StemCell Therapy

The American Society of Gene and Cell Therapy (ASCGT) annual meeting continues to see companies showcasing promising therapeutics for multiple disease indications. As the conference enters its fourth day, BioSpace takes a look at a few of the presentations.

Capsida Biotherapeutics

California-based Capsida showcased its therapeutic approach that the company believes will unlock the potential to treat both rare and common diseases across all ages.

Capsida shared its early generation AAV-engineered pilot programs, as well as results from its capsid engineering platform used to select adeno-associated virus 9 (AAV9)-based vectors for the treatment of diseases of the central nervous system. In its presentation, Capsida Chief Executive Officer Peter Anastasiou said the data demonstrate improved distribution throughout the cortical, subcortical, and deep brain regions at low doses via IV administration compared to invasive AAV9 dosing methods.

The company also included an oral presentation dubbed CAP-001: Systemic AAV Gene Therapy With Next-Generation Capsids for MPS II Disease. CAP-001 is a novel engineered capsid packaging a human iduronate-2-sulfatase (IDS) transgene. The company noted CAP-001 was selected for further characterization as a proof of concept to treat mucopolysaccharidosis type II (MPS II), or Hunter Syndrome, a lysosomal storage disorder.

When administered intravenously, results showed that CAP-001 achieved better biodistribution across the brain than AAV9 through other administered routes. It also provided a significantly more uniform distribution across all brain areas witha >50-fold improvement in subcortical and deep-brain regions, an area where ICM delivery has proven to poorly distribute.

Instill Bio

Texas-based Instil Bio showed off results of genomic and correlative analyses in a cohort of patients with metastatic melanoma treated with tumor-infiltrating lymphocytes (TIL). In its presentation this week, Instil showed a correlation between tumor response and clonal expansion of TILs.

Additionally, the company noted in its oral abstract that there is an inverse correlation between tumor response and specific T cell populations. Instil said that expression profiling and transcriptional network analysis points to what it called master regulator genes that can be manipulated during TIL manufacturing to enhance TIL activity.

We believe that TILs represent more than a potential therapy for patients, as they are also a platform to understand fundamental T cell biology, Bronson Crouch, chief executive officer of Instil Bio said in a statement. We are applying the recent advances in analytical technologies to deeply probe the function of TILs, and expect to generate insights that could be foundational for the development of anti-cancer therapies.

Adverum Biotechnologies

California-based Adverum presented data that further supports its Phase-II development plans for ADVM-022, a therapeutic candidate for wet age-related macular degeneration (wet AMD). Data presented shows results from non-human primate studies that support the companys planned 6 X 10^10 vg/eye (6E10) dose expected to be used in its next clinical trial.

Data highlights from the presentation show that the human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) demonstrated potential therapeutic levels in both aqueous humor and vitreous humor, the company said. Also, Adverum said the administration of the human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) was well tolerated. No adverse clinical signs were observed during the three-month study, the company added.

We are highly encouraged by the aflibercept expression levels and tolerability of the human equivalent dose of 6x10^10 vg/eye supported by our data in non-human primates, Richard Beckman, chief medical officer of Adverum Biotechnologies said in a statement. As we explore doses of 2x10^11 vg/eye and lower, we are excited by the potential of enhancing the safety profile while building on the robust response that ADVM-022 has demonstrated to date in wet AMD.

Metagenomi

Bay Area-based Metagenomi presented preclinical data on novel gene-editing systems that have shown extremely high editing efficiency in human primary immune cells and the ability to integrate at multiple, targeted sites. At ASGCT, the company made two presentations.

The first study, CRISPR-Associated Gene-Editing Systems Discovered in Metagenomic Samples Enable Efficient Genome Engineering in Multiple Primary Immune Cell Types, showcased Metagenomis CRISPR-associated gene editing systems ability to edit primary human cells with high efficiency, including T cells, natural killer cells, B cells, hematopoietic stem cells and induced pluripotent stem cells. The company said they reached an editing efficiency of more than 95%.

The second presentation, Active CRISPR-Associated Transposases from Natural Environments, showed off a novel family of proprietary CRISPR-associated transposase (CAST) gene-editing systems. CASTs

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Capsida, Adverum, Instil and Metagenomi Showcase Therapies at ASGCT - BioSpace

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

GenSight Biologics (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 of Neuro-Ophthalmology has published a qualitative study to explore the impact of Leber Hereditary Optic Neuropathy (LHON) on patients and their relatives. The study was featured in a paper published on the journals website last month titled, The Impact of Leber Hereditary Optic Neuropathy on the Quality of Life of Patients and Their Relatives: A Qualitative Study. It is the first of its kind to explore this condition and its impact for patients and relatives in four different countries.

