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Month: March 2020

COVID-19 Top News – March 30, 2020

March 30, 2020

Coronavirus Therapy / Cocrystal Pharma
Cocrystal Pharma reports 2019 financial results and outlines expected value-driving milestones for 2020 (GlobeNewswire, Cocrystal Pharma, Inc.) – Mar 30, 2020 – “Advancing preclinical COVID-19 Coronavirus program leveraging patent rights recently acquired from Kansas State University Research Foundation (“KSURF”)….Q2 2020: File patent application….Q2/Q3 2020: Develop COVID-19 inhibitors using proprietary platform technology….H2 2020: Initiate preclinical studies of COVID-19 inhibitors.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Sanofi: First patient outside U.S. treated in global Kevzara (sarilumab) clinical trial program for patients with severe Covid-19 (GlobeNewswire) – Mar 30, 2020 – “The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States – all countries that have been impacted by COVID-19….This is the second multi-center, double-blind, Phase 2/3 trial as part of the Kevzara COVID-19 program….The trial outside of the U.S. will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo. The trial has an adaptive design with two parts and is anticipated to enroll approximately 300 patients.”

 

GC LabCell to develop Covid-19 treatment using NK-cell (Korea Biomedical Review) – Mar 30, 2020 – “Green Cross LabCell said that it has begun research into a COVID-19 medication, with a hope to start a clinical trial by the second half of 2020 in Korea and the United States….The company will begin to develop the COVID-19 treatment through a joint study with a biotechnology company, KLEO Pharmaceuticals….One of them is to develop a COVID-19 treatment with its NK cell therapy….The other one uses ARMs, which acts as a neutralizing antibody of NK treatment, to develop COVID-19 treatment. The companies will conduct the research with the National Institute of Allergy and Infectious Disease of the National Institutes of Health and a research team led by Choi Young-ki of the Chungbuk National University College of Medicine.”

 

hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.
FDA issues emergency use authorization of Trump-touted drug to treat coronavirus (The Daily Wire) – Mar 30, 2020 – “Food and Drug Administration (FDA) issued an emergency use authorization for hydroxychloroquine and chloroquine…in the fight against the China-originated novel coronavirus….The United States Department of Health & Human Services (HHS) announced in a statement…that the FDA will allow the drugs to be ‘donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,’ a Politico report said.”

 

DPX-COVID-19 / IMV Inc
IMV Inc. provides updates on the development of DPX-COVID-19 vaccine and ongoing business and clinical operations (Businesswire) – Mar 30, 2020 – “In collaboration with Gary Kobinger, Ph.D….preclinical assays in animal models are also planned in April through May of this year….In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of a Phase 1 clinical study in 48 healthy subjects has been completed and clinical sites identified in both Nova Scotia and Quebec. IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020 with the goal to initiate the clinical study in the summer of 2020.”

 

bucillamine / Revive Therap
Revive Therapeutics provides corporate update on its covid-19 and infectious diseases programs (GlobeNewswire, Revive Therapeutics Ltd.) – Mar 30, 2020 – “The Company is finalizing its regulatory package and clinical study plan for Bucillamine in the treatment of COVID-19 and it will submit for regulatory approval, by way of an IND application submission to the U.S. FDA, to investigate Bucillamine in a proposed Phase 2 clinical study. Revive will also seek to expand the clinical investigation of Bucillamine for COVID-19 in APAC regions, with a particular interest in Japan and South Korea.”

 

AdCOVID (COVID-19 vaccine) / Altimmune
Altimmune and the University of Alabama at Birmingham to collaborate on development of single-dose, intranasal Covid-19 vaccine (GlobeNewswire, Altimmune, Inc.) – Mar 30, 2020 – “Altimmune, Inc….today announced that it is launching a collaboration with the University of Alabama at Birmingham (UAB) on the development of its single-dose, intranasal COVID-19 vaccine, named AdCOVID. In response to the urgent demand posed by the COVID-19 global pandemic, Altimmune has created a COVID-19 vaccine candidate and is currently preparing for immunogenicity studies and manufacture of Phase 1 clinical trial material. Initially, Altimmune will work with UAB investigators on preclinical animal studies and characterization of the vaccine immunogenicity with the goal of enabling a Phase 1 trial in Q3 of this year.”

 

Avigan (favipiravir) / Fujifilm Holdings
Russia now has three drugs that can help treat Covid-19 – Russian Academy of Sciences (UrduPoint) – Mar 30, 2020 – “Three antiviral drugs that can be used to treat COVID-19 were developed in Russia…Chekhonin stated that the antiviral drug triazavirin was created several years ago…now being tested by Chinese scientists for its ability to treat COVID-19….The leading academician also stated that another drug, based on the Japanese-made antiviral treatment favipiravir….Another viral drug, fortepren, has also passed clinical trials and should be assessed for its ability to treat COVID-19, the academician stated.”

