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1. Advaccine will cover all costs for running the trial in China
2. Advaccine and Inovio will both contribute $50M towards the costs of running global P3 INO-4800 trial.
3. Advaccine pays Inovio $3M for signing of the deal + $2M once the first patient is dosed in P3 trial in China
4. Advaccine will pay to Inovio $206M once certain sells metrics are met
5. Advaccine will pay $1.5 yearly maintenance fee to Inovio for the duration of the agreement
6. Assuming Advaccine is able to sell, let’s say, 1B doses in Asia and assuming a conservative $2 royalty per dose, Inovio will get $2B from Advaccine sells on Asian market.” By TygerEye.
4800 Booster 100 ppl data update 6/1. Preprint is imminent.
https://clinicaltrials.gov/ct2/history/NCT04336410?A=10&B=11&C=merged#StudyPageTop
6/3 Ino-5401 GBM Update.
Primary Completion: June => December 30, 2021 [Anticipated]
Study Completion: June => December 30, 2021 [Anticipated]
Last Update Posted: June 3, 2021 [Actual]
https://clinicaltrials.gov/ct2/history/NCT03491683?A=26&B=27&C=merged#StudyPageTop
China's COVID-19 vaccines are being called into question after infections surged in countries using Chinese shots
https://www.yahoo.com/news/chinas-covid-19-vaccines-being-132107776.html
Strong immunogenicity and protection of DNA vaccine regimens expressing prefusion SARS-CoV-2 Spike antigens in macaques. A vaccine comprising simultaneous co-immunization of DNA and Protein showed best neutralizing ability able to effectively control SARS-CoV-2 infection.
The study provided the opportunity to compare vaccines able to induce different humoral and cellular immune responses. DNA vaccines are an important alternative to RNA vaccines, since they induce both humoral and cellular immune responses in animal models and in humans.
it'd be interesting to see if they'd actually used Inovio's INO4800,(no reduction in P1 and via Intradermally) with Novavax's protein vaccine. Regimen of "DNA+protein different site with interval of 5-weeks or more" but DNA alone is already pretty good.
1 Control of SARS-CoV-2 infection after Spike DNA or Spike DNA+Protein co-immunization in rhesus macaques https://t.co/Miu1sBg22S
— George Pavlakis (@georgepavlakis) June 13, 2021
6/11 Preprint: Control of SARS-CoV-2 infection after Spike DNA or Spike DNA+Protein co-immunization in rhesus macaques
The protein was injected in thesame anatomical siteafter the DNA injection. 444DNA vaccination was performed byintramuscular injection followed by electroporation (IM/EP) 445with CELLECTRA 5P (Inovio PharmaceuticalsInc.). Five weeks after the last vaccination, the446animals(G1, G2, G3, G4)together with 4 naïve controls were challenged with 10^5 PFU of 447SARS-CoV-2 (strain-2019-nCoV/USA-WA1/2020, obtained from BEI Resource
National Cancer Institute at Frederick: NCI at Frederick;
Frederick National Laboratory for Cancer Research;
DNA vaccines represent an important alternative since they induce both humoral and cellular immune responses in animal models and in human trials. We tested the immunogenicity and protective efficacy of DNA-based vaccine regimens expressing different prefusion-stabilized SARS-CoV-2 Spike antigens upon intramuscular injection followed by electroporation in rhesus macaques. Different Spike DNA vaccine regimens induced antibodies that potently neutralized SARS-CoV-2 in vitro and elicited robust T cell responses. The DNA-only vaccine regimens were compared to a regimen that included co-immunization of Spike DNA and protein in the same anatomical site, the latter of which showed significant higher antibody responses. All vaccine regimens led to control of SARS-CoV-2 intranasal/intratracheal challenge and absence of virus dissemination to the lower respiratory tract. Vaccine-induced binding and neutralizing antibody titers and antibody-dependent cellular phagocytosis inversely correlated with transient virus levels in the nasal mucosa. Importantly, the Spike DNA+Protein co-immunization regimen induced the highest binding and neutralizing antibodies and showed the strongest control against SARS-CoV-2 challenge in rhesus macaques.
https://www.biorxiv.org/content/10.1101/2021.06.11.448032v1.article-info
Integration of needle-free jet injection with advanced electroporation delivery enhances the magnitude, kinetics, and persistence of engineered DNA vaccine induced immune responses. By t_babur
other DNA vaccines using needle-free jets are going to be lining up for Inovios newly patented device. "Our results show that the addition of EP significantly enhanced in vivo DNA transfection efficiency of rabbit muscle over jet injection alone. Jet-EP delivery augmented the rate and magnitude of DNA vaccine induced humoral and cellular responses over jet injection alone in both rabbits and NHPs. Jet-EP delivery also resulted in higher proportions of polyfunctional antigen specific T cells. Elevated antibody levels were sustained nine months post immunization in NHPs immunized with a DNA vaccine using Jet-EP delivery, far outperforming jet delivery alone. Our results provide proof that addition of advanced EP to needle-free jet injection delivery improves in vivo DNA transfection efficiency, increasing the magnitude, rate and duration of cellular and humoral immune responses to DNA vaccines."
https://www.sciencedirect.com/science/article/pii/S0264410X19306917
“We believe in Cellectra. Its safety profile and effectiveness makes it a superior modality compared to other delivery mechanisms, in our opinion. We also acknowledge that it is currently a two step process. The first step being the injection of the plasmid and the second being the electroporation. We are also working to simply the process so that it can all be achieved in a single step” 5/5/21
CEPI is supporting R&D work on variant-specific vaccines. Most recently, CEPI announced US$170 million additional funding for SK bioscience to support Phase 3 trials of their recombinant protein vaccine candidate (GBP510) and its adaptation for use against variants of concern. CEPI has also initiated a $200 million programme to develop vaccines against Betacoronaviruses with the ultimate objective of developing a vaccine that provides broad protection against the whole Betacoronavirus genus (ie, SARS-CoV-1, SARS-CoV-2, and MERS and potentially novel coronaviruses that have yet to emerge).
It will be critical that such modified shots can be developed and tested within 100 days – a target supported by CEPI in its ambitious forward-looking pandemic preparedness plan, the UK Government, the G7 Health Ministers, and the CEOs of leading pharmaceutical firms – so that necessary clinical data are available within that period for regulatory review.
https://www.gavi.org/vaccineswork/keep-coronavirus-bay-we-must-create-variant-proof-world
Cepi’s BPCoV2 funding rolling review starts June 15
4.1 Submission and review process BPCoV2 [Broad Protective]
For BPCoV2 EOI will serve as the application for the call for proposals, in accordance with the need of moving these candidates faster to the clinic. Applicants will submit their EOIs via the process outlined above. The review process will start on the 15th and 30th of each month or the following business day. A review team composed of CEPI staff and external experts will assess compliance with the eligibility criteria (section 3). EOIs not meeting those criteria will not be further reviewed.
