Mymetics Profile
Mymetics Corporation (Mymetics), a vaccine company, focuses on the research and development of next generation vaccines for infectious and life disabling diseases.
The company's core technology and expertise lays in the use of virosomes, lipid-based carriers containing functional fusion viral proteins, and natural membrane proteins, in combination with rationally designed antigens and if required, adjuvants.
The company has several vaccine candidates in its pipeline: HIV-1/AIDS and Covid-19, while its intra nasal influenza, RSV, malaria, and Chikungunya vaccines candidate programs have been stopped or are on hold. Besides infectious diseases, the company has shown good results in several discovery projects in immunotherapy, one in the allergy field and several in the field of oncology, for which it collaborated with other biotech companies.
The company's vaccines for infectious diseases are designed to induce protection against early transmission and infection, focusing on the mucosal immune response as a first-line defense in combination with humoral and cellular immune responses as a second-line defense, which, for some pathogens, may be essential for the development of an effective prophylactic vaccine. Additionally, for certain immunotherapies, the company is exploring the use of virosome platform to trigger specific immune responses.
The company owns all of the outstanding voting stock of Mymetics S.A., a company originally organized as Mymetics Management Sàrl in 2007 under the laws of Switzerland; Bestewil Holding B.V.; and Bestewil Holding B.V's subsidiary, Mymetics B.V., both of which are organized under the laws of the Netherlands and were acquired in 2009.
Products Under Development
The company's pipeline has proprietary vaccines in development: HIV-1 and Covid-19 vaccines, while its Chikungunya, intra-nasal influenza, malaria, and Respiratory Syncytial Virus (RSV) vaccine candidates are on hold. The vaccines in the company's portfolio are primarily prophylactic. The company's human immunodeficiency virus type 1 (HIV-1) vaccine with one antigen (p1) has finished successfully a Phase 1, however its improved HIV-1 vaccine (including the two antigens P1 and rgp41) is in preclinical development under the National Institutes of Health (NIH) project. The malaria vaccine has successfully finished a Phase Ib but currently on hold.
Additionally to the above pipeline, the company has successfully finished a collaboration project in immunotherapy in the field of allergy. This collaboration project with Anergis SA, evaluated the use of Mymetics' virosomes in combination with Anergis SA Continuous Overlapping Peptides against birch pollen allergy for which the company issued a joint publication in January 2021 after two successful studies in the scientific journal Clinical & Experimental Allergy with Stallergenes Greer SA and Anergis SA, with the title 'Bet v 1 contiguous overlapping peptides anchored to virosomes with TLR4 agonist enhance immunotherapy efficacy in mice'. As of February 1, 2021, Anergis SA entered into liquidation since it was not able to raise sufficient funds to continue to operate and as of June 17, 2022, Anergis SA has entered into bankruptcy proceedings. The company also has started and finished several collaboration immunotherapy projects with Biotech companies in the field of oncology, using its virosome vaccine platform to improve the response rates in cancer treatment.
Covid-19
Since the end of April 2020, Mymetics has started a project for the development of an intranasal Covid-19 virosome-based vaccine and is thereby partnering with leading academic institutions to explore and select the most effective SARS-CoV antigens incorporated in virosomes, while optimizing the route of administration and thermostability of the vaccine, before moving into human clinical trials.
In May 2020, Mymetics signed a research collaboration agreement with Baylor College of Medicine and Texas Children's Center for Vaccine Development for evaluating their rationally designed recombinant protein-based SARS-CoV and SARS-CoV-2 antigens and combining them with Mymetics' virosomes for the development of a safe and effective Covid-19 vaccine. Mymetics piloted and successfully produced different virosome formulations, which incorporate the SARS-CoV-2 recombinant protein. The preclinical studies started in September 2020 at Baylor College of Medicine where the formulations are tested and compared in a pre-defined preclinical model.
