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INO-4802 CEPI, US gov Funding talks.
Advaccine’s INO-4800 P2 data imminent: “Our partner, Advaccine, has finished dosing all patients for their P2 trial. They are currently doing data analysis as we speak. We expect them to release their P2 data shortly.
They ran into little trouble finding GLP labs for the data analysis but they are now on the right track.
In terms of P2 data, as Dr. Kim had noted, we are planning to release the data this quarter and are hoping to FDA concurrence on P3 initiation by June. 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....
DoD's commitment to Inovio and DNA vaccines has not wavered and they have been and are continuing to be one of our greatest champions; we are truly blessed to have such an awesome organization supporting us.” 4/15/21. No link will be provided.
4/15 The “One World Protected” Event, hosted today by the United States and Gavi, the Vaccine Alliance, launched a campaign to raise US$ 2 billion for the global fight against COVID-19.
The additional funding from donors and countries with MDB support will enable the Gavi COVAX Advance Market Commitment (AMC) to secure 1.8 billion doses of COVID-19 vaccines for 92 lower-income countries by the end of the year.
At the event, governments and private sector partners made early pledges worth nearly US$ 400 million and committed to donate millions of COVID-19 vaccine doses to COVAX to benefit the most vulnerable in lower-income economies.
The new campaign will culminate in June 2021, at the Gavi COVAX AMC Summit, which will be hosted by Prime Minister Yoshihide Suga of Japan.
https://www.gavi.org/news/media-room/global-leaders-rally-accelerate-access-covid-19-vaccines-lower-income-countries
Inovio management to meet virtually with Oppenheimer. Virtual Meeting to be held on April 16 hosted by Oppenheimer.
https://m.thefly.com/news-story/3282605/2021-04-14%2014:58:33/search
Inovio's COVID-19 vaccine candidate shows response against all tested variants. Inovio announced the results of a study focusing on the human immune responses induced by Inovio's DNA vaccine candidate for COVID-19, INO-4800, against variants of concern. The results showed that INO-4800 induced a robust T cell response against all spike protein variants tested, which the company believes will be key in providing protection against SARS-CoV-2 variants, in addition to providing similar levels of neutralizing activity against both the UK and Brazilian variants as those against the original strain. The study has been submitted for peer review. The study showed the T cell responses induced by INO-4800 vaccination were fully maintained against the UK, South African and Brazilian variants when compared to the T cell responses to the original Wuhan strain. The neutralization levels of INO-4800 against South Africa and UK variants were reduced to the levels similar to the previous reports of mRNA or viral vector vaccines. Furthermore, despite recent reports showing a reduction in neutralizing activity against the Brazilian variant by the mRNA or viral vector vaccines, INO-4800 generated robust neutralizing antibodies at levels against Brazilian variant which were comparable to those against the Wuhan strain. Collectively, the studies showcase how the combination of robust T cell responses in conjunction with neutralizing antibody responses provide an important defense against both emerging and potential future viral variants, exhibiting broad protection against the virus and less impacted by the mutational changes a virus may undergo.
https://m.thefly.com/news-story/3283123/2021-04-15%2008:10:49/search
“We performed a SARS-CoV-2 pseudovirus neutralization assay using sera collected from thirteen subjects two weeks after administration of a third dose of either 0.5 mg, 1 mg, or 2 mg of INO- 4800 (Table S1). Neutralizing activity was detected against WT and the emerging variants in all serum samples tested (Fig. 1B). The mean ID50 titers for the WT, B.1.1.7, B.1.351 and P.1. were 643, 295, 105, and 664, respectively (Table S1). Compared to WT, 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 WT 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 2-fold or less [4, 7-9, 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 WT strain in INO-4800 vaccinated individuals [18, 19]. The P.1 lineage has similar changes in the RBD to the B.1.351 lineage as they contain the N501Y mutation found in the B.1.1.7 lineage and identical E484K mutations. However, they have similar but different mutations at position K417, with a change to T for the P.1 and to N for the B.1.351 lineage. While both are changes to polar uncharged side chains, the B1.351 N mutation carries an additional amide group. It is possible that this position and this change allows for the impact of neutralizing responses observed. 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 WT 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.“
https://www.biorxiv.org/content/10.1101/2021.04.14.439719v1.full.pdf
4/15 8AM EST INOVIO's COVID-19 Vaccine Candidate, INO-4800, Provides Broad Cross-reactive Immune Responses In Humans Against Variants of Concern
Results in new study showed INO-4800 vaccine-induced neutralizing antibodies and T cell responses against UK, South African and Brazilian variant strains
Paper entitled, "INO-4800 DNA Vaccine Induces Neutralizing Antibodies and T cell Activity Against Global SARS-CoV-2 Variants," submitted for peer review and available via preprint in bioRxiv.
Regarding INO-4800 development Dr. Kim said, "We will report Phase 2 results in 2Q, and, with FDA concurrence, expect to move into Phase 3 in the second quarter of this year. Our COVID vaccine's projected safety profile, its stability at room temperature for more than a year, and likely ability to safely boost numerous times positions INOVIO's COVID-19 vaccine as an important factor in addressing the virus in its pandemic and endemic states."
