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October 31, 2022 / eMedClub News /-- October 26, 2022, at the Neoantigen-Based Therapies Summit in Boston Nykode Therapeutics announced the latest data from its therapeutic individualized neoantigen DNA tumor vaccine VB10.
Phase 1/2a clinical trial of NEO for locally advanced or metastatic solid tumors, and off-the-shelf therapeutic DNA vaccines against HPV16-induced malignancies A Phase 2 study
of VB10.
16 in combination with atezolizumab in the treatment of advanced cervical cancer.
NEO is a DNA-based, individualized neoantigen vaccine for the treatment of locally advanced or metastatic solid tumors
.
VB N-01 is an open-label, first-in-human phase 1/2a clinical trial to evaluate the safety, feasibility and efficacy of multiple doses of VB10.
NEO or VB10.
NEO in combination with NKTR-214 in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial carcinoma, or head and neck squamous cell carcinoma who have previously received standard care immune checkpoint blocking therapy, However, complete remission
was not achieved.
Huihe Bio is recruiting Senior Registration & Regulatory Affairs Manager, salary 2-5w, click to view>>> ▲ Security In this clinical trial, 41 patients received VB10.
NEO dosing, and the data showed that after receiving VB10.
NEO in combination with various anti-cancer drugs, patients were generally safe and well
tolerated.
The most common adverse events were fatigue (34%) and diarrhoea (27%)
.
The observed adverse events were broadly consistent with known safety features with no obvious signs of
additional toxicity.
▲ Immunogenicity data show VB10.
NEO induced a broad, intense, and long-lasting CD8 T cell response
against a patient's specific tumor.
Of the 22 patients included in the interim analysis, all developed neoantigen-specific immune responses, with vaccine-induced T-cell responses observed in 95% of patients; Multifunctional Th1 CD4 and Tc1 CD8 T cell responses were observed in patients, with 53% to 100% (mean 85%) of new epitopes inducing CD8 T cell responses
.
After multiple vaccinations, the breadth and intensity of the immune response increased, and the response to most new epitopes was maintained for at least one year
.
In addition to VB N-01, Nykode is conducting another Phase 1b clinical trial evaluating VB N-02 for VB10.
NEO in this open-label dose-escalation study to evaluate the safety and antigen-specific immune response
of VB10.
NEO in combination with atezolizumab in patients with locally advanced and metastatic tumors.
Nykode did not update the data of the therapeutic HPV vaccine VB10.
16 previously published in May, and overall, at a median follow-up of 6 months, the ORR was 21% for 39 patients, including 2 patients in complete response and 6 patients with partial response, and the DCR was 64%.
In addition, antitumor activity
was observed in both PD-L1-positive and PD-L1-negative patients.
Recommended reading: Disease control rate of 64%! DNA HPV cancer vaccine combined with PD-L1 has a significant anti-tumor effect
Nykode: Focus on DNA vaccine development
Nykode Therapeutics, formerly known as Vaccibody, founded in 2007 and announced a name change in 2021, is a biopharmaceutical companydedicated to vaccine research and development.
The company has developed a unique and innovative vaccine platform for the development of therapeutic and preventive disease vaccines
.
▲ Vaccibody technology platform Source:
Nykode Therapeutics' proprietary modular Vaccibody technology platform can induce rapid, Strong and long-lasting specific immune response
.
The Vaccibody molecule consists of three functions: targeting to bind to antigen-presenting cell surface receptors, dimerization, and antigens derived from causative agents (cancer cells or pathogens
).
At the same time, the Vaccibody platform uses DNA plasmids to encode these modularities, and since each module is relatively independent, it is possible to rapidly develop multiple different DNA vaccines
by replacing modules.
▲ Nykode pipeline Source: the company's official website
Nykode's product candidates include the therapeutic DNA vaccine VB10.
16 for cervical cancer mentioned above, the neoantigen vaccine VB10.
NEO, and the COVID-19 vaccine VB10.
COV2
.
Compared with other cancer vaccines, the antigens encoded by DNA tumor vaccines can be presented by MHC class I and II molecules, thereby activating CD4+ and CD8+ T cells, and indirectly activating humoral immunity, which can induce systemic immune response, which has certain advantages in antigen specificity and safety, but in clinical trials, DNA tumor vaccines have shown poor immunogenicity.
The success rate of therapeutic vaccines in preclinical models and clinical trials is relatively low
.
Nykode chose a strategy of personalized neoantigens as well as multiple epitopes to improve the immunogenicity
of DNA oncology vaccines.
Tumor neoantigens are antigens deliberately expressed by cancer cells, which are highly tumor-specific and not affected by T cell tolerance, but not all neoantigens are immunogenic and need to be predicted, screened and identified
.
In addition, the same group of plasmids of DNA vaccines can deliver major immunoepitopes and unconventional epitopes at the same time, inducing a broad CTL response against multiple antigens, which can overcome immune escape
caused by mutations or deletions of antigens in tumor cells.
Many preclinical and clinical studies have shown that DNA tumor vaccines can control tumor growth and cause a strong immune response, but they cannot completely clear tumors
.
In this case, combination with other treatments can enhance the antigen response and reduce immunosuppression in TME, so that the DNA tumor vaccine can achieve the best effect
.
Nykode, which has a targeted strategy to optimize the immunogenicity of DNA oncology vaccines, has reached a high degree of cooperation with a number of large companies, including vaccine development and combination with other therapeutic modalities, including oncology vaccines, and the following major collaborations
are still underway today.
- In November 2021, Nykode and Regeneron announced that the two companies would collaborate to develop five DNA vaccines, including three oncology vaccines and two infectious disease vaccines
.
Regeneron made a $30 million upfront payment and a $20 million equity financing for Vaccibody, with an additional $875 million milestone payment, for a total of up to $925 million
. - In October 2020, Nykode entered into a global licensing and development agreement for VB10.
NEO, a Roche company, under which Genentech received a global development and commercialization license for VB10.
NEO with $200 million in upfront and near-term payments
. - In February 2019, Nykode entered into a collaboration with Roche to explore the efficacy and safety
of the combination of cancer vaccine VB10.
and Roche PD-L1 blocking immune checkpoint inhibitor atezolizumab in patients with advanced cervical cancer.
brief summary
Cancer vaccines aim to provide cancer patients with a more targeted and gentle cancer treatment, but the existing data show that there is still a certain gap in the clinical effectiveness of therapeutic tumor vaccines compared with other drugs, and the development of personalized tumor neoantigens is one ofthe key factors affecting its effectiveness.
Vaccine target design is critical to its effectiveness, and combination dosing has great potential
to improve clinical outcomes.
Nykode's original vaccine platform and DNA tumor vaccine design have improved the immunogenicity and safety of this drug itself, and based on its own original drug, we have cooperated with other companies to explore more treatment possibilities
.
Resources:
1.
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https://nykode.
com
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