Good-Risk Group of Patients With Myeloma Saw Better Outcomes – Cancer Therapy Advisor

Researchers have used deep whole-genome sequencing (WGS) to identify genomic markers of a good-risk group of patients with multiple myeloma with prolonged survival. Specifically, patients found to have a low genomic scar score and chromosome 9 gain had superior outcomes.

In the study, researchers analyzed WGS data from a 2009 study from 183 patients with newly diagnosed myeloma who had been treated with lenalidomide, bortezomib, and dexamethasone alone or in combination with autologous stem cell transplant. These data were then integrated with clinical data.

The researchers calculated a genomic scar score (GSS) using allele-specific copy-number alterations. Patients with a total score of 5 or less were considered to have a low GSS.

On average, WGS identified 7343 single nucleotide variants, 235 small insertions, and 376 deletions per patient. Significant variations in mutational load were found, with hyperdiploid myeloma having the lowest and t(14;16) myeloma having the highest load (P =.004).

In all, patients with a low GSS had significantly longer median progression-free survival and overall survival than other patients. The researchers identified a genomically defined subgroup of patients accounting for about 17% of patients with low DNA damage (a low genomic scar score with chromosome 9 gain) and a superior outcome. These patients had 100% overall survival at 69 months.

Other characteristics of this subgroup included lower mutational load with significant contribution from age-related mutations and NRAS mutation. Specifically, patients with low GSS and chromosome 9 gain had significantly lower mutational load compared with other groups (P =.0002).

Interestingly, the superior outcome group identified here was independent of traditional clinical risk factors, such as ISS, response to treatment, and achievement of [minimal residual disease] negativity, the researchers wrote. Importantly, our study shows that, in addition to traditional risk markers, we can use genomic markers such as low GSS and gain9 to identify true low-risk groups.

Reference

Samur MK, Samur AA, Fulciniti M, et al. Genome-wide somatic alterations in multiple myeloma reveal a superior outcome group [published online July 20, 2020]. J Clin Oncol. doi: 10.1200/jco.20.00461

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Good-Risk Group of Patients With Myeloma Saw Better Outcomes - Cancer Therapy Advisor

Stem Cell Treatment Seen to Safely Aid Speech in ALS Patients in… – ALS News Today

Stem cells collected from a patients bone marrow and infused into the spinal fluid safely improved speaking abilities after 28 daysfor most of the 12 adults with amyotrophic lateral sclerosis (ALS) evaluated in a small study.

Its researchers recommend further investigation of this approach in treatingspeech difficultiesin ALS, a common and early symptom of this neurological disease that is known as dysarthria.

The study, Articulation recovery in ALS patients after lineage negative adjuvant cell therapy preliminary report, was published in the International Journal of Medical Sciences.

Current treatments for speech disorders in ALS, which is marked by the deterioration of nerve cells that control voluntary muscle movement (motor neurons), are medicines to ease muscle weakness, tongue twitching, and excess salivation, as well as speech therapy support.

Despite widespread use of these approaches, treatments that address speech problems in ALS are still limited.

The administration of stem cells isolated from a patient then used as a treatment in that same person (autologous) may help to trigger the release of neurological growth factors, called neurotrophic factors, provide support for motor neurons, and slow disease progression.

Researchers atPomeranian Medical University in Poland conducted an open-label, Phase 1 clinical trial (NCT02193893) in 12 ALS patients, four women and eight men, between the ages of 21 and 65.

Bone marrow was collected from each person, and stem cells then isolated to include only lineage-negative cells (LIN-). These are immature stem cells and progenitor cells that have not yet become functioning blood cells.

The LIN- cells were returned to each patient via an infusion into the cerebrospinal fluid (CSF, the liquid that surrounds the brain and spinal cord) of the lumbar vertebrae of the lower spine.

Before the procedure, and 28 days after, patients were evaluated for speech using the Frenchay Dysarthria Assessment (FDA), a standardized test that relies on a nine-point rating scale, measuring oral structure, function, and speech.

CSF was collected to measure levels of various neurotrophic factors and pro-inflammatory proteins, both before cell infusion and 28 days later.

Two particular factors nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) were tested in patients blood on the day of the infusion, and three and seven days later, and again at three months.

Of note, neurotrophicfactors are signaling molecules that play an important role in the survival and growth of nerve cells.

Based on their FDA scores, patients were divided into two groups: group 1 was composed of eight patients who improved in five or more speech measures; the four patients in group 2 did not show such improvement.

Patients in group 1 were older (average age of 55.8), and had a shorter disease duration (average of 2.6 years), the researchers noted.

Compared to baseline (study start) measurements, seven out of the eight group 1 patients had marked improvements in phonation time the time a person can say a vowel. Lip performance was enhanced in six people in group 1, and palate functioning and voice loudness improved in five of these patients.

