Tag Archives: immunotherapy

Science Advisory Board | Instant News


Science Advisory Board<br />

COVID-19 has long-term effects on the biotechnology industry

January 5, 2021 – The COVID-19 pandemic will have far-reaching and lasting effects on the biotechnology industry, according to speakers at a January 5 presentation held ahead of the virtual Biotech Showcase being held on January 11-15. Biotech companies have been swirling around on a large scale pursuing infectious disease research – and not all of them will succeed.
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An allergic reaction to the COVID-19 vaccine should not stop vaccination

January 4, 2021 – The COVID-19 vaccine currently approved for emergency use by the US Food and Drug Administration (FDA) is safe even among people with food or drug allergies, according to allergists from Massachusetts General Hospital. A review of all relevant information is published on Journal of Allergy and Clinical Immunology: In Practice on December 31st.
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Top 10 ScienceBoard stories for 2020

21 December 2020 – For many of us, 2020 didn’t go according to plan. The emergence of the COVID-19 pandemic has drastically changed our daily lives. Right here at ScienceBoard.net, we have provided our readers with timely and evidence-based information regarding COVID-19, as well as many other topics in the biopharmaceutical and life sciences industry.
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The FDA issued the EUA for the Moderna COVID-19 vaccine

18 December 2020 – Just one day after the committee’s favorable recommendation, the US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the COVID-19 messenger RNA (mRNA) vaccine from Moderna. The company’s mRNA-1273 vaccine is now the second COVID-19 vaccine on the US market, after vaccines from Pfizer and BioNTech were administered EUA last week.
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New discoveries could produce broad-spectrum antivirals

18 December 2020 – Scientists have identified key human genes that cells need to consume and destroy viruses. Research results are published in Natural on December 16 and could demonstrate new treatments to target viral infections, including COVID-19.
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The FDA committee voted in favor of the Moderna COVID-19 EUA vaccine

17 December 2020 – Moderna’s COVID-19 messenger RNA (mRNA) vaccine candidate, mRNA-1273, received favorable recommendations on December 17 from an advisory committee for the US Food and Drug Administration (FDA). The OK Committee means that mRNA-1273 may receive emergency use authorization (EUA) within a few days.
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The new immunotherapy supports the polio vaccine to treat cancer

17 December 2020 – As if we needed another reason to get vaccinated, researchers have developed technology that uses the polio vaccine to help treat cancer in those who later develop the disease. The technology, developed at Duke University and developed by Istari Oncology, uses the antigen produced by the polio vaccine to trigger the immune system to eat away at targeted cancer cells.
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The genes provide new targets for COVID-19 therapy

15 December 2020 – Genes associated with antiviral immunity and lung inflammation have been linked to severe cases of COVID-19 in a new genome analysis carried out in the UK. The result, published in Natural on December 11, revealed new therapeutic targets for drug reuse and development efforts.
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Global health R&D has stalled as resources shifted to COVID-19

December 14, 2020 – The current coronavirus pandemic has slowed progress in research and development (R&D) on neglected diseases and other long-term global health challenges by disrupting ongoing research and directing resources to the work of COVID-19, according to a new report released on December 11. by the nonprofit Global Health Technologies Coalition.
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The FDA issued the EUA for Pfizer’s vaccine, BioNTech COVID-19

12 December 2020 – The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. This step comes after the FDA’s Vaccines and Biological Products Advisory Committee issued positive recommendations for the vaccine.

Google’s DeepMind is making a quantum leap in solving the problem of protein folding

11 December 2020 – Artificial intelligence has made breakthroughs in protein structure prediction. The results come as part of the 14th Critical Assessment of Structure Prediction, a friendly contest and conference organized by the Protein Structure Prediction Center with sponsorship from the National Institute of General Medical Sciences, part of the US National Institutes of Health.
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Science Advisory Board | Instant News


Science Advisory Board<br />

The FDA committee voted in favor of the Moderna COVID-19 EUA vaccine

17 December 2020 – Moderna’s COVID-19 messenger RNA (mRNA) vaccine candidate, mRNA-1273, today received favorable recommendations from the advisory committee for the US Food and Drug Administration (FDA). The OK Committee means that mRNA-1273 may receive emergency use authorization (EUA) within a few days.
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The new immunotherapy supports the polio vaccine to treat cancer

