Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
INOVIO Completes Enrollment of Phase 1B Clinical Trial for its DNA Vaccine Candidate Against Lassa Fever, INO-4500, in West Africa
PLYMOUTH MEETING, Pa., Oct. 26, 2021 /PRNewswire/ -- INOVIO announced its Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, completed full enrollment of 220 participants. This trial (LSV-002 - NCT04093076) is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, and is the first vaccine clinical trial for Lassa fever conducted in West Africa, where the viral illness is endemic.
INOVIO is advancing INO-4500 with full funding from CEPI, a global partnership between public, private, philanthropic, and civil society organizations to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people in need during outbreaks. The company was awarded up to US $56 million from CEPI in 2018 under which INOVIO is advancing vaccine candidates against Lassa fever and MERS. INOVIO and CEPI plan to establish a stockpile of these vaccines for emergency use after P2 testing, if successful. As part of CEPI's $3.5B plan to reduce, or even eradicate, the risk of epidemics and pandemics, CEPI's goal is to get a licensed Lassa vaccine for use in endemic countries. The forward-looking strategy also includes the aim to advance clinical trial capacity, infrastructure, and expertise in low- and middle-income countries.
Dr. Laurent Humeau, INOVIO's Chief Scientific Officer, said, "Completing enrollment of LSV-002 is an important milestone for the clinical development of INO-4500, our DNA vaccine candidate against Lassa fever. INOVIO and our partners are committed to addressing this significant unmet public health need, considering the prevalence of the Lassa virus, the potential severity of Lassa fever, and the lack of any licensed vaccines or other treatments for this disease.
We are grateful to CEPI for their support as we work with our partners to advance INO-4500."
Dr. Humeau added, "This milestone represents another example of the progress we are making across INOVIO's infectious disease portfolio, including our late-stage development efforts with INO-4800 against COVID-19 as well as advancements with INO-4700 against MERS."
Dr. Melanie Saville, Director of Vaccine R&D at CEPI, said, "I am delighted to see the rapid progress in enrollment for this pivotal trial to assess the safety and immunogenicity of INOVIO's promising Lassa vaccine candidate in Ghana. At a time when much scientific attention is drawn towards COVID-19, it is critical that we continue to progress research against this potentially fatal disease which affects many countries across the West African region. Data provided by this study will be critical for assessing potential of the candidate to advance into late-stage clinical trials and towards our goal, at CEPI, Lassa vaccine for use in endemic countries."
Professor Dorothy Yeboah-Manu, Director of the Noguchi Memorial Institute for Medical Research (NMIMR) in Ghana, said, "This achievement is another feather in our cap that goes to demonstrate the expertise and dedication of the NMIMR in the global fight against infectious diseases. As a leading biomedical institute in the West African sub region and considering the public health importance of Lassa fever in West Africa, we are happy to be part of INO-4500 development, indeed the fight against these emerging infections requires us to work together and we look forward to such further collaborations."
Professor Kwadwo Koran, the PI for the Noguchi Memorial Institute for Medical Research site in Ghana, said, "It has been exciting working on this trial, a great achievement for the Institute and the country as whole. Personally, I see this as NMIMR continuing in the noble ideals of contributing to solutions for public health problems.
in the sub region. With the successful enrollment, even under the trying conditions engendered by the COVID-19 pandemic for nearly two years now, the Institute and indeed the country as a whole has demonstrated the capacity to be able to conduct early-stage trials in support of product development for emerging and re-emerging diseases such as Lassa Fever. It is my sincere hope that this will be built upon not only for Lassa Fever but other important infections that plague us."
10/26 WHO and the Ministries of Health of Colombia, Mali, and the Philippines announce the launch of the co-sponsored Solidarity Trial Vaccines.
This is an international, randomized clinical trial platform designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines selected by an independent vaccine prioritization advisory group composed of leading scientists and experts.
This announcement comes after the relevant regulatory authorities and ethics committees have granted approval for the study to progress.
The national principal investigators and their research teams in Colombia, Mali, and the Philippines have begun recruiting volunteers joining the trial.
The Solidarity Trial Vaccines is beginning with research teams in over 40 trial sites spread across the three countries. National research teams bring together experienced investigators well-versed in good clinical practice and the conduct of clinical trials.
To date, the independent vaccine prioritization advisory group has reviewed the evidence of around 20 candidate vaccines. Following the recommendation of the working group, 2 candidate vaccines are now included in the Solidarity Trial Vaccines. These are a protein subunit vaccine from Medigen, and a DNA vaccine encoding the spike protein from Inovio.
Two additional vaccines are expected to enter the Solidarity Trial Vaccines once additional evidence and documentation has been reviewed and accepted as satisfactory by the independent vaccine prioritization advisory group.
It is expected that other candidate vaccines currently under consideration by the vaccine prioritization advisory group may be added to the trial in late 2021 and during 2022.
The Solidarity Trial Vaccines aims to accelerate the evaluation of multiple promising candidate COVID-19 vaccines, contributing to the creation of a larger portfolio of vaccines needed to protect people from COVID-19 around the world. The trial has the additional potential to uncover second-generation vaccines with greater efficacy, conferring greater protection against variants of concern, offering longer duration of protection, and/or using needle-free routes of administration.
https://www.who.int/news/item/26-10-2021-who-statement-on-solidarity-trial-vaccines
11/30/21 2:25 PST DNA encoded monoclonal antibody (dMAb®) treatment for infectious disease and beyond
Dr Laurent Humeau, CSO–EVP of R&D, Engineering and Clinical Developments, Inovio
The Vaccine & Immunotherapy Congress West Coast is returning to reunite the community in real life (yes, in-person!) - on 30 November - 2 December in San Diego!
https://www.terrapinn.com/conference/world-vaccine-immunotherapy-congress-west-coast/speakers.stm?utm_source=pardot&utm_medium=email&utm_campaign=email&utm_term=email
COVID-19 dMAb P1/P2 to start before 12/15/21.
“The dMAb candidates will then be advanced into preclinical studies and then into rigorous, first-in-human clinical trials within one year of funding.” 12/15/20
https://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-to-Develop-DNA-encoded-Monoclonal-Antibody-dMAb-Candidates-to-Treat-COVID-19-with-Funding-from-the-Defense-Advanced-Research-Projects-Agency-DARPA-and-the-Department-of-Defenses-DoD-Joint-Program-Executive-Office-for-Chemical-Biological-Radiol/default.aspx
10/5 AZN seeks EUA for AZD7442 also being dMAb®-cloned by Ino
Under DARPA’s two-year grant, INOVIO and Wistar teams will construct COVID-19 dMAb candidates designed to mirror AZN’s traditional recombinant monoclonal antibody candidates now being tested in clinical trials to treat COVID-19, such as AZD7442.
https://news.vumc.org/2021/10/05/astrazeneca-seeks-emergency-approval-for-covid-19-antibodies-isolated-at-vumc/
4800 P3 is effectively fully funded by the WHO. MOU signed with Columbia to manufacture there. 4800 heterologous Prime-Booster is funded by Advaccine. 4802 P1/2 will be externally funded by CEPI, BARDA, or NIAID under HHS pending news. AZN COVID-19 dMAb was funded by DARPA. MERS, Lassa fever are funded by CEPI, stockpiled by DoD, CEPI after P2. Ebola booster is funded by DoD. VGX-3100 was licensed to Apollo in China. C2K was licensed to Apollo in SK for $37M per GeneOne. JK said GBM success would expand collaboration with REGN to new diseases.
4802 will likely become a Blockbuster.
Many NGOs and BPs know that and are very interested in it. Hope BPs don’t resort to hostile takeover as Sanofi has done for the following CV vaccine company.
Sanofi acquired all outstanding shares of Translate Bio for $38.00 per share in cash, representing a total equity value of about $3.2 billion.
Ino has a deep pipeline and several platforms.
“In terms of funding for 4800 P3 trial we are asking various parties for support and are also considering doing the P3 together with Advaccine in order to save on costs.
Various NGOs have expressed interest in our 4802 program; now, it can be a long road from interest to actual financial support but we are trying to do everything possible to minimize our burn rate. We hope that today’s pre print is the first step on that road.