Improvements were found in about 54% of the analyzed speech functions among group 1 patients, and 35% of those in group 2.

It is noteworthy that tongue mobility was the only articulatory function that did not improve in all 12 patients, the researchers wrote.

No significant pre- and post-treatment differences were seen in pro-inflammatory proteins in the CSF of either group. However, one such protein, called C3, was almost two times higher in group 2 patients at the studys start.

At 28 days after the procedure, lower levels of the inflammation marker C-reactive protein in the CSF, particularly in group 1 patients, were found.

Baseline concentrations of the neurotrophic factor BDNF and ofplatelet-derived growth factor alpha (PDGF-AA) were higher in group 1 patients compared with group 2. At 28 days post-treatment, however, group 1 patients showed a significant decrease in concentrations of BDNF, PDGF-AA, andangiopoietin 2 (ANGP-2), and a downward trend in VEGF-A. No significant differences were found among those in group 2.

Growth factors are signaling molecules that, among other things, arecapable of stimulating cell proliferation and differentiation.

It remains unclear why, in parallel with the improvement of articulation, a statistically significant decrease in neurotrophins concentration was observed, the researchers wrote.

BDNF blood levels in both groups reached were highest two to three days after the infusion, then steadily decreased. The nerve growth factor (NGF) followed a similar pattern in group 2 patients. No difference in the levels of BDNF and NGF were found between these groups.

The outcomes of the LIN- cell application in ALS treatment of articulatory organs are promising, the researchers wrote, and proved to be both safe and feasible.

A short-lasting trophic effect of autologous LIN- administration could encourage repeated [cell] application in order to sustain their beneficial effects, however this approach needs further investigation, they added.

Steve holds a PhD in Biochemistry from the Faculty of Medicine at the University of Toronto, Canada. He worked as a medical scientist for 18 years, within both industry and academia, where his research focused on the discovery of new medicines to treat inflammatory disorders and infectious diseases. Steve recently stepped away from the lab and into science communications, where hes helping make medical science information more accessible for everyone.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Stem Cell Treatment Seen to Safely Aid Speech in ALS Patients in... - ALS News Today

Study Evaluates Diagnostic Value of the Karius Test for Pneumonia in Immunocompromised Patients – OncoZine

Immunocompromised patients are generally at high risk of Invasive Fungal Infections (IFI), potentially leading to diseases like pneumonia, an infection in the lungs which can be caused by a fungus, bacteria, or viral infection.

Pneumonia is a major cause of morbidity and mortality in these individuals and this may especially be the case in patients with hematological malignancies undergoing remission-induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and recipients of allogeneic hematopoietic stem cell transplants (HSCT).[1]

Although new treatment options have become available to treat patients with cancer and hematological malignancies, Invasive Fungal Infections remain a major concern due to the increased potential of morbidity and mortality in these patient populations.

The effects of novel anti-cancer agents Although a growing number of new immune-modulating drugs has shown to advance the treatment of patients with cancer, some of these agents have also attribute to the increase of risk for Invasive Fungal Infections. This increased risk may especially be seen in patients treated with tyrosine kinase inhibitors (TKI), in particular inhibitors of Bruton tyrosine kinase (BTK) mammalian target of rapamycin (mTOR) Janus kinase (JAK) and phosphatidylinositol 3 kinases (PI3K) delta.[1]

Inhibition of immune checkpoints, such as programmed cell death protein 1 (PD1) or cytotoxic T lymphocyte-associated protein 4 (CTLA4) may show a wide-ranging of mostly immune-related adverse events. Subsequent immunosuppression, primarily including corticosteroids, may, in turn, result in the development of opportunistic infections including fungi, requiring optimizing the management of immune-related adverse events.[1]

Diagnostic failure Immunocompromised patients can be infected by a broad range of potential pathogens. However, in many cases, diagnostic testing fails to identify a microbial etiology for lower respiratory illness even with bronchoalveolar lavage (BAL).

Studies have shown that culture methods, PCR, and antigen testing on BAL samples only yields a positive result of 30-67% of the time. In addition, Idiopathic Pulmonary Syndrome (IPS), a non-infectious pulmonary complication of transplants, can have many overlapping symptoms with infectious pneumonia. Treatment for IPS is the administration of steroids which can exacerbate infections. As a result, there is a major unmet medical need for better diagnostics to aid in the management of immunocompromised patients with pneumonia.

Clinical evaluation Karius, a life sciences company focused on generating genomic insights for infectious diseases, has developed a microbial cell-free plasma next-generation sequencing test for pathogen detection capable of detecting >1,000 organisms. The test is performed in a CLIA-certified/CAP-accredited laboratory with results typically provided within one day from sample receipt.

To understand the increased risk and to improve the timely diagnosis of pneumonia in immunocompromised adult patients, including those with hematological cancers, Karius, in collaboration withDuke Clinical Research Institute, has launched a multicenter, prospective study designed to evaluate the diagnostic value of the Karius Test.

