Valitor Presents Multiple Preclinical Datasets on the Potential of its Innovative Anti-VEGF Therapy Dosed Twice Yearly for Wet AMD at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

May 07, 2025 08:00 ET | Source: Valitor, Inc. -VLTR-559, a long-acting anti-VEGF therapy, could reduce dosing frequency for the treatment of wet AMD to twice-yearly, as compared to every eight to twelve weeks for standard-of-care anti-VEGFs -VLTR-559 shown to be more durable, while maintaining potency and a similar, clean safety profile in preclinical models -VLTR-559 is expected to enter clinical testing in 2026 BERKELEY, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Valitor, a biotechnology company engineering a new generation of ophthalmic medicines, today announced data from VLTR-559, its long-acting anti-VEGF biologic in development for durable wet age-related macular degeneration (AMD) treatment, and its multivalent polymer (MVP) technology platform were presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Salt Lake City, UT. “VLTR-559 was developed using our pioneering MVP technology platform and was designed to be an anti-VEGF therapy with increased potency and extended therapeutic duration compared to the current standard-of-care anti-VEGF biologics,” said Wesley Jackson, Ph.D., president and chief scientific officer of Valitor. “Based on our clinical modeling from preclinical results, we anticipate VLTR-559 could enable a twice-yearly dosing regimen for patients with wet AMD, thereby improving long-term outcomes while also reducing the clinical costs required to treat this disease. We are making great progress through IND-enabling activities with the goal of initiating a Phase 1 clinical study next year. Additionally, we are excited by the broader potential of our MVP platform, which is based on our proprietary methods of combining large molecular weight hyaluronic acid biopolymers with diverse active pharmaceutical ingredients to create potent and long-acting drugs.” Data PresentationsA poster (#3766 - A0490) titled, “VLTR-559: An anti-VEGF Antibody-Hyaluronic Acid Conjugate Targeting 6-Month Treat-and-Release Durability for Wet-AMD” reviewed how VLTR-559 has been engineered for durable, long-acting treatment of neovascular ocular disease, targeting a twice-yearly dosing regimen. VLTR-559 is highly potent to inhibit VEGF signaling in vivo, and its intravitreal half-life was over three times longer than the reported half-life for aflibercept (the active ingredient in EYLEA HD). Given its slower elimination from the ocular tissues, VLTR-559 is expected to extend re-administration frequencies at least three-fold relative to current standard-of-care anti-VEGF biologics typically dosed every 8-12 weeks. The safety profile of VLTR-559 was consistent with preclinical reports for marketed anti-VEGF biologics. A poster (#2538 - B0251) titled, “Multivalent Conjugation to Hyaluronic Acid Enhances the Potency of Anti-VEGF Antibody Fragments and Enables a Long Intravitreal Half-Life” showed preclinical pharmacokinetics (PK) and pharmacodynamics (PD) data that can be used to predict the duration and efficacy that VLTR-559 will provide when administered through a standard in-office intravitreal injection to treat wet-AMD. In vivo and in vitro studies confirmed: the long-term intraocular half-life of VLTR-559, VLTR-559’s high potency to inhibit VEGF in vitro, and its equivalent potency to aflibercept in VEGF inhibition that prevented VEGF-driven laser-induced choroidal neovascularization (CNV) lesion area growth in ocular tissues as compared to vehicle control. A poster (#1776 - B0511) titled, “Optimization of Hyaluronic Acid Conjugation Chemistry Provides a Safe and Stable Platform for Long-Acting Intravitreal Medicines” outlined the chemical composition, stability profile, and biophysical properties of the company’s hyaluronic acid-based platform technology for synthesizing long-acting therapeutics based on the MVP technology. Hyaluronic acid (HA) is a favorable strategy for driving durability due to its biocompatibility, high molecular weight, and demonstrated safety in ocular use. Valitor’s plug-and-play MVP platform is based on proprietary modification of HA to enable covalent attachment of multiple copies of different drug moieties, such as its proprietary single-domain (VHH) antibodies. Based on the intravitreal half-life of the MVPs and safety findings that were consistent with approved biologics for intravitreal indications, the platform has the potential to safely enable a reliable six-month clinical dosing frequency for therapies administered via intravitreal administration. A poster (#1778 - B0513) titled, “A Versatile Multivalent Polymer (MVP) Conjugation Platform to Enable Long-Acting Intravitreal Medicines” reviewed a variety of drug moiety payloads that can be conjugated to HA using in vitro potency and stability assays and select candidate MVPs that were assessed for durability. MVPs composed of a variety of payloads and Valitor’s proprietary plug-and-play chemistry for covalent attachment to hyaluronic acid showed in vitro potency at least equivalent to unconjugated active pharmaceutical ingredients and comparable to commercial anti-VEGFs, confirming the versatility of the MVP platform. About the MVP TechnologyValitor’s Multivalent Polymer (MVP) technology platform originated at U.C. Berkeley. The MVP platform is based on proprietary multivalent biopolymers that are coupled with bioactive molecules. The biopolymers and bioactive molecules are interchangeable, which enables Valitor to assemble novel macromolecular entities that are engineered to overcome a multitude of specific drug design challenges for their target indications. Unlike other methods of drug modification that are designed to modify individual drug properties, Valitor’s novel approach allows for independent control of multiple drug attributes, including pharmacokinetic/pharmacodynamic properties, improved target engagement/tissue localization, therapeutic durability, and improved safety. In research studies, Valitor’s novel compounds have shown 10-fold increases in potency, up to 5-fold increases in tissue retention, and excellent preclinical safety. About ValitorValitor is conquering limitations of established drug targets by leveraging its multivalent biopolymer technology to maximize benefits for patients. The company is initially focused on developing long-acting molecules aimed at capturing several large markets in ophthalmology. Valitor’s lead product is a long-acting inhibitor of VEGF designed to reliably extend the duration of a single dose in humans to six months or more, which would offer a substantial benefit for the majority of patients that require dosing approximately every 8-12 weeks with the current market leaders. Valitor’s proprietary platform technology has been shown in preclinical models to safely enable intravitreal treatment with unprecedented target tissue durability and potency. For more information on the company, please visit its website at https://www.valitorbio.com/ or follow its LinkedIn page. Investor Contact Alexandra Santos asantos@wheelhouselsa.com Media ContactAljanae Reynoldsareynolds@wheelhouselsa.comValitor Contactinfo@valitorbio.com

Valitor Presents Multiple Preclinical Datasets on the Potential of its Innovative Anti-VEGF Therapy Dosed Twice Yearly for Wet AMD at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

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