We are working with our CRO to select and prepare required documents to agencies of various nations where we are targeting our P3 trial. We are hoping to have additional news to share with you in the coming days and weeks.” 5/12/21
“We have begun talks with various organizations like CEPI, Barda, etc for the support of our INO-4802. Hopefully, we will receive a positive response....” 4/15/21
10/21/22 WHO considering solidarity trials for covid-19 vaccines
The aim is to test jab efficacy across different geographies to help speed up regulatory process
MUMBAI : The World Health Organization (WHO) is in talks with vaccine makers to start a solidarity trial for covid-19 vaccines that is modelled on the lines of a global solidarity trial for therapeutics, said people aware of the development.
The aim of the solidarity trial for vaccines that are in the early and mid-stage of clinical trials is to test vaccine efficacy across different geographies that could help speed up the regulatory process and also ensure that vaccine makers have diversity in their trial participants that could help establish vaccine effectiveness across different ethnic and racial groups.
A WHO spokesperson asked for additional details to respond to queries from Mint.
Vaccine makers in India and South Africa are in talks with WHO to get their vaccines to the solidarity trial, a senior official at a vaccine manufacturer from India said, requesting anonymity, as the discussions are still private. “We have agreed to participate in the trial once we receive an approval for our vaccine candidate from the Indian regulators," said the official whose company was approached by WHO.
The solidarity trial would look at new vaccine platforms such as messenger RNA (mRNA) vaccines that are under development.
Last year, WHO decided to establish a global solidarity trial for covid-19 therapies across 52 countries involving 600 hospitals to test the effectiveness of re-purposed drugs such as Remdesevir, Interferon, hydroxychloroquine, and Lopinavir. The trials proved that these drugs had little or no impact on reducing mortality rates, duration of stay, and initiation of ventilation of hospitalized covid-19 patients.
A solidarity trial for covid treatments was possible as companies such as Gilead, IPCA, Johnson & Johnson, and Novartis donated medicines to the trial. However, the biggest challenge for this initiative is likely to be the sharing of vaccine doses by countries and vaccine makers. At least more than a million doses would be required to start a multi-country trial of this scale.
Several companies who are in the early and mid-stage of covid-19 vaccine development have been facing hurdles in getting comparator vaccines as placebo controls are no longer viable due to the availability of vaccines. In September, the Coalition for Epidemic Preparedness and Innovations (CEPI), a not-for-profit organization funding vaccine research, called on governments and pharma companies to ease supply for clinical trials.
“While the number of doses of comparator vaccine needed to support clinical trials is small, covid-19 vaccines remain scarce and they are not available for purchase in the open market," said Melanie Saville, director of vaccine research and development, CEPI. The approved vaccines are bound by contractual agreements between vaccine companies and governments that limit the use of these vaccines to public vaccination programmes, Saville said. “Thus far, vaccine manufacturers have been reluctant to change this arrangement, threatening to bring vital covid-19 vaccine research and development to a standstill," Saville said.
One of the Indian vaccine companies approached by WHO has also said that the company will be able to donate only a few doses to this initiative. In India too, vaccine makers such as Biological E and Genova encountered problems with vaccine development due to the unavailability of comparator vaccines.
https://www.google.com/amp/s/www.livemint.com/v/s/www.livemint.com/news/india/who-considering-solidarity-trials-for-covid-19-vaccines/amp-11634760551693.html%3famp_js_v=0.1&usqp=mq331AQKKAFQArABIIACAw%253D%253D#ampf=
10/22/21 TAIPEI (Taiwan News) — The World Health Organization (WHO) is including Taiwan's domestic COVID-19 vaccine developed by Medigen Vaccine Biologics Corp. (????, MVC) in its Phase III trials and has already tested the shot on human subjects prior to the trials to confirm its safety and ability to provide an immune response.
On Wednesday (Oct. 20), a consent form appeared on the WHO website listing four latest COVID vaccine candidates in the organization's Solidarity trial. The four candidates listed include Medigen's MVC-COV1901, Arcturus' ARCT-021, Codagenix's COVI-VAC, and Inovio's INO-4800, the latter three of which are developed by American companies.
According to the ISRCTN Registry, the Solidarity trial for the COVID-19 candidates is sponsored, run, and funded by the WHO. The multi-country trial is recruiting participants from Jan. 2021 to Jan. 2022 and will be published on Jan. 7, 2022.
To be eligible, participants must be at least 16 years of age and have lived in a designated country for a minimum of six months. Volunteers will be randomly administered the vaccine or a placebo and will be contacted weekly for 52 weeks to see if there are any symptoms or adverse reactions, with testing administered if COVID-19 is suspected.
Based on the consent form, Taiwan's MVC-COV1901 is composed of a combination of spike proteins and adjuvant. Arcturus' ARCT-021 is an mRNA vaccine, Inovio's INO-4800 is a DNA vaccine, and Codagenix's COVI-VAC is based on a live attenuated virus.
The organization indicated that it has already carried out preliminary testing of Medigen's jab. The document added that the research demonstrated that "these vaccines are safe and that they prompt the immune system to develop a response that could potentially protect from COVID."
https://www.taiwannews.com.tw/en/news/4322230
ISRCTN registry
https://www.isrctn.com/ISRCTN15779782
10/19/21 Update: P2 Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in 542 Healthy Volunteers
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
[ Not yet => Recruiting]
Irbid, Jordan, 21110
Pharmaceutical Research Center / Jordan University of Science and Technology
[Recruiting]
Irbid, Jordan, 22110
Kenya
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)***[Added recently]
[Not yet recruiting]
Kericho, Kenya, 20200
Ahero Clincal Trials Unit
[Not yet recruiting]
Kisumu, Kenya, 40100
Lebanon
American University of Beirut Medical Center
[Recruiting]
Beirut, Lebanon
Hammoud Hospital University Medical Center
[Recruiting]
Saida, Lebanon
https://clinicaltrials.gov/ct2/history/NCT04588428?A=13&B=14&C=merged#StudyPageTop
Colombia will manufacture vaccines against Covid with the pharmaceutical company Inovio | Government | business
October 21, 2021
As part of the strategies and projects to manufacture vaccines in the country and to achieve a CONPES of sanitary security, Colombia signed a new Memorandum of Understanding this time with the American pharmacist Inovio.
At the signing ceremony in the Casa de Nariño, the Minister for Health and Social Protection, Fernando Ruiz Gómez stated that for the portfolio and the sector “it is a very special moment for the opportunity to sign this agreement“.
“Since the last week of July of this year, our first mission to look into health security was chosen to be in the United States and we had the opportunity with Ambassador Pinzón to hold discussions with various pharmaceutical companies in the United States, with Moderna, Pfizer, AstraZeneca“He counted.
In these discussions the possibility of producing vaccines in Colombia was addressed. “We arrived a little disappointed because Latin America was not a priority for production and unfortunately we had no relationship with Inovio. We have to thank Ambassador Goldberg, his persistence and work have helped us a lot“Declared Minister Ruiz.
Inovio knows the four experiences of clinical trials in the country and this will be the basis to move forward quickly, in the development of vaccines in Colombia, In addition, health security is a goal and should be concretized in the country on the basis of these agreements.
https://newsbeezer.com/colombiaeng/colombia-will-manufacture-vaccines-against-covid-with-the-pharmaceutical-company-inovio-government-business/
“including the possibility of integrating the work being carried out by the WHO Solidarity vaccine trial in Colombia that includes INOVIO as one of the four vaccine candidates in the clinical studies. As we discussed in the previous meeting today, the possibility of moving forward quickly is due to INOVIO considering Colombia as a priority country,” 10/21/20 Columbia, Brazil ????,Mexico ???? , Philippines ???? host the WHO-funded SVT. Combining INNOVATE P3 with SVT trial will save Ino money. Ino cleverly targets the same countries which host SVT. Up next are Argentina, Peru ????.
PLYMOUTH MEETING, Pa., Oct. 21, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced the signing of a non-binding memorandum of understanding (MOU) with Colombia's Ministry of Health and Social Protection reflecting the intent to advance efforts to combat the pandemic and endemic threat posed by COVID-19 and to better prepare for future public health emergencies. The MOU creates a framework for a collaboration arrangement under which INOVIO and the government plan to explore knowledge sharing, technology licensing, and capacity building that support developing and producing vaccines and other biopharmaceuticals in Colombia. The potential results of these efforts include developing local manufacturing capabilities for INOVIO's DNA medicines and related products and technologies.
Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO's memorandum of understanding with Colombia is a sign of our shared commitment to develop and advance potentially life-saving DNA medicines and vaccines to those in need. This partnership grew out of the intended advantages of INOVIO's DNA medicines platform to address current and future global health threats due to the anticipated stability of its product candidates, speed of design and manufacture, as well as the immune response and tolerability that have been observed to date in clinical trials."