CEPI staff and external experts (as needed) will evaluate the eligible EOIs against the review criteria outlined in section 5. CEPI call core team will provide notice to the applicant of either an invitation to proceed to Due Diligence and negotiations or that the application was unsuccessful.
Applicants may resubmit with different or substantially modified EOIs at any time. The call will be open from April 1 2021 and closes on May 31 2021, 1500 CEST.
To be eligible the applicants need to fulfil the following criteria:
1. Applicants must be legal entities, or consortia comprised of legal entities.
2. At least one of the partners in the applicant organisations or consortia of partnering organisations should have
experience in human vaccine development and have a track record of bringing vaccine candidates through to
human clinical trials in the past 5 years.
3. Have a Target Product Profile (TPP) clearly stipulating the intended indication that drives subsequent immunogen
design and R&D plans. Accompanying the TPP, have rationale that justifies the desired breadth of protection
being sought.
4. Have access to an established or licensed vaccine technology platform that needs to have mid-stage clinical data
on safety and immunity and has ideally rapid response attributes, as well as parameters suitable for LMICs
5. Scientific and operational plans for the design and selection of antigen(s) aiming to provide a sufficient breadth
of protection against variants.
6. Definition for a successful preclinical and clinical POC.
7. Have plans for preclinical immunogenicity, safety and toxicology studies in relevant small animal models and
NHPs.
8. Clinical and development plans that align with CEPI’s targets timelines for this part of the call.
9. Present plans to produce Good Manufacturing Practice (GMP) batch for clinical trial materials and subsequent
full-scale production.
10. A regulatory strategy articulated that includes the pathway to licensure of a BPCoV2 vaccine.
11. Present plans to integrate Phase I immunological testing which would utilize CEPI’s available Centralised
Laboratory network, and apply for sample testing, by completing and submitting the Sample Analysis Request Form.
CfP Broad Protective Corona vaccines
https://cepi.net/wp-content/uploads/2021/03/CfP-BPCV-Call-Text-FINAL.pdf
4800, 4802: something like 5/21 “CEPI will provide up to $173.4 M in additional funding to SK bioscience to support its COVID-19 vaccine development programme. Of this funding, $41 M will be provided in the form of a forgivable loan that is repayable based on sales of the vaccine and will be used to secure raw materials needed for manufacturing. This brings CEPI’s total investment in SK bioscience to $210.1 M.
CEPI’s funding will support P3 clinical trials of SK bioscience’s recombinant protein vaccine candidate (GBP510). The GBP510 candidate—which is currently undergoing P1/2 testing in the Republic of Korea—is manufactured using a nanoparticle platform.
CEPI previously invested up to $10 M towards the cost of P1/2 trials of in SK bioscience’s vaccine candidate in Dec 2020, followed by an additional $26.7 M to begin adaptation against variants and support scale-up of manufacturing in Mar 2021.
SK bioscience started P1/2 studies of GBP510 early in 2021.“
“We have begun talks with various organizations like CEPI, Barda, etc for the support of our INO-4802. Hopefully, we will receive a positive response.” 4/15/21
“In terms of funding for 4800 P3 trial we are asking various parties for support and are also considering doing the P3 together with Advaccine in order to save on costs.
Various NGOs have expressed interest in our 4802 program; now, it can be a long road from interest to actual financial support but we are trying to do everything possible to minimize our burn rate. We hope that today’s pre print is the first step on that road.
We are working with our CRO to select and prepare required documents to agencies of various nations where we are targeting our P3 trial. We are hoping to have additional news to share with you in the coming days and weeks.” 5/12/21
Jefferies 2021 Virtual Healthcare Conference 6/1, JK said:
”the gating factor for our Phase 3 start is really -- and we've already begun this process is submitting all of our Phase 3 plans, and getting them approved through various countries that we have planned.
So once our first country is set and we're rolling out the trial, and there will be multiple countries at once, we will fully disclose and articulate our strategy and the design more fully. our primary focus right now is executing and opening the countries and the sites for our Phase 3 outside the U.S. using CELLECTRA 2000 delivering INO-4800. And we're on track as we had anticipated earlier this year that we'll be starting this summer and interim data by year end.
Execute the ex-U.S. Phase 3 trials, show the efficacy, get the approvals, get the doses to the people who need them in the world, and then bring it back to the U.S. as a potential booster over time. So that's what we're doing in a nutshell.“
The call for proposals for this, “For the development of broadly protective vaccine against new emerging variants and variants of concern of the SARS-CoV-2 virus,” closed May 31. Announcement of recipients should be out soon.
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. 3/31/21
[Professor Stanley Plotkin was re-elected as A 2-yr member of Scientific Advisory Committee of CEPI last week. He has been a member of Ino SAB for a long time. Ino has applied for 4802 P1/2 funding.]
The call for proposals invites funding application for development of the following:
– A broadly protective vaccine against new emerging variants and variants of concern of the SARS-CoV-2 virus, with funding up to 18-24 months to achieve clinical proof of concept.
– A broadly protective Betacoronavirus vaccine with funding potentially awarded for up to 4 years to demonstrate clinical proof of concept.
For the development of broadly protective vaccine against new emerging variants and variants of concern of the SARS-CoV-2 virus, the main R&D objectives will focus on:
1. Immunogen design and selection, based on the Spike protein, but also other relevant immunogens where applicable to induce a broader immune response.
2. Immunogen design that considers existing variants of concern, emergent variants of interest, and potentially future variants predicted computationally or experimentally.
3. Development of safe and proven, rapid response vaccine technology platforms.
4. Technology platforms that can be accelerated through development and offers the potential for production of large volumes of vaccine to support equitable access to vulnerable populations.
