-- HAV implanted in nearly 500 patients with more than 1,000 patient-years of follow up to date, for treatment of peripheral arterial disease, arteriovenous access for hemodialysis, and trauma –

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Humacyte Announces JAMA Surgery Publication Highlighting Potential of Human Acellular Vessel™ (HAV™) to Expand Vascular Trauma Reconstruction and...

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Industry veteran brings over two decades of global experience in pharmaceutical, medical devices and biotech industries Industry veteran brings over two decades of global experience in pharmaceutical, medical devices and biotech industries

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Amolyt Pharma Strengthens Leadership Team with Appointment of Mark Sumeray, M.D., as Chief Medical Officer

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Positive Data for Istaroxime in Early Cardiogenic Shock

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Windtree Is Leveraging Positive Istaroxime Early Cardiogenic Shock Results to Proactively Engage in Licensing Discussions and Explore Strategic...

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BEDFORD, Mass., June 29, 2022 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today participation and presentations at the following conferences:

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Homology Medicines to Present at Upcoming Conferences on its Gene Editing and Gene Therapy Programs for PKU

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Read the full announcement in PDF

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Novozymes’ financial calendar 2023

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TEL AVIV, Israel, June 29, 2022 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (the "Company" or "SciSparc"), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that it has successfully completed the development of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase IIb study for Tourette Syndrome ("TS").

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SciSparc Successfully Completed The Development of its Proprietary Drug Candidate SCI-110 for its Upcoming Phase IIb Study In Tourette Syndrome

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Completion of enrollment for Phase 3 study targeted within 18-24 months

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Palisade Bio Initiates Phase 3 Study of LB1148 in Lead Indication for Postoperative Return of Bowel Function

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Newly Issued Patent Broadens Medical Uses of Oral APX3330 Therapy in Patients with Diabetes and Extends Expiry Thru 2038

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Ocuphire Granted New U.S. Patent for Late-Stage Oral Drug Candidate APX3330 for Use in Diabetics and Announces New Peer-Reviewed APX3330 Publication

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Orphazyme A/SCompany announcementNo. 33/2022                                                                    www.orphazyme.comCompany Registration No. 32266355

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Resolutions passed at the Annual General Meeting

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Study Supports Translation of Potential New Mechanism of Action for Neuropathic Pain and Advancement of LX9211 Development in Painful Diabetic Neuropathy

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Lexicon Announces Positive Top-Line Results From Phase 2 Proof-Of-Concept Study Of LX9211 In Painful Diabetic Neuropathy

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UNIONDALE, N.Y., June 29, 2022 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases, today announced the discontinuation of JUNIPER, its Phase 2 dose-finding trial of ANG-3070, an oral tyrosine kinase inhibitor (TKI), in patients with primary proteinuric kidney diseases, specifically focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy (IgAN). This trial, which began enrolling patients in December 2021, is being discontinued in the interest of patient safety based upon a reassessment of the risk/benefit profile of ANG-3070 in patients with established serious kidney disease.

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Angion Announces Discontinuation of Phase 2 Trial of ANG-3070 in Patients with Primary Proteinuric Kidney Disease

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-- Recorded Fourth Quarter and Full Fiscal Year Revenue of $31 Million and $120 Million, Respectively ---- Signed $44 Million in Net New Business Orders and Ended the Quarter with a Record High Backlog of $153 Million --

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Avid Bioservices Reports Financial Results for Fourth Quarter and Full Fiscal Year Ended April 30, 2022 and Recent Developments

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DUBLIN, Ireland, June 29, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the steps it is taking to explore every available pathway to accelerate the decision by the U.S. Food and Drug Administration (FDA) to grant final approval of its lead drug candidate, FT218, prior to June 2023. Concurrent with this strategy, Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy (“REMS”) with FDA and expects to receive tentative approval of FT218.

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Avadel Pharmaceuticals Provides Corporate Update

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Meenu Chhabra Karson appointed to Board succeeding Dr. Kenneth Fong as Chair of the Board Meenu Chhabra Karson appointed to Board succeeding Dr. Kenneth Fong as Chair of the Board

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Apexigen Announces Board Appointment and New Chair

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NEW YORK and MAINZ, GERMANY, JUNE 29, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year.

