iNtRON Confirms Efficacy of CDL200 Against CDI Clinical Isolates

Shows potent and rapid antibacterial activity against clinical isolates in Europe and Korea both

CDL200,a novel endolysin pipeline for the treatment of Clostridioides difficile Infection (CDI)

The world's first endolysin in capsule formulation to be administered orally

BOSTON and SEOUL,South Korea,July 12,2022 --iNtRON Biotechnology ("iNtRON",www.intodeworld.com) announced today that CDL200,a novel biological drug candidate under the development of the world's first enteric colon-targeted capsule formulation for the treatment of intractable and recurrent CDI (Clostridioides difficile Infection),confirmed the strong efficacy against clinical isolates from CDI patients.

A company official explained that the antibacterial activity of CDL200 was evaluated for 20 clinical isolates from patients in Europe and Korea,and rapid lysis effect within few minutes (1-5 minutes) after treatment was confirmed from all of the tested strains. In particular,even though majority of the tested strains are resistant strains to the commonly used antibiotics such as Metronidazole,Vancomycin,and Rifaximin,CDL200 showed very potent and rapid bactericidal activity.

CDL200 is an endolysin-based novel biological drug candidate for the treatment of Clostridioides difficile infection,a hard-to-treat and recurrent bowel diseases. CDL200 has innovative drug properties that can eradicate bacteria much faster than the conventional antibiotics in the market,and also can be used for the infection caused by antibiotic-resistant bacteria and/or highly virulent bacteria.

CDI patient population has been increasing globally and resulting in high mortality rate due to resistance to the existing antibiotics and serious complications such as toxic megacolon,sepsis,and intestinal perforation. Although there is growing interest in refractory CDI that does not respond well to primary treatment,there are only few studies on effective treatment yet. The more serious problem is the frequency of recurrent CDI is increasing,since the risk of subsequent recurrence is over 45% in patients who have had at least one recurrence.

The conventional treatment based on Metronidazole and Vancomycin is not effective for CDI with severe intractability and repeating recurrence. And the recently attempted FMT (fecal microbiota transplantation),that is,the treatment of administering donor feces to the patient's intestinal tract,has advantages such as not suppressing the intestinal flora and not creating resistant strains,but the treatment brings objection to the general public and is limited in that there is a possibility that other pathogens from the donor may be transmitted.

The mortality rate of CDI was about 3-4% in the past,but due to intensification of antibiotic-resistant bacteria and the emergence of highly virulent strain (NAP1/027),the recent mortality rate has been rapidly increased to over 10%,which makes global awareness growing.

Dr. KANG,Sang Hyeon,CTO of iNtRON,said,"We have a number of new endolysin pipelines under the development utilizing our unique itLysin® technology for the serious infection that the development of effective therapeutic agents are urgently needed."

Mr. YOON,Kyung Won,CEO of iNtRONadded,"Based on the development experience of SAL200,we will strive to enhance the value of our rich itLysin® pipelines and will continue to secure global competitiveness in the endolysin field."

About CDL200

CDL200 is a novel endolysin-based anti-Clostridioides difficilecauses an infection of the large intestine (colon),which is often referred to as C. difficile or C. diff. CDL200 showed potent and rapid activity against 100% clinical isolates from multi-nation and has no disturbance of the normal flora in human's gut. The potential clinical usage and indications are CDI and IBD (Inflammatory Bowel Disease),and the targeted administration route of CDL200 is oral in capsule formulation. CDL200 is under non-clinical stage development and IND enabling studies will be conducted throughout the year.

About iNtRON Biotechnology,Inc.

iNtRON is a leader in bacteriophage-based technology with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since their foundation and accelerated development after entering its IPO in KOSDAQ,the company honed in on innovating BIO New Drugs by developing various 'First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area.

About iNtODEWORLD,Inc.

iNtRON has established its wholly owned US subsidiary,iNtODEWORLD,Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news,updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US.

Contact Us

YOON,Kyung Won (Kevin) / CEO,Vice President / kwyoon@intron.co.kr

SHIN,Tae Kyu (TK) / BD Team Leader / tkshin@intron.co.kr

BD Team / partner@intron.co.kr

www.intodeworld.com

iNtRON Biotechnology,Inc.

#708,148,Sagimakgol-ro,Jungwon-gu,Seongnam-si,

Gyeonggi-do,Republic of Korea

iNtODEWORLD,Inc.

1500 District Avenue,Suite 2097,Burlington,MA 01803,USA

it is iNtRON.

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