Oncologie Expands and Strengthens Management Team with Key Appointments and Promotions – GlobeNewswire

July 09, 2020 07:00 ET | Source: Oncologie, Inc.

-Appoints Matthew Osborne as Chief Financial Officer-

-Names Hagop Youssoufian, M.D., as Interim Chief Medical Officer-

-Hires Bill McDonald, Ph.D., as Vice President of CMC-

-Promotes Kerry Culm-Merdek, Ph.D., to Vice President of Clinical Development-

WALTHAM, Mass., July 09, 2020 (GLOBE NEWSWIRE) -- Oncologie, Inc., a precision medicine company using an innovative RNA-based biomarker platform to develop novel, targeted oncology therapies, today announced an expansion of its management team with the appointments of Matthew Osborne as Chief Financial Officer, Hagop Youssoufian, M.D., as Interim Chief Medical Officer, Bill McDonald, Ph.D., as Vice President of Chemistry, Manufacturing and Controls (CMC), as well as the promotion of Kerry Culm-Merdek, Ph.D., to Vice President of Clinical Development.

We are pleased to expand Oncologies management team with the additions of Matt, Hagop and Bill, and the promotion of Kerry, and look forward to their contributions, said Laura Benjamin, Ph.D., Founder and CEO of Oncologie. Their collective experience and leadership will be critical as we further develop and deploy our RNA-based biomarker platform to advance the state of the art of precision medicine to identify the right patients for our clinical stage programs, Navicixizumab and Bavituximab.

Mr. Osborne brings to Oncologie more than 20 years of leadership, financial and industry experience, gleaned from years on Wall Street and through professional roles with small to large cap biotechnology companies. In these roles, he successfully led multiple equity financings, applying his expertise across disciplines spanning scientific, financial, strategic planning, investor relations and corporate communications functions. Before joining the company in 2020, Mr. Osborne served as Chief Financial Officer at Unum Therapeutics, Inc. Prior to joining Unum Therapeutics, Mr. Osborne served as Head of Corporate Affairs, Communications and Investor Relations at Voyager Therapeutics, Inc., and through similar roles at Shire, Plc (acquired by Takeda Pharmaceutical Company in 2019), Synageva BioPharma Corp. (acquired by Alexion Pharmaceuticals, Inc. in 2015) and Vertex Pharmaceuticals Incorporated. Mr. Osbornes Wall Street experience includes serving as a sell-side analyst at Lazard Capital Markets and Leerink Swann (now SVB Leerink), where he covered small to large cap biotechnology companies, analyzed drug launches and launched several initial public offerings. He received a B.S. in Biology from Syracuse University and an M.B.A. from the DAmore-McKim School of Business at Northeastern University.

Dr. Youssoufian is a physician-scientist with more than 25 years of experience in drug development working with seed-stage ventures to multi-national biotech and pharmaceutical corporations. After a successful academic career as a clinician, teacher and NIH-funded investigator, he held increasingly senior roles in clinical and translational science including Head of Experimental Medicine at Bristol-Myers Squibb Company, Distinguished Scientist at Sanofi Aventis, Chief Medical Officer at ImClone Systems Incorporated, President of Research and Development and Chief Medical Officer at Ziopharm Oncology, Inc., Executive Vice President of Research and Development at Progenics Pharmaceuticals, Inc., and Chief Medical Officer at BIND Therapeutics, Inc. He supported or led the development and approval of a number of medicines including Sprycel, Taxotere, Erbitux, Cyramza, Lartruvo and Copiktra. He is an elected member of the American Society for Clinical Investigation, the recipient of many national and international awards, and the author of more than 100 publications. He received a B.S. in biology from Boston College and M.Sc./M.D. from University of Massachusetts Medical School, followed by fellowships at Johns Hopkins University, Harvard University and the Massachusetts Institute of Technology.

William Bill McDonald, Ph.D., brings more than 20 years of experience in process development and the manufacturing of antibodies, recombinant enzymes, antigens, antibody targets, viral vectors and vaccines. Prior to joining Oncologie, Bill served as Vice President, CMC at Contrafect Corporation where he was responsible for all CMC activities for Contrafects novel biologics platform of anti-microbial therapies. Previously, Bill served as Executive Director and Manufacturing Site Head at Celldex Therapeutics, Inc., where he oversaw the Fall River GMP manufacturing facility and was responsible for internal manufacturing of all early clinical stage biologics. Bill also held roles of increasing responsibility at Synageva BioPharma Corp. (acquired by Alexion Pharmaceuticals, Inc. in 2015), including Senior Director of Process Development. He also previously served as Head of Process Science at Pfizer, Inc., Director of Antigen Production at Genocea Biosciences Inc. and Director of Biochemistry at VaxInnate Corporation. Within the scope of technical operations, he has supported the development and manufacture of several approved biologics including Kanuma, Soliris and Strensiq. Bill received a B.S. in Microbiology from the University of Florida and received a Ph.D. in Molecular Biology at Cornell University.

Kerry Culm-Merdek, Ph.D., brings over 15 years of clinical drug development expertise and experience in small molecule and therapeutic protein development in rare disease and oncology indications including her role as Head of Clinical Pharmacology and Quantitative Bioanalytics at ImmunoGen Inc., where she was responsible for clinical pharmacology strategy for global clinical and preclinical development of oncology therapies. Prior to joining ImmunoGen, Kerry spent 13 years at Sanofi Genzyme, most recently serving as a Global Project Head, where she led the therapy project teams for Fabry disease, Gaucher disease type 3 and multiple gangliosidosis/galatosialidosis indications. Kerry received a B.S. in Biochemical Pharmacology from the State University of New York at Buffalo. She received a Ph.D. in Pharmacology and Experimental Therapeutics at Tufts University School of Medicine.

