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HOW DO NUCLEIC ACID VACCINES TRIGGER IMMUNITY?
In the case of DNA vaccines, a piece of DNA encoding the antigen is first inserted into a bacterial plasmid. This is a circular piece of DNA used by a bacterium to store and share genes which may benefit its survival – a bit like a computer flash drive. Plasmids can replicate independently of the main chromosomal DNA and provide a simple tool for transferring genes between cells. Because of this, they are already widely used within the field of genetic engineering.
DNA plasmids carrying the antigen are usually injected into the muscle, but a key challenge is getting them to cross into people’s cells. This is an essential step, because the machinery which enables the antigen to be translated into protein is located inside cells. Various technologies are being developed to aid this process - such as electroporation, where short pulses of electric current are used to create temporary pores in patients’ cell membranes; a ‘gene gun’ which uses helium to propel DNA into skin cells; and encapsulating the DNA in nanoparticles which are designed to fuse with the cell membrane.
RNA vaccines encode the antigen of interest in messenger RNA (mRNA) or self-amplifying RNA (saRNA) – molecular templates used by cellular factories to produce proteins. Because of its transitory nature, there is zero risk of it integrating with our own genetic material. The RNA can be injected by itself, encapsulated within nanoparticles (as Pfizer’s mRNA-based Covid vaccine is), or driven into cells using some of the same techniques being developed for DNA vaccines.
Once the DNA or RNA is inside the cell and it starts producing antigens, these are then displayed on its surface, where they can be detected by the immune system, triggering a response. This response includes killer T cells, which seek out and destroy infected cells, as well as antibody-producing B cells and helper T cells which support antibody production.
https://www.gavi.org/vaccineswork/what-are-nucleic-acid-vaccines-and-how-could-they-be-used-against-covid-19
Inovio Pharmaceuticals: Once Bitten, Twice Shy
May 05, 2021 2:16 AM
Inovio's INO-4800 path forward remains ex-US.
Expect an announcement on the FDA partial hold to be removed very soon.
A spin-off opportunity is available and should be considered.
This remains a buy at these levels.
INO-4800
Since the dust has finally taken the time to settle surrounding the recent co-announcement by Inovio (INO) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense about the withdrawal of Phase III funding for the advancement of INO-4800, it’s time to step back and take an in-depth dive into the announcement and what it could mean for Inovio investors in the future.
Before I begin, it’s important to understand that this recent announcement is not the end of the relationship between INO and the DoD - rather, the doors remain wide open for the continued advancement of other infectious disease medicines, now and in the future. I remain extremely confident in making this argument based on prior government funding of Inovio’s platform which is capable of designing, developing, constructing and manufacturing an infectious disease vaccine from bench to bedside within 90 days.
Additionally, their vaccines will never require ultra-deep freeze storage and face the distribution logistical issues surrounding super cold chain development. Inovio's vaccines are stable at room temperature and “off the shelf ready” with a favorable safety profile that’s been tested on thousands of patients in clinical settings. Inovio's vaccines can also be produced in large quantities at a relatively lower cost and, because their vaccines do not use vectors (human, plant or animal/insects) they carry no potential for toxicity.
Finally, their vaccines do not use lipid-nano particles (LNP) like mRNA platform technologies, and thus don't require the use of chemical ingredients such as poly-ethylene glycol (PEG), a lipid nanoparticle surface hydrophilic polymer, in their vaccine solutions to manufacture their vaccine.
Parsing Out Words
Parsing out words from a press release reminds me of what economists and the media scrambles to do every time Jerome Powell speaks. They hang on every word, grammatical structure, tone, and punctuation. In the biotech world, ITT or mITT is a good analogy? Is it cherry picking a subset of results to get a better p-value by going with the modified intent to treat (mITT) or, can a case be made that an ITT has skewed data when an overpopulated and disproportionate number of traits in the trial population could explain a negative p-value? Regardless of what we feel, a bit of comfort can be found after readers take a deeper dive into the press release and sort through the language and see what led to the decision-making process at the DoD. Far removed from the science and the technology, it makes fiscal sense to the "bean counters" at the DoD to discontinue PHIII funding. In part, their message should allay any concerns about this partnership and the progress of INO-4800 outside DoD participation:
"The decision results from the changing environment of COVID-19 with the rapid deployment of vaccines. This decision is not a reflection of the awardee or product, rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products…This decision does not impact other work that INOVIO does with the US government and is neither a result of the partial clinical hold nor a reflection of the data generated to date for INO-4800 vaccine.”
For at least a decade the DoD has worked with INO because of their unique DNA medicines platform and after all these years, they’re not going to pack it in and walk away. This announcement wasn’t a case of ‘cut our losses and run’ rather it’s a clear statement by the DoD ‘we need to remain good stewards of funding and further funding doesn’t make financial sense at this time.’ The statement to discontinue funding by the DoD left the relationship intact and undamaged.
The defense of this country and the military apparatus that supports our nation will always rely on partnerships with innovative companies like Inovio Pharmaceuticals and many others that span across all sectors, in order to secure our nation’s defense and protect their most precious commodity, their personnel.
Partial Phase II/III Clinical Hold
Every Inovio investor is aware of the partial hold placed on the PHII/III INO-4800 clinical trials due to questions the Food and Drug Administration (FDA) raised at the last minute concerning Inovio’s CELLECTRA 2000 delivery device. This, according to the September 28, 2020, press release concerning the hold, is going to be used in the remaining COVID vaccine trials. The after-shocks this delay created cannot be overstated enough. The financial losses, the loss of US clinical field time and the diminished availability to enroll US volunteer trial patients, the subsequent loss of valuable data, as well as the potential to Inovio’s manufacturing relationships are all in jeopardy and should therefore be a serious concern to investors.
With that said, I do believe the FDA clinical hold will be lifted soon, but the destruction of time and the pure insanity of placing an impediment in the path towards the advancement of this vaccine - especially when a hold on a very similar device that performs in a nearly identical method and which the FDA recently approved in other human phase II and phase III trials - during a pandemic and national emergency when all hands on deck are needed remain inexcusable. But the buck doesn't stop at the doorsteps of the FDA.
I want to say this as succinctly and as genuinely as possible to CEO Joseph Kim, without sounding alarmist, “You should never allow this to happen to you again. Fool me once, shame on you, fool my twice, shame on me” and the sentiment in social media platforms serves as an echo chamber of this exact sentiment.
What does this device mean to Inovio and to the Inovio investors?
Electroporation and the devices are the ‘yellow brick road’ the ‘pot of gold’ and the ‘lottery win’ for Inovio. It is used in every facet of their medicines platform. Without it, Inovio could be forced to close or spend another decade on redesign and development of a new device, something this investor is not willing to support.
Far be it from me to become an armchair CEO - however, Dr. Kim should take a good hard look at the organizational culture, as well as its structure inside Inovio and determine if he needs to separate INO by spinning off CELLECTRA into its own company, only after FDA approval. This measure could make sense as well as unlock additional value. One company can focus solely on the development of the pipeline while the spin-off can focus on everything CELLECTRA, including further development, design improvements, related patents, approvals, marketing, etc.
Dr. Kim, you have the wisdom, humility and generosity to allow the brightest minds that surround you at Inovio Pharmaceuticals to advance the electroporation technology outside your office as an exciting new spin-off. I think you can take the risk and go beyond your comfort level without sacrificing the ultimate prize. “Once bitten twice shy” and another FDA hold for a device can’t be allowed to happen again under your your watch. It will be catastrophic.
Share Price Activity
Looking at the charts, it's clear that the share price has been slipping away from investors who jumped into the COVID vaccine foray last July. Untimely and many, if not most, have abandoned this ship for better returns. Not me. I've been adding and those on social media platforms now that I've added at a few points along the way while, at the same time, taking profits on swings to the upside. My overall sentiment is long and I suspect good news soon.
Conclusion
I certainly have come to appreciate the thesis by stalwart Inovio bears who, for the last decade have seen their thesis proliferate time and time again. Their main thesis, if you're new to this investment, focuses on Inovio's inability to bring a product to market. It has been their thesis for decades and it hasn't changed and why should it? Whether it's the science, the people, the epic missteps of the CEO, the bears have owned Inovio. But, for how long will they be able to maintain their thesis?
An announcement of further advances of INO-4800 PHIII human trials in China with their China partner Advaccine, announcements of further funding from CEPI, orders from COVAX or another international partner who may want to stockpile their MERS vaccine or even stockpile INO-4800 could change the outlook for Inovio's price action and an erosion of the bear thesis.
Additionally, Inovio is going to report in the coming quarters the 24 month overall survival for patients enrolled in clinical trials for the treatment of the deadly brain disease Glioblastoma while using INO-5401 in combination with INO-9012 and a PD-1 checkpoint inhibitor from Regeneron (NASDAQ:REGN). For that reason, I remain optimistic on the price being a buy at these levels. Your due diligence is necessary in the volatile biotech investing arena. Some sage advice: Only invest what you can afford to lose. Time, not timing, creates wealth. Margin calls create liquidity in the market.
One final note: Learning and knowledge are key to investing. It's already difficult for the casual retail investor to find morsels of information behind the backdrop of high speed-high frequency investment houses that collate data and trade in milliseconds. My promise is that I will always do my best to provide you with accurate information, when it is submitted to SA. You will still need to do your part complete more research before making any investments. By David Eberhart.