For the development of a broadly protective Betacoronavirus vaccine, the main R&D objections will focus on:
1. Design of immunogens that elicit a broad immune response inducing protection to multiple Betacoronaviruses
2. Computational identification and design of potentially conserved immunogens—using machine learning—to identify genetic sequence, protein sequences, or epitopes (ie, parts of an antigen capable of stimulating a broad protective immune response)
3. Using characterised immunoglobulin/antibody-binding-specific regions of the Betacoronavirus as a tool to identify broadly protective conserved/cryptic regions of the viral antigens to induce protection across the Betacoronavirus
4. Any other vaccine and immunogen design approaches that address the objectives of the call for proposals.
https://cepi.net/news_cepi/cepi-launches-funding-call-to-advance-development-of-broadly-protective-coronavirus-vaccines/?swcfpc=1
8K 6/11: Under the Restated Agreement, the Company has granted to Advaccine the exclusive right to develop, manufacture and commercialize INO-4800 within 33 additional countries in Asia. the Company will have the right to convert the exclusive license to a non-exclusive license in the licensed territories, other than Greater China, unless Advaccine agrees to pay the Company its full share of development costs in excess of a specified maximum.
The parties may continue to conduct clinical trials of INO-4800 outside of the territories covered by the Restated Agreement.[Latin America]
Under the Restated Agreement, the Company will continue to supply Advaccine’s clinical requirements of INO-4800 and devices, although Advaccine may manufacture INO-4800 for its clinical use and may procure alternate suppliers. Advaccine will continue to be responsible for the manufacture and supply of INO-4800 itself or through a contract manufacturer for commercial use.
In the event that a global purchasing entity desires to enter into a purchase agreement for INO-4800 in both parties’ territories, the parties will enter into good faith negotiations for an arrangement to supply INO-4800 to such entity. In addition, the Company is permitted to enter into an agreement with a global purchasing entity to authorize the entity to conduct a portion of the global Phase 3 trial in the licensed territory outside of Greater China.
Under the Original Agreement, Advaccine made an upfront payment to the Company of $3.0 million and a payment of $2.0 million upon the dosing of the first subject in a Phase 2 clinical trial of INO-4800 in China. Under the Restated Agreement, the Company is entitled to receive up to an aggregate of $206.0 million upon the achievement of additional specified milestones related to the development, regulatory approval and commercialization of INO-4800, including the achievement of specified net sales thresholds for INO-4800 in the expanded territory, if approved.
The Company will also be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within the licensed territory, subject to reduction in the event of competition from biosimilar products in a particular region and in other specified circumstances.
Advaccine’s obligation to pay royalties will continue, on a licensed product-by-licensed product basis and region-by-region basis, for ten (10) years after the first commercial sale in a particular region in the licensed territory or, if later, until the expiration of the last-to-expire patent covering a given licensed product in a given region.
Beginning in the first calendar year following the first commercial sale of INO-4800 in the licensed territory outside of Greater China, Advaccine will pay the Company an annual maintenance fee of $1.5 million for a period of five years, which fee will be creditable against any royalties payable by Advaccine with respect to sales outside of Greater China.
Moderna,BioNTech-trade-lower-as-CDC-points-to-heart-condition-linked-to-COVID-19-shot
Update 12.12PM EST: According to the CDC, out of hospitalized patients with myocarditis or pericarditis following the second dose of the COVID-19 shot, 15 people remained hospitalized and three required intensive care as of May 31.
Most patients appeared to be men with three to four days of median time to show symptoms. The CDC in coordination with the FDA is conducting the investigations.
Previously: The U.S. Centers for Disease Control and Prevention (CDC) has said that the number of cases of heart inflammation following the second dose of mRNA-based vaccines from Pfizer (PFE +1.1%)/ BioNTech (BNTX -1.3%) and Moderna (MRNA -1.7%) were higher than normal in younger people.
Citing preliminary data from its vaccine safety monitor system, the CDC said on Thursday that there were 275 cases of myocarditis or pericarditis in people aged 16 – 24 years as of May 31, compared to the expected number of cases of 10–102, CNBC reported.
In the presentation prepared for a meeting of an FDA expert panel, the federal agency has pointed to 475 cases of myocarditis or pericarditis in people aged 30 years and younger. Most patients who were hospitalized or 81% of them had fully recovered from the symptoms.
Early this month, Israel's Health Ministry found a possible link between the second dose of the Pfizer/BioNTech COVID-19 shot and rare cases of heart inflammation in young men.
Ino’s long-standing partnership with Regeneron on an immune-oncology glioblastoma therapy has prompted speculation Regeneron could eventually buy out Inovio. How much truth these rumors have remains to be seen. However, any time a company with a $55 billion market capitalization partners with a company like Inovio with a $2 billion market cap, such speculation makes sense.
Thus, the rumor mills on social media have once again lit up. Retail investors are increasingly focusing on INO stock as a potential squeeze candidate, with some “moon shot” attributes given various factors. Let’s dive into two of the key things retail traders are focusing in on today.
In addition to the company’s core drug/therapeutics portfolio, Inovio is also working on a Covid-19 vaccine. The company’s INO-4800 vaccine has become a focal point of investors of late. As global vaccination efforts ramp up, there may be more room for additional vaccine players. That is, if Inovio can get its vaccine approved in short order.
Yesterday, the company announced an expanded vaccine partnership with Advaccine for its INO-4800 vaccine. This partnership calls for both parties to conduct a Phase 3 trial for this vaccine. Indeed, this announcement is big news for the company, and is cause for more speculative buying today.
Additionally, Inovio’s aforementioned high level of short interest is prompting further speculation this company could be a short squeeze target. Various posts on Reddit highlight this thesis. Indeed, given the momentum around such plays today, more volatility can be expected on the horizon for INO stock.
6/9 Vaccine specialists and global health experts selected for CEPI's Scientific Advisory Committee: Stanley Plotkin*, Emeritus Professor, University of Pennsylvania, USA
Nationality: USA
Area of Expertise: Virology, immune responses, vaccination strategy
Comprising of thirty-four expert individuals from a broad range of key disciplines—including epidemiology, vaccine development, vaccine manufacturing, public health and regulatory sciences—the group will work as an independent body to provide world-class scientific input and recommendations to guide CEPI staff and the CEPI Board in responding to the current COVID-19 pandemic. They will also deliver guidance and challenge towards CEPI’s US$3.5bn plan, announced in March 2021, to mitigate or even dramatically reduce the threat of future pandemics and epidemics.
The 2021-2024 CEPI Scientific Advisory Committee includes new members, as well as existing members who have served on the committee since its launch in 2018 and will run an additional two-year term.
