Category Archives: Gene Medicine

WASHINGTON, May 24, 2021 /PRNewswire/ --An article published in Experimental Biology and Medicine (Volume 246, Issue 10, May, 2021), describes a new treatment strategy for glioma.The study, led by Dr. Julun Yang, in the Department of Pathology at the 920th Hospital of the Joint Logistics Support Force of PLA in Kunming (China), reports that targeting RAS, a gene that promotes tumorigenesis in multiple cancers, enhances antitumor activity against glioma xenografts.

Gliomas are the most common type of central nervous system tumor in humans, with approximately 250,000 cases reported annually worldwide. Current treatment options include aggressive surgical resection, radiation therapy and chemotherapy.Nonetheless, the survival rate for patients is poor, and new treatments are needed.RAS genes play a critical role in regulating cell proliferation, differentiation, migration, apoptosis and senescence.Overexpression of and mutations in RAS genes promote tumorigenesis in numerous types of cancers, including gliomas.Nevertheless, there are no therapies targeting RAS approved for use in patients.

In the current study, Dr. Yang and colleagues used a gene therapy approach to deliver antibodies that inhibit RAS to glioma cells and tumors.Adenovirus delivery of a RAS antibody gene to glioma cells resulted in anti-RAS antibody expression, decreased growth and proliferation, and increased cell death.Intravenous delivery using cytokine-induced killer cells resulted in expression of high levels of RAS antibodies in tumors and low levels in normal organs.Furthermore, tumor volume was reduced and accompanied by decreased cell proliferation and expression of anti-apoptotic genes as well as increased cell death and expression of pro-apoptotic genes.Collectively, these results suggest that gene therapy targeting RAS may be a safe and effective treatment for glioma and other RAS-driven cancers.

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said, "Dr. Yang and colleagues have performed in vitro and in vivo studies that provide compelling evidence that the delivery of anti-p21Ras scFv by recombinant adenovirus and cytokine-induced killer cells may be an effective therapy against gliomas and, by extension, other Ras-driven cancers."

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit http://www.sebm.org. If you are interested in publishing in the journal, please visit http://ebm.sagepub.com.

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Using Gene-Therapy to Target RAS in Gliomas - PRNewswire

GenSight Biologics has reported the partial recovery of the vision of a retinitis pigmentosa patient treated with its mutation-independent approach to the restoration of visual function.

Spark Therapeutics, now part of Roche, won FDA approval for its retinitis pigmentosa gene therapy Luxturna in 2017. However, the approval only covered the use of Luxturna in patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. As retinitis pigmentosa is caused by changes to more than 70 genes, it is questionable whether mutation-specific approaches can cover all patients.

Recognizing that, GenSight is developing GS030, an optogenetic therapy. The drug component of the intervention consists of a viral vector designed to cause the expression of the light-sensitive opsin ChrimsonR in retinal ganglion cells.

In a phase 1/2 clinical trial, physicians administered the gene therapy via a single intravitreal injection to the worse-seeing eye of a 58-year-old man who was diagnosed with retinitis pigmentosa 40 years ago and was unable to detect objects visually. The patient was still unable to detect objects visually after the injection.

However, the patient could perceive, locate, count and touch different objects using his treated eye while wearing a pair of goggles. The goggles detect changes in light intensity and send pulses of light to the retina in real time, effectively amplifying the signal sent to the ChrimsonR-expressing cells.

Writing in Nature Medicine, the investigators said the patient is the first reported case of partial functional recovery in a neurodegenerative disease after optogenetic therapy. The claim is based on three visual tests, the last of which was performed five months after the others, that took place in an indoor laboratory, but there is also patient-reported evidence of real-world benefits.

The patient spontaneously reported identifying crosswalks and he could count the number of white stripes. Subsequently, the patient testified to a major improvement in daily visual activities, such as detecting a plate, mug or phone, finding a piece of furniture in a room or detecting a door in a corridor but only when using the goggles, the authors of the research paper wrote.