In the study, clinical samples were collected at varying timepoints post-immunization from subjects in INOVIO's Phase 1 US-based INO-4800 clinical trial. Antibodies capable of neutralizing activity were measured against the spike protein variants tested, including B.1.1.7 (UK variant), B.1.351 (South African variant) and P.1. (Brazilian variant). The study showed the T cell responses induced by INO-4800 vaccination were fully maintained against the UK, South African and Brazilian variants when compared to the T cell responses to the original Wuhan strain. The neutralization levels of INO-4800 against South Africa and UK variants were reduced to the levels similar to the previous reports of mRNA or viral vector vaccines. Furthermore, despite recent reports showing a reduction in neutralizing activity against the Brazilian variant by the mRNA or viral vector vaccines, INO-4800 generated robust neutralizing antibodies at levels against Brazilian variant which were comparable to those against the Wuhan strain. Taken together with the data showing the maintenance of T cell activity, the results reported in this study provide a comprehensive overview of cross-reactive cellular and humoral immune responses against SARS-CoV-2 variants for INO-4800 vaccinated individuals that may be important for protection against variant strains of SARS-CoV-2.
https://www.prnewswire.com/news-releases/inovios-covid-19-vaccine-candidate-ino-4800-provides-broad-cross-reactive-immune-responses-in-humans-against-variants-of-concern-301269572.html
EU Commission 'not to renew' AstraZeneca and Johnson & Johnson contracts. “The European Commission, in agreement with the leaders of many (EU) countries, has decided that the contracts with the companies that produce (viral vector) vaccines that are valid for the current year will not be renewed at their expiry,” the newspaper reported.
It added that Brussels would rather focus on Covid-19 vaccines using messenger RNA (mRNA) technology, such as Pfizer’s and Moderna’s.
A spokesman for the EU Commission said it was keeping all options open to be prepared for the next stages of the pandemic, for 2022 and beyond.
It comes as Denmark announced it would stop administering Oxford/AstraZeneca's Covid-19 vaccine following its possible link to very rare cases of blood clots, several Danish media outlets reported, citing unnamed sources.
The decision, which would remove the shot from Denmark's vaccination scheme, could delay the country's vaccine rollout by up to four weeks.
https://www.google.com/amp/s/www.telegraph.co.uk/global-health/science-and-disease/covid-news-coronavirus-vaccine-uk-lockdown-latest-pubs-shops/amp/
'Mix and match' UK Covid vaccine trial expanded
https://www.bbc.com/news/health-56730526
CDC has tracked data about adverse reactions for both vaccines in the agency's V-safe surveillance system. Last week, CDC scientists published an article in the online medical journal JAMA that analyzed the V-safe data recorded between Dec. 14, 2020, and Feb. 28, 2021.
This analysis showed that 73.9% of respondents in the V-safe system experienced side effects after taking the first dose of Moderna's COVID-19 vaccine. The number was lower -- 65.4% -- for individuals receiving the first dose of Pfizer's vaccine.
It was a similar story after the second dose of each vaccine. Among respondents receiving Moderna's shot, 81.9% reported experiencing side effects. For those receiving the Pfizer vaccine, 68.6% reported a reaction after the second dose.
When countries aren't forced to scramble to secure vaccine doses, they could (and probably will) place greater emphasis on the efficacy and safety profiles of the vaccines they buy. That just might give Pfizer a leg up over Moderna.
Pfizer and BioNTech have begun testing a third booster dose of their COVID-19 vaccine. Moderna is testing a modified version of its mRNA vaccine that specifically targets the B.1.351 variant first identified in South Africa.
Moderna's vaccine could demonstrate significantly greater efficacy against the South African variant than Pfizer's vaccine. If that happens, a slightly lower chance of adverse reactions likely wouldn't help Pfizer compete against Moderna. There's also the possibility that another COVID-19 vaccine could win authorization or approval down the road that's even more safe and effective than Pfizer's or Moderna's vaccines.
Don’t miss @TheWistar’s Dr. David Weiner at @PHLBizJournal’s “Taking on COVID-19” virtual event where local life science leaders will discuss the region's contributions to counter the pandemic. Register today: bit.ly/3dbmI5b
4/13
WHEN
Monday, April 19, 2021
10:00am –11:15am
WHERE
Philadelphia
Philadelphia, PA
https://www.bizjournals.com/philadelphia/event/167121/2021/virtual-event-taking-on-covid19
4/13 FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.
CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.
Marks said in a media call that the probable cause may be a similar mechanism seen in other adenovirus vector vaccines, like the AstraZeneca Covid-19 vaccine, which underwent a similar safety review in Europe. He said one person has died and one person is in critical condition from the blood clots. FDA acting commissioner Janet Woodcock added that the timeframe for this review of the J&J vaccine “will be a matter of days.”
J&J said in a statement on Tuesday that it has made the decision to proactively delay the rollout of its vaccine in Europe. “The safety and well-being of the people who use our products is our number one priority,” the company said.
“All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination,” they noted, adding that almost 7 million doses of the vaccine have now been administered in the US. The CDC and FDA said that people who have received the J&J vaccine and who develop severe headache, abdominal pain, leg pain, or shortness of breath 3 weeks after vaccination should contact their health care provider.
Treatment of this specific type of blood clot is different from heparin, which is the treatment that might typically be administered, as in this setting, CDC and FDA said, “administration of heparin may be dangerous, and alternative treatments need to be given.”
Senators on Tuesday began weighing in on what the FDA should do with its review.
Jeff Zients, White House Covid-19 response coordinator, said in a statement that the Biden administration is working with states to reschedule J&J appointments for Morderna or Pfizer vaccines. New York said all appointments for J&J vaccines today at New York State mass vaccination sites will be honored with the Pfizer vaccine.
The news comes as the European Medicines Agency’s safety committee said last Friday that it has initiated a review of four “serious cases of unusual blood clots with low blood platelets,” including one death, reported after people received the J&J vaccine in the US.
As of April 4, EMA said a total of 169 cases of cerebral venous sinus thrombosis (CVST) and 53 cases of splanchnic vein thrombosis were reported to the database, among 34 million people who have been vaccinated with the AstraZeneca vaccine in the EEA and UK. By comparison, the agency noted that for the J&J vaccine, 3 CVST cases were found among 4.5 million vaccinated worldwide, for Pfizer, 35 CVST cases worldwide were found and 54 million received the vaccine in the EEA, and for Moderna, 5 CVST cases worldwide were among 4 million vaccinated in the EEA.
