ExpreS2ion Biotechnologies

Fourth quarter and full year 2022 financial results and business update

Retrieved on: 
Thursday, April 27, 2023
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Technology advances: Novel ObsERV™ technology -- In March 2023, Evaxion reported the discovery of a novel new source of antigens for personalized cancer immunotherapy, based on endogenous retroviruses (ERVs). The AI-enabled technology has the potential to make “cold” tumors responsive to immunotherapy, which has the potential to broaden the patient population for immunotherapy significantly.

Key Points: 
  • Looking ahead to the rest of the year, we plan to report final Phase 1/2a results and interim Phase 2 data from the EVX-01 program in melanoma.
  • In addition, we intend to initiate recruitment in a Phase 1 study with EVX-03 in Q4 2023.
  • The Phase 2 study, initiated in September 2022, is expected to enroll up to 20 patients and report interim data in Q4 2023.
  • EVX-B2 (N. gonorrhoeae, preclinical) – In June 2022, Evaxion announced gonorrhea as a new bacterial vaccine candidate for N. gonorrhoeae.

Evaxion and ExpreS²ion initiate research collaboration on a novel cytomegalovirus (CMV) vaccine candidate

Retrieved on: 
Tuesday, December 6, 2022
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During the discovery phase of the collaboration, Evaxion will use its proprietary AI platform, RAVEN, to design a next-generation vaccine candidate that elicits both cellular and humoral/antibody responses.

Key Points: 
  • During the discovery phase of the collaboration, Evaxion will use its proprietary AI platform, RAVEN, to design a next-generation vaccine candidate that elicits both cellular and humoral/antibody responses.
  • Under the terms of the collaboration, ExpreS2ion will have the exclusive right to license the CMV vaccine candidate under a potential Development and Commercialization Agreement.
  • The research and intellectual property licensing costs for the collaboration project will be divided 50/50 between the parties until 2025, with all costs expected to be contained in each party’s existing operating expenses.
  • Since 2010, the Company has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies.

Bavarian Nordic’s COVID-19 Booster Vaccine Candidate Demonstrates Durable Antibody Response Six Months After Vaccination in Phase 2 Clinical Trial

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Monday, October 17, 2022
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COPENHAGEN, Denmark, October 17, 2022 Bavarian Nordic A/S (OMX: BAVA) announced today the results of a six-month follow-up analysis from a Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.

Key Points: 
  • COPENHAGEN, Denmark, October 17, 2022 Bavarian Nordic A/S (OMX: BAVA) announced today the results of a six-month follow-up analysis from a Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.
  • We look forward to generating further data in the ongoing Phase 3 trial that will shortly open sites in Denmark.
  • ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac, Denmark, using their proprietary capsid virus like particle (cVLP) technology.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.

Bavarian Nordic Reports Omicron Data from Phase 2 Trial of its COVID-19 Booster Vaccine Candidate

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Thursday, May 5, 2022
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COPENHAGEN, Denmark, May 5, 2022 Bavarian Nordic A/S (OMX: BAVA) announced today additional results from its Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 vaccine candidate.

Key Points: 
  • COPENHAGEN, Denmark, May 5, 2022 Bavarian Nordic A/S (OMX: BAVA) announced today additional results from its Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 vaccine candidate.
  • Paul Chaplin, President and CEO of Bavarian Nordic, commented: We now have demonstrated a large range of immune responses against different variants of concern, including Omicron.
  • Supported by the Danish State, Bavarian Nordic plans to initiate soon a Phase 3 program of ABNCoV2.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.

Bavarian Nordic Reports Additional Positive Phase 2 Results for its COVID-19 Vaccine Candidate Ahead of Phase 3 Trial

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Monday, February 28, 2022
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While the 50 g dose has shown positive results, it has been decided to use the 100 g dose in the Phase 3 trial to maximize the likelihood of success.

Key Points: 
  • While the 50 g dose has shown positive results, it has been decided to use the 100 g dose in the Phase 3 trial to maximize the likelihood of success.
  • Based on these encouraging results, Bavarian Nordic continues its preparations to initiate a Phase 3 trial in the first half of 2022.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.
  • Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines.

Bavarian Nordic Reports Positive Topline Phase 2 Results for its COVID-19 Vaccine Candidate

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Sunday, December 5, 2021
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Paul Chaplin, President and CEO of Bavarian Nordic, commented: We are very pleased to report positive top-line results for our COVID-19 vaccine candidate, confirming the perfect profile as a non-adjuvanted universal booster vaccine.

Key Points: 
  • Paul Chaplin, President and CEO of Bavarian Nordic, commented: We are very pleased to report positive top-line results for our COVID-19 vaccine candidate, confirming the perfect profile as a non-adjuvanted universal booster vaccine.
  • These results highlight the urgent need for an improved vaccine providing a more robust and long-lived level of protection.
  • ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac using their proprietary capsid virus like particle (cVLP) technology.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.

Bavarian Nordic Receives Funding from the Danish Ministry of Health to Advance the Development of COVID-19 Booster Vaccine

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Monday, August 23, 2021
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All payments are potentially subject to repayment, however only upon successful marketing authorization of the vaccine by the European Commission.

Key Points: 
  • All payments are potentially subject to repayment, however only upon successful marketing authorization of the vaccine by the European Commission.
  • Repayment may occur via supply of vaccines and royalty payments from the sale of the vaccine to other customers.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.
  • Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines.

Bavarian Nordic Initiates Phase 2 Clinical Trial of COVID-19 Booster Vaccine

Retrieved on: 
Monday, August 23, 2021
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COPENHAGEN, Denmark, August 23, 2021 Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a Phase 2 clinical trial of its COVID-19 vaccine candidate, ABNCoV2.

Key Points: 
  • COPENHAGEN, Denmark, August 23, 2021 Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a Phase 2 clinical trial of its COVID-19 vaccine candidate, ABNCoV2.
  • The trial will investigate the potential of ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination.
  • In parallel with the Phase 2 trial, Bavarian Nordic is preparing for a Phase 3 trial of ABNCoV2 in 2022, pending external funding.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.

Bavarian Nordic Reports Initial Results from First-in-Human Trial of COVID-19 Vaccine

Retrieved on: 
Monday, August 9, 2021
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Strong cross neutralization of SARS-CoV2 variants, including the Delta variant

Key Points: 
  • Strong cross neutralization of SARS-CoV2 variants, including the Delta variant
    COPENHAGEN, Denmark, August 9, 2021 Bavarian Nordic A/S (OMX: BAVA) today reported initial results from the first-in-human trial of ABNCoV2, led by the PREVENT-nCoV consortium.
  • Bavarian Nordic will further advance the development of the vaccine candidate and has planned a Phase 2 trial in up to 210 subjects.
  • In parallel, Bavarian Nordic is preparing for a Phase 3 trial of ABNCoV2 in 2022, pending external funding.
  • Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.