Delving into the Latest Updates on NECVAXNEO1 with Synapse

Overview

Basic Info

Drug Type

DNA vaccine, Therapeutic vaccine

Synonyms

NECVAXNEO1, Personalised neoantigen-targeting cancer vaccine( NEC Corp), NECVAX NEO1

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesMouth and Tooth Diseases+ [2]

Active Indication

Triple Negative Breast CancerSolid tumorMelanoma, Cutaneous Malignant+ [4]

Inactive Indication-

Originator Organization

Active Organization

Inactive Organization-

License Organization

NEC Corp.Vaximm AG /Neoantigen Vaccine Development Assets/

Vaximm AG

+ [1]

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Phase I/II, multicenter, open-label, single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody (PD-1 inhibitor), epirubicin/cyclophosphamide chemotherapy, and nab-paclitaxel therapy (cohort 1) or SoC carboplatin/paclitaxel and epirubicin/cyclophosphamide or doxorubicin/cyclophosphamide chemotherapy (cohort 2). NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks, according to the investigator's decision taking into consideration the study patient's health status.

Start Date20 Nov 2024

Sponsor / Collaborator

NEC Corp.

[+1]

NCT06631079

/ Active, not recruitingPhase 1/2

An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients With Solid Tumors

Phase I/II multicenter, open-label, single-arm trial in patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1/PD-L1 mABs in patients with solid tumors. Patients with solid tumors who will be treated with approved standard of care (SoC) PD-1 or PD-L1 monoclonal antibody inhibitor therapy, and who after starting treatment with PD-1/PD-L1 inhibitor reached either Stable Disease (SD) or Partial Response (PR) (Cohort 1) or PD (Cohort 2) according to RECIST 1.1 and iRECIST assessed at the Baseline visit may be enrolled in the study

Start Date07 Oct 2024

Sponsor / Collaborator

NEC Corp.

[+1]

NCT05354323

/ Active, not recruitingPhase 1

An Open-label, Phase I Multicenter, Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Checkpoint Inhibitor Monotherapy in Patients With Solid Tumors

NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in n=6 patients with solid tumors

Start Date05 May 2022

Sponsor / Collaborator

NEC OncoImmunity AS

100 Clinical Results associated with NECVAXNEO1

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100 Translational Medicine associated with NECVAXNEO1

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100 Patents (Medical) associated with NECVAXNEO1

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1

Literatures (Medical) associated with NECVAXNEO1

01 Apr 2010·VaccineQ3 · MEDICINE

Liposomal oral DNA vaccine (mycobacterium DNA) elicits immune response

Q3 · MEDICINE

Article

Author: Sasaki, Jin-ichi ; Liu, Ying ; Lu, Changlong ; Wang, Danan ; Feng, Yonghui ; Shan, Fengping ; Xu, Jia ; Mchenga, S. S. Salum

Tuberculosis is one of the leading causes of mortality from an infectious disease worldwide, however, the efficacy of BCG vaccine against adult pulmonary tuberculosis still remains instability. Therefore, it is an urgent work to develop both safe and effective vaccine to TB. To clarify the liposome encapsulated DNA vaccine was effectively working as a vaccine delivery system to evoke mucosal intestinal immune responses. A Mycobacterium pcDNA3.1(+)/Ag85A DNA was constructed and encapsulated into liposome. Ag85A protein antigen was observed to substantially express in the epithelium, microfold cells (M cells), dendritic cells (DCs) and Peyer's patches (pp) of the small intestine, respectively, after oral administration into C57BL/6 mice 3 times each 14 days interval. Furthermore, levels of IL-2 and IFN-gamma in the IELs isolated from the small intestine were markedly increased, IL-4 level was not significantly changed as compared to those in control group after oral administration of Ag85A DNA encapsulated in liposome, together with the augmented Ag85A-specific cytotoxicity of IELs, indicating a local Th1 dominant cellular immune response was elicited, and thus enhanced cytotoxicity of IELs as compared to those in control mice. Furthermore, sIgA level was also elevated in liposomal encapsulated Ag85A DNA immunized mice. These data indicated that oral vaccination with the liposomal-pcDNA 3.1(+)/Ag85A DNA is able to induce antigen specific mucosal cellular and humoral immune responses. Especially, cellular compartment in the epithelium of small intestine plays a key role on the regulation of immune response to eliminate TB. These findings have important understanding and possible implications for the design of new strategies based on oral DNA vaccine on regulation of immune response in protection against TB. Further study is clearly necessary to improve the effectiveness of Ag85A DNA vaccines against TB as compared with BCG.

1

News (Medical) associated with NECVAXNEO1

13 Dec 2024

·pharma.economictimes.indiatimes.com

NEC Bio’s AI-based oral cancer vaccine shows positive results in early trials

Tokyo: Germany-based cancer therapeutics developer NEC Bio Therapeutics, shared that its AI-driven personalized oral cancer vaccine , NECVAX-NEO1 has shown positive interim results in the ongoing phase 1 trial. At the ongoing ESMO Immuno-Oncology Congress in Geneva, Switzerland, the company presented 24-week ‘promising interim results’ from an ongoing phase 1 basket clinical trial of its orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPI) for treating patients with solid tumours. NEC Bio informed that the pipeline vaccine is a personalised 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 tumour cells based on the individual’s unique neoantigens. As per the company, “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 and the safety run-in phase showed no treatment-related toxicities, allowing a dose increase. An ELISPOT response was induced by 68 per cent of neoepitopes, with 40 per cent of patients showing significant neoantigen-specific signals. After a 24-week treatment period, 80 per cent of patients had a stable disease status, indicating a high disease control rate, it added. On the results of the clinical study, Dr Heinz Lubenau, CEO of NEC Bio Therapeutics, commented, “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." Nec Bio informed that the under-trial vaccine is currently under evaluation at additional clinical trial sites in Lithuania, Germany, and Spain. By Online Bureau ,

Phase 1Clinical ResultVaccine

100 Deals associated with NECVAXNEO1

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Triple Negative Breast Cancer	Phase 2	Germany	NEC Corp.	20 Nov 2024
Solid tumor	Phase 2	Lithuania	NEC Corp.	07 Oct 2024
Solid tumor	Phase 2	Spain	NEC Corp.	07 Oct 2024
Melanoma, Cutaneous Malignant	Phase 1	Lithuania	NEC OncoImmunity AS	05 May 2022
Mouth Neoplasms	Phase 1	Lithuania	NEC OncoImmunity AS	05 May 2022
Non-Small Cell Lung Cancer	Phase 1	Lithuania	NEC OncoImmunity AS	05 May 2022
Renal Cell Carcinoma	Phase 1	Lithuania	NEC OncoImmunity AS	05 May 2022
Squamous Cell Carcinoma of Head and Neck	Phase 1	Lithuania	NEC OncoImmunity AS	05 May 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05354323 (NECVAX-NEO1-LT, ESMO_IO2025)	Phase 1	Solid tumor	22	NECVAX-NEO1 plus CPI	ozparelqwf(jmhpuiytij) = zngfycsezv ujyoeongvn (vneufqpfwa ) View more	Positive	12 Oct 2025
NCT05354323 (ESMO_IO2024) Manual	Phase 1	Solid tumor	5	NECVAX-NEO1	zlkflbvdzp(pvhqotcqgg) = kqjkwjxeyj xmfkvmgrjm (vhnigrnowv ) View more	Positive	12 Dec 2024