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Pfizer and BioNTech Announce New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine

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LA JOLLA, Calif., June 29, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). The contract was amended to extend the period of performance until March 2023.

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MediciNova Announces Extension of BARDA Contract to Develop MN-166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

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HALIFAX, Nova Scotia, June 29, 2022 (GLOBE NEWSWIRE) -- MedMira Inc. (MedMira) (TSXV: MIR), reported today on its financial results for the quarter ended April 30, 2022.

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MedMira Reports Third Quarter Results FY2022

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A paper recently published in the journal Biomaterials reviewed the new advances in three-dimensional bioprinting (3DBP) for regenerative therapy in different organ systems.

Study:Advances in 3D bioprinting of tissues/organs for regenerative medicine and in-vitro models. Image Credit:luchschenF/Shutterstock.com

Organ/tissue shortage has emerged as a significant challenge in the medical field due to patient immune rejections and donor scarcity. Moreover, mimicking or predicting the human disease condition in the animal models is difficult during preclinical trials owing to the differences in the disease phenotype between animals and humans.

3DBP has gained significant attention as a highly-efficient multidisciplinary technology to fabricate 3D biological tissue with complex composition and architecture. This technology allows precise assembly and deposition of biomaterials with donor/patients cells, leading to the successful fabrication of organ/tissue-like structures, preclinical implants, and in vitro models.

In this study, researchers reviewed the 3DBP strategies currently used for regenerative therapy in eight organ systems, including urinary, respiratory, gastrointestinal, exocrine and endocrine, integumentary, skeletal, cardiovascular, and nervous systems. Researchers also focused on the application of 3DBP to fabricate in vitro models. The concept of in situ 3DBP was discussed.

In this extensively used low-cost bioprinting method, rotating screw gear or pressurized air is used without or with temperature to extrude a continuous stream of thermoplastic or semisolid material. Different materials can be printed at a high fabrication speed using this technology. However, low cell viability and the need for post-processing are the major drawbacks of extrusion bioprinting.

In this method, liquid drops are ejected on a substrate by acoustic or thermal forces. High fabrication speed, small droplet volume, and interconnected micro-porosity gradient in the fabricated 3D structures are the main advantages of this technique. However, limited printed materials and clogging are the biggest drawbacks of inkjet bioprinting.

A laser is used to induce the forward transfer of biomaterials on a solid surface in the laser-assisted bioprinting method. High cell viability and nozzle-free noncontact process are the biggest advantages of laser-assisted bioprinting, while metallic particle contamination and the time-consuming nature of the printing process are the major disadvantages.

Several studies were performed involving the development of neuronal tissues using the 3DBP method. The pressure extrusion/syringe extrusion (PE/SE) bioprinting technique was used for central nervous tissue (CNS) tissue replacement. The layered porous structure was fabricated using glial cells derived using human induced pluripotent stem cell (iPSC) and a novel bioink based on agarose, alginate, and carboxymethyl chitosan (CMC) formed synaptic networks and displayed a bicuculline-induced enhanced calcium response.

Similarly, stereolithography (SLA) was used to fabricate a 3D scaffold for CNS and the viability of the scaffold was evaluated for regenerative medicine application. Layered linear microchannels were printed using poly(ethylene glycol) diacrylate-gelatin methacrylate (PEGDA-GelMA) and rat E14 neural progenitor cells (NPCs). The 3D scaffold restored the synaptic contacts and significantly improved the functional outcomes. Cyclohexane was used to bond polystyrene fibers to matrix bundle terminals during crosslinking.

Multiphoton excited 3-dimensional printing (MPE-3DP) was employed for the regeneration of myocardial tissue. A layer-by-layer structure was fabricated using GelMA/ sodium 4-[2-(4-morpholino)benzoyl-2-dimethylamino]-butylbenzenesulfonate (MBS) and human hciPSC-derived cardiomyocytes (CMs), endothelial cells (ECs), and smooth muscle cells (SMCs). The crosslinking was performed by photoactivation. The structure promoted electromechanical coupling and improved cell proliferation, vascularity, and cardiac function.

Fused deposition modeling (FDM) and PE/SE bioprinting method were used for complex tissue and organ regeneration. A micro-fluid network heart shape structure was fabricated using polyvinyl alcohol (PVA), agarose, sodium alginate, and platelet-rich plasma and rat H9c2 cells and human umbilical vein endothelial cells (HUVECs). 2% calcium dichloride was used during the crosslinking mechanism. The fabricated structure possessed a valentine heart with hollow mechanical properties and a self-defined height.