The study determined that the impact of LHON extends beyond vision-related activity limitations, while addressing its psychosocial impact. It concluded that helping patients and their relatives adapt and cope with vision loss is vital. An accurate and timely diagnosis for patients is also crucial to address these issues and also to allow for early intervention.

This study is the first to describe the impact of LHON on the families of affected individuals. Partners and families of affected individuals take on many responsibilities and shoulder some of the burden of LHON. The impact that LHON has on partners and families has not been reported previously and it is vital that we acknowledge the support and care that they provide, explained Patrick Yu-Wai-Man, MD, PhD, Moorfields Eye Hospital and Department of Clinical Neurosciences, University of Cambridge, United Kingdom.

Participants reported feeling devastated by the diagnosis of LHON after a lengthy and worrisome diagnostic journey. They were also frustrated by the loss of autonomy that affected their relatives. Participants described challenges across several domains: physical capabilities, emotional well-being, interpersonal relationships, work and studies, finances, and recreational activities.

Additionally, the study determined that despite residing in different countries, LHON patients and their relatives described similar experiences in the four areas of focus in this study. These areas include (1) experience leading to the point of diagnosis; (2) impact of their condition on various aspects of life; (3) perceptions about treatment; and (4) expectations toward future therapies.

This study confirms what we have known all along in the eye clinic - that LHON impacts every aspect of quality of life, not just activities that rely on vision. Understanding how LHON affects individuals who develop vision loss enables doctors to intervene early and provide care that will improve the quality of life of affected individuals, commented Benson Chen, MD, Department of Clinical Neurosciences, University of Cambridge, United Kingdom. This might include different kinds of assessments in the eye clinic that measure the emotional and psychological impact of LHON or developing the referral pathways that enable affected individuals to access psychological support and work or skills re-training, he added.

LHON is an inherited mitochondrial disease characterized by severe bilateral vision loss and chronic visual impairment. The objective of this study was to comprehensively explore the impact of LHON on the lives of patients and their relatives at the time of diagnosis and now.

The qualitative study design encompassed eight focus group interviews conducted in France, Germany, the United Kingdom, and the United States, involving 17 individuals with m.11778G>A mutation and their relatives. Separate focus groups for patients and their relatives were facilitated by a moderator in French, German, or English. Neuro-ophthalmologists in the four countries who participated helped to identify additional patients who fulfilled under-represented sampling criteria. The four countries were selected because all have established networks of individuals with LHON and were places where previous LHON studies have been conducted.

Focus group interviews were conducted as part of a market research study sponsored by GenSight Biologics, and independently designed and conducted by groupH, a health care market research and analytics firm. The design and conduct of the study complied with the European Pharmaceutical Market Research Association and British Healthcare Business Intelligence Association guidelines.

We, at GenSight, have long been convinced that by providing an innovative therapeutic solution for LHON we would offer much more than an improved vision. Documenting the impact of LHON experienced by all study participants highlights the fact that we could empower patients and improve their ability to enjoy a fulfilling life, while easing the demands on their loved ones. This is precisely why we are dedicated to developing a long-lasting therapeutic solution for patients with LHON, explained Magali Taiel, Chief Medical Officer of GenSight. We are hopeful that we may one day help patients to recover not only their vision, but also their sense of autonomy and well-being, she added.

Full text versions of this article are available on the journals website: https://journals.lww.com/jneuro-ophthalmology/Abstract/9900/The_Impact_of_Leber_Hereditary_Optic_Neuropathy_on.77.aspx.

*About the paper:

The Impact of Leber Hereditary Optic Neuropathy on the Quality of Life of Patients and Their Relatives: A Qualitative Study

Authors: Benson S. Chen, MD, Erik Holzinger, MBA, Magali Taiel, MD, Patrick Yu-Wai-Man, MD, PhD

