Pipeline

A broad pipeline of unique, world-class candidates with the potential to revolutionize the prevention and treatment of cancer and infectious disease. Our AI-Immunology™ platform enables a high level of scalability, offering the potential to expand our portfolio and our proprietary platforms to the benefit of patients worldwide.

Cancer

About EVX-01
  • Peptide-based personalized vaccine for first-line treatment of advanced melanoma (skin cancer)
  • Vaccine targets (neoantigens) identified by AI-Immunology™ based on individual tumor profile
  • Combined with an anti-PD1 antibody with the aim of improving clinical outcome
  • Well-tolerated in all patients
  • Granted Fast Track-designation by FDA

*Pembrolizumab supply agreement with MSD (Tradename of Merck & Co., Inc., Rahway, NJ, USA)

Key data
  • The combination of EVX-01 and anti-PD-1 therapy led to an Overall Response Rate of 75% (Objective Response in 12 out of 16 patients)
  • 92% of responders demonstrating sustained response at 24 months
  • In 15 out of the 16 patients, the tumor target lesions were reduced
  • 4 out of 16 (25%) patients achieved complete remission of tumor target lesions
  • 86% of vaccine targets induced a specific immune response

ABOUT EVX-04
  • EVX-04 is an off-the-shelf therapeutic cancer vaccine candidate for Acute Myeloid Leukemia (AML)
  • Designed with AI-Immunology™ and targets tumor-specific antigens derived from endogenous retrovirus elements (ERVs)
  • EVX-04 is planned to be investigated in a first-in-human study in AML patients unfit for allogeneic stem cell transplantation in combination with azacitidine and venetoclax
  • The novel targets and therapeutic modality may allow for increased durability of clinical response
Key data
  • All ERV fragments included in EVX-04 elicit a specific immune response​
  • Induces antitumor immunity with complete responses in mouse tumor model​s
  • No EVX-04 related toxicity or off target effects observed in mice

About EVX-05
  • EVX-05 is an off-the-shelf therapeutic cancer vaccine candidate for glioblastoma (GBM)
  • Builds on same novel and broadly applicable concept as EVX-04
  • Designed with AI-Immunology™ and targets tumor-specific antigens derived from endogenous retrovirus elements (ERVs)
  • Target selection process allows for broad tumor coverage regardless of immune and tumor ERV antigen differences across patients
Clinical manifestations
  • GBM is the most common and most aggressive primary malignant brain tumor
  • Median age of onset is 64 years with incidence 1.6 times higher in males compared to females
  • Standard of care is surgical resection followed by chemoradiation
  • Survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades

Infectious diseases

About EVX-B1
  • Multi-component vaccine for prevention of Skin and Soft Tissue Infections (SSTI)
  • Designed to act against SA across multiple parameters, ensuring high efficacy, high immunogenicity and targeting of functionality​
  • Targets essential toxins and major virulence factors widely present and conserved in relevant clinical strains​
  • Next milestone: CMC and toxicology
Key data
  • Protects against surgical site infections in
    minipigs
  • Protects against lethal sepsis and skin infections in mice
  • Immunized mice clear the infection from
    internal organs
  • Induces long lasting immune response in mice

About EVX-B2
  • Multi-component prophylactic vaccine against Gonorrhea
  • Contains antigens that are present in all 1,200 published N. gonorrhoeae (Ng) genomes analyzed. This implies efficacy against bacteria strains globally
  • Unique Mode of Action; kills off bacteria by targeting its cell division processes
Key data
  • Demonstrates strong efficacy against 50 clinically relevant Ng strains
  • Protects against Ng in a mouse infectious model
  • Induces strong humoral and cellular immune responses
  • Established Mode of Action: antibody-dependent complement mediated killing

About EVX-B2
  • Multi-component prophylactic vaccine against Gonorrhea
  • Contains antigens that are present in all 1,200 published N. gonorrhoeae (Ng) genomes analyzed. This implies efficacy against bacteria strains globally
  • Unique Mode of Action; kills off bacteria by targeting its cell division processes
Key data
  • Demonstrates strong efficacy against 50 clinically relevant Ng strains
  • Protects against Ng in a mouse infectious model
  • Induces strong humoral and cellular immune responses
  • Established Mode of Action: antibody-dependent complement mediated killing

 

About EVX-B4
  • Prophylactic vaccine against Group A Streptococcus (GAS)
  • Development and testing of potential GAS vaccines can be traced back to 1923
  • Initial computational analysis demonstrated that AI-Immunology™ can identify novel vaccine targets to combat GAS
  • Ongoing and future activities: Identification and testing of novel antigens for immunogenicity, functionality and protection in mouse models and in vitro assays
CLINICAL MANIFESTATIONS
  • GAS causes broad spectrum of health issues, including severe invasive infections (e.g. necrotizing fasciitis and streptococcal toxic shock syndrome) and the development of immune-mediated life-threatening conditions (e.g. acute rheumatic fever and rheumatic heart disease)
  • Invasive infections may require intensive care and surgical interventions
  • Increase in antibiotic resistance
  • Most common manifestation is strep throat

 

ABOUT EVX-V1
  • Multi-component vaccine for prevention of CMV infection in connection with e.g. solid organ transplantations
  • Contains novel B- and T-cell antigens and a proprietary pre-fusion glycoprotein B (gB) construct
  • No CMV vaccine approved to date
Key data
  • AI-Immunology™ identified novel B-cell antigens induce a strong humoral immune response​
  • AI-Immunology™ identified T-cell epitopes induce a strong cellular immune response
  • Pre-fusion gB immune serum significantly neutralizes CMV infection