iNtRON Biotechnology, Inc.

Plus, news about Basilea, TME Pharma and Perceive Biotherapeutics: Septerna stops work on Phase 1: The newly public biotech ended a healthy volunteer trial for SEP-786, its hypoparathyroidism candidate, after “unanticipated events of elevated unconjugated bilirubin levels.” The company had been targeting a readout in the middle of this year, CEO Jeffrey Finer told Endpoints News at last month’s JP Morgan Healthcare Conference. The biotech now expects to select a follow-up candidate “to accelerate toward the clinic later this year to quickly regain momentum with our PTH1R program,” Finer said Tuesday. Multiple drugmakers are doing work in the rare endocrine disorder field, and Ascendis’ hypoparathyroidism drug was recently approved. Septerna’s stock $SEPN was down about 63% on Tuesday morning. — Kyle LaHucik FDA approves Sanofi’s Merilog: It’s the first FDA-approved, fast-acting insulin biosimilar to Novo Nordisk’s NovoLog, and is now the third insulin biosimilar approved by the agency to treat diabetes. — Alexis Kramer Basilea abandons MRSA drug ahead of clinic entry: The Swiss biotech decided not to exercise its option for its endolysin candidate, dubbed tonabacase, because it didn’t meet “stringent risk-return criteria.” Basilea licensed the option for tonabacase from iNtRON Biotechnology back in 2023 and did a preclinical assessment of the candidate last year. — Ayisha Sharma German cancer biotech has new eye focus: TME Pharma is planning to establish a “new entity” focused on the “rapid advancement” of NOX-E36 for ophthalmic indications, with support from private investors. The company said it has enough supply of the drug for initial preclinical and clinical studies. TME is also looking for a strategic partner for its lead asset, dubbed NOX-A12, for glioblastoma. — Ayisha Sharma Ophthalmology biotech reveals $15M Series A: Johnson & Johnson’s corporate venture arm, Deerfield Management and other investors are backing Perceive Biotherapeutics. The small molecule startup, a spinout of Perceive Pharma, is working on “neuroprotective therapeutics” for glaucoma and other eye conditions. — Kyle LaHucik

“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” Basilea Pharmaceutica said.\n Basilea Pharmaceutica has cited its “stringent risk-return criteria” as a reason for not taking up its option to bring a MRSA antibiotic into clinical development.Basilea secured the license option for the endolysin antibiotic, called tonabacase, from Korea’s iNtRON Biotechnology in 2023. Basilea had been conducting a preclinical evaluation of the asset throughout 2024 ahead of a decision on whether to secure the exclusive rights to take tonabacase into human trials.When it signed the agreement with iNtRON, Basilea pointed to preclinical evidence of tonabacase’s activity against methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA and MSSA) as well as coagulase-negative staphylococci.“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,” Basilea Chief Medical Officer Marc Engelhardt, M.D., said back in 2023. “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.” That trial is now off the menu, as Basilea has completed its own preclinical profiling of the medicine and “taken the decision not to pursue further development,” the Swiss company said in its full-year earnings report.“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” the company added.Basilea currently markets Cresemba for invasive fungal infections and Zevtera for bacterial infections. The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.Meanwhile, Basilea has swum against the tide, pivoting away from cancer toward anti-infectives last year. The company’s clinical pipeline is headed up by fosmanogepix, an antifungal licensed from Amplyx Pharmaceuticals that Basilea is planning to enter into its second phase 3 study against mold infections.Basilea’s work developing new antifungals received a significant boost last September from the U.S. Department of Health and Human Services, which signed off on up to $268 million of funding to the biopharma over more than a decade.

▶ 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.