Moderna said in a statement on Tuesday that more than 64.5 million doses of its vaccine have been administered globally and its assessment of the data “does not suggest an association with cerebral venous sinus thrombosis (CVST) or thrombotic events.”
Anne Schuchat, principal deputy director at the CDC, also said on the media call that they are not seeing concerns with these clotting events for the Moderna or Pfizer vaccines.
4/10 Dr. Kim’s Shareholder Letter in Full
https://materials.proxyvote.com/Approved/45773H/20210316/SHLTR_462417.PDF
Dear Shareholder:
The COVID-19 pandemic created an unprecedented challenge for our industry in 2020, a challenge which continues to this day. It has been both remarkable to see, and inspiring to be part of, the global effort to develop safe and effective vaccines to combat COVID-19. Moreover, I am incredibly proud of our team’s unwavering dedication in moving our COVID-19 vaccine candidate, INO-4800, forward while, at the same time, continuing to make meaningful progress across our portfolio of other DNA medicines. The support and commitment of our many partners including U.S. Department of Defense, The Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill & Melinda Gates Foundation to INO-4800 development has also been outstanding.
Our DNA medicines platform continues to represent a revolutionary approach to combatting infectious diseases, cancers, and HPV-associated diseases. One of the hallmarks of our technology is the ability to respond to emerging infectious disease through rapid vaccine construct design and manufacture. For example, we designed, tested, manufactured, and placed into clinical trials our COVID-19 vaccine in less than three months. The versatility of our technology – supported by a strong safety track record of more than 3,000 patients receiving our investigational DNA medicines in more than 7,000 applications across a range of clinical trials – will enable us to meet urgent medical needs now and in the future.
I am proud to say that over the past 12 months we have achieved several important clinical milestones, including positive endpoint data from our Phase 3 program for VGX-3100 for cervical dysplasia (REVEAL 1), positive Phase 2 data for VGX-3100 for vulvar and anal dysplasia, and positive 18-month overall survival data from our Phase 2 clinical trial for INO-5401 for glioblastoma multiforme.
Looking ahead, I believe that 2021 will be a watershed year for INOVIO. In the second quarter we will have results from Phase 2 clinical trial of INO-4800 and hope to begin a global Phase 3 trial this summer following US FDA concurrence. In addition to our COVID-19 efforts, we have initiated promising clinical trials with INO-4500 for Lassa fever and INO-3107 for HPV-related recurrent respiratory papillomatosis, a rare disease for which we were granted orphan drug designation from FDA. We will continue enrolling subjects in those programs as we leverage our strong balance sheet to advance the rest of our infectious disease, cancer, and HPV pipeline.
Thank you again for your continued support of INOVIO and we look forward to sharing additional details on the company’s progress with you this year.
4/13/21 From investor.relations@inovioasiaDoTcom
“As Dr. Kim mentioned during our last conference call, we are still on track to announce our data for P2 in Q2 and we are still hopeful of FDA approval for P3 initiation by end of Q2.
We are already working with manufacturing partners for our Cellectra device, so we do not believe that manufacturing issues will be a bottleneck.
In terms of our partner Advaccine, they too, have finished dosing all the patients for P2, and are in the process of data analysis.“
https://fl2dova4ycsfarri5gqnovr6x4-adwhj77lcyoafdy-inovioasia-cafe24.translate.goog/about-us/
4/12 Resilience Continues Expansion with Acquisition of Biologics Manufacturing Company Ology Bioservices
SAN DIEGO & BOSTON--(BUSINESS WIRE)--Resilience (National Resilience, Inc.), a company building the world’s most advanced biopharmaceutical manufacturing ecosystem, announced it has acquired Ology Bioservices, Inc., (Ology Bio) a privately held company that also specializes in biologic drug substance manufacturing from early stage through commercial products.
Ology Bio, based in Alachua, Florida, develops and manufactures drugs and biologics for commercial customers as well as the U.S. government, with more than $1.8 billion in government contracts awarded. The acquisition provides Resilience with 300 skilled employees as well as more than 200,000 square feet of manufacturing, office, process development and quality assurance and quality control space across locations in Florida, California and Maryland, with additional expansion projects underway.
“This acquisition gives us additional resources and capabilities as we continue on our mission of broadening access to complex medicines, protecting biopharmaceutical supply chains, and strengthening preparedness,” said Rahul Singhvi, Sc.D, Chief Executive Officer of Resilience. “This premier space, and the talented employees who are joining Resilience, will help us expand our business in new directions.”
Ology Bio’s infrastructure will provide unique services for Resilience customers, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3). Ology Bio’s manufacturing capabilities include cell and gene therapies, live viral vaccines and vectors, oncolytic viruses, plasmids and monoclonal antibodies.
In November, Ology was awarded a $37 million contract by the U.S. Department of Defense (DOD) to develop an advanced anti-COVID-19 monoclonal antibody cocktail. The contract also included supporting the DOD with a request for an Emergency Use Authorization and/or Expanded Access (EA) of the monoclonal antibody cocktail for at-risk military personnel.
April 2021 ASCCP Poster Presentations. Poster #000891 Preliminary Results of a Phase 2 Study of VGX-3100 for the Treatment of HPV16 and/or HPV18 (HPV16/18) Related Anal HSIL
Results: At this time, all 22 currently enrolled participants received 3 doses and completed follow-up through 36 weeks. The proportion achieving both undetectable virus and regression of HSIL at the primary endpoint evaluation is shown in Table 1. Of these 22 subjects, 77% (17/22) showed a decrease in the number of HPV16/18 HSIL lesions, 50% (11/22) showed no HPV16/18 associated HSIL, and 48% (10/21) had a decrease in the total number of HSIL lesions. There has been 1 discontinuation due to an unrelated AE, and there have been no related SAEs. No cases of carcinoma have been observed.
