Tevogen Bio Secures Funding from Team of Doctors to Support Clinical Trials of Its Investigational Curative T Cell Therapy for COVID-19 – PRNewswire

METUCHEN, N.J., Jan. 25, 2021 /PRNewswire/ -- Tevogen Bio today announced it has secured necessary funding from HMP Partners of New Jersey, an investment firm managed by medical doctors, which will allow Tevogen to support all clinical trials of its investigational, potentially curative COVID-19 treatment. Tevogen's Investigational New Drug (IND) application for its proprietary antigen-specific T cell therapy is under review by the U.S. Food and Drug Administration (FDA).

All COVID-19 therapeutics utilized to date have sought to slow the progression of the infection and/or moderate its symptoms. These approaches buy time for the patient's own T cells to activate and respond to the infection, which is the mechanism that the body employs to rid itself of viruses such as the SARS-CoV-2.

In the upcoming trials, Tevogen will study its investigational treatment, TVGN-489, allogeneic T cells that have been programmed and grown in the laboratory, for its safety and capability to recognize and destroy COVID-19 infected cells. Lead investigator Dr. Neal Flomenberg, Chair of the Department of Medical Oncology at Thomas Jefferson University, stated his optimism, "We're excited by the purity and potency of the cells we've been able to generate in the lab. Based on prior experience with these sorts of cells in other settings, we're very hopeful that they will be both safe and effective when the clinical trials are launched."

HMP Partners is supporting Tevogen's efforts to develop a curative treatment due to concerns over recent COVID-19 mutations and the current lack of curative options for this deadly infection. HMP CEO Dr. Manmohan Patel, a prominent pulmonary and critical care specialist, said, "We believe it's imperative to create a curative treatment that is not expected to be compromised by mutations." He added, "Unmodified virus specific T cells are well established as being effective and safe at treating viral infections, which is why we are supporting Tevogen's efforts to develop a much-needed COVID-19 cure."

While Tevogen has raised private investment from HMP Partners to launch its clinical trials, the company is seeking government funding to expedite capacity to manufacture at the scale necessary to develop pandemic-level product supply, just as have a number of vaccine and antibody manufacturers.

Tevogen's proprietary solution is designed to enable a single donation from a donor to generate more than a thousand doses of COVID-19 specific cytotoxic T cells.Yale-trained infectious disease epidemiologist Dr. Ryan Saadi is leading Tevogen's efforts and is among those who are financing the trials. Dr. Saadi stated, "We halted our pursuit for an oncology cure in order to focus solely on COVID-19, and our manufacturing efficiencyand agile business model will allow us to deliver a cure that will be affordable and accessible to all."

About Tevogen Bio

Tevogen Bio was formed after decades of research by its contributors to concentrate and leverage their expertise, spanning multiple sectors of the healthcare industry, to help address some of the most common and deadly illnesses known today. The company's mission is to provide curative and preventative treatments that are affordable and scalable, in order to positively impact global public health.

About HMP Partners

HMP Partners of New Jersey is a consortium of medical doctors who are dedicated to supporting the advancement of potentially life-saving technologies. HMP CEO Dr. Manmohan Patel, a prominent pulmonary and critical care specialist, has nearly 50 years of medical expertise in a diverse field of specialties, including pulmonary, internal, geriatric and emergency medicine as well as critical care. Dr. Patel's commitment to community and medical management is demonstrated by his distinguished appointments, including serving as the Director of Post Cardiac Surgery at Saint Michael's Medical Center in Newark, NJ and as Chairman of the Department of Medicine at Meadowlands Hospital Medical Center in Secaucus, NJ. In 2000, he was appointed by the Governor of New Jersey to the Board of Medical Examiners Executive Committee for the state and served on various other committees, including reviewing malpractice actions, in that capacity.

About Dr. Neal Flomenberg

Dr. Neal Flomenberg is the Chairman of the Department of Medical Oncology and Deputy Director of the Sidney Kimmel Cancer Center at Jefferson University in Philadelphia.Dr. Flomenberg launched Jefferson's Blood and Marrow Transplantation (BMT) Program in 1995. Throughout his four decades of practice, he has maintained a longstanding interest in the immunogenetics and immunology of stem cell transplantation, with the goal of making transplantation safer and more widely available. He is board certified in the fields of internal medicine, hematology, and medical oncology.

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Novel Treatment Leads to Dog’s Recovery – The Bark

Life for Miro, a 5-year-old German shepherd, has been what his owner describes as an emotional roller coaster over the past two years. Several peaks and valleys have dotted his metaphorical landscape as he has gone from premiere fitness to dealing with injuries and disease. But a clinical trial at the UC Davis veterinary hospital may have put him back on a positive track.

Working as a patrol dog with his handler/owner Martin Gilbertson, a ranger with California State Parks, Miro spent three years performing duties that required him to be at the top of his game. In early 2019, he was just that, having won the top dog award for his department.