INOVIO-to-Present-at-Upcoming-Investor-Conferences-in-May: 5/12-BofA-Merrill-Lynch, 5/18-RBC
PLYMOUTH MEETING, Pa., May 4, 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 that INOVIO management will present at the following virtual investor conferences in May:
Bank of America Merrill Lynch Health Care Conference
Date: Wednesday, May 12, 2021
Time: 9:30 AM ET
Presentation Format: Fireside Chat
RBC Global Healthcare Conference
Date: Tuesday, May 18, 2021
Time: 9:45 AM ET
Presentation Format: Fireside Chat
China deal and royalties. AdVaccine CEO said they will go to Phase 3 this quarter. It gives profit (royalties) not revenue, use trial / efficacy data to show to others.
I am thinking the royalty is between 7 - 9% (Dr Kim said high single digits).
We don’t know price per dose (because AdVaccine mostly will not fall under DoD restrictions). Sinovac is $29.75 per dose in China. So assuming $30 per dose.
We don’t know how many doses they will make in China. (I think they will make at least 100 million doses this year. So around 3 billion in revenue for AdVaccine)
3 Even royalties number is a guess (7 - 9%). Assuming 7.5 and the
4 Payments that AdVaccine to make in addition to royalties upon reaching milestones is also not clear for us (CEO didn’t disclose what are the milestones and how much money per milestones)
So royalties may be 3b * .075 = 225m. In addition if they meet all milestones we may get additional $100million. So we are talking $325 million from China minimum. I excluded Cellectra assuming that will cover taxes. So we are talking 1.625 EPS from China. Bio has 35 * EPS. That gives share price of $56.875 from China deal alone. I think this is conservative and China needs 3 billion doses and not many vaccine players there. Every additional 100 million doses in China are 1.125 EPS. That is 35 * 1.125. So every 100 million gives 39.75 PPS.
Now if anyone wants to use 20 as multiplier of EPS then $33 from China as base and additional $25 per every 100 million doses.
Now coming to the rest of the world also each of the three big manufacturers (not including RH) can make at least 100 million per year but our CEO says 100 million in 2021 even after adding new manufacturers...
Pricing rest of the world is around $20 ($19 per DoD document and they cannot sell below it. Cellectra cost per dose is less than $ 1 - 3 .
Cellectra manufacturing scaling absolute black box.
With all these uncertainties it is extremely difficult to value the company... but shorts will run for the hills.
By Mark
It took me a while to see the real benefit of working with Advaccine. The license structure looks fine but nothing to scream from the rooftops about. It is pretty standard and a low capital revenue stream (once sales kick in and milestone payments are hit). The real benefit is the transferability of the clinical data to other countries for EUA or the equivalent elsewhere. I am starting to think that both the Chinese and South Korea studies will benefit Inovio indirectly and directly, respectively through the ability to garner approval in other jurisdictions / countries. I'm certain there is a long game being played that we are not all privy to, and it would be good to be able to convert conjecture into understanding but communication has never been a hallmark of this company.
By HDL Doc
8.2 Development Milestone Payments. Advaccine shall pay to Inovio the one-time, non-refundable, non-creditable payments set forth in the table below. Advaccine shall notify Inovio in writing within ten (10) days of achievement by a Product of a regulatory milestone event (except for milestone No. 3, which Inovio shall notify Advaccine upon achievement) and Advaccine shall pay to Inovio the required milestone payment within thirty (30) Business Days of the achievement by a Product of the applicable milestone event.
No. Milestone Event Milestone Payment
1 Enrollment of first subject in first Phase 2 Clinical Trial or Pivotal Clinical Trial for the Product in the Advaccine Territory [***]
2 Enrollment of first subject in first Phase 3 Clinical Trial or Pivotal Clinical Trial for the Product in the Advaccine Territory [***]
3 Marketing Authorization for a Product in the Field in the U.S. by the FDA [***]
4 Marketing Authorization for a Product in the Field by the NMPA [***]
5 First Commercial Sale of a Product in the Advaccine Territory [***]
Commercial Milestone Event: 4 rev tiers below.
The aggregate Net Sales of the Products in the Advaccine Territory in a given Calendar Year first reaches [***]
Inovio Phase-3 Covid-19 Trial Marches On Courtesy Of China
May 03, 2021 9:24 AM ETINO, MRNA...
Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors.
Summary
US Department of Defense rescinded Phase 3 of INO-4800 blaming over abundance of vaccines.
China's Advaccine files public offering with stated purpose of continued Phase 3 Trial of US Made INO-4800 for EUA and distribution in China.
Inovio and China's Advaccine set to release dual results of Phase 2 INO-4800 Trials.
Your enemies always get strong on what you leave behind. Michael Corleone of Godfather 2 had it right. Last week the US Department of Defense decided to pull the plug on Phase 3 Trial costs of Inovio Pharmaceuticals highly successful INO-4800 DNA Covid-19 vaccine and therapeutic. After having fully funded Phase 2 of the same trial the Government decided to walk back payments it had already contracted for catching many investors of guard. The reason the DOD claimed was simple, We have to many vaccines. The truth is few want to take the vaccines the Government has already purchased. This policy change gave Investors the feeling that Inovio was destined to create a Breakthru vaccine that nobody wanted. The stock plummeted shedding more than 20% in one day.
But this was not the end.
Feeling a bit left out from Operation Warp Speed grant money, (Inovio had no former Directors or Shareholders serving as the OWS Czar) CEO Joseph Kim (or should I say Don Corleone) in January of 2021 shrewdly signed a deal with China's Advaccine. As part of the China Deal Advaccine paid Inovio $3 million along with committing to a $100 million payment under additional terms not disclosed. For this Inovio receives a high single digit royalty from net sales within China. This sounds all well and good but hey the US Government just stopped paying for Phase 3. What happens next?
Enter the Dragon
Last week $600 million Advaccine files an Initial Public Offering in HONG KONG listing INO-4800 as its prime vaccine candidate for COVID-19 in China. Covered in the prospectus are statements asserting Advaccine is paying the full costs of Phase 3 Trials pertaining to their flagship vaccine INO-4800. The Prospectus states Phase 2 data of the 600 people tested belongs exclusively to Advaccine. China is known for its attention to detail and speed. The filing last week seems to coincide with the release of Phase 2 Data as both seem to be occurring at the same time, that's not a coincidence. The Chinese know what they have and its my believe the Inovio's Data will make Sinovacs vaccine obsolete. As more and more data keeps poring into VAERS the stigma of a Polyethelyne Glycol mRNA vaccine will leave the US giving away stockpiles. Sadly we could be importing INO-4800 from China. If only the other 5 families at the DOD or FDA had a little "Corleone wisdom"
Apollobio: The clinical trial of VGX-3100 is progressing rapidly, and the domestic phase III clinical trial is officially launched! Recently, the VGX-3100 project for cervical precancerous lesions, which was participated in the research and development of the Chinese oncology innovative pharmaceutical company Dongfanglue, has passed new progress. Its domestic phase III clinical trial project has successfully passed the scientific research approval of China Human Genetic Resources International Cooperation and was listed in 2021. The fifth batch of administrative licensing projects for human genetic resources in 2009 means that the VGX-3100 Phase III clinical trial was officially launched in China.
The project is jointly developed by Orient Technology and Inovio Pharmaceuticals, Inc. ( NASDAQ : INO ). Orient Technology has the exclusive right to develop, produce and commercialize VGX-3100 in Greater China (Mainland China, Hong Kong, Macau, Taiwan), and adapt to Symptoms include the treatment and prevention of precancerous lesions of the cervix, vulva and anus caused by HPV infection.
VGX-3100 progress in clinical trials optimistic, had in 2021 Nian 3 Yue 1 Ri, Inovio announced VGX-3100 Shou multicenter, randomized, double-blind, placebo-controlled III clinical trial results on the show, for all subjects evaluable Achieve the primary endpoint of clinical efficacy and all secondary endpoints.
Source: Government Service Platform of the Ministry of Science and Technology
About Dongfang [Apollobio] Strategy
Oriental Strategy focuses on the clinical development and commercialization of innovative oncology drugs, and provides solutions for unmet clinical needs. Currently, it has three new drug platforms, of which the VGX-3100 project is the fastest progressing , and multi-center clinical trials are being carried out in China. . The first indication for this platform is cervical precancerous lesions, and the first ongoing multi-center phase III clinical trial has achieved positive results. If successfully listed, it will be expected to provide the first alternative to surgical resection for tens of millions of patients with HPV infection-related precancerous lesions in China .
The other two indications for anal precancerous lesions and vulvar precancerous lesions are expected to enter Phase III clinical trials in 2021 . In addition, Orient Strategy is also looking for differentiated anti-tumor drug cooperation projects on a global scale through the model of internal development and external cooperation.
https://pz24bkvgtknmlvdgc65qpgp6pq-ac5fdsxevxq4s5y-apollobio-com.translate.goog/newsitem/278565364Inovio
KB: 4802: Second Generation Pan-Covid vaccine. Promising data from testing in mice shows immune responses are retained against Wuhan and UK strains with improved immune responses against SA and Brazil strains (cellular response and NAb)
Inovio’s platform has enabled rapid evolution of our COVid vaccine approach from optimized for single strain to optimized for newly emerging variants, with the potential to offer protective immune responses against further emerging variants.
Phase 1/2 trial is planned for 2021 demonstrating accelerated timeline from lab to clinic.
“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
Inov could get Ino-4800 P3 funding from CEPI, and/or partner with a BP? Merck, GSK, Sanofi.
Advaccine to preprint P2 data this May. So will Ino.
Advaccine to receive NMPA OK to start P3 before Ino.
Ino to receive FDA OK to start P3 this June at a few small sites in US, larger sites in Brazil, Mexico, Philippines.
