Technology

Scientific Rationale: The Immunological Imbalance

Long-lasting Immune Retraining from Th1 to Th2 Profile Remains the Critical Breakthrough in Allergy Immunotherapy

We Retrain the Immune System

Vaccination Designed to Permanently Switch Immune Response which Drives Allergen-Specific Immune Memory

  • Vaccination generates IMMUNE MEMORY
    • Switch the immune response away from the allergy‑driving pathway and toward a more tolerant pathway.
    • Create long‑lived immune “memory”, so the effect could last for years and potentially permanently.
    • Produce “blocking antibodies” that can bind to the allergen.
  • SCV Vaccinia-Based Viral Vector Vaccine is CRITICAL to IMMUNE RETRAINING

Mechanism of Action

Designed to Stop the Allergic Reaction Before it Starts

  • MEMORY IMMUNE RESPONSE
    • Circulating allergen-specific blocking antibodies RAPIDLY RESPOND to allergen exposure
    • Activates MEMORY T-cell and B-cells
    • Mops up allergens PREVENTING IgE BINDING
  • Unique Dual B-cell and T-cell Immune Response Potential
  • Competing approaches offer only temporary results;
    • Allergen Immunotherapy – NO MEMORY RESPONSE, requires ongoing vaccination to produce T-cell and B-cell activation
    • Passive Immunotherapy – 4-6 weekly direct injection of blocking antibodies – NO T-CELL RESPONSE

Our proprietary SCV Vaccine Platform
enables the Immune Retraining Approach.

The SCV Vaccine Platform

Sementis was founded in 2009 with the aim to improve on the MVA-BN viral vector and the overall success of vaccinia vectors by overcoming:

  • Manufacturability (complexity, scale, and lead times)
  • Perceived immunogenicity limitations

The core technology is protected by a comprehensive patent portfolio and consists of two key elements.

  • A fourth-generation vaccinia vector
    “Sementis Copenhagen Vector (SCV)”
  • An advanced manufacturing platform

The SCV Vaccine Platform is built on more than 10-years of research to establish the platform. An extensive preclinical data package supports its broad utility including demonstration of the ability to generate strong, broad, and long lasting protective immune responses in animal models, and the ability to protect against disease in higher order animal challenge models.

The SCV Vaccine Platform is ready to enter Phase I clinical trials.

Features of the SCV Platform

Safe and Immunogenic

Vaccinia-based viral vector backbone.  History of inducing memory immune response

Engineered for replication deficiency

“Plug and Play” Capability

Insert genetic codes to treat  multiple IgE mediated allergies

Large genetic capacity for complex allergies with multiple allergens

Scalable platform

Proprietary and scalable manufacturing platform suitable for commercial production

Regulatory Fit

Developed to conform with proposed FDA Platform Technology Guidance and to streamline product development

The Core Technology includes a 4th Generation Vector and an Advanced Manufacturing Process

Sementis Copenhagen Vector (SCV) – a fourth generation vaccinia

Targeted deletion of D13L (assembly protein D13) of the vaccinia Copenhagen strain.

  • Unable to make infectious progeny (replication-deficient)
  • Preserves viral genome amplification (enables transgene / antigen expression).
  • No known homolog of D13 beyond poxviruses (inherently safe)

High genetic packaging capacity enables integration of large/multiple transgenes into the genome encoding immunogens.

 SCV has capacity for high genetic payloads and is replication deficient.

Advanced Manufacture: large-scale, high-capacity, and surge capable

The manufacturing process for SCV is designed to leverage the well-established biomanufacturing features and platform-infrastructure of CHO cell lines.

A proprietary, modified Chinese Hamster Ovary (CHO-S) cell line expresses CP77 to enable vaccinia replication and the D13 assembly protein to enable SCV to mature and generate infectious progeny.

Virus manufacture in a suspension CHO cell line is unique.

 

Vaccination: safe and immunogenic

The deletion of D13L gene prevents production of mature infectious SCV, making it safe for in vivo application.

SCV retains the full vaccinia genome and genome / transgene replication, resulting in the generation of strong, broad, and long lasting protective immune responses in animal models.

SCV has the ability to protect against disease in higher order animal challenge models.

SCV vaccines are designed to be safe, immunogenic, and efficacious.

 

 

SCV builds on the established safety and immunogenicity of vaccinia vectored vaccines.

Origin of vaccination

Vaccinia

In 1796, Edward Jenner vaccinated a boy with cowpox lesion to protect against smallpox. The protective virus was later determined to be vaccinia virus (VACV)

First Generation VACV Vaccines

New York City Board of Health (NYCBH), Lister, Tian Tan, Tashkent, Copenhagen

The Global Smallpox Eradication Campaign saw multiple vaccinia strains used for vaccination worldwide.

Second Generation VACV Vaccines

Lister-RIVM, Lister/CEP, Lister-Elstree-BN NYCBH-CCSV, NYCBH-ACAM2000, NYCBH-Western Reserve

Production of vaccines transitioned from use of live animals to standardised tissue culture systems or embryonated chicken eggs.

Third Generation VACV Vaccines

Lister clone 16m8, Dairen I strain, M65 and Ml0l, Modified Vaccinia Virus Ankara (MVA)

Safer vaccine strains attenuated through the generation of random mutations and deletions after serial passages in cell culture

Fourth Generation VACV Vaccines

Sementis Copenhagen Vector (SCV)

Replication-deficient and highly immunogenic vaccinia vector due to targeted genetic modifications in the viral genome

The SCV Platform is built on 10 years of research & development

2017

Does not replicate in human cell lines and induces long-lived antigen specific responses

Production of a Chikungunya vaccine using a CHO cell and attenuated viral-based platform technology

Read article from doi.org

2018

Validated utility as a combination vaccine and protection against two pathogens confirmed in challenge models

A vaccinia-based single vector construct multi-pathogen vaccine protects against both Zika and chikungunya viruses

Read article from doi.org

2020

Single-shot immunogenicity of combination vaccine and protection confirmed in challenge model

The vaccinia virus based Sementis Copenhagen Vector vaccine against Zika and Chikungunya is immunogenic in non-human primates

Read article from doi.org

2022

Robust and durable humoral and cell-mediated responses

The vaccinia-based Sementis Copenhagen Vector coronavirus disease 2019 vaccine induces broad and durable cellular and humoral immune responses

Read article from doi.org

2022

Immunogenicity in NHPs and utility as a heterologous boost to enhance immune responses

Data on file – Commercial-in-Confidence

2023

Multi-antigen COVID vaccine demonstrates a broad protective immune response in hamster challenge models

Pending publication

Patent protected technology

Sementis owns 4 global patents for the SCV core technology and products based on the SCV Vaccine Platform

SCV Core Technology

Title: Viral Vector Manufacture
International Publication No: WO 2015/061858
Expiration date: Year 2034

Peanut Vaccine

Title: Immune Modulation
International Publication No: WO 2014/138824
Expiration date: Year 2034

Chikungunya/Zika Vaccine

Title: Viral Vaccines
International Publication No: WO 2018/032057
Expiration date: Year 2037

COVID Vaccine

Title: Attenuated Poxvirus Vector Based Vaccine for Protection Against COVID-19
International Publication No: WO 2021/195694
Expiration date: Year 2041