The test developed by Karius is a non-invasive liquid biopsy, based on next-generation sequencing of microbial cell-free DNA that can rapidly detect over 1,000 bacteria, DNA viruses, fungi, and parasites. The test helps clinicians make rapid, treatment decisions and is currently being used by over 100 hospitals nationwide by mapping each patients microbial landscape from a single blood draw.

Diagnostic yield Given the medical need, the clinical evaluation will compare the diagnostic yield of the Karius Test to standard testing methods used to diagnose infectious causes of pneumonia in immunocompromised patients including those with hematological cancers.

Patients with suppressed immune systems are especially vulnerable to life-threatening pneumonia due to their decreased ability to fight infections. Standard methods to diagnose pneumonia can be invasive, time-consuming, often requiring weeks to months for a result, and in some cases inconclusive, failing to identify the pathogen causing the infection.

The PICKUP study (NCT04047719) will investigate the additive diagnostic value of the Karius Test in the diagnosis of pneumonia in these patients and its impact on clinical decision-making in this specific population. In addition, the Karius Test will be used to serially monitor pathogen levels during treatment to examine the association between microbial load and pneumonia progression.

The ability to diagnose invasive life-threatening infections in immunocompromised patients has been one of the most challenging areas in clinical infectious disease practice, noted Mickey Kertesz, Chief Executive Office of Karius.

We are enthusiastic to be collaborating with a number of leading cancer centers for this study and anticipate that the Karius Test will demonstrate a higher diagnostic yield than traditional invasive testing methods, Kertesz added

Unknown causative pathogen Often in pneumonia, the causative pathogen is unknown or can be challenging to diagnose despite extensive diagnostic testing, explained Stephen P. Bergin, M.D., Assistant Professor of Pulmonary and Critical Care Medicine at Duke University Health System and lead investigator for the PICKUP study.

Accurate and timely pathogen identification is particularly critical for immunocompromised patients who are susceptible to life-threatening infections from a much broader array of pathogens. We look forward to exploring the potential value of a non-invasive tool capable of rapidly diagnosing respiratory infections in this vulnerable population, Bergin concluded.

Overcoming limitations Previous studies have demonstrated the ability of the Karius Test to overcome many of these limitations to diagnose the cause of pneumonia and enable targeted treatment.

The PICKUP study will include approximately 200 patients from up to 10 centers in the United States, including Duke University Health, University of Pittsburgh Medical Center, Fred Hutchinson Cancer Research Center, The University of Texas MD Anderson Cancer Center, City of Hope, Tulane Cancer Center and Tulane Medical Center and The University of California, San Francisco Medical Center.

Clinical trials Pneumonia in the ImmunoCompromised Use of the Karius Test for the Detection of Undiagnosed Pathogens (PICKUP) NCT04047719

Reference [1] Mellinghoff SC, Panse J, Alakel N, et al. Primary prophylaxis of invasive fungal infections in patients with hematological malignancies: 2017 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO). Ann Hematol. 2018;97(2):197-207. doi:10.1007/s00277-017-3196-2

Featured image: Karius laboratory. Photo courtesy: 2020 Karius. Used with permission.

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Study Evaluates Diagnostic Value of the Karius Test for Pneumonia in Immunocompromised Patients - OncoZine

Cytovia Therapeutics Acquires Worldwide Rights to CytoImmune Therapeutics’ First-In-Class EGFR Dual-targeting CAR for NK Cell Treatment of…

August 03, 2020 08:03 ET | Source: Cytovia Therapeutics

NEW YORK and MONROVIA, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, Inc (Cytovia), an emerging biopharmaceutical company developing natural killer (NK) immunotherapies for cancer, today announces that it has acquired worldwide rights from CytoImmune Therapeutics for its novel EGFR Dual-targeting CAR to be used for NK cell therapy. Cytovia will conduct and finance all future development and will apply the EGFR Dual-targeting CAR to its iPSC CAR NK technology. CytoImmune will receive an upfront equity grant in Cytovia, future development milestones, and royalties.

Dr. Daniel Teper, Chairman and CEO of Cytovia added: We are honored to collaborate with Dr. Caligiuri, a pioneer in translating biological research on NK cells into impactful therapeutics. He has published solid data with intracranial injection of EGFR CAR NK cells to support their clinical development in glioblastoma. Additionally, EGFR is a clinically validated target which will allow us to expand the use of NK cellular therapy in multiple solid tumors.