The framework of the planned collaboration builds on INOVIO's recently announced authorization to proceed in Colombia with the Phase 3 segment of its global Phase 2/3 clinical trial, INNOVATE, for INO-4800, the company's DNA vaccine candidate for COVID-19. INOVIO is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries underserved by COVID-19 vaccines throughout Latin America, Asia, and Africa. INOVIO previously announced approvals to conduct the trial in Brazil, the Philippines, and Mexico.
Dr. Fernando Ruiz Gomez, Minister of Health and Social Protection, Republic of Colombia, said, "Today is very special for us. We have a complete circle of what is possible with a North American company for the production of vaccines, including the possibility of integrating the work being carried out by the WHO Solidarity vaccine trial in Colombia that includes INOVIO as one of the four vaccine candidates in the clinical studies. As we discussed in the previous meeting today, the possibility of moving forward quickly is due to INOVIO considering Colombia as a priority country, a gesture that we appreciate, and is indicative of the will of our country and the Ministry of Health to advance the development of vaccines in Colombia."
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Announces-Collaboration-with-Colombia-Memorandum-of-Understanding-Focuses-on-Protecting-Against-COVID-19-and-Supporting-Broader-Health-Preparedness-Initiatives/default.aspx
“In our purpose of advancing the development and production of vaccines in Colombia, not only for covid-19 but for other pathologies, we attended the signing of the memorandum of understanding with @InovioPharma , an agreement that is consolidated after our visit to the United States.”
En nuestro propósito de avanzar en el desarrollo y producción de vacunas en Colombia, no solo para covid-19 sino para otras patologías, asistimos a la firma del memorando de entendimiento con @InovioPharma, acuerdo que se consolida luego de nuestra visita a Estados Unidos. pic.twitter.com/qyyLg0sEAN
— Iván Duque 🇨🇴 (@IvanDuque) October 21, 2021
I listened to the tweet of the Minister of Health of Colombia speaking. He said some very interesting and powerful things. 1. Colombia's Ambassador has been trying to connect with an American Biopharmaceutical Company since July, specifically Moderna, Pfizer and AstraZeneca to no avail. In his words, Latina America is not a priority for them, which disappointed the Colombian officials. 2. They want a biopharm that will not only deliver Covid vaccines, but will also produce them in Colombia for Colombia and Latin America. He expressed great pleasure that they have found a biopharm called Inovio that will set up production in their country. 3. The Minister expressed excitement to be announcing an agreement with Inovio! You could see the pride on his face that they have won over a very capable biopharm with DNA technology and stability that would partner with Colombia. 4. He stated that Inovio was integrated with global organizations like the WHO and others that was important to Colombia. 5. He expressed the hope and even confidence that the partnership between Colombia and Inovio would quickly be productive and fruitful. Dr, Kim sat next to the President of Colombia and near the Health Minister on a stage. Very impressive indeed. I listened to it 4 times and enjoyed it more each time. This doesn't happen by accident and is the result of years of quality track record that is understood and appreciated by the Colombia Health Ministry.
By Benjamin
¡Atención! Colombia firma memorando de entendimiento con Inovio, con el objetivo de producir vacunas en el territorio nacional. El ministro @Fruizgomez explica la importancia de este acuerdo para garantizar la seguridad sanitaria del país. pic.twitter.com/yipzUX3cJf
— MinSalud Colombia 🇨🇴 (@MinSaludCol) October 20, 2021
China approves first mixed-vaccine trial as Delta spreads
by zonia wiers October 20, 2021
BEIJING: China’s drug regulator has approved the country’s first mixed-vaccine trial, a company involved in the study said, as the rapid spread of the Delta variant raises concern about the efficacy of domestically produced jabs.
The trial will test the efficacy of combining an “inactivated” vaccine made by China’s Sinovac with a DNA-based one developed by US pharmaceutical company Inovio, a statement issued on Tuesday said.
The statement was put out by Advaccine Biopharmaceuticals Suzhou, Inovio’s trial partner in China.
Preclinical work has found that “two different vaccine applications… produce an even stronger and more balanced immune response”, Advaccine chairman Wang Bin said in the statement.
There are several types of Covid vaccines, including those using an inactivated or weakened virus to generate an immune response, and more cutting-edge RNA- or DNA-based jabs that use engineered versions of the coronavirus’ genetic code to create a protein that safely prompts an immune response.
Five out of the seven vaccines approved in China are two-shot inactivated vaccines.
Their published efficacy lags RNA jabs by Pfizer-BioNTech and Moderna, which have pre-Delta success rates above 90%.
The World Health Organization has said there is still not enough data to say whether using two different vaccines together is safe or can boost immunity.
Inovio has not published any efficacy data from its global clinical trials. It is the first DNA-based vaccine to be trialled in China.
China is battling its worst coronavirus outbreak in months, with officials saying many of those infected had already been vaccinated.
This has added to calls for China’s two biggest vaccine producers — state-run Sinopharm and privately owned Sinovac — to provide data proving their jabs work against the Delta variant.
Beijing is yet to approve any foreign vaccines for domestic use. — AFP
https://senegalbgc.org/blog/2021/10/20/china-approves-first-mixed-vaccine-trial-as-delta-spreads/
Colombia will produce vaccines against covid-19 in association with the pharmaceutical company Inovio
This decision opens the way for the country to continue associating with more pharmaceutical companies and to have its own vaccines
October 20, 2021
The Colombian Minister of Health, Fernando Ruiz Gómez, speaks in an interview with Efe today, at the Colombian embassy in Washington (USA). EFE / Lenin Nolly
This October 20, it was known that Colombia signed a new memorandum of understanding, this time with the US pharmaceutical Inovio. At the signing ceremony held at Casa de Nariño, the Minister of Health and Social Protection, Fernando Ruiz Gómez, indicated that for the portfolio and the sector, "it is a very special moment due to the possibility of signing this understanding agreement."
“Since the last week of July of this year, our first mission, to seek the issue of health security, was elected to the United States and we had the opportunity with Ambassador Pinzón to establish conversations with various pharmaceutical companies in the United States, with Moderna, Pfizer, AstraZeneca ” , he said in his speech.
He pointed out that in those conversations the possibility of producing vaccines in Colombia was raised, which, since the instruction of the President of the Republic and Ministry of Health, has been working on.
We arrived a little disappointed because Latin America was not a priority for production and, unfortunately, we did not have a relationship with Inovio. We have Ambassador Goldberg to thank, his persistence and hard work has helped us a lot.
“Today it is special for us to have this complete circle of having the possibility, which was the first one we sought, to have interaction with a company in the United States, to integrate it with the work that has been carried out by the WHO with the Solidarity study, in which Inovio is like one of the four experiences of clinical studies that we will do ”, said the minister.
In addition, all the possibilities of advancing "very quickly, because the will of Inovio, which considers Colombia as a priority country, and also the will of our country and Minsalud to advance in everything that is the development of vaccines in Colombia" Ruiz said, recalling that health security is an objective and is expected to be realized from these agreements.
"We need to go up and grow more in vaccination speed": MinSalud
On the other hand, the Minister of Health and Social Protection, Fernando Ruiz Gómez, presented an overview of the progress of vaccination against covid-19, highlighting the intensification days held during this week in different regions of the country.
Likewise, the minister assured that although vaccination has grown in recent weeks, with 250,000 and 300,000 daily doses applied, “we need to go up and grow even more at that speed. We need to vaccinate 7.5 million people for the first doses, ” said Ruiz Gómez.
On the other hand, the head of the health portfolio stressed that it has been observed that there is still a population of 70 and 80 years old and more who still do not receive their vaccines, which is risky, since it is the population group that is reporting the most deaths from covid today.
"In highly rural municipalities we still have very large populations that have not been vaccinated," said the minister, noting that efforts must be added to reach these populations with vaccines.
“We are doing well, but we need to meet the goal; therefore, we need to cover the Colombian population, protect it, it is our responsibility to move forward, "he added.
In the same sense of protecting the population, he pointed out that people over 70 who attend the vaccination points for their booster doses will not need scheduling. "Whoever arrives for their vaccination without being scheduled must be given the vaccine."
A concern raised by the minister has to do with pregnant women, noting that there is a record of 188 deaths and the covid became the leading cause of death for this group.