About Bavituximab

Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Oncologie is conducting a Phase 2 trial of bavituximab plus pembrolizumab as a second-line treatment in patients with advanced gastric or gastroesophageal cancer. Using its biomarker platform, Oncologie is analyzing patient tissue samples from this on-going trial with results expected later this year to inform future clinical development for this program.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody designed to inhibit both Delta-like ligand 4 (DLL4) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (VEGF) and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor activity across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. In a Phase 1a trial of 66 patients with various types of refractory solid tumors, treatment with single agent navicixizumab generated an overall response in three of 12 (25%) patients with ovarian cancer. In a Phase 1b trial in platinum-resistant ovarian cancer patients who had failed more than two prior therapies including bevacizumab, treatment with navicixizumab plus paclitaxel generated an interim overall response in 10 of 30 (33%) patients. Treatment-related adverse events in the Phase 1b trial were manageable and included hypertension (58%), headache (29%), fatigue (26%) and pulmonary hypertension (18%). Using its RNA-based biomarker platform, Oncologie is analyzing patient tissue samples from all navicixizumab trials with results expected later this year to inform future clinical development with this program. The FDA granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with bevacizumab.

About Oncologies RNA-based Biomarker Platform

Predictive biomarkers historically worked on single-driver mutations yet only approximately 10% of cancer patients have known driver mutations with available targeted therapies. Using its proprietary biomarker platform, Oncologie is advancing a new paradigm of precision oncology with an RNA-based approach to identify the dominant biology in the tumor microenvironment. This could improve clinical outcomes by matching patients to therapies with a mechanism of action that targets that specific biology and expand precision medicine to those therapies whose potential remains unrealized. Oncologie is further optimizing the biomarker platforms tumor microenvironment panel through multiple research collaborations, including a collaboration with Moffitt Cancer Center.

About Oncologie, Inc.

Oncologie, Inc. aims to advance the state of the art of precision medicine to dramatically improve the lives of people with cancer. Leveraging a deep understanding of the evolving biology of cancer, Oncologie is developing unique RNA-based biomarker panels to match patients to novel, targeted therapies that modulate the bodys tumor immune system and angiogenesis pathways. Oncologie, Inc., based in Waltham, Massachusetts, and Oncologie Shanghai Co., Ltd., based in Shanghai, China, are subsidiaries of Oncologie, Ltd., and are working with global partners to acquire and further develop innovative drugs for cancer patients around the world. For more information on Oncologie, Inc., please visit https://oncologie.com/.

Investor and Media Contact:

Ashley R. Robinson LifeSci Partners, LLC arr@lifesciadvisors.com

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Oncologie Expands and Strengthens Management Team with Key Appointments and Promotions - GlobeNewswire

Global Nicotine Addiction Treatment Market 2020 Business Outlook with Pandemic Scenario Analysis and Forecast 2026|Sosei Group Corporation, CV…

The global Nicotine Addiction Treatment Market and its growth prospects are influenced by a variety of factors. Through our report, we seek to inform the reader regarding the nature of the market, the factors that influence its growth as well as the key players involved. The reader is informed about the market variables in order to provide an understanding of the scope for business activities during the forecast period. The report begins with an evaluation of the current market status. The global Nicotine Addiction Treatment market has a current market valuation of Nicotine Addiction Treatment, and is projected to reach a market value of Nicotine Addiction Treatment by the end of the forecast period 2020 -2026. Our report estimates the CAGR growth that will take place by the end of the forecast period.

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High prevalence of tobacco products consumptions acts as a market driver

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Global Precision Cancer Therapies Market Briefing 2020, Trends, Applications, Types, Research, Forecast To 2025 – Red & Black Student Newspaper

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13 promising Covid-19 treatments emerging from Israel – The Yucatan Times

In parallel to vaccine research, theres an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus.

ISRAEL (Scientists across the globe are working on vaccines to prevent Covid-19 infection. After initial vaccines are approved, there is an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus.

Most potential treatments target the life-threatening lung inflammation typical of covid-19 severe cases. Its caused by a phenomenon called a cytokine storm.

Cytokines are proteins that trigger inflammation as a natural response to infection. In response to a virus overload, in this case, in the lungs, the immune system activates a storm of cytokines. Too many cytokines lead to too much inflammation, which can damage the lungs and cause respiratory distress.

Israeli hospitals were among the first anywhere to use dexamethasone, a steroid drug, to stop cytokines storms and reduce lung inflammation in severely ill Covid-19 patients. However, steroids can suppress the immune response too actively.

Additionally, an Israeli hospital is among the first to do a randomized, double-blind, placebo-controlled clinical trial of ivermectin, a drug to treat parasitic infections in people and animals, to see if it can shorten the duration of the disease if given to Covid-19 patients immediately after diagnosis.

Israelis are also formulating novel therapeutics of their own. Here are 13 potential Israeli treatments using a variety of approaches.

Pluristem On June 11, Pluristem Therapeutics of Haifa announced a multicenter Phase 2 US Food and Drug Administration (FDA) efficacy and safety study of its PLX-PAD cells for treating severe Covid-19 complicated by acute respiratory distress syndrome (ARDS).