17 December 2020 – As if we needed another reason to get vaccinated, researchers have developed technology that uses the polio vaccine to help treat cancer in those who later develop the disease. The technology, developed at Duke University and developed by Istari Oncology, uses the antigen produced by the polio vaccine to trigger the immune system to eat away at targeted cancer cells.
Discuss

The genes provide new targets for COVID-19 therapy

15 December 2020 – Genes linked to antiviral immunity and lung inflammation have been linked to severe cases of COVID-19 in a new genome analysis carried out in the UK. The result, published in Natural on December 11, revealed new therapeutic targets for drug reuse and development efforts.
Discuss

Global health R&D has stalled as resources shifted to COVID-19

December 14, 2020 – The current coronavirus pandemic has slowed progress in research and development (R&D) on neglected diseases and other long-term global health challenges by disrupting ongoing research and directing resources to the work of COVID-19, according to a new report released on December 11. by the nonprofit Global Health Technologies Coalition.
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The FDA issued the EUA for Pfizer’s vaccine, BioNTech COVID-19

12 December 2020 – The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. This step comes after the FDA’s Vaccines and Biological Products Advisory Committee issued positive recommendations for the vaccine.

Google’s DeepMind is making a quantum leap in solving the problem of protein folding

11 December 2020 – Artificial intelligence has made breakthroughs in protein structure prediction. The results come as part of the 14th Critical Assessment of Structure Prediction, a friendly contest and conference organized by the Protein Structure Prediction Center with sponsorship from the National Institute of General Medical Sciences, part of the US National Institutes of Health.
Discuss

The FDA committee approved the transfer of Pfizer, the BioNTech COVID-19 vaccine to EUA

December 10, 2020 – Pfizer-BioNTech’s COVID-19 vaccine candidate, BNT162b2, passed an important milestone today when the US Food and Drug Administration (FDA) advisory committee determined that the candidate’s benefits in preventing COVID-19 outweigh the risks. The committee’s advice is likely to lead to the issuance of an emergency use authorization (EUA) for vaccines by the FDA within days.
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The new study found the SARS-CoV-2 antibodies disappeared rapidly

8 December 2020 – Antibodies developed after being infected with the SARS-CoV-2 virus disappeared rapidly, according to an analysis published in Immunology Science on December 7th. These findings may suggest that SARS-CoV-2 infection may not offer long-term immunity from subsequent reinfection with the virus.
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The new universal flu vaccine targets conserved areas of viral surface proteins

December 7, 2020 – A new universal influenza vaccine has been developed that targets the surface protein stem of the influenza virus rather than the head. This vaccine, which is capable of neutralizing various strains of influenza, was evaluated in a phase I clinical study whose results were published in Natural Medicine on December 7th.
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Regulatory Roundup: The appointment is made before the end of the year

December 7, 2020 – This week’s Regulatory Roundup covers activities from November 30 to December 4 and is filled with breakthroughs, orphans, and rare disease appointments from the US Food and Drug Administration and the European Medicines Agency. Several cancer, immunotherapy, and vaccine companies also submitted biological licensing applications to advance their candidates.
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Immunophotonics Announces the Appointment of Jonathan Knowles to the Board of Directors | Instant News


BERN, Switzerland, 05 Oct 2020 (GLOBE NEWSWIRE) – Immunophotonics, Inc., a biotech company focused on discovering and developing immune-activating carbohydrate polymers for the treatment of solid and metastatic cancers, has strengthened its expertise through the appointment of Jonathan Knowles, Ph.D. to the Board of Directors.

“Dr. Knowles has made important contributions in developing and commercializing many drugs in several therapeutic areas. His insights will be invaluable in advancing IP-001 through clinical development and commercialization, ”said Dr. Bobby W. Sandage, Jr., Chair of the Immunophotonics Council. IP-001 is the company’s main asset in clinical development.