 

Coronavirus Vaccine / J&J, Beth Israel Deaconess Medical Center
Johnson & Johnson announces a lead vaccine candidate for Covid-19; Landmark new partnership with U.S. Department of Health & Human Services; And commitment to supply one billion vaccines worldwide for emergency pandemic use (PRNewswire) – Mar 30, 2020 – “Johnson & Johnson…today announced the selection of a lead COVID-19 vaccine candidate from constructs….The significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA)….The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021…”

 

FDA warns against use of Prodex-B as antiviral treatment for Covid-19 (GMA News) – Mar 30, 2020 – “The Food and Drug Administration (FDA)…warned the public against the use of Prodex-B as an antiviral treatment for coronavirus disease 2019 (COVID-19). In an advisory, the FDA said the drug cocktail composed of Procaine, Dexamethasone, and Vitamin B is not registered. The use of such unregistered drug may harm the patient, it added….Earlier in the day, the Department of Health also warned that other approved off-label drugs for COVID-19 treatment shall only be administered at hospitals and shall not be used for self-medication.”

 

Pluristem treated first three Covid-19 patients in Israel under compassionate use (GlobeNewswire, Pluristem Therapeutics, Inc.) – Mar 30, 2020 – “Company is in discussions with regulators in the U.S. and Europe to define its clinical strategy for COVID-19….Pluristem Therapeutics Inc….it has dosed three patients in two different hospitals in Israel under a compassionate use program for the treatment of COVID-19, as approved by the Israeli Ministry of Health. Pluristem expects to enroll additional patients in Israel in the coming days and anticipates providing updates on clinical outcomes once significant data has been gathered.””

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Weekly Top News – Ovarian Cancer – March 30, 2020

March 30, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza + cediranib: Acceptance of regulatory submission in US for recurrent platinum-resistant ovarian cancer (based on CONCERTO trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
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Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Acceptance of regulatory submission in US for BRCA mutated ovarian cancer (based on SOLO-3 trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
[Screenshot]

 

ofranergene obadenovec (VB-111) / VBL Therapeutics
VBL therapeutics announces positive outcome of the interim analysis in the OVAL phase 3 ovarian cancer pivotal study (GlobeNewswire) – Mar 26, 2020 – P3, N=400; OVAL (NCT03398655); Sponsor:VBL Therapeutics; “VBL Therapeutics…announced an encouraging outcome of the planned interim analysis in the OVAL study, a double-blind controlled potential-registration study in patients with platinum-resistant ovarian cancer…The DSMC confirmed that the study met the interim pre-specified efficacy criterion, of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm, and recommended the study continuance. The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.”

 

Bavencio (avelumab) / EMD Serono, Pfizer; magrolimab (Hu5F9-G4) / Forty Seven Inc, Ono Pharma
Magrolimab + Bavencio: “The combination of magrolimab + avelumab has a tolerable safety profile and no maximum tolerated dose was reached”; Solid tumor (Forty Seven) – Mar 26, 2020 – ASCO-SITC 2020: “Ovarian cancer pt had SD by RECIST but had -46% reduction in tumor size and was a PR by irRECIST and GCIG CA-125 criteria and remains on treatment for 9+ months” 
[Screenshot]

 

Paclical (micellar paclitaxel) / Oasmia, HLB Bio Group
Elevar Therapeutics acquires global rights to European approved Apealea from Oasmia Pharmaceutical (PRNewswire) – Mar 25, 2020 – “Elevar Therapeutics, Inc…announced…an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea®, except in Nordics, Russia, and certain countries in Eastern Europe….The companies are also in discussions with the FDA to determine the best route for a New Drug Application (NDA) in the US.”

 

Opdivo (nivolumab) / Ono Pharma, BMS; Yervoy (ipilimumab) / Ono Pharma, BMS
CheckMate 032: A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) – Mar 24, 2020 – P1/2; N=1131; Active, not recruiting; Sponsor: Bristol-Myers Squibb; N=1620 –> 1131

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Weekly Top News – IBD – March 30, 2020

March 30, 2020

AVT02 (adalimumab biosimilar) / Alvotech, Cipla
Alvotech and DKSH partner on adalimumab in Asia (Generics Bulletin – Informa) – Mar 26, 2020 – “Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.”

