iNtRON Biotechnology, Inc.

▶ Robot Bacteriophage against microbiome associated with colorectal cancer ▶ Bacteriophage Improvement Platform technology with a broad antimicrobial activity ▶ Proprietary Technology incorporating CRISPR/Cas Technology BOSTON, Feb. 14, 2024 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", ) has announced today that New Drug Part has secured a potent anti-cancer candidate, PHAGERIA®, with broad antimicrobial activity against ETBF (Enterotoxigenic B. fragilis), a harmful microbe associated with colorectal cancer. iNtRON stated that following the proprietary development of the Robot Bacteriophage 2nd generation technology, additional in-vitro evolution technology was applied. The Company previously secured the technology to customize and edit bacteriophage genomes as desired using tailored CRISPR/Cas technology and Random Transposon Mutagenesis in 2022. Recently, the Company has advanced this technology further to develop a more potent anti-cancer candidate, PHAGERIA®. According to the Company, in-vitro Evolution technology was employed to induce the evolution of specific genes of ETBF bacteriophages under specialized experimental conditions, resulting in the selection of PHAGERIA® anti-cancer candidates with enhanced antimicrobial activity. This achievement is significant as it is the first instance of applying in-vitro Evolution technology to ETBF bacteriophages, demonstrating the excellence of the bacteriophage gene editing technology (CRISPR/Cas) and Robotic Bacteriophage improvement platform technology of the Company. Additionally, iNtRON identified the mutation patterns of tail fiber genes closely associated with antimicrobial activity, extracting and securing core sequences along with information about variable or invariant regions. The Company anticipates effectively utilizing this to further enhance the antimicrobial activity of future PHAGERIA® anti-cancer candidates. Dr. SON, Ji-soo, the head of the BD Department emphasized, "As ETBF is known to have a direct correlation with the occurrence and progression of colorectal cancer, it was the primary target of this screening for PHAGERIA® anti-cancer candidates." He added, "We plan to gradually expand the application of this technology to other bacteriophages to improve the broad antimicrobial properties against harmful gut microbiomes and further advance the Robotic Bacteriophage improvement platform technology." Mr. YOON, Kyung-won, CEO of iNtRON said that "The Robotic Bacteriophage Improvement Platform technology is the core technology that underpins not only PHAGERIA® but also PHAGERUS® for developing antiviral agents and PHAGERIARUS® for developing immune-modulating agents. He further stated, "We will focus more on related research and development and enhance technological capabilities to achieve success in the development of new drugs based on bacteriophage technology, solidifying our position as a global leader in the bacteriophage field." About PHAGERIA® Platform iNtRON's PHAGERIA® is a technical term for iNtRON, synthesized from bacterio phages and bacte ria. In simple terms, PHAGERIA® is a platform for researching the impact of bacteriophages on intestinal bacteria and their effect on human health. When bacteriophages consume intestinal bacteria, it can lead to changes in the intestinal flora. These changes may have an impact on human immunity and overall health. About iNtRON Biotechnology, Inc. iNtRON () is a BIO New Drug developing venture company and a leader in bacteriophage-based technology for human with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since the foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Class" and "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. it is iNtRON. SOURCE iNtRON Biotechnology, Inc.

