AlloVir’s IPO Raises $276M to Test Cell Therapies in Transplant Patients

AlloVir’s IPO Raises $276M to Test Cell Therapies in Transplant Patients

  • July 30, 2020

Xconomy
Boston
— 

AlloVir is the latest biotech company to go public, raising about $276.3 million to pull its cell therapies off the shelf and run multiple clinical trials testing them in stem cell and organ transplant patients.

On Thursday, Cambridge, MA-based AlloVir (NASDAQ: ALVRpriced its offering of 16.25 million shares at $17 apiece, the midpoint of its targeted $16 to $18 per share price range. The company was able to sell more shares than it planned, boosting the size of the stock offering from the initial target of 14.75 million shares. AlloVir shares opened at $20 apiece, up 17.6 percent from the IPO price.

AlloVir is developing cell therapies intended to treat and prevent viral infections in transplant patients. These patients have weak immune systems that make them particularly susceptible to infection. The standard of care includes antiviral drugs. But sometimes these drugs aren’t enough to stop viruses, and these treatments can damage the kidneys. Instead of taking viruses head on, AlloVir’s cell therapies are intended to restore the ability of a patient’s immune system to tackle them.

The AlloVir cell therapies are called virus-specific T cells, or VSTs. The process for making a VST therapy is similar to the way that CAR-T cancer treatments are produced. Immune cells are removed from the body and multiplied in a lab. But unlike CAR-T therapies, AlloVir’s process doesn’t engineer the cells in any way. The AlloVir cell therapies also don’t start with a patient’s own immune cells. The allogeneic approach uses the T cells of healthy people who have already been exposed to viruses. That exposure is expected to be enough get these cells to go after these viruses after the therapy has been infused into a transplant patient.

Once produced, AlloVir’s therapies can be stored and pulled “off the shelf” for use as needed. Speaking to Xconomy last year, company co-founder and Chief Scientific Officer Ann Leen, an immunologist at the Baylor College of Medicine, likened the process to growing an immune system outside of the body, and giving it to transplant patients at the first sign of infection.

The most advanced AlloVir product candidate, Viralym-M, is a VST that targets five viruses: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, and human herpesvirus 6. The company is testing the cell therapy as a treatment for both stem cell transplant patients and organ transplant patients.

So far, Viralym-M has been evaluated in a Phase 2 clinical trial. According to the prospectus, the experimental therapy was given to 58 stem cell transplant patients whose infections had not responded to earlier antiviral treatments. The study was not designed to show statistical significance or that the VST was superior to antivirals. The proof-of-concept clinical trial was intended to show how the therapy works and whether it can be given safely.

In the study, 93 percent—54 patients—responded to the therapy in some way. A complete response, defined as the viral load returning to the range found in healthy people and resolution of the signs and symptoms of infection, was observed in 17 patients. Another 37 patients showed a partial response, defined as the viral load falling by half.

The therapy was well-tolerated by patients. The serious complications and patient deaths in the study were deemed unrelated to the AlloVir therapy. Graft-versus-host-disease, an immune response that is a known risk of stem cell transplants, was reported in 14 patients. A total of 23 patients in the study died. Preliminary clinical trial data were published in the Journal of Clinical Oncology in 2017.

There are no cell therapies approved for use in the US or Europe for treating or preventing the viral infections that AlloVir is targeting. But the company faces potential competition from South San Francisco-based Atara Biotherapeutics (NASDAQ: ATRA), which has advanced an allogeneic cell therapy called tabelecleucel to Phase 3 testing. That study is evaluating the therapy as a treatment for stem cell and organ transplant patients who develop Epstien-Barr viral infection along with post-operative lymphoproliferative disease, a known complication of transplant procedures.

AlloVir was founded in 2013 based on technology developed in Leen’s research lab, which is part of the Center for Cell and Gene Therapy at Baylor. The company, which was initially named ViraCyte, is led by CEO David Hallal. Hallal is also the chief executive of ElevateBio, a Waltham, MA-based company that provides manufacturing services for cell and gene therapy companies and also invests in them. ElevateBio is AlloVir’s largest institutional shareholder, holding a 21.9 percent post-IPO stake, according to the prospectus. Prior to the IPO, the filing shows that AlloVir had raised $156.3 million, including a $12o million Series B round last year.