 

ozanimod (RPC1063) / BMS
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=675; Recruiting; Sponsor: Celgene; Trial primary completion date: Feb 2020 –> Mar 2022

 

Humira (adalimumab) / Eisai, AbbVie
Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn’s Disease Patients With Loss of Response ( PRADA ) (clinicaltrials.gov) – Mar 26, 2020 – P=N/A; N=98; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

ozanimod (RPC1063) / BMS
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=535; Recruiting; Sponsor: Celgene; Trial primary completion date: Apr 2021 –> Mar 2023

 

ozanimod (RPC1063) / BMS
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=1040; Recruiting; Sponsor: Celgene; Trial completion date: Oct 2024 –> Jun 2024; Trial primary completion date: Dec 2022 –> Mar 2024

 

ozanimod (RPC1063) / BMS
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – Mar 25, 2020 – P3; N=675; Recruiting; Sponsor: Celgene; Trial completion date: Mar 2022 –> Jun 2022; Trial primary completion date: Mar 2020 –> Mar 2022

 

filgotinib (GLPG0634) / Gilead
Galapagos CEO talks next steps as coronavirus stalls the biotech’s top drug (BioPharma Dive) – Mar 25, 2020 – “As the companies await the agency’s decision, they’re investigating filgotinib across other immune-related diseases. A federal database of clinical trials shows 14 ongoing studies testing the drug in Crohn’s disease, ulcerative colitis and psoriatic arthritis, among other conditions….The new coronavirus, however, has prompted Gilead and Galapagos to pause enrollment for more than half of these trials.”

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Weekly Top News – Psoriasis – March 30, 2020

March 30, 2020

ANB019 / AnaptysBio
ANB019: “Both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy”; Generalized pustular psoriasis (Cowen & Co. 40th Annual Health Care Conference 2020, AnaptysBio) – Mar 24, 2020 – “Patients demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113” 
[Screenshot]

 

Taltz (ixekizumab) / Eli Lilly
Taltz approved for pediatric patients with moderate to severe plaque psoriasis (eMPR) – Mar 27, 2020 – “The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy….The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (IXORA-Peds) that evaluated the efficacy and safety of ixekizumab in 171 patients aged 6 to less than 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.”

 

AVT02 (adalimumab biosimilar) / Alvotech, Cipla
Alvotech and DKSH partner on adalimumab in Asia (Generics Bulletin – Informa) – Mar 26, 2020 – “Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.”

 

vunakizumab (SHR-1314) / Jiangsu Hengrui Medicine
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults (clinicaltrials.gov) – Mar 23, 2020 – P2; N=120; Suspended; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Jun 2021 –> Dec 2020; Not yet recruiting –> Suspended; Trial primary completion date: Mar 2021 –> Jun 2020

 

BMS-986165 / BMS
Epidemic ‘secondary’ impact: Clinical trials and CDMO industry pressing the pause button [Google translation] (Sina Corp) – Mar 26, 2020 – “In the face of the epidemic, clinical trials can also respond in some ways, but the biggest risk may be that patients cannot follow up, and a large number of clinical trials are being threatened by the epidemic, and the delay has become a reality….At least five of these blockbusters were affected, including…Bristol-Myers Squibb’s BMS-986165 (Tyk2)….On March 23, Galapago’s founder and CEO Onno van de Stolpe also said that he would “suspend clinical trials of filgo to protect patient safety.”

 

 Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
IMMpact2: A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (clinicaltrials.gov) – Mar 27, 2020 – P3; N=444; Active, not recruiting; Sponsor: AbbVie; Trial primary completion date: Jun 2020 –> Jan 2021

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COVID-19 Top News – March 29, 2020

March 29, 2020

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
Relief Therapeutics, NeuroRx get FDA nod to start coronavirus trial (Reuters) – Mar 29, 2020 – “The U.S. Food & Drug Administration has authorised the start of a mid-stage trial by U.S.-Israeli NeuroRx and Relief Therapeutics for the use of Aviptadil to treat Acute Respiratory Distress in coronavirus patients….They are recruiting study sites and pharmacies to begin a phase 2 trial. The FDA issued a ‘study may proceed’ letter 24 hours after their investigational new drug application.”

 

chloroquine phosphate / Generic mfg.
Covid-19: NIMR begins test trial tomorrow – Prof Salako (Vanguard Media Limited) – Mar 29, 2020 – “…Nigerian Institute of Medical Research, NIMR, will begin clinical trials on three rapid testing kits for the disease tomorrow. Also, the institute will commence clinical trials on the efficacy of chloroquine on people who tested positive to COVID-19 and those showing symptoms but not confirmed yet.”

 

hydroxychloroquine / Generic mfg.; azithromycin / Generic mfg.
US coronavirus: Trump asks FDA to immediately approve malaria drug and antibiotic combo (InfoSurHoy.com) – Mar 29, 2020 – “…the president urged the Food and Drug Administration in a tweet to speed approval for a malarial drug and an antibiotic to treat coronavirus patients…‘HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine’….”

 

azithromycin / Generic mfg.; hydroxychloroquine / Generic mfg.
Covid 19 treatment: French expert says second study shows malaria drug helps fight coronavirus (Financialexpress) – Mar 29, 2020 – “Dr Philippe Gautret, who was part of the team behind Raoult’s latest findings, admitted that they only used the combination of drugs on ‘patients who had not been showing signs of being seriously ill after admission’ to the hospital….They said the testing was not carried out in a controlled study and that the results were purely ‘observational’. Dr Raoult…said his new study of 80 patients showed that four out of five of those treated with the drug had ‘favourable’ outcomes.”