SE printing was utilized to fabricate a capillary-like network using collagen type1/ xanthan gum and human fibroblasts and ECs for applications in blood vessels. The fabricated network possessed endothelial networks and sprouting between the fibroblast layers.

Bone, cartilage, and skeletal muscle tissue can be repaired and regenerated using the 3DBP technique. For instance, FDM printing was used to print multifunctional therapeutic scaffolds for the treatment of bone. Filopodial projections were fabricated using polylactic acid (PLA) platform loaded with hyaluronic acid (HA)/ iron oxide nanoparticles (IONS)/ minocycline and human MG-63 and human bone marrow stromal cells (hBMSCs), which improved the osteogenic stimulation of the IONS and HA.

PE/SE method was used to fabricate disks and cuboid-shaped scaffolds using - tricalcium phosphate (TCP) microgel and human fetal osteoblast (hFOB) and bone marrow-derived mesenchymal stem cell (BM-MSC) for bone repair, multicellular delivery, and disease model. The fabricated structures promoted osteogenesis.

PE/SE bioprinting was also utilized to fabricate complex porous layered cartilage-like structures using alginate/gelatin/HA, rat bone marrow mesenchymal stem cells (BMSCs), and cow cardiac progenitor cells (CPCs) for hyaline cartilage regeneration. The CPCs upregulated gene expression of proteoglycan 4 (PRG4), SRY-box transcription factor 9 (SOX9), and collagen II.

PE/SE printing was also used to fabricate multinucleated, highly-aligned myotube structures using polyurethane (PU), poly(-caprolactone) (PCL), and mouse C2C12 myoblasts and NIH/3T3 fibroblasts for in-situ expansion and differentiation of skeletal muscle tendon. The fabricated constructs demonstrated more than 80% cell viability with initial tissue differentiation and development.

SLA bioprinting technique was used to fabricate bi-layered epidermis-like structure using collagen type I, mouse NIH 3T3 fibroblast cells, and human keratinocyte cells for tissue model and engineering. The fabricated constructs effectively imitated the tissue functions.

Similarly, PE was employed to fabricate microporous structures using human amniotic mesenchymal stem cells (AFSCs) and heparin-HA-PEGDA for wound healing. The construct improved the wound closure and reepithelialization, increased extracellular matrix synthesis and vascularization, and prolonged the cell paracrine activity.

PE technique was utilized to prepare a multilayered cornea-like structure using human keratocytes and methacrylated collagen (ColMA)-alginate. The cell viability of the keratocytes decreased from 90% to 83% after printing.

PE/SE bioprinting was utilized to bioprint multilayered liver-like structures using GeIMA and human HepG2/C3A for liver tissue engineering. Similarly, hepatocytes were also bioprinted to fabricate multiple organ precursors with branching vasculature. A small intestine model with improved intestinal function and high cell proliferation was fabricated using caco-2 cell-loaded polyethylene vinyl acetate (PEVA) scaffold.

Spheroids of mesenchymal stem cells (MSCs) and chondrocytes and lung endothelial cells were utilized to fabricate scaffold-free tracheal transplant. After implantation in the rat model, the matured spheroids displayed excellent vasculogenesis, chondrogenesis, and mechanical strength. FDM technique was used to fabricate a glomerular structure for kidneys using human iPSCs and hydrogel and a hollow porous network using poly(lactic-co-glycolic acid (PLGA)/PCL/tumor-associated endothelial cells (TECs) for the urethra.

In in-situ bioprinting, the tissue is directly printed on the specific defect or wound site in the body for regenerative and reparative therapy. This method provides a well-defined structure and reduces the gap between host-implant interfaces. In-situ bioprinting is better than in vitro bioprinting techniques as the patients body, as a natural bioreactor, provides a natural microenvironment.

Several studies have evaluated this technique for tissue regeneration. For instance, PE/SE method was used for skin tissue regeneration in pigs and mice using fibrin/collagen/HA and human fibroblast cells. Skin-laden sheets of consistent composition, thickness, and width were formed upon rapid crosslinking of biomaterial. PE/SE technique was also used for neural tissue regeneration in mice using agarose/CMC/alginate and human iPSCs.