George Gao
Director-General, Chinese Center for Disease Control and Prevention
Nationality: China
Area of Expertise: Pathogen biology, immunology
*Members listed with an asterisk next to their name are re-joining the CEPI Scientific Advisory Committee for a second term.
https://cepi.net/news_cepi/vaccine-specialists-and-global-health-experts-selected-for-cepis-scientific-advisory-committee/
JK-at-BofA-fireside-chat-5/12. FDA-has-30 days-to-respond. If-FDA-doesn’t-by-6/11 and let 30 days expire, hold will be automatically lifted per FDA rule.
5/12 BofA “we submitted all of our device related responses that was part of the Phase 3 hold to the FDA in May. We also plan to submit all of our Phase 3 submissions to the FDA, for 2 reasons, one is the optics, the other is the credibility to and the optionality, as we plan to bring the total global package back to the US for a regulatory application for INO-4800, not to just prove around the world, but also in the US, because it’s not just for the primary vaccination that we are going after. We are also looking at the long-term annual boosting for seasonal boosting potential of INO-4800.
We are 100% confident that we will be meeting the FDA questions with the CELLECTRA device prior to starting their Phase 3 trials.
We have developed and are currently testing our commercial CELLECTRA 3PSP device. It is a hand held, easy to use, easy to manufacture, and scalable device, the size and shape of an electric toothbrush. We plan to manufacture in high scale to meet the global demand using the CELLECTRA 3PSP. We are very close to having the device ready and when we launch INO-4800, and with INO-4802 following, we will be using 3PSP as our commercial delivery system and we are scaling up manufacturing for global demand right now.
We are working with our funders and our partners to bring this all together within the next few weeks.“
6/8/21 “ In addition to the initiation of the clinical trial itself, INOVIO is in discussions with several countries [primarily in Latin America and Asia] which are expected to provide clinical trial sites, regarding advanced market contracts to potentially supply INO-4800 upon respective regulatory approvals in those countries.”
Inovio Pharmaceuticals (INO) rises after expanding its partnership with Advaccine Biopharmaceuticals Suzhou.
Inovio to expand partnership with Advaccine Biopharmaceuticals Suzhou
INOVIO announced an expansion of its previously announced partnership with Advaccine Biopharmaceuticals Suzhou to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE. Together, the companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen, administered one month apart, in a two-to-one randomization in subjects 18 years and older across several countries, primarily in Latin America and Asia. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. The 2.0 mg dose was selected from the Phase 2 segment, where INO-4800 was shown to be generally well-tolerated and immunogenic in all tested age groups.
FDA to lift C2K hold this Fri 6/11/21
Inovio Pharmaceuticals Granted U.S. Patent Titled 'Intradermal jet injection electroporation device' 6/8 by Benzinga
Inovio Pharmaceuticals Completes Acquisition of Needle-Free Injection Technology
Inovio will integrate needle-free injection with needle-free electroporation delivery in next-generation device for large-population vaccine administration
Inovio acquired BioJect for $4.3 million in Inovio common stock and $1.2 million in cash.
Since administration of Inovio’s products is a two-step process involving injection and electroporation delivery, it is also focused on enhancing ease and cost of administration to best serve clinical requirements. An integrated injection and electroporation device that eliminates needles and reduces disposable materials in an automated process would be a paradigm-changing step in vaccine administration in large populations.
Inovio has been developing needle-free electroporation technology that works on the surface of the skin. BioJect’s needle-free jet injection technology uses high pressure gas or springs to propel liquid medicine into skin. Its devices have demonstrated favorable utility, safety, and tolerability attributes in animals and humans. Under a prior research agreement Inovio tested the two separate technologies together and generated compelling antigen expression and immune responses in animals. Inovio will now be combining the two technologies into one highly optimized integrated delivery device.
Last week, Geneos Therapeutics updated the data from a phase I/II clinical trial for its personalized cancer vaccine GNOS-PV02 which is based on GT-EPIC Neoantigen-Targeting Platform licensed from Inovio.
As of May 13, 2021, out of nine evaluable patients, three patients with advanced hepatocellular carcinoma showed a partial clinical response after nine weeks of treatment with GNOS-PV02 in combination with plasmid pIL-12 and pembrolizumab, Geneos said.
Geneos Therapeutics Announces Clinical Updates on Personalized Cancer Vaccine Program
Jun. 03, 2021 8:00 AM ETPR NewswireInovio Pharmaceuticals, Inc. (INO)
Data from first 10 patients in the HCC trial demonstrates clinical responses
PR Newswire
PLYMOUTH MEETING, Pa., June 3, 2021 /PRNewswire/ -- Geneos Therapeutics, a clinical stage company focused on the development of tumor neoantigen targeted personalized immunotherapies for cancer, announced today positive preliminary results of its ongoing first-in-human trial. GT-30 is a phase I/II trial of personalized vaccine, GNOS-PV02, in combination with plasmid pIL-12 and pembrolizumab in patients in second line advanced hepatocellular carcinoma (HCC).
As of May 13, 2021, 12 patients had initiated treatment in the GT-30 trial and received at least 1 dose of their combination therapy. The treatment was generally safe and well tolerated with no treatment related serious adverse events noted on the trial. Ten patients had reached at least the first on-treatment imaging timepoint of 9 weeks to enable evaluation of objective response by RECIST 1.1. The best overall response by the data cut-off date consisted of 3 patients achieving a partial clinical response (PR); 4 patients demonstrated stable disease (SD); and 3 patients had progressive disease (PD); representing an overall response rate (ORR) of 3/10 (30%) and a disease control rate of 7/10 (70%). The observed ORR of anti-PD1 alone monotherapy is 14%-17% in the 2nd line advanced HCC setting. Immune analysis of the pre-treatment and on-treatment patient samples demonstrated the induction and expansion of T cell clones in the peripheral blood and infiltration of T cells in the tumor tissue following vaccination.
Dr. Mark Yarchoan, Assistant Professor of Oncology, Johns Hopkins University will discuss the clinical trial design and advantages of Geneos' GT-EPIC platform in an oral poster presentation titled:
Abstract #: TPS2680
"Personalized DNA neoantigen vaccine in combination with plasmid IL-12 and pembrolizumab for the treatment of patients with advanced hepatocellular carcinoma." – Yarchoan et al
Geneos is also presenting data from its ongoing collaboration with Dr. Tanner Johanns and colleagues at Washington University School of Medicine to treat a patient with newly diagnosed anaplastic astrocytoma/GBM under a single patient compassionate use IND. The patient is undergoing monotherapy treatment with their personalized cancer vaccine (GNOS-PV) and pIL12 in an adjuvant setting following resection of their tumor. As of the ASCO 2021 conference date the patient remains recurrence free 36 months since primary surgery and 23 months since initiation of the GNOS-PV + pIL12 treatment. The interim data demonstrated that the treatment was generally well tolerated with no treatment related serious adverse events. The patient received a vaccine comprising of 30 tumor antigens including 27 cancer neoantigens and 3 shared antigens. On-treatment immune analysis showed the induction and persistence of neoantigen directed T cells in the patient's blood to 28 of 30 (93%) encoded antigens following GNOS-PV + pIL12 treatment.