“It is very important that the health secretaries and the EPS follow up the doctors who do the prenatal control. I especially want to ask the EPS to carry out an analysis to see if they are effectively recommending their vaccination to pregnant women , " said the minister, emphasizing the need to protect this population group against covid-19.
Another task raised by the minister is to vaccinate migrants, both regular and irregular, without any type of barriers. "To vaccinate they do not need to be insured," he said, making it clear that there are more than a million migrants loaded in Mi Vacuna and those that are missing will be loaded according to the census of the territorial entities.
“I want to ask departments and cities that are lagging behind to make a very strong effort. We want the secretaries to appear and the IPS and EPS become aware of continuing in the vaccination process ”, concluded Ruiz Gómez.
https://www-infobae-com.translate.goog/america/colombia/2021/10/21/colombia-producira-vacunas-contra-el-covid-19-en-asociacion-con-la-farmaceutica-inovio/?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui
“The countries do not have to start at the same time. Different countries will have different start dates based on conditions on the ground.” 10/20/21
Is it correct that 4800 participates in both INNOVATE P3 And the WHO-sponsored Solidarity Vaccine Trial which is head-to-head in Columbia, Mexico, Philippines, Brazil, and more.
Will INNOVATE P3 and SVT start early Nov 2021?
Will each country have to start at the same time or can they start independently depending on whether they are ready first.
Will the remaining countries be Argentina, Peru, Vietnam, Thailand, Nigeria, Uganda, Tunisia, Rwanda?
Dr Kim said 4802 P1/2 will start before this year end. Will it start in India, S. Africa?
From what I understood, 4802 P3 won’t be necessary, right?
The minister @Fruizgomez provided details of how through the signing of the memorandum of understanding with the US pharmaceutical @InovioPharma , Colombia is approaching the purpose of producing vaccines.
El ministro @Fruizgomez entregó detalles de cómo a través de la firma del memorando de entendimiento con la farmacéutica estadounidense @InovioPharma, Colombia se acerca al propósito de producir vacunas. pic.twitter.com/lUEU08zULg
— MinSalud Colombia 🇨🇴 (@MinSaludCol) October 21, 2021
Attention! Colombia signs a memorandum of understanding with Inovio, with the aim of producing vaccines in the national territory. The minister @Fruizgomez explains the importance of this agreement to guarantee the health security of the country.
¡Atención! Colombia firma memorando de entendimiento con Inovio, con el objetivo de producir vacunas en el territorio nacional. El ministro @Fruizgomez explica la importancia de este acuerdo para garantizar la seguridad sanitaria del país. pic.twitter.com/yipzUX3cJf
— MinSalud Colombia 🇨🇴 (@MinSaludCol) October 20, 2021
IMPACT (INOVIO INO-4802 Multi-variant Pan- COVID-19 Vaccine Trial)
• In parallel with INO-4800, INOVIO is developing a second generation, pan-COVID vaccine candidate, INO-4802
• Strategy against current and future variants of concern
• Can potentially provide boosting capabilities in addition to an initial vaccination regimen with INO-4800 and/or other first-generation vaccines, including both adenovirus and mRNA-based platforms
*Manuscript published as a preprint in bioRxiv, “Design, immunogenicity and efficacy of a Pan-SARS-CoV-2 synthetic DNA vaccine”; Posted August 04, 2021
• Cross-reactive immune responses demonstrated against current and emerging viral variants*
• Induced potent neutralizing antibodies, T cell responses, and protection in a pre-clinical model against the original wildtype strain as well as against the alpha, beta, gamma, and delta variants
Applied for CEPI, BARDA, NIAID fundings
Platform Development
? 3Q21: Initiate Phase 2 MERS study with INO-4700 funded by CEPI
? 4Q21: Fully enroll Phase 1B field study for Lassa with INO-4500 funded by CEPI
? 4Q21: Fully enroll Phase 1 Ebola study with INO-4201 as a booster to Ervebo®
INO-4800
? 1H22: Report interim efficacy data from Phase 3 INNOVATE trial
VGX-3100
? 4Q21: Report complete REVEAL 1 data (ITT, mITT, per protocol)
? 4Q21: Report on pre-treatment biomarker with QIAGEN
INO-5401
? 4Q20: OS18 data from Phase 1/2 GBM clinical trial (INO-5401 plus Libtayo®)
? 4Q21: Present 24-month overall survival and immunology data
HPV-associated disease; caused by HPV 6 and 11
• Rare, orphan disease with ~15,000 total active cases within the U.S., where virtually all of those require surgical procedures
• ~6,000 new cases per yr. in the U.S.
• Growths can lead to life-threatening airway obstructions
• SoC is lifelong surgery (repeated/multiple times per yr)
• Currently, disease is incurable and can only be treated by surgery to remove tumors, which temporarily restores the airway
• RRP may occur in adults as well as in children who are thought to have contracted the virus during childbirth
• INO-3107 granted Orphan Drug Designation in July 2020
• Dosed first patient in Ph 1/2 trial in November 2020 (n=63)
INNOVATE Global Phase 3 Trial
• INOVIO with Advaccine jointly conducting a global Phase 3 trial for INO-4800
• Healthy men and non-pregnant women 18 years and older (2.0 mg dose)
• Focus on countries currently underserved by vaccines, primarily in Latin
America, Asia and Africa
• Recently received regulatory approval to proceed from Brazil, Mexico, Colombia, and the Philippines, with other countries anticipated to follow
Heterologous Prime-Boost Trials
• Received regulatory allowance in China to conduct two clinical trials
investigating heterologous boosting with INO-4800
o Heterologousprime-boostsequentialimmunizationsusingINO-4800and
CoronaVac®
o Completed cross prime-boost pre-clinical animal tests; prime-boost
strategy stimulated high-level of humoral and cellular response
• The WHO also continues tracking 2 Variants of Interest (VOI) - Lambda and Mu - and at least 14 Variants Under Monitoring (VUM)1
• The US SARS-CoV-2 Interagency Group (SIG) now designates only Delta as a VOC2
• Delta is the most transmissible VOC discovered to date2
“The overarching goal is for COVID-19 vaccines to contribute significantly to the equitable protection and promotion of human well-being among all people of the world.”
“As part of DARPA's two-year grant, INOVIO and Wistar teams will construct COVID-19 dMAb candidates mirroring AZN’s traditional recombinant monoclonal antibody candidates currently being tested in clinical trials to treat COVID-19. dMAb candidates can be quickly developed and produced in vivo, offering a cost-effective and scalable therapeutic and preventive option for treatment of SARS-CoV-2 virus infection. The dMAb candidates will then be advanced into preclinical studies and then into rigorous, first-in-human clinical trials within one year of funding.” 12/15/20
COVID-19 dMAb P1/P2 to start before 12/15/21.
10/5 AZN seeks EUA for AZD7442 also being dMAb®-cloned by Ino
Under DARPA’s two-year grant, INOVIO and Wistar teams will construct COVID-19 dMAb candidates designed to mirror AZN’s traditional recombinant monoclonal antibody candidates now being tested in clinical trials to treat COVID-19, such as AZD7442.
https://news.vumc.org/2021/10/05/astrazeneca-seeks-emergency-approval-for-covid-19-antibodies-isolated-at-vumc/
https://www.genengnews.com/covid-19-candidates/inovio-pharmaceuticals-and-astrazeneca-dmabs/
3rd GBM Drug Development Summit. Conference Day Two
Thursday, January 20, 2022, 8:40A EST
A Deep Dive into DNA Damage Repair for GBM
Jeffrey Skolnik
VP Clinical Development Inovio
Inovio’s DNA Medicine for the Treatment of Glioblastoma:
• Using novel DNA-encoded medicines to treat human cancers such as GBM
• Generating robust, specific anti-tumor T cells against GBM antigens
• Combining DNA medicine with immune checkpoint inhibitors to build clinical responses
https://glioblastoma-drugdevelopment.com/full-event-guide/
Tuesday 30th November
Track EMERGING APPROACHES TO ANTIVIRALS
2:25 PST DNA encoded monoclonal antibody treatment for infectious disease and beyond
Dr Laurent Humeau, CSO–EVP of R&D, Engineering and Clinical Developments, Inovio
The Vaccine & Immunotherapy Congress West Coast is returning to reunite the community in real life (yes, in-person!) - on 30 November - 2 December in San Diego!
