ImmuneOncia targets niche market in cancer immunotherapy

[ESMO Asia 2022] ImmuneOncia makes oral presentation on the interim results of its Phase II IMC-001 trial

Patients with rare lymphoma that has a survival of only 6 months upon recurrence received treatment for over 1 year with IMC-001

6 out of 10 patients showed a response, and all those showed response had complete response...” will work for its rapid commercialization”

More common in Asia than in the West...a niche market where existing immuno-oncology drugs have not yet entered

“NK/T-cell lymphoma is a niche market that has no approved immunotherapy.

 

After completing the trial in Q2 next year, we plan to promptly receive approval and extend our indication if we see good results.“

Heung Tae Kim, CEO of ImmuneOncia Therapeutics Inc

On the 3rd (local time), Heung Tae Kim, CEO of ImmuneOncia Therapeutics, expressed his aspirations at the ‘ESMO Asia Congress 2022’ that was held in Singapore.

 

ImmuneOncia is a new cancer immunotherapy drug-developing company that was established as a joint venture company between Yuhan Corp and the US bio-company Sorrento.

 

The company owns various pipelines including the PD-L1 antibody IMC-001 and the CD47 antibody IMC-002, etc.

 

The results that were presented were interim analysis results of a domestic Phase II trial that enrolled 13 patients with relapsed or refractory NK/T cell lymphoma who failed to see an effect with ‘L- asparaginase,’ the standard therapy.

 

Professor Won-Seog Kim of the Hemato-Oncology Department at Samsung Medical Center presented the findings at the Mini Oral session on Haematological malignancies.

 

Interim analysis efficacy results of Phase II IMC-001 trial (Source: ESMO Asia)

Interim analysis results showed that of the 10 evaluable patients, 6 showed a response (ORR=60%), and all patients that showed a response had a complete response (CR=100%).

 

4 of the patients have continued treatment for at least 1 year.

 

Based on the results, the evaluation was that the drug produced excellent results in terms of drug safety and continued response.

 

The drug also was acceptable in terms of safety.

 

No cytokine release syndrome hematologic toxicity that commonly arises with the use of immuno-oncology drugs was observed.

 

Only 1 patient was observed with Grade 3 uveitis.

 

During the clinical trial, 3 patients adjusted the medication period due to side effects, and 1 patient was delayed due to COVID-19 infection.

 

The major adverse reactions were fatigue, headache, skin rash, and itching, most of which were mild and manageable.

 

Interim analysis safety results of Phase II IMC-001 trial (Source: ESMO Asia)

Professor Kim said, “Due to the small number of patients that were analyzed, we cannot conclude that IMC-001 is a far superior treatment, but I think it is at least similar or slightly superior (compared to existing immuno-oncology drugs).

 

Although the survival period of recurrent patients is only 4-6 months, 4 out of 6 patients that responded to IMC-001 have survived long-term, receiving treatment for over a year.

 

IMC-001 is a PD-L1 immunotherapy.

 

Other drugs with the same mechanism of action include the global blockbuster ‘Keytruda (pembrolizumab)’ which sold over KRW 2.1 trillion and ‘Opdivo (nivolumab)’ which sold KRW 1 trillion globally.

 

However, the two drugs do not indicate NK/T-cell lymphoma, the disease IMC-001 is being studied for.

 

Professor Won-Seog Kim, Samsung Medical Center

NK/T-cell lymphoma is a rare EBV-associated lymphoma.

 

90% of Asians are infected with the virus.

 

Although an ordinary person would have no problem when infected, when immunocompromised, the dormant virus is activated and causes cancer.

 

The current treatment option mainly consists of radiation and chemotherapy, but the 2-year recurrence rate is 75%.

 

The company plans to start the approval process immediately after completing the clinical trial by Q2 next year and receiving the final data.

 

ImmuneOncia will also actively promote the technical export of IMC-001 for its global entry.

 

CEO Kim said, “We plan to first preoccupy the niche market through rapid domestic commercialization, then gradually expand its scope of indications.

 

Also, we plan to promote technology exports to Asian regions including China, where many patients remain.

 

We plan to reapply for the technical evaluation around Q3 next year."