In June 2020, Mymetics was supported for virosome-based Covid-19 vaccine development from European Vaccine Infrastructure project (Transvac2). In November 2020, Mymetics started a Helmholtz Center of Infection Research (HZI) in Germany to evaluate the safety and immunogenicity of different virosome-based Covid-19 vaccine candidates by intramuscular and intranasal administrations. The virosome formulations incorporate and evaluate two different SARS-CoV-2 antigens, one full length stabilized S protein, for which Mymetics is collaborating with the group of Dr. Rogier Sanders at the Amsterdam Medical Center of the University of Amsterdam, the Netherlands, and the second is a receptor binding domain recombinant protein of SARS-CoV-2. The study at HZI is part of the Transvac2 services, funded by the European Union's Horizon 2020 research and innovation program under grant agreement N° 730964.
In November 2020, Innosuisse (Swiss Innovation Agency) granted Mymetics and Insel Gruppe AG, of which the Inselspital, Bern University Hospital, are part of, were awarded a grant from the Swiss Innovation Agency (Innosuisse). The grant will allow Mymetics in collaboration with the Department of Pneumology at the Inselspital, Bern University Hospital and the Department of Biomedical Research DBMR of Bern University to execute multiple preclinical studies investigating Mymetics' virosome-based Covid-19 nasal vaccine candidate for safety and tolerance, and its capacity to elicit protective respiratory immunity to block nasal infection and virus spreading to the lungs and brain. These studies were executed during 2021 and 2022 but generated mixed results. While the comparator intramuscular virosome vaccine worked very well and generated good immunological responses, the intranasal virosome vaccine formulation had to be adjusted several times to optimize the immune responses.
As of December 31, 2022, Mymetics was planning to start pre clinical SARS-CoV-2 challenge studies, but uncertainty about funding has delayed this further development.
HIV-1 and AIDS
The company's prophylactic HIV-1 vaccine candidate includes virosomes linked to conserved antigens (epitopes) derived from the HIV-1 gp41 proteins from the clade B, the dominant clade found in Europe and North America. The vaccine is designed to trigger blood and mucosal antibodies of both isotype IgG and IgA, for example in the vaginal and intestinal tracts. The rationale for the design of the vaccine was based on the observation that certain people who are repeatedly exposed to HIV-1 do not contract infection; they were shown to have mucosal antibodies in the semen or vaginal secretions against the HIV-1 gp41 that apparently protect them. The company intends for its vaccine to imitate 'Mother Nature'.
Mymetics is evaluating further collaboration opportunities, specifically if the protection data in Non-Human Primates from the NIH project is positive, it plans to apply for grant funding for the acceleration towards the clinical trial development for the Mymetics HIV vaccine candidate.
Malaria
The malaria vaccine design is based on optimized mimicry of the native parasite protein structure and eliciting antibodies against two stages of the parasite life cycle, unlike 70% of vaccine candidates, which target only one or the other parasite. It is among the rare malaria vaccine candidates able to also boost existing malaria immune responses (it has both prophylactic and therapeutic effects) in subjects that were previously exposed to malaria. A second malaria vaccine candidate has been investigated as Mymetics virosome technology and know-how had been selected to collaborate with PATH-MVI and the Laboratory of Malaria Immunology and Vaccinology (LMIV) (NIAID) to develop a transmission blocking malaria vaccine candidate based on the virosome technology and two antigens provided by LMIV.
From January to November 2018, Mymetics had continued to collaborate with LMIV and produced different malaria transmission blocking virosome formulations that were tested in in vivo pre-clinical studies at LMIV and compared with clinical trial formulations.
Due to limited resources and the focus on Covid-19, Mymetics has halted the further development of its malaria vaccine for an indefinite time.
