Eleva administers first dose of its Factor H biological treatment in C3-Glomerulopathy to healthy volunteers
Freiburg im Breisgau, Germany, July 7, 2025 – Eleva, a pioneer in discovering and developing previously inaccessible biologics based on a breakthrough technology platform, announced today the first dosing in its Phase 1 clinical study investigating the company's Factor H (CPV-104) program in C3-Glomerulopathy (C3G). In the first part of the clinical study, Eleva is investigating single-ascending doses of CPV-104 in healthy volunteers.
'Today's news marks our second proprietary program advancing into clinical trials, which is a great achievement from an organizational standpoint,' commented Björn Cochlovius, Ph.D., Chief Executive Officer of Eleva. 'Our Factor H biological therapy platform continues to evolve, gaining visibility among clinicians and potential partners alike. We will continue to add value to this program in C3G as our initial focus, dry AMD as a second indication, and potentially several others down the road, while creating the best infrastructure for its successful clinical development.'
'We are thrilled to advance our Factor H molecule into a first-in-human study to evaluate the safety and tolerability and pharmacokinetics for further clinical studies. I like to thank all team members at Eleva and our clinical partners for their continued efforts and commitment to meet this milestone,' commented Dr. Martin Bauer, Chief Medical Officer of Eleva.
C3G represents a rare renal disease caused by the abnormal regulation of the complement system, particularly the alternative pathway of the complement cascade, a central part of the body's immune defense. Naturally occurring complement regulators such as Factor H offer a therapeutic approach to help restore balance within the complement system and have shown therapeutic potential in a range of indications. Preclinical data sets were recently published in Frontiers in Immunology and underscored Factor H (CPV-104)'s ability to act as a functional analogue of human Factor H, support normalization of serum C3 levels and lead to a rapid degradation of C3 deposits in the kidney. The program has received the Orphan Drug Designation in the European Union for C3G and is also being pursued by Eleva in dry AMD as a second indication.
ABOUT ELEVAEleva is a clinical-stage biopharmaceutical company discovering and developing previously inaccessible biological therapeutics. Eleva's disruptive moss-based technology platform enables GMP-scale manufacturing of human proteins with tremendous therapeutic potential that other platforms cannot achieve. The company's proprietary pipeline includes candidates for complement disorders and enzyme replacement therapies. The lead program, Factor H (CPV-104), a recombinant human complement Factor H, has entered a Phase 1/2 clinical studies to treat C3 Glomerulopathy (C3G). An intravitreal formulation of the candidate is in late preclinical development to treat dry AMD. The company's aGal (RPV-001) program has completed a positive Phase 1b single-dose clinical trial to treat Fabry disease.
MEDIA CONTACTS
Fabienne ZeitterDirector Marketingpr@elevabiologics.comPhone: +49 761 470 99 0
Valency CommunicationsMario Brkuljmbrkulj@valencycomms.euPhone: +49 160 9352 9951
INVESTOR CONTACT
Cohesion BureauGiovanni Ca' Zorzigiovanni.cazorzi@cohesionbureau.comPhone: +33 7 84 67 07 27
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The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. References: Action Bladder UK. Non-muscle invasive bladder cancer. May 2021. Available at: World Cancer Research Fund. Bladder Cancer Statistics. 2022. Available at: Aldousari S, Kassouf W. Update on the management of non-muscle invasive bladder cancer. Canadian Urological Association Journal, 4(1), 56–64. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;10.1097/JU.0000000000003846. Grabe-Heyne, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023 Jun 2;13:1170124. doi: 10.3389/fonc.2023.1170124. Kodera A, Mohammed M, Lim P, Abdalla O, Elhadi M. The Management of Bacillus Calmette-Guérin (BCG) Failure in High-Risk Non-muscle Invasive Bladder Cancer: A Review Article. Cureus. 2023 Jun 26;15(6):e40962. doi: 10.7759/cureus.40962. PMID: 37503461; PMCID: PMC10369196. 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Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as "anticipates," "believes," "continues," "goal," "could," "estimates," "scheduled," "expects," "intends," "may," "plans," "potential," "predicts," "indicate," "projects," "is," "seeks," "should," "will," "strategy," and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, (ii) risks and uncertainties regarding regulatory submissions in foreign jurisdictions, filing and review process and the timing thereof, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding commercial launch execution, success and timing, (v) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (vi) whether clinical trials will result in registrational pathways and the risks, (vii) whether clinical trial data will be accepted by regulatory agencies, (viii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (iv) potential delays in product availability and regulatory approvals, (x) ImmunityBio's ability to retain and hire key personnel, (xi) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. 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