Quotient Limited Participate in the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
By Dr. Matthew Watson
JERSEY, Channel Islands, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ: QTNT), a commercial-stage diagnostics company (Quotient or the Company), headquartered in Eysins, Switzerland, today announced the Company will participate in the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Thursday, February 18.
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Quotient Limited Participate in the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Cronos Group Inc. to Hold 2020 Fourth Quarter and Full-Year Earnings Conference Call on February 26, 2021
By Dr. Matthew Watson
TORONTO, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos Group” or the “Company”) will hold its 2020 Fourth Quarter and Full-year Earnings Conference Call on Friday, February 26, 2021 at 8:30 a.m. EST. Cronos Group’s senior management team will discuss the Company’s financial results and will be available for questions from the investment community after prepared remarks.
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Cronos Group Inc. to Hold 2020 Fourth Quarter and Full-Year Earnings Conference Call on February 26, 2021
Oyster Point Pharma to Report Fourth Quarter and Full Year 2020 Financial Results on February 18, 2021
By Dr. Matthew Watson
Conference Call and Webcast Scheduled for February 18, 2021, 4:30 pm ET Conference Call and Webcast Scheduled for February 18, 2021, 4:30 pm ET
Shattuck Labs Announces Participation in Citi’s 2021 Virtual Immuno-Oncology Day
By Dr. Matthew Watson
AUSTIN, TX & DURHAM, NC, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced it will participate in Citi’s 2021 Virtual Immuno-Oncology Day Conference being held virtually February 17-18, 2021.
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Shattuck Labs Announces Participation in Citi’s 2021 Virtual Immuno-Oncology Day
Revive Therapeutics Announces Closing of $23.0 Million Short Form Prospectus Offering
By Dr. Matthew Watson
TORONTO, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE:RVV) (USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that it has closed its previously announced bought deal prospectus offering of 46,000,000 units (“Units”) at a price of $0.50 per Unit for aggregate gross proceeds of $23,000,000 (the “Offering”), which includes the exercise in full of the 15% over-allotment option. The syndicate of underwriters was led by Canaccord Genuity Corp. and Leede Jones Gable Inc. as the co-lead underwriters (together, the "Underwriters"). The Units were offered and sold by way of a short form prospectus filed with the securities commissions in each of the provinces of Canada, other than Québec.
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Revive Therapeutics Announces Closing of $23.0 Million Short Form Prospectus Offering
Delisting of AS „Grindeks” shares from the Baltic Main list
By Dr. Matthew Watson
Delisting of AS „Grindeks” shares from the Baltic Main list
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Delisting of AS „Grindeks” shares from the Baltic Main list
Trading in Novo Nordisk shares by board members, executives and associated persons on 11-12 February 2021
By Dr. Matthew Watson
Bagsværd, Denmark, 12 February 2021 — This document discloses the data of the transaction(s) made in Novo Nordisk shares by the company’s board members, executives and their associated persons in accordance with Article 19 of Regulation No. 596/2014 on market abuse.
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Trading in Novo Nordisk shares by board members, executives and associated persons on 11-12 February 2021
Tauriga Sciences Inc. to Commence Development of its 1st Full Spectrum CBD Infused Edibles Product Line
By Dr. Matthew Watson
NEW YORK, NY , Feb. 12, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a revenue generating, diversified life sciences company, with a proprietary line of CBD & CBG infused Supplement chewing gums (Flavors: Pomegranate, Blood Orange, Peach-Lemon, Pear Bellini, Mint, Black Currant) as well as an ongoing Pharmaceutical Development initiative, today announced that it has commenced development of its 1st full spectrum Cannabidiol (“CBD”) infused edibles product line. The Company plans to develop this above referenced product line, with the following attributes: Kosher Certified, Halal Certified, Vegan Formulation, Dairy-Free, Infused with Full Spectrum Hemp Extract (“Full Spectrum”), All-Natural Flavors, Sugar Free/Diabetic Friendly Version(s), and Full Adherence to U.S. Federal Laws & Regulations. The Company expects to provide concrete details about this proposed full spectrum product line within the near term.
