The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Ovarian Cancer – May 25, 2020

May 25, 2020

Rubraca (rucaparib) / Clovis
Clovis Oncology announces presentations at 2020 ASCO Virtual Scientific Program (Businesswire) – May 21, 2020 – “Clovis Oncology…announced today that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca® (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology 2020 Virtual Scientific Program taking place May 29 – 31….The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as findings from real-world evidence studies of the epidemiology and current treatment landscape of mCRPC.”

 

dostarlimab (TSR-042) / GSK; GSK3377794 / GSK; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
GSK highlights scientific innovation and advances in its growing oncology portfolio at ASCO 2020 (PRNewswire) – May 20, 2020 – “As part of its ongoing work to advance potentially transformational medicines, GlaxoSmithKline plc will present new data at the upcoming 2020 American Society of Clinical Oncology (ASCO) Annual Meeting from 29-31 May 2020. The depth and breadth of the presentations represent GSK’s progress in helping people affected by cancer achieve better outcomes and build on the recent US Food and Drug Administration (FDA) approval of a new indication for Zejula® (niraparib).”

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Weekly Top News – IBD – May 25, 2020

May 25, 2020

spesolimab (BI 655130) / Boehringer Ingelheim
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis (clinicaltrials.gov) – May 22, 2020 – P2/3; N=98; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Completed

 

synthetic biotic therapeutic / Synlogic
Synlogic announces termination of AbbVie collaboration agreement (PRNewswire) – May 21, 2020 – “Synlogic, Inc….today announced the termination of its collaboration with AbbVie…for the development of Synthetic Biotic medicines for the potential treatment of inflammatory bowel disease (IBD)….Upon termination, Synlogic regains all rights to develop these and new IBD Synthetic Biotic medicines for all effectors targeting IBD. This allows Synlogic to fully leverage its expertise in strain engineering, quantitative biology, regulatory, and manufacturing of living medicines to expand its wholly owned GI-based program portfolio to include IBD. Synlogic further regains the rights to partner its IBD programs.”

 

filgotinib (GLPG0634) / Gilead
Gilead and Galapagos announce positive topline results of phase 2b/3 trial of filgotinib in moderately to severely active ulcerative colitis (GlobeNewswire) – May 20, 2020 – P2b/3, N=1,351; SELECTION1 (NCT02914522); Sponsor: Gilead Sciences; “Gilead Sciences…and Galapagos…today announced positive topline results from SELECTION…Phase 2b/3 trial evaluating the efficacy and safety of…filgotinib…adult patients with moderately to severely active ulcerative colitis (UC). Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.”

 

Tremfya (guselkumab) / J&J
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – May 21, 2020 – P3; N=25; Not yet recruiting; Sponsor: Janssen Pharmaceutical K.K.

 

mirikizumab (LY3074828) / Eli Lilly
LUCENT 2: A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 19, 2020 – P3; N=1044; Recruiting; Sponsor: Eli Lilly and Company; Trial primary completion date: Jun 2021 –> Mar 2021

 

PF-06826647 / Pfizer
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis (clinicaltrials.gov) – May 20, 2020 – P2b; N=202; Recruiting; Sponsor: Pfizer; Not yet recruiting –> Recruiting

 

AMT-101 / Applied Molecular Transport
Inflammatory disease biotech Applied Molecular Transport files for a $100 million IPO (Nasdaq) – May 18, 2020 – “Applied Molecular Transport’s pipeline contains lead candidate AMT-101…that has completed a Phase 1b trial for ulcerative colitis (UC). The company plans to initiate Phase 2 trials of AMT-101 in UC and related inflammatory indications between 2020 and 2021.”

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Weekly Top News – Psoriasis – May 25, 2020

May 25, 2020

Enbrel (etanercept) / Pfizer, Amgen
Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients (clinicaltrials.gov) – May 21, 2020 – P; N=1; Not yet recruiting; Sponsor: Pfizer

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall; Skilarence (dimethyl fumarate) / Almirall; Fumaderm (dimethyl fumarate) / Biogen
TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) – May 20, 2020 – P4; N=250; Active, not recruiting; Sponsor: Almirall, S.A.; Recruiting –> Active, not recruiting

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COVID-19 Top News – May 25, 2020

May 25, 2020

Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA approves Octapharma USA Investigational New Drug Application for severe Covid-19 patients (Businesswire) – May 20, 2020 – “The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam® 10%….The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam® 10% therapy will slow or stop respiratory deterioration….The study will begin immediately at approximately 10 U.S. research sites with the goal of enrolling about 54 adult patients diagnosed with COVID-19….Octapharma hopes to report study results by the third quarter of 2020.”

 

fingolimod / Generic mfg.
[VIRTUAL] Sphingosine 1-Phosphate Receptor Modulators as a Potential Treatment Option in COVID-19 Induced Acute Res- piratory Distress Syndrome: Mechanistic Insights and Benefit-Risk Assessment (EAN 2020) – May 24, 2020 – Abstract #C10; “S1P receptor modulators, such as fingolimod, may represent a potential treatment option to ameliorate immune responses against SARS-CoV-2 and merit further investigation following careful benefit-risk evaluation in this setting.”

 

bone marrow-derived mesenchymal stem cells / NantKwest
NantKwest announces FDA authorization of IND application for mesenchymal stem cell product for the treatment of severe Covid-19 patients (Businesswire) – May 18, 2020 – “NantKwest, Inc….today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC….NantKwest has entered into an agreement with the National Marrow Donor Program….The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting.”