Poster #000941 Preliminary Phase 2 Efficacy Results of VGX-3100 for Treatment of HPV-16 and/or 18 (HPV16/18) Associated Vulvar HSIL
Methods: Women with tissue-confirmed HPV16/18-related vulvar HSIL received 4 doses (0, 1, 3, and 6 months) of VGX-3100 intramuscularly with electroporation (EP) either alone (n=25) or with topical imiquimod thrice weekly for 20 weeks (n=8). The primary endpoint was proportion of subjects without vulvar HSIL and non-detectability of HPV16/18 (by SPF10) in vulvar tissue post-treatment compared to baseline.
Results: Among the women in the VGX-3100 group who completed their efficacy assessment 6 months following treatment, 3 of 20 (15%) resolved their vulvar HSIL and had no virus detectable in the healed area. As of submission of this abstract, there have been no related serious adverse events and no treatment discontinuations from adverse events.
Journal of Lower Genital Tract Disease: April 2021 - Volume 25 - Issue 2S - p 9-11
https://pdfs.journals.lww.com/jlgtd/2021/04001/2021_ASCCP_Oral_Presentations.1.pdf?token=method|ExpireAbsolute;source|Journals;ttl|1618199451495;payload|mY8D3u1TCCsNvP5E421JYK6N6XICDamxByyYpaNzk7FKjTaa1Yz22MivkHZqjGP4kdS2v0J76WGAnHACH69s21Csk0OpQi3YbjEMdSoz2UhVybFqQxA7lKwSUlA502zQZr96TQRwhVlocEp/sJ586aVbcBFlltKNKo+tbuMfL73hiPqJliudqs17cHeLcLbV/CqjlP3IO0jGHlHQtJWcICDdAyGJMnpi6RlbEJaRheGeh5z5uvqz3FLHgPKVXJzdS9tlr7qK1S6KYbQlc0vxInckV8n5ENrcoYKXQlU9uw8=;hash|JNOmjSDssI2CgFqMvJpOlA==
HPV Competition is Scared of VGX-3100. There are no pharmacological agents approved for the treatment of CIN There are a number of companies actively developing treatments for CIN and other HPV related pre-cancers and cancers, including a number of immunotherapies. We believe the most advanced immunotherapeutic candidate is VGX 3100 which is being developed by Inovio to target CIN 2/3 and is currently in a Phase 3 clinical trial .To date VGX-3100’s ability to clear CIN 2/3 has been associated with the induction of an antigen-specific CD8+ T cell response. We believe that our approach of induction of high magnitude, durable, & polyfunctional antigen specific CD8+ T cells is well suited to this indication. While VGX 3100 has been successful in establishing proof of mechanism it faces a number of limitations including significant patient acceptability issues driven by the need for delivery by electroporation of multiple doses, which some recipients have found uncomfortable [false].
https://www.sec.gov/Archives/edgar/data/1828185/000110465921048698/tm2035121-9_s1.htm
4/8 INO-4800 and PENNVAX-GP to address Covid-19 and HIV concurrently as requested by NIH. NIH experts call for accelerated research to address concurrent HIV and COVID-19 pandemics.
https://www.nih.gov/news-events/news-releases/nih-experts-call-accelerated-research-address-concurrent-hiv-covid-19-pandemics
HIV/AIDS in the Era of COVID-19: A Juxtaposition of Two Pandemics
Robert W Eisinger, Andrea M Lerner, Anthony S Fauci
The Journal of Infectious Diseases, jiab114, https://doi.org/10.1093/infdis/jiab114
Published: 07 April 2021 Article history
Received: 21 January 2021
Published: 07 April 2021
INOVIO has PENNVAX®-GP in development to prevent and treat HIV strains present in Africa, Asia, Europe, and North America. It has been optimized to target two env antigens, as well as gag and pol antigens. This comprehensive targeting gives PENNVAX-GP the potential to provide global coverage against HIV-1 subtypes. Using a $25 million contract from the NIH, PENNVAX-GP entered into a Phase 1 clinical study in 2015. In addition, INOVIO and academic collaborators, including University of Pennsylvania, University of Massachusetts, Emory University, and Duke University, received a $16 million grant from the NIAID to test various approaches using PENNVAX-GP in preclinical models.
4/9 Australia’s vaccine agreements w/ COVAX includes Ino.
https://www.health.gov.au/node/18777/australias-vaccine-agreements#other-agreements
Australians under 50 are advised to avoid the AZN vaccine. So what are the alternatives? "There are currently 9 vaccines available that may become available through Covax which are made by AstraZeneca, Novavax, Moderna, Curevac, Sanofi, Inovio, Clover Biopharmaceuticals, Institut Pasteur, and the University of Hong Kong."
https://www.theguardian.com/australia-news/2021/apr/09/australians-under-50-are-advised-to-avoid-the-astrazeneca-vaccine-so-what-are-the-alternatives
4/8 INO-4800 and PENNVAX-GP to address Covid-19 and HIV concurrently as requested by NIH. NIH experts call for accelerated research to address concurrent HIV and COVID-19 pandemics.
https://www.nih.gov/news-events/news-releases/nih-experts-call-accelerated-research-address-concurrent-hiv-covid-19-pandemics?utm_source=dlvr.it&utm_medium=twitter
US to host launch event for Gavi COVAX AMC 2021 investment opportunity on 4/15
https://www.gavi.org/news/media-room/united-states-host-launch-event-gavi-covax-amc-2021-investment-opportunity
A-variant-of-the-coronavirus-that-has-two-mutations-was-recently-detected-in-the-San-Francisco-Bay-Area-by researchers at Stanford University.
