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Singapore's Lion TCR Keeping Pace in T-cell Therapy Development

By Pearl Liu 
Staff Writer, BioWorld (Original article published in BioWorld)

HONG KONG – Research in T-cell therapy has been gaining momentum, with biotech giants like Gilead Sciences Inc. keenly investing in the area. Meanwhile, Lion TCR Pte. Ltd., a smaller company based in Singapore, is also seeing progress with its T-cell therapy treatment for hepatocellular carcinoma (HCC).

Attention to immune cell therapy has increased, with Novartis AG obtaining the first CAR T FDA approval for Kymriah (tisagenlecleucel). And Foster City, Calif.-based Gilead recently paid $11.9 billion to acquire Kite Pharma Inc., which focuses on allogeneic therapies. (See BioWorld, Aug. 29, 2017, and Aug. 31, 2017.)

Lion TCR, which may not be on par with those big names for now, has been quietly working on its T-cell treatments. Recently, the FDA granted two orphan drug designations (ODDs) for T-cell therapy products targeting HCC.

"We focus on developing T-cell therapy fighting virus-related cancer as the WHO Cancer Report 2014 indicates that over one-fifth of cancer cases in Asia are related to primary viral infection," Victor Li, Lion TCR CEO, told BioWorld. "For instance, nasopharyngeal carcinoma is 100 percent related to the Epstein-Barr infection and more than 60 percent of the world's HCC cases are a result of chronic hepatitis B virus [HBV] infection."

HCC, according to the company, is the world's second leading cause of death due to cancer, and there are 780,000 new HCC cases reported annually. The general prognosis of HCC is poor, with overall survival rates of 3 percent to 5 percent.

"China is our primary market and over 90 percent of patients suffering HCC are caused by hepatitis B infection," Victor said. "Lion TCR's first product candidate TCR T-cell therapy aims for treatment of hepatitis B-related HCC."

Roughly 400,000 people are diagnosed with liver cancer annually in China, which is about 11 to 18 times the rates in Europe and the U.S. Incidence of HBV in China is nearly 30 times the rate in the U.S. as well, according to a report by McKinsey & Co.

However, Lion TCR chose to register its products in the U.S. because the regulatory framework there is more mature and the approval is expected to be faster than that in China.

"We do not want to waste time on waiting among the backlog of applications and unclear regulation," Victor explained. "The ODD can reduce our costs, including future tax benefit and FDA agency fee waivers, which is about $2 million. The ODD will also allow us earlier access to the market of our products."

For products with ODD that can treat diseases that do not have satisfactory alternative drugs available in the market, the FDA may consider granting approval for marketing as long as the product completes a phase II pivotal trial.

"The designation also entitles our company to a seven-year period of marketing exclusivity in the U.S. after we get the new drug license and we might also be waived from some tax during the period," said Victor.

One of the candidates is an HBV-specific T-cell receptor (TCR) redirected T-cell therapy against HCC with transient mRNA; the other one has longer lasting DNA transduction technologies.

"We see that mRNA gene transfer T-cell therapy is a safer approach to be adopted mostly; however, the DNA treatment can be applied to some particular cases, for example, relapsed liver cancer after transplantation," said Victor.

Currently both treatments are in phase I, and with the ODD, the company's focus is to accelerate the clinical programs.

"We started clinical trials in January and are expecting a multiple-center phase I to phase II clinical trial, and in theory it will speed up bringing the products to the market under an early market access regulation framework in selected countries," he said.

The company is conducting trials in Asia, including sites in Singapore and Guangdong, China. To better access patients and cases in China, the company expanded to Sino-Singapore Guangzhou Knowledge City in Guangzhou's Development District last year.

"Guangdong has the highest number of patients suffering from hepatitis B and HCC in China, which is the main reason why we chose Guangdong as our base in the country," Victor said. "Also, Guangzhou is an ideal city for biopharmaceutical companies, especially when it comes to industry and talent support."

Guangdong is also home to research in nasopharynx carcinoma, which is the target area of some other T-cell therapy treatments currently in Lion TCR's product pipeline.

With the R&D center set up in Guangzhou and clinical trials launched in China, Lion TCR has already started fostering its presence in the country.

"We've already communicated with local experts of T-cell therapy and HCC," Victor said. "Currently, it is still unclear how immune cell therapy will be regulated in terms of approval application. We are hoping that the FDA's approval can set an international standard and the rest, including China, will follow that. If that is the case, then the ODD we got will facilitate our further development in Asia."

While the biotech currently focuses on TCR treatment, the CAR T therapy is under development and will be included in its clinical pipeline in the near future.

"We have plans for further expanding our research areas," Victor said. "For now, the most important part is to finish the clinical trial of the two therapy treatments for HCC and our first round of fundraising."

Original article published in BioWorld.