Ino GBM P2 OS24 will be published this May. If positive, Ino could get a collaboration and licensing agreement with REGN.
https://stocktwits.com/Tracker7/message/324029944
5/5 WVC 09:00 – 10:30 EST Vaccine deployment and implementation – how do we deliver billions of vaccines globally? - How COVID-19 Variants Could Change Timelines
Moderator: Dr Jerome Kim, Director General, IVI
Christina Yi, COO, COVAXX
Jean-Cedric Meeus, Chief Transport Centre, UNICEF Supply Division, UNICEF Dr Prashant Yadav, INSEAD, CGD and Harvard Medical School
Dr Kate O’Brien, Director of Vaccines, WHO
Anuradha Gupta, Deputy CEO, GAVI
10:30 – 12:00 Keynote panel: What of our second generation COVID-19 vaccines? Is SARS-CoV2 here to stay?
- What will happen when more vaccines come to market?
- How will the different vaccines interact in the immune system?
- Will we need new COVID vaccines and boosters annually?
- Should we be vaccinating children?
Moderator: Dr Kayvon Modjarrad, Director, Emerging Infectious Diseases Branch, Walter Reed Army Institute of Research
Dr Stanley Plotkin, Emeritus Professor, University of Pennsylvania School of Medicine
ViE Awards Finals Shortlist:
Best Contract Manufacturing Organization Award
Ology Bioservices
Best Production/Process Development Award
ThermoFisher Scientific
Best New Vaccine Technology/platform Award
Bavarian Nordic – MVA-BN platform
BioNtech – mRNA platform
GeneOne Life Science – DNA platform
Inovio - DNA vaccine technology platform
Janssen - AdVac® / PER.C6® technologies
Medicago - Proficia technology
Moderna - mRNA platform
Novavax - Recombinant Nanoparticle Vaccine Technology / Matrix-M
Vaccitech - T cell-inducing platform
Best Pharma Award
Inovio
4802 pre-clinical result: Nucleic acid delivery of immune-focused SARS-CoV-2 nanoparticles drive rapid and potent immunogenicity capable of single-dose protection. 4/28
Antibodies from SARS-CoV-2 vaccines may target epitopes which reduce durability or increase the
potential for escape from vaccine-induced immunity. Using a novel synthetic vaccinology pipeline, we
developed rationally immune focused SARS-CoV-2 Spike-based vaccines. N-linked glycans can be employed to alter antibody responses to infection and vaccines. Utilizing computational modeling and comprehensive in vitro screening, we incorporated glycans into the Spike Receptor-Binding Domain (RBD) and assessed antigenic profiles. We developed glycan coated RBD immunogens and engineered seven multivalent configurations. Advanced DNA delivery of engineered nanoparticle vaccines rapidly elicited potent neutralizing antibodies in guinea pigs, hamsters and multiple mouse models, including human ACE2 and human B cell repertoire transgenics. RBD nanoparticles encoding wild-type and the P.1 SARS-CoV-2 variant induced high levels of cross-neutralizing antibodies. Single, low dose immunization protected against a lethal SARS-CoV-2 challenge. Single-dose coronavirus vaccines via DNA-launched
nanoparticles provide a platform for rapid clinical translation of novel, potent coronavirus vaccines.
We rapidly screened 19 nanoparticles directly in vivo using a single mouse per construct at a single low dose of 2µg. We observed that 14 of the 19 nanoparticles were immunogenic (Figure 4B). Strikingly, rapid antibody responses were detected just 1 week after immunization with RBD g5.1 24mer, RBD 136 48mer and RBD g5.1 120mer
https://www.biorxiv.org/content/10.1101/2021.04.28.441474v1.full.pdf
“So I just spoke to my clinical trial phase 3 site for ino-4800. Bummed the location I was planning to attend is now back up site. They did reiterate that there will be sites in the US but a reduced number and more sites outside the US.
Just passing along to whomever wants a INO shot.
They said mid June start date, I did not ask about the phase 3 hold being removed and they said their facility was updated last night about the trial.
Just passing along to whomever is looking for a solid vaccine.
We will get there it just takes time.” By Joeddie23 4/28
“that's very positive tid bits IMO
Just the fact they are working on the P3 details and reiterate the ex-US predominantly approach.” Obx4me 4/28
joeddie23
4/26/21, 04:18 PM
So quick update. I am on list for enrollment of phase 3 ino4800. I was told today that they would likely start screening mid June. There would be a couple sites in the US.
NMPA granted an umbrella IND for phase I and phase II trial to pGX9501 in July 2020. Based on the umbrella approval and the preliminary data obtained from phase I clinical trial in the U.S. and China, we have consulted with the CDE of the NMPA and the CDE had not expressed objection to the initiation of phase II clinical trials of pGX9501. In November 2020, we received an approval letter for commencement of phase II clinical trial from the Ethics Committee of Jiangsu Provincial Center for Disease Control and Prevention. We commenced phase II clinical trial in December 2020 and expect to commence phase III clinical trial for pGX9501 in the second quarter of 2021 and file a BLA or EUA application with the NMPA in the second half of 2021.
Inovio is actively working to address the FDA’s questions and plan to respond in May 2021, after which the FDA will have up to 30 days to notify Inovio of its decision as to whether its phase III clinical trial may proceed. Our Directors are of the view that as our clinical trials of pGX9501 in China are independent to the clinical trials conducted by Inovio in US, we do not expect the status of Inovio’s clinical trials in the US to affect our ongoing phase II or later clinical trials in China. Pg 193
We expect to commence pilot production in the second quarter of 2021 and are expected to produce vaccine samples for our phase III clinical trial and bridging trials for pGX9501 in the second quarter of 2021 in our manufacturing facilities in Suzhou. During the Track Record Period, we engaged third-party contract development and manufacturing organizations (CDMOs) and manufacturers to produce vaccine samples for our clinical trials. In order to develop our manufacturing capacity, we acquired Suzhou Si’ao in 2020.
Favorable manufacturing process ensuring stable supply. pGX9501 utilizes E. coli as a host for plasmid production, which is easier and cheaper to produce, more stable and easy to control the production process, in comparison with many major vaccine development platforms. In addition, our manufacturing process has shown consistency across DNA vaccine candidates developed in the past, with the potential to circumvent the complexities of conventional vaccine production based on cell culture systems, which are generally utilized in many major vaccine development platforms, enabling a more responsive and stable supply during both outbreak settings and routine immunization. The production of pGX9501 require lower biosafety level than that of inactivated virus vaccines. Pg 189
Favorable immunogenicity. In the US phase I clinical trial, pGX9501 demonstrated strong immunogenicity with a balanced humoral and cellular immune responses. All evaluable participants displayed a balanced antibody or T cell response or both responses following two doses of pGX9501. Based on published early immunogenicity analyses of the first cohort of 40 participants in the 18-50 years age group, pGX9501 was immunogenic in all vaccinated subjects, effectively generating humoral (displaying neutralizing antibodies) and/or cellular responses (both CD4+ and CD8+ T cells) in early stages. Humoral responses measured by binding or neutralizing antibodies were observed in 95% of the participants in each dose group. Cellular immune responses were observed in 74% and 100% of 1.0 mg and 2.0 mg dose groups, respectively. We expect pGX9501 to achieve a comparable immunogenicity profile in clinical trials in China. The following table sets forth the non head-to-head comparison between pGX9501 and currently approved COVID-19 vaccines that have conducted clinical trials in China.
Fewer safety and tolerability concerns. In US phase I clinical trial, pGX9501/INO- 4800 was safe and well-tolerated in all 40 participants. Most TEAEs classified as Grade 1 (lowest) AEs and were mostly local injection site reactions with short duration. Only six treatment related Grade 1 (lowest) AEs were observed in US phase I clinical trial, demonstrating a potentially better safety and tolerability profile compared to other competitors. The most common Grade 1 (lowest) systemic symptoms with pGX9501 include pain and redness at the injection site. The following table sets forth a non head-to-head comparison of safety data between our pGX9501 and currently approved COVID-19 vaccines that have conducted clinical trials in China:
Strong stability for vaccine storage and distribution. The stability profile of a vaccine plays directly to its ability to be deployed and stockpiled in an efficient and executable manner, especially during a pandemic. As pDNA is naturally stable, pGX9501 can be stored and delivered efficiently and effectively across a much broader temperature range to remote regions without ultra-cold chain logistics and storage. This enables pGX9501 to be more suitable and cost-effective for longer- term storage and for distribution across China, especially to regions with less developed infrastructure, as well as for long-term stockpiling. The following table sets forth a comparison of storage and logistics requirement for our pGX9501 and currently approved vaccines that have conducted clinical trials in China as of the Latest Practicable Date:
https://www1.hkexnews.hk/app/sehk/2021/103371/documents/sehk21042602171.pdf
Advaccine filed for HK IPO 4/26/21, “pGX9501 COVID-19 vaccine candidate. We are expected to be one of the first group of companies to launch a COVID-19 vaccine based on innovative vaccine technologies in China. As of the Latest Practicable Date, our pGX9501 candidate was the first and only clinical-stage DNA-based COVID-19 vaccine candidate in China. It is widely recognized that safe and effective vaccines are essential to control the COVID-19 pandemic, which has had a devastating social and economic impact in China and globally and caused over 100 thousand infections and over 4.8 thousand deaths in China alone as of the Latest Practicable Date. According to the F&S Report, based on efficacy data and the dosing regimens of currently approved vaccines in China, it is estimated that at least 99.4% of the PRC population, or 1.4 billion individuals, will need to be vaccinated in order to control the pandemic, translating to a total of approximately 2.8 billion doses needed assuming that the approved COVID-19 vaccines would confer life-long immunity. Based on clinical trials and pre-clinical studies, we believe that our pGX9501 has potentially favorable immunogenicity, a better safety and tolerability profile, an advanced manufacturing process and strong stability, differentiating it from other COVID-19 vaccines approved and in development. We commenced phase II clinical trial in December 2020 and expect to commence a phase III clinical trial for pGX9501 in the second quarter of 2021 and file a biologics license application (BLA) or emergency use authorization (EUA) application to the National Medical Products Administration of the PRC (?????????) (the “NMPA”) in the second half of 2021.” Pg12.