According to the prospectus, AlloVir plans to use the IPO cash to advance Viralym-M to a Phase 3 study testing it against hemorrhagic cystitis, inflammation of the bladder that is a virus-associated complication faced by stem cell transplant patients. The drug will also be tested in separate late-stage studies in cytomegalovirus and adenovirus. About $98 million is planned for those Phase 3 tests.

Another $83 million is earmarked for Phase 2 tests of Viralym-M. Those tests will cover the prevention of multiple viral infections in stem cell transplant patients, treating BK virus infection in kidney transplant patients, and treating cytomegalovirus infections in solid organ transplant patients.

The IPO cash will also support two respiratory virus programs. ALVR106 is being developed to treat respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus. That VST is expected to start Phase 1 tests in the second half of this year. The other respiratory virus program, ALVR109, is in development as a treatment for infection by the novel coronavirus SARS-CoV-2. The company plans to advance that program to Phase 1/2 testing.

Image: iStock/Jay_Zynism

 

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Frank Vinluan is an Xconomy editor based in Research Triangle Park. You can reach him at fvinluan@xconomy.com. Follow @frankvinluan

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NeoImmuneTech Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients | Business

  • July 28, 2020

ROCKVILLE, Md.–(BUSINESS WIRE)–Jul 27, 2020–

NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the second study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment of COVID-19. The investigator-initiated Phase 1 trial is being conducted by Jian Li Campian, M.D., Ph.D. of Washington University School of Medicine, St. Louis. The trial is a multi-center, double-blind, randomized, placebo-controlled study that will evaluate the safety and efficacy of NT-I7 in adult COVID-19 patients.

IL-7 is an important growth factor for the immune system, the release of which induces the development, proliferation, and persistence of naïve and memory T cells. IL-7 has been shown to restore lymphocyte count, enhance anti-viral T cell response, reduce T cell exhaustion and death, and thereby potentially improve clinical outcomes in patients with COVID-19, where low lymphocyte count strongly correlates with poor prognosis. NT-I7 is the only clinical-stage long-acting IL-7, and has demonstrated in multiple clinical trials to restore lymphocyte count, including naïve and memory T cells, and exhibits a well-tolerated safety profile.

“Treatments that harness and enhance the immune system, helping it fight diseases such as cancer and infectious diseases, hold promise in treating a viral infection such as COVID-19, where the immune system is extremely burdened and exhausted,” said Dr. Campian. “As a T-cell amplifier, NT-I7 is designed to boost the adaptive immune response, which is crucial for the clearance of the virus in COVID-19. I look forward to evaluating this therapeutic candidate in patients with COVID-19.”

“Continuing on our mission to improve patient lives, NeoImmuneTech is very pleased to have received FDA clearance to begin a second trial studying NT-I7 as a potential immune enhancer for adult COVID-19 patients. The two trials will complement each other and speed up enrollment as well as increase the number of patients,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “Since lymphopenia is a hallmark of COVID-19, patients with weakened immune systems are at particularly high risk for a serious infection of COVID-19, and subsequently have unfavorable clinical outcomes, including death. NeoImmuneTech hopes that NT-I7 could help to prevent the progression to severe COVID-19 and ultimately improve clinical outcomes for patients affected by this pandemic.”

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T-cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20200727005123/en/

CONTACT: MacDougall

Shai Biran, Ph.D.

781-235-3060

sbiran@macbiocom.com

KEYWORD: MARYLAND UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH FDA INFECTIOUS DISEASES GENERAL HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: NeoImmuneTech, Inc.

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California Cherry Harvest Signals A Sweet Way to Boost Your Mood | Coronavirus

NeoImmuneTech Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients | Coronavirus

  • July 27, 2020

ROCKVILLE, Md.–(BUSINESS WIRE)–Jul 27, 2020–

NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the second study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment of COVID-19. The investigator-initiated Phase 1 trial is being conducted by Jian Li Campian, M.D., Ph.D. of Washington University School of Medicine, St. Louis. The trial is a multi-center, double-blind, randomized, placebo-controlled study that will evaluate the safety and efficacy of NT-I7 in adult COVID-19 patients.

