," said Zang.
From the editors of PharmAsia News.