 

Fighting Covid-19: Houston hospital first in US to try coronavirus blood transfusion therapy (New Indian Express) – Mar 29, 2020 – “A prominent US hospital here has infused the blood of a patient, who has recovered from COVID-19, into a critically ill patient, becoming the first medical facility in the country to try the experimental therapy….Methodist…began recruiting blood plasma donors from among 250 patients who have tested positive for the virus at the system’s hospitals.”

 

UofL researchers focus on coronavirus treatment, testing cells growing quickly in host tobacco plants (NKyTribune) – Mar 29, 2020 – “The University of Louisville’s biocontainment laboratory is being called upon in research efforts focusing on the coronavirus and the disease it causes, COVID-19, and a Kentucky crop could be a key….The research goal is to identify the best potential treatment option that could eventually be tested in humans, first at UofL to gauge its safety and efficacy and then later at the University of Pittsburgh and other clinical trial sites to continue to test its effectiveness….Some of the compounds are already showing promise in the laboratory.”

 

Telehealth, new social media sources and a glimmer of hope that Covid-19 curve is flattening (The RiotACT) – Mar 29, 2020 – “The Prime Minister’s major announcement today concerned the immediate rollout of Telehealth from Monday morning and ways to distribute official information via a new What’s App feature and the Apple coronavirus app….Health Minister Greg Hunt described ‘a time of profound and understandable stress, anxiety, depression, isolation, and need for access to services’, but said the telehealth changes enacted in 10 days would otherwise have taken 10 years to accomplish and would mean substantial assistance was available during the crisis.”

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COVID-19 Top News – March 28, 2020

March 28, 2020

lopinavir/ritonavir / Generic mfg.; hydroxychloroquine / Generic mfg.; remdesivir (GS-5734) / Gilead; chloroquine phosphate / Generic mfg.
A patient in Norway is the first to enroll in a global ‘solidarity trial’ testing 4 coronavirus treatments (Business Insider) – Mar 28, 2020 – “Hoie said the trial starts today, and that the first patient is somone at Oslo Universoty Hospital….The trial…includes more than 45 countries around the world…”

 

US biotech firm wants to test its pneumonia treatment in Covid-19 patients – Mar 28, 2020 – “BioAegis Therapeutics has been testing a protein called gelsolin to treat pneumonia….BioAegis has applied to the FDA for rapid authorization to begin a clinical trial of its treatment for COVID-19 patients that are on or nearly to the point of needing ventilators.”

 

Study shows good results with plasma treatment for Covid-19 (The Hindu) – Mar 28, 2020 – “…Convalescent plasma transfusion may be helpful in the treatment of critically ill patients with COVID-19 and ARDS….While the cohort is small, there is less scepticism about the study results, experts argue, because the method (convalescent plasma) has worked well for other conditions….’Following plasma transfusion, body temperature normalised within 3 days in 4 of 5 patients, the Sequential Organ Failure Assessment score decreased, and the ratio that determines severity of ARDS increased within 12 days….Viral loads also decreased and became negative within 12 days after the transfusion’.”

 

lopinavir/ritonavir / Generic mfg.; chloroquine phosphate / Generic mfg.; hydroxychloroquine / Generic mfg.; remdesivir (GS-5734) / Gilead
India to participate in WHO solidarity trial for developing potential drugs for Covid-19 – Mar 28, 2020 – “Mr Gangakhedkar also informed that India has indicated willingness to go for vaccine trials for country’s population….Our correspondent reports that WHO’s Solidarity trial is expected to witness participation from many countries including Thailand, Argentina, Canada, France, Iran, and Spain. The trial will not only test different drugs but will also compare their effectiveness.”

 

lopinavir/ritonavir / Generic mfg.; hydroxychloroquine / Generic mfg.; remdesivir (GS-5734) / Gilead; chloroquine phosphate / Generic mfg.
WHO enrolls Spain and Norway for Covid-19 initial clinical trial (Biospectrumasia) – Mar 28, 2020 – “Spain and Norway are ready to enrol their patients for COVID-19 clinical trial….’More the countries join the trial, the faster we will have results. In the meantime, we call on individuals & countries to refrain from using therapeutics that have not been demonstrated to be effective in the treatment of COVID-19′.”

 

mRNA-1273 / Moderna Therapeutics
US coronavirus vaccine trial expands to second test location – Mar 28, 2020 – “A coronavirus vaccine study has expanded to a second location, with new volunteers for the potentially COVID-19-preventing injection being sought in Atlanta….Now, Emory University in Atlanta plans to enroll a second cohort as the Phase 1 trial expands its footprint. In total it’s expected to amount to 45 participants spread across both sites.”