By that summer, however, things started declining for Miro. He was diagnosed with lumbosacral intervertebral disc disease that caused spinal cord compression. UC Davis veterinary neurosurgeons performed a surgical decompression, and Miro eventually recovered after a lengthy recuperation period.

Miro with his handler Martin Gilbertson

Life was great, said Gilbertson. By early December 2019, Miro was cleared to return to work. I thought all the troubles were behind us.

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It only took a few weeks, though, until the roller coaster cleared a peak and started to descend.

In late December 2019, Miro collapsed for no apparent reason and started shaking in a way Gilbertson had never seen. So, the pair returned to UC Davis where Miro was diagnosed with myasthenia gravis, a disease in which there is a malfunction in the transmission of signals between the nerves and muscles. This causes muscle weakness, and an inability to walk or run properly, as well as potentially devastating neuromuscular disorders.

Gilbertson was devastated.

To go from the pinnacle of our profession to potentially being a couch potato at best for the rest of his life was a real gut check, he said.

But hope appeared a few weeks later when Neurology/Neurosurgery Service faculty members Drs. Pete Dickinson and Bev Sturges informed Gilbertson of a myasthenia gravis clinical trial they were beginning with the help of the schools Center for Companion Animal Health (CCAH) and the Veterinary Institute for Regenerative Cures.

I thought, What do we have to lose? stated Gilbertson. Dr. Dickinson told me that Miro would be the first dog to ever receive this new treatment. We were excited and grateful to be able to participate.

A computer program shows Miro's stride pattern on the Tekscan Strideway pressure walkway.

Over the next few months, Miro received three stem cell treatments, as well as traditional medications to treat myasthenia gravis. Additionally, part of Miros recovery involved examining his gait, which utilized a new piece of equipment aimed at better analyzing a dogs stride pattern. Thanks to CCAH funding, the school recently acquired a Tekscan Strideway pressure walkway that allows clinicians and researchers to better gauge a patients step pattern and make decisions about their optimal care and recovery. To fully understand a patients gait abnormalities associated with injuries or neuromuscular diseases, veterinarians and researchers rely on objective, quantitative ways to assess locomotor function. The Strideway system complements the force plates in the schools J.D. Wheat Veterinary Orthopedic Research Laboratory, which captures extensive information, but only for one gait step. The new pressure walkway expands the capabilities to quantify pressure, vertical force, and stride parameters (timing and spacing) on all limbs for several strides during walking, trotting or landing. Miros progress was able to be tracked with pinpoint accuracy throughout his recovery.

Before the trial, Miro could only walk about 10 steps before falling down. After the trial, he seemed fully recovered, and blood tests revealed no trace of antibodies to the disease. While the disease may not be completely gone from his system, the clinical trial seems to have repressed the disease to a point where it no longer inhibits Miro from his normal activities. Retired from his job, Miro now enjoys life as a family pet.

It is true that Miro is now in remission, but until more analysis of data is completed, it is still too early to determine if the stem cells were the driving force behind his recovery, since they were administered at the same time as standard-of-care medications. Miros results are being closely examined, along with the results of two other dogs that have completed the trial, to see if this stem cells treatment truly can be considered a cure for myasthenia gravis. Regardless of the final outcome of the study, Miros recovery, in one way or another, came from a novel combination of treatments pioneered at UC Davis.

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Identification and Targeting of ThomsenFriedenreich and IL1RAP | OTT – Dove Medical Press

Raghda E Eldesouki,1,2 Chengxiang Wu,2 Fayez M Saleh,2,3 Eman Abdel-Moemen Mohammed,1 Soha Younes,4 Naglaa Elsayed Hassan,5 Theresa C Brown,6 Eckhard U Alt,7 James E Robinson,8 Fouad Mohamed Badr,1 Stephen E Braun2,9

1Genetics Unit, Department of Histology and Cell Biology, School of Medicine, Suez Canal University, Ismailia, Egypt; 2Division of Immunology, Tulane National Primate Research Center, Covington, LA, USA; 3Department of Medical Microbiology, Faculty of Medicine, University of Tabuk, Tabuk, Kingdom of Saudi Arabia; 4Department of Clinical pathology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt; 5Womens Hospital, Hamad Medical Corporation, Doha, Qatar; 6Hayward Genetics Center, Tulane University School of Medicine, New Orleans, LA, USA; 7Applied Stem Cell Laboratory, Departments of Medicine, Tulane University School of Medicine, New Orleans, LA, USA; 8Sections of Infectious Disease, Departments of Pediatrics and Internal Medicine, Tulane University School of Medicine, New Orleans, LA, USA; 9Departments of Pharmacology, Tulane University School of Medicine, New Orleans, LA, USA