In vitro models provide significant assistance in understanding the mechanism of therapeutics and disease pathophysiology. Recently, in vitro models of human tissues and organs were engineered using 3DBP technology for safety assessment and drug testing.

In the 3DBP of organs and tissues, biomaterials play a crucial role in maintaining cellular viability, providing support, and long-term acceptance. Specifically, bioinks must possess unique properties, such as cell growth promotion and structural stability, that can be optimized for clinical use. Additionally, bioinks must be compatible with printers for high-precision rapid prototyping.

Bioinks fulfilling all of these requirements are yet to be identified. Moreover, managing the time during the bioprinting of the constructs is another major challenge, as the time required to fabricate them is often more than the survival time of cells. A bioreactor platform that supports organoid growth and provides time for tissue remodeling can be used to overcome this challenge. Ethical challenges and issues are also a hurdle since fabricating internal tissues/organs can lead to liability and biosafety concerns.

In the future, 3DBP can provide novel solutions to engineer organs/tissues and revolutionize modern healthcare and medicine if these challenges can be addressed.

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Jain, P., Kathuria, H., Dubey, N. Advances in 3D bioprinting of tissues/organs for regenerative medicine and in-vitro models. Biomaterials 2022. https://www.sciencedirect.com/science/article/abs/pii/S0142961222002794?via%3Dihub

Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.

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What New Advances are there in 3D Bioprinting Tissues? - AZoM

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Global Surgical Mesh Market Is Estimated To Be Valued At US$ 1.29 Bn In 2022, And Is Forecast To Surpass US$ 2.2 Bn Valuation By The End Of 2032

Sales of surgical meshes are expected to account for more than 21 Mn units by 2032-end, owing to their increasing application in untapped markets, says a Fact.MR analyst.

Fact.MR A Market Research and Competitive Intelligence Provider: The global surgical mesh market is estimated to exceed a valuation of US$ 1.29 Bn in 2022, and expand at a significant CAGR of 5.5% by value over the assessment period (2022-2032).

The availability of surgical meshes in absorbable and non-absorbable forms has expanded their application for temporary as well as permanent reinforcement. In recent years, demand for surgical meshes has escalated in aiding breast reconstruction as they reduce the exposure risk of the implant. Increasing health literacy in North America and Europe will create ample opportunities for surgical mesh manufacturers over the coming years.

Sedentary lifestyle and increasing obesity among the population have resulted in several chronic health issues. The consequent weakening of the muscles extends space for organ prolapse and hernia. Putting these organs back in place by stitching the muscles together can result in muscle tearing and the recurrence of prolapse. However, reinforcing the weakened muscles with the help of a surgical mesh has shown to decrease recurrence and increase the longevity of the repair.

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Winning Strategy

To attract new customers, market players are focusing on portfolio enhancement. Robust investments in R&D are driving product innovation for key market players. Meshes inhibiting the growth of bacterial films and preventing tissue adhesions are luring new consumers. Collaboration of manufacturers with scientific personnel and operating surgeons have enabled bespoke designing of meshes to best fit patients needs.

Manufacturers are also aiming for portfolio expansion through acquisition and partnerships. Partnering with companies that offer a well-aligned portfolio has significantly increased consumer penetration for key manufacturers. However, augmenting relations with local players and operating surgeons will be a key determinant of the products commercial success.

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Scientific collaborations and robust R&D investments have also guided product innovation and became a common strategic approach adopted by leading surgical mesh manufacturing companies to upscale their market presence.

For instance:

Surgical Mesh Industry Research by Category

Surgical Mesh Market by Product Type:

Surgical Mesh Market by Nature:

Surgical Mesh Market by Surgical Access:

Surgical Mesh Market by Use Case:

Surgical Mesh Market by Raw Material:

Surgical Mesh Market by Region:

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More Valuable Insights on Offer

Fact.MR, in its new offering, presents an unbiased analysis of the global surgical mesh market, presenting historical market data (2017-2021) and forecast statistics for the period of 2022-2032.

