Stem Cell Clinic

The Global Cell Culture Market is expected to grow from USD 14,923.23 Million in 2018 to USD 35,236.23 Million by the end of 2025 at a Compound Annual…

The positioning of the Global Cell Culture Market vendors in FPNV Positioning Matrix are determined by Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) and placed into four quadrants (F: Forefront, P: Pathfinders, N: Niche, and V: Vital).

New York, March 25, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Cell Culture Market - Premium Insight, Competitive News Feed Analysis, Company Usability Profiles, Market Sizing & Forecasts to 2025" - https://www.reportlinker.com/p05872141/?utm_source=GNW

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Culture Market including are Becton, Dickinson and Company, Cellgenix, Corning, Danaher, Eppendorf, Fujifilm Irvine Scientific, GE Healthcare, Hi-Media Laboratories, Invivogen, Lonza Group AG, Merck KGaA, Miltenyi Biotec, Promocell, and Sartorius AG.

On the basis of Product, the Global Cell Culture Market is studied across Consumables and Equipment.

On the basis of Application , the Global Cell Culture Market is studied across Biopharmaceutical Production, Diagnostics, Drug Screening and Development, Stem Cell Research, and Tissue Engineering & Regenerative Medicine.

On the basis of End User , the Global Cell Culture Market is studied across Cell Banks, Hospitals and Diagnostic Laboratories, Pharmaceutical & Biotechnology Companies, and Research Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Cell Culture Market 2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Cell Culture Market 3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Cell Culture Market 4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Cell Culture Market 5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Cell Culture Market

The report answers questions such as:1. What is the market size of Cell Culture market in the Global?2. What are the factors that affect the growth in the Global Cell Culture Market over the forecast period?3. What is the competitive position in the Global Cell Culture Market?4. Which are the best product areas to be invested in over the forecast period in the Global Cell Culture Market?5. What are the opportunities in the Global Cell Culture Market?6. What are the modes of entering the Global Cell Culture Market?Read the full report: https://www.reportlinker.com/p05872141/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Cell Culture Market is expected to grow from USD 14,923.23 Million in 2018 to USD 35,236.23 Million by the end of 2025 at a Compound Annual...

The Global Cell Isolation/Cell Separation Market is expected to grow from USD 5,721.23 Million in 2018 to USD 15,089.25 Million by the end of 2025 at…

New York, March 25, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Cell Isolation/Cell Separation Market - Premium Insight, Competitive News Feed Analysis, Company Usability Profiles, Market Sizing & Forecasts to 2025" - https://www.reportlinker.com/p05872137/?utm_source=GNW

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Isolation/Cell Separation Market including are Beckman Coulter Inc. (Subsidiary of Danaher Corporation), Becton, Dickinson and Company, Merck KGaA, Terumo Bct, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., GE Healthcare, Miltenyi Biotec, Pluriselect Life Science Ug (Haftungsbeschrnkt) & Co. Kg, and Stemcell Technologies, Inc..

On the basis of Product, the Global Cell Isolation/Cell Separation Market is studied across Consumables and Instruments.

On the basis of Cell Type, the Global Cell Isolation/Cell Separation Market is studied across Animal Cells and Human Cells.

On the basis of Cell Source, the Global Cell Isolation/Cell Separation Market is studied across Adipose Tissue, Bone Marrow, and Cord Blood/Embryonic Stem Cells.

On the basis of Technique, the Global Cell Isolation/Cell Separation Market is studied across Centrifugation-Based Cell Isolation, Filtration-Based Cell Isolation, and Surface Marker-Based Cell Isolation.

On the basis of Application, the Global Cell Isolation/Cell Separation Market is studied across Biomolecule Isolation, Cancer Research, In Vitro Diagnostics, Stem Cell Research, and Tissue Regeneration & Regenerative Medicine.