Correspondence: Raghda E Eldesouki Email rag.eldesouki@gmail.com

Introduction: Quiescent leukemia stem cells (LSCs) play a major role in therapeutic resistance and disease progression of chronic myeloid leukemia (CML). LSCs belong to the primitive population; CD34+CD38-Lin-, which does not distinguish normal hematopoietic stem cells (HSC) from CML LSCs. Because ThomsenFriedenreich/CD176 antigen is expressed on CD34+ HSC and IL1RAP is tightly correlated to BCR-ABL expression, we sought to increase the specificity towards LSC by using additional biomarkers. Methods: We evaluated the co-expression of both antigens on CD34+ peripheral blood mononuclear cells (PBMCs) from both healthy volunteers and CML patients, using flow cytometry. Then, we used site-directed mutagenesis to induce knob-in-hole mutations in the human IgG heavy chain and the human lambda light chain to generate the bi-specific antibody (Bis-Ab) TF/RAP that binds both antigens simultaneously. We measured complement-directed cytotoxicity (CDC) in CML samples with the Bis-Ab by flow cytometry. Results: In contrast to healthy volunteers, CML samples displayed a highly significant co-expression of CD176 and IL1RAP. When either a double-positive cell line or CML samples were treated with increasing doses of Bis-Ab, increased binding and CDC was observed indicating co-operative binding of the Bis-Ab as compared to monoclonal antibodies. Discussion: These results show that the bi-specific antibody is capable of targeting IL1RAP+ and CD176+ cell population among CML PBMCs, but not corresponding normal cells in CDC assay. We hereby offer a novel strategy for the depletion of CML stem cells from the bulk population in clinical hematopoietic stem cell transplantation.

Keywords: TF antigen, ThomsenFriedenreich/CD176 antigen, IL1RAP, chronic myeloid leukemia, bi-specific antibodies, complement-dependent cell cytotoxicity, CDC

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Identification and Targeting of ThomsenFriedenreich and IL1RAP | OTT - Dove Medical Press

Regenerative Medicine Market Size Worth $74831.35 Million With CAGR of 22.27% By 2024 | Segmented by Product Type, Top Manufacturers, By End-User…

The latest research report on Regenerative MedicineMarket delivers a comprehensive study on current market trends. The outcome also includes revenue forecasts, statistics, market valuations which illustrate its growth trends and competitive landscape as well as the key players in the business.

Regenerative Medicine Market: Increased in bone and joint surgeries and increased prevalence of neurodegenerative, orthopedic, oncology, and genetic diseases are the key drivers for Global Regenerative Medicine Market.

Regenerative Medicine Market is valued at around USD 16148.16 Million in 2017 and expected to reach USD 74831.35 Million by 2024 with the CAGR of 22.27% over the forecast period.

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Regenerative Medicine market report published by the Brandessence Market Research and Consulting Pvt. Ltd. provides the detail information about regenerative medicine market from various aspects. This report consists of drivers, restrains, Opportunities which help the market to grow over the analysis period and recent trends which support the growth of market. This report consists of regional segmentation with of Product Type, application, therapy.

Regenerative medicines are those medicines which are used to repair, regenerate, and replace the tissues or organs damaged due to disease, injury or natural aging. Regenerative medicines are used in the treatment of various disorders such as orthopedic, neurodegenerative, oncology and others. These medicines help in the restoration of natural functioning of the organs and tissues. Regenerative medicines can also be used for the treatment of various chronic and genetic disorders, it also helps in the treatment of organ transplant which has reduced the rejection cases to a major extent.

There are various factors driving the growth of the regenerative medicine market, one of the major driving the growth of the market are increased prevalence of various chronic and genetic diseases over the period of time. Moreover, increase in technological advancement has also help in the development of effective and better therapies for the treatment of chronic disorders. Furthermore, the increased burden of these diseases has increased the demand of various effective medications which led to the increase in the regenerative medicine market. Increased research on stem cells has given a new direction to the regenerative medicines an expected to create various opportunities over the forecast period. However, high cost of treatment and stringent government regulations are expected to inhibit the growth of regenerative medicines over the forecast period.

Global regenerative medicines market report covers prominent players like Stryker Corporation, Cook Biotech Inc., Vericel Corporation, DePuy Synthes, Inc. Medtronic, Inc., Organogenesis Inc., Osiris Therapeutics, Inc., NuVasive, Inc., Acelity (KCI Concepts), Zimmer Holdings, Inc., Integra LifeSciences, C.R. Bard and others.