The study reveals essential insights on the basis of product type (synthetic, biosynthetic, biologic, hybrid/composite), nature of mesh (absorbable, non-absorbable, partially absorbable), surgical access (open surgery, laparoscopic surgery), use case (hernia repair, pelvic floor disorder treatment, breast reconstruction, others), and raw material (polypropylene, polyethylene terephthalate, expanded polytetrafluoroethylene, polyglycolic acid, decellularized dermis/ECM, others), across seven major regions (North America, Latin America, Europe, East Asia, South Asia & ASEAN, Oceania, MEA).

Fact. MRs Domain Knowledge in Healthcare Division

Expert analysis, actionable insights, and strategic recommendations of the highly seasoned healthcare team at Fact.MR helps clients from across the globe with their unique business intelligence needs

With a repertoire of over thousand reports and 1 million-plus data points, the team has analysed the healthcare domain across 50+ countries for over a decade. The team provides unmatched end-to-end research and consulting services.

Check out more studies related to Healthcare Industry, conducted by Fact.MR:

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Doxorubicin Market - Doxorubicin Market Analysis, By Formulation (Lyophilized Doxorubicin Powder, Doxorubicin Solution), By Cancer Type (Breast Cancer, Prostate Cancer, Ovarian Cancer, Lung Cancer, Bladder Cancer, Stomach Cancer, Leukemia), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, e-Commerce) - Global Market Insights 2022 to 2026

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Technical Advancements & Innovative Products Likely to Expand Application of Surgical Meshes in Untapped Domains, States Fact.MR - BioSpace

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Second-line lisocabtagene maraleucel (liso-cel; Breyanzi) provides an earlier CAR T-cell treatment option that improves survival outcomes and produces a manageable safety profile in patients with relapsed/refractory large B-cell lymphoma (LBCL), including those who are older and have comorbidities, according to Nilanjan Ghosh, MD, PhD.

On June 24, 2022, the FDA approved liso-cel in the second line for patients with relapsed/refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal LBCL, follicular lymphoma grade 3B, and high-grade B-cell lymphoma. This approval was supported by data from the phase 3 TRANSFORM trial (NCT03575351) and the phase 2 TRANSCEND-PILOT-017006 study (NCT03483103).

Liso-cel is a fantastic option, because it has a great efficacy profile and is also a safe product amongst the available CAR T-cell products, with a relatively low incidence of cytokine release syndrome [CRS] and neurological events [NEs], the majority of which are low grade, Ghosh said.

In an interview with OncLive, Ghosh, director of the Lymphoma Program at the Levine Cancer Institute of Atrium Health, discussed the significance of the liso-cel approval in this patient population. He also highlighted how liso-cel will influence current treatment sequencing, which patients might derive the most benefit from this therapy, and the adverse effects (AEs) to be aware of and try to mitigate when prescribing liso-cel.

Ghosh: This approval is highly significant. The majority of patients with primary refractory DLBCL and early relapsed DLBCL do not derive benefit from standard-of-care [SOC] salvage chemotherapy followed by ASCT [autologous stem cell transplant], [which had been the best option until now].

The data from the TRANSFORM study showed liso-cel to be superior to high-dose salvage chemotherapy and ASCT. This approval will allow earlier access to CAR T-cell therapy for this group of patients.

Most patients with LBCL receive frontline therapy in the community setting. In addition to making our community aware of this indication, we need to educate our community about the time it takes to receive CAR T-cell therapy. The process includes many steps, such as gaining financial clearance and setting a date for T-cell collection, or leukapheresis. This date must be acceptable to both the institution [providing the treatment] and the company manufacturing the CAR T cells. [We also need to factor in] the time spent manufacturing the CAR T cells, often known as the vein-to-vein time. This entire process can take 6 weeks or more.

We often focus on just the vein-to-vein time, but there are many other steps even before leukapheresis. These patients are also refractory or have early relapsed disease that must be controlled while they are waiting to receive CAR T-cell therapy. Early referral to a CAR T-cell center is crucial to get the process going while discussing with the referring physician ways and means to control the disease in the interim. Those might include strategies like bridging therapy, which was allowed on the TRANSFORM study.

Insome patients, liso-cel may end up being a third-line therapy, despite its indication as a second-line therapy, because you may have to give another therapy to control the disease while the patients are waiting to receive CAR T cells. That discussion would best be done with the treating center and the referring physician, because some treatments can be toxic to lymphocytes, and you may want to avoid those kinds of treatments prior to collecting the lymphocytes. At the same time, we must make sure we control the disease so the patients can receive the treatment they may benefit from in the future.