PLX, an injected regenerative placenta-derived cell therapy, stimulates the immune systems natural regulatory T cells and M2 macrophages, possibly preventing or reversing a cytokine storm. PLX cells potentially reduce the incidence or severity of Covid-19 pneumonia and pneumonitis.

Pluristem has treated Covid-19 patients under compassionate use programs in the United States and Israel. Initial data from 18 patients showed that 75% were off mechanical ventilation within 28 days.

PLX cells are available off-the-shelf and once commercialized, can be manufactured in large-scale quantities, offering a key advantage in addressing a global pandemic, the company said.

Silkim Jerusalem-based Silkim Pharma recently submitted Coronzot, its novel treatment for Covid-19 patients with moderate to severe symptoms, to the FDAs Investigational New Drug (IND) program.

IND designation would give Silkim permission to start human clinical trials and ship Coronzot across state lines before a marketing application has been approved.

Coronzots novel mechanism targets a pivotal factor in cytokine storms. It removes an inflammatory overaccumulation of labile iron and replaces it with a minute amount of gallium or zinc.

This not only suppresses the storm but also inhibits viral proteins that attack the lungs and heart. Gallium inhibits virus replication and promotes apoptosis (self-destruction) of already invaded cells. Zinc helps suppress inflammatory reactions and enzymes that enable coronavirus replication.

The company is actively engaged in the FDA process. We look forward to finalizing the IND and then moving towards conducting clinical studies of Coronzot for Covid-19, said Silkim Pharma CEO Dror Chevion.

RedHill Biopharma RedHill Biopharma, based in Raleigh, North Carolina, and Tel Aviv, is racing to advance our development program with opaganib for Covid-19, according to a June 10 statement by Dr. Mark L. Levitt, RedHill medical director.

RedHill acquired opaganib from US-based Apogee Biotechnology, which developed this oral drug to fight cancer, inflammation, and viruses.

RedHill has seen encouraging preliminary findings from six Israeli Covid-19 patients given opaganib under compassionate use to reduce lung inflammation. All were weaned from supplemental oxygen and discharged from the hospital without having to receive mechanical ventilation.

RedHill plans a multicenter, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study on 270 US patients with severe Covid-19 pneumonia.

We are expanding the development program to Russia and additional European countries, parallel with the US clinical study, to accelerate the collection of robust data on the potential efficacy of opaganib against Covid-19, said Levitt.

The company is working with government agencies worldwide to allow more patients access to the investigational drug through clinical studies and compassionate use programs.

InnoCan InnoCan founders, from left, Ron Mayron, Iris Bincovich, Yoram Drucker. Photo by Rotem Lahav InnoCan Pharma Israel and Tel Aviv University tech-transfer company Ramot are collaborating to develop a new CBD-loaded exosome technology to fight lung inflammation.

Exosomes, small particles created from stem cells, can act as homing missiles targeting specific damaged organs and facilitating cell-to-cell communication.

Combining the cell-healing properties of exosomes with the anti-inflammatory properties of the cannabis-derived compound CBD is expected to have a strong synergetic effect. The treatment is administrated by inhalation.

Stero Biotechs Stero Biotechs of Bnei Brak has started a small clinical trial at Rabin Medical Center in Petah Tikva on the tolerability, safety, and efficacy of CBD-enhanced steroid treatment for hospitalized Covid-19 patients.

Steroid treatment is usually the first or second line of treatment for hospitalized patients. CBD enhances the therapeutic effect of steroid treatment and treats the bio-mechanism affected by the virus, the company explained.

Eybna and CannaSoul Two Israeli cannabis R & D firms, Eybna Technologies and CannaSoul Analytics, develop a proprietary terpene formulation for modulating cytokine storms.

Terpenes are organic compounds found in cannabis and other plants. Studies suggest they can be effective antiviral agents.

CannaSouls Cytokine Storm Assay (from its Myplant-Bio subsidiary) will aid in optimizing and customizing Eybnas novel NT-VRL inhaled formulation for treatment and prevention of viral infections in high-risk populations and actively ill patients.

The FDA considers this assay as a good predictor for cytokine storm response and immunotoxicity, and it is commonly required in the development of biological treatments, according to CannaSoul Chairman and CSO Prof. Dedi Meiri.

The NT-VRL formulation intended to be used via inhalation, said Eybna CEO Nadav Eyal. This delivery method dramatically increases the terpenes bioavailability by directly contacting the infected cells in the respiratory system.

CannaSoul aims to identify other cannabis molecules capable of suppressing a cytokine storm in response to Covid-19 without completely suppressing the immune system. It is also studying how cannabis molecules could modulate the ACE2 receptor, which allows the virus to inject its genetic expression into human cells.

Kamada Based in Rehovot, Kamada has begun supplying its experimental plasma-derived Hyperimmune IgG therapy for compassionate use in severe Covid-19 cases in Israel.

The treatment is based on plasma donated by recovered Israeli Covid-19 patients. One critically ill patient at Hadassah Medical Center showed initial improvement after having the experimental IgG therapy but ultimately did not survive.

During the third quarter of this year, Kamada expects to start a Phase 1/2 clinical study in hospitalized Covid-19 patients in Israel and hold a pre-IND meeting with the FDA to expand clinical development in the United States in partnership with Kedrion Biopharma.

Kedrion is collecting plasma from recovered American Covid-19 patients at 23 FDA-approved centers across the United States. This will be used by Kamada to manufacture additional batches of the product.

To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of Covid-19, said Kamada CEO Amir London.