Lu Alleruzzo, CEO of Immunophotonics, was honored to welcome the new Board members and commented “I really look forward to working with Dr. Knowles to advance our program, leveraging his strategic, operational and scientific knowledge as we continue to validate the science behind the IP-001 immune modulation properties. “

Dr. Knowles has reached the pinnacle of academic achievement and applied his studies to the pharmaceutical industry with a proven track record of advancing scientific innovation through clinical development and global adoption. In his opinion, “Immunophotonics has a unique and innovative approach to treating serious cancer through immune stimulation. Initial data look very interesting and the drug could potentially help many metastatic cancer patients who are eligible for ablation or radiation therapy. I look forward to interacting more closely with the company’s great scientists in the future. “

About Prof. Dr. Jonathan Knowles, Ph.D.

Dr. Jonathan Knowles has held faculty positions at various first-class institutions, including the University of Oxford, Swiss EPFL, University of Basel, and University of Helsinki. His innate curiosity and determination to apply cutting-edge science to develop effective pharmaceuticals propelled him into leading positions in the pharmaceutical industry, including Research Group President and Member of the Roche Group Executive Committee, Member of the Board of Directors of Genentech and Chugai Pharmaceuticals, and Chair of the Federation’s Research Directors Group. European Pharmaceutical Industry Association (EFPIA). Most recently, he served as Chairman of the Board for Immunocore Ltd. and Adaptimmune Ltd., two major British biotech companies. Dr. Knowles is a visionary who dares to overcome the limitations of existing therapies and has dedicated his talents to developing innovative diagnostics and drugs with healing potential.

About Immunophotonics

Immunophotonics is a privately owned clinical stage biotechnology pioneering the field of Interventional Immuno-OncologyTM. IP-001, the first asset of the company’s intellectual property platform, has the potential to transform routine tumor ablation into systemically active cancer immunotherapy in a variety of solid tumor indications. The company is based in St. Petersburg. Louis, Missouri, USA with subsidiaries in Bern, Switzerland and Tianjin, China.

Contact:
Dr. Theresa Visarius
Vice President of Business Development, Immunophotonics, Inc.
Managing Director, IPS Biopharma AG
[email protected]
www.immunophotonics.com

This press release contains forward-looking statements it may be involves inherent uncertainty and actual results maybe differ materially. Immunophotonics, Inc. is not obligated to update the information, except as required by applicable law.

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Why is the UK so much better on the Molecular Profile? | Instant News


Molecular testing is an invaluable resource in lung cancer, but the latest evidence shows that many US practitioners do not use it. Real world data in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) found that only 54% were tested for epidermal growth factor receptor (EGFR) and 22% for anaplastic lymphoma kinase (ALK), ROS-1, and BRAF. Even when testing is done, it may not be enough to inform treatment decisions. A 2019 study at JAMA reported that only two thirds of patients with EGFR mutation or ALK rearrangements never receive an appropriate inhibitor during the course of their disease.

In comparison, Britain seems to have a lot to be proud of when it comes to molecular testing. Recently reported data from the United Kingdom National Lung Cancer Audit revealed that 83% of patients with advanced adenocarcinoma underwent testing EGFR, ALK, ROS-1, and programmed death ligand 1 (PD-L1). However, audit findings at the level of patients receiving appropriate targeted care and average survival indicate that the UK also has room to improve.

To find out what caused the differences in the UK and US approaches, Medscape contributor Dr. Jack West spoke with Dr. Sanjay Popat, professor of chest oncology at The Institute of Cancer Research and consultant in medical oncology at Royal Marsden Hospital in London, United Kingdom.

H. Jack West, MD: Let’s discuss what works and what hurts in both of our systems, because that is an important step to fix it.

Sanjay Popat, MD: In Britain, some things are a little better, some are similar to problems in the United States, and some are a little worse.

What we do very well is the penetration that testing has in the population. That’s clear in the 83% testing rate for biomarkers funded by the National Health Service (NHS). The data is for every patient who walks through the doors of a number of centers in 2017.

But when you look a little deeper, you see the problem. Of those identified EGFR positive mutants, only 75% received EGFR tyrosine kinase (TKI) inhibitors upfront. Even worse, only 58% ALKPositive patients receive ALK inhibitors. I feel this is very sad because this is the most effective medicine we have.

