HONG KONG – Singapore's Tessa Therapeutics Pte. Ltd. is more than halfway through the recruitment for what it said is the world's largest phase III T-cell immunotherapy trial for any cancer indication. If all goes well, the company is expecting a product launch in two years.

The subject of the trial is TT-10, an immunotherapy treatment for nasopharyngeal cancer (NPC). It is based on Tessa's virus-specific T-cell (VST) platform that has shown compelling results in solid tumors.

The treatment works by immunologists extracting T cells from a patient's blood, enhancing the antitumor potency in the immune cells, selectively expanding them in the laboratory, and then infusing the cells back into the patient. The infused VSTs are designed to recognize and kill virus-associated tumor cells they encounter.

Han Chong Toh, Tessa's chief medical officer, likened it to "soldiers that grow in your body, unlike antibiotics," at the Phar-East 2018 conference in Singapore last week.

The phase II trial in 35 patients has already been extremely promising, with the best survival outcome to date for first-line treatment of advanced NPC reported when compared to historical clinical trials in similar settings. The two- and three-year overall survival rates in the study was at 62.9 percent and 37.1 percent, respectively, with no severe (grade 3 and above) adverse effects observed during the immunotherapy phase.

The treatment protocol for both the phase II and phase III NPC trials consisted of four cycles of gemcitabine and carboplatin followed by up to six infusions of Epstein-Barr VST cells. The first T-cell infusion under Tessa's trial in the U.S. was carried out at City of Hope National Medical Center. And by all accounts, it seems to be going well.

"We recognize the potential of Tessa's VST technology to treat solid tumors and are working closely with the Tessa team to bring these innovative therapies to patients who currently have few treatment options. The first infusion was well-tolerated, and we look forward to continuing this important work," said Erminia Massarelli, the site's principal investigator.

Toh said he expects TT-10 to reach the market sometime in 2020.

A patient-centric approach

There are about 30 trial sites in five countries involved in the phase III study. A recent partner that joined the company's trial network is the Stanford Cancer Institute, making it the seventh site in the U.S. Some of the other U.S. site partners include the City of Hope National Medical Center, UCSF Medical Center, Baylor College of Medicine, Baylor Scott & White Health, as well as other centers in Massachusetts and California.

"Nasopharyngeal cancer is a very common cancer in Asia but less so in the U.S.," said Toh.

But even with diseases that are rare, Jessie Lee, associate director of patient recruitment programs in Asia Pacific for health care consultancy firm Iqvia, recommends "a patient-centric approach" for clinical trial recruitment.

"Patient-centricity is putting patients first in an open and sustained engagement," Lee told BioWorld.

Lee recommended that companies start with profiling patients through the use of artificial intelligence. She draws on data garnered from social media platforms and forum networks.

"Even with rare diseases, it doesn't hurt to have patient profiling done. This would be helpful in the next phase: targeted advertising. With an enhanced patient profile, it can lead to more efficient spending of the media budget by limiting the guessing," Lee said.

And that translates into improved engagement, retention and adherence to the study once the trial is in progress. It can also provide patient insights that support future recruitment material.

Toh told BioWorld more than 200 out of 330 candidates have been recruited in the NPC study so far.

As one of Singapore's leading biotech success stories, Tessa has come a long way since it was founded after a coffee meeting between Toh and John Connolly, Tessa's chief scientific officer, in 2012. "When Tessa started six years ago with just five people, we were met with a lot of skepticism and criticism. Then a year later, a Science cover story on cancer immunotherapy changed the perception in the industry," said Toh.

He said he believes forming strong partnership is the way to go forward for any biotech company aspiring to be a "unicorn." Toh cited Tessa's partnership with the San Francisco-based Parker Institute for Cancer Immunotherapy on clinical and preclinical projects to develop new cellular therapy and immuno-oncology combination treatments as an example.

Singapore has emerged as a hub for biotech innovation. The Scientific American Worldview placed Singapore as second on its 2016 list of countries with strong biotech potential, just behind the U.S. Many of the management team members of Tessa are also involved in other biotech startups in the country. (See BioWorld, Jan. 17, 2018.)