The paper only describes the experience of one patient, and the recovery in his vision was partial. GenSight recruited six patients across the first two cohorts of the dose-escalation trial before putting enrollment on hold in response to the pandemic. Enrollment in the third cohort is now complete, and GenSight expects to recruit an extension cohort that will get the optimal dose by the end of 2021.

A clearer picture of the efficacy of GS030 will emerge as GenSight shares data on other recipients of the treatment. Other companies are pursuing the same opportunity. Novartis, for example, bought optogenetic gene therapy startup Vedere Bio for $150 million upfront last year.

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GenSight's mutation-agnostic gene therapy triggers partial vision recovery - FierceBiotech

BOSTON, May 24, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced the appointment of leading experts in gene therapy, cochlear development and molecular genetics to its Scientific Advisory Board (SAB).

These additions to our SAB bring a deep understanding of the genetic roots of hearing loss and balance disorders, and we look forward to working closely with them as we progress our pipeline of gene therapies and regenerative medicines, said Joe Burns, Ph.D., Vice President, Discovery.

We value their insights and tremendous experience in the translational considerations for the development of gene therapies as Decibel works to address the vast unmet needs in hearing and balance disorders, said John Lee, Chief Development Officer.

Career summaries of the Scientific Advisory Board appointees:

Connie Cepko, Ph.D., is the Bullard Professor of Genetics and Neuroscience at Harvard Medical School and a Howard Hughes Medical Institute Investigator. She trained in virology with Dr. Phillip Sharp at MIT for a Ph.D., and later with Dr. Richard Mulligan at the MIT Whitehead Institute. She helped develop retroviral vectors for transduction into the central nervous system (CNS) for lineage analysis and for studies of gene function in vivo. Her laboratory has focused on the mechanisms of cell fate determination in the CNS with focus on retina through the analysis of progenitor and stem cells. More recently, she has been studying the mechanisms of photoreceptor death in diseases that cause blindness, such as retinitis pigmentosa and macular degeneration, and is developing gene therapies to avert photoreceptor death in order to prevent vision loss.

GuangpingGao, Ph.D.,is an internationally recognized researcher who played a key role in the discovery and characterization of a new family of adeno-associated virus (AAV) serotypes to advance the gene therapy field. He has published extensively in the field, with more than 300 papers, and holds more than 191 patents, with hundreds more pending. The Penelope Booth Rockwell Professor in Biomedical Research at the University of Massachusetts Medical School, Dr. Gao is an elected fellow of both the U.S. National Academy of Inventors and the American Academy of Microbiology. He is the Past President of the American Society of Gene and Cell Therapy. Dr. Gao co-founded Voyager Therapeutics, Adrenas Therapeutics and Aspa Therapeutics to develop AAV-based gene therapies for rare diseases.

Matthew Kelley, Ph.D., directs the Laboratory of Cochlear Development in the Intramural Program at the National Institute on Deafness and Other Communication Disorders, National Institutes of Health. A widely published and well-respected research scientist, he focuses on the cellular and molecular development of the mammalian cochlea. Dr. Kelley has long been an active member and is the past President of the Association for Research in Otolaryngology (ARO).

Glenn Pierce, M.D., Ph.D.,is Entrepreneur-in-Residence at Third Rock Ventures. He has 30 years of experience in drug discovery and developmentwith a particular focus on tissue regeneration, gene therapy and hematologyand has contributed to the development of six marketed products.As the former Chief Medical Officer, Hemophilia Therapeutic Area at Biogen, he led work culminating in multiple regulatory approvals for hemophilia therapeutics. Dr. Pierce has served in multiple leadership roles for the National Hemophilia Foundation as well as on advisory boards for the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services. He has co-authored more than 150 scientific papers and has received more than 15 patents. Dr. Pierce serves on the Boards of Directors of Global Blood Therapeutics and Voyager Therapeutics.