Israel Institute for Biological Research The government-run Israel Institute for Biological Research (IIBR) announced in May that analogs of two drugs for Gauchers disease proved effective against SARS-CoV-2.

This drug cocktail is made up of the FDA-approved Cerdelga and an analog of the second drug in advanced stages of the approval process.

The IIBR study on cell cultures demonstrated that the two-drug treatment significantly reduced the coronaviruss replication capacity and the destruction of the infected cell. This potential treatment is currently being tested in animals infected with the coronavirus.

The IIRB also isolated several critical coronavirus antibodies that successfully neutralized aggressive coronavirus in lab tests. These could form the basis of future treatment following further testing.

Pepticom Based in Jerusalem, Pepticom computationally designs novel peptide drug candidates using artificial intelligence. The company raised $5 million last year.

Three months ago, Pepticom began implementing its proprietary AI technology on various coronavirus proteins to identify novel peptides that inhibit the interaction between the spike protein of SARS-Cov-2 and the ACE2 receptor thereby stopping the virus from entering the cell.

CEO Immanuel Lerner says three such proteins have already been identified and are being validated in the lab.

Using AI is a fast way to find these peptides, which are less expensive and easier to produce than antibodies, Lerner tells ISRAEL21c. Many parties are interested in looking at our results and finding ways to develop this further.

Bonus BioGroup In April, Bonus BioGroup initiated a preclinical study of MesenCure, its unique drug for treating acute and life-threatening respiratory distress in coronavirus and pneumonia patients.

MesenCure consists of activated mesenchymal stromal (stem) cells from healthy adult donors. The activation of these MSCs is intended to boost their ability to reduce lung inflammation, promote regeneration of the diseased lung tissue, and alleviate respiratory and other symptoms in the lungs.

The development of MesenCure relies on more than a decade of related experience and technologies that Bonus BioGroup has used in developing its lead product, a tissue-engineered bone graft, also based on MSCs.

With the current coronavirus outbreak, Bonus BioGroup has started tissue culture studies into the potential of these MSCs, further activated, to alleviate inflammation, including in the lungs, and possibly attenuate the cytokine storm in COVID-19 patients, the company explained.

The preclinical study in several animal models is expected to be completed in the third quarter of 2020. The company said preliminary results indicate that following the treatment with MesenCure, the microscopic appearance of the treated lungs was similar to a healthy lung, and a significant improvement in additional related parameters was achieved.

Bonus BioGroup presented these results to 1,800 scientists, physicians, and public opinion leaders at the International Society for Cell & Gene Therapy virtual conference in May.

NanoGhost Technion-Israel Institute of Technology Prof. Marcelle Machluf developed a drug-delivery technology that uses reconstructed mesenchymal stem cells as nano-vesicles to transport medicine directly to a target.

NanoGhost is the startup she established to commercialize the technology, which has proven successful in treating pancreatic, lung, breast, prostate, and brain cancer in mice. The NanoGhost technology has been patented in the United States and Europe, with additional patents pending in India and China.

Now, Machluf is adapting her technology to create decoy NanoGhosts that attract and entrap the coronavirus, making for a less severe infection. She explains it in the video below.

Enlivex Enlivex Therapeutics of Ness Ziona is developing Allocetra, a novel immunotherapy medication to treat organ dysfunction and acute multiple organ failure associated with sepsis and Covid-19, as well as solid tumors.

Allocetra rebalances a severely unbalanced immune system by engaging with the immune systems own regulation mechanisms. It is designed to restore a safe immune balance following a cytokine storm.

Enlivex is starting to recruit Covid-19 patients in Israel and in the United States to test the potential effect of Allocetra on moderate to severe cases. A patent from the Japan Patent Office is expected during the third quarter of 2020.

Weizmann Institute of Science Organic chemist Nir London of the Weizmann Institute of Science in Rehovot is co-leading a collaborative project to identify small molecules that can bind to and inhibit a protease enzyme that the SARS-CoV-2 virus needs to reproduce.

London and his research team had previously developed an advanced method for identifying potential inhibitors for numerous proteins.

So far, we have made close to 800 compounds and tested more than 650 and keep getting closer to sufficiently potent inhibitors, London tells ISRAEL21c.

These inhibitors will be further investigated for their potential as a starting point for new drugs against the coronavirus.

London is working with researchers from Oxford University, Memorial Sloan Kettering Cancer Center, University of British Columbia, and Californian-based biotech company.

The Yucatan Times Newsroom

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Surat: Engineer falls to death from tenth floor of under construction Covid hospital – The Indian Express

By: Express News Service | Surat | Published: July 10, 2020 8:50:59 pm He was immediately taken to the NCH trauma centre where doctors declared him dead on arrival.

A 56-year-old executive engineer fell down from the tenth floor of the Stem Cell Hospital at New Civil Hospital (NCH) in Surat, where work to convert the facility into a dedicated Covid hospital is in progress. It has not been established whether the engineer committed suicide or accidentally fell down, police said.

Jashwant Shihora (56), a resident of Parle Point area in Surat, who worked as an executive engineer at the electrical department of Project Implementation Unit, reached the Stem Cell Hospital at NCH on Friday morning, to conduct a routine check.

According to police sources, Jashwant had gone to the tenth floor alone and fell down under mysterious circumstances. The other labourers immediately gathered at the spot even as Jashwants head was profusely bleeding. He was immediately taken to the NCH trauma centre where doctors declared him dead on arrival.

Surat district collectorate officials along with Khatodara police had also reached the spot. The statements of a few engineers working there were taken and the police began a probe.