This is the West Coast edition of our most recognised World Vaccine Congress series, and it will attract hundreds of vaccine & immunotherapy leaders.
https://www.terrapinn.com/conference/world-vaccine-immunotherapy-congress-west-coast/speakers.stm?utm_source=pardot&utm_medium=email&utm_campaign=email&utm_term=email
https://www.terrapinn.com/template/Live/PDF/Vaccine--Immunotherapy-Congress-West-Co/10488/21818/bmV3LXd2aWMtLXd
3rd GBM Drug Development Summit. Conference Day Two
Thursday, January 20, 2022
A Deep Dive into DNA Damage Repair for GBM
Jeffrey Skolnik
VP Clinical Development Inovio
8:40A EST
Inovio’s DNA Medicine for the Treatment of Glioblastoma:
• UsingnovelDNA-encodedmedicinestotreathumancancerssuchasGBM
• Generating robust, specific anti-tumor T cells against GBM antigens
• Combining DNA medicine with immune checkpoint inhibitors to build clinical responses
January 18 - 20, 2022 | Boston MA
https://glioblastoma-drugdevelopment.com/
‘They rushed the process’: Vaccine maker’s woes hamper global inoculation campaign
The U.S. and the world made a huge bet on Novavax, but manufacturing problems are jeopardizing billions of doses earmarked for poor and middle-income countries. 10/19/21
The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.
But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.
The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.
The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.
Although Novavax recently attested to some of its analytics and testing issues in a quarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.
The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.
COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.
“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.
The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.
Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.
In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.
“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.
The White House and the Department of Health and Human Services did not respond to multiple requests for comment.
But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.
Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.
Unlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.
The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.
That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.
That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.
Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnson halted work at a Baltimore facility run by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.
J&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.
“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”
Unlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.
Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.
The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.
But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.
In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.
“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”
Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.
Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During a Sept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and close to submitting a final regulatory application.
“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”
U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.
And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.
Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.
“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”
9/28/21 NIAID issues new $36.3M awards to fund “pan-coronavirus” vaccines
“The available COVID-19 vaccines have proven to be remarkably effective at protecting against severe disease and death,” said NIAID Director Anthony S. Fauci, M.D. “These new awards are designed to look ahead and prepare for the next generation of coronaviruses with pandemic potential.”
The new awards are funded by NIAID’s Division of Microbiology and Infectious Diseases and its Division of Allergy, Immunology, and Transplantation through the Emergency Awards Notice of Special Interest (NOSI) on Pan-Coronavirus Vaccine Development Program Projects. The notice was issued in November 2020 while many SARS-CoV-2 vaccines were still under development because a critical need remained for prophylactic vaccines offering broad protective immunity against other coronaviruses, such as Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV).
The following awards have been issued:
University of Wisconsin, Madison
Project Title: PanCorVac (Center for Pan-Coronavirus Vaccine Development)
Grant: 1 P01AI165077-01
Brigham and Women’s Hospital, Boston
roject Title: Discovering Durable Pan-Coronavirus Immunity
Grant: 1 P01AI165072-01
Duke University, Durham, North Carolina
Project Title: Design and Development of a Pan-Betacoronavirus Vaccine
Grant: 1 P01AI158571-01A1
NIAID has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants.
Additional awards are expected to be issued under the NOSI in 2022 to support pan-coronavirus vaccine research at more institutions.
The new awards build on the $1.2 billion investment NIAID has made in coronavirus vaccine research since the COVID-19 pandemic began, including multiple projects in pan-coronavirus vaccine research in the NIAID intramural and extramural programs.
More information on these awards is available at reporter.nih.gov/.
https://www.nih.gov/news-events/news-releases/niaid-issues-new-awards-fund-pan-coronavirus-vaccines
Up Next CEPI, BARDA (under HHS) funding decision for 4802 P1/2 which will start this 4Q21 Possibly in India, S. Africa.
4/15/21 “We have begun talks with various organizations like CEPI, Barda, etc for the support of our INO-4802. Hopefully, we will receive a positive response.”
5/12 “In terms of funding for 4800 P3 trial we are asking various parties for support and are also considering doing the P3 together with Advaccine in order to save on costs.
Various NGOs have expressed interest in our 4802 program; now, it can be a long road from interest to actual financial support but we are trying to do everything possible to minimize our burn rate. We hope that today’s pre print is the first step on that road.
We are working with our CRO to select and prepare required documents to agencies of various nations where we are targeting our P3 trial. We are hoping to have additional news to share with you in the coming days and weeks.”
”all the antibodies will wane overtime, maybe four months, maybe six months, maybe eight months. Now that doesn't mean you don't have any protection because there are memory B-cells in your immune system that can rise up again. But having T-cell responses along with the antibody responses that INO-4800 Inovio DNA vaccines can provide -- will provide a better, what I think is better protection overtime.
And so, there is a huge potential market for the booster markets, right. So, this is potentially seasonal vaccination to boost the immune system.
this was a DNA vaccine that was tested and gotten emergency approved in India is a similar DNA vaccine by another company called Zydus. That achieved 66% efficacy against the delta predominantly delta strain. In India, where we're Delta variant actually originated initially, now deltas are everywhere in the world, they were able to achieve 66% efficacy. It's a three dose regimen of DNA vaccines delivered with jet injection“ JK at Cantor
“there are three those regimen is not as immunogenic as our two those regimens deliver with CELLECTRA system. But I think the success of Zydus in DNA vaccine although kudos to them, provides a great proof-of-concept for our INO-4800 deliver with a better delivery system, better immune responses against the delta, I'm very optimistic that we will be able to achieve the efficacy levels that is at least as good as Zydus. And I'm very hopeful that we will achieve efficacy that are better than Zydus has.”
“total case for the primary endpoint is the lab confirmed COVID-19 case, symptomatic COVID-19 case. It's about 149, it's exactly 149 total cases, is the primary. So, our first analysis is going to be 50% of that. So 75 people will be when the first analysis will be made. So, with the variance, delta being predominant, most experts are saying, anywhere between 60% to 80% of efficacy is fantastic, even approved vaccines, likely will not be reaching 90 as they've demonstrated against the original one.
So, I'm very heartened by Zydus this interim data with their 36% efficacy. I think we will be very happy, if we can match that and or even best that level with INO-4800.
we will be talking about emergency approved COVID-19 vaccine, INO-4800, achieving the efficacy endpoint earlier in the year in '22. Looking forward to the BLA in May present for 4800.”
“efficacy readout from our P3 REVEAL 2, meeting our endpoint of our REVEAL 2 which we were looking forward to fully enrolling that study and having the full follow-up data from REVEAL 1 by the end of this year.”
INO-4802 includes:
• Cross-reactive immune responses demonstrated against current and emerging viral variants*
• Induced potent neutralizing antibodies, T cell responses, and protection in a pre-clinical model against the original wildtype strain as well as against the alpha, beta, gamma, and delta variants
INO-4800
? 1H22: Report interim efficacy data from Phase 3 INNOVATE trial
VGX-3100
? 4Q21: Report complete REVEAL 1 data (ITT, mITT, per protocol)
? 4Q21: Report on pre-treatment biomarker with QIAGEN
INO-5401
? 4Q21: Present 24-month overall survival and immunology data
Platform Development
? 3Q21: Initiate Phase 2 MERS study with INO-4700 funded by CEPI
? 4Q21: Fully enroll Phase 1B field study for Lassa with INO-4500 funded by CEPI
10/11/21 Sweden, Norway, and Finland Pause Use of Moderna Vaccine in Young People
The pause “for precautionary reasons” in Sweden and Finland concerns anyone born 1991 or later. In Finland, under 30s will now be offered the Pfizer vaccine as their second dose. Swedish officials are still discussing the second dose for the 81?000 under 30s who received a first dose of Moderna. All three countries based their decision on an unpublished study with Sweden’s Public Health Agency saying that it signals “an increased risk of side effects such as inflammation of the heart muscle or the pericardium” — the double-walled sac containing the heart and the roots of the main vessels, a very rare side effect associated with the shot.
https://www.bmj.com/content/375/bmj.n2477.short
https://apnews.com/article/coronavirus-pandemic-business-denmark-public-health-health-453163d8f93618fde90c06d3474921a0
10/14/21: Nature Comms: INO-4800 DNA vaccine induces neutralizing antibodies and T cell activity against global SARS-CoV-2 variants.
