Finalizes separation from INVO Fertility (formerly INVO Bioscience) to focus on maximizing value in rapidly-growing multifunctional antibody & radioimmunotherapy markets
INVO to retain a minority non-voting equity interest in NAYA
NAYA positioned for leadership in hepatocellular carcinoma (HCC) and multiple myeloma with clinical readouts in 2026-2027 for first and potential best-in-class GPC3/NKp46/CD16, PD-1/VEGF, and CD38/NKp46/CD16 multifunctional antibodies as well as a novel targeted radioimmunotherapy candidate
Formation of new board of directors and executive team to accelerate clinical development and corporate growth
MIAMI, FL / ACCESS Newswire / May 29, 2025 / NAYA Therapeutics, a clinical-stage biopharmaceutical company dedicated to pioneering the next generation of cancer immunotherapies, has regained its status as a privately-held company, separating from its recent merger with INVO Bioscience. This strategic decision enables NAYA Therapeutics to optimize its portfolio development strategy for value maximization and market attractiveness as it advances towards clinical development milestones for its portfolio of first and potential best-in-class candidates.
NAYA is harnessing the power of its innovative clinical candidates towards two priority franchises: hepatocellular carcinoma (HCC), where 70-85% of candidates for systemic therapy are non-responders to checkpoint inhibitors, and multiple myeloma, with a large and rapidly-growing market in need of new therapies to address the limitations of daratumumab and T-cell engagers.
"We're incredibly excited about the clinical potential of NAYA's first and best-in-class cancer immunotherapetics and their advancement towards near-term clinical milestones," commented NAYA's CEO, Dr. Daniel Teper. "Enrollment of HCC patients for Phase I/II clinical trials of NY-303, which shows unique potential to unlock the biology of checkpoint inhibitor non-responders, is expected in 2025. Next, we are aiming to initiate Phase I/II clinical trials of NY-500, positioned to be the first PD-1/VEGF to market in HCC, in 2026. Finally, NY-338, which shows a differentiated profile to daratumumab and T-cell engagers, is anticipated to commence enrolling patients in its Phase I/II clinical trials in multiple myeloma in 2026. In addition, we are initiating the development of a novel radioimmunotherapeutic for HCC to further strengthen our therapeutic franchise. As we accelerate the advancement of these breakthrough therapies to market, NAYA is positioned to rapidly unlock its valuation and partnership attractiveness."
About NAYA Therapeutics
NAYA Therapeutics is a clinical-stage biopharmaceutical company dedicated to pioneering the next generation of cancer immunotherapies.
NAYA has developed a versatile plug and play multifunctional antibody construct that promotes avidity and immunological synapse, enhancing precision tumor killing.
NAYA is also developing a novel radioimmunotherapy platform, further leveraging its antibody targets and strengthening its therapeutic franchises.
The company's expanding portfolio of first & best-in-class assets currently includes:
NY-303, a GPC3/NKp46/CD16 trifunctional antibody positioned as a potential best-in-class second-line therapy for HCC, differentiated by a unique mechanism of action designed to unlock the biology of non-responders to PD(L)1 Inhibitors (+/- VEGF Inhibitors) - 70-85% of HCC patients - cleared to enroll patients in a Phase I/IIa monotherapy trial in H2 2025.
NY-500, a PD-1/VEGF bifunctional antibody positioned as a potential first-in-class first-line therapy in HCC, differentiated by AI-optimized binders and its potential to be the first PD-1/VEGF to market in HCC and set to initiate its Phase I/II clinical trials in H1 2026.
NY-700, a novel targeted radioimmunotherapy aiming to address the needs of advanced metastatic, pre-transplant, and post-resection HCC patients
NY-338, a CD38/NKp46/CD16 trifunctional antibody positioned as a potential best-in-class second-line therapy for Multiple Myeloma, differentiated by a unique mechanism of action addressing the limitations of both daratumumab & BCMA T-cell engagers and set to enroll patients in its Phase I/II clinical trials in H1 2026.
NY-303 & NY-338's NKp46 engagement has been shown to enhance NK cell infilitration and persistence in tumor microenvironment, maximizing immune activation and minimizing toxicity in both hematological and solid tumors compared to T-cell engagers.
NAYA's data has been presented at major oncology meetings including the American Society of Hematology (ASH), The American Association of Cancer Research (AACR), The Society for Immunotherapy of Cancer (SITC), and the European Society for Medical Oncology (ESMO).
NAYA's clinical development has been designed by its scientific advisory board of leading liver cancer and multiple myeloma experts to allow for early inflection points and accelerated development based on early data.
For more information, please visit www.nayatx.com.
NAYA Media & Investor Contact
Lyn Falconio
Chief Communications Officer
917-575-1844
lyn@nayatx.com
SOURCE: Naya Bio Sciences
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