IL-7 is an important growth factor for the immune system, the release of which induces the development, proliferation, and persistence of naïve and memory T cells. IL-7 has been shown to restore lymphocyte count, enhance anti-viral T cell response, reduce T cell exhaustion and death, and thereby potentially improve clinical outcomes in patients with COVID-19, where low lymphocyte count strongly correlates with poor prognosis. NT-I7 is the only clinical-stage long-acting IL-7, and has demonstrated in multiple clinical trials to restore lymphocyte count, including naïve and memory T cells, and exhibits a well-tolerated safety profile.

“Treatments that harness and enhance the immune system, helping it fight diseases such as cancer and infectious diseases, hold promise in treating a viral infection such as COVID-19, where the immune system is extremely burdened and exhausted,” said Dr. Campian. “As a T-cell amplifier, NT-I7 is designed to boost the adaptive immune response, which is crucial for the clearance of the virus in COVID-19. I look forward to evaluating this therapeutic candidate in patients with COVID-19.”

“Continuing on our mission to improve patient lives, NeoImmuneTech is very pleased to have received FDA clearance to begin a second trial studying NT-I7 as a potential immune enhancer for adult COVID-19 patients. The two trials will complement each other and speed up enrollment as well as increase the number of patients,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “Since lymphopenia is a hallmark of COVID-19, patients with weakened immune systems are at particularly high risk for a serious infection of COVID-19, and subsequently have unfavorable clinical outcomes, including death. NeoImmuneTech hopes that NT-I7 could help to prevent the progression to severe COVID-19 and ultimately improve clinical outcomes for patients affected by this pandemic.”

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T-cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20200727005123/en/

CONTACT: MacDougall

Shai Biran, Ph.D.

781-235-3060

sbiran@macbiocom.com

KEYWORD: MARYLAND UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH FDA INFECTIOUS DISEASES GENERAL HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: NeoImmuneTech, Inc.

Copyright Business Wire 2020.

PUB: 07/27/2020 07:00 AM/DISC: 07/27/2020 07:00 AM

http://www.businesswire.com/news/home/20200727005123/en

Copyright Business Wire 2020.

NeoImmuneTech Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients

NeoImmuneTech Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients

  • July 27, 2020

ROCKVILLE, Md.–()–NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the second study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, for the treatment of COVID-19. The investigator-initiated Phase 1 trial is being conducted by Jian Li Campian, M.D., Ph.D. of Washington University School of Medicine, St. Louis. The trial is a multi-center, double-blind, randomized, placebo-controlled study that will evaluate the safety and efficacy of NT-I7 in adult COVID-19 patients.

IL-7 is an important growth factor for the immune system, the release of which induces the development, proliferation, and persistence of naïve and memory T cells. IL-7 has been shown to restore lymphocyte count, enhance anti-viral T cell response, reduce T cell exhaustion and death, and thereby potentially improve clinical outcomes in patients with COVID-19, where low lymphocyte count strongly correlates with poor prognosis. NT-I7 is the only clinical-stage long-acting IL-7, and has demonstrated in multiple clinical trials to restore lymphocyte count, including naïve and memory T cells, and exhibits a well-tolerated safety profile.

“Treatments that harness and enhance the immune system, helping it fight diseases such as cancer and infectious diseases, hold promise in treating a viral infection such as COVID-19, where the immune system is extremely burdened and exhausted,” said Dr. Campian. “As a T-cell amplifier, NT-I7 is designed to boost the adaptive immune response, which is crucial for the clearance of the virus in COVID-19. I look forward to evaluating this therapeutic candidate in patients with COVID-19.”