On the basis of End User, the Global Cell Isolation/Cell Separation Market is studied across Biotechnology & Biopharmaceutical Companies, Hospitals & Diagnostic Laboratories, and Research Laboratories & Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Cell Isolation/Cell Separation Market 2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Cell Isolation/Cell Separation Market 3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Cell Isolation/Cell Separation Market 4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Cell Isolation/Cell Separation Market 5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Cell Isolation/Cell Separation Market

The report answers questions such as:1. What is the market size of Cell Isolation/Cell Separation market in the Global?2. What are the factors that affect the growth in the Global Cell Isolation/Cell Separation Market over the forecast period?3. What is the competitive position in the Global Cell Isolation/Cell Separation Market?4. Which are the best product areas to be invested in over the forecast period in the Global Cell Isolation/Cell Separation Market?5. What are the opportunities in the Global Cell Isolation/Cell Separation Market?6. What are the modes of entering the Global Cell Isolation/Cell Separation Market?Read the full report: https://www.reportlinker.com/p05872137/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Cell Isolation/Cell Separation Market is expected to grow from USD 5,721.23 Million in 2018 to USD 15,089.25 Million by the end of 2025 at...

How Crucial is the Cellular Communications Between the Detached Cancerous Cells and Fibroblast for Growing Metastasis – Spark Health MD

Researchers from the German Cancer Research Center and the Heidelberg Institute for Stem Cell Technology and Experimental Medicine have found that some tumor cells get separated from the parent tumors and then stimulate the connective tissue cells to release certain transmitters for promoting metastasis. This process is done to colonize the other organs and the detached tumors manipulate the environment according to their needs for creating the metastatic niche.

This discovery is helpful for scientists to better understand the mechanism that how these harmful metastases arise. This research paper is published in the journal Nature Communications.

When cancer spreads to other parts of the body from the initial site then the process is called metastasis. It usually develops when the cancerous cells break their connection from the main or parent tumor and move to the bloodstream or lymphatic system. Through these systems, the detached tumor travels far away from the main site and form new tumors when they settle down in specific tissue.

If the cancerous cells detached from the parent tumors, then many of them were died before colonizing other tissues and forming metastases. Because When a tumor detached from the parent tumor then the body immunes system gets activated and protects the healthy cells and tissues of the body from the intruding effects of cancerous cells.

These migrant cells will only survive in the body if they have the power to manipulate their new environment for creating the metastatic niche. This metastatic niche makes them survive in the body by protecting against the bodys immune system.

Thordur Oskarssan and his team of researchers from the German Cancer Research Center (DKFZ) and the Heidelberg Institute for Stem Cell Technology and Experimental Medicine (HI-STEM gGmbH) are concerned in exploring the mechanism that how this metastatic niche evolves. Scientists found that in breast cancer some specific aggressive cells stimulate a certain condition which is similar to the inflammation in the lung tissue. So, it confirms that these cells colonize the other healthy tissues and promote metastases.

Also Read: Human Immune System is Effective Against a Number of Viruses

Two inflammatory signaling molecules known as interleukins are released from the detached cancerous cells. In microenvironment, these interleukins stimulate fibroblasts in the lungs to release two more inflammatory signaling molecules i.e. CXCL10 and CXCL9.

Migrant cancer cells carry receptors on their surface that attach to these signaling molecules which is a pivotal step during the process of metastases. The signaling molecules (CXL10 and CXCL9) and inflammation aid the particular aggressive breast cancerous cells to colonize other tissues and form metastases.

Maren Pein who is a lead author of the study said that the same tumors cells that provoke the fibroblast to release CXCL10 and CXCL9 also contain some other receptors for theses cytokines which help the growing process of metastases. This indicates that cellular communication between fibroblasts and detached cancerous cells in the new microenvironment is very crucial for metastasis.

During the experimental studies, scientists treated the lungs of mice with an inhibitor which blocked the receptors on the cancer cells. These inhibitors used to prevent the growing process of metastasis.

Scientists took tissue samples from the patients of breast cancer and found that the same cellular communication was also present in breast cancer cells. The process in which tumors cells having the relevant receptors utilize these interactions along with fibroblast to create the metastatic niche is also found in the breast cancer patients.