Five more cases of the “double mutant” strain have been detected since.
This particular variant originated in India and is responsible for a recent 55% surge in the state of Maharashtra following months of falling cases.
https://www.cnbc.com/2021/04/08/researchers-identify-five-new-cases-of-double-mutant-covid-variant-in-california-.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Message
C-2K and 3PSP are functionally equivalent. The later has smaller form factor and newer UI.
3PSP runs on AA batteries and can “function reliably in challenging environments,” the biotech says, which can be beneficial during pandemics when vaccine demand is extremely high, and in some countries where health systems and supply chains are underdeveloped.
The contract “further supports Inovio's large-scale production of devices and arrays to deliver potentially hundreds of millions of doses of INO-4800 to combat the global COVID-19 pandemic,”
C-2K is used to expedite P3 and EUA. 3PSP is used in the BLA after master device file and device stack are sent to FDA.
Immunotherapy-of-prostate-cancer-using-novel-synthetic-DNA-vaccines-targeting-multiple-tumor-antigens https://doi.org/10.18632/genesandcancer.214
Devivasha Bordoloi1,*, Peng Xiao1,*, Hyeree Choi1, Michelle Ho1, Alfredo Perales-Puchalt1, Makan Khoshnejad1, J. Joseph Kim2, Laurent Humeau2, Alagarsamy Srinivasan3, David B. Weiner1, Kar Muthumani1,4
1 Vaccine & Immunotherapy Center, The Wistar Institute, Philadelphia, PA, USA
2 Inovio Pharmaceuticals, Plymouth Meeting, PA, USA
3 NanoBio Diagnostics, West Chester, PA, USA
4 GeneOne Life Science Inc., Seoul, Korea
* authors contributed equally
Correspondence to: Kar Muthumani, email: kmuthumani@gmail.com
Keywords: prostate cancer; synthetic DNA vaccines; immune responses
Received: November 06, 2020 Accepted: February 10, 2021 Published: March 22, 2021
Prostate cancer is a prevalent cancer in men and consists of both indolent and aggressive phenotypes. While active surveillance is recommended for the former, current treatments for the latter include surgery, radiation, chemo and hormonal therapy. It has been observed that the recurrence in the treated patients is high and results in castration resistant prostate cancer for which treatment options are limited. This scenario has prompted us to consider immunotherapy with synthetic DNA vaccines, as this approach can generate antigen-specific tumor-killing immune cells. Given the multifocal and heterogeneous nature of prostate cancer, we hypothesized that synthetic DNA vaccines targeting different prostate specific antigens are likely to induce broader and improved immunity who are at high risk as well as advanced clinical stage of prostate cancer, compared to a single antigen approach. Utilizing a bioinformatics approach, synthetic enhanced DNA vaccine (SEV) constructs were generated against STEAP1, PAP, PARM1, PSCA, PCTA and PSP94. Synthetic enhanced vaccines for prostate cancer antigens were shown to elicit antigen-specific immune responses in mice and the anti-tumor activity was evident in a prostate tumor challenge mouse model. These studies support further evaluation of the DNA tools for immunotherapy of prostate cancer and perhaps other cancers.
4/7 EU medicines regulator finds possible link between AstraZeneca Covid vaccine and blood clots. Most of the cases occurred in women under 60 within two weeks of the shot, officials said. The EMA hasn’t yet identified specific risk factors that contributed to the phenomenon. Researchers also don’t know what’s specifically causing the blood clots, but one plausible explanation is that the vaccine causes an immune response in some people that’s similar to one seen in patients treated with heparin, which is called heparin-induced thrombocytopenia, Cooke said.
Separately, the U.K.’s medicine regulator said on Wednesday that it also identified a possible link between the shot and the rare blood clots.
Britain’s Joint Committee on Vaccination and Immunisation said people under 30 who don’t have any underlying health conditions should get a different vaccine if possible.
A U.K. trial of the Oxford-AstraZeneca vaccine on children had already been paused while the medicines regulator investigated a possible link between the shot and the blood clotting disorders, specifically, cases of blood clots in veins within the brain, known as cerebral venous sinus thrombosis (CVST) as well as thrombocytopenia (low levels of blood platelets which help the blood to clot).
The U.K. government noted that, up to and including March 24, there had been 22 reports of CVST and 8 reports of other thrombosis events with low platelets.
Other side effects
“These include, for example, shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms including severe or persistent headache or blurred vision and skin bruising beyond the site of injection,” Dr. Sabine Straus, chair of EMA’s safety committee, said.
4/7 U.S. begins-study-assessing-allergic-reactions-to-Pfizer-and-Moderna-Covid-vaccines. An immediate allergic reaction usually happens within 4 hours of getting vaccinated and may include symptoms such as hives, swelling and wheezing, according to CDC.
The NIH study will enroll 3,400 adults ages 18 to 69 at up to 35 academic allergy-research centers nationwide, the agency said. Participants will be divided into groups and be assigned at random to receive either the Pfizer-BioNTech vaccine, the Moderna vaccine, a placebo followed by the Pfizer-BioNTech vaccine or a placebo followed by the Moderna vaccine.
Alkis Togias, chief of the NIAID’s allergy, asthma and airway biology branch, told CNBC in December that researchers at the U.S. agency became interested in the rare phenomenon after reports that a few people had reactions to Pfizer’s vaccine that qualified as anaphylaxis, a severe and potentially life-threatening allergic reaction.
P3 in China is under NMPA jurisdiction which is independent of FDA. If NMPA allows Advaccine to use 3PSP for P3, that could significantly speed up TTM as that would make large scale Biologics+device use data available for BLA in US.