Abstract #: e14561
"Personalized DNA neoantigen vaccine in combination with plasmid IL-12 for the treatment of a patient with anaplastic astrocytoma." – Johanns et al
"We are encouraged by the interim data from our personalized cancer vaccine program showing tumor shrinkage in combination with anti-PD1. Our GT-EPIC™ platform's ability to drive CD8 T cells leading to meaningful clinical responses in intractable tumors is exciting," said Dr. Niranjan Y. Sardesai, President and CEO of Geneos Therapeutics. "A distinguishing feature of our HCC trial is that all the patients receive their first dose of GNOS-PV02+pIL12 at the same time as they receive their first dose of PD1 thus enabling direct comparison to the historical responses achieved by PD1 alone. These early data represent the first objective responses reported in HCC patients with plasmid DNA encoded cancer vaccines."
Delta Covid variant first found in India spreads to 62 countries, hot spots form in Asia and Africa, WHO says
The Covid variant now named Delta, which was first detected in India, has been reported in 62 countries, the WHO said Wednesday.
The P.1 variant, now named Gamma, which was first detected in Japan in people who had traveled from Brazil, has spread to 64 countries.
The WHO’s new naming system for Covid variants, after letters of the Greek alphabet, simplify the scientific names and avoid stigmatizing countries that detect new strains.
The African and Western Pacific regions have seen a rise in infections, with a rise in Covid deaths in the African region in the past week.
https://www.cnbc.com/2021/06/02/delta-variant-first-found-in-india-spreads-to-62-countries-hot-spots-form-in-asia-and-africa-who-says-.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Message
If the coronavirus pandemic continues to spread worldwide, vaccines could become ineffective and strains could escape immunity. The right vaccines need to go to the places where they are needed.
This is what INOVIO is planning with their Phase 3 trials.
The world's richest countries have secured some 70% of supplies of the five top COVID vaccines despite having less than 16% of the globe's population. According to the WHO, only 0.2% of the population in poorer countries have been vaccinated against SARS-COV2. The Economist estimates that mass vaccinations will not start there until 2024 at the earliest, if programs continue at this pace.
"The pandemic is far from over," WHO Director General Tedros Adhanom Ghebreyesus has warned.
But if the coronavirus variants continue to spread as rapidly as they are and to adapt to their human hosts, that inequality could come home to roost for wealthier nations.
Virus variants in Asia threaten the whole world. By Tracker7
https://www.dw.com/en/virus-variants-in-asia-threaten-the-whole-world/a-57745685
What makes INOVIO's INO-4800 different is our ability to generate strong T-cell responses along with neutralizing antibody titers, and we think that's going to be a work in tandem to bring a -- better efficacy results. And we look forward to demonstrating that.
The other advantages as you know are better temperature stability of our platform and INO-4800, as well as being able to safely and tolerability boost. We don't see the types of reactogenicity and safety signals as some of the other platforms have seen. So we're very much looking forward to starting the Phase 3 trials this summer and potentially by the end of this year or very early part of '22 of our first interim efficacy readout. And we think if we're successful, that would be the basis for emergency use license through the WHO mechanism, as well as other ex U.S. countries who still have those conditional or emergency use authorizations available right now.
we test for serology and T-cell responses, so binding and neutralizing antibodies as well as the T-cell responses to INO-4800. So for most of the other vaccines in development, they rely predominantly on antibody responses as the mechanism of action. Unlike those vaccines, INO-4800 has demonstrated, and we've published on this from Phase 1 and Phase 2 and across our other clinical programs in our pipeline that we can generate high levels of antibodies and strong CD4 and CD8 T-cell responses as well.
So it provides like a one-two punch of the immune system, two arms of the immune system. So the best way to quantify that effect really is to conduct a case driven efficacy trial that we're planning to start this summer and then execute that rest of this year. How much of T-cell response can contribute to overall efficacy? I personally believe that it would have a huge contributing factor to just the antibodies alone. But really we have to do the trial -- we have to do the efficacy trial to really quantitate that. But I'm very bullish and optimistic about that.
The second part of your question about the variance. We've published a pre-print paper as well in bioRxiv now about a month ago where we've tested INO-4800 vaccine samples from the clinical trials from Phase 1 and tested against the new variants, I guess now they're called alpha, beta and gamma. So we tested against all three, which were available at the time, and the [one behold] -- our neutralizing antibody titers are pretty well conserved from the Wuhan original strain to the UK variant to South Africa and the Brazil. In particular, the UK and the Brazil was maintained perfectly well, and also we tested the T-cell responses as well. And they were 100% cross reactive across these variants. So, we think, so far, so good. INO-4800 should be able to demonstrate efficacy in this trial in a well-controlled manner in the Phase 3.
Now, what is going to be the future, newly emerging variants on the vaccine? Well, that's we don't know yet, but we feel very good about 4800. And certainly, as a pan-COVID variant, we also have a second vaccine candidate as a second generation product that's strictly designed to deal with this popping up of the new variants that are concerning many people, for instance, such as South Africa or Brazil, but the one from India has been a concern, and I guess that's the delta or gamma-delta, yes. And then the -- we're now reading about the Vietnamese variant that's really concerning folks in that area.
So, pan-COVID vaccine, INO-4802 the candidate, we just published great immune data in animal models in bioRxiv. Our plan is to advance this program into an accelerated Phase 1 plus 2 trial, whereby the end of this year or very early part of '22, we will have a full immune data set from this new candidate 4802 from several hundred volunteers from the globe. So we're moving both our lead product, INO-4800, through efficacy and our goal is to commercialize that in those countries initially, go attend WHO emergency use license, as well as getting the conditional or emergency approval in these various countries. And we also plan to bring it fully back to the U.S. for BLA application on approval.
we test for serology and T-cell responses, so binding and neutralizing antibodies as well as the T-cell responses to INO-4800. So for most of the other vaccines in development, they rely predominantly on antibody responses as the mechanism of action. Unlike those vaccines, INO-4800 has demonstrated, and we've published on this from Phase 1 and Phase 2 and across our other clinical programs in our pipeline that we can generate high levels of antibodies and strong CD4 and CD8 T-cell responses as well.