“ In December 2020, we entered into a collaboration and license agreement, or the Inovio Collaboration and License Agreement, with Inovio for COVID-19 DNA vaccine candidate pGX9501/INO-4800 (the “Vaccine”). Under the Inovio Collaboration and License Agreement, Inovio has granted us an exclusive license to develop, manufacture and have manufactured, distribute, market, promote, sell, have sold, offer for sale, import, label, package and otherwise commercialize the Vaccine product in the Greater China region for all prophylactic and therapeutic use in humans. We will be solely responsible for the development of the Vaccine in Greater China region, including all non-clinical and clinical studies and collection of CMC Information, at our own cost and expense, as necessary to obtain the regulatory approval for the Vaccine in the Greater China region. Upon mutual agreement between the parties, Inovio will expand our license to allow us to conduct phase III clinical trial in regions out of the Greater China region. Inovio will use commercially reasonable efforts to develop and obtain regulatory approval for the Vaccine in the United States and will provide all reasonable assistance and cooperation to assist and support our research and development of the Vaccine. Inovio will supply our clinical requirements of the Vaccine and applicable device for clinical use in the Greater China region. See “Business—Collaboration and Technology Transfer Agreement—Collaboration with Inovio.” pg 14.
• Demand for COVID-19 vaccines. Although the COVID-19 outbreak is generally under control in China, new indigenous cases were reported from time to time across regions in China. Moreover, the virus is prone to mutations and there have been patients infected with mutated viruses. Virus mutations will require new and effective vaccines, such as DNA vaccines, which can react faster to virus mutations. Vaccines have been widely recognized by experts to be the key to controlling the pandemic. As COVID-19 mutations have been observed, there is a potential huge need for COVID-19 vaccines able to address virus mutation problems.
• Increasing government support for COVID-19 vaccines. To expedite the vaccine development process, many countries, including China, have implemented faster approval processes to shorten the development period from the usual 10-15 years to 2-3 years or even less. For example, accordingly to relevant regulations regarding research and development of COVID-19 vaccines in China promulgated by NMPA, in light of the current public health emergency, applicants are encouraged to submit preclinical data for IND approval on a rolling basis and will receive immediate feedback from the NMPA. Pg 122
https://www1.hkexnews.hk/app/sehk/2021/103371/documents/sehk21042602171.pdf
CEPI: We've launched a $3.5bn plan to advance vaccines and other innovative tools to dramatically reduce or even eliminate the future risk of pandemics and epidemics
https://endpandemics.cepi.net/
ACT now, ACT together 2020-2021 Impact Report
https://www.who.int/docs/default-source/coronaviruse/act-accelerator/act-a-impact-report.pdf?sfvrsn=3db8f257_1&download=true
4/26 Israel Examines Heart Inflammation Cases After Pfizer Shot.
Health officials are investigating whether the cases are connected with the shot which has been administered to more than 5 million people, Corona Commissioner Nachman Ash said Sunday in an interview with Radio 103FM. The government identified 62 incidents of inflammation of the heart muscle, or heart-muscle membrane, Channel 12 reported last week, citing a health ministry study.
The condition developed in one out of 100,000 people who received the shot, while the incidence rate for men of 18 to 30 years was one in 20,000. Two people died and the rest recovered.
4/25 “We-are-currently-communicating-with-FDA-about-Cellectra, and-we-are-working-hard-to-receive-FDA-Phase-3-concurrence in June.” By Inovio.
Following the announcement, Oppenheimer analyst Hartaj Singh reiterated a Buy and a price target of $35 on the stock. Singh said in a note to investors, “We spoke briefly with management regarding the press release put out earlier today. Inovio assured us that the government has no insight on the ongoing Phase 2/3 trial, which is randomized and blinded.”
“Recent data from INO-4800 against COVID-19 variants adds to our belief that INO’s vaccine is safe and effective; which it should demonstrate in the Phase 2 update of the trial, planned shortly. In a counterintuitive way, we think that this release by the US Government could give INO significant flexibility on issues of timing, deployment, intellectual property and profitability for INO-4800,” Singh added."
4/24 “4800 not giving up. We think the P2 results will be announced sooner or later. P3 is planned to be conducted overseas and is already being searched for a place.
We will do our best to share it with good news in the future.
Thank you”
4/23 “First of all, I am very sorry to share this news.
1. We don't think it is a decision related to our INO-4800 P2 data. And other contracts concluded with INOVIO and the Ministry of Defense will remain in effect.
2. The biggest reason for this decision is that vaccines are currently being distributed in the United States, and recruitment of P3 patients is expected to be difficult. So, we are seeking to apply for INO-4802 through the Ministry of Defense and BARDA.
3. Even if not, we were considering alternatives for P3 in South America [Brazil] and Southeast Asia [Philippines] as well as in the US due to patient recruitment issues. P3 launch approval is expected in June.
4. P2 data analysis is ongoing, but the company is positive. We are striving to release P2 data at an early point in the company.
5. We are currently discussing Phase 3 cooperation with Advaccine and IVI.”
[Brazil, Philippines sites will cost much less.]
4/15 “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.”
4/14 “1. Phase 2 done. Share their Result in early May.
2. Phase 3, hope to start June.
3. IPO for S Korea almost ready
4. GeneOne, cannot comment.
5. Many partners seeking INO to work with
6. They are disappointed about SP since they thought cervical cancer vaccine result was good.”
In English. Dovetailed with what posted before. 4800 P3 in Brazil, Philippines who has considered ordering 4800.
“First of all, I am very sorry to share this news.
1. We don't think it is a decision related to our INO-4800 P2 data. And other contracts concluded with INOVIO and the Ministry of Defense will remain in effect.
2. The biggest reason for this decision is that vaccines are currently being distributed in the United States, and recruitment of P3 patients is expected to be difficult. So, we are seeking to apply for INO-4802 through the Ministry of Defense and BARDA.
3. Even if not, we were considering alternatives for P3 in South America [Brazil] and Southeast Asia [Philippines] as well as in the US due to patient recruitment issues. P3 launch approval is expected in June.
4. P2 data analysis is ongoing, but the company is positive. We are striving to release P2 data at an early point in the company.
5. We are currently discussing Phase 3 cooperation with Advaccine and IVI.”
Reply in Korean.
https://stocktwits.com/m633/message/320224075
JK’s ASH letter April 10, 2021 said “begin a global Phase 3 trial this summer”.
“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.”
https://materials.proxyvote.com/Approved/45773H/20210316/SHLTR_462417.PDF
The countries that have managed to get a lot of people vaccinated — the U.S., the United Kingdom, India — all happen to have manufacturing plants that are producing the vaccines. They also have had export restrictions that have meant their own citizens have been at the front of the line to get immunized. Important regional players such as South Africa have fully vaccinated only half of 1% of their population. In the Philippines it's less than 0.1%. Even wealthy nations in Europe such as Germany, Spain, Italy and France haven't gotten above 7%.
Vaccination Rates In The World’s Most Populous Countries
Share of population that received at least one COVID-19 vaccine dose.
US 39.6%
China 13.5%
Brazil 11.7%
Mexico 8.7%
India 8%
Russia 6.9%
Indonesia 4%
Bangladesh 3.5%
Philippines 1.1%
Japan 1%
Pakistan 0.6%
Nigeria 0.5%
Egypt 0.1%
Ino could conduct P3 in India which has highest attack rate, 325K new cases yesterday alone, only 8% had 1st dose.
That would almost complete the BRIC nations. Mexico is a good possibility. Philippines which has considered ordering 4800 is a possible site.
The same 5 Brazil sites for REVEAL 2 could be used for 4800 P3 - cost effective. Will not reveal source.
https://www.npr.org/sections/goatsandsoda/2021/04/22/988814093/what-does-vaccine-inequality-look-like-see-chart
4800 P3 Global Expansion “Thank you for your thoughtful questions. Your points are valid. As such, we are looking at all options to make sure our P3 progresses quickly, including going to countries with lower vaccination rates and/or higher burden rates. We absolutely share your desire to start and get our P3 done as soon as possible, once FDA provides concurrence.
Right now, we are busily working on the analysis of our P2 data. We know that folks are waiting to see the data and as such we are working hard to release it as soon as possible” 4/22. Link doesn’t exist.
This validates JK’s statement of going global besides China.
Note Nvax conducts Phase 3 in UK, US, Mexico, Phase 2b in South Africa.
Ino is conducting VGX-3100 Cervical Dysplasia REVEAL 2 at 5 sites in Brazil.
4800 is proven as effective in NAb and T-cell for Brazil P1 variant from Phase 1 booster as Wuhan type. 4800 P3 could happen in Brazil in addition to US, China.