Device hold up by FDA was not about C-2K device by itself. It’s about it’s usage together with Biologics in a larger scale setting for which Ino needs to submit two test results to FDA.
It can be answered easily as KB said - just a routine C-2K has to go through with P2 Biologics. That’s why it took 8 months from Sept to April.
This miscommunication with FDA could have been avoided had Ino started Device trial in parallel with P1 enabled by Fast Track Designation or conducted 400-ppl P1 to provide 2 test results for C-2K. KB said b/c we wanted to run so fast, we were slowed down.
VGX-3100 Phase 3 Cervical HSIL launched in China
https://l4q2pohjktpbfv3qk765dirgny-adwhj77lcyoafdy-m-maoyihang-com.translate.goog/index.php?moduleid=21&itemid=14908&alloc=3
Is expected to launch the world's first DNA new Corona vaccine, this Chinese pharmaceutical company is about to go public on Hong Kong stocks | IPO information
According to information from the China Securities Regulatory Commission, DNA vaccine manufacturer Ai Di Weixin Biotechnology has submitted materials for approval of overseas initial public offerings (including common stocks, preferred stocks and other forms of stocks and stock derivatives).
Once accepted, Ai Di Weixin Bio will obtain a "small road" or submit a prospectus on the Hong Kong Stock Exchange soon.
Ai Di Weixin Bio has already experienced 6 rounds of financing before. The company just completed a new round of financing of US$66 million on March 26 this year. Strategic investors include Jingwei China, Hony Capital, Watson Investment, and Star Capital.
In terms of new crown vaccines, Ai Diweixin Biologics announced at the beginning of this year that it has signed an agreement with Inovio, a US vaccine manufacturer, to produce and sell Inovio's new crown vaccine candidates in China, and obtain the exclusive rights of the vaccine in China. It is expected to be available in 2021. China produces as many as 100 million doses of vaccine.
https://wallstreetcn.com/articles/3626359
3/24 P3 INO-4800 Vaccine Trial at Thomas Jefferson University (was P2 site): “We’re actually in the planning stages of a few difference COVID vaccine trial options so we are trying to sort through our list of interested people to see who is still interested and hasn’t been vaccinated yet. We are hoping to have more specific details in the next month or so.”
Thanks,
Kaitlyn Davis, MS
Clinical Research Coordinator II
Family and Community Medicine
Thomas Jefferson University
33 S. 9th Street, Suite 301
Philadelphia, PA 19107
215-503-7272
Kaitlyn.Davis@Jefferson.edu
3/23 “I hope this email finds you well! You contacted our office a few months ago regarding your interest in participating in a COVID vaccine trial. Our group here at Jefferson Department of Family and Community Medicine has been preparing to start a new trial and it will likely open for recruitment in the next few months. Are you still at all interested in participating in a COVID vaccine trial? For this trial in particular, we are looking for participants ages 18-40 who are healthy and have not tested positive for COVID-19. If you are still interested, please let me know.”
Posted on Twitter by Ben Matone 3/31.
That edge could come from logistics. To be effective, vaccines have to get into people’s bodies. So unlike the Pfizer and Moderna shots, vaccines that don’t have to be frozen have a better chance of being used in rural or remote areas and places that don’t have resources to buy and maintain freezers, Gasca says.
“The variants emerging are changing the landscape of the kind of virus we’re fighting now versus the virus that we were fighting in the fall and in the summer,” Krofah says. New vaccines may need to combat even more variants.
Thoughts on being behind: The company isn’t worried about standing out against other vaccines, Kim says. “We have several advantages as a vaccine,” he says. “We are extremely motivated to get to our efficacy trial.… We’re working very eagerly and passionately to make sure that INO-4800 is one of the arsenals that global health will have to fight this infection around the world.
Combating variants: The company is testing whether antibodies made against the vaccine can still fight off the variants. In addition, INOVIO, headquartered in Plymouth Meeting, Pa., hopes to engineer a universal COVID vaccine that could fight off known and unknown versions of SARS-CoV-2.
https://www.sciencenews.org/article/coronavirus-covid-vaccine-new-upcoming-pill-electricity
4/5 How This COVID-19 Vaccine Creator Practices Self-Care When She's Not Saving the World. Kate Broderick, Ph.D. shares how she balances being a scientist, leader, and mother as she works toward getting a new COVID-19 vaccine approved.
By Kate Broderick, Ph.D. as told to Faith Brar
April 05, 2021
https://www.shape.com/lifestyle/mind-and-body/coronavirus/how-covid-vaccine-creator-practices-self-care
Chinese Co-Developer of DNA Covid Vaccine Raises $66 Million
A Chinese vaccine-maker that is developing a DNA coronavirus vaccine with U.S.-based Inovio Pharmaceuticals Inc. has raised $66 million in new funding, according to a company press release issued late last month.
Beijing Advaccine Biotechnology Co. Ltd. secured the strategic investment in its latest financing round, which was led by Matrix Partners China Management Ltd. and Hony Capital Ltd.
The investment came as Advaccine’s INO-4800 coronavirus vaccine candidate is in the midst of phase 2 clinical trials, said Liu Xiaoyan, strategic director of Advaccine. The company expects the DNA vaccine candidate to enter phase 3 trials in the second quarter.
Liu added that the vaccine could be put into use by the end of this year if all goes to plan.
Founded in 2009 with a registered capital of nearly 30 million yuan ($4.5 million), Advaccine primarily develops vaccines, including a respiratory syncytial virus vaccine and hepatitis B vaccine, though none of its inoculations has made it to the market as yet.
In January 2020, Advaccine partnered with Nasdaq-listed vaccine manufacturer Inovio to work on the INO-4800 DNA vaccine candidate.
https://www.caixinglobal.com/2021-04-05/chinese-co-developer-of-dna-covid-vaccine-raises-66-million-101685856.html
The WHO SOLIDARITY trial for Covid vaccines has protocols & a new acronym (SVT), so it's real! Philippines saying it will start April. Still don't know which vaccines.
