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ImmuneOncia: A PD-L1 Latecomer Hoping To Break Into The Market

Executive Summary

Emerging Company Profile: ImmuneOncia may be late entering the market for PD-L1 inhibitors, but the joint venture between Yuhan and Sorrento Therapeutics aims to develop best-in-class immuno-oncology drugs with differentiated products and strategy.

ImmuneOncia Therapeutics Inc. is a one-year-old immuno-oncology start-up that made a splash when it was established in South Korea by leading Korean pharma Yuhan Corp. and US-based biopharma Sorrento Therapeutics Inc.

It is the first R&D-based joint venture created by Yuhan – a milestone for the pharma, which strives to focus more on development of innovative novel drugs. The joint venture, which launched in 2016, is focused on immune checkpoint antibodies, seen as a rare move by a South Korean pharma.

“Yuhan has high expectations on ImmuneOncia. Although Yuhan is a top South Korean pharma, its R&D capabilities have not been top quality relatively,” said Kwang Ho Cheong, CEO of ImmuneOncia, in a recent interview with Scrip.

Yuhan controls 51% of the venture, while Sorrento holds the remaining 49%. Sorrento will provide required technology and therapeutics for the pipeline, while Yuhan will fund clinical trials.

Growing Importance Of PD-1/PD-L1

Cheong confessed it may be little bit late for the company to enter the PD-L1 market as there are already marketed products, but stressed it will keep on developing the pipeline due to the growing importance of PD-1 and PD-L1 inhibitors.

“In the end, PD-1 and PD-L1 will become backbone therapies. And we need the backbone to evolve,” the CEO said. “In South Korea, no pharmas are known to be developing PD-1 and PD-L1. We are the first one. The [Ministry of Food and Drug Safety (MFDS)] is supportive to enter clinical development quickly.”

ImmuneOncia Therapeutics Inc.

Location: Yongin, Gyeonggi Province, South Korea

R&D Focus: Immune checkpoint antibodies

Disease Area: cancer

Founding Year: 2016

Founders: Yuhan Corp., Sorrento Therapeutics

Employees: 8

ImmuneOncia, operating from Yuhan’s research institute in South Korea, has three early-stage monoclonal antibody programs; IMC-001 (anti-PD-L1), IMC-002 (anti-CD47) and IMC-003 (unspecified). It also has some early-stage bispecific antibody programs.

Among them, the most advanced program is IMC-001, a fully human anti-PD-L1 monoclonal antibody, which shows robust efficacy both in vitro and in vivo. It is in investigational new drug (IND) application-enabling studies and is expected to enter clinical development soon. The company aims to file an IND with the MFDS this year.

“Scientifically, I think it’s been proven already, since our immuno-oncologic pipelines are using an antibody platform on a validated cancer target. As a biopharma drug, I think it is after a clinical Phase II study officially to reach proof of concept, but we expect to see the preliminary results after a Phase I,” Cheong said.

Datamonitor Healthcare’s lead oncology analyst Hardik Patel said in a report titled “Big Pharma Outlook 2026” published in June that while the development of targeted therapies for specific mutations continues, companies have turned their attention to targeting pathways that dictate immune response in an effort to allow each patients’ own immune system to fight the disease.

The first major wave of these immunotherapies to arrive to market – the PD-1/PD-L1 inhibitors – already has revolutionized treatment of non-small cell lung cancer, melanoma and bladder cancer, and will undoubtedly impact the treatment paradigm of many other cancers. Like prior targeted therapies, PD-1/PD-L1 inhibitors are marketed at a high price point due to their potential to elicit deep and durable responses, so their continued development as a class will contribute to overall growth of the oncology market, the analyst wrote.

“We all know from a few examples with PD-1/PD-L1 marketed products and amazing clinical efficacies in various indications that we are going to have the next big wave in immuno-oncology. We hope to enjoy the ride on the new wave and reach out to the next level together with our collaborators to bring safe, effective and novel immunotherapies to cancer patients worldwide,” Cheong said.

Capitalizing On Samsung Experience, Different Strategy

Cheong who has more than a decade of experience with Samsung Group affiliates, including Samsung Bioepis, said ImmuneOncia’s strategy is in line with Samsung’s tactic to focus on investing in the backbone technology rather than following the latest targets.

He cited an example of Samsung Electronics which made a huge investment in building a 64K dynamic random access memory factory at the time when 128K DRAMs were beginning to be introduced. “Everyone said Samsung was crazy and said what good would it be to invest in 64K DRAM, but things turned to be a right decision after a long period,” he said.

“When we do marathons, the one that led the race in the beginning usually doesn’t end up winning the race. Those who maintain the second or third place end up winning. This strategy worked for Samsung,” Cheong continued. “Being a latecomer also has its merits as we can learn from the failures made by those ahead of us and avoid repeating the mistakes.”

Another differentiation point is that ImmuneOncia has engineered greater stability of its molecule. This could be a good selling point for countries with weak logistics systems and weak refrigeration facilities, such as those with many islands, the CEO said.

The company also has a different development and commercialization strategy for each pipeline program.

For IMC-001, it wants to become a fast-follower to make it a backbone treatment in immuno-oncology so that ImmuneOncia can begin testing further applications, including combination regimens. The company also has a best-in-class strategy to increase response rates among non-responding patients.

For IMC-002, ImmuneOncia aims to collaborate with global pharma companies. The drug candidate is a fully human IgG monoclonal antibody that binds human CD47 with an optimal affinity that maximizes efficacy (tumor phagocytosis) without causing hemagglutination.

IMC-002 blocks CD47-SIRPα interaction to promote phagocytosis of cancer cells by macrophages. Combinational blockade of PD-L1 and CD47 has been shown to enhance anti-tumor effects in vivo. This presents an interesting opportunity to combine checkpoint inhibitors, such as IMC-001, in combination with IMC-002 in the clinic.

CD47 is a transmembrane protein broadly expressed on a cell’s surface and often overexpressed on cancer cells. CD47 on cancer cells interacts with the myeloid inhibitory immunoreceptor SIRPα on macrophages to deliver a “don’t-eat me” signal that inhibits phagocytic (cancer cell killing) activity. Blocking CD47-SIRPα interaction restores phagocytic activity of macrophages, which was shown to inhibit tumor growth in a mouse xenograft model.

Considering Various Combo Therapies, Partnerships

ImmuneOncia is considering various combination therapies involving its pipeline programs and has begun to seek collaborations to increase response rate of its antibodies.

“We could partner with domestic pharmas and seek combination therapies with oncolytic virus or cell therapies. For solid tumors, in particular, combination therapies will be more effective,” Cheong said. “Some Japanese firms are also inquiring us for collaborations in their effort to find ways to provide cheaper immuno-oncology drugs.”

Yuhan is slated to provide funds for Phase I clinical trials, but after that ImmuneOncia plans to seek partners to proceed with further development. The company needs partnering and investment companies to work together and it plans to go public at some time point, the CEO added.

Yuhan is the largest South Korean pharma in terms of revenue. It is also known for reaching successful joint ventures with foreign companies such as Yuhan-Kimberly Ltd. which manufactures and sells sanitary products in South Korea.

San Diego-based Sorrento has a fully human antibody library and the company claims it is one of the largest and most diverse naïve human phage libraries made from more than 600 healthy donors. In addition to the G-MAB Ab library, it has its own innovative technologies to make biobetters and cellular therapies, internalizing Ab technology and for Ab-drug conjugates.

[Editors note: For more information, see Datamonitor Healthcare's in-depth report on Big Pharma Outlook 2026.]

From the editors of PharmAsia News.

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