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Tauriga Sciences Inc. to Commence Development of its 1st Full Spectrum CBD Infused Edibles Product Line
New Positive Phase 1/2 Interim Data Presented at WORLDSymposium™ Shows Neurocognitive Development of Young MPS IIIA Patients Preserved up to Three…
By Dr. Matthew Watson
In addition to preservation of neurocognitive development with ABO-102 in MPS IIIA, new clinical results of ABO-102 in MPS IIIA and ABO-101 in MPS IIIB continue to show dose-dependent and sustained reductions in disease-specific biomarkers, denoting clear biologic effects
Radius Health, Inc. Provides Abaloparatide Business Update
By Dr. Matthew Watson
BOSTON, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) provided a business update on the abaloparatide global business. Progress was made, and continues to be made, across the following areas.
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Radius Health, Inc. Provides Abaloparatide Business Update
Equillium Presents Positive Interim Clinical Data of Itolizumab in First-line Treatment of Acute Graft-Versus-Host Disease at the…
By Dr. Matthew Watson
Higher dose cohorts demonstrated 100% overall response rate, resulting in substantial reduction in baseline corticosteroid use
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Equillium Presents Positive Interim Clinical Data of Itolizumab in First-line Treatment of Acute Graft-Versus-Host Disease at the...
Tauriga Sciences, Inc. Now Configured to Accept the Following Cryptocurrencies as Payment Options on Its E-Commerce Platform: Bitcoin (BTC), Etherium…
By Dr. Matthew Watson
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Tauriga Sciences, Inc. Now Configured to Accept the Following Cryptocurrencies as Payment Options on Its E-Commerce Platform: Bitcoin (BTC), Etherium...
Enlivex Announces Closing of Previously Announced Bought Deal Offering of Approximately $46.0 Million Ordinary Shares
By Dr. Matthew Watson
Nes Ziona, Israel, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ: ENLV), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced the closing of its previously announced offering of 2,296,107 ordinary shares, par value NIS 0.40 per share, of the Company at a price to the public of $20.00 per ordinary share, less underwriting discounts and commissions.
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Enlivex Announces Closing of Previously Announced Bought Deal Offering of Approximately $46.0 Million Ordinary Shares
FDA Approves G1 Therapeutics’ COSELA™ (trilaciclib): The First and Only Myeloprotection Therapy to Decrease the Incidence of Chemotherapy-Induced…
By Dr. Matthew Watson
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FDA Approves G1 Therapeutics’ COSELA™ (trilaciclib): The First and Only Myeloprotection Therapy to Decrease the Incidence of Chemotherapy-Induced...
Bio-Path Holdings, Inc. Announces Proposed Public Offering of Common Stock
By Dr. Matthew Watson
HOUSTON, Feb. 13, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (Nasdaq:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in a public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
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Bio-Path Holdings, Inc. Announces Proposed Public Offering of Common Stock
Prime Minister, Boris Johnson visits Newcastle-based QuantuMDx
By Dr. Matthew Watson
Prime Minister, Boris Johnson visits Newcastle-based QuantuMDx
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Prime Minister, Boris Johnson visits Newcastle-based QuantuMDx
Neck Hammock Reviews – Does this gadget really help? – Product Review by Mike Vaughn
By Dr. Matthew Watson
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Neck Hammock Reviews – Does this gadget really help? – Product Review by Mike Vaughn
Network-based screen in iPSC-derived cells reveals therapeutic candidate for heart valve disease – Science
By daniellenierenberg
Machine learning for medicine
Small-molecule screens aimed at identifying therapeutic candidates traditionally search for molecules that affect one to several outputs at most, limiting discovery of true disease-modifying drugs. Theodoris et al. developed a machine-learning approach to identify small molecules that broadly correct gene networks dysregulated in a human induced pluripotent stem cell disease model of a common form of heart disease involving the aortic valve. Gene network correction by the most efficacious therapeutic candidate generalized to primary aortic valve cells derived from more than 20 patients with sporadic aortic valve disease and prevented aortic valve disease in vivo in a mouse model.
Science, this issue p. eabd0724
Determining the gene-regulatory networks that drive human disease allows the design of therapies that target the core disease mechanism rather than merely managing symptoms. However, small molecules used as therapeutic agents are traditionally screened for their effects on only one to several outputs at most, from which their predicted efficacy on the disease as a whole is extrapolated. In silico correlation of disease network dysregulation with pathways affected by molecules in surrogate cell types is limited by the relevance of the cell types used and by not directly testing compounds in patient cells.