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Regenerative Medicine Market Segmentation

By Product Type Cell-based products, Acellular products

By Application Orthopedic & Musculoskeletal Disorders, Cardiology, Dermatology, Diabetes, Central Nervous System Disorders, Others

By Therapy Cell therapy, Gene therapy, Tissue engineering, Immunotherapy

By Region

North America, US, Mexico, Chily, Canada, Europe, UK, France, Germany, Italy, Asia Pacific, China, South Korea, Japan, India, Southeast Asia, Latin America, Brazil, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa

Table of Content

1.1. Research Process

1.2. Primary Research

1.3. Secondary Research

1.4. Market Size Estimates

1.5. Data Triangulation

1.6. Forecast Model

1.7. USPs of Report

1.8. Report Description

2.1. Market Introduction

2.2. Executive Summary

2.3. Global Regenerative Medicine Market Classification

2.4. Market Drivers

2.5. Market Restraints

2.6. Market Opportunity

2.7. Regenerative Medicine Market: Trends

2.8. Porters Five Forces Analysis

2.9. Market Attractiveness Analysis

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Regenerative Medicine Market Size Worth $74831.35 Million With CAGR of 22.27% By 2024 | Segmented by Product Type, Top Manufacturers, By End-User...

Immunotherapy Inches Forward in Development of Myeloid Malignancies – OncLive

Survival for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) remains poor, and although immunotherapy has been positioned as a holy grail, it would be preemptive to predict its future based on the number of small studies that have been performed to date, according to Amer Zeidan, MD, MHS.

Nonetheless, one of the first studies that showed the potential for checkpoint inhibition in hematologic malignances was a phase 1/1b study that evaluated ipilimumab (Yervoy) after allogeneic stem cell transplant. In the study, ipilimumab was administered at a dose of 3 mg/kg and 10 mg/kg every 3 weeks. The results demonstrated efficacy in patients who received the 10 mg/kg dose. Specifically, 5 of 13 patients with heavily pretreated AML achieved a complete response (CR).

Ipilimumab has also demonstrated activity in patients with relapsed/refractory MDS in a single-arm study of 29 patients. Although the marrow CR rate was only 3.4%, 7 patients experienced prolonged stable disease for 46 weeks or more, including 3 patients with stable disease surpassing 1 year. Moreover, the median survival was 9.8 months (295 days; 95% CI, 240-671+).

In correlative analysis, we observed that patients who had increased expression of the costimulatory marker ICOS seemed to have better disease stabilization, so the direction is clearly headed toward trying to select patients using biomarker-driven strategies, Zeidan, an associate professor of medicine in the Department of Internal Medicine and Section of Hematology at Yale University School of Medicine, Yale Cancer Center, said in a presentation during the5th Annual International Congress on Immunotherapies in Cancer.

In another phase 2 study that evaluated the combination of nivolumab (Opdivo) and azacitidine vs ipilimumab and azacitidine in MDS, a higher response rate was observed with either combination compared with ipilimumab alone, at 70% and 62% vs 30%, respectively. However, the median overall survival (OS) was similar, at 11.8 months, not reached, and 8.5 months, respectively, said Zeiden.

Pembrolizumab (Keytruda) is also being subject to research in myeloid malignancies. Specifically, in a phase 1b study in combination with entinostat in MDS after failure on hypomethylating agents (HMAs). Data from the study have yet to read out, but are highly anticipated, said Zeiden.

Findings from a phase 2 study (NCT02775903) however stunted some of the excitement that had been generated with immunotherapy, putting into perspective the work that had been done to date. When the combination of a checkpoint inhibitor and an HMA, specifically durvalumab (Imfinzi) and azacitidine, was taken into a randomized trial vs azacitidine alone in patients with high-risk MDS and older AML, no difference was seen in progression-free survival (PFS) or OS.

Bispecific antibodies are another treatment class under investigation as a potential avenue forward for immunotherapy. One such antibody is sabatolimab, which targets IgG4 and TIM-3, and is the focus of several ongoing studies in MDS and AML. Specifically, the phase 2 STIMULUS-MDS1 (NCT03946670) and phase 3 STIMULUS-MDS2 (NCT04266301) trials in MDS and phase 2 STIMULUS-AML1 trial (NCT04150029) in AML.

Another path that will be explored is that of checkpoint inhibition plus chemotherapy, explained Zeiden. In a phase 2 study, the combination of pembrolizumab and 7+3 chemotherapy will be evaluated as frontline therapy in fit patients with AML.

The combination of azacitidine and venetoclax (Venclexta) has become the standard of care for older patients with AML, and preclinical evidence suggests that the BCL-2 inhibitor can augment the antitumor response of PD-L1 inhibitors.

As such, investigators have launched the phase 2 BLAST AML 2 study in which unfit patients with AML will be randomized to azacitidine plus venetoclax vs azacitidine/venetoclax plus pembrolizumab as frontline therapy.

Anti-CD47 antibodies are also under study and have shown promising, though early, activity in AML and MDS. For example, in combination with azacitidine, magrolimab has shown objective responses exceeding 60% in untreated AML and 90% in untreated MDS, with CR rates of 41% and 50%, respectively.