“Continuing on our mission to improve patient lives, NeoImmuneTech is very pleased to have received FDA clearance to begin a second trial studying NT-I7 as a potential immune enhancer for adult COVID-19 patients. The two trials will complement each other and speed up enrollment as well as increase the number of patients,” said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “Since lymphopenia is a hallmark of COVID-19, patients with weakened immune systems are at particularly high risk for a serious infection of COVID-19, and subsequently have unfavorable clinical outcomes, including death. NeoImmuneTech hopes that NT-I7 could help to prevent the progression to severe COVID-19 and ultimately improve clinical outcomes for patients affected by this pandemic.”

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T-cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

Heart Attacks Boost Risk of Death in Breast Cancer Patients

Heart Attacks Boost Risk of Death in Breast Cancer Patients

  • July 23, 2020

Women with breast cancer who have also experienced a heart attack or other cardiac event are 60% more likely to die of the disease, a new study has revealed.

While previous research had shown that breast cancer patients are more likely to develop heart disease thanks to the toxic effects of chemotherapy and radiation on cellular health, this study is the first to establish a correlation between heart attacks and an increased risk of mortality from breast cancer, which one in eight American women will develop in their lifetime. 

A team of researchers led by Graeme Koelwyn, PhD, of New York University Robert I. Grossman School of Medicine found that of 1,700 women with early-stage breast cancer, those who experienced heart failure or a stroke or heart attack often had worse outcomes—recurrence, metastasis, death—than those who did not. 

How might cardiovascular disease hasten the progression of breast cancer? The researchers point to an animal study that demonstrated that heart attacks trigger an immune cell-crippling autoimmune reaction, allowing cancer to spread unchecked throughout the body. 

“By blunting the immune system’s assault on cancer cells, a heart attack appears to provide an environment that enables tumor growth,” said coauthor Kathryn Moore, PhD, director of the cardiovascular research center at NYU Langone Health, though she cautions that further study of the relationship between cardiovascular disease and cancer is needed. 

To induce nondeadly heart attacks in mice that had had cancer cells implanted in their breast tissue, the researchers “ligated,” or limited the blood flow to, their coronary arteries. Subsequent testing revealed a marked increase in the size of tumors that sported surface markers associated with rapid proliferation; a decrease in the function of immature monocytes, a type of white blood cell that can be found in the bone marrow and the bloodstream as well as in tumors; and changes in the expression of genes and proteins linked to the production of a heightened immune response. These effects were not seen in mice that had cancer but had normal blood flow to the coronary arteries, meaning that they could be safely attributed to the reduced cardiovascular function caused by the operation. 

Published in Nature Medicine last week, the results could potentially change the way breast cancer is treated, according to Koelwyn. “Given the evidence of cross-talk between cardiovascular disease and breast cancer,” he said, “measures that lower the risk for a cardiovascular event, such as exercise and treating high cholesterol and high blood pressure, warrant further study as potential ways to keep patients’ cancer from getting worse.”

For more on the connection between heart health and cancer, click here.


Coronavirus treatment reduces number of intensive care patients in clinical trial, biotech firm says

Coronavirus treatment reduces number of intensive care patients in clinical trial, biotech firm says

  • July 20, 2020

Alex Trebek is emotionally opening up, and sharing some more good news with fans, as he continues to fight pancreatic cancer.

The Jeopardy! host, who in 2019 was diagnosed with Stage 4 pancreatic cancer, spoke with Good Morning America on Monday about the “good days” and “bad days” he has experienced while undergoing treatment, describing recently feeling “like I want to die” and worrying that he’s a burden to his wife, Jean.

“I feel like I’m a terrible burden to her, and that bothers me tremendously,” Trebek said.

Trebek went on to choke up while discussing the support he’s received from his wife throughout his cancer battle, explaining that she has told him he’s not a burden and that she’s been a “saint.”

“She has so much goodness in her that she is always giving out, always putting out to help me get over difficult moments, and there have been some difficult moments,” Trebek said. “And I’m just in awe of the way she handles it.”