In principle, mapping the architecture of the dysregulated network in disease-relevant cells differentiated from patient-derived induced pluripotent stem cells (iPSCs) and subsequent screening for small molecules that broadly correct the abnormal gene network could overcome this obstacle. Specifically, targeting normalization of the core regulatory elements that drive the disease process, rather than correction of peripheral downstream effectors that may not be disease modifying, would have the greatest likelihood of therapeutic success. We previously demonstrated that haploinsufficiency of NOTCH1 can cause calcific aortic valve disease (CAVD), the third most common form of heart disease, and that the underlying mechanism involves derepression of osteoblast-like gene networks in cardiac valve cells. There is no medical therapy for CAVD, and in the United States alone, >100,000 surgical valve replacements are performed annually to relieve obstruction of blood flow from the heart. Many of these occur in the setting of a congenital aortic valve anomaly present in 1 to 2% of the population in which the aortic valve has two leaflets (bicuspid) rather than the normal three leaflets (tricuspid). Bicuspid valves in humans can also be caused by NOTCH1 mutations and predispose to early and more aggressive calcification in adulthood. Given that valve calcification progresses with age, a medical therapy that could slow or even arrest progression would have tremendous impact.
We developed a machine-learning approach to identify small molecules that sufficiently corrected gene network dysregulation in NOTCH1-haploinsufficient human iPSC-derived endothelial cells (ECs) such that they classified similar to NOTCH1+/+ ECs derived from gene-corrected isogenic iPSCs. We screened 1595 small molecules for their effect on a signature of 119 genes representative of key regulatory nodes and peripheral genes from varied regions of the inferred NOTCH1-dependent network, assayed by targeted RNA sequencing (RNA-seq). Overall, eight molecules were validated to sufficiently correct the network signature such that NOTCH1+/ ECs classified as NOTCH1+/+ by the trained machine-learning algorithm. Of these, XCT790, an inverse agonist of estrogen-related receptor (ERR), had the strongest restorative effect on the key regulatory nodes SOX7 and TCF4 and on the network as a whole, as shown by full transcriptome RNA-seq.
Gene network correction by XCT790 generalized to human primary aortic valve ECs derived from explanted valves from >20 patients with nonfamilial CAVD. XCT790 was effective in broadly restoring dysregulated genes toward the normal state in both calcified tricuspid and bicuspid valves, including the key regulatory nodes SOX7 and TCF4.
Furthermore, XCT790 was sufficient to prevent as well as treat already established aortic valve disease in vivo in a mouse model of Notch1 haploinsufficiency on a telomere-shortened background. XCT790 significantly reduced aortic valve thickness, the extent of calcification, and echocardiographic signs of valve stenosis in vivo. XCT790 also reduced the percentage of aortic valve cells expressing the osteoblast transcriptional regulator RUNX2, indicating a reduction in the osteogenic cell fate switch underlying CAVD. Whole-transcriptome RNA-seq in treated aortic valves showed that XCT790 broadly corrected the genes dysregulated in Notch1-haploinsufficient mice with shortened telomeres, and that treatment of diseased aortic valves promoted clustering of the transcriptome with that of healthy aortic valves.
Network-based screening that leverages iPSC and machine-learning technologies is an effective strategy to discover molecules with broadly restorative effects on gene networks dysregulated in human disease that can be validated in vivo. XCT790 represents an entry point for developing a much-needed medical therapy for calcification of the aortic valve, which may also affect the highly related and associated calcification of blood vessels. Given the efficacy of XCT790 in limiting valve thickening, the potential for XCT790 to alter the progression of childhood, and perhaps even fetal, valve stenosis also warrants further study. Application of this strategy to other human models of disease may increase the likelihood of identifying disease-modifying candidate therapies that are successful in vivo.
A gene networkbased screening approach leveraging human disease-specific iPSCs and machine learning identified a therapeutic candidate, XCT790, which corrected the network dysregulation in genetically defined iPSC-derived endothelial cells and primary aortic valve endothelial cells from >20 patients with sporadic aortic valve disease. XCT790 was also effective in preventing and treating a mouse model of aortic valve disease.