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COVID-19 Top News – March 27, 2020

March 27, 2020

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi; remdesivir (GS-5734) / Gilead
N.J. hospital flooded by Covid-19 patients begins clinical drug trials (NJ.com) – Mar 27, 2020 – “Holy Name Medical Center…is conducting trials of two drugs to treat the disease caused by the novel coronavirus. ‘We are trying to do clinical trials of a drug, Kevzara, and expanded access (compassionate use) of the drug remdesivir,’ Saggar said.”

 

ChAdOx1 nCoV-19 / Jenner Institute, University of Oxford
Oxford Covid-19 vaccine programme opens for clinical trial recruitment (Mirage News) – Mar 27, 2020 – “University of Oxford researchers…have started screening healthy volunteers (aged 18-55) today for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region….The team will enrol healthy volunteers aged between 18 – 55….The trial…will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison.”

 

AdCOVID (COVID-19 vaccine) / Altimmune
Altimmune announces financial results for the year ended December 31, 2019 and provides a corporate update (GlobeNewswire, Altimmune, Inc.) – Mar 27, 2020 – “…Company began development of AdCOVID, a vaccine candidate to protect against COVID-19. The Company designed and created the vaccine candidate…and plans to begin animal testing in Q2 2020. The Company is engaged in discussions with a number of organizations who are addressing this crisis, including The United States Medical Countermeasures Task Force, The World Health Organization, academia, and other institutions engaged in the effort.”

 

leronlimab (PRO 140) / CytoDyn, Vyera Pharma
CytoDyn files FDA-suggested modifications to IND and protocol for phase 2 clinical trial for Covid-19 patients with mild to moderate indications and a second randomized protocol for all Covid-19 patients in severe condition will be filed next week per FDA recommendation (GlobeNewswire, CytoDyn Inc.) – Mar 27, 2020 – “CytoDyn Inc….announced today that, at the suggestion of the U.S. Food and Drug Administration (FDA), the Company filed another round of modifications to its IND and protocol for a Phase 2 clinical trial with leronlimab (PRO 140). In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab….The first Phase 2 clinical trial…is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Two clinical studies to treat Covid-19 launched (Medical Xpress) – Mar 27, 2020 – “UC Davis is one of up to 50 sites in the U.S. assessing sarilumab….Approximately 400 hospitalized patients age 18 and older with acute COVID-19 infection can be enrolled in the study nationwide….The researchers will be determining whether the health of individuals with high IL-6 levels and severe/critical levels of infection improve with the drug. The study is sponsored by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Timothy Albertson, professor and chair of the Department of Internal Medicine, is leading the study at UC Davis.”

 

Arcturus Covid-19 vaccine to benefit from Duke-NUS genetic correlation system (GlobeNewswire, Arcturus Therapeutics, Inc.) – Mar 27, 2020 – “Arcturus Therapeutics…today provided details about the Company’s strategy to rapidly learn about the safety and efficacy profile of its COVID-19 vaccine using Duke-NUS’ genetic correlation system….Arcturus’ COVID-19 vaccine, LUNAR-COV19, is based on its STARR™ and LUNAR® technologies.”

 

EIDD-2801 / Emory University, Ridgeback Biotherap
Emory-discovered antiviral is poised for Covid-19 clinical trials (Chemical & Engineering News) – Mar 27, 2020 – “A small-molecule antiviral discovered by Emory University chemists could soon start human testing against COVID-19….That’s the plan of Ridgeback Biotherapeutics, which licensed the compound, EIDD-2801, from an Emory nonprofit….EIDD-2801 lacks human safety data. Ridgeback founder and CEO Wendy Holman says she expects the US Food and Drug Administration to give the green light for a Phase I study in COVID-19 infections within “weeks, not months.””

 

remdesivir (GS-5734) / Gilead
Two clinical studies to treat Covid-19 launched (Medical Xpress) – Mar 27, 2020 – “UC Davis Health has two clinical trials underway for hospitalized patients with severe COVID-19….UC Davis is one of approximately 75 sites worldwide evaluating the benefits of remdesivir for severe COVID-19 infection….The study will enroll up to 440 patients over the next several months, including about 10 or more at UC Davis….It is part of the study recently launched at the University of Nebraska.”

 

leronlimab (PRO 140) / CytoDyn, Vyera Pharma
Leronlimab used in seven patients with severe Covid-19 demonstrated promise with two intubated patients in ICU, removed from ICU and extubated with reduced pulmonary inflammation (GlobeNewswire, CytoDyn Inc.) – Mar 27, 2020 – “CytoDyn Inc….announced today the three-day results post-leronlimab treatment of the first four patients under an Emergency Investigational New Drug (EIND)….’We found that patients with severe COVID-19 disease are in the midst of immunologic chaos which includes the cytokine storm. Our companion diagnostics showed that after three days of therapy, the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm were much improved’.”