Pre-clinical proof of concept data with intracranial administration of the EGFR Dual-targeting CAR-NK cells for the treatment of glioblastoma has been published in Nature Scientific Reports. The EGFR Dual-targeting CAR targets glioblastoma cells expressing EGFR wild-type and/or the mutant EGFR vIII. A single intracranial injection of EGFR CAR NK cells reduced the growth of glioblastoma and showed a statistically significant improvement in survival in animal models. The intracranial injection of the EGFR CAR NK cells remained localized in the brain without entering the systemic circulation or infiltrating extracranial organs or tissues, thus limiting toxicity.

Michael A. Caligiuri, MD, the scientific founder of CytoImmune, is joining the Cytovia Scientific Advisory Board. Dr Caligiuri is the Deana and Steve Campbell Physician in Chief Distinguished Chair and President of the City of Hope Cancer Center in Duarte, CA. Dr. Caligiuri is a world-renowned physician, scientist, builder, innovator, leader and visionary. He was elected a Member of the National Academy of Medicine for his work on NK cell biology and its clinical applications. He is a past President of the American Association for Cancer Research (AACR).

Dr Caligiuri commented: CAR NK cell therapy has the potential to transform cancer outcomes. We are excited to partner with Cytovia to rapidly bring EGFR Dual-targeting CAR NK cells, a next generation therapy, to patients with the ultimate goal of curing glioblastoma. Cytovias off-the-shelf iPSC CAR NK cell technology should increase the access to precision immunotherapy for many cancer patients.

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

ABOUT GLIOBLASTOMAGlioblastoma affects 290,000 new patients every year worldwide. Chemotherapy and radiotherapy lack specificity and provide limited efficacy along with high toxicity. The median overall survival from the time of diagnosis is only 14.6 months. Systemic and particularly intracranial or intratumoral immunotherapy, which can target localized and infiltrating cells, has shown initial promise in early clinical trials.

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

ABOUT CYTOIMMUNE THERAPEUTICS CytoImmune Therapeutics (CytoImmune) is biotechnology company focused on the application of proprietary chimeric antigen receptors (CAR) for use in both off-the-shelf human natural killer (NK) cells and autologous cytotoxic effector T cells in the treatment of liquid and solid tumors. Our CoalesceNT platform harnesses the power of both a specific CAR and a different secretory bispecific antibody in a single construct to coordinate an immune response with CAR NK cells, cytolytic effector T cells, NK-T cells and g/d T cells. This combination of NK- and T-cell therapy expedites time-to-treatment and delivers a dynamic response that reflects both innate and adaptive immunity in an effort to reduce tumor evasion and the incidence of cancer recurrence.

Learn more at http://www.cytoimmune.com

Contact for media enquiries Sophie Badr Vice President, Corporate Affairs Sophie.badre@cytoviatx.com 1(929) 317 1565

Will Rossellini President will@cytoimmune.com 1(469) 222 2350

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Cytovia Therapeutics Acquires Worldwide Rights to CytoImmune Therapeutics' First-In-Class EGFR Dual-targeting CAR for NK Cell Treatment of...

FDA hands MorphoSys and Incyte a quick OK on their potential blockbuster CAR-T alternative – Endpoints News

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

The first approved indication is in second-line DBLCL, for patients ineligible for autologous stem cell transplant. Mizuhos Mara Goldstein estimated that market at around 6,000 US patients and said the drug had blockbuster potential, but she noted those patients have several other options available to them.

The initial market opportunity as a second-line treatment is meaningful, she wrote in a note to investors, though we are somewhat cautious on the ramp of the drug given the competitive landscape for this indication that includes seven drug regimens as well as treatment with CAR-T therapy.

SVB Leerinks Geoffrey Porges called the approval a best case scenario, noting it had been unclear whether the drug would be approved for second-line or third-line therapy. He estimated a potential patient population around 12,000.

Both analysts singled out Monjuvis duration in particular. The 21.7 months it showed at the top line readout is more than twice the 6 months to a year Roches antibody-drug Polivy, approved last year, has shown.

We believe the CAR-T like efficacy demonstrated by tafa, as well as its favorable safety profile should enable broad adoption in the 2L setting, Porges wrote in a note to investors, and expect the product to be preferred over Roches CD79 ADC Polivy.

Former MorphoSys CEO Simon Moroney positioned Monjuvi as an option for patients who cant handle the intense bodily stress of high-dose chemotherapy or stem cell transplant, or of CAR-T. In addition to the costly and lengthy process of extracting, treating and re-implanting T cells, CAR-T therapies also require patients to undergo conditioning regimens of intensive chemotherapy to clear out the bone marrow and essentially give a pocket for the new cells to take hold.

By contrast, Monjuvi is an anti-CD19 antibody that is given intravenously and requires no conditioning.

Our patients tend to be older median age in the trial is 72, Moroney told MedCity Newslast June, referring to participants in their pivotal Phase II study. They have comorbidities and are not eligible for CAR-T.

