University of Wisconsin Carbone Cancer Center

Invenra’s bispecific antibody is under development to treat neuroblastoma. Credit: Kateryna Kon/Shutterstock. Invenra has received rare pediatric disease designation (RPDD) and orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its bispecific antibody, INV724, under development to treat neuroblastoma. These designations are claimed to provide strategic benefits that will accelerate the development of this promising therapy, apart from reductions in cost and financial incentives. INV724, stemming from Invenra’s B-Body Bispecific Platform, is the product of a collaboration with the University of Wisconsin Carbone Cancer Center. It is said to target GD2 and B7-H3 tumour antigens and has been engineered to reduce severe pain typically associated with GD2-targeted therapies. Preclinical results have highlighted INV724’s strong therapeutic potential and developability. See Also: LOTTE BIOLOGICS’ East Syracuse Pharmaceutical Manufacturing Facility, US Entos Pharmaceuticals GMP Clinical Manufacturing Facility, California, USA The RPDD and ODD designations come with multiple benefits, including a transferrable priority review voucher, extended market exclusivity, and eligibility for grants and research support. These incentives are vital for expediting the development and improving the availability of critical therapies for rare paediatric diseases. Invenra’s B-Body Platform allows for the rapid engineering and development of therapeutic antibodies with robust performance. Invenra CEO Roland Green said: “Invenra is deeply committed to advancing INV724 as a potentially transformative treatment for children with neuroblastoma. “The FDA’s RPDD and ODD designations not only validate our innovative approach but also give us the critical support to fast-track its development in collaboration with potential partners. We are eager to bring this therapy to patients who need it most.” In August 2021, Invenra and Exelixis extended their discovery and licensing partnership to include 20 more oncology targets for multi-specific antibodies, antibody-drug conjugates, and developing other biologic candidates. In May 2018, the companies collaborated to discover and develop mono-specific and multi-specific antibodies for integration into new biologic therapies to treat cancer.

MADISON, Wis.--( BUSINESS WIRE )--Invenra Inc. is pleased to announce that its innovative bispecific antibody, INV724, developed for the treatment of neuroblastoma, has been awarded both Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations by the U.S. Food and Drug Administration (FDA). These designations provide strategic advantages, including accelerated development, cost reductions, and financial incentives, further driving the advancement of groundbreaking therapies for rare pediatric diseases. INV724, a product of Invenra’s proprietary B-Body ® Bispecific Platform, was developed in collaboration with the University of Wisconsin Carbone Cancer Center. The antibody simultaneously targets GD2 and B7-H3 tumor antigens, demonstrating exceptional specificity for neuroblastoma. Designed to mitigate the severe pain associated with GD2-targeted therapies, INV724 has shown promising preclinical results, including strong therapeutic potential and robust developability. “Anti-GD2 antibodies are a key component in treating neuroblastoma, but their use is often limited by severe pain due to nerve binding. Our studies indicate that INV724 binds effectively to neuroblastoma cells while sparing nerves, offering a significant advantage over existing therapies. Our next goal is to transition from laboratory research to clinical trials, aiming to provide effective treatment with fewer side effects,” stated Dr. Paul Sondel, Professor of Pediatrics and Human Oncology at the University of Wisconsin. The pressing need for improved neuroblastoma therapies has garnered interest from leading researchers and clinicians, including the New Approaches to Neuroblastoma Care (NANT) consortium, a coalition of 18 universities and children's research hospitals. Dr. Julie R. Park, Chair of the Department of Oncology at St. Jude Children’s Research Hospital and Scientific Chair of NANT, added, “Invenra’s work with INV724 opens the door to developing a new agent that may offer enhanced anti-tumor activity with reduced side effects.” The RPDD and ODD designations afford numerous benefits, such as a transferrable priority review voucher, extended market exclusivity, and eligibility for grants and research support. These advantages are crucial in facilitating the development and accessibility of life-saving therapies. “Invenra is deeply committed to advancing INV724 as a potentially transformative treatment for children with neuroblastoma. The FDA's RPDD and ODD designations not only validate our innovative approach but also give us the critical support to fast-track its development in collaboration with potential partners. We are eager to bring this therapy to patients who need it most,” said Roland Green, Invenra’s CEO. About Invenra Inc. Invenra Inc. is at the forefront of bispecific antibody technology, driven by a mission to deliver transformative therapies. Our B-Body ® Platform enables rapid engineering and development of therapeutic antibodies with unparalleled performance. With a strong portfolio of innovative bispecifics, Invenra continues to lead in therapeutic innovation.

BOSTON, April 24, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, announced today that it will present an oral abstract and poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL. The presentations will highlight the Company’s Phase 1 trials of its lead interleukin 2 (IL-2)-based biologics, CUE-101 in recurrent/metastatic head and neck cancer and CUE-102 in Wilms’ Tumor 1 positive recurrent/metastatic cancers. The Company will host a Business Update call and webcast in June 2024 that will include a discussion on the clinical progress and associated data presented at ASCO on June 1 and June 4. Call details will be issued prior to the event. Oral Abstract and Poster Details Abstract Number: 6004Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).Presenter: Douglas R. Atkins, M.D., Professor of Medicine, Washington University School of MedicineSession Type and Title: Oral Abstract Session; Head and Neck CancerSession Date and Time: June 4, 2024, 9:45 AM-12:45 PM CDT Abstract Number: 3553Title: A phase 1 open-label, dose escalation and expansion study of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein, in patients with HLA-A*0201 positive disease and WT1-positive recurrent/metastatic cancers. Presenter: Nataliya Uboha, M.D., Ph.D. University of Wisconsin Carbone Cancer Center Session Type and Title: Poster Session; Gastrointestinal Cancer, Colorectal and AnalSession Date and Time: June 1, 2024, 1:30 PM-4:30 PM CDT The oral abstract and poster presentations will be available in the Investor & Media section of the Company’s website at www.cuebiopharma.com under Scientific Publications and Presentations, following ASCO. About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on Twitter and LinkedIn. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Inc.mcampinell@cuebio.com Media ContactJonathan PappasLifeSci Communicationsjpappas@lifescicomms.com