ImmuneOncia seeks opportunity in the PD-1 market

‘Opportunities abound in PD-1 immuno-oncology drugs’

Heung-Tae Kim, CEO of ImmuneOncia

Aims to commercialize Korea's first immuno-oncology drug by 2029, and expand indications from rare cancers to solid cancers

“Big Pharma halt CD47 development, opens opportunity for ImmuneOncia... expects IMC-002 to become a game changer”

“PD-(L)1 antibodies are the backbone of immuno-oncology drugs.

 

In the future, immuno-oncology developers will be divided into companies with PD-(L)1 drugs and those without.

 

ImmuneOncia will commercialize its own PD-(L)1 drug and continue to grow based on this.” Heung-Tae Kim, CEO of ImmuneOncia, said so about the company's growth strategy and vision when Dailpharm met with him at the company's headquarters in Magok-dong, Gangseo-gu, Seoul.

 

The company aspires to take the lead in the immuno-oncology market by launching actual products, not just licensing out new drug candidates.

 

Heung-Tae Kim, CEO of ImmuneOncia

ImmuneOncia was established in 2016 as a joint venture company between Yuhan Corp and US-based Sorrento Therapeutics.

 

In late 2023, Yuhan acquired all of Sorrento's shares and currently holds a 67% stake in the company.

 

Yuhan acquired the entire stake in Sorrento after Sorrento lost a 200 billion-dollar lawsuit and filed for bankruptcy.

 

ImmuneOncia seeking to IPO with its technology and proprietary pipeline.

 

Kim is a medical oncologist and an authority in the field of oncology with experience in academia, healthcare, and government.

 

After graduating from Seoul National University School of Medicine and earning his M.D.

 

from the same graduate school, Kim served as a professor at Dankook University School of Medicine and trained at the National Cancer Institute (NCI).

 

He has then served at the National Cancer Center for more than 17 years, holding key positions such as Director of the Clinical Trials Center, Director of the Lung Cancer Center, Director of the Office of Planning and Coordination, and Deputy Director.

 

For 4 years, he served as the head of the planning team that oversaw the National Cancer Control Planning Board, the only national R&D project on cancer in Korea, and is credited with dramatically improving the level of cancer research in Korea.

 

Kim joined ImmuneOncia in 2021.

 

With more than 30 years of clinical experience, Kim emphasizes the commercialization of new drugs.

 

He believes that true drug development entails bringing a drug to market and making it safe and effective for patients.

 

Kim explained that it is important to contribute to patient treatment by launching new drugs directly rather than realizing early profits or spreading risks through technology exports.

 

This is why Kim advocated for the launch of Leclaza (lasertinib), a drug for non-small cell lung cancer that he had led a clinical trial in, in the Korean market after initiating a monotherapy Phase III trial.

 

“In 2018, Janssen, a Johnson & Johnson subsidiary, introduced lasertinib from Yuhan Corp.

 

If Janssen failed the lasertinib-amivantamab combination trial, lasertinib would have disappeared from the market,” explained Kim.

 

”I convinced the company that if lasertinib was to survive, Yuhan should conduct a monotherapy trial in Korea and sell it on its own.” “By launching Leclaza in Korea, Yuhan Corp has secured a stable revenue base while also gaining brand value as a global drug developer.

 

When I first came to ImmuneOncia, most people were against the idea of bringing a drug to market, but now everyone agrees that it is necessary to commercialize new drugs,’ he added.

 

ImmuneOncia's goal is to bring immuno-oncology drugs to market.

 

Cancer cells evade immune cell attacks by using a trick called immune checkpoints to block immune cell attack signals and disguise themselves as normal cells.

 

Immuno-oncology drugs block this evasion, allowing immune cells to work properly and effectively attack the cancer cells.

 

ImmuneOncia currently has a pipeline of immuno-oncology drugs, including IMC-001, which targets PD-L1, IMC-002, which targets CD47, and IMC-201, which targets CD47 and PD-L1.

 

Of these, IMC-001 is the most advanced in development.

 

IMC-001 demonstrated excellent efficacy and safety in a Phase II monotherapy trial, with an objective response rate (ORR) of 79% and a complete response rate (CR) of 58%.

 

However, some have questioned the possibility of success of new immuno-oncology drugs.

 

With multiple PD-(L)1 therapies on the market, the question is whether the immuno-oncology market is already saturated.

 

Currently, there are 10 drugs in the PD-(L)1 class approved by the U.S.

 

Food and Drug Administration (FDA), eight of which are approved domestically.