2 or 3 vaxes, with 1 shared placebo group. Seems to be in Philippines & Colombia.
It makes too much sense for Inovio to be the vaccine of choice in the Philippines. Tropical climate off the coast of China and cold chain storage will not be an option there.
There's a small chance that INOVIO might be included in it. The Philippines have been eyeing INOVIO for the longest time.
it really doesnt matter how many deals a company makes--the bottleneck is at manufacturing and securing raw materials.
Half of the worlds vaccines goes to garbage due to temperature--low-mid income countries doesnt have the luxury and risk securing a vaccine that ALL might go to waste due to power failure or whatever -- which happens a lot.
https://mb.com.ph/2021/03/27/whos-covid-19-solidarity-vaccine-trials-likely-to-start-in-april-dost-official/
CEPI will allocate the US$3.5bn to prepare for known epidemic and pandemic threats, transform the response to the next novel threat.
1.Strengthening our defenses against COVID-19 and reducing the risk of future coronavirus pandemics, by optimizing our current vaccines, addressing variants of concern, developing next-generation COVID-19 vaccines, and initiating the development of broadly protective or universal coronavirus vaccines.[INO-4802 is next up to receive CEPI funding.]
2.Developing vaccines for known threats, to include completing the development of vaccines for Chikungunya, Lassa Fever, Nipah, and MERS, advancing the development of vaccines against Rift Valley Fever, and completing additional clinical trials to broaden the populations eligible for the Ebola vaccines. [CEPI has funded Ino’s Lassa Fever and MERS vaccine trials].
3.Working to compress vaccine development timelines to 100 days by optimizing the capabilities of rapid response platforms including mRNA, preparing clinical trial networks to respond rapidly to new threats, working closely with global regulators to streamline regulatory requirements, and linking manufacturing facilities to enable rapid production of pandemic vaccines.
https://cepi.net/news_cepi/cepi-launches-plan-to-tackle-risk-of-future-pandemics-and-epidemics/
Up to US$200 million in CEPI funding to be allocated for development of vaccines that provide broad protection against SARS-CoV-2 and betacoronaviruses.
R&D will focus on novel immunogens for use in vaccines that can elicit durable broadly protective immune responses.
Funding call forms part of CEPI’s longer term $3.5bn investment strategy, announced earlier in March, 2021, which is being activated now to mitigate the urgent threat posed by COVID-19.
CEPI’s call to develop broadly protective coronavirus vaccines forms part of its long-term $3.5bn investment strategy, announced earlier in March, 2021. CEPI is activating key elements of this plan now—including this call for proposal and its work on variant and next-generation vaccines—to mitigate the immediate threat posed by COVID-19.
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.1.153, 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.
https://cepi.net/news_cepi/cepi-launches-funding-call-to-advance-development-of-broadly-protective-coronavirus-vaccines/
Latest 10-K pg 9-10 and JK answered Hartaj Singh -- Oppenheimer & Company -Analyst.
BTW, Ino to submit this April month:
selection of doses based on week six immunogenicity, and week eight safety data. to confirm the most appropriate dose for each of three age groups with high-risk of infection. That 18 to 50-year olds, 51 to 64 year olds and 65 and older for the subsequent Phase 3 efficacy evaluation.
third booster data with INO-4800 in 93 out of 120 subjects from our Phase 1 clinical study. The subject received the booster doses 6 to 10 months post the second vaccination. 51 to 64 years of age, and elderly subjects, 65 and older.
Two C-2K 400-ppl test results of real use data with Biologics. No safety issue, only larger scale real world use, routine but required.
Advaccine’s 640-ppl P2 fully analyzed Wk8 immunogenicity, efficacy, safety.
This is a large enough data set for Biologics and device, N=400+93+640=1,133, for FDA to OK P3 start late April or early May. FDA has seen raw data, rolling reviews.
Smart Shorts started to cover April Fools day. I concur with CAD on pps direction. Short Risk/reward is very high 2Q21. April Immediate resistances are $15.4, $19. Medium term R could be in the 20’s as Advaccine will start P3 followed by Inovio.
We have filed device master files with FDA covering the use of the CELLECTRA® smart devices in human clinical trials. Smart devices with these configurations have been validated, manufactured under Current Good Manufacturing Practices (cGMP) and are being used in human clinical trials.
Our CELLECTRA®-SP smart devices combine the functionality of our current generation of skin and intramuscular devices in clinical testing with enhanced form, design and portability. All components of the pulse generator and applicator are integrated into a cordless, rechargeable device. The rechargeable battery can enable immunization of several hundred subjects, making the device useful for mass vaccinations. The devices are designed to accommodate different electrode arrays to meet the requirements of the particular DNA medicine and targeted tissue for delivery.
We are also advancing a new generation of ID delivery devices called CELLECTRA®-3P. Currently used ID devices penetrate no more than 3 mm into the target tissue, compared to IM devices that go deeper. All of our current vaccine clinical studies are using these CELLECTRA®-3P smart devices.
The medical arm of the U.S. Defense Threat Reduction Agency (DTRA) has agreed to fund the further development of our commercial ID delivery device or CELLECTRA 3PSP®. DTRA provided $8.14 million of grant funding to support us in developing a small, portable, battery-powered ID device to be branded as CELLECTRA®-3PSP, which will be used in the administration of our vaccines and therapies, including DTRA-developed products. In addition to the development of CELLECTRA®-3PSP, this award will fund the investigation of DNA vaccines developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) using the new device.