References: 1. Carelli V, Carbonelli M, de Coo IF, Kawasaki A, Klopstock T, Lagrze WA, La Morgia C, Newman NJ, Orssaud C, Pott JWR, Sadun AA, van Everdingen J, Vignal-Clermont C, Votruba M, Yu- Wai-Man P, Barboni P. International consensus statement on the clinical and therapeutic management of Leber hereditary optic neuropathy. J Neuroophthalmol. 2017;37:371381.2. Wallace DC, Singh G, Lott MT, Hodge JA, Schurr TG, Lezza AM, Elsas LJ II, Nikoskelainen EK. Mitochondrial DNA mutation associated with Lebers hereditary optic neuropathy. Science. 1988;242:14271430.3. Newman NJ, Carelli V, Taiel M, Yu-Wai-Man P. Visual outcomes in Leber hereditary optic neuropathy patients with the m.11778G.A (MTND4) mitochondrial DNA mutation. J Neuroophthalmol. 2020;40:547557.4. Yu-Wai-Man P, Newman NJ, Carelli V, La Morgia C, Biousse V, Bandello FM, Clermont CV, Campillo LC, Leruez S, Moster ML, Cestari DM, Foroozan R, Sadun A, Karanjia R, Jurkute N, Blouin L, Taiel M, Sahel JA; Group LRS. Natural history of patients with Leber hereditary optic neuropathy-results from the REALITY study. Eye (Lond). 2021 Apr 28 doi: https://doi.org/10.1038/ s41433-021-01535-9 (epub ahead of print).5. Braithwaite T, Calvert M, Gray A, Pesudovs K, Denniston AK. The use of patient-reported outcome research in modern ophthalmology: impact on clinical trials and routine clinical practice. Patient Relat Outcome Meas. 2019;10:924.6. Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD. National Eye Institute visual function questionnaire field test I. Development of the 25-item National Eye Institute visual function questionnaire. Arch Ophthalmol. 2001;119:10501058.7. Kirkman MA, Korsten A, Leonhardt M, Dimitriadis K, De Coo IF, Klopstock T, Griffiths PG, Hudson G, Chinnery PF, Yu-Wai-Man P. Quality of life in patients with Leber hereditary optic neuropathy. Invest Ophthalmol Vis Sci. 2009;50:31123115.8. Cui S, Jiang H, Peng J, Wang J, Zhang X. Evaluation of vision- related quality of life in Chinese patients with Leber hereditary optic neuropathy and the G11778A mutation. J Neuroophthalmol. 2019;39:5659.9. Gale J, Khoshnevis M, Frousiakis SE, Karanjia R, Poincenot L, Sadun AA, Baron DA. An international study of emotional response to bilateral vision loss using a novel graphical online assessment tool. Psychosomatics. 2017;58:3845.10. Garcia GA, Khoshnevis M, Gale J, Frousiakis SE, Hwang TJ, Poincenot L, Karanjia R, Baron D, Sadun AA. Profound vision loss impairs psychological well-being in young and middle-aged individuals. Clin Ophthalmol. 2017;11:417427.11. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi- disciplinary health research. BMC Med Res Methodol. 2013;13:117.12. Steinberg EP, Tielsch JM, Schein OD, Javitt JC, Sharkey P, Cassard SD, Legro MW, Diener-West M, Bass EB, Damiano AM, Steinwachs DM, Sommer A. The VF-14. An index of functional impairment in patients with cataract. Arch Ophthalmol. 1994;112:630638.13. Cohen JS, Biesecker BB. Quality of life in rare genetic conditions: a systematic review of the literature. Am J Med Genet A. 2010;152A:11361156.14. von der Lippe C, Diesen PS, Feragen KB. Living with a rare disorder: a systematic review of the qualitative literature. Mol Genet Genomic Med. 2017;5:758773.15. James CA, Hadley DW, Holtzman NA, Winkelstein JA. How does the mode of inheritance of a genetic condition influence families? A study of guilt, blame, stigma, and understanding of inheritance and reproductive risks in families with X-linked and autosomal recessive diseases. Genet Med. 2006;8:234242.16. Turriff A, Nolen R, DAmanda C, Biesecker B, Cukras C, Sieving PA. There are hills and valleys: experiences of parenting a son with X-linked retinoschisis. Am J Ophthalmol. 2020;212:98104.17. Nyumba TO, Wilson K, Derrick CJ, Mukherjee N. The use of focus group discussion methodology: insights from two decades of application in conservation. Methods Ecol Evol. 2018;9:2032.

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 Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of patients have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. The estimated incidence of LHON is approximately 800-1,200 new patients who lose their sight every year in the United States and the European Union.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220518006010/en/

Source: GenSight Biologics S.A.

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GenSight Biologics Announces Publication of a Study of the Impact of LHON Disease on the Lives of Patients and Relatives in Journal of...