 

In particular, Merck's (MSD) Keytruda has expanded its indications to more than 30, including lung cancer, melanoma, renal cell carcinoma, and bladder cancer, making it a dominant player in the immuno-oncology market.

 

Kim's answer is clear: the immuno-oncology market will continue to expand, and there are still opportunities for strategic approaches.

 

“The PD-(L)1 market will continue to grow through combination therapies.

 

There are only 20 PD-(L)1 drugs licensed in China, and the fact that China continues to develop new PD-(L)1 drugs shows the growth of the market.” ImmuneOncia's plan for tapping into the PD-(L)1 market as a late entrant is to go niche.

 

Instead of focusing on common cancers, where competition is fierce, ImmuneOncia's strategy is to first gain approval in rare cancers where no one else is developing, i.e., where there are fewer treatment options, and then expand indications to solid tumors, based on biomarkers.

 

“It's hard to get initial approval, but once you do, it's fairly easy to add indications,” said Kim, ”Some have asked whether we could go niche and achieve meaningful results, but I believe I can create our market.” ImmuneOncia expects to commercialize IMC-001 in 2029.

 

The company is implementing a comprehensive strategy for commercialization and early market entry.

 

The license agreement stipulates that the parent company, Yuhan, will be the exclusive distributor in Korea.

 

This means that Yuhan will be in charge of drug price and reimbursement listing, sales, inventory management, etc.

 

after approval.

 

After the approval of IMC-001, the company plans to accelerate the development of next-generation antibodies.

 

The company plans to strengthen its position in the immuno-oncology market by expanding its development area to include a pipeline of bispecific immuno-oncology drugs.

 

Kim explained, “ImmuneOncia is also implementing a 'franchise antibody' strategy to continuously discover and develop next-generation antibodies based on its own PD-(L)1 drug.” IMC-002 is also a key part of ImmuneOncia's pipeline.

 

In 2021, ImmuneOncia transferred the development and commercialization rights for IMC-002 to 3D Medicines in China for a total worth of USD 470.5 million, including an upfront payment of USD 8 million.

 

The drug is in Phase Ib clinical trials based on its mechanism that blocks CD47 and macrophage signaling in cancer cells.

 

A few years ago, CD47-targeted immuno-oncology drug was considered the next big target after PD-(L)1.

 

CD47 is overexpressed in most cancers, whereas PD-(L)1 is only effective in a subset of cancers, so targeting CD47 was likely to overcome the limitations of existing therapies.

 

The ability to block the earliest stages of immune privilege was also highlighted as a differentiating feature of CD47-targeted immuno-oncology drugs.

 

However, the mood has changed somewhat.

 

Global big pharma companies such as AbbVie, Gilead Sciences, and Pfizer have stopped developing CD47-targeted immuno-oncology drugs.

 

There had been skepticism on whether CD47 class drugs can become the next generation of immuno-oncology drugs without overcoming their side effects or efficacy issues.

 

Kim believes that the big pharma's discontinuation can be an opportunity for ImmuneOncia.

 

To solve the problem of side effects of CD47-targeted immuno-oncology drugs, ImmuneOncia has been focusing on discovering antibodies that can selectively bind to cancer cells and normal cells.

 

And the company’s result is IMC-002.

 

IMC-002 binds strongly to cancer cells while barely binding to red blood cells.

 

ImmuneOncia will present efficacy and safety data from the Phase Ib trial of IMC-002 at the American Society of Clinical Oncology (ASCO) Congress in June.

 

“I think this is an opportunity to boom up the CD47 market, which has been somewhat stagnant.

 

I believe IMC-002 could be a game-changer that can address the efficacy and safety issues that were an issue with CD47 drugs.

 

'Changing the standard of cancer treatment By bringing Korea's 1st immuno-oncology drug.' This is the slogan that Kim created upon joining ImmuneOncia.

 

It means that he aims to change the standard of cancer treatment by creating Korea's 1st immuno-oncology drug.

 

He engraved this phrase on the company's business card.

 

It is not just a slogan, but an expression of his determination to make it a reality.

 

Kim is committed to leveraging the IPO to accelerate clinical trials of ImmuneOncia’s key pipeline drugs and commercialize the first domestic immuno-oncology drug.

 

Kim said, “If ImmuneOncia succeeds in developing the first domestic immuno-oncology drug, we expect to have a strong brand value as the company that launched the second Leclaza.

 

Based on our technological excellence and differentiated R&D capabilities, we will lead innovation in the immuno-oncology field and provide high value to prospective investors.”