Respiratory Syncytial Virus (RSV)
The RSV vaccine consists of the reconstituted membrane of RSV containing the native viral proteins, which can be adjuvanted with a lipopeptide or other adjuvants. In mice, the company's RSV vaccine was shown to induce cellular and humoral immunity to the virus, with a balanced Th1/Th2 response, resulting in protection against a live virus challenge, and without inducing 'enhanced disease' (a skewed Th1/Th2 response being the hallmark of enhanced disease). In cotton rats, a better model than mice for RSV, the vaccine protected against a live virus challenge, without inducing enhanced disease. In a direct comparison with the 1960's vaccine of another pharmaceutical company that caused severe safety issues in infants, another group of cotton rats was immunized with formaldehyde-inactivated virus and developed enhanced disease after vaccination and challenge. Mymetics focuses on developing an RSV vaccine for elderly followed by a vaccine for children.
In December 2013, Mymetics signed a license and collaboration agreement with RSV Corporation (RSVC), a dedicated entity specifically set-up for developing the Mymetics RSV vaccine. Under this agreement Astellas Pharma Inc. agreed to fund RSVC's development of the virosome vaccine technology, licensed from Mymetics for the respiratory syncytial virus (RSV) through completion of a Phase 2b human proof of concept study. Based on the strategic partnership, Astellas Pharma Inc. received exclusive rights to acquire RSVC, as well as further develop and commercialize the vaccine product. The company provided research and development activities for the pre-clinical phases, prepared for the upscale production and assay developments and provided further scientific advice on the development of the RSV virosome vaccine.
In January 2016, Mymetics received notice from RSV Corporation (RSVC) that it would no longer pursue the development of a vaccine technology for RSV in order to focus on other infectious therapies. The License and Collaboration Agreement (LCA), which was signed on December 27, 2013, between Bestewil Holding BV and RSVC, was formally terminated as of July 25, 2016. Mymetics regained all the rights, results, and data related to the research, development, and commercialization of this vaccine candidate.
Following the termination of the license and collaboration agreement with RSVC in 2016, Mymetics has put the further development of this vaccine candidate on hold for an indefinite time.
Intranasal Influenza
The intranasal influenza vaccine consists of the reconstituted membrane of influenza virus, also containing a lipopeptide adjuvant. In mice, intranasal application of virosomes without adjuvant does not induce immunity to influenza; however, incorporation of the lipopeptide in the virosomes produces a candidate vaccine that does induce cellular immunity, as well as serum and mucosal antibodies to the virus. The vaccine was licensed to Solvay Pharmaceuticals, a major European pharmaceutical company, which was acquired by Abbott Laboratories. Since October 2011, Mymetics has been able to reclaim the intra-nasal influenza vaccine in its portfolio as Abbott decided not to continue the product due to strategic decisions.
Chikungunya Virus (CHIKV)
Mymetics' novel approach in CHIKV vaccine development is the generation of virosomal vaccines using the CHIKV envelope glycoproteins produced in insect cells. Virosomes are reconstituted viral envelopes, consisting of membrane lipids and viral spike glycoproteins. The external surface of the virosome resembles that of a virus particle, with spike (glyco) proteins protruding from the lipid membrane. Virosomes lack viral genetic material. The advantage is that highly purified CHIKV spikes (expressed in insect cells) will be used to constitute the virosomes. Thus, insect cell material (DNA, proteins) will be completely absent from the virosomal vaccine material. CHIKV spikes can be obtained from different sources: VLPs, from baculovirus virions or from the plasma membrane of insect cells.
Since January 2016 to as of December 31, 2022, Mymetics had started the discovery phase of this project where it is assessing the overall CHIKV glycoprotein yields in scale up insect cell culture. In this project, the company has worked with the University of Wageningen in the Netherlands that has extensive expertise in this field. The project has been delayed due to other priorities and it has no plan to restart this.
Immunotherapy Evaluation Projects
Mymetics is exploring the application of the virosome vaccine technology for the use in immunotherapy in the fields of allergy and in oncology. This exploration and testing are done through collaboration and research projects with specialist biotech companies in the appropriate fields.