 

Rare case of Pulmonary Necrotic Rhodococcus equi infection in a Kidney Pancreas Transplant Recipient. (NKF-CSM 2020) – Mar 27, 2020 – Abstract #463; “At the time of presentation, he was on tacrolimus, mycophenolate mofetil, prednisone and basiliximab for immunosuppression…He was prescribed azithromycin, doxycycline, and ciprofloxacin by his local providers with no improvement…He was started on IV vancomycin, meropenem for 6 weeks and his symptoms improved…He recieved voriconazole for his aspergilllus for 12 months… R.equi is a unique Acid fast positive cocci and a intracellular pathogen.We report a very rare case of Rhodococcus infection in a kidney pancreas transplant recipient which was successfully treated without surgical intervention. Choice of antibiotics was challenging while maintaining dual organ transplant function and avoiding acute rejection.”

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COVID-19 Top News – March 26, 2020

March 26, 2020

Berkeley Lights announces the creation of the Global Emerging Pathogen Antibody Discovery Consortium (GEPAD) to address Covid-19 and other viruses (PRNewswire) – Mar 26, 2020 – “In collaboration with Vanderbilt University Medical Center, La Jolla Institute for Immunology and Emory University , viral neutralization workflows using the Berkeley Lights platform are being accelerated in response to the epidemic coronavirus….The consortium will use the Berconey Lights Beacon platform to discover antibodies using blood from patients in remission as the basis for treatment, COVID-19 being the first target.”

 

ExThera’s affinity blood filter is used to treat Covid-19 Patients – Mar 26, 2020 – “Treatment of COVID-19 with ExThera’s Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) has begun in hospitals in Germany and Italy. Seraph 100 treatments of COVID-19 are also expected to begin soon in France and the USA….ExThera has received clinician interest in individual emergency use of Seraph 100 in the USA and we expect COVID-19 treatments to begin here soon, when they meet the criteria outlined in the FDA Guidance.”

 

Relief Therapeutics and NeuroRx, Inc. file FDA IND for Aviptadil to treat Covid-19-induced respiratory distress (PRNewswire) – Mar 26, 2020 – “RELIEF THERAPEUTICS Holding AG…filed an Investigational New Drug (IND) Application with the US FDA for a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute and Moderate Respiratory Distress in patients infected by the COVID-19 coronavirus….Relief also holds a US patent for Aviptadil and proprietary manufacturing processes for its synthesis.”

 

remdesivir (GS-5734) / Gilead
Gilead rescinds orphan status request for Covid-19 drug (pharmaphorum) – Mar 26, 2020 – “Gilead decided to rescind the request for orphan status after drug pricing campaigners accused the company of gaming US drug laws to maximise any profits made from remdesivir should it get approved….While Gilead did not acknowledge the pricing row in its brief statement saying it had rescinded the request, the company noted that orphan status also waives the need for a paediatric study plan that can take 210 days to review.”

 

FDA grants VERO Biotech expanded access emergency use for the treatment of patients with COVID-19, with the Genosyl DS, the first and only FDA-approved tankless system for the delivery of inhaled nitric oxide (PRNewswire) – Mar 26, 2020 – “VERO Biotech LLC…announced that the U.S. Food and Drug Administration (FDA) has granted ‘expanded access emergency use’ allowing its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS, to immediately be used for the treatment of cardiopulmonary symptoms associated with COVID-19.”

 

Beroni Group announces submission of Emergency Use Authorization to US FDA for its COVID-19 rapid test detection kit (GlobeNewswire) – Mar 26, 2020 – “Beroni Group….announces submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its IgG/IgM antibody SARS-CoV-2 rapid test detection kit.”

 

Dynavax and CEPI announce collaboration to support global effort to develop a vaccine for coronavirus (COVID-19) (GlobeNewswire, Dynavax Technologies Corporation) – Mar 26, 2020 – “Dynavax Technologies Corporation…and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a collaboration supporting the global effort to develop a vaccine to prevent the coronavirus (COVID-19). Dynavax will make the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018TM, available for the development of effective vaccines against COVID-19….CEPI and Dynavax will work together to identify and coordinate engagements with entities around the world working on COVID-19 vaccines. The focus of this collaboration is to identify programs that could benefit from combination with CPG 1018 to provide a more rapid or robust immune response.”

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COVID-19 Top News – March 25, 2020

March 25, 2020

FDA now allows treatment of life-threatening Covid-19 cases using blood from patients who have recovered (TechCrunch) – Mar 25, 2020 – “The U.S. Food and Drug Administration (FDA)…include use of ‘convalescent plasma’, in cases where the patient’s life is seriously or immediately threatened. This isn’t an approval of the procedure as a certified treatment, but rather an emergency clearance that applies only on a case-by-case basis, and only in extreme cases….FDA has granted this temporary authorization under its Investigational New Drug Applicants (eINDS) exemption.”