Dinah Sah, Ph.D., is an accomplished drug developer and R&D leader with over 25 years of experience in research and drug development in the biotechnology industry. Most recently, she was Chief Scientific Officer at Voyager Therapeutics, joining soon after its start in 2014. Prior to Voyager, Dr. Sah was Vice President of Research at Alnylam, overseeing many of the research programs during her seven-year tenure. She has successfully led multiple research and preclinical programs toward and into clinical development across new modalities, including the CNS-focused AAV programs at Voyager and the groundbreaking novel class of RNAi therapeutics developed at Alnylam.

About Decibel TherapeuticsDecibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibels pipeline, including its lead gene therapy program, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of a world in which the privileges of hearing and balance are available to all. For more information about Decibel Therapeutics, please visitwww.decibeltx.comor follow us onTwitter.

Investor Contact:Julie SeidelStern Investor Relations, Inc.julie.seidel@sternir.com212-362-1200

Media Contact:Chris RaileyTen Bridge CommunicationsChris@tenbridgecommunications.com617-834-0936

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Decibel Therapeutics Expands World-Class Scientific Advisory BoardAdds leaders with expertise in hearing loss and balance disorders, combined with...

PARIS--(BUSINESS WIRE)--Regulatory News:

GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the highly-regarded journal Nature Medicine has published the first case report of partial recovery of visual function in a blind patient with late stage retinitis pigmentosa (RP). The subject is a participant in the ongoing PIONEER Phase I/II clinical trial of GenSight Biologics GS030 optogenetic therapy. Published in the May issue under the title Partial recovery of visual function in a blind patient after optogenetic therapy, the paper* is the first peer-reviewed documentation of visual recovery after a blind patient was treated with optogenetic therapy.

These are truly groundbreaking findings that move the promise of optogenetics another step from therapeutic concept to clinical use, commented Bernard Gilly, Co-Founder and Chief Executive Officer of GenSight. These could not have occurred without the close collaboration we enjoyed with our partners at the Institut de la Vision, the Institute of Ophthalmology Basel and Streetlab. We are especially grateful to the patients who are participating in our trial, whose experiences and input will help us design the next stage of GS030s clinical development. We will now accelerate the GS030 program to make it our second product to reach the market after LUMEVOQ.

Optogenetic therapies combine cellular expression of light-sensitive opsins with light stimulation using a medical device. GS030 uses an optimized viral vector (GS030-DP) to express the light-sensitive opsin ChrimsonR in retinal ganglion cells and proprietary light-stimulating goggles (GS030-MD) to project the right wavelength and intensity of light onto the treated retina. GS030-DP is administered via an intravitreal injection.

It was breathtaking to witness the first recovery of some visual function in a blind patient, commented Dr. Botond Roska, MD, PhD, last and co-corresponding author and a pioneer in the field of optogenetic vision restoration. Dr. Roska is Founding Director of the Institute of Molecular and Clinical Ophthalmology Basel (IOB) in Switzerland and a Co-Founder of GenSight. We have worked on optogenetic therapy in the lab for 16 years and now seeing the proof of concept in a patient is a unique experience, he said. I am most grateful to have shared this long journey with Jos Sahel, a fellow founder of GenSight; the dedicated team at GenSight; and our other collaborators.

The subject in the case report, who had been diagnosed with RP 40 years prior to enrollment, had such low visual acuity that prior to receiving GS030, he could only perceive light. His gene therapy injection was followed four and a half months later by training on the use of the GS030-MD device. Seven months after the start of his training, he began to report signs of visual improvement. Visual function tests showed he acquired the ability to perceive, locate, count and touch objects when his treated eye was stimulated with the GS030-MD goggles. Without the goggles, he could not perform the tasks.

While the patient performed vision-oriented tasks, recordings were taken using extracranial multi-channel electroencephalography (EEG), a non-invasive technique that provides a readout of neuronal activity across the cortex. The EEG signals suggest that the act of carrying out the visual perception tests was accompanied by neurophysiological activity in the visual cortex.