Mapping the gene-regulatory networks dysregulated in human disease would allow the design of network-correcting therapies that treat the core disease mechanism. However, small molecules are traditionally screened for their effects on one to several outputs at most, biasing discovery and limiting the likelihood of true disease-modifying drug candidates. Here, we developed a machine-learning approach to identify small molecules that broadly correct gene networks dysregulated in a human induced pluripotent stem cell (iPSC) disease model of a common form of heart disease involving the aortic valve (AV). Gene network correction by the most efficacious therapeutic candidate, XCT790, generalized to patient-derived primary AV cells and was sufficient to prevent and treat AV disease in vivo in a mouse model. This strategy, made feasible by human iPSC technology, network analysis, and machine learning, may represent an effective path for drug discovery.
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Network-based screen in iPSC-derived cells reveals therapeutic candidate for heart valve disease - Science
Energy drinks may damage the heart, researchers warnshould the FDA get involved? – Cardiovascular Business
By daniellenierenberg
Drinking certain energy drinks may cause significant damage to the heart, according to new findings published in Food and Chemical Toxicology.
Because the consumption of these beverages is not regulated and they are widely accessible over the counter to all age groups, the potential for adverse health effects of these products is a subject of concern and needed research, lead researcher Ivan Rusyn, MD, PhD, a professor at Texas A&M University in College Station, said in a prepared statement.
Rusyn et al. assessed a total of 17 popular energy drinks, studying their chemical profiles and looking for any associations with potential cardiac complications. Energy drinks sold by Adrenaline, Shoc, Bang Star, C4, CELSIUS, HEAT, EBOOST, Game Fuel, GURU, Kill Cliff, Kickstart, Monster Energy, Red Bull, Reign, Rockstar, RUNA, UPTIME, Venom Energy and Xyience Energy were all part of the teams analysis.
Overall, the authors found that stem cell-derived cardiomyocyteshuman heart cells grown in a laboratoryshowed signs of an increased beat rate after being exposed to some energy drinks. Also, theophylline, adenine and azelate were all ingredients the team associated with potentially contributing to QT prolongation in cardiomyocytes.
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Energy drinks may damage the heart, researchers warnshould the FDA get involved? - Cardiovascular Business
Apamistamab Conditioning Treatment Induces High Rates of HCT Success in AML – OncLive
By daniellenierenberg
Apamistamab (Iomab-B) conditioning treatment with targeted radioimmunotherapy to the bone marrow resulted in high rates of successful allogeneic hematopoietic stem cell transplants in patients with active, relapsed, or refractory acute myeloid leukemia (AML), according to interim results from the phase 3 SIERRA trial, which were presented virtually at the 2021 Transplant and Cellular Therapies Meetings.1
In these patients with relapsed or refractory AML, we observed high rates of allogeneic stem cell transplant with curative intent [in] 88% of patients on the Iomab-B arm, 18% of patients who were randomized to the conventional care arm achieved complete remission and received standard of care allo-transplant, and an overall rate of 79% of allo-transplant in all enrolled patients, Boglarka Gyurkocza, MD, said in a virtual presentation.
Investigators sought to prove with this study that targeted radiation to the marrow with apamistamab, a radioactive iodine (131I)labeled anti-CD45 antibody, could enable the successful engraftment of patients despite active disease in the marrow. Safety and robust efficacy had previously been demonstrated with the agent in 271 patients treated in 9 different phase 1 and 2 clinical trials.
The SIERRA trial is looking to enroll 150 patients, and the trial is already over 75% enrolled. Recently, an independent data monitoring committee recommended that the trial continue to the planned full enrollment based on a positive pre-planned ad-hoc analysis.2
In the study, patients with active, relapsed, refractory AML are randomized 1:1 to receive either apamistamab conditioning therapy and allogeneic HCT or conventional care. In the control arm, patients who do not achieve a complete remission (CR) by day 42 are allowed to cross over to receive Iomab-B, and those who do have a CR undergo HCT or receive standard-of-care therapy of the physicians choice.
Durable CR (dCR) rate is the primary end point of the study, characterized as complete response at 6 months after initial CR, and the secondary end point is overall survival (OS) rate at 1 year.