Published on May 19, 2022

Hypertension or increased blood pressure may occur in Diabetics because of the impact of Diabetes on the walls of the arteries and the fluid balance. Hypertension may however co-exist as an independent risk factor along with Diabetes Mellitus. In either case, it can significantly increase the chances of developing heart conditions or conditions like stroke as well as the risk of developing other complications like renal or eye related conditions like nephropathy, retinopathy etc.

Consensus guidelines from the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, the American Diabetes Association (ADA) and the National Kidney Foundation (NKF) recommend a blood pressure goal of less than 130/80 mm Hg in patients with diabetes. Based on the recent survey report conducted by Indus Health Plus, it was found that 26% of the people tested had high blood pressure out of which 13% had systolic blood pressure above 140 mm Hg. The sample size of the report was 21000. Controlling hypertension is the key to reducing cardiovascular risk in patients with diabetes. It is an integral component of a comprehensive care plan that should include optimal management of diabetes and hyperlipidaemia, aspirin therapy, and lifestyle modifications.

How can Diabetes cause hypertension?

In diabetes, the body does not produce enough insulin so it does not work effectively, or they cannot process glucose. Insulin is a hormone that aids the body in converting glucose from food into energy. When a person has insulin issues, glucose cannot enter their cells to provide energy, so it accumulates in the bloodstream instead. In addition to causing widespread damage to tissues and organs, high blood glucose can also interfere with the control of blood pressure. Damage to the blood vessels and kidneys can increase blood pressure, for instance.

How can you prevent or control both Diabetes and Hypertension effectively?

Lifestyle modifications include following appropriate diet, engaging in 30 to 45 minutes of moderate-intensity activity most days of the week, avoiding smoking and alcohol. Appropriate medical treatment needs to be followed with good compliance for controlling the two conditions effectively. Here are some preventive measures that people can take to control these conditions in an effective manner.

Diabetes and hypertension often occur together and have multiple risk factors and causes in common. The risk of developing one condition increases when a person has another. The early detection and treatment of hypertension and diabetes can prevent serious complications. A healthy lifestyle can help manage blood pressure and blood glucose levels.

The article is contributed by Mr. Amol Naikawadi, Joint Managing Director and Preventive Healthcare Specialist, Indus Health Plus

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How Diabetes can be a driver for High blood pressure and eventually leads to Hypertension - APN News

Daewoong Pharmaceutical and HanAll Biopharma invest in the broad potential of Turn Biotechnologies

Turn has developed a novel cell rejuvenating platform with significant potential for application in an array of age-related diseases

SEOUL, South Korea, April 11, 2022 /PRNewswire/ -- Daewoong Pharmaceutical (KRX: 069620.KS) and HanAll Biopharma (KRX: 009420.KS) today announced expansion of their open collaboration strategy by investing in Turn Biotechnologies, a Silicon Valley based company focused on developing novel mRNA medicines. The companies are supporting Turn Bio's continued development of a high-potential platform and are considering future long-term collaborations.

Turn Bio is a pre-clinical-stage biopharmaceutical company focused on cellular repair via epigenetic reprogramming of cells. The technological foundation for Turn Bio's proprietary Epigenetic Reprogramming of Age (ERA) methodology was developed by Turn Bio's co-founders in the Sebastiano Lab, Institute for Stem Cell Biology and Regenerative Medicine, Stanford School of Medicine. The technology has since been patented and Turn Bio is currently using it to complete pre-clinical research on therapies targeting indications in dermatology and immunology, as well as developing therapies for ophthalmology, osteoarthritis and the muscular system.

"Many age-related diseases have long been significant areas of patients' unmet need," said Dr. Almira Chabi, chief medical officer and chief development officer at HanAll Pharmaceutical International. "Turn Bio's innovative platform may bring a pivotal transformation to a wide array of therapeutic areas. HanAll is committing support and investment to help realize the full potential of this pioneering technology as Turn Bio advances to a new phase of growth."

"The support of Daewoong Pharmaceutical and HanAll Biopharma validates our approach to cellular rejuvenation and enables Turn to expand its efforts in multiple therapeutic indications," said Anja Krammer, the company's CEO. "We are thrilled that a company as well known for its innovation, has taken interest in our promise to transform the way medicine treats diseases of aging and we look forward to further collaborations to help change quality of life and healthcare economics globally."

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The proceeds from this round of financing will support Turn Bio's advancement towards a phase 1 trial of its mRNA therapy candidate TRN-001, which targets indications in dermatology.

About HanAll Biopharma Co., Ltd.

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 48 years.

HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hymolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease.

For further information visit our website, and connect with us on linkedin. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).