Many factors must be taken into account before giving liso-cel. We look at the ECOG performance status [PS], as well as cardiac function and renal function.

Looking at comorbidities, fortunately, the TRANSCEND-PILOT-017006 trial included patients with comorbidities who were not considered good candidates for ASCT. To enroll in the study, the investigators needed to verify that the patients were not good candidates for transplant. [They also needed to meet at least 1 of the criteria], which included being over 70 years of age, having impaired renal function, having impaired cardiac function, or having a decrease in [diffusing capacity of the lungs for carbon monoxide], which is reflective of pulmonary function. The investigators also looked at hepatic function.

The outcomes of this study were good. The bottom line is that patients who are going to receive liso-cel need not only be candidates you would otherwise consider for ASCT. The eligibility for liso-cel is much broader than standard transplanteligibility in terms of age, comorbidities, and disease status. That is the most important thing. A patient who is older, has some comorbidities, and has relapsed or refractory LBCL can still benefit from liso-cel with high efficacy and low toxicity, which is what liso-cel offers in this patient population.

TRANSFORM was a randomized study of patients with DLBCL not otherwise specified, which includes de novo DLBCL and those who have transformed from indolent non-Hodgkin lymphoma; high-grade B cell lymphoma, which includes double-hit and triple-hit lymphoma; follicular lymphoma grade 3B; primary mediastinal B-cell lymphoma; and T-cell or histiocyte-rich DLBCL. Eligible patients needed to have either developed refractory disease from frontline therapy or relapsed within 12 months after frontline therapy. The frontline therapy should have included an anthracycline anda CD20 agent, which is the SOC. In addition, these patients should have been otherwise considered to be eligible for ASCT and had an ECOG PS of 0 to 1.

Eligible patients underwent leukapheresis and then were randomized to receive liso-cel or SOC, which was salvage chemotherapy followed by ASCT for those who responded to salvage chemotherapy. Importantly, this study included crossover from the SOC arm to the liso-cel arm. This was allowed for those who failed to respond to SOC by 9 weeks post-randomization, those who progressedat any time, or those who started a new antineoplastic therapy after transplant.

The primary end point was event-free survival [EFS]. Events were defined as death from any cause, progressive disease, failure to achieve complete response [CR] or partial response by 9 weeks post randomization, or the start of an antineoplastic therapy, whichever occurred first. The median EFS with liso-cel was 10.1 months compared with 2.3 months with SOC. At 12 months, the EFS rates were 44.5% with liso-cel and 23.7% with SOC. That was a significant margin of benefit.

In terms of responses, in this recent population, were most interested in CR. A total of 66% of the patients who received liso-cel achieved a CR compared with 39% of those who received SOC.

Progression-free survival [PFS] was also a secondary end point. The median PFS was 14.8 months with liso-cel and 5.7 months with SOC. Efficacy-wise, liso-cel hit all the marks. Overall survival [OS] data is maturing, so well need some longer follow-up, but we are starting to see trends in the right direction.

We have to remember that this study included crossover. Of the 91 patients in the SOC arm, 50 [crossed over to receive] CAR T-cell therapy with liso-cel. Those data will affect the OS data, but even so, were starting to see some separation of the OS curves in the TRANSFORM study.

The TRANSCEND-PILOT-017006 study is a little different because its a single-arm study. It was not intended for patients who would be otherwise considered transplant candidates. These patients did not need to relapse within 1 year [of frontline therapy], and they could have relapsed or refractory disease. A total of 25% of patients had late relapses as well, which was not the case in TRANSFORM. Otherwise, they all had 1 prior line of therapy, [like in TRANSFORM].

This is also a second-line study but in a different population of patients. This was an elderly population. Compared with the TRANSFORM study, the median age in the TRANSCEND-PILOT-017006 study was 74 years, with the oldest patient being 84 years of age. In total, 33% of patients in this study had double-hit and triple-hit disease, which I want to highlight because this is the toughest group of patients to treat. A total of 54% of the patients had primary refractory disease, [and many patients had comorbidities].