In addition, the patient also reported significant improvements in his ability to conduct day-to-day activities such as navigating in outdoor and indoor environments and detecting household objects and furniture.

Watching a patient benefit for the first time from this trial using optogenetics to treat blindness has been a uniquely rewarding experience, commented Dr. Jos-Alain Sahel, MD, PhD, lead and co-corresponding author, Co-Founder of GenSight, and Founder of the Institut de la Vision (Sorbonne-Universit/Inserm/CNRS), Paris, France. Dr. Sahel is also Director of Institut Hospitalo-Universitaire FOReSIGHT, Paris, France, and Distinguished Professor and Chairman of the Department of Ophthalmology at the University of Pittsburgh School of Medicine and UPMC (University of Pittsburgh Medical Center), USA. He added, Being able to take part in bringing this new scientific approach to the clinic reflects the long-term collaboration with Botond Roska, the scientists of the Vision Institute, our clinicians, the Streetlab and psychophysics teams, and GenSight.

A video of the patient performing the tests, which was submitted as supplementary material to Nature Medicine, can be viewed at http://www.gensight-biologics.com.

Key Opinion Leader Webcast: June 4, 2021 at 2:00 PM CEST/8:00 AM EDT

Dr. Sahel and Dr. Roska will discuss the case report on a KOL webcast dedicated to Optogenetics and GS030 and hosted by GenSight Biologics.

Details will be announced at a later date.

Context

RP is the leading cause of inherited blindness and is caused by mutations in more than 71 different genes.a By using gene therapy to induce light sensitivity in unaffected retinal ganglion cells, GS030 overcomes the challenge among genetics-based treatments of exclusively addressing a specific underlying mutation and thus offers a treatment that is independent of the underlying pathogenic mutation.

PIONEER is the Phase I/II first-in-human, multi-center, open-label dose-escalation clinical trial to evaluate the safety and tolerability of GS030 in subjects with late-stage RP. A total of 12 to 18 subjects are planned to be enrolled. Three cohorts with three subjects each will be administered an increasing dose of GS030-DP via a single intravitreal injection in their worse-seeing eye. An extension cohort will receive the highest tolerated dose. A Data Safety Monitoring Board (DSMB) reviews the safety data of all treated subjects in each cohort and makes recommendations before the next cohort is enrolled. The primary outcome analysis will be the safety and tolerability at one year post-injection.

In line with the PIONEER protocol, the subject received the lowest dose (5.0E10 vector genomes) of GS030-DP in his worse-seeing eye. Four and a half months after injection, the patient began systematic training at Streetlab, a specialized visual rehabilitation facility, to learn how to use the light-stimulating goggles. The timing of the training was based on the estimated time it takes for the expression of light-sensitive opsin to stabilize in foveal ganglion cells.

Highlights of Visual Function Findings from Case Report

In the first visual test, the subject was asked to perceive, locate, and touch a single object placed in front of him on a white table. The subject had no success without the goggles. When the subjects treated eye was stimulated by the GS030-MD goggles, his ability to perceive, locate, and touch an object depended on the size of the object, with a significantly higher rate of successful trials with a large object (a notebook; 92%) than with the smaller object (a staple box; 36%). The success rate was similar for objects at different contrasts, suggesting that even objects at lower contrasts generated enough retinal activity for perception. Finally, the success rate was similar for the different tasks of perceiving, locating, and touching, suggesting that once the object was perceived, the patient could coordinate his motor system with the percept.

The second visual test required the subject to perceive, count, and locate two or three tumblers of different contrasts placed in front of him on a white table. As in the first test, the subject had no success without the goggles. When the subjects treated eye was stimulated by the GS030-MD goggles, the patient perceived, correctly counted, and located the objects in the majority (58-63%) of the trials. As in the first test, the success rate was similar for objects of different contrasts.

