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Dr. Boris Reznik of Biorasi and Venvalo Group joins CureScience as Advisor

Dr. Boris Reznik of Biorasi and Venvalo Group joins CureScience as Advisor, CureScience

CureScienceTM Institute, a San Diego-based 501(c)(3) non-profit organization dedicated to accelerating novel curative therapies, announced today that Dr. Boris Reznik, has joined the organization's Advisory Board. Dr. Reznik is a veteran of multiple startups and has a strong track record of building companies across a diverse set of technologies-based industries with biomedical sciences being one of his primary focuses.

Boris Reznik is the Chairman of Venvalo Group, venture value optimization firm. During his career, Dr. Reznik founded and built technology companies into market leaders and successfully dealt with both Fortune 500 and emerging companies as clients and partners. He has been a lead or co-investor in startups and mid-market firms and has participated in M&A transactions ranging from Millions to Billions. Dr. Reznik has a depth of experience in processes and systems – a unique perspective in the drug and device development world. As the Chairman of Biorasi, a global CRO, he led development of novel therapeutics, from filing IND to getting approved NDA, for companies ranging from startups to Big Pharma.

"I am delighted to welcome Dr. Reznik to our Advisory Board," said Dr. Shashaanka Ashili, CEO of CureScienceTM Institute. "He brings a unique experience in accelerating drug and device development for life sciences companies. We at CureScienceTM look forward to benefiting from Dr. Reznik's counsel as we work towards developing personalized therapeutic approaches."

"CureScienceTM is a nonprofit institute with a strong team of professionals and an agile approach to novel therapeutics development," said Dr. Reznik. "I am impressed by CureScienceTM 's unconventional methodologies to improving patients' lives. With the rapidly changing life sciences industry, partnerships and collaborations are key to advancing science and I look forward to working with the CureScienceTM team on this front."

"Dr. Reznik's experience in novel therapeutics development will be valuable to the researchers at CureScienceTM as we navigate the complex world of translating innovations and discoveries into clinical applications," said Dr. Tom Ichim, Director, Clinical Sciences at CureScienceTM. The Institute is committed to developing a preemptive and personalized approaches based on the early diagnosis, immunology, and regenerative medicine. To this end, CureScienceTM is focused on accelerating research and development programs internally and through the establishment of strategic partnerships with academic and industry partners.

More information on CureScience at [www.CureScience.org]

More information on Boris Reznik at [www.venvalo.com]

[https://www.prnewswire.com/news-releases/curescience-institute-names-dr-boris-reznik-as-advisory-board-member-301233633.html]

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COVID-19 Vaccine Surveillance- November update