Oskarsson further explained that before developing any treatment approaches, it is necessary to understand the exact mechanism of metastasis. Initially, the study was carried out to explore the actual process that helps to arise metastases. A better understanding will enable scientists to develop different ways to prevent metastases in the future.

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How Crucial is the Cellular Communications Between the Detached Cancerous Cells and Fibroblast for Growing Metastasis - Spark Health MD

Sangamo Therapeutics: Market Cap Is At A Bargain Relative To Its Cash Position – Seeking Alpha

Introduction

Sangamo Therapeutics (SGMO) is a clinical-stage biotech company focusing on the research and development of genomic medicine across 4 distinct technology platforms: gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation.

Sangamo is best-known for developing its proprietary gene-editing technology, zinc finger proteins ("ZFPs"), which is a naturally occurring class of transcription factor proteins found in humans and other species. The company has used its internal know-how and technical expertise to develop a proprietary synthetic ZFP platform with potential clinical utility in ex vivo gene-edited cell therapy, in vivo genome editing, and in vivo genome regulation.

ZFPs also can be engineered to make zinc finger nucleases ("ZFNs") which proteins that can be used to specifically modify DNA sequences by knocking in or knocking out select genes, or genome editing, and ZFP transcription-factors ("ZFP-TFs") which are proteins that can be used to selectively increase or decrease gene expression.

Sangamo is developing a series of clinical programs, which are either wholly-owned or partnered with well-established pharma and biotech companies, to focus on 3 therapeutics areas in inherited metabolic disease ("IMDs"), central nervous system ("CNS), and inflammatory and autoimmune diseases. Its full list of clinical pipeline programs is listed in Figure 1.

Figure 1 Sangamo Therapeutics' Clinical Pipeline (Source)

The company's most advanced program is an investigational gene therapy for severe hemophilia A, SB-525. SB-525 is developed under a global collaboration with Pfizer (PFE), of which the rights of SB-525 have been transferred to Pfizer to run a phase 3 trial. In December 2019, both companies announced updated initial data from the phase1/2 trial of SB-525. SB-525 was generally well-tolerated and demonstrated a sustained increase in Factor VIII activity. SB-525 has been granted RMAT, Orphan Drug, and Fast Track designation by the FDA as well as Orphan Medicinal Product Designation by the European Medicines Agency ("EMA").

Beyond SB-525, the company is also investigating 2 wholly-owned gene therapy. ST-920 is being evaluated to treat Fabry disease, a rare inherited metabolic disease, in a phase 1 study in the US and UK. SB-920 has received Orphan Drug designation by the FDA. The company also plans to advance ST-101 into clinical trials in 2021 to treat phenylketonuria ("PKU") which is a rare inherited disorder that originates from a defect in the PAH gene and results in a harmful accumulation of phenylalanine in cells throughout the body.

Sangamo is working with Sanofi (NASDAQ:SNY) to develop ex vivo gene-edited cell therapies, ST-400 and BIVV-003, for transfusion-dependent beta-thalassemia ("TDT") and sickle cell disease ("SCD") respectively. Both ST-400 and BIVV-003 are related product candidates using the same technology involving gene editing of a patient's own hematopoietic stem progenitor cells using non-viral delivery of ZFN technology.

Sangamo is the phase 1/2 study of ST-400 in 6 patients with TDT while Sanofi is recruiting the phase1/2 study evaluating BIVV-003 in patients with SCD, and Sanofi is responsible for the subsequent development, manufacturing, and commercialization of both programs.

In Dec 2009, Sangamo presented interim results for the first 3 patients ST-400. As of the data cut date, 2 more patients have been enrolled although they were not included in the interim updates. The 3 patients treated with ST-400 experienced prompt hematopoietic reconstitution, demonstrating neutrophil engraftment in 14-22 days and platelet engraftment in 22-35 days. No emerging clonal hematopoiesis had been observed as measured by on-target indel pattern monitoring in the three treated patients. The downside of the data readout is that its treatment of TDT appears to be not as efficacious as other competitors such as bluebird bio (BLUE).

