'Increased' competitiveness in autoimmune diseases

after successful out-licensing deals

AprilBio and HK inno. N have signed out-licensing deals with pharmaceutical companies in the U.S.

The new drugs that have been successfully out-licensed by Hanall, LG Chem, and Daewoong are making good progress

The Korean biopharmaceutical industry is successfully signing license agreements of drugs for autoimmune diseases.

 

HK inno.

 

N, IMBiologics, and Y-Biologics have signed license agreements for their jointly developed novel drug candidates.

 

AprilBio has also signed a license agreement for a novel drug candidate that has shown efficacy in a phase 1 trial.

 

This is not the first time Korean companies have successfully entered into license agreements for novel drugs for autoimmune diseases.

 

LG Chem, Voronoi, Hanall Biopharma, and Daewoong have also completed technology transfers overseas.

 

Even after out-licensing, these treatments have demonstrated efficacy, confirming South Korea’s R&D capacity.

 

Autoimmune diseases occur when the body’s immune system attacks healthy cells after mistakenly recognizing them as antigens rather than exterior antigens, such as germs and viruses.

 

Since the cause of these diseases is still unknown, targeted treatments are not available.

 

As a result, there is an unmet need for more new treatment options.

 

According to industry sources on June 25th, HK inno.

 

N signed a license agreement with Navigator Medicines, a U.S.

 

new drug development company, for 'IMB-101,' a novel drug candidate for the treatment of autoimmune diseases.

 

The contract totaled US$940 million (approximately KRW 1.3 trillion), including an up-front payment of US$20 million (KRW 27.6 billion).

 

Navigator Medicines secured global development and sales rights through this agreement, excluding Asia.

 

IMB-101 was jointly developed by HK inno.

 

N and Y-Biologics in 2016, and it was transferred to IM Biologics in 2020.

 

The current agreement was led by IM Biologics, a bioventure company established by people who worked at HK inno.N.

 

IMB-101 is a novel bispecific antibody candidate that is designed to target both OX40L and TNF, simultaneously modulating adaptive and innate immune responses.

 

OX40L pathway is involved in activating T cells, and TNF is a cell signaling protein involved in immune responses.

 

Until now, no novel drugs have targeted both OX40L and TNF.

 

IBM-101 and Sanofi’s SAR442970, in a phase 2 trial, are the only two novel drug candidates that have entered clinical trials.

 

IM Biologics received approval from the U.S.

 

Food and Drug Administration (FDA) to conduct Phase 1 trials for 'IMB-101' in August of last year.

 

The company is currently conducting a Phase 1 trial.

 

Phase 1 trial will evaluate the safety and drug tolerance of the drug in healthy adults and in patients with autoimmune diseases.

 

AprilBio has also successfully signed a license agreement with Evommune, a novel drug development company in the United States, for 'APB-R3,' a novel drug candidate for the treatment of autoimmune diseases.

 

The deal was valued at a total amount of up to US$475 million (approximately KRW 655 billion), including a non-refundable up-front payment of US$15 million (KRW 20.7 billion).

 

The sales royalty will be paid separately.

 

APB-R3 is a biologics candidate targeting interleukin (IL)-18.

 

So far, there are no commercialized products with similar mechanisms of action.

 

Once APB-R3 is commercialized, it will become the first-in-class.

 

AprilBio has confirmed the drug tolerance and safety of APB-R3 in a phase 1 trial.

 

Evommune plans to conduct a phase 2 trial of APB-R3 in the first half of next year.

 

This marks the second time AprilBio has signed a license agreement for novel drug candidates for treating autoimmune diseases.

 

In 2021, it out-licensed APB-A1 to Danish pharmaceutical company Lundbeck for US$448 million (approximately KRW 540 billion).

 

APB-A1 is a novel drug candidate that inhibits CD40L..

 

CD40L is commonly expressed in activated T-cells due to inflammations.

 

When T Cells’ CD40L binds to CD40 of natural killer cells, large quantities of cytokines are released.

 

APB-A1 works by targeting CD40, inhibiting the formation of cytokine-releasing antibodies through B cells and natural killer cells.

 

Now, UCB’s dapirolizumab and the U.S.

 

biotech company Horizon Therapeutics’ Dazodalibep are under development with mechanisms of action similar to APB-A1.

 

Increased out-licensing of novel drugs for autoimmune diseases…clinical trials are making good progress Clinical trials conducted by companies that have developed novel drug candidates for autoimmune diseases are going well.

 

Hanall Biopharma is developing a subcutaneous formulation of a drug candidate for FcRn antibody therapy batoclimab (HL161).

 

In 2017, Hanall Biopharma out-licensed HL161, a drug candidate for the treatment of autoimmune diseases, to Roivant Sciences, a Swiss company that also owns Immunovant.

 

The company is investigating the potential of batoclimab for treating various autoimmune diseases, including myasthenia gravis (MG), thyroid eye disease (TED), immune thrombocytopenic purpura (ITP), neuromyelitis optica (NMO), and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

 

The efficacy of batoclimab has been confirmed in a phase 2 trial, and it is currently undergoing multinational phase 3 trials.

 

Hanall Biopharma plans to present its top-line results within this year.

 

LG Chem is developing an autoimmune disease pipeline, ‘LC510255.’ In 2021, the company successfully out-licensed the pipeline to China’s TransThera Biosciences.

 

The drug is undergoing a phase 2 trial involving patients with ulcerative colitis and atopic dermatitis.

 

The drug tolerance and satey of LC510255 have been confirmed in a phase 1 trial.

 

Daewoong Pharmaceutical is developing a novel drug called 'DWP213388' for the treatment of autoimmune diseases.

 

DWP213388 has a bispecific mechanism of inhibiting both BTK and ITK, which are involved in activating immune cells such as B cells and T Cells.

 

The phase 1 trial is being conducted in the United States.

 

Daewoong Pharmaceutical has proven its potential by signing a global license agreement with Vitalli Bio of the United States for DWP213388 at the Korea-U.S.

 

Digital and Bio-Health Business Forum, which was held in Boston, U.S., last year.

 

The agreement amounted to US$477 million, including an up-front payment of US$11 million, excluding a royalty payment.