COVID-19 Vaccine Surveillance- November update

Adverse effects of COVID-19 vaccines – what are they? Mass vaccinations against COVID-19 are being done around the globe. As of 3rd November 2021, over 7.1 billion doses of the COVID-19 vaccine have been administered throughout the world. Before their approval, these vaccines went through rigorous clinical trials and were found to be safe. Their administration to the general population on such a large scale has uncovered some adverse effects. However, most of the adverse effects are minor such as pain at the site of injection, headache, fatigue, and muscle pain. The major adverse effects are extremely rare which include anaphylaxis, vaccine‑induced immune thrombotic thrombocytopenia (VITT), myocarditis, and pericarditis. These latter disorders are by far the most important adverse effects caused by COVID-19 vaccines. Some other adverse effects include skin reactions, Bell’s palsy, rhabdomyolysis, vasculitis, pityriasis-rosea, reactivation of herpes simplex, varicella-zoster, reactivation of hepatitis C, ocular adverse effects, stroke, myelitis, and more. People with a history of chronic diseases and those who have previously been exposed to SARS-COV 2 are at greater risk to these reactions. Studies have also found that these adverse effects are slightly more prevalent in women. The exact type of adverse effect depends upon the medical history, age, and gender of the individual as well as the type and dose of the vaccine administered. The following are the developments in the understanding of some of the previously known adverse effects: Anaphylaxis Anaphylaxis is a potentially life-threatening allergic reaction that occurs minutes after receiving the COVID-19 vaccine. Anaphylaxis is one of the earliest reported adverse effects due to the COVID-19 vaccination. It is being hypothesized that anaphylaxis can occur due to the formation of a polyethylene glycol (PEG)-conjugated lipid derivative triggered by mRNA vaccines. This explains an observed trend that females are more susceptible to this allergic reaction. Hormonal differences can also be one of the contributing factors for the adverse reaction of anaphylaxis. Myocarditis Myocarditis is the inflammation of the walls of the heart. It is also one of the earliest reported adverse effects of COVID-19 vaccines. Myocarditis is more prevalent in males of younger age who received Pfizer/BioNTech, Moderna, or Janssen vaccine. According to a hypothesis, myocarditis is somehow associated with IFN-gamma and TNF-alpha. This hypothesis also explains the observed trend in terms of the age and gender of the affected individuals. Neurological Adverse Effects There are a variety of neurological adverse effects which occur following COVID-19 immunization. These include Guillain-Barre syndrome, Bell’s palsy, venous sinus thrombosis, and acute transverse myelitis. It is difficult to draw a causal association between such a wide spectrum of neurological adverse effects and COVID-19 vaccines, but identification of risk factors can reduce the incidence of these unwanted events. Patone et al. compared the risk of neurological disorders caused by the COVID-19 virus to the neurological adverse effects caused by the vaccines in an important review. The article reported that neurological complications of COVID-19 infection are much more prevalent than the adverse effects of the vaccines. This is an encouraging finding for the general population concerned about the devastating neurological adverse effects caused by COVID-19 vaccination. Recommendations regarding Vaccination Although the exact mechanisms of many of the adverse effects are still unknown, the epidemiological data can be used to understand certain patterns about these adverse effects which can help us prevent these events. Some recommendations are given below: People suffering from metabolic, musculoskeletal, immune system, and renal disorders should avoid inactivated virus-based COVID-19 vaccines. People suffering from diseases related to the vascular system should avoid mRNA-based vaccines. Studies have found that antibodies produced in response to the vaccination do cross the placental barrier and are also secreted in breast milk. Despite this, there were no significant adverse effects on the health of newborns. Therefore, it is safe for pregnant women to get the vaccination. CDC advises women younger than 50 years of age to be aware of the risk of TTS associated with Johnson & Johnson’s Janssen vaccine. Deaths after COVID-19 vaccine About 9,367 deaths following COVID-19 vaccination have been reported to the Vaccine Adverse Event Reporting System (VAERS). It is important to note that these deaths do not necessarily have a causal relationship with COVID-19 vaccination. They only have a temporal association with the administration of either the first or second dose of the vaccine. Schneider et al. performed an autopsy investigation on 18 individuals who died after receiving a shot of the COVID-19 vaccine. The authors reported that 13 of these 18 individuals died due to pre-existing diseases which were not related to the COVID-19 vaccine. CONCLUSION The benefits of COVID-19 vaccines clearly outweigh their potential risks. Mass vaccination is still the best way out of this pandemic. The transparency regarding the reporting of adverse effects of COVID-19 vaccines is essential to this mass vaccination strategy. It also allows to point out some general patterns so that at-risk individuals can take proper preventive measures. Written by: Numair Arshad