Trebek says that, should the current treatment he’s undergoing not succeed, he won’t go to any “extraordinary measures to ensure my survival,” as “if the quality of life is not there, it’s hard sometimes to push” and keep going. But after recently sharing with viewers that his treatment is “paying off,” Trebek told GMA that “I expect to be around” in February to mark two years since he was diagnosed, and his results show that he’s “going in the right direction.” Brendan Morrow


Ottawa-led clinical trial seeks to protect cancer patients from COVID-19

Ottawa-led clinical trial seeks to protect cancer patients from COVID-19

  • July 18, 2020


OTTAWA – July 16, 2020 – Dr. Rebecca Auer, surgical oncologist and director of cancer research at The Ottawa Hospital, will lead a $2.8-million clinical trial that seeks to protect cancer patients from COVID-19 by strengthening their depleted immune systems. If it proves successful, the immunotherapy approach could help many of the people most vulnerable to COVID-19. Photo courtesy of The Ottawa Hospital.

Postmedia

A surgical oncologist at The Ottawa Hospital will lead a $2.8 million Canada-wide clinical trial that seeks to protect cancer patients from COVID-19 by strengthening their depleted immune systems.

If it proves successful, the approach could help not only cancer patients, but anyone vulnerable to COVID-19 because of immune systems weakened by age or disease.

“We think harnessing innate immunity could be one of our best weapons for fighting COVID-19 — and could easily be adapted to tackle future pandemics,” said Dr. Rebecca Auer, director of cancer research at The Ottawa Hospital, and the study lead.

The clinical trial involves IMM-101, an immune-boosting biotherapeutic made with a heat-killed bacterium, Mycobacterium obuense, found in soil and water.

Developed as an immunotherapy cancer treatment, IMM-101 has demonstrated the ability to activate the body’s first line of defence, including the natural killer (NK) cells responsible for guarding against viral and bacterial infections. It has been safely used in other clinical trials with cancer patients.

“An effective vaccine against COVID-19 could take another year or more to develop, test, and implement,” said Auer, an associate professor at the University of Ottawa. “In the meantime, there is an urgent need to protect people with cancer from severe COVID-19 infection, and we think this immune stimulator, IMM-101, may be able to do this.”

The researchers hope that boosting cancer patients’ immune systems with IMM-101 will protect them from developing COVID-19 or other respiratory illnesses, such as the flu, that can force delays in their treatment.

Cancer patients are often vulnerable to infection because chemotherapy indiscriminately targets fast-dividing cells, whether cancer cells or immune cells. The cancer itself can also attack a patient’s bone marrow, where most immune cells are made.

More than 90,000 people in Ontario received chemotherapy or radiation treatments last year alone, and COVID-19 has greatly complicated their care.

The clinical trial, approved by Health Canada, is expected to launch later this summer. It will enrol 1,500 patients — including about 250 in Ottawa — at nine cancer centres across the country.

Patients in the study will be randomly assigned to two groups: One that receives regular care, and one that has IMM-101 added to it.

Those in the latter group will be given three doses of IMM-101 over the course of 45 days then carefully observed for COVID-19, other flu-like illnesses, and respiratory infections.

Researchers want to understand if patients who receive IMM-101 are less likely to develop such illnesses.

There’s considerable evidence to support the scientific theory on which the trial is built. Immune boosters have been successfully used for years in veterinary medicine to prevent the transmission of respiratory viruses in cattle, horses and other animals.

What’s more, clinical trials in Europe are now testing the ability of the BCG vaccine — a tuberculosis vaccine that contains a live, weakened strain of Mycobacterium bovis — to prime the immune system against COVID-19. Research has shown BCG can train the immune system to better fight all kinds of respiratory infections.

“It’s like sending your innate immune system to the gym for a while,” Auer explained. “So when it comes back to attack the next pathogen, it’s much stronger and better.”

Researchers believe that an individual’s innate immune system response helps to explain why some people get severely ill with COVID-19 while others have only mild symptoms.

Innate immune cells, such as NK cells, recognize and attack a broad spectrum of infectious agents based on their general characteristics. (Our second line of defence, known as the adaptive immune system, recognizes specific features of a bacterium or virus, and those that it has previously encountered.)

But BCG and other live vaccines can’t be given to cancer patients, so Auer and her colleagues looked for an alternative and found IMM-101. Even though it’s not a live vaccine, IMM-101 creates a response because the innate immune system recognizes it as a foreign invader.

