TOKYO, Dec 12, 2024 - (JCN Newswire) - NEC Bio Therapeutics today presents 24-week promising interim results from an ongoing Phase 1 basket clinical trial of an orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPI) for treating patients with solid tumors. The findings are being presented in a poster at the ESMO Immuno-Oncology Congress in Geneva, Switzerland from December 11 to 13, 2024.

NECVAX-NEO1 is a personalized bacteria-based oral DNA therapeutic vaccine, developed using AI prediction of the most immunogenic patient-specific neoepitopes. This vaccine is designed to activate the patient’s immune system, prompting a T-cell response that can precisely target and eliminate tumor cells based on the individual’s unique neoantigens.

In the phase 1 study, 5 patients with melanoma, renal cell cancer, or head and neck cancer, who have been on CPI treatment for at least three months, were treated with NECVAX-NEO1. The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. An ELISPOT response was induced by 68% of neoepitopes, with 40% of patients showing significant neoantigen-specific signals. After a 24-week treatment period, 80% of patients had a stable disease status, indicating a high disease control rate.

On the results of the clinical study, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, commented, "We are very excited about our first proof-of-concept data showing signs of promising immunogenicity and associated biomarker changes in patients. This is very encouraging, especially in light of new clinical trials currently ongoing at various locations in early and late-stage cancer patients. We are looking forward to generating more data for NECVAX-NEO1 as an additional treatment option for patients with difficult to treat cancer in the future."

Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, further commented, "We are certainly excited to present the progress of the NECVAX-NEO1 trial demonstrating safety and signs of immunogenicity. NECVAX-NEO1 is the first cancer vaccine asset to be clinically developed at NEC. This development ties in with the larger NEC mission of providing healthcare solutions globally using the state of art technologies developed in-house."

Details of the poster:

Poster title: Oral DNA vaccination targeting personalised neoantigens in immune checkpoint inhibitor treated solid tumor patients - Interim results.

Authors: Domas Vaitiekus, E. Juozaityte, L. Puzauskienė, S. Tulyte, L. Gatijatullin, M. Platten, I. Poschke, I.Hulsmeyer, A. Kuhn, A. Aranguren, H. Lubenau, H. Fontenelle, B. Simovski, Y. Yamashita, C.Chaput, A. Meiser, V. Urbonas

Poster Number: 160P

Date: 12 December 2024

The poster may also be found here: NEC Bio website:
nec-bio.com/en_DD/img/20241212_ESMO2024_NECVAX-NEO1_poster.pdf

Trial details can also be viewed at: NCT05354323
https://clinicaltrials.gov/study/NCT05354323?term=necvax-neo1&rank=1 

NECVAX-NEO1 is currently under evaluation at additional clinical trial sites in Lithuania, Germany, and Spain. These sites are actively recruiting patients and are open for enrollment.

About NEC Bio Therapeutics

NEC Bio Therapeutics, established in Mannheim, Germany, focuses on the clinical strategy and development, as well as planning and execution of clinical trials in the oncology area. It is a subsidiary of NEC Bio, the biotech arm of NEC Corporation. NEC Bio is located in the Netherlands and dedicated to the development of innovative biotechnological solutions to tackle some of the most pressing health challenges. NEC Bio's research and development efforts are focused on creating personalized therapies that improve the quality of life for patients worldwide. NEC OncoImmunity in Oslo, Norway, is also a subsidiary of NEC Bio. For more information, visit: www.nec-bio.com

About NEC Corporation

NEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of “Orchestrating a brighter world.” NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com.

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