The FDA decision is an accelerated approval based on results from that Phase II study. Topline results released last year showed a 55% overall response rate and a 37% complete response rate. The latest data, released in May, showed a 59% response rate, a 39% complete response rate, and a median duration of response that had risen to 34.6 months nearly 3 years. The complete response rates were in line with the early CAR-T trials, and the FDA granted the drug priority review.

Both MorphoSys and Incyte have staked a lot on Monjuvi. MorphoSys raised $208 million in an IPO in 2018, funneling much of that cash into building out a US commercial operation in anticipation of their lead drugs approval. They tapped the US commercial lead for Merck KGaAs Bavencio, David Trexler, to lead that effort. And after Moroneys retirement, Jean-Paul Kress stepped in to lead a new stage for the company.

Incyte, meanwhile, spent $900 million earlier this year to join with Incyte on the commercial launch, hoping the CAR-T alternative could pour some oil into a sputtering R&D engine. Mizuhos Goldstein said the drug would help diversify Incytes revenue base, but its overall impact may be muted.

Monjuvi may not have enough impact in the near term to alter the fundamental picture for the company, she said of Incyte.

Goldstein also called the drug validation for Xencors platform. The California biotech originally developed the antibody. The approval triggered a $25 million milestone for them.

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Humanigen to Host Investor Conference Call to Discuss NIH’s Selection of Lenzilumab for Big Effect Trial – Business Wire

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc., (HGEN) (Humanigen), announced today that the Company will host an investor call and webcast to discuss the National Institute of Healths selection of lenzilumab, the companys proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19.

Humanigen will host the conference call and webcast today at 4:30 p.m. EDT. All stakeholders are invited to participate in the call.

To participate on the conference call, please dial toll free (833) 714-0938 or toll number +1 (778) 560-2680. The conference ID number is 1154357. A simultaneous webcast of the call and presentation can be accessed by visiting: https://event.on24.com/wcc/r/2551709/C2EEA514D519C23B4A3E9E777BF19147.

In addition, a replay of the webcast will be available on the company website for 30 days following the event.

More details on the companys programs in COVID-19 can be found on the companys website at http://www.humanigen.com under the COVID-19 tab, and details of the Phase III potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The companys immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit http://www.humanigen.com.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase III study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to be approved by FDA for such use and its potential commercialization, or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

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Humanigen to Host Investor Conference Call to Discuss NIH's Selection of Lenzilumab for Big Effect Trial - Business Wire

Neural Progenitor Cells Discovered in the Optic Nerve – Technology Networks

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Researchers at the University of Maryland School of Medicine (UMSOM) have for the first time identified stem cells in the region of the optic nerve, which transmits signals from the eye to the brain. The finding, published this week in the journal Proceedings of the National Academy of Sciences (PNAS), presents a new theory on why the most common form of glaucoma may develop and provides potential new ways to treat a leading cause of blindness in American adults.

"We believe these cells, called neural progenitor cells, are present in the optic nerve tissue at birth and remain for decades, helping to nourish the nerve fibers that form the optic nerve," said study leader Steven Bernstein, MD, PhD, Professor and Vice Chair of the Department of Ophthalmology and Visual Sciences at the University of Maryland School of Medicine. "Without these cells, the fibers may lose their resistance to stress, and begin to deteriorate, causing damage to the optic nerve, which may ultimately lead to glaucoma."

The study was funded by the National Institutes of Health's National Eye Institute (NEI), and a number of distinguished researchers served as co-authors on the study.

More than 3 million Americans have glaucoma, which results from damage to the optic nerve, causing blindness in 120,000 U.S. patients. This nerve damage is usually related to increased pressure in the eye due to a buildup of fluid that does not drain properly. Blind spots can develop in a patient's visual field that gradually widen over time.

"This is the first time that neural progenitor cells have been discovered in the optic nerve. Without these cells, the nerve is unable to repair itself from damage caused by glaucoma or other conditions. This may lead to permanent vision loss and disability," said Dr. Bernstein. "The presence of neural stem/progenitor cells opens the door to new treatments to repair damage to the optic nerve, which is very exciting news."

To make the research discovery, Dr. Bernstein and his team examined a narrow band of tissue called the optic nerve lamina. Less than 1 millimeter wide, the lamina lies between the light-sensitive retina tissue at the back of the eye and the optic nerve. The long nerve cell fibers extend from the retina through the lamina, into the optic nerve. What the researchers discovered is that the lamina progenitor cells may be responsible for insulating the fibers immediately after they leave the eye, supporting the connections between nerve cells on the pathway to the brain.

The stem cells in the lamina niche bathes these neuron extensions with growth factors, as well as aiding in the formation of the insulating sheath. The researchers were able to confirm the presence of these stem cells by using antibodies and genetically modified animals that identified the specific protein markers on neuronal stem cells.