Researchers from The Ottawa Hospital worked with the Canadian Cancer Trials Group at Queen’s University to design the clinical trial. 

Funding and support has also come from the Canadian Cancer Society, BioCanRx, the Ontario Institute for Cancer Research, The Ottawa Hospital Foundation, The Ottawa Hospital Academic Medical Organization, ATGen Canada/NKMax, a biotechnology company, and Immodulon Therapeutics, the manufacturer of IMM-101.

The clinical trial is expected to completed by the end of the year.

Auer warned that COVID-19 will not be the last pandemic.

“I imagine that if this trial was positive, this would be something you could have in your back pocket when the next pandemic came,” she said. “You’d be able to say, ‘We have something that works and can protect high risk people.’”

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Modi govt’s boost for Yoga! Ministry of Ayush deploys Yoga instructors for COVID-19 patients in Delhi

  • July 17, 2020
international yoga day, international yoga day 2020, 6th international yoga day, yoga, June 21 yoga celebrations, Dutch defence minister yoga dayBasavaraddi said that these instructors will teach patients yoga every morning for three hours.

Modi govt’s boost for Yoga! Once again, the Modi government has emphasized the importance of practicing old-age Yoga at a time when the country is reeling under the impact of the Coronavirus pandemic. This time, the government has taken initiatives to help Coronavirus infected patients. According to a statement by Ishwar V Basavaraddi, director, Morarji Desai National Institute of Yoga, Ministry of Ayush, the government has deployed as many as 30 Yoga instructors in COVID-19 centres that are being run by the Delhi government. Basavaraddi said that these instructors will teach patients yoga every morning for three hours. The decision has come as Yoga is known to benefit and strengthen the immune system of people, and strengthening the immune system is a necessity during these times as Coronavirus directly impacts the immune system of people.

Speaking at a webinar arranged by the Associated Chambers of Commerce and Industry of India (ASSOCHAM) and Savlon, Ishwar V Basavaraddi said that the Ministry has also undertaken yoga lessons for COVID-19 infected patients in the neighbouring 11 districts. Further, he added that around 500 applications from the Department of Science & Technology have also been sent to them asking the beneficial aspects of yoga, especially for Coronavirus patients. Because of this, he said that the Ministry has taken up three projects with renowned yoga institutes in order to arrive at findings and assess the benefits of Yoga among patients.

He added that the programme is also available for people who have come in contact with any Coronavirus positive patients within their families, or belong to police or medical professions.

Time and again, the Modi-led government has highlighted the need of practising Yoga and staying fit during the novel Coronavirus outbreak. Prime Minister Narendra Modi too, in an episode of Mann Ki Baat, has urged people to continue doing Yoga and “pranayam” at their houses in order to improve their mental health as well.

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OTTAWA - July 16, 2020 - Dr. Rebecca Auer, surgical oncologist and director of cancer research at The Ottawa Hospital, will lead a $2.8-million clinical trial that seeks to protect cancer patients from COVID-19 by strengthening their depleted immune systems. If it proves successful, the immunotherapy approach could help many of the people most vulnerable to COVID-19. Photo courtesy of The Ottawa Hospital.

Ottawa-led clinical trial seeks to protect cancer patients from COVID-19 | News

  • July 17, 2020

A surgical oncologist at The Ottawa Hospital will lead a $2.8 million Canada-wide clinical trial that seeks to protect cancer patients from COVID-19 by strengthening their depleted immune systems.

If it proves successful, the approach could help not only cancer patients, but anyone vulnerable to COVID-19 because of immune systems weakened by age or disease.

“We think harnessing innate immunity could be one of our best weapons for fighting COVID-19 — and could easily be adapted to tackle future pandemics,” said Dr. Rebecca Auer, director of cancer research at The Ottawa Hospital, and the study lead.


The clinical trial involves IMM-101, an immune-boosting biotherapeutic made with a heat-killed bacterium, Mycobacterium obuense, found in soil and water.


Developed as an immunotherapy cancer treatment, IMM-101 has demonstrated the ability to


activate the body’s first line of defence, including the natural killer (NK) cells responsible for guarding against viral and bacterial infections. It h

as been safely used in other clinical trials with cancer patients.