 

Study tests proven blood clot buster against Covid-19 (Drug Discovery & Development) – Mar 25, 2020 – “In a clinical trial being planned for hospitals in Massachusetts and Colorado, patients with severe cases of COVID-19 would be given the blood thinner tissue plasminogen activator (tPA), a protein prescribed for heart attack and stroke victims….The researchers will test tPA in patients under the FDA’s ‘compassionate use’ program….BARDA ( the Biomedical Advanced Research and Development Authority) will fund the trial. Genentech is donating the drug for the initial trial.”

 

remdesivir (GS-5734) / Gilead
Lives are on the line: Science matters in finding coronavirus treatments (NBC News) – Mar 25, 2020 – “In Nebraska, researchers are studying whether an experimental drug, remdesivir, can treat COVID-19, the illness that results from coronavirus infection.”

 

trabedersen (OT-101) / Autotelic, Mateon Therapeutics
Mateon report positive results for multiple COVID-19 drug candidates (GlobeNewswire) – Mar 25, 2020 – “OT-101 continued to show significant activity against coronaviruses and in the new testing results, two additional therapeutic oligonucleotides designed to target COVID-19 also demonstrated potent anti-viral activity….OT-101 and the other candidates work by inhibiting virus binding to its target, thereby stopping the virus from replicating itself and stopping viral induced pneumonia, which often leads to patient complications….The Company has begun preparations to submit an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA) for OT-101 against COVID-19 to expedite testing in COVID-19 patients.”

 

BioSig subsidiary NeuroClear acquires license for a broad-spectrum anti-viral agent that may treat Covid-19. Laboratory results demonstrate high level of activity against Covid-19 in cell culture (GlobeNewswire) – Mar 25, 2020 – “BioSig Technologies, Inc…acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19)….Anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing….The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials….The Company intends to develop Vicromax(tm) and take it through clinical trials under a new NeuroClear subsidiary, ViralClear Pharmaceuticals, Inc.”

 

CytoSorb used to treat more than 70 critically-ill Covid-19 patients and specifically added to coronavirus treatment guidelines in Italy and Panama (PRNewswire) – Mar 25, 2020 – “CytoSorb use has generally been associated with a marked reduction in cytokine storm and inflammation, improved lung function, weaning from mechanical ventilation, and a reversal of shock. Certainly not all treatments have been successful in this critically-ill patient population that verges on death, particularly when used too late.”

 

Nu-Med Plus closely monitoring outcomes on two new human clinical trials using inhaled nitric oxide in treatment of Covid-19 (GlobeNewswire, Nu-Med Plus Inc.) – Mar 25, 2020 – “Nu-Med Plus, Inc…today announced that the Company is closely monitoring two new clinical trials that are testing Nitric Oxide Gas Inhalation Therapy for the treatment of mild/moderate COVID-19….Data on SARS-CoV suggest that iNO could have a similar effect on COVID-19 due to the genomic similarities between the two coronaviruses.”

 

Eurobio Scientific gets CE marking for its proprietary COVID-19 test (GlobeNewswire) – Mar 25, 2020 – “Eurobio Scientific…is today announcing the CE marking for its EBX 041 SARS CoV2 proprietary test, developed specifically for the clinical diagnosis of COVID-19. The EBX 041 SARS CoV2 proprietary kit follows the design recommended by the French National Reference Center (CNR) and has been approved based on clinical samples with an independent hospital. This is a multiplex kit with three targets: two for identifying the virus and one target for a control integrated into each patient test.”

 

Sorrento Launches Novel I-Cell COVID-19 Cellular Vaccine Program (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 25, 2020 – “STI-6991 is an I-CellTM COVID-19 cellular vaccine made of replication-deficient human erythroleukemia K562 cells expressing membrane-bound S1 protein of the SARS-CoV-2 virus….The I-Cell vaccine is expected to elicit both T cell and B cell immunities against SARS-CoV-2.”

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COVID-19 Top News – March 24, 2020

March 24, 2020

remdesivir (GS-5734) / Gilead
Gilead’s potential coronavirus treatment gets FDA’s Orphan Drug label (cnbc) – Mar 24, 2020 – “Gilead Sciences’ experimental drug remdesivir…received the orphan drug designation from the U.S. Food and Drug Administration….The announcement comes days after U.S. President Donald Trump called on the FDA to streamline its approval process for treatments such as remdesivir….It was temporarily putting new emergency access to remdesivir on hold due to an exponential increase in so-called compassionate-use requests for the drug.”

 

CpG 1018 / Dynavax, University of Queensland
Dynavax and Clover Biopharmaceuticals announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with CpG 1018 adjuvant (GlobeNewswire) – Mar 24, 2020 – “Dynavax Technologies Corporation…and Clover Biopharmaceuticals…announced that they have entered into a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is advancing evaluation of its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) in preclinical studies. Dynavax is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this initiative…Utilizing its patented Trimer-Tag© technology, Clover has produced a COVID-19 S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system….Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.”