Importantly, a lot of the responses seem to occur in patients who have TP53 mutations, which is one of the highest areas of unmet need in AML and MDS, because those patients do very poorly with conventional treatment, said Zeidan.

Although magrolimab will move forward in development, Zeidan cautioned that the antitumor effects of anti-CD47 antibodies may not be class specific. For example, in a phase 1 study, CC-90002 failed to demonstrate any benefit in patients with relapsed/refractory AML and higher-risk MDS.

In conclusion, Zeidan stated, Many of the studies that have been conducted are single-arm trials with small sample sizes. [However,] we are doing more and more randomized studies using novel inhibitors against TIM-3 and CD47. The field is definitely exciting for us, and we are hoping to see some clinical activity for our patients soon.

Reference

Zeidan A. Immunotherapy for treatment of myeloid malignancies: will it fill the promise? Presented at: 5thAnnualInternational Congress on Immunotherapies in Cancer; December 12, 2020; virtual. gotoper.com/go/ICIC20Virtual

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Immunotherapy Inches Forward in Development of Myeloid Malignancies - OncLive

Cytovia Therapeutics Partners with National Cancer Institute to Develop Novel Gene-Edited, iPSC-Derived GPC3 CAR NK Cells for the Treatment of Solid…

January 13, 2021 07:47 ET | Source: Cytovia Therapeutics

CAMBRIDGE, Mass., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, an emerging biopharmaceutical company focusing on Natural Killer cells in cancer, announced today that it has signed a licensing agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, to apply its gene-edited iPSC-derived NK cell technology to develop GPC3 CAR NK cell therapeutics. Dr Mitchell Ho, PhD, Director of the Antibody Engineering Program and Deputy Chief of the Laboratory of Molecular Biology at the NCI Center for Cancer Research has developed novel antibodies and chimeric antigen receptors (CAR) binding to glypican-3 (GPC3) on liver cancer cells. Dr. Ho has published data on the humanized GPC3 antibody in scientific reports (nature research) in 2016 as well as on the GPC3 CAR in Gastroenterology in 2020.

GPC3 is an oncofetal antigen involved in Wnt-dependent cell proliferation. It is highly expressed in Hepatocellular Carcinoma tumor cells as well as multiple other solid tumors, including ovarian cancer and lung cancer, but not expressed in adult normal tissues.

Cytovia has also signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. Under the CRADA, Cytovia will collaborate with Dr. Hos laboratory to develop and evaluate gene-edited iPSC-derived GPC3 CAR NK cells. Cytovia expects to file an initial new drug application (IND) for its GPC3 CAR NK cells in the first half of 2022.

Dr. Daniel Teper, Chairman and CEO of Cytovia Therapeutics commented: GPC3 is an exciting new validated target for Hepatocellular Carcinoma, an area of major unmet medical need, as well as other solid tumors. We look forward to collaborating with Dr. Ho, a pioneer in GPC3 research, to develop a novel gene-edited, iPSC-derived GPC3 CAR NK that will advance toward a cure for liver cancer.

Dr. Ho added: Natural Killer cells play a major role in the immuno-surveillance of liver cancer. GPC3 is expressed in more than 70% of Hepatocellular Carcinoma cells but not on healthy cells. We look forward to investigating whether GPC3 CAR-NK therapy could provide a new safe and effective off-the-shelf option for patients with liver cancer.

ABOUT GENE-EDITED, IPSC-DERIVED NK CELLS Chimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). In addition, CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the induced pluripotent stem cell (iPSC)-derived CAR-NKs, an innovative technology, allow large quantities of homogeneous genetically modified CAR NK cells to be produced from a gene-edited iPSC master cell bank, and thus hold promise to expand access to cell therapy for many patients.

ABOUT HCC Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and a leading cause of death worldwide, with 800,000 new cases diagnosed globally every year. The incidence in Asia is amongst the highest in the world (75%) with 400,000 in China alone. In the US, it is estimated to reach upwards of 30,000 by the end of 2020 and continues to be on the rise. Despite advances in immunotherapy, with current treatment options including multi-kinase inhibitors (TKI) and checkpoint inhibitors, life expectancy for patients diagnosed with HCC remains very low. The disease is often diagnosed at an advanced stage, with a median survival of approximately 6 to 20 months following diagnosis, and a 5-year survival rate below 10% in the US. Fortunately, new options including cell therapy and bispecific antibodies offer promise towards a cure for liver cancer.

ABOUT GPC3 Glypican-3 (GPC3) is a cell-surface heparan sulfate proteoglycan expressed in the liver and the kidney of fetuses but is hardly expressed in adults, except in the placenta. However, it is highly expressed in HCC, ovarian clear cell carcinoma, squamous cell carcinoma of the lung, melanoma, hepatoblastoma, nephroblastoma (Wilms tumor), yolk sac tumor, and some pediatric cancers. GPC3 promotes Wnt-dependent cell proliferation and has been strongly suggested that it is related to the malignant transformation. Therefore, GPC3 is a promising target for cancer immunotherapy and can serve as a biomarker for predicting tumor recurrence and treatment efficacy.