“An effective vaccine against COVID-19 could take another year or more to develop, test, and implement,” said Auer, an associate professor at the University of Ottawa. “In the meantime, there is an urgent need to protect people with cancer from severe COVID-19 infection, and we think this immune stimulator, IMM-101, may be able to do this.”


The researchers hope that boosting cancer patients’ immune systems with IMM-101 will protect them from developing COVID-19 or other respiratory illnesses, such as the flu, that can force delays in their treatment.

Cancer patients are often vulnerable to infection because chemotherapy indiscriminately targets fast-dividing cells, whether cancer cells or immune cells. The cancer itself can also attack a patient’s bone marrow, where most immune cells are made.

More than 90,000 people in Ontario received chemotherapy or radiation treatments last year alone, and COVID-19 has greatly complicated their care.

The clinical trial, approved by Health Canada, is expected to launch later this summer. It will enrol 1,500 patients — including about 250 in Ottawa — at nine cancer centres across the country.

Patients in the study will be randomly assigned to two groups: One that receives regular care, and one that has IMM-101 added to it.

Those in the latter group will be given three doses of IMM-101 over the course of 45 days then carefully observed for COVID-19, other flu-like illnesses, and respiratory infections.

Researchers want to understand if patients who receive IMM-101 are less likely to develop such illnesses.

There’s considerable evidence to support the scientific theory on which the trial is built.

Immune boosters have been


successfully used for years in veterinary medicine


to prevent the transmission of respiratory viruses in cattle, horses and other animals.

What’s more,

clinical trials in Europe

are now testing the ability of the BCG vaccine — a tuberculosis vaccine that contains a live, weakened strain of

Mycobacterium bovis —

to prime the immune system against COVID-19. Research has shown BCG can train the immune system to better fight all kinds of respiratory infections.

“It’s like sending your innate immune system to the gym for a while,” Auer explained. “So when it comes back to attack the next pathogen, it’s much stronger and better.”

Researchers believe that an individual’s innate immune system response helps to explain why some people get severely ill with COVID-19 while others have only mild symptoms.

Innate immune cells, such as NK cells, recognize and attack a broad spectrum of infectious agents based on their general characteristics. (Our second line of defence, known as the adaptive immune system, recognizes specific features of a bacterium or virus, and those that it has previously encountered.)

But BCG and other live vaccines can’t be given to cancer patients, so Auer and her colleagues looked for an alternative and found IMM-101. Even though it’s not a live vaccine, IMM-101 creates a response because the innate immune system recognizes it as a foreign invader.


Researchers from The Ottawa Hospital worked with the Canadian Cancer Trials Group at Queen’s University to design the clinical trial.


Funding and support has also come from the Canadian Cancer Society, BioCanRx, the Ontario Institute for Cancer Research, The Ottawa Hospital Foundation, The Ottawa Hospital Academic Medical Organization, ATGen Canada/NKMax, a biotechnology company, and Immodulon Therapeutics, the manufacturer of IMM-101.

The clinical trial is expected to completed by the end of the year.

Auer warned that COVID-19 will not be the last pandemic.

“I imagine that if this trial was positive, this would be something you could have in your back pocket when the next pandemic came,” she said. “You’d be able to say, ‘We have something that works and can protect high risk people.’”

Copyright Postmedia Network Inc., 2020

Too soon to say whether recovered COVID patients lose immunity with time: Scientists

Too soon to say whether recovered COVID patients lose immunity with time: Scientists : The Tribune India

  • July 17, 2020

New Delhi, July 17

Recent studies suggest that those recovering from COVID-19 may have antibodies for only a few months, a signal that long-term immunity is difficult to achieve, but several scientists dispel the gloom and say it is too soon to determine if such individuals can contract the disease again.

Some special cells of the immune system may still offer protection against the disease, the scientists said as questions swirl on whether people who have recovered from COVID-19 can get it again—even those whose antibodies dwindle progressively as the days and weeks pass.