INO-4800 generates robust neutralizing antibodies against P.1 at levels comparable to the Wuhan strain. Despite similarities in the RBD of P.1 and B.1.351, studies have reported a reduced impact in neutralization against P.1, compared to B.1.35118,19. In sera from individuals who received the SARS-CoV-2 mRNA-1273 or the BNT162b2 vaccines, there was a 2.8 and 2.2-fold reduction in neutralization against P.1, compared to 8.6 and 6.5-fold for B.1.351, respectively18. The lower resistance to neutralization conferred by the P.1 variant suggests that changes outside the RBD, especially in the NTD, where P.1 and B.1.351 acquired and accumulated different mutations, may play a role in neutralization. INO-4800 induces cross-reactive T cell responses against B.1.1.7, B.1.351, and P.1 variants that are comparable to the Wuhan strain. Taken together, these data demonstrate maintenance of one or both cellular and humoral arms of the immune response against emerging SARS-CoV-2 variants for the INO-4800 vaccine, which will likely be critical factors to impact the ongoing COVID-19 pandemic.
We performed a SARS-CoV-2 pseudovirus neutralization assay using sera collected from thirteen subjects two weeks after administration of a third dose of 0.5, 1, or 2?mg of INO-4800 (Supplementary Table 1). Neutralizing activity was detected against Wuhan and the emerging variants in all serum samples tested (Fig. 1b). The mean ID50 titers for the Wuhan, B.1.1.7, B.1.351, and P.1. were 643, 295, 105, and 664, respectively (Supplementary Tables 1 and 2). Compared to Wuhan, there was a 2.1 and 6.9-fold reduction for B.1.1.7 and B.1.351, respectively, while there was no difference between Wuhan and the P.1 variant. These results are consistent with other recent studies, which have demonstrated a significant reduction in neutralizing activity in vaccinated individuals towards the B.1.351 (≥6-fold reduction), while the B.1.1.7 lineage has demonstrated a reduced activity of two-fold or less4,7,8,9,17. Strikingly, while the P.1 strain presents with similar RBD mutations as B.1.351, we did not observe any reduction in neutralizing activity compared to the Wuhan strain in INO-4800 vaccinated individuals.
Received
13 April 2021
Accepted
06 July 2021
Published
14 October 2021
https://www.nature.com/articles/s41541-021-00384-7
REGN+INO GBM at SITC, AACR, ESMO, and ASCO
Our next question comes from Esther Rajavelu with UBS.
Esther Rajavelu
Hi. Thank you for taking my questions. Can you talk a little bit about the Libtayo combo strategy with agents other than the bispecifics? I mean you have a number of Phase 2 trials ongoing with oncolytic viruses. So, curious what your thought process is there, and if we should be expecting to see any of those data readouts in the near-term?
Israel Lowy - REGN Senior Vice President, Transitional Sciences and Oncology
we also have – looking at DNA vaccines where we did a study with Inovio and their DNA vaccine platform in GBM. So, these are all in the early stages, exploratory stages. We hope we will be able to present data at meetings like SITC, AACR as well as ESMO and ASCO. And all I can say there is kind of stay tuned. We are pushing them all forward. And we picked these. We also have studies that we are looking at in combination with cellular therapy companies like bluebird and [indiscernible], because we believe there is opportunities for not just bispecifics, there may be reasons to try cellular therapies. So, we have a very broad outlook. We have, as a central foundation in our whole approach, have always believed that combination therapy is essential, and we have a very broad approach to that.
Regeneron Pharmaceuticals, Inc.'s (REGN) Management Presents at Regeneron Oncology Investor Event, ESMO 2021 Conference (Transcript)
Sep. 20, 2021 1:47 PM
https://seekingalpha.com/article/4456194-regeneron-pharmaceuticals-inc-s-regn-management-presents-regeneron-oncology-investor-event
“we plan to present at a fourth quarter cancer conference, our results of OS24 but also median OS. And I don't want to take the punchline but we have been achieving better than standard of care in each of those characteristics and milestones. So we couldn't be any happier in the progress from this trial.
We also plan to bring out what our next steps might be around that time. So as I said, Regeneron has been a wonderful partner and we look forward to executing with them this trial and potentially additional ones to come.“ 9/21/21 JK @Oppehheimer
Inovio Pharmaceuticals, Inc. (INO) CEO Joseph Kim on Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit Conference (Transcript)
Sep. 21, 2021 4:23 PM
https://seekingalpha.com/amp/article/4456431-inovio-pharmaceuticals-inc-ino-ceo-joseph-kim-on-oppenheimer-fall-healthcare-life-sciences
10/20/21 15:45 CET or 9:45 AM EST WORLD VACCINE CONGRESS EUROPE 2021
BARCELONA, 19 - 21 OCTOBER 2021
Room 1
15:45 [Virtual] Inovio’s
DNA COVID vaccine update
Dr Joseph Kim, CEO, Inovio
16:00 End of Track
https://www.terrapinn.com/conference/world-vaccine-congress-europe/agenda.stm?utm_source=pardot&utm_medium=email&utm_campaign=UK_10450_WVC+EU+2021_CONFPROM_Awareness_-4&utm_term=email
https://www.terrapinn.com/template/Live/PDF/World-Vaccine-Congress-Europe-2021---Age/10450/21801/ZmluYWwtYWdlbmRhLXd2Y2UtMjAyMS0xMi0xMC0yMDIxLnBkZg==
FDA still isn't really throwing its weight behind Covid-19 vaccine boosters, Moderna's adcomm briefing docs show
Zachary Brennan
Senior Editor
As the two top vaccine experts at the FDA retired in protest over the way the Covid-19 booster shot process has transpired, the agency on Tuesday released its findings on the Moderna vaccine booster data ahead of an adcomm meeting later this week, offering the same tentative support that the Pfizer booster received.
While authorization of the Moderna booster is basically a done deal, as it was with Pfizer’s before the process began (since the post-authorization CDC advisory committee has already been scheduled), the FDA’s briefing documents make clear that the agency doesn’t find the data on booster efficacy to be particularly persuasive.
“Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not. However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States. There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” the agency said.
But overall, Moderna appears to have met what FDA has requested for a booster EUA, based on its submission of immunogenicity data from 149 participants in an ongoing Phase II study in individuals 18 years of age and older who received the primary series of the vaccine about 6-8 months prior to the booster.
And as far as safety, FDA isn’t seeing any particular issues beyond what’s been seen with the primary series, noting “solicited safety data do not show evidence of increased frequency or severity of local or systemic reactions after the booster dose (N=129) relative to dose 2 of the primary series (N=155).”
But Moderna makes the case that because of the Delta variant, the need for a booster is real.
While the efficacy of Moderna’s vaccine to prevent Covid-19 was demonstrated to be 93% after 5.3 months median follow-up, that occurred when the original strain and the Alpha variant were the major circulating SARS-COV-2 strains.
“However, decreased levels of neutralizing antibody titers 6-8 months post-primary series, particularly against VoCs [variants of concern], have been observed. Clinical trial data breakthrough infections as well as real world evidence of reduced effectiveness against the Delta variant indicate that a booster dose of mRNA-1273 for those vaccinated more than 6 months previously could be beneficial to restore antibody titers to higher than post-dose 2 levels and reduce the number of breakthrough cases particularly against VoCs,” Moderna said in its documents.
The FDA’s Vaccines and Related Biological Products Advisory Committee will convene Thursday to discuss the data. The committee will vote on whether the half-dose booster should be given at least 6 months after completion of the primary series in the same populations as Pfizer received its EUA for: individuals 65 years of age and older, adults older than 18 at high risk of severe Covid-19, and those whose jobs puts them at high risk of serious complications of Covid-19.
10/12 INOVIO is grateful for the support of Mexican Foreign Secretary @m_ebrard and his team at SRE. INOVIO looks forward to building a partnership with Mexico to support the health of the Mexican people as we begin P3 trial of #COVID19 vaccine INO-4800 in Mexico in the coming weeks.
INOVIO is grateful for the support of Mexican Foreign Secretary @m_ebrard and his team at SRE. INOVIO looks forward to building a partnership with Mexico to support the health of the Mexican people as we begin P3 trial of #COVID19 vaccine INO-4800 in Mexico in the coming weeks.