Sangamo also has a global collaboration and license agreement with Kite Pharma, a wholly-owned subsidiary of Gilead Sciences (GILD), for the development of engineered cell therapies for cancer. The company is working together with Kite to design ZFNs and viral vectors to disrupt and insert select genes in T cells and natural killer cells. The first program of this agreement expected to start a clinical trial in 2020 is KITE-307, which is an allogeneic anti-CD19 CAR-T cell therapy. Given the well-documented struggles of Kite's approved autologous CAR-T, Yescarta, the success of allogeneic CAR-Ts will be very beneficial.

Lastly, Sangamo is also evaluating the potential of regulatory T-cells ("Tregs") genetically modified with a CAR ("CAR-Tregs") in solid organ transplantation. CAR-Treg cell therapies are being conducted in several preclinical studies in autoimmune and inflammatory diseases such as multiple sclerosis ("MS") and inflammatory bowel disease ("IBD"). The most advanced CAR-Treg cell therapy is TX200, which is an autologous treatment for the prevention of solid organ transplant rejection and the clinical trial is expected to be initiated in 2020.

Sangamo is only planning to start a new clinical trial for its in vivo genome editing programs. SB-913 is a second-generation ZFNs program that will be used to treat Mucopolysaccharidosis type II ("MPS II") and a new clinical trial is planned to start this year.

The company had previous programs from first-generation ZFNs that have been halted as they did not demonstrate enough clinical benefits. The company plans to use data from the SB-913 study to definite the next steps for its in vivo genome editing programs.

The company also has several preclinical programs evaluating their ZFP-TF technology as a novel therapeutic approach for CNS diseases. In December, Sangamo announced a collaboration with Biogen (BIIB) to develop and commercialize ST-501 for tauopathies including Alzheimer's disease, ST-502 for synucleinopathies including Parkinson's disease, a third undisclosed neuromuscular disease target, and up to 9 additional neurological disease targets. Under the terms of the agreement, Biogen will pay Sangamo $350M upfront, inclusive of a license fee and equity investment, and Sangamo is eligible to receive up to $2.37B in future milestones.

Sangamo also has a partnership with Pfizer and Takeda (NYSE:TAK) to develop and evaluate ZFP-TFs. The company is working with Pfizer to evaluate ALS and frontotemporal lobar degeneration ("FTLD") that are linked to the mutations in the C9ORF72 gene. In the partnership with Takeda, the company is evaluating a preclinical program for Huntington's disease in which ZFP-TF is designed to differentially down-regulate the mutated disease-causing huntingtin gene ("HTT gene") while preserving the expression of the normal version of the gene.

As of 31 December, 2019, cash and equivalents on hand was $385M. The amount is excluding the $350M injection from the collaboration with Biogen, and when factored in, cash on hand should comfortably be in the range of high $600-700M. This should give them a comfortable runway to fund all operations well into 2021, an important point given that the recent stock market crash which limits any secondary offering options.

Impressively, the company has managed to strike several high-profile partnerships with 5 global biotech/big pharma companies. Such partnerships not only validate Sangamo's technology and capabilities, but they also provide future avenues of funding with as much as $6.34B royalties on net product sales and potential milestone payments due to the company.

Figure 1 Sangamo Therapeutics' Partnerships (Source)

In terms of competition, the company competes with several players, particularly in the cell and gene therapy space. bluebird bio has more advanced programs in both TDT and SCD and, to date, has shown much better efficacy. There are also other companies such as CRISPR Therapeutics (CRSP) that are using an alternative gene-editing method, CRISPR/Cas9 in gene therapy. Other companies such as Editas Medicine (EDIT) and Intellia Therapeutics (NTLA) are also developing CRISPR/Cas9 for treatments in TDT and SCD, although it must be noted that these are not their lead programs.