About Daewoong Pharmaceutical. Co., Ltd. (https://www.daewoong.co.kr/en)

Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on its course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide.

About Turn Biotechnologies

Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level. The company's proprietary mRNA platform technology, ERA, restores optimal gene expression by combatting the effects of aging in the epigenome. This restores the cells' ability to prevent or treat disease, and heal or regenerate tissue and will help to fight incurable chronic diseases.

Turn Bio's technology provides a platform from which to attack a variety of now incurable chronic diseases. The company is currently completing pre-clinical research on tailored therapies targeting indications in dermatology and immunology, as well as developing therapies for ophthalmology, osteo-arthritis and the muscular system. For more information, see turn.bio or contact Jim Martinez, rightstorygroup / jim@rightstorygroup.com or (312) 543-9026.

Disclaimer statement

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should" and include statements HANALL (the company, we) makes concerning its 2022 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors our expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; our reliance on collaborations with third parties; estimating the commercial potential of our product candidates; our ability to obtain and maintain protection of intellectual property for its technologies and drugs; our limited operating history; and our ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.

Cision

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Daewoong Pharmaceutical and HanAll Biopharma Invest in Turn Biotechnologies to Expand Growth Initiative - Yahoo Finance

Andrea Williams, chief executive of Christian Concern, said: Whatever is announced by the Government in May, the problems remain: the definitions are inadequate, human rights will be breached and there is no evidence that a ban will help anyone.

In such a scenario we will face no alternative but to pursue legal action against any proposed legislation in this area.

Ms Williams added: The Government is being strong-armed by manipulative campaigns rather than following its own research that further legislation is not needed.

The fear of upsetting privileged lobbyists runs so deep the Prime Minister capitulated within hours.

No one has produced any evidence of what LGBT activists call coercive conversion therapy. What the activists describe would already be illegal.

The Governments proposals would only stop people seeking the change they want to see in their lives. That is a basic freedom which the Government should not try to take away.

Last week the Government was forced to cancel its first ever LGBT+ conference after more than 100 activist groups quit over its U-turn on conversion therapy.

As a result of the Government reiterating its commitment to excluding transgender people from the conversion therapy ban, a number of leading charities and organisations pulled out of the inaugural and international event, called Safe To Be Me.

It was set to take place in London from June 29 to July 1, coinciding with the 50th anniversary of the first official London Pride marches.

Christian Concern has threatened, if the Government does go ahead with any of its proposals as part of the Queens Speech on May 10, to bring legal proceedings on grounds of infringement upon rights of religious freedom enshrined in the European Convention on Human Rights.

A spokesman for Stonewall, one of the groups which pulled out of the Governments now collapsed Safe To Be Me conference, said: From the British Medical Association and NHS England to the UK Council for Psychotherapy and the Royal Colleges of GPs and Psychiatrists, medical and psychiatric expertise is in agreement: conversion practices do not work, can cause lifelong trauma and must be banned.

With half of conversion practices happening in religious settings, LGBTQ+ people of faith make up one of the largest groups of victims. Thats why were heartened that numerous religious leaders, including the former Archbishop of Canterbury, Rowan Williams, recently wrote to the Prime Minister in support of a ban.

We must continue to look to religious leaders who, rather than turn a blind eye to abuse, wish to address the harms done to other people who deeply hold and value their religious beliefs and community.

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Christian group prepares legal challenge over conversion therapy ban - The Telegraph

Bank of America (BAC) was the latest major bank to issue a recession shock warning two weeks after the Treasury yield curve inverted. Economists at the Bank of America expect inflation to worsen as the Russia-Ukraine war drags out, while the interest rate shock is just beginning to set in. Because the Fed is expected to remain aggressively hawkish for the foreseeable future to control the 40-year-high inflation rates, the U.S. is currently on recession watch.

Thanks to the inelastic demand for healthcare products, investing in healthcare stocks can hedge some of the markets risks. Furthermore, only 66.4% of the total population have received at least one COVID-19 vaccine dose. As economies collectively push to accelerate the global vaccination drive, healthcare companies with COVID-19 vaccines in their portfolios are expected to benefit from the robust global demand.

Given this backdrop, we believe fundamentally strong healthcare companies Pfizer Inc. (PFE), Johnson & Johnson (JNJ), AbbVie Inc. (ABBV), Eli Lilly and Company (LLY), and Merck & Co., Inc. (MRK) are expected to grow substantially even during a recession. Thus, investing in these stocks now could hedge ones portfolio against the forthcoming potential recession.