Khatodara police inspector KB Zala said, We have registered a case of accidental death and started a probe, It is difficult to say at this moment whether he had committed suicide or accidentally fallen down. He was alone at the topmost floor of the building. We are looking into all aspects.

In view of the rise in Covid-19 cases in Surat, Gujarat Chief Minister Vijay Rupani had arrived in the city on July 4 to take stock of the situation. While addressing media persons at the district collectors office, he had said, The Stem Cell Hospital building (600 beds) which at present is not being used, as some work is pending there, will be converted to a Covid hospital within a week. The Kidney Hospital building (700 beds) will also be converted into a dedicated Covid hospital.

Both buildings are located in the premises of the NCH campus and only their external structure has been made so far. Following the CMs announcement, district administrative officials had given contracts to three agencies to develop both hospitals.

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Global Stem Cell Therapy Market Outlook 2025: Top Companies, Trends, Growth Factors Details by Regions, Types and Applications – Owned

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Brazilian HIV patient cured: Can this be true? – Deutsche Welle

The Sao Paulo patient is a 36-year-old man who finished an antiretroviral therapy treatment to specifically address HIV/AIDS in March 2019. The news raises myriad questions in the scientific community. Additionally, the data are preliminary and the case is particularly compelling because, of the five people who received the treatment, only one has been cured.

Jrgen Rockstroh, professor and doctor of medicine and the head of the outpatient Clinic for Infectious Diseases and Immunology at the Center for Integrated Oncology at the University Clinic in Bonn, said: "These are exciting findings, but they're very preliminary. This has happened to one person, and one person only, but it did not succeed in four others given the same treatment. Clearly, reproducibility of the findings or confirmation in an additional individual would be important."

If the case were proven, it would be a monumental discovery. However, Brazilian scientists say the results are yet to be confirmed, and testing is ongoing.

Why is it so difficult to cure HIV?

HIV inserts its genetic material into the DNA of its target immune cell obliging the cell to form copies of the virus. In this way, the HIV integrates itself directly into the DNA and literally becomes part of its host's body. This makes the virus incredibly difficult to treat.

HIV hides in those cells residing dormant in them for years before it wakes up and causes acquired immunodeficiency syndrome (AIDS). Some scientists believe that the dormant stage is an evolutionary advantage to the virus. In the sites where HIV first enters the body, there are few immune cells to infect.

If the virus destroys all these few existing cells immediately after invasion, there will be no immune cells left to carry the infection to further cells. Rather, the HIV delays its activation until it is carried by those cells initially infected to tissues where it can infect even more cells.

This process ensures a better chance for the virus to spread. This dormant or latent stage can last up to 12 years. After the virus wakes up, the immune system weakens, and AIDS develops. A weakened immune system leaves the patient prone to mild infections that an otherwise healthy individual would likely not develop.

Only two people have been completely cured from HIV

Two patients in London and Berlin underwent a risky bone marrow transplant from a very particular donor, who was discovered to have a natural immunity to HIV. The bone marrow from this individual is immune to the virus due to a mutation in one of the receptors of the immune cells that HIV must be able to enter to successfully cause AIDs.

Before the stem-cell transplantation, doctors destroyed the immune cells carrying the HIV virus in their DNA from the Berlin patient's bone marrow. Later, the naturally mutated stem-cells from the donor were transplanted. The procedure is precarious and can result in life threating conditions, such as graft-versus-host disease, where the body rejects the transplant.

While long-term remission was achieved in these two patients, a bone marrow transplant is not a viable cure for all cases. These patients underwent this experimental treatment to address cancer diagnoses.

How is HIV treated?

Antiretrovirals hinder viral replication, as well as attachment to target cells. The purpose is to stop any viral activity and viral production. Currently, antiretroviral therapy can decrease the viral load in the body to an extent that the person is no longer infectious.

Read more:Stem cell transplants and HIV: What you need to know

If the viral load remains undetectable, one could have unprotected sex without infecting their partner. Moreover, HIV would not be transmitted from a mother to a child in this case. However, if the antiretroviral therapy is stopped, the control of virus replication ends.

The So Paulo patient received antiretrovirals. When asked whether it is possible to expect a complete elimination of a virus which integrates itself in the DNA by antiretroviral drugs, Dr. Rockstroh said, "numerous studies including intensified 3-drug therapy (including maraviroc and dolutegravir given to the Brazilian patient) even very early in HIV-infection were not able to achieve viral elimination or even decrease reservoir over time in multiple clinical trials."

Dr. Rockstroh explained that patients taking post-treatment controllers showed no signs of restarted viral replication for over one year after interrupting anti-retroviral therapy. However, the complete elimination of the virus has not been found in these patients.

How does the immune system react?

The physician added, "As each individual immune system reacts very differently and the spectrum of immune response ranges from rapid disease progression to elite controllers who have no signs of ongoing replication in plasma over years without treatment makes single cases very difficult to generalize from."

The So Paulo patient received a cocktail of antiretroviral drugs, including nicotinamide, a form of vitamin B3, which is thought to wake up the hidden virus and lure it out of its reservoirs. This is done to highlight infected cells for other drugs, so the immune system can kill the virus.

Dr. Rockstroh suggested the approach of virus activation could be significant in finding a functional cure for HIV. Whether this approach works or contributes to this specific case is still unknown.

Scientists are questioning the case and raising the concerns that the patient may have continued to take antiretroviral drugs without the knowledge of the study team. The team commented that they plan to check his blood for antiviral drugs to rule out this possibility.