In the third visual test, the patient had to assess the presence or absence of a tumbler on a white table. The success rate with the goggles stimulating the treated eyes was statistically significantly higher than without the goggles (41% vs. 6%; p < 0.001).

Highlights of Safety Findings from Case Report

In-depth ocular examinations were performed regularly before and after injection, and potential intraocular inflammation was monitored according to international guidelines of the Standardization of Uveitis Nomenclature (SUN) Working Group.b Both eyes of the subject showed no intraocular inflammation and no changes in the anatomy of the retina; there were no ocular or systemic adverse events over the 84 weeks of assessment.

The subject tested the light-stimulating goggles three times before being injected with the gene therapy. On each of these occasions, he reported no change of vision or photophobia.

Detailed findings can be found at https://www.nature.com/articles/s41591-021-01351-4.

*About the paper:

Partial recovery of visual function in a blind patient after optogenetic therapy

Authors:

Jos-Alain Sahel1,2,3,4, Elise Boulanger-Scemama3,4, Chlo Pagot5, Angelo Arleo1, Francesco Galluppi6, Joseph N Martel2, Simona Degli Esposti7, Alexandre Delaux1, Jean-Baptiste de Saint Aubert1, Caroline de Montleau5, Emmanuel Gutman5, Isabelle Audo1,3, Jens Duebel1, Serge Picaud1, Deniz Dalkara1, Laure Blouin6, Magali Taiel6, Botond Roska8,9

Affiliations:

1 Sorbonne Universit, INSERM, CNRS, Institut de la Vision, Paris, France

2 Department of Ophthalmology, The University of Pittsburgh School of Medicine, Pittsburgh, USA

3 INSERM-Centre d'Investigation Clinique 1423, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France

4 Dpartement d'Ophtalmologie, Fondation Ophtalmologique Rothschild, Paris, France

5 Streetlab, Institut de la Vision, Paris, France

6 GenSight Biologics, Paris, France

7 NIHR Moorfields Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, United Kingdom

8 Institute of Molecular and Clinical Ophthalmology Basel, Basel, Switzerland

9 Department of Ophthalmology, University of Basel, Basel, Switzerland

References:

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics lead product candidate, LUMEVOQ (GS010; lenadogene nolparvovec), has been submitted for marketing approval in Europe for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens and young adults that leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About GS030

GS030 leverages GenSight Biololgics optogenetics technology platform, a novel approach to restore vision in blind patients using a combination of ocular gene therapy and tailored light-activation of treated retinal cells. The gene therapy, which is delivered via a single intravitreal injection, introduces a gene encoding for a light-sensitive protein (ChrimsonR-tdT) into retinal ganglion cells, making them responsive to light and bypassing photoreceptors killed off by diseases such as retinitis pigmentosa (RP). Because ChrimsonR-tdT is activated by high intensities of amber light, a wearable medical device is needed to stimulate the treated retina. The optronic lightstimulating goggles (GS030-MD) encode the visual scene in real-time and project a light beam with a specific wavelength and intensity onto the treated retina. Treatment with GS030 requires patients to wear the external wearable device in order to enable restoration of their visual function. With the support of the Institut de la Vision in Paris and the team of Dr. Botond Roska at the Friedrich Miescher Institute in Basel, GenSight is investigating GS030 as therapy to restore vision in patients suffering from late-stage RP. GenSights optogenetics approach is independent of the specific genetic mutations causing blindness and has potential applications in other diseases of the retina in which photoreceptors degenerate, like dry agerelated macular degeneration (dry-AMD). GS030 has been granted Orphan Drug Designation in the United States and Europe.

About Optogenetics

Optogenetics is a biological technique that involves the transfer of a gene encoding for a light sensitive protein to cause neuronal cells to respond to light stimulation. As a neuromodulation method, it can be used to modify or control the activities of individual neurons in living tissue and even in-vivo, with a very high spatial and temporal resolution. Optogenetics combines (1) the use of gene therapy methods to transfer a gene into target neurons with (2) the use of optics and electronics (optronics) to deliver the light to the transduced cells. Optogenetics holds clinical promise in the field of vision impairment or degenerative neurological disorders.