Click here to checkout our Healthcare Sector Report for 2022

Pfizer Inc. (PFE)

New York City-based PFE specializes in biopharmaceutical products globally. Its portfolio includes medicines and vaccines served to wholesalers, retailers, healthcare providers, government agencies, pharmacies, and local communities.

On April 4, PFE agreed to acquire ReViral for up to $525 million. With this acquisition, the company would strengthen its capabilities in treating RSV disease and expand its anti-infective pipeline further.

On March 29, the FDA expanded emergency use authorization of COVID-19 vaccine booster in adults aged 50 years and older and authorized a second booster dose for individuals 12 years of age and older who have received the first shot. The second booster dose offers increased protection against severe disease and hospitalization.

Also last month, PFE announced positive results from a yearlong phase 3 trial of etrasimod, which is expected to be a best-in-class therapy in treating ulcerative colitis (UC).

PFEs revenue increased 105% year-over-year to $23.84 billion in its fiscal fourth quarter (ended December 31). Its net income grew 300.6% from its year-ago value to $3.39 billion, while its income from continuing operations improved 464.4% year-over-year to $3.58 billion over the period. The companys non-GAAP EPS increased 151.2% from the year-ago value to $1.08.

The $1.57 consensus EPS estimate for its fiscal first quarter (ended March 31, 2022) represents a 68.3% improvement year-over-year. The $24.55 billion consensus revenue estimate for the to-be-reported quarter indicates a 68.4% increase from the same period last year. The company has an excellent earnings surprise history; it surpassed the consensus EPS estimates in each of the trailing four quarters.

Over the past year, the stock has gained 50.7% in price to close its last trading day at $55.17.

PFEs POWR Ratings reflect this promising outlook. The company has an overall A rating, which translates to Strong Buy in our proprietary rating system. The POWR Ratings assess stocks by 118 distinct factors, each with its own weighting.

It has a B grade for Value, Growth, and Quality. Among the 174 stocks in the Medical Pharmaceuticals industry, it is ranked #14. Click here to see the additional POWR ratings of PFE for Momentum, Sentiment, and Stability.

Johnson & Johnson (JNJ)

JNJ in New Brunswick, N.J., is engaged in the research and development, manufacturing, and selling of healthcare products that are primarily focused on human health and well-being. The company operates through three segments: Consumer; Pharmaceutical; and Medical Devices. It offers its products to the public, retail outlets and distributors, wholesalers, hospitals, and healthcare professionals.

On March 14, JNJ was named in Fortune Worlds Most Admired Companies list for the 20th consecutive year. In addition, it was also ranked #1 on the Pharmaceutical Industry list for the ninth year in a row. These honors are indicative of JNJs unwavering commitment and strong performance within the industry.

On January 6, JNJ announced that based on the largest study in the U.S., a single shot of the JNJ vaccine demonstrated long-lasting protection for up to six months against COVID-19 breakthrough infections, hospitalizations, and ICU admissions. Given the resurgence of COVID-19 cases of late, the vaccine is expected to remain in demand globally.

On December 30, the company announced that the booster shot of the JNJ COVID-19 vaccine reduced the risk of hospitalization among healthcare workers in South Africa when Omicron was dominant, representing 85% of effectiveness.

During its fiscal 2021 fourth quarter (ended Dec. 31, 2021), JNJs net sales increased 10.4% year-over-year to $24.8 billion. Its gross profit rose 14.9% from its year-ago value to $16.85 billion. Its non-GAAP net earnings grew 14.4% from the same period last year to $5.68 billion, while its adjusted EPS came in at $2.13, representing a 14.5% increase year-over-year.

Analysts expect JNJs revenues to increase 6% year-over-year to $23.65 billion in the fiscal first quarter (ended March 31, 2022). Its EPS is expected to increase 0.4% to $2.60 in the about-to-be-reported quarter. It is no surprise that the company has surpassed the consensus EPS estimates in each of the trailing four quarters, which is excellent.

The stock has gained 13.2% in price over the past six months to close Fridays trading session at $182.12.

JNJs strong fundamentals are reflected in its POWR Ratings. The stock has an overall A rating, which equates to a Strong Buy in our POWR Ratings system. JNJ also has an A grade for Stability and a B grade for Value and Quality. The stock is ranked #5 of 174 stocks in the Medical Pharmaceuticals industry.

Click here to see the other ratings of JNJ for Growth, Sentiment, and Momentum.