So it provides like a one-two punch of the immune system, two arms of the immune system. So the best way to quantify that effect really is to conduct a case driven efficacy trial that we're planning to start this summer and then execute that rest of this year. How much of T-cell response can contribute to overall efficacy? I personally believe that it would have a huge contributing factor to just the antibodies alone. But really we have to do the trial -- we have to do the efficacy trial to really quantitate that. But I'm very bullish and optimistic about that.
The second part of your question about the variance. We've published a pre-print paper as well in bioRxiv now about a month ago where we've tested INO-4800 vaccine samples from the clinical trials from Phase 1 and tested against the new variants, I guess now they're called alpha, beta and gamma. So we tested against all three, which were available at the time, and the [one behold] -- our neutralizing antibody titers are pretty well conserved from the Wuhan original strain to the UK variant to South Africa and the Brazil. In particular, the UK and the Brazil was maintained perfectly well, and also we tested the T-cell responses as well. And they were 100% cross reactive across these variants. So, we think, so far, so good. INO-4800 should be able to demonstrate efficacy in this trial in a well-controlled manner in the Phase 3.
Now, what is going to be the future, newly emerging variants on the vaccine? Well, that's we don't know yet, but we feel very good about 4800. And certainly, as a pan-COVID variant, we also have a second vaccine candidate as a second generation product that's strictly designed to deal with this popping up of the new variants that are concerning many people, for instance, such as South Africa or Brazil, but the one from India has been a concern, and I guess that's the delta or gamma-delta, yes. And then the -- we're now reading about the Vietnamese variant that's really concerning folks in that area.
So, pan-COVID vaccine, INO-4802 the candidate, we just published great immune data in animal models in bioRxiv. Our plan is to advance this program into an accelerated Phase 1 plus 2 trial, whereby the end of this year or very early part of '22, we will have a full immune data set from this new candidate 4802 from several hundred volunteers from the globe. So we're moving both our lead product, INO-4800, through efficacy and our goal is to commercialize that in those countries initially, go attend WHO emergency use license, as well as getting the conditional or emergency approval in these various countries. And we also plan to bring it fully back to the U.S. for BLA application on approval.
So the reason for that you may ask is, while the primary vaccination strategies are pretty well saturated with the current players, I think the long-term opportunity is in the booster market, the season of boosting in the endemic stage. And INO-4800’s superior boost ability, we discussed about this before. We have our Phase 1 booster study that's ongoing, where we boosted about 100 of our Phase 1 subjects with a third dose between six months and 10 months from their second dose. And I don't want to give out the punchline, but I can give you that it was very tolerable. And we were able to boost the immune responses and we plan to publish as a preprint later this summer, the full data set. So we think the boost ability of INO-4800 is very strong, and we think we could potentially have them approved to be boosted with our own vaccine, administer subjects but also potentially other first generation vaccine recipients who can then be boosted with 4800 in the upcoming season.
So that's our near-term and long-term strategy. Near-term is, execute the ex-U.S. Phase 3 trials, show the efficacy, get the approvals, get the doses to the people who need them in the world, and then bring it back to the U.S. as a potential booster over time.
Jefferies 6/1 CC: U.S. FDA partial hold on our CELLECTRA 2000 device, there's no bearing in any other territories. In fact, it's the same device that we had received CE marking from the EU several years ago. So most of the countries outside the U.S. follow the CE marking for medical devices, the EU convention. So we feel very good about the acceptability of our device outside the U.S. And of course, the gating factor for our Phase 3 start is really -- and we've already begun this process is submitting all of our Phase 3 plans, and getting them approved through various countries that we have planned.
So once our first country is set and we're rolling out the trial, and there will be multiple countries at once, we will fully disclose and articulate our strategy and the design more fully. But all of the trials right now in Phase 3 will be conducted outside the U.S.
you asked about the FDA partial hold. We still want to clear that up. As I articulated our strategy long-term submit our BLA. And also we want to make sure that all of the hard work that our team has done is fully realized. So we still plan to do that. But our primary focus right now is executing and opening the countries and the sites for our Phase 3 outside the U.S. using CELLECTRA 2000 delivering INO-4800. And we're on track as we had anticipated earlier this year that we'll be starting this summer and data -- interim data by year end as I discussed earlier.
INO-4800’s ability to cross-protect against those variants, of UK variant, the Brazil variant, really is in our sweet spot. So we're going to go where those variants and the original strains are more dominant, and those are the areas of you can imagine, Latin America, Asian Pacific and so on. So there's plenty of regions that we can execute our trial. We overlay that with our own variants levels in those regions, as well as our CROs.
So we selected a handful of great countries do these trials. And we -- as I mentioned, in the next few weeks, we will be able to articulate the full strategy and discuss with the public in regards to what we're doing. But what I can share with you now is we're broadly in -- on time and on schedule to start this summer of this case-driven trial. And we look forward to -- I wait till we really are able to do that. That's what we've been focused on for the last several months. So, I think that will be a huge milestone for INOVIO, our stakeholders and our shareholders.
REVEAL 2. So we're also executing that and we should have full enrollment this year and data readout in '22.
What's different about REVEAL 1 and REVEAL 2 is they're identical across the design, except for the safety follow-up. So REVEAL 1 has a one year safety follow-up from the 36 week initial primary time point. REVEAL 2 has a one month follow-up. So it's much closer to finish from the primary endpoint. So we're very looking forward to having both REVEAL 1 full data set this year and REVEAL 2 in 2022. So that program is moving well, and we're very active and very excited around these programs.
the side effects of this current standard treatment besides the typical surgical related side effects is a reduction in capabilities to carry the babies post surgery. So, it's been well published that the surgery doubles the rate of spontaneous abortions and preterm birth.
So what VGX-3100 offers these patients is an opportunity to avoid surgery and treat the disease and the original cause of the disease, which is an HPV infection in the first place. So we think there's a strong market need for and want for a therapeutic like VGX-3100 and we'll demonstrate the efficacy through our pivotal trials, but we will also be able to present this strong case for the patients and the providers alike.
we're right now looking at the best path to expand the label. So through additional trials and additional efforts to expand from a cervical dysplasia, which is our initial target indication to expand into vulvar and anal dysplasia, we think VGX-3100 has the potential to become a pan-anal genital immunotherapy those are caused by HPV-16 and 18.
the 5401 really, again, using the same concept of our platform generating antigen specific T-cells that can be used to clear the tumors, already existing disease cells. And GBM expresses many antigens, including the three antigens that comprise INO-5401, in a DNA form these are hTERT, WT1, and PSMA. So we combined it into a single therapy with our IL-12 gene expressing plasmids. And then we partner up with Regeneron, who's contributing their PD-1 checkpoint inhibitor. So in a very hard to treat cancer in glioblastoma, we layered on these immunotherapies on top of the standard-of-care, which is right now surgery and chemo radiation.