About Retinitis Pigmentosa

Retinitis pigmentosa (RP) is a family of orphan genetic diseases caused by multiple mutations in numerous genes involved in the visual cycle. Over 100 genetic defects have been implicated. RP patients generally begin experiencing vision loss in their young adult years, with progression to blindness by age 40. RP is the most widespread hereditary cause of blindness in developed nations, with a prevalence of about 1.5 million people throughout the world. In Europe and the United States, about 350,000 to 400,000 patients suffer from RP, and every year between 15,000 and 20,000 new patients with RP lose sight. There is currently no curative treatment for RP.

About the PIONEER Phase I/II trial

PIONEER is a first-in-man, multi-center, open label dose-escalation study to evaluate the safety and tolerability of GS030 in 12-18 subjects with late-stage retinitis pigmentosa. GS030 combines a gene therapy (GS030-DP) administered via a single intravitreal injection with a wearable optronic visual stimulation device (GS030-MD). Eligible patients in the first three cohorts are those affected by end-stage non-syndromic RP with no light perception (NLP) or light perception (LP) levels of visual acuity. The extension cohort will include patients with hand motion (HM) and counting fingers (CF) levels of visual acuity.

As per protocol, three cohorts with three subjects each will be administered an increasing dose of GS030-DP via a single intravitreal injection in their worse-seeing eye. An extension cohort will receive the highest tolerated dose. The DSMB will review the safety data of all treated subjects in each cohort and will make recommendations before a new cohort receives the next dose. The primary outcome analyses will be on the safety and tolerability at one year post-injection. PIONEER is being conducted in three centers in the United Kingdom, France and the United States.

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GenSight Biologics Announces Nature Medicine Case Report Showing Visual Recovery after GS030 Optogenetic Treatment - Business Wire

MIAMI--(BUSINESS WIRE)--Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that the Company will be presenting at the annual meeting of the International Society of Cell and Gene Therapy (ISCT) taking place on May 26-28, 2021.

Organicells work, which was selected for an oral presentation, will be part of a session titled: "EVs for Infectious Diseases and Preparedness for Future Pandemics - ISCT-ISEV Joint Session and is scheduled to be broadcast live to program registrants on May 27th.

This presentation comes as a follow up to recently published case report studies demonstrating the investigation of Zofin in three severely ill COVID-19 patients. In these studies, results found the administration of Zofin to be associated with decreased levels of inflammatory biomarkers, such as CRP and IL6.

COVID-19 infection complications are, in part, the result of an excessive immune response with the over-production of pro-inflammatory cytokines such as IL6 and CRP. Therefore, the observation of reduced concentration of these biomarkers may indicate a positive trend towards recovery.

ISCT is the global steward fostering cell and gene therapy translation to the clinic. With a network of leading clinicians, regulators, researchers, technologists and industry partners, ISCT members have a shared vision to translate cell and gene therapies into safe and effective therapies to improve patients lives worldwide. For more information about the organization, please visit: isctglobal.org.

We are excited that our work was selected amongst other researchers investigating the therapeutic potential of extracellular vesicles for infectious disease of future pandemics, said Mari Mitrani, M.D., Ph.D., Chief Science Officer of Organicell.

About Zofin:

Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

ABOUT ORGANICELL REGENERATIVE MEDICINE, INC.

Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The Companys proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.

FORWARD-LOOKING STATEMENTS

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the Securities Act), the Securities Exchange Act of 1934, as amended (the Exchange Act), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as will, believes, expects, potential or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Companys periodic reports that are filed with the SEC and available on the SECs website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.