 

eTheRNA launches an international consortium and starts development of cross-strain protective CoV-2 mRNA vaccine for high risk populations (PRNewswire) – Mar 24, 2020 – “eTheRNA Immunotherapies nv…announced that a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against CoV-2 and preclinical development has started. Chinese partners may be added in the consortium in due course…eTheRNA and its partners EpiVax, Nexelis, REPROCELL and CEV* have extensive experience in the mRNA vaccine field and this will help accelerate progress towards clinical trials with patient enrolment expected in early 2021.”

 

Actemra IV (tocilizumab) / Roche, JW Pharma
Roche response to Covid-19 pandemic (GlobeNewswire, F. Hoffmann-La Roche Ltd) – Mar 24, 2020 – “The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra®/RoActemra® (tocilizumab) on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care….This is the first global study of Actemra/RoActemra in this setting.”

 

hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.
New York to start clinical trials for Covid-19 treatment after a go signal from the FDA (Tech Times) – Mar 24, 2020 – “…Food and Drug Administration has already approved one of the drugs that are involved in the clinical trials for the state of New York….New York Gov. Andrew Cuomo has stated…they have now acquired 10,000 doses of Zithromax, 70,000 doses of hydroxychloroquine and 750,000 doses of chloroquine….The main drug that was approved by the FDA for clinical trials was Chloroquine…brand-name antibiotic called Zithromax was included, and another one named hydroxychloroquine….These drugs are all considered as potential treatments for coronavirus.”

 

COVID-19 immunotherapy / CEL-SCI
Embattled Cel-Sci to tackle Covid-19 with immunotherapy platform tech LEAPS (FierceBiotech) – Mar 24, 2020 – “Cel-Sci announced…it has formed a research partnership with the University of Georgia’s Center for Vaccines and Immunology to develop a drug candidate for patients at high risk of dying from COVID-19.”

 

Sorrento collaborates with Mabpharm on development and commercialization of ACE-MAB to potentially treat COVID-19 (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 24, 2020 – “Sorrento Therapeutics, Inc…today announced it has entered into an exclusive license agreement with China-based antibody biopharmaceutical company, Mabpharm Limited…for the clinical development and commercialization of the ACE-MAB fusion protein (Sorrento’s product code name STI-4920 and Mabpharm’s product code name CMAB020) for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. Mabpharm has generated a fusion protein (CMAB020) that binds to the spike protein of the SARS-CoV-2 virus.”

 

 

Ampio is preparing an expanded access FDA protocol to study nebulized Ampion as a treatment for moderate to severe acute respiratory distress syndrome associated with Covid-19 (PRNewswire) – Mar 24, 2020 – “Ampio Pharmaceuticals…announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2….The anticipated aim of a preliminary protocol for FDA review would be to evaluate patients with moderate to severe ARDS, triggered by COVID-19 for (1) reduced ventilator time; (2) reduction in mortality and (3) improvements in oxygenation parameters compared to non-Ampion treated patients.”

 

Cell>Point plans to expedite research program on 99mTc-EC-Amifostine and 177Lu-EC-Amifostine as a potentially effective theranostic technology for Covid-19 (PRNewswire) – Mar 24, 2020 – “Cell>Point announced today its plans to move forward with its research program to clinically develop 99mTc-EC-Amifostine and 177Lu-EC-Amifostine to assess, treat and follow-up with confirmatory imaging for people who contract COVID-19.”

 

VERO Biotech announces first patient with Covid-19 infection complicating pulmonary hypertension treated with GENOSYL DS, the first and only FDA-approved tankless system for the delivery of Inhaled Nitric Oxide (PRNewswire) – Mar 24, 2020 – “VERO Biotech…today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS at home….The patient was treated under an emergency IND filed by a qualified Investigator and approved by the US FDA.”

 

Soligenix’s Covid-19 vaccine (Pharmaceutical-technology.com) – Mar 24, 2020 – “Soligenix has collaborated with the University of Hawaiʻi at Mānoa (UH Mānoa) to study Covid-19 vaccine candidates….The company will assess the use of its heat-stable technology platform against coronaviruses, including SARS-CoV-2.”

 

INO-4800 / Inovio
Ology Bioservices, Inovio Partner to manufacture COVID-19 DNA vaccine with $11.9 million department of defense grant (PRNewswire) – Mar 24, 2020 – “Ology Bioservices Inc…and Inovio Pharmaceuticals Inc…announced today that the Department of Defense (DOD) has awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines….Under this program, Ology Bioservices will work with Inovio Pharmaceuticals to manufacture Inovio’s DNA vaccine (INO-4800) for prevention of infection with the COVID-19 virus.”

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