There must be a reason why this genotype was not translated into TKI recipes. Do cancer experts really take the results and find out the next step based on this limited amount of biomarkers? In general, I think they did, because to prescribe immunotherapy in the UK, you have to prove on the form that patients are the wild type to EGFR and ALK.

One possible cause is the turnaround time, which we have a problem with. Or maybe more complex.

West: Completion time is certainly a major challenge in the United States, where it routinely takes 3 weeks or more to complete network-based testing. Many patients want to be treated very quickly.

If molecular testing will take 3 to 4 weeks or more, even cancer experts who have a preference for it might feel that they might not be wrong in giving chemotherapy and immunotherapy. Or say you get the PD-L1 returned very quickly and then have to wait for molecular testing; it is very tempting to act at high PD-L1 levels and maybe just starting a single agent pembrolizumab.

Then there is a sense of competition in the United States. Patients who are not inclined to wait can leave your place of practice for an oncologist at the end of the road who will start treating them quickly. Many of my colleagues have expressed concern about having to convince patients that it is better to wait for the test results than to start treatment now, just to get things going.

Popat: We do not have the same commercial pressures that desperately need to start some form of systemic therapy, although it may not be clinically indicated. Patients have no hope of going to other practices, which may not have availability even if they do.

There are some cultural differences too. The NHS system does not allow you to prescribe pembrolizumab unless you really confirm that the patient is a wild type EGFR and ALK. That is the same thing for chemotherapy plus immunotherapy. You can prescribe it, but you have to prove that the patient is a wild type.

Another thing to consider is that in many centers, if you decide you want to provide some kind of systemic therapy, the patient may wait 2 weeks (if not longer) for the first cycle. That allows a little time buffer so that molecular results can appear.

Biopsy on Both Sides of the Atlantic

West: About 1 in 10 patients in the National Lung Cancer Audit report has insufficient tissue. In the United States, these patients can start chemotherapy plus temporary immunotherapy. It does not seem like a real possibility in the UK, because basically you are required to do whatever needs to be done to get molecular data. What is the impact of retesting?

Popat: Retest rate in UK audits is around 10% because initial specimens are inadequate. However, that possibility is too low. I suspect that many people who start chemo, with or without immunotherapy, are in situations where we do not have enough specimens to understand their true genotype. These patients may be biopsied at some stage in the future, which is also a challenge to do after they start receiving chemotherapy.

We really want to move towards liquid biopsy. I would love to be in a position where we have the next generation of DNA sequencing (ctDNA NGS) circulation in advance. Unfortunately, Britain lags behind this, given the large costs associated with NGS ctDNA. Several commercial providers have signed schemes with each institution to allow this approach for the selection of biomarker patients for trial registration, but certainly not close to standards.

West: Liquid biopsy is available in the United States, but is not consistently used and replaced.

Another problem that we sometimes face here is that genetic testing reports can be uploaded to random media tabs from challenging and expansive electronic medical records, never seen by the human eye. How likely is it in the UK system?

Popat: In general, our system works very well in this regard. Stopping hard is basically not prescribing chemotherapy plus immunotherapy or immunotherapy alone unless you know what you are seeing. It really forces these results to be seen and verified.

Most pathology and molecular diagnostic tests occur in established tissues with oncologists, so the results get feedback from both oncologists and clinical nurse specialists. Nurse specialists have a role in instigating molecular testing, ensuring results have reached the laboratory and returned, and marking one of the positive results to the oncologist. This means there is a much smaller chance of results just drifting off to random pages in electronic medical records.

Room for Improvement in Both Systems

West: Success reported in the National Lung Cancer Audit is accompanied by quite serious results. The average survival for the wider population is only 7 months, and only 1 year for those who have EGFR mutation. That’s a lot less than I expected to see a population enriched with a targeted therapy. What do you think contributed to that?