Brazil, Bahia
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio
[Active, not recruiting]
Salvador, Bahia, Brazil, 40420-000
Brazil, Goiás
Hospital das Clinicas de Goiânia
[Active, not recruiting]
Goiânia, Goiás, Brazil, 74605-050
Brazil, Paraná
Hospital Erasto Gaertner
[Active, not recruiting]
Curitiba, Paraná, Brazil, 80530-010
Brazil, São Paulo
Hospital Amaral Carvalho
[Recruiting]
Jaú, São Paulo, Brazil, 17210-120
Contact: Study Coordinator Adriana dos Santos +551436021397 centrodepesquisas.adrianasantos@amaralcarvalho.org.br
Principal Investigator: Dr. Beato
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
[Recruiting]
Ribeirao Preto, São Paulo, Brazil, 14048-900
Contact: Study Coordinator Michelle Silveira +551636025257 mcsmurari@hcrp.usp.br
Principal Investigator: Dr. Quintana
4/22 Low-dose Administration of MERS DNA Vaccine Candidate Induces Potent Immunity and Protects From Virus Challenge in Preclinical Models
Co-authors: Ziyang Xu, Faraz I. Zaidi, Kevin Y. Kim, Regina Stoltz, and Kar Muthumani from The Wistar Institute; Dana P. Scott, Friederike Feldmann, Tina Thomas, Rebecca Rosenke, Dan Long, Jamie Lovaglio, Patrick W. Hanley, and Greg Saturday from National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT; Janess Mendoza, Stephanie Ramos, Laurent Humeau, and Kate E. Broderick from INOVIO Pharmaceuticals, Inc.
Work supported by: Funding from the Intramural Research Program, National Institutes of Allergy and Infectious Diseases, and the Coalition for Epidemic Preparedness Innovations (CEPI).
https://wistar.org/news/press-releases/low-dose-administration-mers-dna-vaccine-candidate-induces-potent-immunity-and?fbclid=IwAR1SpzX7qi2YMUE84-MI66tzfW23D3fHdEkqoTm_Y67XLZdtEJjYEb17D1Y
Intradermal delivery of a synthetic DNA vaccine protects macaques from Middle East respiratory syndrome coronavirus
https://insight.jci.org/articles/view/146082
“Given that human efficacy trials for MERS vaccines may be challenging due to the low number of yearly cases, animal models such as our NHP model are valuable as a bridge with human data coming from early-phase clinical trials,” said Weiner.
In this study, Weiner and team report robust antibody neutralizing antibodies and cellular immune responses in all conditions tested. A rigorous virus challenge experiment showed that all vaccination groups were protected against MERS-CoV compared to unvaccinated control animals. However, the low-dose regimen with intradermal delivery was more impactful in controlling disease and symptoms than the higher dose delivered intramuscularly in NHP models.
“To our knowledge, this is the first demonstration of protection with an intradermally delivered coronavirus vaccine,” said Ami Patel, Ph.D., Caspar Wistar Fellow at the Vaccine & Immunotherapy Center and one of the lead authors of the paper. “Intradermal delivery of synthetic DNA vaccines has significant advantages for rapid clinical development. It can be dose sparing and has higher tolerability in people compared with intramuscular injection. The positive results of this study are important not only for the advancement of this MERS vaccine but also for development of other vaccines.”
“Our team is also advancing a COVID-19 vaccine through clinical trials, and we were able to do so in a very short time thanks to our previous experience developing the MERS vaccine,” added Weiner.
Importantly, no evidence of adverse effects on the lungs was observed in any of the dosing groups compared to unimmunized control animals. Through the assessment of a large panel of blood cytokines, researchers showed significant decrease in all mediators of inflammation, which further suggests the vaccine prevents the destructive inflammation induced by coronaviruses.
Dr. Fauci's statement is good news for Inovio because it confirms the great need for a pan-COVID vaccine. Such a product could be a game-changer. If Inovio can make it work, the program could be transformative for the company. The company or companies that make pan-COVID vaccines likely will generate billions of dollars in government orders worldwide.
"What we're putting a lot of effort in, is to try and get a more universal vaccine that would cover all different types of variants," Fauci said. "That's the ultimate end game." Fauci referred to overall efforts in the scientific community.
Why is this good news for Inovio? Because Inovio's next-generation vaccine program is working to meet that goal. And if it does, Inovio may finally get its opportunity to shine.
But it's too early to say whether Inovio can win this new vaccine race. It's clear the company doesn't have the upper hand from a timeline perspective. This new program isn't a booster that can gain authorization based on the earlier authorization of a vaccine. The FDA says companies with authorized vaccines don't have to perform huge new trials for a vaccine update or booster. Moderna and Pfizer both fall into this category.
Experts say the coronavirus will be around well into the future. So, if Inovio launches a pan-COVID vaccine in a few years, there could be a huge market for it.
And Inovio's next-generation program is in the early stages. But it is a stock you'll want to keep on your watch list -- possible progress in the next-generation vaccine program could make it a buy in the future.
Recombinant monoclonal antibodies, which represent the largest segment of pharmaceutical markets today with more than $100B in sales, are designed to enhance the immune system's ability to regulate cell functions. However, the technology has some limitations, including long and costly laboratory development and large-scale production, limited duration of in vivo potency, and a pharmacokinetic profile that can result in toxicity.
Empowered by more than $80 million in previous development funding from DARPA, as well as from the Bill and Melinda Gates Foundation and the National Institutes of Health, the dMAb® platform provides potential new avenues for treating a range of diseases. The DNA plasmids are delivered directly into cells of the body and the encoded monoclonal antibody is then produced by the locally transfected cells. Previously published studies show that a single administration of a highly optimized DNA-encoded monoclonal antibody targeting Zika virus (INO-A002) produced a high level of expression of the antibody in the bloodstream of mice that was protective against lethal animal challenge. INOVIO initiated the first human study of INO-A002, marking a major step towards the development of a broad range of INOVIO's dMAb and DNA-encoded Bi-specific T Cell engagers (dBTE) programs. Additional studies similarly reported data showing that dMAbs® against Ebola, flu, chikungunya, Lyme, and dengue protected animals against lethal or pathogenic challenge. Anti-tumor dMAb candidates, including those for PD-1 and CTLA-4 checkpoint inhibitors, have demonstrated therapeutic effects against prostate, breast, and ovarian cancers in animal models.
Dr. Kayvon Modjarrad, director of WRAIR's Emerging Infectious Diseases Branch, the principal investigator of the study and first author on the publication, said, "The world witnessed the emergence and devastation of SARS in 2002 and then MERS 10 years later. MERS hasn't gone away. And there's every indication that the family of viruses to which SARS and MERS belong, coronaviruses, are here to stay. U.S. military personnel are at particular risk for MERS, given the deployments to the Middle East and South Korea where the largest MERS outbreaks have occurred. This study is, therefore, an important advancement for the U.S. Army, the military community as a whole and the global stakeholders in the research and development of both MERS and corona virus countermeasures."
Inovio plans to initiate a larger Phase 2 field trial in the Middle East with through a partnership with CEPI, based on Phase 1b/2a data for INO-4700. Inovio received a $56 million funding last year from CEPI under which Inovio will develop vaccine candidates through Phase 2 against MERS and Lassa fever. The shared goal of Inovio and CEPI is for a MERS vaccine to be available as soon as possible for emergency use as a stockpile post-Phase 2 testing.
4/11/21 60 Minutes:
Dr. Kayvon Modjarrad: We're trying to not just make a vaccine for this virus, we're trying to make a vaccine for the whole family of coronaviruses. This is the core of our vaccine. We engineer the spike so that we can attach it to this protein.
If his concept, now in clinical trials, proves successful, Dr. Modjarrad says in five years a single vaccine could defeat all coronaviruses: that means many common colds, the deadly strain causing this pandemic and thousands of others.
Bill Whitaker: Is that at this point-- a dream?
Dr. Kayvon Modjarrad: This is not science fiction, this is science fact. We have the tools, we have the technology, to do this all right now.
60-minutes-shed-light-on-DARPA-Covid-19-antibody-given-to-AZN-which-Ino’s dMAb-is-creating-w/$37.6M grant
Don't be fooled by that smile, Dr. Hepburn is a hard taskmaster. Stopwatch in hand, he set up a simulated Zika virus outbreak. He gave Dr. Crowe $28 million and his first challenge: test every cell in a vial of survivor's blood and find a cure. They did, in 78 days.
Dr. James Crowe: We're used to getting all As. And, you know, Matt was kinda giving us a C for effort. We were preparing to do a simulated sprint number two. And in the middle of that COVID happened. And so DARPA turned to us and said, "No more simulations. This is real. We need you to deliver antibodies for COVID."
Dr. Crowe's lab delivered an antibody treatment to drugmaker AstraZeneca in a record 25 days. Others funded by the government's pandemic response program also shattered Matt Hepburn's 60-day mark, including biotech company AbCellera, working with Eli Lilly and Regeneron, which was used to treat President Trump.
Dr. James Crowe: This is the new normal. It's gonna be 60 days from here on out.
Well not quite yet - currently, antibodies are grown in a bioreactor like one at this Defense Department Rapid Response Plant in Florida. It'll take three weeks for this to produce 7,500 doses.
Dr. James Crowe: And so-- a lot of scientists are trying to figure out, can this be done faster?
Dr. Crowe has successfully tested a faster way: RNA, the genetic tool DARPA helped pioneer that was used to make the coronavirus vaccine in record time. In the next outbreak -- RNA would allow factories like this to churn out millions of doses a day.
Dr. James Crowe: We would start from-- a blood sample from a survivor and be done with all of this and be giving you an injection of the cure within the 60 days.
With their promise of speed, immediate protection, and a cure, Dr. Hepburn says RNA antibodies could stop the next Wuhan-like outbreak cold.
Dr. Matt Hepburn: It's really beyond vaccines, That's our future. That's our next step.