Additionally, 44% of the patients had an HCT-CI [Hematopoietic Cell Transplantation-Specific Comorbidity Index] score of 3 or more. We dont know the relevance [of this score] for CAR T-cell therapy, but outcomes are typically poor in patients who have an HCT-CI score of 3 or higher who undergoallogeneic transplant or ASCT.

[In this trial], the overall response rate was great, at 80%, with 54% achieving CR. Responses were seen in all prespecified subgroups, including patients with high-risk features, with no notable differences in efficacy or safety outcomes based on HCT-CI score. Investigators did separate out patients who had scores of less than 3 vs 3 or higher, and they didnt see any differences.

The median duration of response [DOR] was [11.2 months in patients with an HCT-CI score under 3, and not reached in patients with an HCT-CI score of 3 or higher].In patients who achieved a CR, the median DOR was 21.7 months.

The median PFS was [7.4 months in patients with an HCT-CI score under 3, and NR in patients with an HCT-CI score of 3 or higher]. The median OS was not reached.

Importantly, 32.8% of the patients were monitored as outpatients in this study, and 35% of those needed to be hospitalized for concerns of CRS and neurotoxicity after receiving liso-cel. Most of the patients who received liso-cel as outpatients did not need hospitalization within 3 days of receiving it. These results support liso-cel as a second-line treatment in patients with LBCL in whom transplant is not intended.

In general, the acute AEs that occur with any CAR T-cell therapy, but which are much lower with liso-cel, are CRS and NEs. These occur immediately post-CAR T-cell therapy, within days.

However, the incidence of CRS and NEs was low in both [TRANSFORM and TRANSCEND-PILOT-017006]. Most CRS events were grade 1 or grade 2. In total, 1 patient in each study had grade 3 CRS, and there were no instances of grade 4 CRS [in either study].

The incidence of neurotoxicity was also quite low. [A total of 4% of patients in the TRANSFORM study and 5% of patients in the TRANSCEND-PILOT-017006 study experienced] grade 3 neurotoxicity. Most of the neurotoxicity that was seen was grade 1 or grade 2. Importantly, the utilization of tocilizumab [Actemra] and steroids was also low [in both trials].

However, there are other AEs which we need to monitor. For example, by the time a patient is out of that CRS and neurotoxicity window and thinking of going back to their referring physician, they may still [be at risk for AEs such as] prolonged cytopenias, [which some patients exhibited in these trials]. In the [TRANSFORM] study, prolonged cytopenias were defined as [grade 3 cytopenias that persisted] at day 35 or beyond. [In the TRANSCEND-PILOT-017006 study, prolonged cytopenias were defined as grade 3 or higher cytopenias that persisted at day 29 or beyond.]

We should also monitor for hypogammaglobulinemia. This is important because if a patient has hypogammaglobulinemia or lymphopenia, and neutropenia, they are more prone to infection. Preventing infection, providing supportive care, and giving treatment medications [as early as possible] is important, and monitoring AEs is crucial.

The field of LBCL has exploded with new treatments over the past few years, including what we saw recently in the frontline setting. CAR T-cell therapy, in general, is a huge advancement within this field.

Having said that, its important to be aware of and monitor the AEs. A question that comes up is: How accessible are CAR T-cell therapies going to be? We need to work as a community to make them more accessible to patients, cut down the time from when we first consider CAR T-cell therapy to when we deliver it, and make that process more efficient, so more patients can benefit from it.

We also need to be aware of the many other treatments that have come out in the space, such as bispecific antibodies that are in development and antibody-drug conjugates. Over the next few years, we need to figure out how to sequence thesetherapies so that we can maximize the benefits and help our patients who still have unmet needs. We do have to recognize that even though CAR T-cell therapy has excellent outcomes, there are many patients who are still refractory to CAR T-cell therapy and relapse after CAR T-cell therapy. [We need to find] the best way to sequence the other treatments that are out there to help these patients. Thats an area of active investigation.

I hope we are in a much better place in the years to come. However, weve made huge strides in the past several years, and its been great to be a part of that research.

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Liso-cel Approval Provides Earlier, Expanded Access to CAR T-cell Therapy in Second-line LBCL - OncLive

Cardiac Stem Cells Comments Off on Liso-cel Approval Provides Earlier, Expanded Access to CAR T-cell Therapy in Second-line LBCL – OncLive | June 30th, 2022