Exclusive license to evaluate tonabacase in preclinical studiesExclusive option to license tonabacase at pre-agreed terms Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, October 31, 2023 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company, committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an exclusive evaluation license and option agreement for tonabacase, with iNtRON Biotechnology, Inc. (KOSDAQ: 048530), a company based in the Republic of Korea. Tonabacase is a potential first-in-class clinical-stage antibacterial of the endolysin class. Over the course of 2024, Basilea will investigate various hypotheses in a number of preclinical studies to determine the optimal future clinical development program for tonabacase. Upon successful completion of the preclinical evaluation phase, Basilea will have the exclusive option to license tonabacase for further clinical development and commercialization. The use of endolysins represents a novel and innovative approach in the treatment of bacterial infections. Endolysins are recombinant proteins derived from bacteriophages, i.e. viruses that infect bacteria. They cause a rapid destabilization of the bacterial cell wall, leading to the death of bacteria. In addition, endolysins have shown significant advantages over conventional antibiotic treatments including activity against biofilms, a frequent cause of persistent and recurring infections, synergy with other antibiotics and a low risk of resistance development.1 Tonabacase has shown activity in vitro and in preclinical animal models of infection against methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA and MSSA) as well as in-vitro activity against coagulase-negative staphylococci.2, 3 In phase 1 studies, tonabacase single and multiple dose administrations were shown to be well-tolerated.4, 5 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “There continues to be a high medical need for new treatment options for patients with persistent infections caused by Gram-positive bacteria and tonabacase is an exciting and innovative asset for us to evaluate over the coming months. If the outcome of our evaluation is positive and we enter into a full license agreement, we may be able to start directly a phase 2 clinical study in 2025.” Under the terms of the agreement, Basilea is making an undisclosed upfront payment to iNtRON and will make one additional payment if Basilea decides to exercise its exclusive option and execute the license agreement at pre-agreed financial terms. This transaction has no impact on Basilea’s financial guidance for 2023, provided on August 15, 2023. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have an R&D portfolio of anti-infective assets. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerlandPhone+41 61 606 1102E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References H. Liu, Z. Hu, M. Li et al. Therapeutic potential of bacteriophage endolysins for infections caused by Gram-positive bacteria. Journal of Biomedical Science 2023 (30), 29N.-H. Kim, W. B. Park, J. E. Cho et al. Effects of Phage Endolysin SAL200 Combined with antibiotics on Staphylococcus aureus infection. Antimicrobial Agents and Chemotherapy 2018 (62), e00731-18D. B. Huang. H. S. Sader, P. R. Rhomberg et al. Anti-staphylococcal lysin, LSVT-1701, activity: In vitro susceptibility of Staphylococcus aureus and coagulase-negative staphylococci (CoNS) clinical isolates from around the world collected from 2002 to 2019. Diagnostic Microbiology and Infectious Disease 2021 (101), 115471Single ascending dose phase 1 study: ClinicalTrials.gov identifier NCT01855048S. Y. Jun, I. J. Jang, S. Yoon et al. Pharmacokinetics and Tolerance of the Phage Endolysin-Based Candidate Drug SAL200 after a Single Intravenous Administration among Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2017 (61), e02629-16Single and multiple ascending dose phase 1 study: Clinicaltrials.gov identifier NCT03446053M. B. Wire, S. Y. Jun, I.-J. Jang et al. A Phase 1 Study To Evaluate Safety and Pharmacokinetics following Administration of Single and Multiple Doses of the Antistaphylococcal Lysin LSVT-1701 in Healthy Adult Subjects. Antimicrobial Agents and Chemotherapy 2022 (66), e01842-21 Attachment Press release (PDF)

iNtRON Grants Basilea exclusive right for preclinical evaluation with an undisclosed payment Basilea has the option to enter into exclusive License Agreement following the evaluation BOSTON and SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", ) has announced today that they have signed an "EVALUATION LICENSE AND OPTION AGREEMENT" with Basilea Pharmaceutica Ltd, Allschwil ("Basilea"), granting Basilea the option to enter into an exclusive license agreement for the antibacterial bio-drug SAL200 (Tonabacase). Basilea, headquartered in Switzerland, is a commercial-stage biopharmaceutical company specializing in the development of anti-infective drugs. Basilea has successfully developed and commercialized "Cresemba®," a treatment for invasive fungal infections, and "Zevtera®," a treatment for bacterial infections. They possess significant expertise in late-stage clinical development and commercialization. Basilea has assessed the clinical success potential by reviewing certain preclinical and clinical data and entered into this agreement with iNtRON to conduct evaluation studies to determine the optimal future clinical development program for SAL200. iNtRON will receive an initial upfront payment upon the execution of this agreement and will receive an additional payment upon Basilea exercising the option to negotiate an exclusive license agreement after the completion of the evaluation test, which can last up to one year. Certain essential terms of the exclusive license agreement have been pre-agreed upon along with the current agreement. The total contract amounts shall be undisclosed under the confidential obligations between the two companies. iNtRON has been actively discussing the exclusive license agreement with Basilea, who showed keen interest in SAL200. It was determined that Basilea is a suitable partner for the further development and commercialization of SAL200 in the field of infectious disease, and iNtRON has signed the agreement to ensure the development progress of SAL200. YOON, Kyung Won, the CEO of iNtRON, stated, "Basilea is a suitable partner, since they have a strong track record of successfully developing and commercializing anti-infective drugs, and in particular, they are a stable company with ample clinical development experience, including a recent NDA submission to the US FDA." He added "We are confident that the planned evaluation tests will significantly increase the probability of successful completion of a Phase 2 study. With a partner who already possesses commercialization capabilities, we believe in the success of SAL200." About SAL200 (Tonabacase) SAL200 is a novel endolysin-based anti-staphylococcal drug formulated for injection. Its active pharmaceutical ingredient is the recombinant phage endolysin SAL-1, derived from the staphylococcus-specific bacteriophage SAP-1. SAL200 is proven to be effective in treating staphylococci-associated infections including MSSA, MRSA, and other so-called superbugs through the previous in vitro, in vivo and clinical studies. The phase 1a, 1b MAD and 2a study for SAL200 was completed in Korea and the further development is expected to be conducted in global. The IND application for the US Phase 2 study has been approved by FDA. About iNtRON Biotechnology, Inc. iNtRON () is a bio-new drug developing venture company and a leader in bacteriophage-based technology for human with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since the foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Class" and "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. Contact Us YOON, Kyung Won (Kevin) / CEO, Vice President / [email protected] SHIN, Tae Kyu (TK) / BD Team Leader / [email protected] BD Team / [email protected] it is iNtRON. SOURCE iNtRON Biotechnology, Inc.