In terms of allogeneic CAR-T, there are more established players such as Allogene Therapeutics (ALLO), Cellectis (CLLS), and Precision Biosciences (DTIL). The main difference among these companies is primarily the choice of gene-editing tools with Allogene and Cellectis using TALEN while Precision is using ARCUS. All these companies are, currently, in a similar stage of clinical development.

In addition to healthy donors derived allogeneic therapies, Fate Therapeutics (FATE) is developing allogeneic therapies from induced pluripotent stem cells ("iPSCs") as a renewable cell source. The advantage of this is that product consistency and potency will be improved, and the manufacturing process will be akin to the well-established biologics where they are produced from a single cell line. It is notable to note that Allogene is also investigating using iPSCs as a renewable cell source. Also, Atara Biotherapeutics (ATRA) is developing an Epstein-Barr Virus ("EBV")-based allogeneic T cell therapy platform. Their lead program is in Phase 3 and a BLA filing is expected by the second half of the year. That should put them in the lead position of commercializing an allogeneic T cell therapy and the company is gradually moving into allogeneic CAR-T space as well.

Sangamo is, currently, trading at a market cap of around $700M, which is almost as much as its cash position. While its cash position will eventually deplete to fund operations and clinical trials, the current valuation means that there is also no value for its technology and intellectual position. I consider it a good time to take up a small position in Sangamo, especially if investors have a time horizon of at least a year to weather the COVID-19 black swan event and wait for further clinical updates from the company.

It must be cautioned though that investing in clinical-stage biotech can be extremely risky, given the binary nature of the field. This is especially so, given the market turmoil from the COVID-19 pandemic. The pandemic has also led to several countries announcing lockdowns, which have disrupted supply chain and operations. Several clinical trials have already been delayed globally and this may impact Sangamo negatively, as their cash burn will continue even if clinical trials are delayed.

Disclosure: I am/we are long ATRA, BLUE. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Sangamo Therapeutics: Market Cap Is At A Bargain Relative To Its Cash Position - Seeking Alpha

Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness – P&T…

LEXINGTON, Mass., March 24, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx) announced that Leukine (sargramostim, rhu-GM-CSF)is being assessed in the SARPAC trial (sargramostim inpatients withacute hypoxic respiratory failure due toCOVID-19 EudraCT #2020-001254-22) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes.

"Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate," said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the Flanders Institute of Biotechnology (VIB). "We rapidly initiated this study with Leukine, because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms."

Granulocyte macrophage colony stimulating factor (GM-CSF) is essential for the health of the lungs. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining proper functioning of the immune system.1 GM-CSF confers resistance to influenza by enhancing innate immune mechanisms.2 In animal studies, GM-CSF reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia.3 In clinical studies, use of Leukine showed beneficial effects in patients with viral pneumonia.4,5 Recent data highlight the importance of understanding the immune status of patients and role of immunomodulating agents like GM-CSF to activate the immune system to help clear virus and reduce the risk of secondary infections.6

"Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort," said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. "We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues."

"In pre-clinical studies, GM-CSF protects the lungs from viral pneumonia and the influenza A virus", stated E. Scott Halstead, MD, PhD, Associate Professor, Penn State University College of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine. "Preliminary data indicate an apparent benefit of inhaled Leukine therapy for autoimmune pulmonary alveolar proteinosis ("aPAP") and suggest it has reduced the need for whole lung lavage therapy for patients receiving treatment. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID-19 and Influenza A."

For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomizedtrials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.

Leukine was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. In 2018, Leukine was approved for use as a medical countermeasure to treat Acute Radiation Syndrome (ARS) and has been procured for use by the U.S. Strategic National Stockpile. Leukine is distributed outside the U.S. on a named-patient basis through PTx's designated program manager, Tanner Pharma Group. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

About Leukine(sargramostim)Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

About Partner Therapeutics, Inc.: PTx is an U.S.-based commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.

References

Cited References

Other RelevantReferences

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Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness - P&T...