Patients are eligible for enrollment if they have marrow blast count 5% or the presence of peripheral blasts, age 55 years, a Karnofsky score 70, and related/unrelated donor matching at human leukocyte antigen (HLA)-A, HLA-B, HLA-C, and DRB-1. Active, relapsed, or refractory AML was defined for the sake of the trial as primary induction failure after 2 cycles of therapy including chemotherapy or 2 cycles of venetoclax (Venclexta) with a hypomethylating agent or low-dose cytarabine, first early relapse after first CR of less than 6 months, relapse refractory to salvage chemotherapy regimen, or second or subsequent relapse. Secondary or treatment-related AML was also allowed.
In the SIERRA trial, patient-specific dosimetry was used to generate an individualized therapeutic dose to target marrow and spare non-hematopoietic organs. Patients in the investigational arm received a dosimetric dose of apamistamab ( 20 mCi) approximately 19 days prior to HCT followed by a therapeutic dose of apamistamab, which is individually calculated for each patient based on an upper limit of 24 Gy to the liver. After, patients remain on radiation isolation for several days before receiving fludarabine conditioning therapy (30 mg/m2/day for 3 days) and finally low-dose total body irradiation (200 cGy) prior to HCT.
Among the first 75% of enrolled patients (n = 113), patients in the apamistamab arm (n = 56) had a median age of 63 years (range, 55-77), 35% had intermediate risk and 61% had adverse risk, the median
percent of marrow blasts at baseline was 29% (range, 4%-95%), and had received a median of 3 prior treatment regimens (range, 1-7). At randomization, 56% were in primary induction failure, 16% were in first early relapse, 15% had relapsed or refractory disease, and 13% were in their second or later relapse.
In the conventional care arm, the median age was 65 years (range, 55-77), 32% had intermediate risk and 63% had adverse risk, median marrow blasts was 20% (range, 5%-97%), and had received a median of 3 prior regimens (range, 1-6). At randomization, 49% were in primary induction failure, 21% were in first early relapse, 21% had relapsed or refractory disease, and 8.8% were in their second or later relapse. Patients who crossed over to receive apamistamab (n = 30) had similar baseline characteristics.
Forty-nine patients in the apamistamab-randomized arm were able to go on and undergo allogeneic HCT compared with 10 patients in the conventional care arm. In the investigational arm, a median of 646 mCi (range, 3541027) of apamistamab was infused at a dose of 14.7 Gy (range, 4.6-32) to the marrow. The median infused CD34-positive cell count was 5.6 x 106/Kg (range, 1.8-208). Forty-five patients received peripheral blood stem cells (PBSCs), 3 received marrow grafts, 17 had related donors, and 31 had unrelated.
Individualized therapy of Iomab-B provided myeloablative doses of radiation to the marrow, Gyurkocza, a medical oncologist at Memorial Sloan Kettering Cancer Center, commented.
These patients had a median of 30 days (range, 23-60) to HCT after randomization and 14 days (range, 9-22) to neutrophil engraftment, with no graft failure reported. Patients also had 18 days (range, 4-39) until platelet engraftment.
We also observed 100% neutrophil and platelet engraftment in patients who received Iomab-B conditioning, despite a heavy leukemia burden, Gyurkocza said.
In patients in the conventional arm who went on to HCT, conditioning regimens for HCT consisted of fludarabine/melphalan in 2, fludarabine/melphalan/total body irradiation in 1, busulfan/fludarabine in 1, cyclophosphamide/fludarabine/total body irradiation in 2, and 4 had no data on conditioning regimens available. Eight of these patients had PBSCs, 2 had marrow, 3 had related donors, 6 had unrelated, and 1 was unreported.
Median days to HCT was 67 (range, 52-104) with 17 days (range, 13-83) to neutrophil engraftment and 22 days (range, 8-35) to platelet engraftment. There was 1 graft failure.
Among the patients who crossed over to receive apamistamab before HCT, the median infused dose was 592 mCi (range, 313-1013) with 15.5 Gy (range, 6.3-42) to the marrow. The median infused CD34-positive cell count was 5.1 x 106/Kg (range, 1.8-16.1). Twenty-eight patients had PBSCs, 2 had marrow, 10 had related donors, and 20 had unrelated.
Patients had a median of 62 days (range, 36-100) to HCT, 14 days (range, 10-37) to neutrophil engraftment, and 19 days (range, 1-38) to platelet engraftment. No graft failure was reported in this group.
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Apamistamab Conditioning Treatment Induces High Rates of HCT Success in AML - OncLive