What is also intriguing about the case is the loss of HIV antibodies. Dr. Rockstroh suggested that the weakening of the antibody test overtime is due to a diminishing immune response. However, the reasons for this remain unclear and require further testing.

Former South African president Thabo Mbeki (1999 - 2008) went down in history as the foremost African denier of AIDS. Against all scientific evidence he maintained that HIV did not cause AIDS. He instructed his health officials to combat the disease with herbal remedies. Experts believe his denialism cost up to 300,000 lives. Some have called for Mbeki to be tried for crimes against humanity.

In 2007 former Gambian president Yahya Jammeh (1996 - 2017) forced AIDS patients to undergo a cure that he had personally developed. It turned out to be a concoction based on herbs; an unknown number of people died. Jammeh, who claimed that he had mystic powers, is the first African head of state to be tried for violating the rights of HIV-positive people.

Another former South African head of state to make headlines for an unconventional take on AIDS was Jacob Zuma (2009 - 2018). After being charged with raping an HIV-positive woman in 2006, Zuma said he was not at risk of infection, despite not using a condom, because he had "taken a shower afterwards." In 2010 he disclosed the negative results of his AIDS test, to fight the stigma, he said.

Ugandas President Yoweri Museveni took his time before joining the fight against the epidemic. As late as 2004, during an international AIDS conference in Thailand, he downplayed the effectiveness of condoms, alleging, among other things, that they ran counter to some African sexual practices. "We dont think we can become universally condomised," he said. His remarks were met with laughter.

Some action taken by African heads of state to fight the scourge did not go down well at home. A tax introduced in 1999 by Zimbabwe's President Robert Mugabe (1987-2017) to help orphans and sufferers met with resistance. It is still in place today. In 2004 Mugabe admitted that his own family had been affected by AIDS. He said the disease was "one of the greatest challenges facing our nation."

Fear of economic repercussions affecting, for example, tourism, is one reason why African leaders have been reluctant to acknowledge the threat. But President Kenneth Kaunda of Zambia (1964-1991) announced as early as 1987 that one of his sons had died of AIDS. In 2002 he was the first African leader to take an AIDS test. He still fights against AIDS today.

The fight against AIDS by Kaundas successor Edgar Lungu met with some hitches when he tried to make AIDS-testing compulsory in Zambia. Lungu said in 2016 that the policy was non-negotiable. But a huge outcry in Zambia and abroad forced him to backpedal especially as the World Health Organization made clear that compulsion encourages the stigmatization of HIV-positive people.

After leaving office, Festus Mogae, former president of Botswana (1998-2008), launched Champions for an AIDS-Free Generation, which brings together a number of former African presidents and other influential personalities eager to help fight the scourge. They hope that their experience and influence will enable them to exert pressure on governments and partners to invest in AIDS prevention.

Author: Cristina Krippahl

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Brazilian HIV patient cured: Can this be true? - Deutsche Welle

COVID-19 Imparts Positive Impact on Stem Cell Therapy Market | 2020-2027 – Cole of Duty

The stem cell therapy marketwas valued at US$ 1,534.55 million in 2019 and is expected to grow at a CAGR of 16.7% from 2020to 2027 to reach US$ 5,129.66 million by 2027.

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The report profiles the key players in the industry, along with a detailed analysis of their individual positions against the global landscape. The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Stem Cell Therapy Market. The researcher provides an extensive analysis of the Stem Cell Therapy Market size, share, trends, overall earnings, gross revenue, and profit margin to accurately draw a forecast and provide expert insights to investors to keep them updated with the trends in the market.

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COVID-19 Imparts Positive Impact on Stem Cell Therapy Market | 2020-2027 - Cole of Duty

Gene therapy or immunotherapy: which approach is more likely to deliver a cure for HIV? – aidsmap

Amidst speculation that a five-drug antiretroviral regimen and nicotinamide might have cured HIV in one man, researchers debated whether gene therapy or immunotherapy is more likely to lead to an HIV cure that can be delivered to millions during the AIDS 2020 Cure pre-conference last week.

A cure for HIV could take two forms, either a treatment or procedure that can eradicate the virus from the body or one which can keep the virus under control without the need for antiretroviral drugs remission, in the parlance of the field.

Eradication of HIV is challenging because the virus inserts its DNA into long-lived cells in the body where it may lie dormant for decades - the so-called HIV reservoir. All this virus needs to be found, activated and purged, but presentations at AIDS 2020 show that the reservoir is more complex than previously assumed.

A unit of heredity, that determines a specific feature of the shape of a living organism. This genetic element is a sequence of DNA (or RNA, for viruses), located in a very specific place (locus) of a chromosome.

A type of experimental treatment in which foreign genetic material (DNA or RNA) is inserted into a person's cells to prevent or fight disease.

Use of immunologic agents such as antibodies, growth factors, and vaccines to modify (activate, enhance, or suppress) the immune system in order to treat disease. It is applied in the cancer field and in HIV research (attempts to eliminate the virus). Immunotherapy is also used to diminish adverse effects caused by some cancer treatments or to prevent rejection of a transplanted organ or tissue.

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a persons body, or permanently control the virus and render it unable to cause disease. A sterilising cure would completely eliminate the virus. A functional cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness.

The HIV reservoir is a group of cells that are infected with HIV but have not produced new HIV (latent stage of infection) for many months or years. Latent HIV reservoirs are established during the earliest stage of HIV infection. Although antiretroviral therapycan reduce the level of HIV in the blood to an undetectable level, latent reservoirs of HIV continue to survive (a phenomenon called residual inflammation). Latently infected cells may be reawakened to begin actively reproducing HIV virions if antiretroviral therapy is stopped.

HIV is distributed across numerous tissues in the body, not just cells in the blood or lymph nodes, an autopsy study by the US National Institutes for Allergy and Infectious Disease shows. Predicting which tissues are the most important reservoirs is difficult, as the small study showed big variation between individuals.

Furthermore, the normal work of CD4 memory cells activation and proliferation in response to pathogens inevitably leads to cloning of cells containing HIV DNA and an increase in intact HIV DNA capable of producing new virus over time, Bethany Horsburgh of Australias Centre for Virus Research at Westmead Institute for Medical Research reported.

Even very early antiretroviral treatment appears unable to halt the development of a reservoir that can sustain SIV infection in the body, Dr Henintsoa Rabazantahary of Canadas Universit Laval told the conference. Her macaque study began treating some animals four days after infection, underscoring how quickly an intractable reservoir is established.

These findings emphasise the importance of approaches to curing HIV that go beyond the `shock and kill` regimens designed to activate HIV-infected cells, which have shown disappointing results in clearing the reservoir.

Gene therapy to eradicate HIV or immunotherapy to contain HIV are being explored as potential approaches but which is more likely to be successful? Two leading cure researchers debated the merits of the approaches at a pre-conference HIV cure workshop last week.

Professor Sharon Lewin, Director of the Doherty Institute of Infection and Immunity at the University of Melbourne argues that gene therapy is more likely to deliver an HIV cure than immunotherapeutic approaches aimed at long-term remission of HIV. Proof of concept for a gene therapy approach already exists, she said, in the form of the Berlin and London patients, Timothy Brown and Adam Castellijo, who were cured of HIV after stem cell transplants from donors with the CCR5 delta 32 mutation that confers resistance to HIV infection of cells.

Gene therapy can be used against multiple targets to engineer protection against HIV infection of cells, to purge the virus from infected cells and enhance immune defences that attack HIV.

But the big challenge for gene therapy is to develop an approach that doesnt require cells to be taken out of the body for gene editing in the laboratory. Almost all gene therapy studies underway are using this 'ex vivo' approach, which harvests cells, edits them in the laboratory and then returns them to the patients body. Although the ex vivo approach has already been proved to work, both for HIV and cancer immunotherapy using CAR T-cells, its expensive and requires state of the art laboratory equipment.

The alternative, in vivo gene therapy, would require nanoparticles or a vector such as adenovirus to deliver the edited gene to cells. One study has already shown that its possible to achieve sustained production of a broadly neutralising antibody against HIV, VRC07, using an adenovirus vector to deliver an antibody gene.

Elimination of host stem cells, achieved in the cases of the Berlin and London patients through gruelling chemotherapy prior to bone marrow transplants, might soon be achievable through antibodies-drug conjugates that would target stem cells, Lewin suggested.

Professor John Frater of the University of Oxford sees immunotherapy as more likely to deliver long-term remission. He argued that gene therapy is still largely unproven in any field and the long-term safety of gene therapy is still unclear. In contrast, immunotherapies are already being used to treat cancers such as melanoma and lymphoma, as well as rheumatoid arthritis. Elite controllers of HIV, or long-term non-progressors, also offer evidence that the immune system can control HIV in some circumstances.

Immunity is the best machine you could imagine its had millions of years of R & D so we should use it and make the most of it, he said. Do not confuse the failure of vaccines so far as a red flag for immunotherapy. A vaccine needs to target a rapidly mutating, fast-replicating virus, whereas an immunotherapy targets a stable antigen that is less prone to mutate the cells in the HIV reservoir. We need to think of it more like a strategy for cancer than infection, he said.

Broadly neutralising antibodies represent one promising avenue of immunological research, along with therapeutic vaccination or anti-PD1 to activate exhausted host defences, Professor Miles Davenport of the Kirby Institute of Immunity & Infection, Australia, told a symposium on emerging cure strategies.

But he warned that we still dont understand how immune control relates to viral rebound and how much the HIV reservoir might need to be reduced to make immunological control of HIV viable. What might overcome this challenge, he suggested, would be gene therapy approaches that could render 90% of cells resistant to infection. Modelling by his research group suggest that this level of transduction of cells would dramatically limit viral rebound, permitting immunological control of HIV.

In summary, it may not be a question of choosing between gene therapy or immunotherapy, but using both approaches to achieve HIV remission.

References

Rabezanahary H et al. Contribution of monocytes and CD4 T cell subsets in maintaining viral reservoirs in SIV-infected macaques treated early after infection with antiretroviral drugs. 23rd International AIDS Conference abstract OA004, 2020.

Horsburgh H et al. Cell proliferation contributes to the increase of genetically intact HIV over time. 23rd International AIDS Conference abstract OA005, 2020.

Imamichi H et al. Multiple sanctuary sites for intact and defective HIV-1 in post-mortem tissues in individuals with suppressed HIV-1 replication: Implications for HIV-1 cure strategies. 23rd International AIDS Conference abstract 0A006, 2020.

S Lewin & J Frater. Gene therapy vs. immunotherapy: which is more likely to work? Debate. AIDS 2020 Virtual, HIV Cure pre-conference.

Davenport M. The promise of immunotherapy in HIV infection. AIDS 2020 Virtual symposium presentation, 'Pushing the boundaries: new approaches to a cure'.