Allergy
In April 2018, Mymetics engaged in a Research and Option to License Agreement with Anergis SA. Under the agreement, a mice proof-of-concept immunogenicity study evaluated the effects of the Bet v 1 COPs (Anergis’ proprietary birch pollen allergy peptides) using the five subcutaneous injection schedule used in former AllerT clinical trials.
In October 2019, Mymetics announced that Anergis SA started a new study with Stallergenes Greer SA whereby the COP-Virosomes were tested in the therapeutic mouse model of birch allergy in comparison with positive controls, i.e., birch allergen and birch pollen extract. This model has been confirmed as having predictive value towards the future clinical efficacy of new AIT treatment candidates.
In May 2020, Mymetics announced the results of the study with Stallergenes Greer, a worldwide leader in allergen immunotherapy (AIT) and Anergis, a leader in ultra-fast AIT research and development. The results showed that a treatment with COP-virosomes was able to cure allergic asthma in birch pollen sensitized mice and that the COP-virosomes were significantly superior to the COP or the virosome alone, confirming the synergy between COP and virosomes to foster an improved second-generation AIT treatment.
In January 2021, following the two successful studies with its virosome platform, Mymetics announced the acceptance of its joint publication in the scientific journal Clinical & Experimental Allergy with Stallergenes Greer SA and Anergis SA, with the title: Bet v 1 contiguous overlapping peptides anchored to virosomes with TLR4 agonist enhance immunotherapy efficacy in mice.
As of February 1, 2021, Anergis SA entered into liquidation since it was not able to raise sufficient funds to continue to operate. As of June 17, 2022, Anergis SA entered into bankruptcy proceedings.
Oncology
Mymetics has strong data that shows that its virosomes have the capability to not only trigger good antibody responses, but also are able to trigger specific T-Cell responses as virosomes are able to be absorbed and processed by dendritic cells when specific antigens are incorporated into virosomes. This is of particular importance for developing a specific cancer immunotherapy. Since Q4 2018, Mymetics was exploring the possibilities to collaborate with biotech companies in the field of oncology. The project with eTheRNA immunotherapy did not result in the desired responses. However, other projects are still ongoing. One of these projects started in May 2020, which is a research project with IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win technology. Due to Covid-19 restrictions, the study was delayed and further collaboration is not yet planned.
Material Third Party Agreements
For the development of its vaccines, the company has entered into several agreements in the form of license agreements, exploitation agreements, or co-ownership agreements with third parties. These third parties provide specific experience and capabilities or provide access to specific know how, which are not the core competence of Mymetics.
INSERM
The Co-Ownership Agreement dated January 8, 2008, for two patents PCT IB2005/001180 and PCT IB2005/001182, has been cancelled by Mymetics as it does not fit the strategic direction of the company.
Exploitation Agreement dated January 8, 2008, that allows Mymetics to have global rights to develop, promote, produce, co-produce, sell, and distribute HIV products based on any of the following three patents: PCT IB2005/001180, PCT IB2005/001182 and PCT IB 2006/000466 has been amended on August 4, 2011 and now only includes the PCT IB 2006/000466 patent. On October 9, 2013, this agreement was renegotiated and amended to link the progress of the related technology to milestones.
Strategy
The company's strategy is to strengthen its virosome and membrane protein know how, expertise and intellectual property and extend the application of its key scientific approaches to new vaccines by leveraging the effective and safe virosome vaccine technology and know-how; building on its leading expertise in membrane proteins and lipid membranes; leveraging its expertise in incorporating adjuvants and antigens in the lipid membranes and on the same particle; advancing existing vaccine candidates through Phase II clinical trials with its partners; maintaining a comprehensive IP portfolio; and entering into strategic partnerships with leading pharmaceutical companies and research organizations.
Research and Development
For the year ended December 31, 2022, the company's research and development expenses were €1,442.
History
The company was founded in 1990. It was formerly known as ICHOR Corporation and changed its name to Mymetics Corporation in 2001.