Bill Whitaker: Shoot for the moon.
Dr. Matt Hepburn: Shoot for the moon.
https://www.cbsnews.com/news/last-pandemic-science-military-60-minutes-2021-04-11/
14th Annual Vaccine Industry Excellence Awards, Wed 5th May - 12pm - 1pm EST. Finalists: Ino in 2, Wistar
Best Clinical Trial Site Award
DM Clinical Research
Tekton Research
Ino-4800 P2 sites:
Tekton Research
San Antonio, Texas, United States, 78229
DM Clinical Research
Tomball, Texas, United States, 78229
Best Contract Manufacturing Organization Award
Baxter BioPharma Solutions
Catalent Pharma Solutions
Emergent BioSolutions [should not be here due to JnJ, AZN mix-up fiasco]
FUJIFILM Diosynth Biotechnologies
IDT Biologika
Ology Bioservices [Ino manufacturing partner]
Sterling Pharma Solutions
VGXI
Best Production/Process Development Award
ThermoFisher Scientific [Ino manufacturing partner]
VGXI
Best New Vaccine Technology/platform Award
Bavarian Nordic – MVA-BN platform
BioNtech – mRNA platform
GeneOne Life Science – DNA platform
Inovio - DNA vaccine technology platform
Janssen - AdVac® / PER.C6® technologies
Medicago - Proficia technology
Moderna - mRNA platform
Novavax - Recombinant Nanoparticle Vaccine Technology / Matrix-M
Vaccitech - T cell-inducing platform
Best Academic Research Team Award
Wistar Institute - Dr David Weiner Laboratory
Best Pharma Award
GSK vaccines
Inovio
Janssen
Merck
Novavax
Pfizer
Sanofi
Takeda
Best [P3] COVID Vaccine Award
AstraZeneca/Oxford University
Bharat Biotech
Janssen
Medicago
Moderna/NIH
Novavax
Pfizer/BioNtech
Sputnik V
The winners in each category will then be revealed on the event platform on Wednesday 5th May between 12pm and 1pm EST , as part of the WVC Washington virtual event. Please register for free here to join us for the Awards, as well as the entire event May 4-6.
https://www.terrapinn.com/conference/world-vaccine-congress-washington/VIE-AWARDS-2021.stm?utm_source=pardot&utm_medium=email&utm_campaign=UK_10407_WVC%20DC%202021_ViE%20Awards_Email%205_Nurture&utm_term=pardot-email
As-fears-mount-over J&J and AstraZeneca, Novavax-enters-a-shaky-spotlight. Novavax may, however, still face a different export ban at that point. The Serum Institute contracted to produce 1 billion doses of Novavax’s vaccine in 2021, many of which are designated for COVAX. They’re already behind, and experts fear that India could keep its export ban on vaccines in place even after production scales up.
Nearly eight months after Takeda and Novavax signed an agreement, the Hikari facility is still not making vaccines. And Venkayya said it may not begin production this year.
The problem is the same one that has affiliated the globe: the supply of raw materials. Although Novavax has established a manufacturing network across the globe, they’re missing key components to keep it running. That includes single-use bags that encase the insect cells when they’re inside the bioreactors. To get the Czech facility running, Trizzino says, they also need a filter that’s used throughout the production process, including for purification.
Those delays have cost the company. Reuters reported in March that they forced the company to push back contract negotiations with the EU, as the Czech facility couldn’t make enough doses to supply the continent.
Novavax executives and their partners at the Serum Institute have said the US government is restricting exports, although the reality is a bit more complicated. There’s a shortage of both components globally as supply chains strain under an unprecedented vaccination effort. The companies that make filters, for example, don’t have enough raw materials to make them, says Matthew Johnson, who leads cGMP at the Duke Human Vaccine Institute.
https://endpts.com/as-fears-mount-over-jj-and-astrazeneca-novavax-enters-a-shaky-spotlight/
DoD backs Ino up in Biologics and device. DPA will prioritize Ino-4800, 4802. Additionally, likely large CEPI’s manufacturing scale-up, BARDA funding will start at-risk production for second waved vaccine before EUA. TMO A to Z one Stop production is tremendous. Kaneda, RH, Ologics augment TMO. 100M doses are committed
in 2021. That’s not a lot to ask for.
NHP challenge completed at PHE, result published. Ferret challenge completed at CSIRO, result published. OWS’ NHP challenge completed. Not yet funded Winner could be funded next.
“ We have begun talks with various organizations like CEPI, Barda, etc for the support of our Pan-Covid 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.
Ino has been working with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia to test INO-4800’s efficacy.
One or two dose regimen of the SARS-CoV-2 synthetic DNA vaccine INO-4800 protects against respiratory tract disease burden in nonhuman primate challenge model
https://assets.researchsquare.com/files/rs-269242/v1/3e936ab8-cb0b-4dfd-b7d1-fe5f7bf4844f.pdf
CSIRO: Live virus neutralisation of the 501Y.V1 and 501Y.V2 SARS-CoV-2 variants following INO-4800 vaccination of ferrets 4/19
https://www.biorxiv.org/content/10.1101/2021.04.17.440246v1.full.pdf
Will GSK, Merck and Sanofi do something definitive [partner w/ Ino?] to gain a place in the mRNA field, or risk handing over the entire market to the mRNA leaders as they continue to ramp up manufacturing?
DW-is-on-Advisory-Board-of-AZN, Sanofi leading-to-$37.6M-dMAb-DARPA-grant, possible-Sanofi-Covid-partnership. D.B.W. discloses the following paid associations with commercial partners: GeneOne (Consultant), Geneos (Advisory Board, research funding, stock), Astrazeneca (Advisory Board, Speaker), Inovio (BOD, SRA, Stock), Pfizer (Speaker), Merck (Speaker), Sanofi (Advisory Board), BBI (Advisory Board).
DW’s AZN connection helped clinch the $37.6M dMAb DARPA grant. Likewise, his connection with Sanofi, Merck could culminate in some Covid-19 4800, 4802 partnership.
J&J, which today reported a modest $100 million in revenue from their vaccine — sidelined by safety concerns — is going to get iced out of the main market in the US/EU/Japan. AstraZeneca is also getting pushed aside by Pfizer and Moderna, Bernstein’s Ronny Gal expects, as mRNA vaccines dominate the field.
We revise our model to assume no JNJ or AZN doses will be delivered in the US beyond the 100M pre-purchased JNJ doses. Incremental doses (and booster doses in the fall and winter) will come from the mRNA manufacturers (with possibly some from NVAXl). It seems EU will follow a similar pattern as many countries discontinued use of AZN vaccines and now purchased ~600M combined PFE and MRNA doses, and few AdVec doses will be ‘needed’ to vaccinate the population by YE21.
Let’s keep in mind here that J&J was forced to take a knee after a handful of cases of blood clotting, a tiny risk in the world of therapeutics when compared to the potential benefit it offers in terms of ending the pandemic. But with governments raising red flags in front of billions of people, while the mRNA vaccines continue to lengthen their lead, the risk/benefit algorithm that has long decided the winners and losers in this game has been thrown out the window. And even if NIAID director Anthony Fauci is right and J&J gets a green light to jump back in at the end of the week, no one is likely to forget those red flags.
One big question I have is how the major players will yet decide to line up for future pandemics. Will GSK, Merck and Sanofi do something definitive to gain a place in the mRNA field, or risk handing over the entire market to the mRNA leaders as they continue to ramp up manufacturing? Right now they seem virtually dormant in this setting.
Still vying to get into the game are new vaccines from Novavax and CureVac. And with more traditional jabs under a cloud, they may yet have a chance to make their mark as the rest of the world seeks a way out of the pandemic.
This is an extract of the discussion which took place yestersay. Kate and David Weiner were part of it. The Moderator asked the question. Tell us about the DMAB tech. This is what Kate and David answer. PROMISING *transcript from someone on FB
Kate: Instead of using antibodies as a protein element, which are fantastic and have changed how we think about treating many things including cancer, one difficult part of that type of therapy is the cost and difficulty to produce which limits who has access. We've developed a clever way to trick the bodies cells to become factories to make the antibodies. It's a way of bypassing the expensive and time consuming tech as it currently its. They're called DMAB's as the person in the chat stated. It's a very exciting and novel approach and a new way of approach.
Weiner: We've been working on dev this tech for quite a few years. Many people have tried gene therapy, rna approaches. Ours is trying to do it as simple as possible. AZ is involved. AZ has antibodies the clinic so they have advanced help. We're advancing this incredibly fast in a OWS manner thanks to help from the DOD. We can do this in the person, as opposed to externally.
Latest study from @CSIRO: Live virus neutralisation of the 501Y.V1 and 501Y.V2 SARS-CoV-2 variants following INO-4800 vaccination of ferrets 4/19
https://www.biorxiv.org/content/10.1101/2021.04.17.440246v1
“Indeed, the reductions in neutralisation titres ( and by extension , vaccine-induced protec tion) observed with the 501 Y.V2 variant are comparable for leading nucleic acid based COVID -19 vaccines – approximately 4-fold for INO-4800 ( Inovio Pharmaceuticals) , compared to 6.5 -fold for BNT162b2 (BioNTech/Pfizer) and 8.6-fold for mRNA-1273 (Moderna ) – and subst antially less than the 86- fold reducti on reported for AZD1222 (Oxford /AstraZeneca)”
So I have looked and looked and found NO articles indicating any of the volunteers catching Covid-19 after taking Inovio's INO-4800 in any of the trials thus far. So IMO INO-4800 is safe and effective. Can any anyone argue this point??
