BEIJING – Chinese T-cell immunotherapy specialist Immunotech Biopharm Ltd., of Beijing, has become the seventh pre-revenue biotech on the waiting list to go public on the Hong Kong Stock Exchange (HKEX). In an application filed this week, the specific amount was not disclosed, but company said much of the proceeds are expected to advance its lead candidate targeting liver cancer.

Established in 2006, Immunotech is focused on T-cell immunotherapy, which is a budding area in China. Its pipeline includes 10 assets, ranging from non–genetically modified and genetically modified products to multitarget and single-target drug candidates. One is in clinical stage and another is IND-ready.

Core product candidate EAL, an in-house-developed multitarget asset, is the first cellular immunotherapy product in China granted IND approval for a phase II trial, and the only drug candidate undergoing a phase II study that investigates its efficacy in preventing postsurgical recurrence of liver cancer.

EAL 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 has demonstrated efficacy in preventing tumor recurrence and maintaining long-term survival of patients, and when used in combination with chemotherapy, has shown better therapeutic efficacy than chemotherapy alone," Immunotech said in its prospectus. "Encouraged by cases of patients surviving up to 10 years after receiving EAL treatment, we believe EAL can give patients another chance of improving survival prospects.".

Other product candidates include the CAR T-cell series that contains seven assets and the TCR T-cell series.

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 over 90%," the biotech said.

Last month, Chinese regulators accepted the IND application for its CAR-T-19 injection for the treatment of B-cell acute lymphoblastic leukemia.

Based on the model of its CAR-T-19 injection product candidate used for the treatment of hematologic cancer, Immunotech is conducting research into other T-cell products that aim to overcome the immunosuppressive mechanisms in the tumor microenvironment or the high recurrence rate of CAR T-cell therapy.

As for its TCR T-cell product pipeline, the biotech has several candidates undergoing preclinical studies. It has completed pharmacodynamic studies for its NY-ESO-1 TCR-T cell and plans to submit IND applications for its CAR-T-19-DNR, aT19, and NY-ESO-1 TCR-T by the end of 2020.

'A hot area'

Immunotech is one of the oldest cellular immunotherapy companies established in China. It has built a set of R&D platforms for cellular immunotherapy drugs ranging from theoretical demonstration to pharmacological research, from in vitro experiments to animal experiments, and from safety evaluation to clinical research.

According to market researcher Frost & Sullivan, the size of China's cellular immunotherapy market is expected to increase from ¥1.3 billion (US$181 million) to ¥10.2 billion from 2021 to 2023 at a CAGR of 181.5%.

"CAR T-cell immunotherapy is a hot area. There are already clinical trials underway in China," Yu Zhou, chief health care analyst at Chuancai Securities, told BioWorld.

In China, the cellular immunotherapy industry saw a major shift in regulatory environment in 2016, when new rules were promulgated to require all cellular immunotherapy products to go through regulatory processes just like other drugs.

As of August 2019, there were 10 cellular immunotherapy products in clinical trials in China.

Players include Shanghai-based Fosun Kite Biotechnology Co. Ltd., which has advanced its gene therapy candidate, FKC-876, to clinical trials in China. Targeting large B-cell lymphoma, it is already marketed under the brand name Yescarta (axicabtagene ciloleucel) in the U.S. and EU.

Nanjing Legend Pharmaceutical & Chemical Co. Ltd. has partnered with Janssen Biotech Inc. to develop CAR T therapy LCAR-B38M, targeting relapsed or refractory multiple myelomas. Chinese regulators have already approved a clinical trial application.

As rosy as the picture may seem, however, Zhou struck a cautious note on those companies.

"The prospects of companies engaged in cellular immunotherapy are uncertain. It is very costly to develop a therapy and it may affect the penetration rate of the product," he added.

Immunotech, which has yet to generate any income due, has cited R&D costs comprising nearly 90% of its expenses. Backed by sponsors including CCB International and Guosen Securities (HK), it opted for a pre-revenue listing pathway in hopes of raising funds to advance its programs to late clinical and commercialization stage.

To date, nine pre-revenue biotech companies have been listed on the HKEX since April 2018. Seven are pending approval, including Venus Medtech (Hangzhou) Inc., Alphamab Oncology, Sinomab Bioscience Ltd., Tasly Biopharmaceuticals Co. Ltd., Tot Biopharm International Co. Ltd. and Ascentage Pharma Group International.

No Comments