"It took 52 trials to successfully grow the lamina progenitor cells in a culture," said Dr. Bernstein, "so this was a challenging process." Dr. Bernstein and his collaborators needed to identify the correct mix of growth factors and other cell culture conditions that would be most conducive for the stem cells to grow and replicate. Eventually the research team found the stem cells could be coaxed into differentiating into several different types of neural cells. These include neurons and glial cells, which are known to be important for cell repair and cell replacement in different brain regions.

This discovery may prove to be game-changing for the treatment of eye diseases that affect the optic nerve. Dr. Bernstein and his research team plan to use genetically modified mice to see how the depletion of lamina progenitor cells contributes to diseases such as glaucoma and prevents repair.

Future research is needed to explore the neural progenitors repair mechanisms. "If we can identify the critical growth factors that these cells secrete, they may be potentially useful as a cocktail to slow the progression of glaucoma and other age-related vision disorders." Dr. Bernstein added.

The work was supported by NEI grant RO1EY015304, and by a National Institutes of Health shared instrument grant 1S10RR26870-1.

"This exciting discovery could usher in a sea change in the field of age-related diseases that cause vision loss," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "New treatment options are desperately needed for the millions of patients whose vision is severely impacted by glaucoma, and I think this research will provide new hope for them."

Reference:Bernstein, S. L., Guo, Y., Kerr, C., Fawcett, R. J., Stern, J. H., Temple, S., & Mehrabian, Z. (2020). The optic nerve lamina region is a neural progenitor cell niche. Proceedings of the National Academy of Sciences, 202001858. doi:10.1073/pnas.2001858117

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Neural Progenitor Cells Discovered in the Optic Nerve - Technology Networks

Osteonecrosis Treatment Market SWOT Analysis By Top Players Bone Therapeutics, Enzo Biochem Inc., and K-Stemcell Co Ltd. Hospitals, clinics,…

The report offers a systematic presentation of the existing trends, growth opportunities, market dynamics that are expected to shape the growth of the Osteonecrosis Treatment market. The various research methods and tools were involved in the market analysis, to uncover crucial information about the market such as current & future trends, opportunities, business strategies and more, which in turn will aid the business decision-makers to make the right decision in future.

Whats keeping Bone Therapeutics, Enzo Biochem Inc., and K-Stemcell Co Ltd. Hospitals, clinics, universities, Ahead in the Market? Benchmark yourself with the strategic moves and findings recently released by CMI

List of Companies Mentioned:Bone Therapeutics, Enzo Biochem Inc., and K-Stemcell Co Ltd. Hospitals, clinics, universities,

1) Does Study provides Latest Impact on Market due to COVID & Slowdown?

Yes study have considered a chapter on Impact Analysis and this 2020 Edition of the report provides detailed analysis and its impact on growth trends and market sizing to better understand current scenario.

2) How companies are selected or profiled in the report?

List of some players that are profiled in the the report includes Bone Therapeutics, Enzo Biochem Inc., and K-Stemcell Co Ltd. Hospitals, clinics, universities,. list is sorted to come up with a sample size of atleast 50 to 100 companies having greater topline value to get their segment revenue for market estimation.

** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Is it possible to narrow down business segments by Application of this study?

Yes, depending upon the data availability and feasibility check by our Research Analyst, further breakdown in business segments by end use application in relation to type can be provided (If applicable) by Revenue Size or Volume*.

4) What is the base year of the study? What time frame is covered in the report?

Furthermore, the years considered for the study are as follows:

Historical year 2014 2018

Base year 2018

Forecast period** 2019 to 2027 [** unless otherwise stated]

**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players.

Detailed Segmentation:

By Drug ClassNon-steroidal anti-inflammatory drugs (NSAIDS)Anti-coagulantOther drugsBy Distribution ChannelsHospitals pharmaciesRetail pharmaciesOnline pharmacies

Regions included:

o North America (United States, Canada, and Mexico)

o Europe (Germany, France, UK, Russia, and Italy)

o Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)

o South America (Brazil, Argentina, Colombia)

o Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Global Osteonecrosis Treatment Market What to expect from this report:

Focused Study on Niche Strategy and Market Development & penetration Scenario

Analysis of M&As, Partnership & JVs in Global Osteonecrosis Treatment Industry in United States & Other Emerging Geographies

Top 10 Global Osteonecrosis Treatment Companies in Global Market Share Analysis: Leaders and Laggards in 2017, 2019

Gain strategic insights on competitor information to formulate effective R&D moves

Identify emerging players and create effective counter-strategies to outpace competitive edge

Identify important and diverse product types/services offering carried by major players for market development

And many more .

TABLE OF CONTENTS

Report Overview:It includes the Osteonecrosis Treatment market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.

Executive Summary:This section of the report gives information about Osteonecrosis Treatment market trends and shares, market size analysis by region and analysis of global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.

Profiles of International Players:Here, key players of the Osteonecrosis Treatment market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.