So in 52 patients with glioblastoma, we have treated them. And along the 6 months, 12 months and 18 months from the treatment, we've been following their progression-free survival as well as the overall survival, looking for the added impact, added benefits clinically to these patients. And so far through the first 18 months, we have observed really very encouraging and optimistic survival data. So what's coming in rest of '21 is additional data at 24 months, the survival as well as the median overall survival in our second core, our healthier core which we haven't reached the 50% survival rate yet. So we expect to probably reach that later this year. And we plan to present additional data as well as additional immune and tissue level data to go along with the survival data. So please stay tuned for the rest of second half of '21 for our GBM data.
“The shortest time from the detection of a variant of concern to preclinical immunogenicity readout against a panel of pseudoviruses is approximately 2 to 3 months,” said Guillaume Stewat-Jones, a Moderna (ticker: MRNA) scientist who works as associate director of antigen design and selection on their infectious disease team. “And new viral variants are coming — emerging constantly in real time.”
The company said that it tests new variants in the lab against its vaccines, and is “constantly” making and testing new versions of its vaccine. But it warned that the process is not instantaneous, and that the company’s agility is limited by the complexity of the work.
Moderna scientists and executives laid out their plans to combat new strains of the virus that causes Covid-19 at a virtual investor event on Thursday, saying that new waves of the epidemic are on their way.
“As the virus spreads, it is rapidly mutating,” the company’s chief scientific officer, Melissa Moore, said on the call. “Some of these new viral strains appear to be even more transmissible than the original strain… We already know that some of these new strains are less susceptible to neutralization by our current vaccine.”
In recognition of National #DayofGray and #BrainTumorAwarenessMonth, we’re sharing some key facts about Glioblastoma Multiforme (GBM), the most aggressive and most frequently occurring type of brain cancer. Read more about our immuno-oncology programs: bit.ly/3bTjfXF
5/27/21
“Nearly 13,000 people in the U.S. are estimated to get GBM this year, and more than 23,000 in the U.S. currently have GBM.”
While there have been a limited number of new GBM therapies approved over the last 10 years, disease prognosis remains extremely poor.
“The median Overall Survival for GBM patients receiving Standard of Care therapy is approximately 15 months.”
GBM is one of the most awful diseases a human can get. The current 'treatments' and I hate to call them that come with severe side effects and actually make the experience worse with little to no benefit. It's time to improve quality of life and extend it for these patients.
In recognition of National #DayofGray and #BrainTumorAwarenessMonth, we’re sharing some key facts about Glioblastoma Multiforme (GBM), the most aggressive and most frequently occurring type of brain cancer. Read more about our immuno-oncology programs: https://t.co/Yzukmkvup9 pic.twitter.com/LlGcRtPbRY
— INOVIO Pharmaceuticals (@InovioPharma) May 27, 2021
AMC shares pop 25% as the Reddit favorite more than doubles this week on huge volume. Shares of AMC Entertainment jumped 25% in early trading Friday as Reddit traders kept piling into the speculative name this week.
The gain followed a 35% advance in the previous session. Shares have already rallied nearly 200% week to date, bringing its monstrous 2021 rally to 1,500%.
AMC was the most active stock on the New York Stock Exchange by far on Thursday with nearly 700 million shares changed hands. Its 30-day trading volume average is just above 100 million shares, according to FactSet.
“The retail trader is at it again,” said Edward Moya, senior market analyst at Oanda. “AMC500k and AMCSqueeze were trending on Twitter yesterday and that momentum took the stock price above the end of January high that we saw during the peak of meme stock mania.”
The movie theater chain has replaced GameStop as the most popular stock in the infamous WallStreetBets Reddit forum, according to Bank of America’s analysis of stock mentions on the chat page.
Enthusiastic Reddit traders are encouraging each other to double down on AMC’s stock and call options by sharing screenshots of their portfolio and touting massive return. One trending post on WSB Friday reads: ”$AMC YOLO UPDATE : 4948 shares, 10 calls, across 4 brokerages, and I still ain’t selling!”
GameStop, which was the star of the show amid the January retail trading mania, is up a relatively mild 40% this week.
AMC’s surge this week has already inflicted a $1.3 billion loss for short sellers, according to data from S3 Partners.
Short covering could be fueling AMC’s massive rally this week. When a heavily shorted stock jumps higher, short sellers are forced to buy back borrowed shares to close out their short position and cut losses. The forced buying tends to accelerate the rally even further.
AMC is a heavily shorted name, with about 20% of its float shares sold short, compared with an average of 5% short interest in a typical U.S. stock, according to S3 Partners.
The Government of Japan will host the virtual Gavi COVAX Advance Market Commitment (AMC) Summit on 2 June 2021. The event will aim to accelerate access to 1.8 billion COVID-19 vaccine doses for lower-income economies via the Gavi COVAX Advance Market Commitment by raising an additional US$ 2 billion from donors and the private sector, in addition to US$ 6.3 billion already raised before the campaign was launched at the “One World Protected” event on 15 April 2021.
https://www.gavi.org/gavi-covax-amc-summit-2021
With meme stocks on the move again, these are the next Reddit stocks to watch incl. Ino. BofA gave clients a list of the top small- to mid-cap stocks to watch during the return of the meme stock craze.
Meme stocks are grabbing the spotlight once again, and Bank of America said to watch out for a handful of new names seeing a pickup in chatter.
So-called Reddit stocks came back from the dead with double-digit rallies this week, as investors poured back into speculative names with the stock market near record highs. Shares of GameStop soared nearly 16% on Wednesday, pushing its gains this week to 37%. Another Reddit chat room favorite, AMC Entertainment, rallied more than 19%, bringing its weekly advance to more than 60%. Both were in the green again Thursday.
Bank of America is identifying the potential up-and-coming WallStreetBets targets by analyzing for clients how many mentions each stock gets on Reddit, among other things like short interest.
“We believe some of the new retail activity may be here to stay given zero commissions, more time at home, and high savings rates — but we do expect a moderation this year amid peak stimulus, re-opening and any potential regulatory action,” Bank of America equity and quant strategist Jill Carey Hall told clients in a note.