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Organicell To Present Results Of Zofin Clinical Studies At The International Society Of Cell And Gene Therapy Annual Meeting - Business Wire

"Cancer is a disease of genetics, yet clinical practice has struggled to keep pace with rapid advancements in research, particularly with respect to the role of germline genetics. Testing guidelines and medical policy often codify barriers, further lengthening the path to adoption of widespread testing and in some cases restricting access to precision therapies and clinical treatment trials," said Ed Esplin, M.D., Ph.D., FACMG, FACP, clinical geneticist at Invitae. "Research presented at ASCO shows that cancer-linked genetic changes are common across cancer types and when patients do receive germline testing, over two thirds of those with positive results are eligible for changes to their treatment plans. It's clear that incorporating germline testing alongside tumor profiling can help oncologists better tailor treatment for each patient."

Data from 250 pancreatic cancer patients from the landmark INTERCEPT study conducted at the Mayo Clinic found that nearly one in six patients with pancreatic cancer (n=38) showed cancer-linked genetic changes and, importantly, receiving germline testing was associated with improved survival.

A separate study of prostate cancer patients confirmed similar findings in other cancer types that limiting testing deprives patients and clinicians of actionable information. In the first-ever presentation of the PROCLAIM study, which was conducted primarily in community urology clinics, of patients diagnosed with prostate cancer, a significant number of cancer-linked variants were missed if testing was done based on NCCN guidelines. Of the 532 patients with clinician-reported data, nearly half, 45% (n=239), did not meet NCCN criteria. Overall, 59 patients had a cancer-linked variant; one in 10 of them did not meet the criteria (9.6%, n=23), and 12.3% (n=36) of patients met the criteria. When a 12-gene panel was used, only 29 patients were found to have a cancer-linked variant and one third of these patients were missed by guidelines.

A third study showed simply changing medical policy is not enough to drive changes in clinician adoption. In a review of two independent datasets, including commercially insured and Medicare Advantage enrollees, only 3% (n=1,675) of the 55,595 colorectal cancer patients received germline genetic testing, despite medical policy recommending germline genetic testing for all colorectal cancer patients (consistent with the INTERCEPT colorectal cancer study). Of the patients who received testing, 18% (n=143) had a cancer-linked variant and two thirds, or 67% (n=96), of those patients were potentially eligible for precision therapy and/or clinical trials.

"The data have been available for years that show knowing what changes patients have in their genes is beneficial to treating their cancer. Yet the oncology community has been slower to adopt germline testing than tumor profiling, for reasons that are not entirely clear. These data presented at ASCO highlight the need for oncologists to embrace germline genetic testing as routine practice for all cancer patients," said Robert Nussbaum, M.D., chief medical officer at Invitae. "A positive germline genetic result may enable patients to enroll in clinical trials or gain access to new precision medicines. And equally important, the discovery of an inherited variant can alert relatives to seek out earlier cancer screening, helping avoid later-stage diagnoses and offering a treatment benefit if cancer develops."

Invitae aims to help overcome obstacles to the adoption of genetic testing by providing physicians with clinical consults to help interpret results and reducing cost as a barrier to genetic information. Invitae also provides patients direct access to genetic counselors, helping to integrate routine genetic testing into patient care with GIA, a HIPAA-compliant chatbot. Family members are also able to receive no-charge genetic testing if a positive result is found.

Details of the 2021 ASCO presentations:

Oral Abstract Session: Prevention, Risk Reduction, and Hereditary Cancer

Poster Discussion Session: Prevention, Risk Reduction, and Hereditary Cancer

Poster Session: Prevention, Risk Reduction, and Hereditary Cancer

Poster Session: Gastrointestinal Cancer--GastroesophageaI, Pancreatic, and Hepatobiliary

About InvitaeInvitae Corporation(NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of germline testing and genetic information; and that the data presented at ASCO highlight the need for increased germline testing in all cancer patients regardless of medical policy. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Contact:Laura D'Angelo[emailprotected](628) 213-3283

SOURCE Invitae Corporation

http://www.invitae.com

Originally posted here:
Germline genetic testing can benefit all cancer patients as a routine practice in cancer care - PRNewswire