Regional Study:All of the regions and countries analyzed in the Osteonecrosis Treatment market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

About Author:

Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. Our client base includes players from across all business verticals in over 150 countries worldwide. We are uniquely positioned to help businesses around the globe deliver practical and lasting results through various recommendations about operational improvements, technologies, emerging market trends and new working methods.

Mr Raj Shah Coherent Market Insights 1001 4th Ave, #3200 Seattle, WA 98154, U.S. Phone +1-206-701-6702 [emailprotected]

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Osteonecrosis Treatment Market SWOT Analysis By Top Players Bone Therapeutics, Enzo Biochem Inc., and K-Stemcell Co Ltd. Hospitals, clinics,...

What’s Causing Your Hair Loss And The Secrets To Stopping IT – Harper’s Bazaar Singapore

Credit: 123RF

Its perfectly normal to lose up to 100 strands of hair a day. But how do you know if your hair is actually thinning or if youre just losing a little more than usual? And more importantly, what are the causes of hair loss and what can you do to manage it?

Here are five reasons youre losing hair and some solutions, from ways to destress and what food to eat for healthier hair, to an anti-hair loss treatment that uses stem cells.

Why you're losing your hair: Your hairstyle

We get it, the weather is hot and your hair is often tied back in a ponytail or in a bun. While its great to get your hair off your face, it could be the reason why youre losing hair. Constantly securing your locks in a tight and sleek hairstyle can not only damage hair, but also cause breakage. It also makes any hair loss around the crown and temples appear more noticeable.

What you can do: Try not to tie your hair up as often. Instead of knotting it into a tight bun or high ponytail, clip the sides back, just behind the ears, with this seasons trending barrettes.

Why you're losing your hair: You went on an extreme diet plan

Intermittent fasting might be all the rage now, but overdoing it and not feeding your body enough nutrients can result in thinning hair, and eventually, hair loss. Trust us, we know because weve seen it happen.

When you restrict your body from getting the nutrients it needs, the limited amount of energy it gets is diverted to the organs that need it most, like your heart, lungs and brain. This means that your hair, which also needs energy to grow, gets whats left or none at all.

What you can do:Load up on foods rich in iron, protein, omega 3-fatty acids and B vitamins, such as eggs, and green leafy vegetables like spinach and salmon. So even if you love what your new trendy diet has done for your weight, you shouldnt exclude these foods.

Why you're losing your hair: Your genetics

If youre eating and managing your stress well, yet are still shedding an alarming amount of hair daily, its time to visit the professionals. Apart from certain medical conditions that can cause hair loss, your genes can also play a part in early onset hair loss.

What you can do: One way is to head to a trichologist such as PHS Hairscience. The brand (together with bio-scientists and trichologists) has developed a Miracle Stem Cell Solution treatment, which uses a high concentration of stem cell proteins and a cocktail of active ingredients think nano-sized growth factors, peptides, cytokines, vitamins, antioxidants and DHT blockers (DHT is a hormone known to shrink the hair follicles, which can trigger the onset of hair loss).

When applied to the scalp, the stem cell proteins send signals to the hair follicles, to encourage the inactive cells to wake up and work harder.

At the same time, the other active ingredients nourish the scalp, helping it to become healthier. In fact, an independent laboratory study has shown that this Miracle Stem Cell Solution can help boost hairs growth cycle by up to 50 per cent!

The non-invasive hair treatment takes just 45 minutes per session and comes with no side effects or downtime. For best results, PHS Hairscience recommends that you go for bi-weekly sessions over three months, and results are said to be visible in as early as two months.

Its suitable for both women and men, and is available in five options to address the different types of hair loss: Hair Thinning Control, Hair Loss Control, Patchy Hair Loss Control, Hair Thickening Regenerator and Hair Growth Regenerator.

Why you're losing your hair: You have a crazy, stressful life

This current Covid-19 pandemic has put so much stress on everyone. Increased work and family stress can cause our bodies to produce more cortisol, commonly known as the stress hormone. Studies have shown that too much cortisol can disrupt the function and patterns of your hair growth cycle, which can contribute to increased shedding.

What you can do:Find ways to destress, like going out for a run, learning yoga or meditating before bed. The good news is that hair loss from stress is temporary, and once your levels are back to normal, the problem should go away.

Why you're losing your hair: You don't care for your scalp

Healthy hair begins with a healthy scalp. After all, your scalp is an extension of the skin on the face, so you should pay the same attention to the scalp too. Using products that are too drying can irritate the scalp and weaken the hair roots. And not cleansing the scalp of styling product build-up can suffocate the hair follicles all of which can lead to hair loss.

What you can do: In the same way that you have a daily skincare routine, you should also have one for your scalp and hair. Go here to find the right set of products for your hair and scalp concerns, from hair thinning to soothing a dry and sensitive scalp, and more.

