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Aanastra Inc Announces Presentations of Preclinical Data at Upcoming Conferences in Support of its Lead Programs for Anti-CD19 In Vivo CAR-T (AAN-14x) and In vivo Rescue of P53 Mutations in Tumors (AAN-53x)

  • Greater than 90% depletion of B cells within 12 hours of a single dose of AAN-14x
  • Multiple redosing of AAN-14x at desired intervals with no evidence of hepatic or other toxicity
  • Remarkable tumor regressions with AAN-53x across a broad range of P53 mutated tumors
  • Oral presentation to highlight Aanastra’s PEP-NP™ peptide targeting technology for RNA

LOS ANGELES and NIMES, France, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Aanastra, Inc., a biotechnology company leveraging its proprietary targeted peptide delivery technology (PEP-NP™) to advance in vivo targeting and reprogramming of cells with RNA therapeutics, today announced multiple presentations showcasing preclinical data in its lead programs for anti-CD19 in vivo CAR-T (AAN-14x) and for in vivo P53 rescue in P53 mutant tumors (AAN-53x), at upcoming conferences.

“Among the broad applications of the PEP-NP™ technology, we are particularly excited by the preclinical data in our in vivo CAR-T program as well as our ability to target wide-ranging P53 driver mutations in our P53 program for which no therapy exists today ,” said Neil Desai Ph.D., Founder and CEO at Aanastra. “These preclinical data highlight the remarkable versatility of the PEP-NP™ targeted peptide RNA delivery technology, from in vivo reprogramming of immune cells to cause B cell depletion, to in vivo restoration of mutant tumor suppressor function directly in tumors, all with a mRNA approach. Importantly the PEP-NP™ system can completely bypass the liver, without immunogenicity or safety issues upon repeat administration, uses no lipid, viral or protein components, and is fully owned by Aanastra.”

Featured Presentations and Conferences:

Advancing Cell and Gene Therapies for Cancer Conference, Philadelphia, PA, Oct 15-16, 2025

Poster presentation title: In Vivo CAR-T generation of anti-CD19 CAR-T-cells using CAR mRNA delivered with the PEP-NP peptide-based (non-lipid, non-viral) delivery system targeted to CD3/CD5+ T-cells
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

Poster presentation title: P53 mutant tumor regression across P53 mutations with AAN-53x, a P53 mRNA delivered with the PEP-NP tumor-targeted peptide (non-lipid) delivery system
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

mRNA Vaccines and Therapeutics Summit, Barcelona, Spain, Oct 23-24, 2025

Oral Presentation Title: A novel peptide-based nanoparticle platform for systemic targeted delivery of therapeutic mRNA : invivo CAR-T cell engineering and Tumor selectivity
Presenter: Gilles Divita, Ph.D.
Date and Time: Oct 23, 2025, 4.40 pm – 5.20pm. CET

About P53
Known as the “Guardian of the Genome,” P53 is a crucial tumor suppressor that preserves DNA integrity by regulating DNA repair and cell division. Loss of functional p53 causes DNA damage to accumulate, driving uncontrolled cell growth and tumor development. It is mutated or inactivated in over 50% of cancers, affecting 400,000 new U.S. patients annually and over 10 million globally. Mutations span hundreds of variants, making broad therapies difficult. These mutations are markers of poor prognosis and key cancer drivers. No existing treatments restore p53 function across this spectrum, leaving a significant unmet need. Aanastra’s RNA-based approach using its targeted PEP-NP™ delivery offers a promising strategy to broadly restore p53 function, potentially transforming outcomes for aggressive, treatment-resistant cancers.

About In vivo CAR-T
In vivo CAR-T therapy engineers a patient’s T cells inside the body to target and destroy cancer cells, avoiding the costly, complex ex vivo CAR-T process that today is available to less than 20% of eligible patients in the US. Current lentiviral methods for in vivo CAR-T allow only single treatments due to immune responses against viral components. Lipid nanoparticle (LNP)-based mRNA delivery enables transient CAR expression that could be repeated but is limited by liver toxicity and immune related side effects like inflammation. These safety and dosing challenges can restrict sustained treatment effects. Aanastra’s PEP-NP™ system efficiently targets CAR RNA to T cells for safe, repeat dosing without these toxicities, potentially overcoming current limitations and expanding access for hematological cancers and autoimmune diseases.

About PEP-NP
Aanastra’s PEP-NP™ technology is based on short, amphipathic peptides that form stable nanoparticles with RNA for efficient delivery. These peptides are designed with distinct hydrophobic and hydrophilic regions, adopting α-helical conformations facilitating membrane interaction and cellular entry. Importantly, PEP-NP™ peptides can include specific receptor-targeting domains, enabling precise cell and tissue targeting without using antibodies or other large proteins. This antibody-free targeting allows rapid design flexibility and avoids immunogenicity associated with protein-based ligands. PEP-NP™ nanoparticles can enter cells though a non-endosomal mechanism, enhancing RNA release into the cytoplasm for effective therapeutic action. Together, these features make PEP-NP™ a highly versatile, scalable, and safe platform for delivering diverse RNA payloads for treating cancer, autoimmune, and genetic diseases.

About Aanastra, Inc. (www.aanastra.com)
Aanastra Inc is a pioneering biotechnology company dedicated to advancing RNA therapeutics for cancer, autoimmune, and genetic diseases. Using its proprietary PEP-NP™ peptide technology, Aanastra delivers engineered RNA with high precision for cell/tissue selectivity and remarkable safety—overcoming many of the limitations of lipid and viral systems. The company’s innovative pipeline targets immune cells for scalable in vivo CAR-T therapies (PEP-CAR™), undruggable tumor suppressor gene mutations (p53) to restore function (TSG-RESQ™), and mutant oncogenes like KRAS for gene editing and deletion (ONCOEDIT™), all using a RNA based approach. Founded by leading scientists and industry veterans, Aanastra operates at the intersection of cutting-edge RNA biology, advanced delivery technology, and AI-driven target design. Aanastra Inc., (Los Angeles, CA) works closely with its sister company Divincell SAS (Nimes, France) on the development of RNA therapeutics. For more information, visit www.aanastra.com and connect with us on LinkedIn.

Contacts
IR@aanastra.com


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