About Cytovia TherapeuticsCytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, INSERM, and CytoImmune Therapeutics.

Learn more atwww.cytoviatx.comand follow Cytovia Therapeutics on Social Media(Facebook,LinkedIn,Twitter,and Youtube).

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Anna Baran-Djokovic Vice President, Investor Relations Anna@cytoviatx.com 1 (646) 355 1787

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Cytovia Therapeutics Partners with National Cancer Institute to Develop Novel Gene-Edited, iPSC-Derived GPC3 CAR NK Cells for the Treatment of Solid...

Kaleido Biosciences Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-to-Moderate COVID-19 – BioSpace

Preliminary analysis (n=176) demonstrates favorable safety and tolerability; data provide a strong signal of clinical benefit for subjects reporting one or more comorbidities

Topline data from full study population of 350 patients and results of second study of KB109 are expected in the first quarter of 2021

LEXINGTON, Mass., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences Inc. (Nasdaq: KLDO), today announced positive interim results from the K031 non-IND controlled clinical study evaluating outpatients with mild to moderate COVID-19 disease. Patients in this non-IND clinical study were randomized within 48 hours of testing positive for COVID-19 to either receive Supportive Self Care (SSC) or SSC plus Microbiome Metabolic Therapy (MMT) candidate KB109 for two weeks and then followed for an additional three weeks. The planned interim analysis comprised approximately half of the total study population (n=176) and showed that KB109 was well tolerated, with a safety profile consistent with previous studies of MMT candidates and no unexpected treatment-related adverse events. For subjects reporting one or more comorbidities, the median time to resolution of the thirteen overall COVID-19 related symptoms was 18 days with KB109 plus SSC and 27 days with SSC alone.

This interim analysis, from the largest study conducted to date with an MMT candidate, reinforces the safety and tolerability previously observed with MMTs and provides a strong signal of clinical benefit for KB109, commented Dan Menichella, President and Chief Executive Officer of Kaleido. The study reveals that many patients with mild-to-moderate disease, and particularly those patients with a comorbidity, experience symptoms for a period of weeks. This study shows the significant burden experienced by these patients and we look forward to reporting the full dataset later this quarter.

These exciting and relevant data are in line with what we are seeing in the COVID-19 literature and suggests that the microbiome plays a role in this disease, said John P.Haran, M.D., Ph.D., associate professor of emergency medicine, microbiology &physiological systems and clinical director of the UMass Center for Microbiome Research at the University of Massachusetts Medical School. There is increasing evidence supporting the biological plausibility that microbiome restoration has a significant impact on different diseases and seeing an influence in COVID-19 patients with comorbidities aligns with this emerging science.

Summary of Interim Results

The K031 study of 350 subjects is fully enrolled with results expected in the first quarter of 2021. Topline data from a smaller 50 subject study of KB109 is also expected in the first quarter of 2021.

About the Potential Role of the Microbiome in COVID-19

COVID-19 infection has been associated with activation of an inappropriate inflammatory cascade, which in some patients can cause an abnormally aggressive immune response that can lead to pneumonia and respiratory failure. Metabolites such as short chain fatty acids (SCFAs) produced by the microbiome through utilization of glycans are modulators of the immune response and therefore could play a role in limiting this inflammatory cascade.

In preclinical models, increased SFCAs and/or SFCA-producing taxa, have been shown to influence immune pathways, mitigate immune pathology, and improve survival and morbidity associated with severe respiratory viral infections.1,2 Commensal microbiota composition critically regulates the generation of virus-specific CD4 and CD8 T cells and antibody responses following respiratory influenza virus infection.3

In-human data also support the role of SCFAs in reducing the impact of viral infections.In patients undergoing hematopoietic stem cell transplants who have contracted respiratory viral infections, including coronavirus, the presence of SCFA-producing taxa has been associated with a significantly reduced risk of progression to lower respiratory tract infections, which can have substantial morbidity in this patient population.4 KB109 is Generally Recognized as Safe (GRAS) and was selected for evaluation in these COVID-19 clinical studies based on its demonstrated ability to increase production of SCFAs as well as to promote commensal bacteria and reduce pathogenic bacteria ex vivo.