— INOVIO Pharmaceuticals (@InovioPharma) October 12, 2021
We are pleased to share that @invimacolombia has authorized the start of our global Phase 3 trial for INO-4800. This approval marks the fourth country to engage in this #COVID19 vaccine trial, following allowances from Brazil, the Philippines and Mexico. bit.ly/3oRt0x6
We are pleased to share that @invimacolombia has authorized the start of our global Phase 3 trial for INO-4800. This approval marks the fourth country to engage in this #COVID19 vaccine trial, following allowances from Brazil, the Philippines and Mexico. https://t.co/yzilUEJphf pic.twitter.com/8t7O57pqFn
— INOVIO Pharmaceuticals (@InovioPharma) October 11, 2021
10/11/21 By Justify: “We met with Joseph Kim, CEO of @InovioPharma , pharmaceutical that the @invimacolombia authorized to carry out a clinical trial of phase 3 of vaccines against Covid in Colombia. We explore the signing of a memorandum of understanding for the development and production of biologicals in the country.”
translated with Columbia Prez and JK pics in Washington DC from:
Nos reunimos con Joseph Kim, CEO de @InovioPharma, farmacéutica que el @invimacolombia autorizó para realizar ensayo clínico de la fase 3 de vacunas contra Covid en Colombia. Exploramos la firma de memorando de entendimiento para desarrollo y producción de biológicos en el país.
Nos reunimos con Joseph Kim, CEO de @InovioPharma, farmacéutica que el @invimacolombia autorizó para realizar ensayo clínico de la fase 3 de vacunas contra Covid en Colombia. Exploramos la firma de memorando de entendimiento para desarrollo y producción de biológicos en el país. pic.twitter.com/Y32JKgZCq2
— Iván Duque 🇨🇴 (@IvanDuque) October 12, 2021
CEPI opens $25M Call to evaluate fractional COVID-19 booster and third shots as part of efforts to stretch global vaccine supply
Oct 11, 2021, Oslo, Norway – The Coalition for Epidemic Preparedness Innovations, or CEPI, has launched a new Call for Proposals to fund clinical trials evaluating the impact of reduced booster doses and third doses* of COVID-19 vaccines – an approach which could play an important role in stretching the global COVID-19 vaccine supply and increasing access to doses in underserved regions worldwide.
In particular, the research programme is inviting applications from individual organisations and consortia, including COVID-19 vaccine developers, to assess whether smaller doses of a single COVID-19 vaccine booster shot—as opposed to a full booster dose—would improve, broaden, and prolong the immune response following a primary series of COVID-19 vaccination, while also putting less strain on already constricted global COVID-19 vaccine supplies.
Administering smaller vaccine shots—also known as fractionation—has previously been used to maximise global vaccine supply during outbreaks of Yellow fever and Polio**.
CEPI will make up to US $25m funding available as part of the Call, with the intention to fund several clinical trials looking at dose-sparing booster shots for different COVID-19 vaccine candidates. The funding will also support trials investigating whether a third, or additional vaccine doses, administered to immunocompromised people or other demographics, for whom the primary series of vaccine did not provide enough protection from COVID-19, could also be fractional, and still provide sufficient protection. CEPI will also consider trials evaluating the use of a fractional dose of COVID-19 in participants who are ‘primed’ following previous natural infection, as well as studies providing a reduced follow-up shot to participants who have received a single-dose vaccination.
The COVID-19 vaccines to be used as fractional booster and third shots in the studies must have already received authorisation—either full licensure or emergency use authorisation—by a relevant / competent authority, or the World Health Organization (WHO). Use of COVID-19 vaccines currently in advanced stage clinical development may also be considered.
Results from the studies are set to advance the growing bank of data on the safety and immunogenicity of booster and third shots—which have already begun to be rolled out, as full doses, in some high- and middle-income nations. The findings from the CEPI-funded trials are expected to provide important data to inform the public health and scientific community, including groups like the National Immunisation Technical Advisory Groups (NITAGs) and the WHO Strategic Advisory Group of Experts on Immunization (WHO SAGE) on the potential merits of vaccinating people with fractional doses of COVID-19 vaccine.
The data generated by these trials may have multiple benefits when it comes to guiding vaccination strategies. Not only could findings show that a smaller booster or third vaccine dose will still provide an adequate immune response, and therefore has the potential to stretch global supply, but the clinical studies could also offer crucial information as to whether fractional doses of COVID-19 vaccines would also reduce side effects in vaccine recipients following administration.
https://cepi.net/news_cepi/cepi-opens-call-to-evaluate-fractional-covid-19-booster-and-third-shots-as-part-of-efforts-to-stretch-global-vaccine-supply/
Columbia president will begin this Monday 10/11 with a meeting starting at 10:00 am (Washington DC time) with the president of the World Bank, David Malpass, and then continue at noon with a meeting with the Chamber of Commerce of the United States.
Hours later (2:30 pm), Duque will have a new meeting with Kristalina Georgieva, the Director of the International Monetary Fund (IMF). Then, starting at 4:30 pm, the president will speak with Joseph Kem, CEO of Inovio, an American company, who will be in the country's capital. [Probably negotiating for a 4800 pre-order]
In his busy schedule, the president will meet with Mauricio Claver Carone, president of the Inter-American Development Bank (5:30 pm), to end his working day with a meeting with Howard Buffett, businessman and former American politician.
https://www-noticiasrcn-com.translate.goog/colombia/agenda-del-presidente-ivan-duque-durante-su-visita-a-estados-unidos-390531?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui
10/4/21To Prevent the Next Pandemic, Scientists Seek One Vaccine for Many Coronaviruses
A pan-coronavirus vaccine could protect people against Covid-19 variants as well as the next pandemic virus
Kayvon Modjarrad is out to win the war against this pandemic—and the next one.
An emerging-infectious-diseases researcher with the U.S. Army, Dr. Modjarrad is pursuing a vaccine to protect against a range of coronaviruses that cause disease in humans—including Covid-19 variants that might elude today’s vaccines.
The goal is to prevent the next new one from spreading around the globe. Such a shot might even stop coronaviruses that cause some common colds.
His research team is one of roughly 20 groups around the world working on so-called universal, or pan-coronavirus, vaccines: shots that would block many related viruses at once, including ones that have yet to infect anyone. After years of battling Ebola, Zika, H1N1 pandemic flu and other new pathogens, Dr. Modjarrad and other emerging-disease experts say they want to have a vaccine in hand to blunt the next new pathogen to come along, whatever it may be.
“It’s our way out not just of this pandemic but this cycle of epidemics,” said Dr. Modjarrad, director of the emerging-infectious-diseases branch of the Walter Reed Army Institute of Research in Silver Spring, Md.
Three deadly new coronaviruses emerged in the past 18 years, including the virus that causes Middle East respiratory syndrome or MERS, and scientists warn another is likely. Many animals, including bats and rabbits, carry coronaviruses that can spread to humans. Millions of people around the world are being exposed to the pandemic virus, SARS-CoV-2, raising the risk that new, vaccine-resistant variants will arise, scientists say.
“We need to work proactively on these viruses and many, many others,” said David Veesler, a University of Washington School of Medicine biochemist whose lab is testing an experimental vaccine against a group of coronaviruses.
Scientists have spent years trying to develop a universal vaccine against influenza—without success yet. Coronaviruses, which mutate less often and have fewer distinct lineages, may be an easier target. But scientists say it could take years to develop one that protects against most of the coronaviruses that infect humans, with many challenges along the way.
The Coalition for Epidemic Preparedness Innovations, an Oslo-based organization that funds development of vaccines for epidemic diseases, is investing $200 million in grants for early-stage development of vaccines that protect broadly against dangerous coronaviruses. The U.S. National Institute of Allergy and Infectious Diseases, whose scientists are studying ways to make coronavirus vaccines, is awarding a further $95 million to other researchers, including $36 million to teams at Duke University, the University of Wisconsin, Madison and Brigham and Women’s Hospital in Boston.
Several companies are developing multivalent Covid-19 vaccines, which would target SARS-CoV-2 variants. The Biden administration and other funders should give priority to the development of shots that would broadly protect against these variants, said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, Calif. “What we really need is a global collaborative effort,” he said.
The vaccines now in development wouldn’t protect against all coronaviruses. The viruses are quite distinct from one another, making it a scientific challenge to create one vaccine that targets them all. Most researchers are focusing first on vaccines against sarbecoviruses, the group of greatest concern because it includes the pathogens behind Covid-19 and severe acute respiratory syndrome, or SARS.
If they are able to successfully create a sarbecovirus vaccine, then the next step is making vaccines that block betacoronaviruses, which include sarbecoviruses and the virus that causes MERS, which was first detected in 2012 and has about a 35% mortality rate. The group also includes two viruses that cause common colds.