It is too soon to say whether people with lowered levels of novel coronavirus-blocking antibody levels (nAbs) after recovery are at risk of contracting the COVID-19 disease on re-exposure to the virus, Vineeta Bal, an immunologist from the Indian Institute of Science, Education and Research in Pune, told PTI.

“This pandemic is only six-seven months old, and reports of people testing positive for the virus for a second time, post-recovery, are mostly only from those who were first infected in January,” Bal said in a video interview.

The discussion – and disquiet amongst laypersons following news of the pandemic – intensified when a yet-to-be peer-reviewed study, published in medRxiv last week, assessed 90 recovered COVID-19 patients in the UK and found their nAbs decreased between twofold and 23-fold during an 18-65 day follow-up period.

Another study, published last month in the journal Nature Medicine, surveyed the levels of antibodies in COVID-19 patients, including those who did not show symptoms, and revealed that nAbs lasted only two to three months after recovery. 

While reports of people testing positive for re-exposure to the virus emerge, it does not necessarily mean that those losing nAbs will develop the disease, said Bal, who was a member of the Prime Minister’s task force for women in science under the Ministry of Science and Technology.

It might take a year to get sufficient data to confirm this.

While antibody levels, as indicated by the two studies, may decrease in recovered individuals, other immune system players may still offer longer lasting immunity.

“Some reports say detectable T cells which may fight off infection and prevent the COVID-19 disease on re-exposure, can offer protection,” Bal said.

Commenting on the implications of the studies, immunologist Satyajit Rath from the National Institute of Immunology in New Delhi, said the findings are in line with how the human immune system interacts with coronaviruses such as those causing the common cold.

In Rath’s opinion, just like in other coronavirus infections, the more severe the COVID-19 disease, the higher the peak antibody levels’ in patients as well as the tendency of their nAb levels to go down in weeks-to-months.

Asymptomatic infected individuals make very little nAbs to begin with, and may both recover and be protected by non-antibody-based mechanisms, he explained in an email interview.

“There is also some evidence that virus-specific T cells are activated and expanded in infected people, and they too can plausibly provide accelerated recovery re-infection,” Rath said, adding a caveat that there is no direct evidence for such an actual causal relationship.

According to the immunologist, if antibodies do play a major role, the two studies could mean that long term immunity both individually, and for the population, may be difficult to achieve.

Under such a scenario, he said, people may periodically keep getting re-infected and the “virus may keep spreading around” until effective vaccines come into widespread use.

There is no good evidence yet about this, and it may or may not be the case, he said.

Another study, published in the journal Nature on Wednesday, also revealed the involvement of T cells.

The research, conducted by scientists from the Duke-Nus Medical School in Singapore, found that individuals infected with SARS-CoV-2, or the 2002-03 SARS pandemic virus, or other coronaviruses, develop memory T cells.

These coronavirus-specific T cells could last in the body for over 15 years after people recover from infection, and can still proliferate once they encounter a protein from that virus.

According to this study, patients who had recovered from the 2002-03 SARS virus 17 years ago still possess virus-specific memory T cells which cross-reacted with the current pandemic virus.

However, whether such pre-existing T cells affect the clinical manifestation of COVID-19 remains to be studied, said Nina Le Bert, a co-author of this study.

“However, if an individual already has memory T cells which recognise the new infection, the adaptive immune response could start earlier and may reduce the severity of COVID-19,” she told PTI over email, wanting for more studies to confirm this.

According to Le Bert, the immune system is complex, and the different cell types usually complement each other.

“I believe that both cellular and antibody immunity will be equally important,” she added.

Discussing the implications of the involvement of T cells in vaccine development, Bal said, “For a vaccine to be effective, it needs to generate reasonable concentration of nAbs and cytotoxic T cells.”

“Then they can kill viruses on re-exposure,” she said, adding that the combination makes “two components of a perfect vaccine”.

She cautioned that vaccines which rely more on cell mediated immunity may not be effective in every individual to the same extent, compared to those which boost an antibody response alone.

Bal explained that this is due to genetic diversity of the global human population.

“Human cells have surface proteins called HLA antigens which are different for every individual. So there is no way to trigger a cell mediated immune response in a universal vaccine that is generalisable to everyone,” she said. PTI

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