In June 2020, we were awarded $71.1 million in funding from the U.S. Department of Defense (DoD) to support the large-scale manufacture of the CELLECTRA® 3PSP smart device, production of doses and the procurement of CELLECTRA® 2000 devices. The DoD contract, from the JPEO-CRBND-EB through funding provided by the Defense Health Program, builds upon two separate prior $5 million grants from the Bill & Melinda Gates Foundation and CEPI, to accelerate the testing of CELLECTRA® 3PSP.
“We've been receiving multiple levels of funding.
The first is direct funding of our Phase 2 and Phase 3 INNOVATE trial. So that's directly funded through our CRO partner coming from the DoD. And then there is a second level of funding that we have announced in June of last year that involves the funding and completion of 3PSP device as well as some limited number of doses for the DoD, a few hundred thousand doses. And we could project that as we advance our program, those numbers can be increased potentially.”
Advaccine is a leading company in China's innovative vaccines. The new coronavirus DNA vaccine pGX9501 developed by Advaccine is currently in clinical phase II and is about to enter the clinical phase III. It is expected to become the world's first DNA vaccine approved for marketing.
The annual production capacity of the first vaccine production line built by Ai Diweixin in Suzhou is about 20 million doses, and the expanded annual production capacity can reach 100 million doses. We can continue to invest in expansion until it reaches the order of 1 billion doses.
https://enn7bneskmzgg7ff4exv4kxl2u-adwhj77lcyoafdy-mp-weixin-qq-com.translate.goog/s?__biz=MzA3ODk5OTEzOA%3D%3D&mid=2962137745&idx=1&sn=28664c18d2da518fb6ab0a7bf4ae2f39&chksm=aac0399c9db7b08a98a603a6fc8432489312fb25008d8051f61d1f2e2359ddecfe9b47709077&scene=21
Design and synthesis COVID-19 DNA vaccine constructs
Four spike protein sequences were retrieved from the first four available SARS-CoV-2 full genome sequences published on GISAID (Global Initiative on Sharing All Influenza Data). Three Spike sequences were 100% matched and one was considered an outlier (98.6% sequence identity with the other sequences). After performing a sequence alignment, the SARS-CoV-2 spike glycoprotein sequence was generated and an N-terminal IgE leader sequence was added. The highly optimized DNA sequence encoding SARS-CoV-2 IgE-spike was created using Inovio’s proprietary in silico Gene Optimization Algorithm to enhance expression and immunogenicity. The optimized DNA sequence was synthesized, digested with BamHI and XhoI, and cloned into the expression vector pGX0001 under the control of the human cytomegalovirus immediate-early promoter and a bovine growth hormone polyadenylation signal. The resulting plasmids were designated as pGX9501 and pGX9503, designed to encode the SARS-CoV-2 S protein from the three-matched sequences and the outlier sequence, respectively.
https://www.nature.com/articles/s41467-020-16505-0
Fair assessment for the the US market and DOD funding for P2/3 trial + purchase agreement for vaccine and Cellectra for electroporation deliver is huge. What wasn’t explained is the massive plasmid DNA mfg consortium that INOVIO has put into place with Richter Helm and Thermo Fisher. As soon as EUA is granted, INOVIO will be able to flip the switch on an easy to manufacture and distribute vaccine in the 100s of millions. Side note, Advaccine in China is also entering P3 trial with the same INO-4800 vaccine and can also manufacture 100+ million doses per year. So while the US may have many options with varying levels of efficacy (1st World Problems), the rest of mankind (especially in 3rd world counties) will receive tremendous benefit from Inovio’s vaccine that can be stored at room temp for a year! This is critical for regions of the world that don’t have cold transport infrastructure in place. Suffice it so say that while INOVIO has been slower than other big pharma companies who have received tremendous funding and FDA prioritization (Operation Warp
Speed included), INO has progressed steadily through the process. The only “bump” they hit was with regard to the FDA’s approval of the Cellectra Electroporation device for which they have some questions but have already approved a similar device for use in the delivery of cancer vaccines (https://www.outsourcing-pharma.com/Article/2017/06/15/US-FDA-lifts-hold-on-Inovio-s-cancer-vaccine-trials-after-firm-answers-device-questions). It’s just a matter of time before the world’s safest vaccine hits the market.
3/31 Covid-19’s “British” variant is both more infectious and more deadly than the Wuhan original, Kim said, and the British variant is not the most dangerous.
“The Brazilian variant was able to go into a town where we thought there was herd immunity, but now it is killing hundreds,” Kim said. “So herd immunity is not what we thought.”
And Kim does not fear the Brazilian variant the most: That would be the South African mutation.
Unsurprisingly, it is mutations that represent Kim’s nightmare scenario.
“If we fail to provide vaccines to parts of the world where we suspect major outbreaks, or get big countries with political problems, where even 40% vaccinations are not possible … these are mutant generators,” he said.
Currently, vaccines are holding their own, even if efficiency levels are reduced. This raises two questions: Will vaccines continue to maintain efficacy? And will the speed of vaccinations outpace the speed of viral mutations?
“Last March and April the US entered with US$18 billion with ‘Operation Warp Speed,’” Kim said. That enabled a number of companies not in the CEPI program, such as Sanofi and Pfizer, to proceed. It also prompted pharmas that had never developed vaccines, such as Innovio and Moderna, to enter the space.
“The US government said, ‘We will help fund research by buying a vaccine if you are successful,’” Kim said. “If you are a company, this is what you want to hear.” These moves, he added, replicated the kind of incentives Washington usually offers for the development of a new missile.
As prior platform vaccines were known to regulatory authorities, their trial processes could be fast-tracked by National Regulatory Agencies (NRAs) such as the US Food and Drug Administration (FDA) and the EU’s European Medicines Agency (EMA).
https://asiatimes.com/2021/03/vaccinations-in-a-race-against-viral-variants/