About Microbiome Metabolic Therapies (MMT)

Kaleidos Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiomes existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Companys initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome.Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

AboutKaleido Biosciences

Kaleido Biosciencesis a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health. The Company has built a proprietary product platform to enable the rapid and cost-efficient discovery and development of novel Microbiome Metabolic Therapies (MMT).MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the guts existing microbes. Kaleido is advancing a broad pipeline of MMT candidates with the potential to address a variety of diseases and conditions with significant unmet patient needs. To learn more, visithttps://kaleido.com/.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the therapeutic potential of our MMT candidates, the timing of initiation, completion and reporting of results of clinical studies, and our strategy, business plans and focus. The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth of our pipeline of product candidates, the strength of our proprietary product platform, the efficiency of our discovery and development approach, the fact that interim results from KB013 may not accurately predict final results from KB013 and that such final results may not support continued development of KB109, the clinical development and safety profile of our MMT candidates and their therapeutic potential, whether and when, if at all, our MMT candidates will receive approval from theU.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, and other risks identified in ourSECfilings, including our most recent Form 10-Q, and subsequent filings with theSEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contacts Kaleido Biosciences William Duke, Jr. Chief Financial Officer 617-890-5772 william.duke@kaleido.com

Investors Mike Biega Solebury Trout 617-221-9660 mbiega@soleburytrout.com

Media Rich Allan Solebury Trout 646-378-2958 rallan@soleburytrout.com

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Kaleido Biosciences Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-to-Moderate COVID-19 - BioSpace

Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID – CBS San Francisco

MIAMI (CBSMiami) Doctors in South Florida say an experimental treatment involving stem cells has been incredibly successful in treating severe cases of COVID.

The study involved patients at Jackson Memorial Hospital and at the University Miami Tower. Many of them had acute respiratory distress syndrome (ARDS).

I think this could be a turning point, said Dr. Camillo Ricordi, director of the Cell Transplant Center at the University of Miami Miller School of Medicine.

According to Ricordi, the groundbreaking treatment uses stem cells from a babys umbilical cord.

The treatment has shown to safely reduce the risk of death and has made recovery time faster for some of the most ill patients.

We just published the study that using stem cells derived from the umbilical cord of a healthy newborn baby. We generally throw away the placenta that is discarded after birth. But we are using cells that are extracted and expand from that umbilical cord. That can generate and provide therapeutic doses for over 10,000 patients from a single umbilical cord. It is an amazing result, he said.

Ricordi, one of the lead researchers of the study, said treating coronavirus patients with these mesenchymal stem cells just made sense.

When the COVID pandemic exploded, I called our collaborators in China, saying, Why dont we try to use these cells in COVID? Because they have the same properties that help us fight autoimmune conditions, he explained.

The FDA approved to go forward with the trial.

In a double blind study, involving 24 patients with acute respiratory distress syndrome, each received two infusions given days apart of either the stem cells or placebo.

The physician nor the patient knew if someone received a cell or just an infusion of the solution of the cells, Ricordi said.

Researchers found the patient survival rate treated with the stem cells was 91%.

Ricordi said these stem cells have potential to restore normal immune response and also promote tissue regeneration.

When a person develops ARDS, their lungs develop severe inflammation and buildup fluid in their lungs.

Ricordi said ARDS patients usually undergo invasive procedures, but thats not the case with these stem cells.

These cells injected in the IV naturally go with a very simple procedure that does not require any invasive procedure. You can just direct the transfusion to the lung, he explained. The cells go to the lungs and it has just been an amazing kind of result and we are very excited to move to the next step.

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Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID - CBS San Francisco

Mana joins the hectic fight against solid tumors with an ‘off-the-shelf’ candidate angling for an IND this year – Endpoints News

The hunt for effective therapies for solid tumors has heated up in early 2021 with a string of biotechs touting big investor checks and name-brand collaborations to chase those hard-to-treat lumps. Now, with one of its candidates already in the clinic for leukemia, Mana Therapeutics is taking a new round of funding to join the fray.

On Friday, Mana unveiled a $35 million Series A financing round that will help push the Boston-area biotechs lead candidate through a Phase I trial and could help the company secure an IND for an off-the-shelf allogeneic molecule targeting transplant-ineligible AML and solid tumors within the year.

The biotechs leading molecule, dubbed MANA-312, is already engaged in the Phase I study of patients with acute myeloid leukemia, myelodysplastic syndrome after undergoing an allogenic hematopoietic stem cell transplantation. Manas goal is to use its technology to create an inventory of off-the-shelf allogeneic products that can treat the majority of patients with certain targeted cancer indications using whats called a human leukocyte antigen matching system.

Its a different take on a similar line of attack for solid tumors: using the bodys natural immune system to educate healthy cells already in the body to target antigens on the surface of the tumors cancer cells without damaging the otherwise healthy cells. To do this, Mana uses an in-house platform called EDIFY, which it says leverages natural immune system pathways to educate T cells to target multiple cell surfaces and intracellular tumor-associated antigens.

Through multiple antigen targeting processes, the companys technology is designed to prevent the tumors immune escape, and it says the allogeneic method which uses healthy donor cells to create a master cell bank and is then used for specific therapies of attacking the solid cancer tumors could provide superior efficacy to single antigen and other cell therapy approaches.