FRBPhD
Bullish
05:21 AM
@Lookingdown I’m P2 Double Arm 1 Mg going on 6 months. My entire family has had Covid-19. I have not. Travelled the Country from San Fran to Florida, 4 trips to Vegas, Ski Trips to Whistler BC. Pandemic has not slowed me down and I’m a senior citizen. Ino-4800 works!
Deep Dive on 4800 against VOCs. Samples from immunized individuals were tested for serum immunoglobulin G (IgG) antibody binding to the full-length spike protein by an ELISA that used peptides specific for each of the variants.
Among sera isolated from vaccinees at week 8 after administration of two doses of INO-4800, anti-SARS-CoV-2 spike IgG titers were not negatively impacted by wild-type virus or the B.1.1.7 or B.1.351 variant. However, a 1.9-fold reduction in IgG titer was observed for the P.1 variant.
Next, the team performed a SARS-CoV-2 pseudovirus neutralization assay using sera collected from individuals two weeks following the third dose of INO-4800.
Neutralizing antibodies were detected against the wild-type virus and all variants tested.
However, a 2.1-fold reduction in neutralizing antibody titer was observed for B.1.1.7, and a significant 6.9-fold reduction was observed for B.1.351, while no significant difference was observed between wild-type and the P.1 variant.
The team says that while RBD changes are similar between the P.1 and B.1.351 lineages as they both contain the N501Y mutation and identical E484K mutations, they contain similar but different mutations at position K417 (K417T in P.1 and K417N in B.1.351).
What about the cellular response?
Next, the team compared the cellular immune responses to wild-type and SARS-CoV-2 spike variants following vaccination.
Peripheral blood mononuclear cells isolated from ten subjects at week 8 following a second vaccine dose were stimulated with wild-type, B.1.1.7, B.1.351, or P.1 spike peptides. Cellular responses were measured by interferon (IFN)-? ELISpot assay.
This revealed that IFN? T cell responses were consistently maintained between wild-type spike and all of the variants tested, including B.1.351 and P.1.
“This is consistent with published results showing that, compared with neutralizing antibody responses, cellular immunity is relatively unimpaired by the current variants of concern,” say the researchers.
https://www.google.com/amp/s/www.news-medical.net/amp/news/20210415/COVID-19-vaccine-INO-4800-shows-efficacy-against-SARS-CoV-2-variants.aspx
4/19 INO upgraded by Oppenheimer with $35 price target. Buy INO now,
Inovio Pharmaceuticals (INO) Thoughts After INO-4800 Update, Oppenheimer Reiterates Outperform
April 19, 2021 8:01 AM EDT
Oppenheimer analyst Hartaj Singh reiterated an Outperform rating on Inovio Pharmaceuticals (NASDAQ: INO) after the company said it saw positive results from a study focusing on the human immune responses induced by its DNA vaccine candidate for Covid-19, INO-4800, against variants of concern.
The biotechnology company said 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.
Inovio said the results are consistent with its expectations that INO-4800, which was found to be well-tolerated and able to produce a balanced immune response in its Phase 1 trial, is able to generate both neutralizing antibodies and robust T cell responses.
possible CEPI, BARDA, NIAID Pan-Covid-19 INO-4802 funding, BARDA’s precedent: 7/27/20 Moderna has been handed an extra $472 million to run its phase 3 COVID-19 vaccine test.
The new amount is thrown on top of the $483 million the U.S. government-funded Biomedical Advanced Research and Development Authority (BARDA) has already given the biotech, bringing its total to just under $1 billion.
The extra cash comes as Moderna says it is starting its late-stage trial of mRNA-1273, its mRNA vaccine against COVID-19, today.
That money is needed as the biotech, already well funded, says it needs “to conduct a significantly larger phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification.”
7/7/20 Novavax Announces $1.6 Billion Funding from Operation Warp Speed
Funding supports late-stage clinical development, including pivotal Phase 3 clinical trial to support licensure
OWS award funds large-scale manufacturing of NVX-CoV2373, including production of 100 million doses starting in late 2020
5/11/20 Novavax to Receive up to $388 Million Funding from CEPI for COVID-19 Vaccine Development and Manufacturing
After winning a small grant for early vaccine work in March, Novavax just won the largest-ever investment from CEPI, a global coalition aiding COVID-19 vaccine development.
The grant of up to $384 million from the Coalition for Epidemic Preparedness Innovations will fund Novavax’s COVID-19 vaccine testing through phase 2, plus early work to scale-up manufacturing. The funding follows a $4 million award back in March.
Oxford and AZN: Initial CEPI funding $1.1M plus $383M
CEPI, will invest up to $328 million to help Clover Biopharmaceuticals develop a coronavirus vaccine, boosting its funding after previously committing nearly $70 million to the effort earlier this year.
Clover will use the money for a late-stage trial slated to begin before the end of 2020 as well as for studies in special populations, such as people with autoimmune conditions and pregnant women, the China-based biotech said.
Money will also go toward ramping up production, allowing the company to quickly supply doses to the COVAX Facility, an World Health Organization initiative co-led by CEPI that's working to distribute COVID-19 vaccines around the world.
CEPI announced this week that it will invest up to $200 million into promising vaccine candidates for SARS-CoV-2 and Betacoronavirus, following a call for proposals.
This funding will carry candidates through to clinical proof of concept and forms one part of a longer-term, $3.5 billion investment strategy by the coalition in response to the COVID-19 pandemic. While SARS-CoV-2 is the specific virus that causes COVID-19, it is itself a Betacoronavirus, a type of coronavirus that has also caused deadly epidemics like Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).
“The emergence of a coronavirus combining the transmissibility of COVID-19 with the lethality of SARS or MERS would be devastating to civilization,” Melanie Saville, director of vaccine research and development for CEPI, said. “Finding solutions to mitigate the threat posed by coronaviruses is thus an issue of the greatest global urgency. CEPI aims to build on the technological advances that have been made in response to COVID-19 to develop an all-encompassing vaccine that could work against known Betacoronaviruses, including SARS, MERS, and COVID-19, and could potentially be used to quickly suppress future outbreaks of other novel coronaviruses that might jump into the human population.”
The current call for proposals will primarily support the research and development of novel immunogens for use in vaccines to create durable, broadly protective immune responses. Proposals can come from any research and development organizations worldwide, so long as they have expertise in vaccine development. CEPI is particularly interested in broadly protective Betacoronavirus vaccines and vaccines capable of fighting emerging SARS-CoV-2 variants.
NIAID Funding for Program Projects To Advance Pan-Coronavirus Vaccine Candidates. The NOSI has only two receipt dates: January 11, 2021, and June 11, 2021. We will accept resubmission (A1) applications in response to this NOSI.
New CEPI Call will provide up to $140M in funding opens through to May 28, 2021.
Each Expression of Interest will be evaluated on a rolling basis by CEPI vaccine R&D experts and external reviewers with respect to: addressing current gaps in clinical knowledge relating to the specific COVID-19 vaccine; the potential impact of the additional data generated through the research in advancing global efforts to end the COVID-19 pandemic; equitable access provisions; and against the current CEPI COVID-19 portfolio.
4/1 Targeted Therapies in Oncology: In the phase 1b/2 trial mentioned above, MEDI0457induced HPV antigen-specific CD8-positive T-cell activity, generated immune infiltration of tumor tissue, and shifted the composition of TILs in the tumor microenvironment toward a proinflammatory state.5 In this trial, MEDI0457 induced persistent peripheral and tumor responses lasting up to 23 months in patients with HPV-16–positive locally advanced HNSCC, including those who had recently received concurrent chemoradiotherapy. The results of this study demonstrate the value of therapeutic HPV vaccines as a complementary strategy to PD-1/PD-L1 inhibition to improve therapeutic outcomes in HPV-associated HNSCC.5
Investigators are now evaluating MEDI0457 in combination with durvalumab(Imfinzi) in a phase 1b/2a study (NCT03162224) in 35 patients with HPV-associated recurrent or metastatic HNSCC.
https://www.targetedonc.com/view/combining-pd-1-pd-l1-inhibitors-and-hpv-vaccines-holds-promise-in-head-and-neck-cancers
DW-is-on-Advisory-Board-of-AZN, Sanofi leading-to-$37.6M-dMAb-DARPA-grant, possible-Sanofi-Covid-partnership. D.B.W. discloses the following paid associations with commercial partners: GeneOne (Consultant), Geneos (Advisory Board, research funding, stock), Astrazeneca (Advisory Board, Speaker), Inovio (BOD, SRA, Stock), Pfizer (Speaker), Merck (Speaker), Sanofi (Advisory Board), BBI (Advisory Board).
DW’s AZN connection helped clinch the $37.6M dMAb DARPA grant. Likewise, his connection with Sanofi, Merck could cultivate in some Covid-19 4800, 4802 partnership.