Bank of America gave clients a list of the top small- to mid-cap stocks to watch during the return of the meme stock craze. The listed names have the most mentions on Reddit and short interest above the 5% average for the S&P 500.5/27
Jefferies CC 6/1. 5401 GBM OS24 at ASCO 6/8. 4800 P3 hold lifted 6/11 triggering CEPI funding. 4802 P1/2 IND approval with CEPI, BARDA funding. 4800 100-subject Booster Preprint in June. Oppenheimer Meeting management was on 5/25 catalyzing pps. Do your own DD.
COVAX Joint Statement: Call to action to equip COVAX to deliver 2 billion doses in 2021. Fund the Gavi COVAX Advance Market Commitment (AMC)
The AMC mechanism is how COVAX provides doses to lower income economies. Thanks to the generosity of its donors, the AMC has already secured 1.3 billion doses for delivery in 2021. This is enough to protect the most at-risk population groups: health workers, the elderly and those with underlying health conditions. We need an additional $2 billion to lift coverage in AMC countries up to nearly 30%, and we need it by June 2 to lock in supplies now so that doses can be delivered through 2021, and into early 2022. 5/27
https://cepi.net/news_cepi/covax-joint-statement-call-to-action-to-equip-covax-to-deliver-2-billion-doses-in-2021/
Inovio management met virtually with Oppenheimer. Virtual Meetings were held May 24-25 hosted by Oppenheimer. That explained pps increase.
https://m.thefly.com/news-story/3309148/2021-05-25%2005:55:00/search
Chen Mingjian, founder of Dongfang Gaosheng: The era of vaccines for healthy adults has come. "Taking VGX-3100 as an example, we think it will be three "1" drugs, that is, the first drug to be marketed with annual sales exceeding 10 billion. Currently, 47.35 million people are infected with HPV, 36 million are cervical cancer patients, 17 million are HPV-16/18 targets, 5% of patients are nearly 750,000, and a course of treatment is 20,000 yuan, which is 15 billion. It is completely consumer-oriented and does not need to enter the national medical insurance."
Vaccines Go Electric. Inovio’s Electrical Device 3PSP Zaps a COVID-19 Vaccine Into the Body 5/26. Inovio’s vaccine comes with a separate novel device, so that requires additional, independent oversight by the FDA’s device reviewers, says Dennis Klinman, a former senior reviewer of vaccines at the FDA, and now a consultant. The additional device oversight is likely the reason for the clinical hold, he says.
Inovio says it plans to answer the FDA’s questions using data from the phase 2 study [Submitted 5/11 or before 5/12 BofA CC], but it would not disclose the specifics of the agency’s queries. “It was nothing about the safety or the use of the device in the clinic,” Broderick says. “It’s more logistical areas for us to clarify.”
In addition to Inovio, at least three other companies— Genexine, Takis, and OncoSec—are conducting human studies of an electroporated DNA vaccine against COVID-19. Other companies, such as Ichor Medical Systems and IGEA Clinical Biophysics, have developed electroporation devices that they license to pharma companies for DNA vaccine delivery against other diseases.
https://spectrum.ieee.org/biomedical/devices/inovios-electrical-device-zaps-a-covid19-vaccine-into-the-body
EMA advisory group backs Regeneron, Sanofi's Libtayo in lung and skin cancer
May 24, 2021 1:38 AMRegeneron Pharmaceuticals, Inc. (REGN)SNYBy: Mamta Mayani, SA News Editor
The EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NASDAQ:SNY) Libtayo (cemiplimab) as monotherapy in two advanced cancers.
The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations.
Libtayo was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
The European Commission is expected to make a decision on both indications in the coming months.
The positive opinion for Libtayo in advanced NSCLC and BCC is based on results from Phase 3 EMPOWER-Lung 1 trial and Phase 2 EMPOWER-BCC 1 trial, respectively.
Libtayo is currently approved in the European Union and other countries for the treatment of certain patients with advanced cutaneous squamous cell carcinoma.
P2 novel combination trial of INO-5401 and INO-9012 in combination with the PD-1 checkpoint inhibitor Libtayo, which is currently being jointly developed by Regeneron and Sanofi, in the treatment of newly diagnosed glioblastoma multiforme.
4800 3rd booster Pre-print imminent: the consistency of a favorable tolerability profile from the first dose to the second dose in this Phase 2 safety data confirmed the Phase 1 finding of no increase in frequency of side effects after the second dose compared to the first dose. These results further suggest that in addition to being a primary vaccine candidate, INO-4800 could represent a safe booster vaccine without significant limitations such as anti-vector responses or dosing-incremented toxicities. We have observed directly in the Phase 1 100 trial participants who were boosted with a third dose of their INO-4800 vaccine between 6 and 10 months resulted in higher levels of humoral and cellular immune responses without increased levels of AEs (Manuscript in preparation). Given the uncertainty about the durability of the natural infection or vaccine induced responses against COVID-19 disease, vaccine boosting by a benign approach like INO-4800 may be an important way to maintain protection over subsequent epidemic waves of COVID-19. It is also possible that INO-4800 could serve as a useful booster shot for other S protein-targeted vaccine candidates with limitations in boosting ability, and this potential should be further investigated. 5/8
Wealthy nations have bought up huge portions of the global vaccine into the foreseeable future. The Serum Institute of India, which was going to be the primary supplier of doses to COVAX, hasn't delivered any shipments to the program since March. It has been diverting all its production to address the unfolding COVID crisis inside India and may not resume exports until the end of the year.
"We've had a gap of over 150 million doses already up to May," says Bruce Aylward, a senior advisor to the director-general of the WHO. "And that could get greater still going into June."
Thinking beyond COVAX
Many countries are not waiting around for COVAX.
COVAX is the only global tool that's trying to make sure every country gets access to some of the limited global supply, he says. But it is reasonable that many countries are seeking additional ways to get vaccines, he adds. Many wealthy nations managed to buy vaccines on their own. Some have gotten subsidized or free vaccines from Russia and China. And some have managed to purchase small batches to at least get health care workers immunized.
"(COVAX) is an important tool. But COVAX shouldn't be the only effort and countries rightfully are not waiting around for COVAX to save the day," he says.
But, he says, "for the very poor countries, [COVAX] is pretty much their only option."
https://www.npr.org/sections/goatsandsoda/2021/05/19/998228372/what-is-this-covax-program-that-the-u-s-is-pouring-millions-of-vaccines-into
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.