“You have to prove that you can get to the moon before you try to go to Mars,” Dr. Modjarrad said.
Recent studies of antibodies in people infected with SARS-CoV-2 are helping to speed vaccine development, said Dennis Burton, an immunologist at Scripps Research. He and other researchers have identified “broadly neutralizing antibodies” that ward off both the pandemic virus and close viral cousins. Vaccines can then be developed that generate those antibodies when delivered into patients, he said.
To create a universal vaccine, researchers look for portions of viral pathogens that are the same, or conserved, on related viruses. Many are focusing on the spike protein of the coronaviruses they are targeting, which juts out from the surface of the virus and enables it to latch on to and infect human cells.
The U.S. Army’s Dr. Modjarrad and his colleagues recently tested an experimental vaccine consisting of copies of a SARS-CoV-2 spike protein attached to a soccer-ball-shaped nanoparticle made of ferritin, an iron-storing blood protein. The vaccine protected macaques against the original pandemic virus, the researchers reported. The blood serum of the vaccinated macaques also fought off all the major SARS variants, Dr. Modjarrad said.
The researchers are now analyzing data from an early-stage clinical trial of the vaccine in humans, Dr. Modjarrad said, and testing in mice a similar vaccine meant to protect against a larger number of betacoronaviruses, including the virus that causes MERS.
David Martinez, a postdoctoral fellow at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, began designing a vaccine against SARS-like viruses in April 2020 as the pandemic took hold in the U.S. “I thought, we need to start thinking about preventing SARS 3,” he said.
He and his colleagues used messenger RNA, as Moderna Inc. and Pfizer Inc. and BioNTech SE did with their Covid-19 vaccines. Rather than genetic material from one coronavirus, they stitched together genetic codes from pieces of spike proteins of four SARS-like viruses: SARS-CoV, SARS-CoV-2 and two bat viruses.
Dr. Martinez had to wait until November for the hybrid vaccines to be produced, because a critical component also needed for the Pfizer and Moderna vaccines was in short supply. When the experimental vaccine was tested on mice, it protected them against Covid-19 variants, bat coronaviruses and other viruses.
The research team is seeking funding for an early-stage clinical trial in humans and is developing a vaccine against MERS and related betacoronaviruses, Dr. Martinez said.
4/15/21 “We have begun talks with various organizations like CEPI, Barda, etc for the support of our INO-4802. Hopefully, we will receive a positive response.”
5/12 “In terms of funding for 4800 P3 trial we are asking various parties for support and are also considering doing the P3 together with Advaccine in order to save on costs.
Various NGOs have expressed interest in our 4802 program; now, it can be a long road from interest to actual financial support but we are trying to do everything possible to minimize our burn rate. We hope that today’s pre print is the first step on that road.
We are working with our CRO to select and prepare required documents to agencies of various nations where we are targeting our P3 trial. We are hoping to have additional news to share with you in the coming days and weeks.”
Oct 8, We've (CEPI) launched a $200M call on Mar 31, 2021 to fund vaccines that are broadly protective against SARS-CoV-2 variants and other coronaviruses.
The first partnerships to be made through this Call will be announced in the coming weeks.
Inovio has applied for 4802 CEPI grant. 4802 should be a front runner. Ditto BARDA.
Coronaviruses have now demonstrated their pandemic potential. The SARS and MERS coronaviruses are associated with case fatality rates of 10%-35% (5-16 times worse than COVID-19) and we know that coronaviruses circulate widely in animal reservoirs.
While the world has made great advances in vaccines development against the coronavirus that causes COVID-19, variants of concern (such as B.1.1.7; B.1.351, and P.1) now pose a threat to this progress. They spread rapidly, can reinfect people who have been infected before, and they are rendering our countermeasures—including our vaccines and monoclonal-antibody treatments—less effective.
The increased transmissibility of these variants could result in a reversal in the global downward trends in transmission seen in recent weeks resulting in a renewed burden on health systems, and more deaths.
CEPI has already begun development of vaccines against variants of concern, but additional approaches are needed to ensure that we can stay one step ahead of the threat posed by these variants, other Betacoronaviruses, and potentially novel coronaviruses that have yet to emerge.
https://cepi.net/news_cepi/cepi-launches-funding-call-to-advance-development-of-broadly-protective-coronavirus-vaccines/
We've launched a $200million call to fund vaccines that are broadly protective against SARS-CoV-2 variants and other coronaviruses.
— CEPI (@CEPIvaccines) October 8, 2021
The first partnerships to be made through this Call will be announced in the coming weeks⤵️ https://t.co/7qcD4WxxK1
Oct 8 “I think we are very close to adding another country to our INNOVATE trial participation. Nothing is 100% but talks are going very well.
I apologize but we cannot comment any trial of which we are not a sponsor.”
In Some Countries such as Brazil, Mexico, Philippines, Columbia, 4800 is part of both P3 Innovate (starts Nov 2021) and the WHO’s Solidarity Vaccine (starts Oct 2021) Trial which is funded by the WHO, DOH, DOST in Philippines ????. Do they have different protocols?
Oct 6 MF, Is This The Turning Point for Inovio?
The biotech's streak of bad luck may be about to end, but risks remain.
It seems such a long time ago that Inovio Pharmaceuticals (NASDAQ:INO) was considered one of the leaders in the hunt for a COVID-19 vaccine -- but the biotech was left in the dust by peers and many investors have given up on the stock. In the past 12 months, shares of Inovio are down 45% even as the broader market took off.
However, the company hasn't given up hope to develop an effective vaccine for the coronavirus -- and thanks to recent regulatory developments, it could be a bit closer to this goal. Let's see whether the company is finally ready to turn things around.
Phase 3 clinical trials in the works
Inovio's potential COVID-19 vaccine, INO-4800, has already produced promising results in clinical trials. The company ran a phase 2 study that enrolled 400 adult participants in the U.S. Its goal was to test INO-4800's safety, tolerability, and immunogenicity (the ability to trigger an immune response). The trial was a success: INO-4800 proved safe, well-tolerated by participants, and immunogenic.
The company likely would have moved on to a phase 3 trial already, but the U.S. Food and Drug Administration (FDA) had other plans. In September 2020, the agency put the phase 3 portion of Inovio's phase 2/3 clinical trial for INO-4800 on hold because of outstanding issues with the company's proprietary device (the Cellectra 2000) for administering the INO-4800.
With the FDA study still on hold, Inovio has turned elsewhere -- seeking and receiving the green light from regulators in other countries to go ahead with its plans. On Sept. 22, the vaccine maker announced that authorities in Mexico had given the OK to begin its phase 3 study. Brazil and the Philippines have given their go-ahead too.
Together with its partner, China-based Advaccine Biopharmaceuticals Suzhou, Inovio is planning to run its phase 3 study in Latin America and Asia. And the company will focus its efforts on countries where vaccines aren't as readily available as they are in the U.S. Successful clinical trials in other countries could translate to regulatory approvals and sales -- at least, in those places.
Additional candidates in the pipeline
Meanwhile, Inovio is working on a rich pipeline of other potential vaccines and therapies in the areas of cancer and infectious disease. And it is partnering with larger drugmakers such as AstraZeneca and Regeneron, which have greater resources -- and also with non-profit organizations like Norway-based Coalition for Epidemic Preparedness Innovations, which promotes the creation of vaccines.
Inovio's most advanced project is VGX-3100, a potential medicine for cervical dysplasia, a human papillomavirus (HPV)-associated precancerous condition. In a phase 2 study, VGX-3100 reduced HPV-related precancerous vulvar lesions in 63% of treated participants. VGX-3100 is currently undergoing a phase 3 trial, and Inovio plans on unveiling some data from this study before the end of the year. There are no FDA-approved treatments for cervical dysplasia, which annually affects 195,000 people in the U.S. and 233,000 people in Europe.
Of course, not all of Inovio's candidates will make it to the market. But the company's pipeline -- including INO-4800 and VGX-3100 -- offer encouragement.
Should you pull the trigger?
Since Inovio's failure to live up to early expectations, especially when compared to some of its peers, it's not surprising that investors decided to look elsewhere. But if the company can now begin to carve out a niche for itself in the global COVID-19 vaccine market, its fortunes could begin to improve. It does not need the success of a Moderna -- which could reach $20 billion in sales this year -- to see its stock take off again.