Popat: I fully agree and, to be honest, feel very shameful. I think you must remember, however, that this is the whole population. This is not only suitable for patients you normally consider enrolling in trials, but also for those diagnosed as emergencies, sick, or unhealthy. You see the entire population, not just a crème de la crème part

Because of this, the result data is far worse than we expected. I think that can be partly explained by many things.

For example, we still provide first generation inhibitors on EGFR settings and must hunt for testing T790M before giving osimertinib. T790M testing has a problem. I am not sure that we often actually follow up on a negative T790M test with an appropriate biopsy, as the patient slowly develops.

I am also worried that the patients themselves are not interested in undergoing additional biopsies. There is always a fear of having chemotherapy, even though we know it is a very effective rescue treatment for the T790M-negative population. I want to know more about the patient’s perspective here.

There is a lot of work to be done to optimally manage oncogenic addiction. We don’t do very well oncogen oligoprogress here, because stereotactic body radiotherapy is not routinely funded. These patients must undergo trials. Radioturgic stereotactic provisions for patients with central nervous system (CNS) development vary greatly. CNS monitoring in patients with oncogenic addiction is still poor.

This all contributes to suboptimal results. We really need to realize that patients can do very well if treated aggressively, and obtaining a TKI is an absolutely essential part of this. And, clearly, acknowledging that this is a patient who is addicted to oncogenes is initially the key.

West: The message that was brought home to me was that there was clearly remarkable new progress in our care and understanding of how cancers adapted to them. It takes a lot of effort to apply that knowledge and educate the wider community to realize this promise. Even with some of the successes reported in the United Kingdom, none of us has broken this code into a great system of work.

H. Jack West, MD, associate clinical professor and executive director of employer services at the City of Hope Comprehensive Cancer Center in Duarte, California, regularly comments on lung cancer for Medscape. West serves as a web editor for JAMA ONCOLOGY, edit and write several sections about lung cancer for UpToDate, and leads a variety of continuing education programs and other educational programs, including hosting audio podcasts West wind.

Sanjay Popat, PhD, FRCP, is a professor of thoracic oncology at The Institute of Cancer Research and a consultant in medical oncology at the Royal Marsden Hospital in London, England. His research interests include identifying DNA variants that influence the development of thoracic tumors, identifying biomarkers that can predict therapeutic effects, and developing new strategies for treating thoracic tumors through clinical trials.

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ICMR to study whether the BCG vaccine helps prevent coronavirus | Indian News | Instant News


DELHI BARU: The Indian Medical Research Council (ICMR) will begin a new trial next week to study the efficacy of BCG vaccine in preventing Covid-19, with the results expected to help the government decide whether the vaccine can be recommended to frontline health workers caring for patients.
“The ICMR will begin studies next week. Until we have definite results from this, we will not recommend it even for healthcare workers,” said Dr. R R Gangakhedkar, head of epidemiology and infectious diseases at ICMR, on Friday. Possible effects of BCG vaccine increasing anti-viral immunity has been the subject of considerable comment, with some studies showing higher mortality in several European countries that have stopped vaccinating.
More about Covid-19

Bacille Calmette-Guérin (BCG) is a vaccine that is mainly used to fight tuberculosis. In countries where TB or leprosy is common, one dose is recommended for healthy infants as close as possible to the time of birth. Trials on the BCG vaccine will be one of several lines of treatment and prevention being carried out around the world, with work continuing with anti-viruses such as remdesivir, found to be beneficial against Ebola, and plasma or immune therapy in addition to research on anti-Covid- 19 vaccines.
“We have no evidence to take an official position on the BCG vaccine in Covid-19. It can’t even stop TB but can only protect it from its severity. It might stop meningitis – so this is partial protection. There are several studies that show that it is an immunomodulator, ” Dr. Gangakhedkar the word.
Explaining its use and efficacy, he said the vaccine was given at birth and was effective for 15 years. There are studies on revaccination with BCG but even that is up to teens or 15 years. However, there is no evidence or study of the utility of revaccination after the age of 15 years.
Earlier this week, World Health Organization said there was no evidence to suggest that the BCG vaccine was effective in preventing Covid-19 infection.
“Two clinical trials to answer this question are being carried out, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend BCG vaccination for Covid-19 prevention,” the UN agency said.

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