AbbVie Inc. (ABBV)

ABBV is engaged in research and development, manufacturing, commercialization, and global sale of medicines and therapies. The North Chicago, Ill.-based concern offers its products in various categories: immunology, oncology, neuroscience, eye care, and womens healthcare. The company markets its products to wholesalers, distributors, government agencies, health care facilities, and independent retailers.

On April 5, ABBVs subsidiary, Allergan, announced positive results from its Phase 3 VIRGO trial evaluating twice-daily administration of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. The successful trials should strengthen the role of VUITY in treating patients with blurry near vision.

On March 17, the company received Health Canadas approval of SKYRIZI to treat adults with active psoriatic arthritis. This approval should accelerate the expansion of ABBVs immunology portfolio in Canada.

On March 15, ABBV and Scripps research collaborated to develop oral antiviral treatments to combat the new variants of Covid-19.

ABBVs net revenues increased 7.4% year-over-year to $14.89 billion in the fourth quarter, ended Dec. 31, 2021. The companys non-GAAP net earnings increased 13.3% from the year-ago value to $5.92 billion, while its operating earnings grew 35.2% year-over-year to $5.07 billion. ABBVs adjusted EPS rose 13.4% from the prior-year quarter to $3.31.

Analysts expect ABBVs EPS and revenue to increase 6.3% and 5.2%, respectively, year-over-year to $3.14 and $13.61 billion in its fiscal first quarter, ended March 31, 2022. The company has an excellent earnings surprise history; it surpassed the consensus EPS estimates in each of the trailing four quarters.

Shares of ABBV have risen 62.7% in price over the past year to close Fridays trading session at $174.96.

ABBV has an overall A rating, which translates to a Strong Buy in our proprietary rating system. Also, it has a B grade for Sentiment and Quality. Also, it is ranked #8 in the Medical Pharmaceuticals industry.

In addition to the POWR Ratings grades I have just highlighted, one can see the ABBV ratings for Growth, Value, Momentum, and Stability here.

Eli Lilly and Company (LLY)

LLY is a drug manufacturing company. Its offerings include Basaglar, Humalog, Humulin, Jardiance, Trajenta, Erbitux, Retevmo, Tyvyt, Emgality, and Reyvow, among various others. The Indianapolis, Ind.-based company distributes its products in the U.S. and eight other countries.

On April 8, LLY delivered its first shipment of diabetes medicine to Ukraine amid the devastating war there. The company will make additional deliveries of medicines, including cancer treatments and COVID-19 treatments, to ease human suffering in that war.

On March 26, the company announced that adults with alopecia areata who took OLUMIANT 4-mg saw at least 90% scalp hair coverage at 52 Weeks in LLYs Pivotal Phase 3 Studies. With such remarkable results, OLUMIANT could become the first medicine ever approved to treat alopecia areata in 2022.

On January 13, the WHO recommended LLYs baricitinib, sold under the brand name Olumiant, in combination with corticosteroids, for patients with severe COVID-19. The drug has been observed to improve the survival rate and reduce the need for ventilation.

In the fourth quarter, ended Dec. 31, 2021, LLYs revenue increased 8% year-over-year to $8 billion. Its non-GAAP net income increased 8% from the year-ago value to $2.27 billion, while its non-GAAP EPS came in at $2.49, representing an 8% year-over-year improvement.

The $2.15 consensus EPS estimate for its fiscal first quarter (ended March 31, 2022) represents a 15.1% improvement year-over-year. The $7.04 billion consensus revenue estimate for the to-be-reported quarter represents a 3.4% increase from the same period last year.

LLY has gained 69% in price over the past year, closing Fridays trading session at $311.69.

The company has an overall A rating, which translates to Strong Buy in our proprietary rating system. It is no surprise that LLY has a B grade for Growth, Stability, Sentiment, and Quality. In the Medical Pharmaceuticals industry, it is ranked #10.

Beyond what we have stated above, we have also given LLY grades for Momentum and Value. Get all the LLY ratings here.

Merck & Co., Inc. (MRK)

MRK is a global provider of health solutions through its prescription medicines, vaccines, biological therapies, and animal health products. The Kenilworth, N.J.-based company operates through two segments: Pharmaceutical; and Animal Health. It offers its products to drug wholesalers and retailers, hospitals, government agencies, and other health care providers.

On April 4, MRK expanded its vaccines manufacturing facility in Elkton to increase the supply of the companys HPV vaccine and enable broad equitable access. With this expansion, MRK should help meet the growing global demand for vaccines.