MANA-312 also isnt the biotechs only candidate in the works. MANA-412 is a preclinical off-the-shelf allogeneic cell therapy for treating transplant-ineligible acute myeloid leukemia and solid tumors and could be ready for an IND filing by the end of the year, Mana said. The Series A round will help fund preclinical development for that candidate as well.

Mana was founded based on research and human proof-of-concept clinical trials conducted by Catherine Bollard of Childrens National Hospital and her colleagues at Johns Hopkins Medical Center. Those trials, in both solid and hematologic tumors, supported a strong safety profile, showed immunological anti-tumor activity and validated MANAs initial set of tumor antigens, the company said. Then Bollard co-founded the company with industry vet Marc Cohen. Ex-Gilead exec Martin Silverstein is the CEO.

The human proof-of-concept trials conducted by my team and colleagues showed potential for a nonengineered approach to educating T-cells to attack multiple tumor antigens, which MANA is expanding even further through refinement of the manufacturing process for an allogeneic product and application to a broader set of antigens in a variety of clinical indications and settings, Bollard said in a statement.

MANAs $35 million financing round was led by Cobro Ventures and Lightchain Capital and joined by LifeSci Venture Partners with other undisclosed investors.

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Mana joins the hectic fight against solid tumors with an 'off-the-shelf' candidate angling for an IND this year - Endpoints News

Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -…

December 30, 2020 04:38 ET | Source: Research and Markets

Dublin, Dec. 30, 2020 (GLOBE NEWSWIRE) -- The "CAR-T - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

The "CAR-T - Pipeline Insight, 2020," report provides comprehensive insights about 250+ companies and 250+ pipeline drugs in CAR-T pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

CAR-T: Overview

CAR-T is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. CAR T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer. Also called chimeric antigen receptor T-cell therapy.

Potential Mechanisms of CAR-T Cell-Mediated Toxicity

Significant progress has been made in the field of cancer immunotherapy, and CAR-T cells have shown outstanding efficacy in clinical trials. As with all technologies, CAR-T technologies also need to go through a long process of development, and CAR-T cell therapy has related acute and chronic toxicities that have become a roadblock on the developmental path. If these setbacks are not overcome, it will be difficult to make a more significant breakthrough.

Cytokine Release Syndrome

Cytokine release syndrome (CRS) is the most common toxic side effect in CAR-T cell therapy. CRS is a systemic inflammatory response caused by the significant increase in cytokines accompanied by the rapid in vivo activation and proliferation of CAR-T cells, usually occurring within a few days after the first infusion. CRS is a clinical condition with mild symptoms of fever, fatigue, headache, rash, joint pain, and myalgia. Severe CRS cases are characterized by tachycardia, hypotension, and high fever. Mild to moderate CRS is usually self-limiting and can be managed through close observation and supportive care. Severe CRS must be treated with tocilizumab or steroids alone for intensive treatment.

Advances in Research of CAR-T Cell Therapy for Solid Tumors

Although early CAR-T cell trials of solid tumors did not show the same success as observed in leukemia trials, a better understanding of the multiple barriers seen in solid tumors could promote the design of clinical trials for CAR-T cells. In this early stage of clinical development, CAR-T cells offer much hope. The ability of genetic manipulation techniques to modify CAR-T cells provides almost unlimited opportunities for other changes and improvements, thus providing a strong desire for future success.

Global Landscape of CAR-T Cell Therapy

At present, CAR-T cells are widely used in cellular immunotherapy for various tumors. According to statistics, more than 300 clinical trials of CAR-T cell therapies have been approved by many national drug regulatory agencies, including the FDA of the United States. Statistical data from these clinical trials show that although the effects of various clinical trials vary due to the use of different sources and the preparation techniques of CARs and T cells, as well as differences in pretreatment and combinations of drugs, overall, CAR-T cells are effective in treating tumors with an effective rate of 30% to 70% or even more than 90%. For example, the complete remission rate for r/r ALL treated with the Novartis drug CTL0l9, which the FDA has approved, is 93%. Perhaps CAR-T cell therapy will ultimately remedy the fate of human cancer.

CAR-T Emerging Drugs Chapters

This segment of the CAR-T report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

CAR-T: Therapeutic Assessment

This segment of the report provides insights about the different CAR-T drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in CAR-T

There are approx. 250+ key companies which are developing the therapies for CAR-T. The companies which have their CAR-T drug candidates in the most advanced stage, i.e. phase III include, Janssen Research & Development, ViiV Healthcare, Sorrento Therapeutics, Celgene, Novartis, Abbott etc.

Report Highlights

Current Treatment Scenario and Emerging Therapies:

Key Players

Key Products

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/c6ze76

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -...