CAR T-Cell Therapy Appeared Safe, With No Signs of GVHD in Patients With T-Cell Lymphoma/Leukemia – DocWire News

A study presented at the 2022 American Society of Clinical Oncology Annual Meeting found that an autologous CD7 chimeric antigen receptor (CAR) T-cell therapy was effective for patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoma (ALL/LBL), with no signs of graft-versus-host disease (GVHD) reported.

The phase I study included patients with CD7+ relapsed/refractory T-cell ALL/LBL with no leukemic cells in the peripheral blood. Following a 3+3 dose escalation process, the CD7 CAR construct included an endoplasmic reticulum anchor domain fused to a CD7 binding domain to prevent CD7 expression on cell surface, which contributed to minimizing CAR T-cell fratricide. CAR T product was checked to ensure lack of tumor contamination before infusion.

Between September 2021 and January 2022, 5 patients (median age, 3.8 years; range, 1.9-13.0 years) were enrolled in the study. Of those patients, 1 had mediastinal mass and blasts in pleural fluid, 1 had central nervous system-3 status, and 3 had marrow disease with a median burden of 1.35% (range, 0.07%-7.31%).

Patients received CAR T-cell therapy at the following doses: 5 105 cells/kg (n = 3) and 1 106 cells/kg (n = 1). One patient received cells below the target dose.

A total of 3 patients had cytokine release syndrome (CRS), and 1 patient experienced grade 3 CRS. Median onset to CRS was 5 days (range, 1-9 days), with a median duration of 4 days (range, 3-14 days). There were no reports of neurotoxicity, GVHD, or infection.

All patients experienced grade 3/4 hematologic toxicities, which recovered to grade 2 within 30 days.

At 1 month post-infusion, 4 patients achieved complete remission, and 1 patient still had leukemia cells in the cerebrospinal fluid. At a median follow-up of 62 days (range, 35-136 days), 1 patient underwent hematopoietic stem cell transplantation (HSCT) at 2.9 months post-infusion and had a CD7 relapse at 1.4 months post-HSCT. The other 3 patients who experienced a response were in minimal residual disease-negative complete remission.

In the 4 patients who received target dose, the median peak CAR T-cell count in peripheral blood was 4.27 102/L (range, 2.49-5.61) by flow cytometry. All patients had detectable CAR transgene by polymerase chain reaction at their last visits.

Longer follow-up with more patients is needed to further evaluate this CAR T-cell therapy, the researchers noted.

Zhao L, Pan J, Tang K, et al. Autologous CD7-targeted CAR T-cell therapy for refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma. Abstract #7035. Presented at the 2022 American Society of Clinical Oncology Annual Meeting; June 3-7, 2022; Chicago, IL.

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Innovative Therapies, Care Equity Highlight 2022 ASCO Annual Meeting – Targeted Oncology

After a meeting like the 2022 ASCO Annual Meeting, one cannot help but be reinvigorated to continue advancing cancer care and feel optimistic about the future of oncology, says John M. Burke, MD.

After seeing all the amazing presentations at the American Society of Oncology (ASCO) Annual Meeting, I cannot help but reflect on how far our field has come over the course of my 20-year career.

In 2000, I moved from San Francisco, California, to New York, New York, to begin my fellowship at Memorial Sloan Kettering Cancer Center. My first rotation was on the inpatient myeloma, lymphoma, and autologous stem cell transplant service, where I encountered patients with myeloma and painful bone lesions causing fractures and spinal cord compressions. We treated patients with myeloma with chemotherapy and autologous stem cell transplant. Thalidomide (Thalomid) was starting to make a splash by showing strong efficacy in myeloma trials, and bortezomib (Velcade) emerged during those years, as well.

Nevertheless, the state of the art was exemplified by an article in the New England Journal of Medicine in 2003, describing the results of an Intergroupe Francophone du Mylome (IFM) trial. Myeloma patients were treated with vincristine, doxorubicin, and dexamethasone induction followed by single or double autologous stem cell transplant. The median event-free survival was 2 years and the median overall survival was 4 years, which seem grim by modern standards.

Fast forward about 20 years to the Plenary Session of the 2022 ASCO Annual Meeting, at which we saw the results of modern therapy in the DETERMINATION trial (NCT01208662). Patients treated with the modern standard regimen of lenalidomide (Revlimid), bortezomib, and dexamethasone followed by autologous stem cell transplant achieved a median progression-free survival of 5.5 years. In the IFM trial 20 years ago, approximately 50% of patients were alive at 4 years. In DETERMINATION, 85% of patients were alive at 4 years. Weve come a long way.

DETERMINATION represents only an infinitesimal fraction of the degree of innovation demonstrated at the ASCO meeting: an antibody-drug conjugate besting conventional chemotherapy in patients with low expression of the HER2 target in breast cancer; a KRAS inhibitor demonstrating marked activity in KRAS-mutated nonsmall cell lung cancer; a bispecific antibody redirecting T cells to suppress diffuse large B-cell lymphoma; an antibody-drug conjugate added to chemotherapy, extending survival in Hodgkin lymphoma compared with the decades-old standard-of-care regimen; and a checkpoint inhibitor rendering mismatch repairdeficient rectal cancer completely helpless.

After a meeting like this, one cannot help but be reinvigorated to continue advancing cancer care and feel optimistic about the future of oncology. We have a lot of progress to celebrateand a lot more to accomplish.

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Taiwan reports 1st child with cancer cured by CAR T-cell therapy – Taiwan News

TAIPEI (Taiwan News) A 10-year-old girl suffering from leukemia is the first child in Taiwan to receive CAR T-cell therapy and to have fully recovered from the cancer as a result.

The girl, identified as Tingting (), was diagnosed with childhood B-cell acute lymphoblastic lymphoma four years ago. After undergoing first-line therapy, she still relapsed.

In the past, such a patient would have to wait for a stem cell transplant to save their lives. However, with the assistance of doctors at National Taiwan University Hospital (NTUH), she became the first CD19-targeted chimeric antigen receptor-engineered (CD19 CAR) T-cell recipient in Taiwan and has fully recovered, with no residual cancer cells detected in her body.

At a press conference held by the university on Thursday (July 14), Chou Hsien-tang (), a hematologist oncologist at NTUH, said that Tingting had been diagnosed with the cancer when she was 6 years old, reported ETtoday. After receiving a three-year chemotherapy regimen for high-risk groups, the remaining cancer cells were undetectable for a period of time.

However, the cancer recurred, and even with the use of new standard drugs, the cancer cells could not be removed. After discussion with parents, doctors decided to attempt CART T-cell therapy.

Chou explained that the treatment principle relies on high-tech genetic engineering. First, T-cells are isolated from the patient's body, and are genetically modified by adding a gene for a receptor called chimeric antigen receptor (CAR), which enables the T-cells to attach to a specific cancer cell antigen.

The cancer cells from childhood B-cell acute lymphoblastic lymphoma contain an antigen called CD19. Therefore, in this patient's case, the CART T-cell technique was used to design T-cells to attach to the CD19 antigen.

Chou compared it to a precise "immunization army" that can accurately and continuously destroy cancer cells. The advantage is that a one-time injection can generate these results, said Chou, as was the case with Tingting.

In April of this year, NTUH became the first medical center in Taiwan to provide formal clinical use of CD19-targeted CAR T-cell therapy. Tingting was the first patient in Taiwan to receive the treatment and experience a full recovery.

Currently, no cancer cells have been detected in her system, but follow-up examinations will continue to monitor her status. NTUH expressed the hope that it will be able use this therapy in the future to improve the quality of cancer treatment and prevent recurrences.

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Taiwan reports 1st child with cancer cured by CAR T-cell therapy - Taiwan News

Pneumonia and Heart Disease: What You Should Know – Healthline

Your heart and lungs share a close relationship, each relying on the other to replenish your blood with oxygen, remove wastes, and move blood and nutrients around your body.

When one of these players is underperforming or damaged, the other is quickly affected.

Pneumonia is an infection in one or both lungs. The tiny air sacs (alveoli) that move gases like oxygen in and out of your blood fill with fluid or pus.

This article will explore how pneumonia can affect how well your heart works and what can happen if you already have heart disease and then develop pneumonia.

Coronary artery disease is the most common form of heart disease in the United States. It develops when cholesterol and other substances build up in your blood vessels specifically the coronary arteries that supply blood to your heart.

Many things can lead to this buildup, including diet, lifestyle choices, and genetics.

The buildup of substances in your blood vessels is dangerous on its own since it can restrict blood flow to the heart and other body parts. But its even more serious when pieces of this buildup called plaques break off from the walls of your blood vessels.

When these pieces break off, they can travel to other areas of the body like the brain or heart, cutting off the blood supply to these organs resulting in a stroke or heart attack.

On its own, pneumonia is not a heart disease. Its a lung infection caused by bacteria or viruses.

However, heart disease complications like congestive heart failure can cause a condition similar to pneumonia.

Certain types of heart failure can lead to pulmonary edema. In this case, the heart is too weak to effectively pump blood out to the body, so the blood backs up into the heart and eventually into the lungs.

As this backed-up blood builds up in the lungs, pressure in the blood vessels of your lungs increases, and it can cause fluid buildup in the alveoli.

This results in an effect similar to pneumonia, where these air sacs fill with fluid.

Pneumonia is an infection that can cause inflammation throughout the body. This inflammation can lead to other complications, including an increased risk that bits of plaque can break free from your vessel walls and lead to heart attack or stroke.

Even without existing coronary artery disease or plaque buildup, the body-wide inflammation that pneumonia triggers can cause its own problems.

Inflammation can interfere with the normal function of all kinds of systems in your body especially the heart. This makes heart failure one of the most common complications of pneumonia.

About 30% of people hospitalized with community-acquired pneumonia develop heart failure and other cardiovascular problems, but the risk isnt always immediate. Research indicates that the greatest risk of heart complications occurs in the month after a pneumonia diagnosis, and the risk can continue for up to a decade.

It can be difficult to tell when pneumonia is affecting your heart, as pneumonia and heart disease can share symptoms including:

Additional symptoms you may experience with pneumonia that are not as common with heart disease include:

Inflammation in response to a pneumonia infection has some of the greatest impact on your heart.

Although heart damage from pneumonia can happen in anyone, it affects people with preexisting heart disease the most.

Among people who develop pneumonia with preexisting heart failure, about 1.4% who are treated in the outpatient setting find their heart failure gets worse after pneumonia. That percentage increases to 24% in people with more severe pneumonia that requires hospitalization.

Aside from inflammation, some individual cardiac symptoms or complications that can develop after a bout with pneumonia include:

The relationship between pneumonia and cardiovascular disease goes both ways: Pneumonia can increase the risk of heart disease, and a history of heart disease can increase the risk of pneumonia.

One 2018 study found that people with cardiovascular diseases heart failure in particular are three times more likely than others to develop community-acquired pneumonia.

Generally, the best way to prevent problems like pneumonia and heart failure is to take care of your overall health.

This means:

People with heart disease are generally recommended to stay up-to-date on various vaccinations, too. This can prevent acute infection and its complications.

However, there may be little difference in mortality rates among people with heart failure and pneumonia who had been vaccinated against things like influenza and pneumonia.

With every heartbeat and every breath, your lungs and heart work in tandem. Infections and chronic diseases that affect one organ can affect the other.

Pneumonia can increase your risk of developing heart disease or having your existing heart disease worsen. Likewise, heart disease can increase your risk of developing several types of pneumonia.

Talk with your doctor about your overall health and how to avoid chronic heart disease and acute infections like pneumonia.

Vaccines are one part of the equation, but the best strategy involves other health and diet strategies, too.

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Pneumonia and Heart Disease: What You Should Know - Healthline

National Stem Cell Foundation Continues Innovative Neurodegeneration Research on the International Space Station – PR Web

The world is increasingly looking to space for answers to questions about improving human health. NSCF has been funding this important research on the ISS since 2018, said Dr. Paula Grisanti, National Stem Cell Foundation CEO.

LOUISVILLE, Ky. (PRWEB) July 14, 2022

The Louisville-based National Stem Cell Foundation (NSCF) is funding a first-in-kind study of neurodegeneration on the International Space Station (ISS) with a bi-coastal team of leading experts in the fields of Parkinsons disease (PD) and multiple sclerosis (MS). The study uses organoids, 3-D aggregates of cells from PD and primary progressive MS (PPMS) patients that mimic the central nervous system, and microglia, the immune cells that have been recognized as playing a role in neurodegeneration. The project launched from Cape Canaveral on July 14 and traveled to the International Space Station for a fourth time aboard the SpaceX 25 Commercial Resupply Mission for NASA.

The world is increasingly looking to space for answers to questions about improving human health. NSCF has been funding this important research on the ISS since 2018, said Dr. Paula Grisanti, National Stem Cell Foundation CEO. Findings from our earlier missions have been used to refine questions about how and why neurodegeneration occurs in these disorders. We look forward to publishing our initial results from previous flights later this year.

The ability to watch cells interact in microgravity in a way not possible on Earth may provide valuable insight into how these disorders develop, accelerate biomarker discovery for early diagnosis, and open the door to new cell and drug therapy options for millions worldwide diagnosed with these neurodegenerative disorders and others. The annual economic impact of PD and MS in the U.S. alone is estimated at $137 billion.

NSCFs bi-coastal team of leading experts includes research partners at the New York Stem Cell Foundation Research Institute and Dr. Jeanne Loring, Professor Emeritus at Scripps Research in San Diego, California.

While the effort is complex, our goal is simple: to continue the work of changing lives and futures through adult stem cell and regenerative medicine research, said Grisanti. Were excited about the continuation of innovative research with the upcoming mission and another to be scheduled in 2023.

To learn more about the National Stem Cell Foundation, visit nationalstemcellfoundation.org.

About the National Stem Cell Foundation The National Stem Cell Foundation is a 501(c)3 non-profit organization that funds adult stem cell and regenerative medicine research, underwrites the National STEM Scholar Program for middle school science teachers nationwide, and covers copays and deductibles for children of limited means participating in clinical trials for rare diseases. For more information, visit nationalstemcellfoundation.org.

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National Stem Cell Foundation Continues Innovative Neurodegeneration Research on the International Space Station - PR Web

Citius Pharmaceuticals, Inc. Holds Pre-BLA Meeting with the FDA for I/ONTAK (denileukin diftitox) for the Treatment of Cutaneous T-Cell Lymphoma – PR…

Biologics License Application (BLA) submission planned for the second half of 2022

CRANFORD, N.J., July 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products,today announced that the Company held a Type B pre-BLA meeting with the U.S. Food and Drug Administration (FDA) to discuss I/ONTAK (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK. The pre-BLA meeting was held with representatives from the FDA's Center for Drug Evaluation and Research (CDER).

The purpose of the pre-BLA meeting with the FDA was to discuss the content and acceptability of the Company's anticipated BLA for I/ONTAK. The briefing document provided to the FDA included a review of clinical and non-clinical studies and previous meeting minutes with the FDA.

"We appreciate the FDA's continued guidance on the development path of a more purified formulation of ONTAK. Based on the FDA's pre-BLA meeting comments, we intend to move forward with our planned BLA submission for I/ONTAK in the second half of 2022. We look forward to continued engagement with the FDA as we advance this program to provide CTCL patients with a potential new treatment option," stated Leonard Mazur, Chairman and CEO of Citius.

About I/ONTAKI/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively, making it potentially eligible for seven years of market exclusivity post-approval for each indication.

About Cutaneous T-cell LymphomaCutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Szary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple systemic agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL. Approximately 3,000 new cases are reported in the United States every year, with an estimated 30,000 - 40,000 individuals living with the disease.

About Citius Pharmaceuticals, Inc.Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company has two late-stage product candidates, Mino-Lok, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), for which a BLA submission is being prepared for the second half of 2022. Mino-Lokwas granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). For more information, please visit http://www.citiuspharma.com.

Safe Harbor This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "believe," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: we may experience delays or unexpected hurdles in our efforts to submit a BLA for I/ONTAK and we may not be able to submit the BLA on the timelines we expect or at all; the FDA may find inadequacies and deficiencies in our BLA for I/ONTAK, including in the data we submit, and may decide not to accept the BLA for filing; our ability to successfully undertake and complete clinical and non-clinical trials and the results from those trials for our product candidates; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to commercialize our products if approved by the FDA; our dependence on third-party suppliers; the ability of our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating to preclinical and clinical testing; our need for substantial additional funds; the early stage of products under development; market and other conditions; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; patent and intellectual property matters; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our ability to procure cGMP commercial-scale supply; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by Covid-19. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at http://www.sec.gov, including in our Annual Report on Form 10-K for the year ended September 30, 2021, filed with the SEC on December 15, 2021 and updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Investor Relations for Citius Pharmaceuticals:Ilanit Allen Vice President, Investor Relations and Corporate Communications T: 908-967-6677 x113 E: [emailprotected]

SOURCE Citius Pharmaceuticals, Inc.

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Citius Pharmaceuticals, Inc. Holds Pre-BLA Meeting with the FDA for I/ONTAK (denileukin diftitox) for the Treatment of Cutaneous T-Cell Lymphoma - PR...

NexImmune Announces IND Clearance by the US FDA for NEXI-003 for the Treatment of HPV-Related Cancers | DNA RNA and Cells | News Channels -…

Details Category: DNA RNA and Cells Published on Saturday, 16 July 2022 13:48 Hits: 424

GAITHERSBURG, MD, USA I July 14, 2022 I NexImmune, Inc.(Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, has received IND clearance for the Companys first cellular therapy product candidate addressing solid tumors. NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.

Kristi Jones, NexImmunes CEO, commented, The FDA clearance of our third IND marks another significant milestone for NexImmune and demonstrates our teams continued focus and commitment to bringing novel therapies to patients with significant unmet need. NEXI-003 is our third T cell therapy and first candidate to address solid tumors. NEXI-003 consists of T cell populations simultaneously directed against multiple HPV tumor-relevant antigen targets. The T cells in our product candidate will consist of T cell subtypes critical to both potential anti-tumor activity and a phenotype intended to produce long-term immunologic memory required for durable responses.

The Phase 1 trial will enroll patients at multiple clinical sites across the United States. The proposed study is a two-part, multicenter, open-label, dose-finding, first-in-human (FIH) study to characterize the safety and clinical activity of NexImmunes HPV tumor-relevant antigen-specific CD8+ T cell product candidate (NEXI-003) in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers (with confirmed histopathology detection of HPV-16 and/or HPV-18 expression), who have received at least 1 prior regimen of standard therapy according to local standard of care guidance(s). The dose escalation phase will consist of multiple safety cohorts investigating increasing doses of NEXI-003 followed by an expansion phase that will enroll 24 to 36 patients overall, depending on the number of dose escalations. All patients will be followed for at least one year. Following initial data and after the recommended Phase 2 dose has been confirmed, NexImmune plans to expand the NEXI-003 development program to include other HPV related malignancies and evaluate potential SOC combination options across the patient populations.

About HPV-Related Cancers

Human papillomavirus (HPV)-related cancers are common epithelial malignancies that account for approximately 5% of all cancers globally. These cancers cause an estimated 12,500 deaths each year in the United States and more than 300,000 deaths each year throughout the world. Histologically, this family of cancers consists of squamous cell carcinomas and adenocarcinomas that occur in various anatomical sites including the oropharynx, uterine cervix, anus, vagina, vulva and penis. The high-risk HPV subtypes are most commonly HPV-16 and HPV-18. Malignant transformation results through the activation of the expression of the E6 and E7 HPV oncogenes, which inhibit the tumor suppressors p53 and Rb. These oncoproteins also inhibit apoptosis of tumor cells, deregulate the cell cycle, result in the accumulation of genetic instability, promote angiogenesis and facilitate the invasiveness and metastatic spread of cancerous cells.

AboutNexImmune

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the bodys own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmunes approach is a proprietary Artificial Immune Modulation (AIM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

NexImmunes two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least three prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visitwww.neximmune.com.

SOURCE: NexImmune

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Cynata closes in on patent protection – The West Australian

Cynata Therapeutics has taken another step on its path towards commercialising the companys proposed asthma treatment by passing another milestone that adds an important layer of IP protection to its cutting-edge stem cell technology.

The Melbourne-based biotech has received a Notice of Allowance from the United States, flagging imminent good news on its patent application for treatment to combat asthma using its Cymerus mesenchymal stem cells, or MSCs, technology platform. The notice came from the United States Patent and Trademark Office, that sends such notices when it intends to issue a patent.

Cynata expects the patent will be granted about October and be in force until the end of August 2038.

The patent will be wholly owned by Cynata.

However, it will also be an impressive feather in the mortar boards of two academics contracted by the company who invented the proposed treatment, formally called the Method for Treating Allergic Airways Disease/Asthma.

They are Professor Chrishan Samuel, a Monash Biomedicine Discovery Fellow and Head of the Fibrosis Laboratory and Dr Simon Royce, Research Fellow, Department of Pharmacology at Monash University.

We are delighted that Professor Samuels investigations around the utility of Cynatas proprietary MSCs in lung disease has resulted in yet a further patent, particularly in the commercially vital jurisdiction of the USA. This new milestone builds on our portfolio of wholly Cynata-owned patents and patent applications, providing further protection over our proprietary Cymerus technology to 2038 and beyond, particularly in the field of diseases of the lungs.

Professor Samuels earlier work confirmed the potent anti-inflammatory and anti-fibrotic effects of the companys Cymerus MSCs in asthma and idiopathic pulmonary fibrosis, or IPF.

MSCs are regarded as the controllers of functional elements of a bodys immune system and play a vital role in repair and regeneration mechanisms.

They are being widely examined worldwide for their potential in combatting various diseases and have been involved in more than 1000 clinical trials globally over the past decade.

The company says its Cymerus technology addresses many of the issues faced in manufacturing MSCs at commercial scale because it allows cost-effective and consistent production of all the cells ever needed from just a single blood donation.

Cymerus is at the centre of Cynatas attention on a range of diseases and medical conditions. One target is so-called graft versus host disease, typically suffered by recipients of bone marrow transplants.

In another major milestone for the company, Cynata recently received US FDA clearance for an investigational new drug application for a Phase 2 trial for Cymerus treatment for graft versus host disease.

That trial, when it starts, will add to the three trials Cynata already has underway. The busy pipeline of work is one reason the company might not rush to launch a trial on the back of a new patent for its proposed asthma treatment.

However, in the land of medical biotechnology, where Big Pharma and innovative minnows constantly strive for mutually beneficial alliances and deals, waving a patent at the negotiating table is seen as a vital ingredient in any talks involving big money.

The carrot is finding an effective treatment for asthma, that currently soaks up an estimated US$20-25 billion of healthcare spending worldwide every year. One estimate has it passing the US$34 billion mark by 2028.

Junior biotechs such as Cynata Therapeutics that want a slice of the very big medicine pie need to make it as difficult as possible for competitors to encroach on their turf so the more protection they can build around their assets with patents and suchlike, the better.

Is your ASX-listed company doing something interesting? Contact: matt.birney@wanews.com.au

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Cynata closes in on patent protection - The West Australian

Cataract Treatment Market Trends, Drivers and Growth Projection Up to 2029 Alcon Vision LLC, Essilor, Ziemer Ophthalmic Systems, Bausch Health,…

Data Bridge Market Research analyses that thecataract treatment marketwill exhibit a CAGR of around 5.00% for the forecast period of 2022-2029. Growing demand for targeted mode of therapies, surge in the research and development activities for the development of noveldrugsand therapies, increasing programmes by government and non-profit organizations to reduce the burden of cataract-related diseases worldwide and increased expenditure for the development ofhealthcareinfrastructure are the major factors attributable to the growth of cataract treatment market.

Cataract is an eye related disorder wherein one suffers blurry vision due to clouding of lens in the eye. Cataract slowly leads to decrease in the vision ability and in some cases even loss of vision. In this medical condition, the protein, that form the lens of an eye get clumped down.

Get a Sample PDF of the report https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cataract-treatment-market

This cataract treatment market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on cataract treatment market contact Data Bridge Market Research for anAnalyst Brief,our team will help you take an informed market decision to achieve market growth.

Global Cataract Treatment Market Scope and Market Size

The cataract treatment market is segmented on the basis of type, treatment, drugs class, drugs, route of administration, distribution channel and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

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Cataract Treatment Market Country Level Analysis

The cataract treatment market is analysed and market size insights and trends are provided by country, type, treatment, drugs class, drugs, route of administration, distribution channel and end user as referenced above. The countries covered in the cataract treatment market report are U.S., Canada and Mexico in North America, Peru, Brazil, Argentina and Rest of South America as part of South America, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe in Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), South Africa, Saudi Arabia, U.A.E, Kuwait, Israel, Egypt, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA).

North America dominates the cataract treatment market owing to the earliest adoption of innovative technologies, growing research and development capacities and well-structured regulatory framework. Asia-Pacific is projected to undergo substantial gains during the forecast period and score the highest CAGR. This is because of the rising expenditure to develop healthcare infrastructure, increasing health care spending, rising prevalence of cataract disorders, favourable regulations and increasing personal disposable income.

The country section of the cataract treatment market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Competitive Landscape and Cataract Treatment Market Share Analysis

The cataract treatment market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to cataract treatment market.

The major players operating in the cataract treatment market report are Abbott, Johnson & Johnson Services, Inc, Novartis AG, HOYA Corporation, Carl-Zeiss-Stiftung, Alcon Vision LLC, Essilor, Ziemer Ophthalmic Systems, Bausch Health, GENZUM LIFE SCIENCES, AbbVie Inc, Santen Pharmaceutical Co., Ltd, Omeros Corporation, Sun Pharmaceutical Industries Ltd, EyePoint Pharmaceuticals, Inc., Reata Pharmaceuticals, Inc., Acumen BioPharma, LLC, Takeda Pharmaceutical Company Limited, AstraZeneca and F. Hoffmann-La Roche Ltd among others.

Browse the complete table of contents at https://www.databridgemarketresearch.com/toc/?dbmr=global-cataract-treatment-market

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Cataract Treatment Market Trends, Drivers and Growth Projection Up to 2029 Alcon Vision LLC, Essilor, Ziemer Ophthalmic Systems, Bausch Health,...

Global Nerve Repair and Regeneration Market Is Thriving Amid the Pandemic: Projected to Reach USD 10.7 Billion By 2027 | BlueWeave Consulting -…

New Delhi, July 13, 2022 (GLOBE NEWSWIRE) -- Several factors contribute to the growth of the global nerve repair and regeneration market, including the high incidence of nerve injuries, the increase in neurological disorders, and the rise in government funding for research into neurologic disorders

A recent study conducted by the strategic consulting and market research firm, BlueWeave Consulting, revealed that the global nerve repair and regeneration market was worth USD 6.2 billion in the year 2020. And it is estimated to grow at a CAGR of 7.6%, earning revenue of around USD 10.7 billion by the end of 2027. The prevalence of neurological disorders is increasing at a very rapid rate especially due to the rising geriatric population which has fueled the demand for neurological surgeries, further propelling the demand for nerve repair and regeneration products and devices. Furthermore, other factors contributing to the growth of the global nerve repair and regeneration market include the availability of various types of neurological procedures in medical science, such as brain surgery, spine surgery, and endovascular surgery.

Advancement in The Stem Cell Therapy Will Boost the Global Nerve Repair and Regeneration Market in The Forecast Period

Stem cell therapy is the use of stem cells for the treatment and prevention of various medical conditions. It is widely popular as regenerative medicine' because it helps in repairing damaged cells within the body by reducing inflammation. That is why they are widely used in nerve repair and regeneration surgical procedures. Stem cell therapy is one of the fastest-growing applications in neurological surgical procedures. The government is also taking various initiatives and is funding research and approving clinical trials of stem cell therapy which is expected to boost the global nerve repair and regeneration market in the forecast period.

Technological Advancements in Nerve Repair and Regeneration Procedures

The development of various devices and products in the nerve repair and regeneration field is one of the major factors behind the growth of the global nerve repair and regeneration market. The availability of a wide range of products through various market players is supporting the growing demand for neurological surgical procedures. For instance, Mayo Clinic researchers are working on cell-based therapy for a neurological disorder called amyotrophic lateral sclerosis. Through this, they aim to use adipose-derived mesenchymal stem cells from a patient's body, modify it in the laboratory and deliver it back into their body. However, the research is still in its early stages.

Request For Free Sample Report @ https://www.blueweaveconsulting.com/report/global-nerve-repair-and-regeneration-market/report-sample

Neurostimulation & Neuromodulation Will Lead the Market in The Forecast Period

Based on applications, the global nerve repair and regeneration market is classified into neurostimulation & neuromodulation applications and nerve repair & regeneration biomaterials. Among these, the neurostimulation & neuromodulation segment leads the market due to the availability of treatment for various neurological disorders like epilepsy, Alzheimer's disease, and other dementias. In addition, peripheral nerve injuries are increasing largely due to an increase in accidents, which has led to an increase in the demand for neurostimulators and neuromodulators.

Global Nerve Repair and Regeneration Market - Regional Insights

Geographically, the global nerve repair and regeneration market are segmented into North America, Europe, Asia-Pacific, Latin America, Middle-East & Africa. North America holds the largest market share due to the high concentration of major market players in this region. However, the Asia-Pacific region is estimated to witness the highest CAGR in the forecast period due to the increasing geriatric population with more neurological disorders compared to other demographics. Furthermore, the awareness surrounding neurological disorders is going high in Asia-Pacific countries, which is anticipated to pull significant demand for nerve repair and regeneration products during the forecast period.

Please Visit Press Release for the Global Nerve Repair and Regeneration Market: https://www.blueweaveconsulting.com/press-release/global-nerve-repair-and-regeneration-market-is-thriving-amid-the-pandemic-projected-to-reach-usd-10-7-billion-by-2027

Impact of COVID-19 on Global Nerve Repair and Regeneration Market

The global nerve repair and regeneration market has been negatively impacted during the initial phase of the COVID-19 outbreak. Nerve repair and regeneration market demand declined as all non-emergency and elective surgeries were postponed as a result of the recession. However, neurological disorders are sensitive medical conditions that tend to worsen over time. Therefore, they need immediate treatment. Due to this reason, all neurological surgeries have resumed as soon as possible, pulling the demand for nerve repair and regeneration products.

Competitive Landscape

The leading market players in the global nerve repair and regeneration market are Stryker, Neuropace Inc., Livanova, Boston Scientific Corporation, Axogen Corporation, Neuronetics, Medtronic, Integra Lifesciences Corporation, Baxter, Abbott Laboratories, Polyganics, St. Jude Medical, Cyberonics, Inc, Soterix Medical, Inc., Nevro, Kerimedical, Biowave Corporation, Neuronetics, Inc., Synapse Biomedical, Inc., and other prominent players.

The market is highly consolidated and competitive with the presence of global players like Abbott Laboratories, Boston Scientific Corporation, etc. dominating the market. The industry participants invest in extensive research and development and focus on innovating and advancing the products and technologies to grab a larger share in the market.

Don't miss the business opportunity of the global nerve repair and regeneration market. Consult our analysts to gain crucial insights and facilitate your business growth.

The in-depth analysis of the report provides information about growth potential, upcoming trends, and statistics of the global nerve repair and regeneration market. It also highlights the factors driving forecasts of total market size. The report promises to provide recent technology trends of the global nerve repair and regeneration market and industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyses the growth drivers, challenges, and competitive dynamics of the market.

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Global Nerve Repair and Regeneration Market Is Thriving Amid the Pandemic: Projected to Reach USD 10.7 Billion By 2027 | BlueWeave Consulting -...