On March 25, MRK received a positive opinion from EU CHMP for KEYTRUDA for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in five distinct types of cancer. This positive opinion reflects MRKs advancement in the development of cancer treatments.

On March 2, WHO recommended MRKs COVID-19 antiviral pill (molnupiravir), for high-risk patients, such as the immunocompromised, the unvaccinated, older people and those with chronic diseases.

During the fourth quarter, ended Dec. 31, 2021, MRKs net sales increased 24% year-over-year to $13.52 billion. The companys non-GAAP net income increased 84% year-over-year to $4.58 billion, while its non-GAAP EPS grew 84% from the prior-year quarter to $1.80.

Analysts expect MRKs revenues to increase 20.5% year-over-year to $14.56 billion in its fiscal first quarter (ended March 31, 2022). Its EPS is expected to increase 27.8% to $1.79 in the about-to-be-reported quarter. Shares of MRK have gained 20.4% in price over the past year.

MRKs strong fundamentals are reflected in its POWR Ratings. The stock has an overall A rating, which equates to Strong Buy in our proprietary rating system. MRK also has a B grade for Value, Growth, Sentiment, Quality, and Stability. The stock is ranked #2 in the Medical Pharmaceuticals industry.

In addition to the POWR Ratings I have just highlighted, click here to see the MRK ratings for Momentum.

Click here to checkout our Healthcare Sector Report for 2022

PFE shares were trading at $54.01 per share on Monday afternoon, down $1.16 (-2.10%). Year-to-date, PFE has declined -7.84%, versus a -6.71% rise in the benchmark S&P 500 index during the same period.

Shweta's profound interest in financial research and quantitative analysis led her to pursue a career as an investment analyst. She uses her knowledge to help retail investors make educated investment decisions. More...

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PFE: 5 Global Healthcare Stocks to Buy as BofA Warns of a - StockNews.com

REDWOOD CITY, Calif., April 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that it has received feedback via a Type C meeting written response from the U.S. Food and Drug Administration (FDA) related to Adverums planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration (wet AMD). Adverum requested the FDAs feedback to ensure alignment with the regulatory agency ahead of filing the Investigational New Drug (IND) amendment for the Phase 2 trial. The trial is designed to evaluate the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose of ADVM-022, along with new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids.

We are extremely pleased to have feedback from the FDA regarding our clinical development plan for a Phase 2 trial of ADVM-022 in wet AMD. We are looking forward to completing the IND amendment process by mid-2022 and remain on track to initiate our Phase 2 study in the third quarter of 2022, stated Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. ADVM-022 is a single, intravitreal injection gene therapy product that we believe has the potential to provide a durable and safe treatment option that addresses the needs of wet AMD patients, caregivers, retina specialists and health systems.

As an investigator in Adverums OPTIC trial, I am pleased to give my patients the option for a long-lasting, durable treatment for wet AMD, commented David S. Boyer, M.D., physician at Retina-Vitreous Associates Medical Group and member of Adverums Scientific Advisory Board. It is clear that newer long-acting anti-VEGF treatments are needed, especially one that reduces the burden of frequent anti-VEGF injections that many patients currently have to endure. The work that Adverum is doing to advance ADVM-022 as a treatment option is invaluable for patients and the field.

Expected Near-Term ADVM-022 Development Milestones

About Adverum Biotechnologies

Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with neovascular or wet age-related macular degeneration. For more information, please visit http://www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to: statements regarding Adverums plans to initiate a Phase 2 trial of ADVM-022 in wet AMD at the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose; and statements under the caption Expected Near-Term ADVM-022 Development Milestones. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverums novel technology, which makes it difficult to predict the time and cost of product candidate development and regulatory uncertainties; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022.Additional risks and uncertainties facing Adverum are set forth under the caption Risk Factors and elsewhere in Adverums Securities and Exchange Commission (SEC) filings and reports, including Adverums Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Inquiries

Anand ReddiVice President, Head of Corporate Strategy and External Affairs & Engagement Adverum Biotechnologies, Inc.T: 650-649-1358

Or

Investors:Laurence WattsGilmartin GroupT: 619-916-7620E: laurence@gilmartinir.com

Media:Jennifer ArcureCanale CommunicationsT: 917-603-0681E: Jennifer.Arcure@canalecomm.com

Source: Adverum Biotechnologies, Inc.

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Adverum Biotechnologies Proceeds with IND Amendment for ADVM-022 Phase 2 Trial in Wet AMD After Receiving Requested Type C Meeting Feedback from the...