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COVID-19 Vaccines

COVID-19 Vaccines

Types of vaccines Vaccines can stimulate the body to produce a protective immune response. The vaccine itself can mimic natural infection, but it does not actually cause illness. If a pathogen infected the body after vaccination, the immune system would quickly prevent the pathogen from spreading in the body and causing disease. Vaccines can be divided into the 3 types: inactivated pathogen, recombinant protein-based, and genetic vaccine. In general, inactivated pathogen and recombinant protein-based vaccines induce humoral immunity (Th2-biased) via MHC II pathway. Genetic vaccine such as mRNA and DNA vaccine can induce both cellular and humoral immunity via MHC I and MHC II pathways. The emergence and rapid spread of a novel severe acute respiratory syndrome (SARS) like coronavirus SARS-CoV-2 is causing the global coronavirus disease 2019 (COVID-19) pandemic and destroying global health and economy. To date, SARS-CoV-2 has infected over 264 million people and caused more than 5.22 million deaths. Understanding how SARS-CoV-2 enters human cells is a high priority for deciphering its mystery and curbing its spread. Studies revealed that a virus surface spike protein mediates SARS-CoV-2 entry into cells by binding to its receptor human ACE2 (hACE2) through its receptor-binding domain (RBD). Therefore the spike protein is an excellent target for developing successful vaccine to protect from infection and curb the pandemic. To date, there are two mRNA vaccines (Pfizer-BioNTech and Moderna) and two virus vector-based vaccines (JNJ and AstraZeneca) have been approved in USA and Europe, two or three inactivated vaccines has also been approved in China and India. There are a few other vaccines still in clinical trial stages. We briefly discuss as follows: Genetic vaccines Vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson are being administered in the U.S. The FDA has authorized—and the CDC has approved—booster shots for all three vaccines, along with a “mix-and-match” approach that would allow people to choose a different vaccine for their booster than the one they started with. They are all genetic vaccines. 1. mRNA vaccines Both Pfizer-BioNTech and Moderna vaccines are mRNA. Unlike vaccines that put a weakened or inactivated disease germ into the body, the mRNA vaccine delivers a tiny piece of genetic code from the SARS CoV-2 virus to host cells in the body, essentially giving those cells instructions, or blueprints, for making copies of spike proteins (the spikes you see sticking out of the coronavirus in pictures online and on TV). The spikes do the work of penetrating and infecting host cells. These proteins stimulate an immune response, producing antibodies (humoral immune response) and developing T cell and memory cell immune response that will recognize and respond if the body is infected with the actual virus. Both vaccines showed about 95% efficacy in Phase 3 clinical trials with two shots (21-28 days interval). This figure has changed over time. At six months after vaccination both Pfizer and Moderna still are considered highly effective, several recent studies showed Moderna to be more protective. One study published in The New England Journal of Medicine found Moderna vaccine to be 96.3% effective in preventing symptomatic illness in health care workers compared to 88.8% for Pfizer. Another, from the CDC, found Moderna’s effectiveness against hospitalization held steady over a four-month period, while Pfizer’s fell from 91% to 77%. This research is still limited and more data is needed to fully understand the differences between the two vaccines. Moderna reported that studies showed its vaccine is effective against the Beta, Delta, Eta, and Kappa variants, although it did show it to be about two times weaker against Delta than against the original virus. The Pfizer vaccine was found to be more than 95% effective against severe disease or death from the Alpha variant (first detected in the United Kingdom) and the Beta variant (first identified in South Africa) in two studies based on real-world vaccinations. 2. DNA vaccine INOVIO's DNA vaccine candidate (INO-4800) against SARS-CoV-2, is composed of a precisely designed DNA plasmid that is injected intradermally followed by electroporation using a proprietary smart device, which delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response. As one of the only nucleic-acid based vaccines that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage, INO-4800 is anticipated to be well-positioned for a primary series immunization as well as a booster. Currently this DNA vaccine is under Phase 3 clinical trials in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico and Colombia. 3. Virus vector-based vaccine Johnson & Johnson and Oxford-AstraZeneca have developed similar virus vector-based COVID-19 vaccines. Unlike the mRNA vaccines, virus vector-based vaccines can be stored in normal refrigerator temperatures, and because it requires only a single shot, it is easier to distribute and administer. The virus vector-based vaccines use a different approach than the mRNA vaccines to instruct human cells to make the SARS CoV-2 spike protein. Scientists engineer a harmless adenovirus as a shell to carry genetic code on the spike proteins to the cells. The shell and the code cannot make you sick, but once the code is inside the cells, the cells produce a spike protein to train the body’s immune system, which creates antibodies and memory cells to protect against an actual SARS-CoV-2 infection. Both vaccines obtained similar overall efficacy (75%) and over 85% efficacy against moderate and severe disease. Johnson & Johnson reported in July 2021 that its vaccine is also effective against the Delta variant, showing only a small drop in potency compared with its efficacy against the original strain of the virus, although one recent study suggested that the J&J vaccine is less effective against Delta. Recombinant S protein-based or peptide vaccine 1. NovaVax NovaVax has developed a recombinant Spike protein vaccine which is highly effective in clinical trials. It is simpler to make than some of the other vaccines and can be stored in a refrigerator, making it easier to distribute. Unlike the mRNA and vector vaccines, the Novavax vaccine takes a different approach. It contains the spike protein of the coronavirus itself, but formulated as a nanoparticle, which cannot cause disease. When the vaccine is injected, this stimulates the immune system to produce antibodies and T-cell immune responses. Studies have shown 90% effectiveness against lab-confirmed, symptomatic infection and 100% against moderate and severe disease in Phase 3 trial results released in a company statement in June. The company says the vaccine was 91% protective of people in high-risk populations such as people older than 65, those with health conditions that increase risk of complication, and those in situations where they are frequently exposed to the virus. 2. Virus-like particles The company VBI has developed virus-like particle vaccine ( VBI-2900) that consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, (2) VBI-2902, a monovalent COVID-19-specific vaccine expressing the native SARS-CoV-2 spike protein, and (3) VBI-2905, a monovalent COVID-19-specific vaccine expressing the spike protein from the Beta variant (also known as B.1.351). The vaccine program has been developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through their Strategic Innovation Fund. In Phase 1 study, VBI-2902a induced neutralization titers in 100% of participants, with a GMT of 329, 4.3x the GMT of the convalescent serum panel, after two doses. After two doses, VBI-2902a also induced antibody binding titers in 100% of participants, with a GMT of 4,047 units/mL, 5.0x the GMT of the convalescent serum panel 3. Peptide vaccine Emergex announced approval to initiate Phase I clinical trial of its next generation COVID-19 vaccine candidate in November. This is a synthetic peptide vaccine designed to prime T-Cells to rapidly remove viral-infected cells from the body after infection. This vaccine may offer broad immunity against SARS-CoV-1 and all SARS-CoV-2 variants and provide long-lasting immunity that does not require seasonal booster vaccines. Emergex vaccines have been designed to be administered via the skin using micro needles and to be stable at ambient room temperature for more than three months, facilitating rapid and efficient distribution across the world and making administration of the vaccine more patient friendly. Inactivated virus vaccine Inactivated COVID-19 vaccines have also been approved in China (developed by Sino Biologics and Beijing Kexing) and in India (developed by Bharat Biotech). Written by: Feng Lin, M.D., Ph.D. References: Scudellari M. Nature, 2021, 595-640-644 Shang J, Wan Y, Luo C, et al. PNAS, 2020, 117:112-11734

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