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June 29th, 2020

ReNeuron Signs Collaboration to Produce Human Neural Stem Cell (hNSC)-Derived Exosomes & to Load Them with Novel Gene-Silencing Therapeutics from Un-Named Collaborating US Biotech Company; ReNeuron Will Provide Loaded Exosomes to Collaborator

On June 25, 2020, ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, announced that it has signed a new research evaluation agreement with a major US biotechnology company in connection with the use of the ReNeuron’s proprietary exosomes for the delivery of novel gene-silencing therapeutics. This latest research collaboration will focus on the use of ReNeuron’s human neural stem cell (hNSC)-derived exosomes for the delivery of the US biotechnology company’s neuroscience therapeutic candidates. ReNeuron will be responsible for manufacturing exosomes and then loading them with the gene-silencing sequences after which the US biotechnology company will evaluate the loaded exosomes. Assuming positive results, the parties will jointly own the novel therapeutic candidate created for future development. The research evaluation agreement is in line with ReNeuron’s strategy of partnering its exosome technology as a novel delivery vehicle. This new agreement follows an exosome research collaboration with a major pharmaceutical company announced by ReNeuron on April 7, 2020 (http://www.reneuron.com/wp-content/uploads/RENE-Exosome-research-collabo...), reflecting the increasing level of industry interest in exosomes. ReNeuron has developed exosomes derived from hNSCs that have a natural ability to cross the blood-brain barrier and can thus be used to deliver therapeutics for diseases of the brain. The hNSC-derived exosomes can be produced through a fully-qualified, xeno-free, scalable process and the clinical-grade hNSC source cell-line ensures consistent exosome product.

37,000 Attendees Finish Up 3-Day American Association for Cancer Research (AACR) Virtual Annual MeetingII (June 22-24); All Meeting Presentations, Abstracts, and Other Materials Available Online Until September 23

[What follows is a brief report by BioQuick News Editor & Publisher Mike O’Neill on his experience virtually attending the live portion of the American Association for Cancer Research (AACR) 2020 Virtual Meeting II, with live sessions taking place July 22-24.] I just finished virtually attending much of the AACR Virtual Annual Mtg II (Mon-Wed, June 22-24). I even got in a few questions, including one on exosomes (see question at end of this note). The meeting had 37,000 registered attendees from 127 countries. Virtual attendees were rewarded with an incredible conference that included an opening day address by Nobel Prize winner Phillip Sharp and a closing day talk by a possible future Nobelist, NIH Director and former Genome Project leader Francis Collins. In his talk, Sharp mentioned that early in his career he had been recruited from Cold Spring Harbor Laboratory to MIT by Salvador Luria and David Baltimore. That put three future Nobelists in one lab. Not too bad. Collins described a number of COVID-19 efforts that are being undertaken currently by the NIH. His address from his NIH office was given in one of three COVID-19 sessions the AACR offered during this exceptional meeting. In his closing remarks, new AACR President Antoni Ribas noted that this fantastic meeting featured over 600 speakers, 125 sessions, 14 concurrent channels, and over 4,000 abstracts. All the meeting material will be available online to current and future registrants (registration is free) until September 23. Outgoing AACR President Elaine Mardis expressed her profound gratitude to everyone involved in the conference, including the major sponsor Daiichi-Sankyo, which had made it possible to offer the conference for free to registrants.

Unlike ApoE3, ApoE4 Disrupts the Neuroprotective Action of Sortilin In Neuronal Lipid Metabolism and Endocannabinoid Signaling; Results May Point to New Avenue for Development of Therapeutics for Alzheimer’s

Apolipoprotein E (ApoE) is like a delivery service for the human brain. It supplies neurons with important nutrients, including polyunsaturated fatty acids, which are building blocks of the membranes surrounding the neurons. In addition, certain unsaturated fatty acids are converted into so-called endocannabinoids. These are endogenous signaling molecules that regulate numerous functions of the nervous system, such as memory, but also the control of immune response, thereby protecting the brain from inflammation. The ApoE cargo reaches the neurons via a membrane receptor called sortilin. In a process known as endocytosis, sortilin binds ApoE and transports it into the interior of the neuron through invaginations of the cell membrane. The interaction of ApoE and sortilin has a major impact on our brain health: If not enough polyunsaturated fatty acids reach our gray cells, they begin to waste away and become susceptible to inflammatory responses. But not all ApoE is the same. There are three gene variants in humans: ApoE2, ApoE3, and ApoE4. They do not differ in their function of transporting lipids. The ability to bind to sortilin is also the same in all variants. However, people who carry the E4 variant have a twelve times greater risk of developing Alzheimer's than those with the E3 form. About 15 percent of people carry ApoE4. "Why ApoE4 significantly increases the risk of Alzheimer's is one of the central questions in Alzheimer's research," says Professor Thomas Willnow, PhD, Head of the Molecular Cardiovascular Research Lab at Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) in Germany, who for many years has been studying the development of neurodegenerative diseases.

CytoDyn and NIH of Mexico Complete Memorandum of Understanding (MOU) to Conduct Small COVID-19 Phase 3 Trial for Severe and Critically Ill Patients

On June 29, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the company and the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) have entered into a Memorandum of Understanding (MOU) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country. The MOU provides that CytoDyn will supply leronlimab at its expense to the NIH and both parties are proceeding forward expeditiously to complete the mutually agreed protocol for this clinical trial. Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, commented: “We are very pleased with the confidence demonstrated by the NIH of Mexico in our drug, leronlimab, and we are both very motivated to initiate this trial quickly to help mitigate the devastation of the COVID-19 pandemic on the citizens of Mexico. The anecdotal data received by CytoDyn (from over 70 COVID-19 critical patients who were treated under EIND in the U.S.) has impressed the NIH of Mexico and we believe with a small Phase 3 trial of only 25 patients, leronlimab could receive approval in Mexico very quickly. This Phase 3 trial is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.” CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.

June 28th

Age-Related Decline in Eyesight May Be Significantly Improved by Staring at Long-Wavelength Red Light for 3 Minutes Each Day; In Small Study, Color & Night Vision Were Both Improved by Simple Approach That Re-Energizes Retinal Mitochondria

Staring at a deep red light for three minutes a day can significantly improve declining eyesight, finds a new University College of London (UCL)-led study, the first of its kind in humans. Scientists believe the discovery, published online on June 29, 2020 in The Journals of Gerontology, Series A, could signal the dawn of new, affordable, home-based eye therapies, helping the millions of people globally with naturally declining vision. The article is titled “Optically Improved Mitochondrial Function Redeems Aged Human Visual Decline.” In the UK, there are currently presently 12 million people aged over 65: in 50 years, this will increase to approximatley 20 million and all will have some degree of visual decline because of retinal aging. Lead author, Professor Glen Jeffery, PhD, UCL Institute of Ophthalmology, said: "As you age your visual system declines significantly, particularly once over 40. Your retinal sensitivity and your color vision are both gradually undermined, and with an aging population, this is an increasingly important issue. To try to stem or reverse this decline, we sought to reboot the retina's aging cells with short bursts of longwave light."In humans around 40 years-old, cells in the eye's retina begin to age, and the pace of this aging is caused, in part, when the cell's mitochondria, whose role is to produce energy (known as ATP) and boost cell function, also start to decline. Mitochondrial density is greatest in the retina's photoreceptor cells, which have high energy demands. As a result, the retina ages faster than other organs, with a 70% ATP reduction over life, causing a significant decline in photoreceptor function as these receptors lack the energy to perform their normal role.

Australia Announces $1.5 M Grant to Expand Trial of Breakthrough Treatment for Patients with Paralysis; Stentrode™ Is Fully Implantable Therapeutic Device That Interacts with Nervous System from Inside a Blood Vessel to Translate Brain Commands

The University of Melbourne and the Royal Melbourne Hospital have welcomed a $1.48 million Australia Federal Government grant that will expand a world first-in-human clinical trial of an implantable brain-computer interface designed to help Australians with upper limb paralysis restore functional independence. The Federal Minister for Health Greg Hunt made the announcement on Thursday morning, June 25, 2020. The feasibility trial which began last year is based on a device called The Stentrode™ (https://www.synchronmed.com/stentrode)--a fully implantable therapeutic device that interacts with the nervous system from inside a blood vessel to translate brain commands. The feasibility trial is being carried out collaboratively with the University’s licensed commercialization partner Synchron Australia Pty Limited (https://www.synchronmed.com/). It is intended that, through Synchron, the University’s research will be translated into patients worldwide. The device is inserted via the blood vessels as part of a neuro-interventional procedure performed at the Royal Melbourne Hospital. The implant enables patients to achieve hands-free control of operating systems such as Windows, by replacing the mouse and keyboard with thought-controlled command functions. The latest funding announcement by Minister Hunt will: increase the number of patients who can participate in the trial; include patients who experience paralysis due to conditions beyond motor neuron disease, also known as amyotrophic lateral sclerosis (these conditions may include muscular dystrophy, stroke, and spinal cord injury; and expand the trial to the Royal Prince Alfred Hospital in Sydney and the Royal Brisbane and Women’s Hospital.

Exosomes, Pyknons, p53, miRNA, Cancer Progression, & Noam Chomsky; All Are Featured in Great Talk by MD Anderson Physician/Scientist at American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting II (July 22-24)

[What follows is a brief report by BioQuick News Editor & Publisher Mike O’Neill on one of the many fascinating and stimulating presentations delivered during the American Association for Cancer Research (AACR) Virtual Meeting II, with live sessions taking place July 22-24.] I just finished listening to a fantastic talk by George A. Calin, MD, PhD (https://aacr20vm2.onlineeventpro.freeman.com/speakers/gcalin~mdanderson....) at the AACR Virtual Meeting today (Tuesday, June 23). I was in my home living room watching and listening to the live presentation on my computer as were many of the other 37,000 virtual attendees of this rightly-fabled conference that, until this year, has always been done all in person. Dr. Calin’s presentation was one of four talks in Tuesday’s early afternoon session on "Non-Coding RNA in Cancer Progression." I picked that session, hoping to learn a little more and maybe pick up one or two good stories. I got much more than I had bargained for. I got to hear Dr. Calin (Co-Director, RNA Interference and Non-Coding RNA Center, The University of Texas MD Anderson Cancer Center) deliver his address entitled “About Chomsky, Patterns, Noncoding RNAs, and Cancer Patients.” I was mesmerized as a very enthusiastic Dr. Calin told us that "loss of TP53 drives miRNA-dependent peripheral neuron reprogramming in cancers through exosomal miR-34." He also mentioned that elephants have 20 copies of the TP53 tumor suppressor gene (we have just one copy of this gene) and gave us a little lesson on pyknons (https://www.sciencedirect.com/science/article/pii/S0092867406006301), a form of small RNA that I had never heard of before. Dr.

Tongue Microbes Provide Window to Heart Health; Recent Results Suggest These Easily-Obtained Microorganisms Might Assist with Wide-Scale Screening, Diagnosis, and Long-Term Monitoring of Heart Failure

Microorganisms on the tongue could help diagnose heart failure, according to research presented on June 23, 2020 on HFA (Heart Failure Association) Discoveries (https://www.escardio.org/Sub-specialty-communities/Heart-Failure-Associa...), a scientific platform of the European Society of Cardiology (ESC). The abstract of the presentation is titled “Tongue Coating Microbiome Data Distinguish Patients with Chronic Heart Failure from Healthy.” “The tongues of patients with chronic heart failure look totally different from those of healthy people," said study author Tianhui Yuan, PhD, No. 1 Hospital of Guangzhou University of Chinese Medicine. "Normal tongues are pale red with a pale white coating. Heart failure patients have a redder tongue with a yellow coating and the appearance changes as the disease becomes more advanced. Our study (Tongue coating microbiome data distinguish patients with chronic heart failure from healthy) found that the composition, quantity, and dominant bacteria of the tongue coating differ between heart failure patients and healthy people," she said. Previous research has shown that microorganisms in the tongue coating could distinguish patients with pancreatic cancer from healthy people (https://pubmed.ncbi.nlm.nih.gov/30728915/). The authors of that study proposed this as an early marker to diagnose pancreatic cancer. And, because certain bacteria are linked with immunity, the authors suggested that the microbial imbalance could stimulate inflammation and disease. Inflammation and the immune response also play a role in heart failure. The current study investigated the composition of the tongue microbiome in participants with and without chronic heart failure.

Use of Lipophilic Statins Associated with 43% Lower Mortality from Ovarian Cancer; Use of Any Statin Associated with 40% Lower Mortality in Ovarian Cancer; Study Analyzed Data on 10,062 women Diagnosed with Ovarian Cancer

Lipophilic statins, a type of medication commonly prescribed to lower blood cholesterol, are associated with reduced mortality in patients with ovarian cancer, according to a study (https://www.abstractsonline.com/pp8/#!/9045/presentation/5297) presented on Monday, June 22, at the American Association for Cancer Research (AACR) Virtual Annual Meeting II (https://www.aacr.org/meeting/aacr-annual-meeting-2020/aacr-virtual-annua...), held online June 22-24. Ovarian cancer (https://www.aacr.org/professionals/blog/addressing-ovarian-cancers-uniqu...) is a rare cancer type, accounting for only about 1.2 percent of cancer cases diagnosed in the United States each year. It has a five-year survival rate of less than 50 percent, in part due to difficulty of diagnosis. “There are no proven screening strategies, so the disease is typically diagnosed at an advanced stage, when surgery is often not an option,” said Kala Visvanathan (photo), MD, MHS (https://www.hopkinsmedicine.org/profiles/results/directory/profile/00164...), Professor of Epidemiology and Oncology at the Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center in Baltimore. Approximately 28% of U.S. adults over age 40 routinely take statins for cholesterol control. Dr. Visvanathan said they are widely used in other countries as well. The few smaller studies that have evaluated statins and mortality in ovarian cancer patients have shown mixed results. The large sample size of this study of more than 10,000 women with ovarian cancer allowed researchers to evaluate different statin types and their impact on different subtypes of ovarian cancer.

AACR Recognizes Lisa A. Newman, MD, MPH, with 2020 AACR-Minorities in Cancer Research Jane Cooke Wright Lectureship, in Recognition of Contributions to ID of Biomarkers for Triple-Negative Breast Cancer in African-American and African Women

On June 17, 2020, the American Association for Cancer Research (AACR) announced that it is recognizing Lisa A. Newman, MD, MPH, with the 2020 AACR-Minorities in Cancer Research Jane Cooke Wright Lectureship. Dr. Newman is Chief of the Section of Breast Surgery at New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine in New York City, and Leader of the Multidisciplinary Breast Oncology Programs at the New York-Presbyterian David H. Koch Center. Dr. Newman is receiving this award in recognition of her significant contributions to the identification of biomarkers for triple-negative breast cancer (TNBC) in African-American and African women, and her dedication to mentoring students and trainees from groups traditionally underrepresented in medicine and research. The AACR-Minorities in Cancer Research Jane Cooke Wright Lectureship (https://www.aacr.org/awards/aacr-minorities-in-cancer-research-jane-cook...) was first presented in 2006. The lectureship is intended to recognize an outstanding scientist who has made meritorious contributions to the field of cancer research and who has, through leadership or by example, furthered the advancement of minority investigators in cancer research. Dr. Newman is a world-renowned expert in breast surgical oncology, whose exceptional body of research has significantly advanced the understanding of breast cancer risk and clinical outcomes in African and African-American women. To investigate the heterogeneity of breast cancer subtypes and to better understand the complex role of race and ethnicity in breast cancer risk, Dr. Newman formed an international collaboration with physicians and researchers in Ethiopia, Ghana, Nigeria, Uganda, Canada, and the Caribbean.