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Gene therapy or immunotherapy: which approach is more likely to deliver a cure for HIV? - aidsmap

Takeda and the New York Academy of Sciences Announce 2020 Innovators in Science Award Winners – BusinessGhana

The 2020 award celebrates outstanding research in rare diseases Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502/NYSE:TAK) and the New York Academy of Sciences announced today the Winners of the third annual Innovators in Science Award for their excellence in and commitment to innovative science that has significantly advanced the field of rare disease research.

Each Winner receives a prize of US $200,000.

This press release features multimedia.

View the full release here: https://www.

businesswire.

com/news/home/20200708005039/en/ The 2020 Winner of the Senior Scientist Award is Adrian R.

Krainer, Ph.

D.

, St.

Giles Foundation Professor at Cold Spring Harbor Laboratory.

Prof.

Krainer is recognized for his outstanding research on the mechanisms and control of RNA splicing, a step in the normal process by which genetic information in DNA is converted into proteins.

Prof.

Krainer studies splicing defects in patients with spinal muscular atrophy (SMA), a devastating, inherited pediatric neuromuscular disorder caused by loss of motor neurons, resulting in progressive muscle atrophy and eventually, death.

Prof.

Krainers work culminated notably in the development of the first drug to be approved by global regulatory bodies that can delay and even prevent the onset of an inherited neurodegenerative disorder.

Collectively, rare diseases affect millions of families worldwide, who urgently need and deserve our help.

Im extremely honored to receive this recognition for research that my lab and our collaborators carried out to develop the first approved medicine for SMA, said Prof.

Krainer.

As basic researchers, we are driven by curiosity and get to experience the thrill of discovery; but when the fruits of our research can actually improve patients lives, everything else pales in comparison.

The 2020 Winner of the Early-Career Scientist Award is Jeong Ho Lee, M.

D.

, Ph.

D, Associate Professor, Korea Advanced Institute of Science and Technology (KAIST).

Prof.

Lee is recognized for his research investigating genetic mutations in stem cells in the brain that result in rare developmental brain disorders.

He was the first to identify the causes of intractable epilepsies and has identified the genes responsible for several developmental brain disorders, including focal cortical dysplasias, Joubert syndromea disorder characterized by an underdevelopment of the brainstemand hemimegalencephaly, which is the abnormal enlargement of one side of the brain.

Prof.

Lee also is the Director of the National Creative Research Initiative Center for Brain Somatic Mutations, and Co-founder and Chief Technology Officer of SoVarGen, a biopharmaceutical company aiming to discover novel therapeutics and diagnosis for intractable central nervous system (CNS) diseases caused by low-level somatic mutation.

It is a great honor to be recognized by a jury of such globally respected scientists whom I greatly admire, said Prof.

Lee.

More importantly, this award validates research into brain somatic mutations as an important area of exploration to help patients suffering from devastating and untreatable neurological disorders.

The 2020 Winners will be honored at the virtual Innovators in Science Award Ceremony and Symposium in October 2020.

This event provides an opportunity to engage with leading researchers, clinicians and prominent industry stakeholders from around the world about the latest breakthroughs in the scientific understanding and clinical treatment of genetic, nervous system, metabolic, autoimmune and cardiovascular rare diseases.

At Takeda, patients are our North Star and those with rare diseases are often underserved when it comes to the discovery and development of transformative medicines, said Andrew Plump, M.

D.

, Ph.

D.

, President, Research & Development at Takeda.

Insights from the ground-breaking research of scientists like Prof.

Krainer and Prof.

Lee can lead to pioneering approaches and the development of novel medicines that have the potential to change patients lives.

Thats why we are proud to join with the New York Academy of Sciences to broadly share and champion their workand hopefully propel this promising science forward.

Connecting science with the world to help address some of societys most pressing challenges is central to our mission, said Nicholas Dirks, Ph.

D.

, President and CEO, the New York Academy of Sciences.

In this third year of the Innovators in Science Award we are privileged to recognize two scientific leaders working to unlock the power of the genome to bring innovations that address the urgent needs of patients worldwide affected by rare diseases.

About the Innovators in Science Award The Innovators in Science Award grants two prizes of US $200,000 each year: one to an Early-Career Scientist and the other to a well-established Senior Scientist who have distinguished themselves for the creative thinking and impact of their research.

The Innovators in Science Award is a limited submission competition in which research universities, academic institutions, government or non-profit institutions, or equivalent from around the globe with a well-established record of scientific excellence are invited to nominate their most promising Early-Career Scientists and their most outstanding Senior Scientists working in one of four selected therapeutic fields of neuroscience, gastroenterology, oncology, and regenerative medicine.

Prize Winners are determined by a panel of judges, independently selected by the New York Academy of Sciences, with expertise in these disciplines.

The New York Academy of Sciences administers the Award in partnership with Takeda.

For more information please visit the Innovators in Science Award website.

About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines.

Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI).

We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.

takeda.

com.

About the New York Academy of Sciences The New York Academy of Sciences is an independent, not-for-profit organization that since 1817 has been committed to advancing science, technology, and society worldwide.

With more than 20,000 members in 100 countries around the world, the Academy is creating a global community of science for the benefit of humanity.

The Academy's core mission is to advance scientific knowledge, positively impact the major global challenges of society with science-based solutions and increase the number of scientifically informed individuals in society at large.

Please visit us online at www.

nyas.

org.

.

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Takeda and the New York Academy of Sciences Announce 2020 Innovators in Science Award Winners - BusinessGhana