BEIJING – Beijing-based cellular immunotherapy firm Immunotech Biopharm Ltd. said June 28 that it intends to raise up to HK$1.1 billion (US$141.9 million) on the Hong Kong Stock Exchange (HKEX) on July 10, with shares priced between HK$10.5 and HK$11 apiece. Three more biotech IPOs are in the bourse’s pipeline.

Immunotech, with support from CCB International Capital Ltd. and Guosen Securities (HK) Capital Co. Ltd., is the first T-cell immunotherapy developer to seek pre-revenue listing in Hong Kong. It needs capital to advance its lead candidate, EAL, which targets the prevention of postsurgical recurrence of liver cancer, to the Chinese market.

EAL is an activated autologous lymphocyte (AAL) therapy. It is a preparation of activated and expanded T cells originally taken from a patient's peripheral blood and cultured using Immunotech's patented methods. The main active component of the product is CD8-positive cytotoxic T cells, whose surface marker is the CD3 molecule.

EAL is the first and only cellular immunotherapy product in China approved to enter phase II testing for treatment solid tumors.

“We already enrolled 164 patients in our phase II trial and expect to recruit another 108 patients to complete enrollment by the end of 2020,” Immunotech CEO Wang Yu said at the press conference on Sunday. “We expect to complete interim data analysis in the first half of 2021, then we will approach the NMPA for conditional approval for EAL.”

After the IPO, Immunotech plans to use 34.2% of the proceeds to support the clinical trials and commercialization of EAL, and another 18.9% of the proceeds to expand the clinical indications of EAL.

For future R&D plans, Wang emphasized that the company’s key goal is to extend the indications of EAL to more tumor types.

“We hope to control tumor progression and extend patients’ lives in every possible way before there is a product that can eliminate tumors. With negligible side effects, EAL can be used to treat multiple tumor types. It can prevent tumor recurrence and create synergy in combination with chemotherapy,” Wang explained.

Green Cross Cell Corp.’s Immuncell-LC, which is also an AAL therapy-related product, has been approved in South Korea for treating liver cancer since 2014. Clinical data showed that it reduced by about 37% the risk of recurrence of liver cancer after surgery.

The case of Immuncell-LC gives Immunotech confidence that EAL may be approved in China soon. It will then be the first T-cellular immunotherapy product for solid tumors in the country, if statistically significant data about its efficacy are available next year.

“We could achieve commercialization faster than other cell therapy companies [in China] and enjoy an early mover advantage in the market,” Wang said.

With Tasly (Hong Kong) Pharmaceutical Investment Ltd. being one of its cornerstone investors, Immunotech said a commercial partnership with Tasly is possible. The startup hopes to leverage Tasly’s established sales network in China to market EAL.

Established in 2006, Immunotech has built a pipeline that features major classes of cellular immunotherapy products. Besides EAL, the biotech also has CAR T and TCR-T product candidates that it plans to develop with around 33.2% of the IPO proceeds.

“We are also targeting precision cancer medicine. Although our CAR-T-19 and TCR-T series product candidates are still in early development stage, they are still our key R&D focus,” Wang said. “We will continue to expand our pipeline, extend the indications and explore more targets.”

Among those is a CAR-T-19 injection product, which was the subject of a researcher-initiated clinical study in which 63 patients were treated, and the complete response rate was more than 90%. Immunotech expects to move it to clinical trials by the end of 2020.

The biotech is also looking into T-cell products that aim to overcome the immunosuppressive mechanisms in the tumor microenvironment and the high recurrence rate of CAR T-cell therapy. Meanwhile, the TCR-T product candidates are still in preclinical studies. Immunotech plans to file IND applications for those products by mid-2021.

To build its pipeline, Immunotech has established a serum-free cell culture and expansion technology platform, a gene modification and transduction technology platform, a technology platform for in vitro expansion of antigen-specific T cells, and a production and purification technology platform for plasmids and viral vectors.

Three more to come

Besides Immunotech, pre-revenue eye disease specialist Ocumension Therapeutics Ltd. will also make its debut on the HKEX on July 10. The company plans to raise up to HK$1.55 billion (US$200 million), after pricing its shares between HK$13.16 and HK$14.66 apiece.

Its IPO is backed by Morgan Stanley and Goldman Sachs, and it boasts investors such as 6 Dimensions, Boyu, Temasek, General Atlantic, Eight Roads, 3W Partners and Cormorant Asset Management. Its core product is OT-401 (YUTIQ), an intravitreal implant designed to provide the sustained release of a corticosteroid active ingredient for 36 months from a single administration to treat chronic non-infectious uveitis affecting the posterior segment of the eye. OT-401 is approved in the U.S. but not yet in China.

Response from retail investors is said to be encouraging for both Immunotech and Ocumension, after the success of other high-profile pre-revenue biotech IPOs over the past few months.

The HKEX is continuing a string of Chinese biotech IPOs this summer.

Genor Biopharma Co. Ltd. and Simcere Pharmaceutical Group, which filed their applications on June 26 and June 10, respectively, are seeking non-pre-revenue listing on the main board. It remains to be confirmed how much both companies plan to reap from the Hong Kong stock market.

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