SAN FRANCISCO, Calif. -- By Lee Han-soo/Korea Biomedical Review correspondent -- GC Cell, a notable player in the biotechnology field, is increasingly making its mark in the area of cell and gene therapy (CGT).

Under the guidance of CEO James Park, who was appointed in March 2023, the company is actively engaged in advancing research and development within the CGT landscape.

With a strategy encompassing both innovation and expansion, GC Cell is contributing to the broader dialogue and progress in healthcare technology, developing new treatment options, and expanding its reach in the global market, highlighting the company's role in the evolving healthcare sector.

Korea Biomedical Review met with Park during the J.P. Morgan Healthcare Conference (JPMHC) 2024, held in San Francisco from last Monday to Thursday, to talk about the company's goals at the event and its strategies moving forward.

Park started the interview by sharing insightful details about the company's strategic direction and progress since his appointment last March.

"My initial focus was on understanding the various facets of the company, especially the R&D unit, which he considers crucial for GC Cell's future," he said. "The future of the company is driven by the R&D pipeline."

Park emphasized the need to shift the R&D focus from academic pursuits to commercial value, particularly in developing new platforms for CGT.

Under Park's leadership, GC Cell has also been revamping its traditional bio services business, running successfully for over 40 years.

Park highlighted the Immuncell-LC program, a unique adjuvant therapy for hepatocellular carcinoma (HCC), as a "hidden gem" of the company.

The Immuncell-LC T-cell therapy for liver cancer has proven effective in HCC and was approved in 2007 by the Ministry of Food and Drug Safety as an adjuvant therapy for patients with confirmed tumor removal after hepatic cancer surgery.

According to the company, in a large-scale Phase 3 clinical trial of Immuncell-LC for early-stage HCC patients, the treatment reduced the risk of recurrence by 37 percent and the mortality rate by 79 percent compared to the control group, leading to its approval as a post-operative treatment for HCC.

The sales of Immuncell-LC in 2022 amounted to approximately 30.7 billion won ($23.2 million).

"We have great pride in the drug's success as we have up to 10,000 Korean patients' real-world data," he said. "The goal is to extend this successful product beyond Korea, with plans to license it in China and the Middle East."

However, before Park's arrival, such achievements were rarely known in the healthcare field.

To this end, Park stressed that the company's presence at the JPMHC was a significant step in increasing its global brand awareness.

"We met 40 to 60 companies, and they were all highly interested in our data," he said. "This interest reflects the company's potential to impact the global stage substantially.

Discussing GC Cell's strengths in the CGT CDMO sector, Park pointed out the company's decade-long experience in manufacturing cell therapy products, such as Immuncell-LC.

"We're not competing with global leaders like Lonza or Catalent," he said. "We're competing with relatively small and mid-sized CDMOs, but we're confident that our focus on quality and specialized services will set us apart in the industry."

GC Cell's international ambitions are further evidenced by its acquisition of BioCentric in the U.S. last year.

BioCentriq was acquired by GC Cell and Green Cross Holdings in 2022. The company, based in New Jersey, specializes in the contract manufacturing of autologous and allogeneic cell therapies, gene therapies, and viral vectors.

Park, with his extensive experience at Samsung Biologics, is optimistic about expanding their client base. "We feel there's certainly an opportunity for more business," he noted, highlighting the potential to focus on U.S. and Asia Pacific companies.

New pipelines to further add to GC Cell's value

Park also shared the company's future pipelines.

A major highlight was the approval of AB-201, GC Cell's allogeneic chimeric antigen receptor-natural killer (CAR-NK) cell therapy targeting solid tumors, for phase 1 clinical trials in Korea and Australia.

"It's the first CAR-NK to receive IND in Korea," Park said, underscoring the significance of this milestone. "This trial is also significant as although technically and scientifically we know that CAR-NK is safer than the CAR-T, we want to collect data as right now there's no clinical data at all."

The company anticipates the first patient to be enrolled in the trial between March and April timeframe, and it is going to try to quickly collect the data to prove that CAR-NK is safer and has a higher efficacy in breast cancer and gastric cancer compared to traditional treatments within the next year.

Park also brought attention to GC Cell's collaboration with Lunit, focusing on the use of AI in healthcare. This partnership aims to enhance drug discovery, specifically identifying biomarkers in the HER-2 space.

"We're trying to collect data to identify some biomarkers in the HER-2 space," Park said. "This collaboration with Lunit signifies GC Cell's commitment to integrating advanced technologies in its research and development processes."

When asked about the high cost of CGT therapies, Park acknowledged the challenge but pointed out GC Cell's efforts to keep treatments affordable.

"We're far away in terms of talking about cost issues as we only have one product in Korea," he said. "However, we have not changed the price for Immuncell-LC for the last 10 years in Korea, around $50,000 per patient, which is considerably cheaper than other CGT treatments available in the market."

The company will do what it needs to do to provide essential medicines for the patients, he added.

Looking forward, Park shared that GC Cell plans to continue investment and acquisitions, particularly in areas complementing their existing products.

"We definitely will be looking into additional investment and acquisition," he said. "However, we will also be looking into licensing in potential and commercial products."

As the company has been selling Immuncell-LC in Korea for the past decade, it would like to have a complementary product that we could sell alongside the drug, he added.

Park stressed from an R&D perspective, the company will be looking towards what platform they will need to develop future pipelines.

Concluding the interview, Park shared his long-term vision for GC Cell stressing that "We want to be recognized as a global company and a CGT company pioneer that has multiple products in the market and various partnerships with global pharma companies."