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What's Causing Your Hair Loss And The Secrets To Stopping IT - Harper's Bazaar Singapore

Justin Thomas heads to PGA Championship with swagger of a champion – FanSided

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Justin Thomas (Photo by Andy Lyons/Getty Images)

Justin Thomas builds momentum for the PGA Championship by winning WGC in Memphis

A major champion is expected to excel under Sunday pressure, to pull off the right shot at the right time, and, of course, to get a little lucky at times. Justin Thomas is heading to the years first major championship next week after checking off all three boxes on Sunday in Memphis.

Thomas was bold, steady, and, at least for one hole, fortunate on his way to winning the WGC-FedEx St. Jude Invitational at TPC Southwind. He erased a four-shot deficit at the start of the round and ended up winning by three after a five-under 65 on Sunday. Its the 13th PGA Tour title of his still-young career, making the 27-year-old Thomas the third-youngest player in the last 60 years to reach that milestone behind Tiger Woods and Jack Nicklaus.

Hes also the first player this season to reach three victories and will take over the No. 1 spot on the Official World Golf Rankings for the first time since June 2018. Thomas is at the top of his game, and just in time too: the PGA Championship begins on Thursday at TPC Harding Park in San Francisco.

Thomas knows what it feels like to lift the Wanamaker Trophy, winning his lone major championship at Quail Hollow in 2017. But, before this week, he didnt look like a player with the confidence to win another one. Thomas has been in contention twice since the PGA Tour resumed in June. Entering the final round of the Charles Schwab Challenge at Colonial a shot off the lead, he made only two birdies on Sunday and slipped to 10th. Again, last month at the Workday Charity Open, he had a three-shot lead over Collin Morikawa with three holes remaining. He finished bogey-par-bogey before losing in a playoff.

It was those crushing defeats, and the lessons he learned from them, that he admits helped him win this week. It means a lot, especially with how I felt that I did it, he told CBS after completing his round. In the past Ive struggled coming from behind. I learned from it at Colonial. I felt like I got really wrapped up in what was going on on the leaderboard, who was ahead of me, how many people, instead of just focusing on my own game.

(Today) I didnt look at a leaderboard until I accidentally starred at one on 13 tee. And then again at Workday, I learned from that. It sucked. Im going to be mad about that for the rest of my life. But its because of days like that is why I felt like I was able to hold on and get it done today.

Thomas trailed leader Brendon Todd by four shots at the beginning of the day; he completely made up that deficit on the front-nine, rolling in a 20-foot birdie putt at the ninth to take a share of the lead. But then he found trouble at the 12th, his approach shot taking a bad hop off the mound to the left green and nestling in under the lip of a bunker. Rather than attempt a risky, miraculous shot, Thomas made the smart play and chipped out into the rough, settling for a well-earned bogey.

Then came at the 15th hole, where Thomas got a break that may have won him the tournament. His drive on the par-four looked like it was heading well left into an area thick with trees. The ball couldve deflected off any of them and went anywhere. Instead, it went right through the trees and left him just 50 yards to the hole for his second shot. It was the type of luck that seemingly only comes to the winner of a tournament.

I got unbelievably lucky, Thomas admits. But thats the stuff that happens when you win, it really is. Somehow, that kind of calmed me down. You know, when that happened I was like this could be for us. Stuff like that doesnt happen more often than not unless you win the tournament.

The lone challenger to Thomas lead by the end of the round was another former PGA winner, the two-time defending champ Brooks Koepka. Koepka has shown throughout his career he brings his best game to the biggest tournaments; he has seven career wins on the PGA Tour, four of them majors. So, predictably with a major a few days away, Koepka was in contention for his first title since winning this same tournament last year. His run, though, ended when his tee shot at the 18th wound up in the water hazard, sending him into a four-way tie for second at 10-under, three behind Thomas.

Koepka has been dealing with a left knee injury since last fall. He underwent stem cell treatment in September, but that hasnt alleviated the problem. He admitted before the tournament this week that he still cant run and can barely ride a bike. The injury has affected his play on the course; in his last three events, he missed two cuts and finished tied for 62nd.

But a missed cut last week at the 3M Open in Minnesota allowed him to spend more time with his coach Pete Cowen, who he hadnt seen since March, and a new putting coach, Phil Kenyon. The results were immediate; he set a new career-best with a 62 on Thursday.

Thomas and Koepka are peaking at just the right time. The next seven weeks on the PGA Tour will feature the PGA Championship, the FedEx Cup playoffs, and the U.S. Open. Its the types of events both excel in. And now theyre both heading to San Francisco with a little extra bit of confidence.

But its Thomas whos going with a trophy in tow, as well as the top spot in the rankings and a new title: the favorite to win his second Wanamaker Trophy.

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Justin Thomas heads to PGA Championship with swagger of a champion - FanSided