- DARPA to fund innovative public-private partnership between INOVIO, The Wistar Institute, AstraZeneca, the University of Pennsylvania and Indiana University
- $37.6 million grant from DARPA will leverage AstraZeneca's monoclonal antibody and INOVIO's DNA-encoded monoclonal antibody (dMAb®) technologies in the fight against COVID-19
- COVID-19 dMAbs offer a cost-effective treatment option, are fast to administer to subjects, and can be quickly manufactured and scaled up compared to traditional recombinant monoclonal antibody-based therapies
- dMAbs do not require cold chain transport/storage, and the overall approach can be applied beyond COVID-19 for any pathogen or disease that can be treated by recombinant monoclonal antibody-based therapies
4/18 'Like somebody gave me a happy pill': Monoclonal antibodies help Americans most at risk for COVID-19. The therapy can be lifesaving, especially in the early stages of an infection, and it’s becoming easier to access.
https://www.usatoday.com/in-depth/news/health/2021/04/17/covid-19-monoclonal-antibodies-fda-coronavirus/4813685001/?soc_src=yahooapp
DW: Nucleic acid approaches to antibody-based therapeutics for COVID-19: A perspective. DMAbs, studies have demonstrated the ability to administer immune-modulating antibodies with potent in vivo effects (reviewed in Patel et al4 ). Accordingly, we optimized inserts encoding anti– IL-6 and anti–IL-6R DMAbs and administered them in vivo. As shown, anti–IL-6 (Fig 2, F) and anti–IL-6R (Fig 2, G) DMAbs were successfully expressed, able to bind their respective targets, and inhibited IL-6 activation in vitro (data in progress).
https://www.jacionline.org/article/S0091-6749(20)30951-9/pdf
A synthetic DNA vaccine targeting multiple neoantigens induced robust, T cell immunity and controls growth of heterogenous, multi-focal lung and ovarian tumors in mice
Pratik S. Bhojnagarwala, Alfredo Perales-Puchalt, Neil Cooch, Niranjan Y. Sardesai,
David B. Weiner
PII: S2372-7705(21)00055-3
Reference: OMTO 390
To appear in: Molecular Therapy: Oncolytics
Received Date: 14 September 2020
Accepted Date: 7 April 2021
https://www.cell.com/molecular-therapy-family/oncolytics/pdf/S2372-7705(21)00055-3.pdf
Announcement-of-Dezhan-Health-Co., Ltd. on-obtaining-relevant-P3-VGX-3100-and-5PSP-approval documents for joint research and development projects of its subsidiaries
Dezhan Health Co., Ltd. (hereinafter referred to as the “Company” and “Dezhan Health”) received the company’s shareholding subsidiary Beijing Dongfanglue Biomedical Technology Co., Ltd. (hereinafter referred to as “Dongfanglue”) on April 15, 2021 . Letter of notification, Dongfanglue recently received an official approval from the China Human Genetic Resources Management Office (Guo Kewei Office Examination No. [2021] GH0973), agreeing Dongfanglue to carry out the combination of VGX-3100 and the device CELLECTRATM 5PSP in the treatment of HPV-16 and/ Or HPV-18-related high-grade cervical squamous intraepithelial lesion (HSIL) (hereinafter referred to as "this project") Phase III clinical trial.
In view of the fact that Dongfang Strategy has obtained the clinical approval for the Phase III clinical trial of this project by the National Medical Products Administration, and all the administrative approvals required to carry out clinical trials in China have been passed, Dongfang Strategy will officially launch the admission of patients in the domestic Phase III clinical trial in the near future.
https://ipyygza3aglgqcmlmlkvi3jnmm-ac5fdsxevxq4s5y-finance-sina-cn.translate.goog/2021-04-17/detail-ikmyaawc0131788.d.html?from=wap
4/15 Phenomenal BioWorld Interview w/ JK. "full maintenance" of antibody titers again the P.1 variant, commonly known as the Brazilian variant, and “pretty good titers” against the South African variant, Inovio President and CEO J. Joseph Kim told BioWorld.
"The even better news is that Inovio's INO-4800 can generate both antibody responses and T-cell responses," he said, noting that the latter effect is important in maintaining long-term protective efficacy against SARS-CoV-2.
The study also showed the T-cell responses induced by INO-4800 vaccination were fully maintained against the U.K., South African and Brazilian variants when compared to the T-cell responses to the original Wuhan strain, Inovio reported.
"Obviously, the successes with the mRNA vaccines, their efficacy and rollout have been phenomenal. But as public health experts have encountered, recently with troubles with the J&J and AZ vaccines, these are not expected," he said. "We really feel that our DNA vaccines have very important positive attributes that would add to our arsenal against this virus, both during the pandemic period and hopefully soon in the endemic periods."
With the capacity to stay stable at room temperature for more than a year and at 37°C for more than a month, it does not need to be frozen during transportation or storage, which should make it easier to distribute far and wide vs. the mRNA-based headliners that require cold chain logistics. Furthermore, the candidate’s safety profile has, so far, appeared supportive of safe readministration if immunity wanes, a feature that could support its use as a seasonal booster without concern for generating an anti-vector response.
As investors digested the new analyses of data from Inovio's phase I study of INO-4800, the phase II segment of the company's phase II/II trial, Innovate, is wrapping up. "We should have the immune responses and safety data from 400 volunteers in the U.S. this quarter," Kim said. The company is also drawing together materials addressing questions that led the FDA to place a partial clinical hold on the program last year. Assuming concurrence from the FDA on the company's plans to move forward, something Kim expressed confidence in, he said he expects the company will start the phase III portion of the study this quarter.
https://www.bioworld.com/articles/505978-inovios-covid-19-vaccine-appears-active-against-variants
Of the three biggest vaccine candidates, Singh sees INO-4800 as the one offering the most immediate value, and contributing $20 per share to his $35 overall target price.
Less well known than competing coronavirus vaccines from Pfizer or Moderna, Singh notes that INO-4800 has several advantages to recommend it. For one, it’s DNA-based, and thus can theoretically be modified to combat mutated versions of the COVID-19 coronavirus. For another, it offers a better “safety/tolerability profile,” that could recommend it as an alternative to other vaccines. And for a third, INO-4800 is said to be both easier to store and has a longer shelf life than other vaccines on the market today, which might make it more suitable for stockpiling against future coronavirus outbreaks.
VGX-3100 is the next most valuable of Inovio’s vaccine candidates, thinks Singh, being worth perhaps $7 a share. It’s also, says the analyst, the vaccine with the “highest sustainability and potential upside on commercialization” for Inovio, as HPV will presumably remain a problem long after the coronavirus pandemic has gone away. Singh also sees “potential to expand into other (pre)cancerous indications” based on research done for VGX-3100.
Finally, Singh sees INO-5401 as worth perhaps $5 a share to Inovio stock. In the analyst’s view, INO-5401 could be a “potential breakthrough” drug for treating patients with glioblastoma, a cancer that has not seen a real improvement in treatment options “for decades.”
Other vaccine candidates in the pipeline, plus Inovio’s cash on hand, make up the final $3 of the analyst’s target valuation for Inovio.
Not all this value may be immediately apparent to investors, however. Notably, Singh admits that revenues at Inovio over the past three years have been measured in the low single digits of millions of dollars. It won’t be until next year, says the analyst before sales really grow appreciably. But once these vaccines begin coming to market, the analyst sees significant growth potential: $656 million in sales in 2022, twice that in 2023, $2.1 billion in 2024, and $3 billion in 2025.
Profits will only emerge alongside sales next year — $1.46 per share.
Indeed, by 2025, the analyst forecasts that Inovio could be earning $6.48 per share, per year, making today’s price target of $35 (not to mention today’s actual share price of $15) look cheap indeed. And indeed, that’s probably why the analyst is rating the stock “outperform” and recommending that investors buy it.
ST catalysts. Inovio management met virtually with Oppenheimer. Virtual Meeting was held on April 16 hosted by Oppenheimer. Expect a BUY, $35 target iteration next week.
Virtual Event: Taking on Covid-19
Join the Philadelphia Business Journal for our virtual event: Taking on Covid-19.
Kate Broderick from Inovio and David Weiner from Wistar will be speaking
WHEN
Monday, April 19, 2021
10:00am –11:15am
JK at WVC Day 1 - 4th May @ 15:00. Vaccine clinical update. COVID-19: vaccine response & approaches
Presentations followed by Q&A
Joseph Kim, Chief Executive Officer, Inovio Pharmaceuticals
Interestingly May 5th is when FDA is supposed to respond after 30 days To OK P3 Per my calculation.
4800 P2 Last Update Submitted that
Met QC Criteria: March 26, 2021 means Wk6 Readout finished 3/24. Allowing 2 weeks for running assays, QA, analysis, report, Ino could submit P2 data, P1 booster data, device use with P2 Biologics 4/7. FDA has up to 30 days to respond 5/5. IMHO, FDA will respond faster as it held up since early September (8 mos from Sept 2020 to May 2021). FDA held up 5PSP for 6 mos. Two C-2K test results are for use with Biologics, routine but required.
“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 Pan-Covid 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.
INO-4500 P1 for Lassa fever, INO-3107 P1/2 for RRP, REVEAL 2 finish enrollment.
INO-5401 GBM OS24 data readout in May. Collaboration and licensing Agreement with REGN could follow.
Biologics, Device Manufacturing partners announcement.
“We are already working with manufacturing partners for our Cellectra device, so we do not believe that manufacturing issues will be a bottleneck.” 4/13
NIAID Funding for Program Projects To Advance Pan-Coronavirus Vaccine Candidates. The NOSI has only two receipt dates: January 11, 2021, and June 11, 2021. We will accept resubmission (A1) applications in response to this NOSI.
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. 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.
New CEPI Call will provide up to $140M in funding opens through to May 28, 2021.
Each Expression of Interest will be evaluated on a rolling basis by CEPI vaccine R&D experts and external reviewers with respect to: addressing current gaps in clinical knowledge relating to the specific COVID-19 vaccine; the potential impact of the additional data generated through the research in advancing global efforts to end the COVID-19 pandemic; equitable access provisions; and against the current CEPI COVID-19 portfolio.
Obtain Orphan and Rare designation for AIN, VIN to start P3’s.
Start MERS P2 trial in Lebanon, Jordan.
dMAb Covid therapeutic for DARPA grant update.