 

mRNA-1273 / Moderna Therapeutics
Moderna announces positive interim phase 1 data for its mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) – May 18, 2020 – P1, N=45; “Moderna, Inc….today announced positive interim clinical data of mRNA-1273….Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels….Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants….Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg….The NIAID-led Phase 1 study is being amended to include a 50 µg dose….Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.”

 

ChAdOx1 nCoV-19 / Jenner Institute, Vaccitech, AstraZeneca, University of Oxford, Oxford Biomedica
AstraZeneca advances response to global Covid-19 challenge as it receives first commitments for Oxford’s potential new vaccine (AstraZeneca Press Release) – May 21, 2020 – “AstraZeneca today received support of more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA)….The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial….A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries.”

 

AT-527 / Atea Pharma
Atea Pharmaceuticals Announces IND Clearance of AT-527 for COVID-19 and $215 Million Financing (GlobeNewswire, Atea Pharmaceuticals, Inc.) – May 20, 2020 – “Atea Pharmaceuticals, Inc….today announced a $215 million Series D financing. The financing was led by Bain Capital Life Sciences and also included new investors….Atea also announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for AT-527, a novel, oral, purine nucleotide prodrug, for the treatment of adult patients hospitalized with moderate COVID-19 disease, with one or more risk factors for poor outcomes. A Phase 2 clinical trial, scheduled to begin shortly, will evaluate the safety and efficacy of AT-527 in this patient population.”

 

Veklury (remdesivir) / Gilead
Beximco Pharma introduces world’s first generic remdesivir for Covid-19 treatment (The Financial Express) – May 21, 2020 – “Beximco Pharmaceuticals on Thursday announced the launch of Remdesivir…for treatment of COVID-19 patients….Beximco Pharma, listed on the Alternate investment Market (AIM) of London Stock Exchange, was the first company in Bangladesh to apply for regulatory approval, duly completing all the processes, strictly in compliance with local regulations. Following thorough evaluation, Directorate General of Drug Administration (DGDA) granted Emergency Use Authorization to Beximco Pharma’s Remdesivir IV Injection (under the brand name Bemsivir) on 21 May 2020.”

 

favipiravir / Generic mfg.
Health Canada clears Appili Therapeutics’ phase 2 clinical trial evaluating favipiravir as a prophylactic agent against Covid-19 outbreaks (Businesswire) – May 21, 2020 – “Appili Therapeutics Inc….today announced that Health Canada provided regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks….Appili expects trial recruitment to begin imminently….The partially blinded, cluster randomized placebo-controlled trial (cluster-RCT) will recruit approximately 760 participants across 16 LTCHs in Ontario.”

 

Alzumab (itolizumab) / Biocon, Equillium
Cuba credits two drugs with slashing coronavirus death toll (Reuters) – May 22, 2020 – “Communist-run Cuba said this week that use of two drugs produced by its biotech industry that reduce hyper-inflammation in seriously ill COVID-19 patients has sharply curbed its coronavirus-related death toll….One is itolizumab, a monoclonal antibody produced in Cuba and elsewhere. The other is a peptide that Cuba says its biotech industry discovered and has been testing for rheumatoid arthritis….’In Cuba, with the use of these drugs, 80 percent of those who end up in critical or serious condition are being saved’….Scientists caution that large placebo-controlled studies are needed to assess the safety and efficacy of these drugs for treating COVID-19.”

 

Vicromax (merimepodib) / BioSig Tech
FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution to Treat Adult Patients with Advanced COVID-19, to Proceed (GlobeNewswire, BioSig Technologies, Inc.) – May 18, 2020 – “Phase II clinical trial expected to be conducted at multiple centers in the United States, including three Mayo Clinic sites under the leadership of Andrew D. Badley, M.D., Enterprise Chair of COVID-19 Task Force….ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices….The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.”

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COVID-19 Top News – May 18, 2020

May 18, 2020

VPM1002 / Max Planck Institute, SAKK, Serum Institute of India
A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals’ Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System (clinicaltrials.gov) – May 13, 2020 – P3; N=1200; Not yet recruiting; Sponsor: Vakzine Projekt Management GmbH

 

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
Relief Therapeutics announces filing of IND for phase 2/3 clinical trial of inhaled RLF-100 targeting early Covid-19 lung injury (GlobeNewswire) – May 11, 2020 – “RELIEF THERAPEUTICS Holding AG…announced that its U.S. partner, NeuroRx Inc., has filed an investigational protocol…to conduct a Phase 2/3 clinical trial assessing inhaled RLF-100 as a treatment for patients with non-acute lung injury caused by the SARS-CoV-2 virus….The multicenter randomized placebo-controlled trial aims to enroll 144 patients with COVID-19 with shortness of breath and early pulmonary symptoms….The trial will be conducted in at least 20 sites. Patients will be randomized to receive inhaled RLF-100 plus standard of care or placebo plus standard of care. The primary endpoints will be progression to ARDS…”

 

Ampligen (rintatolimod) / AIM ImmunoTech
AIM Immunotech announces FDA authorization for first human Ampligen trial in Covid-19 patients with cancer; provides corporate business update for the first quarter of 2020 (Yahoo Finance) – May 14, 2020 – “AIM ImmunoTech…announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the Company’s lead asset, Ampligen (rintatolimod), in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus….The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski….The phase 1/2b study will enroll approximately 40 patients in two stages.”

 

Veklury (remdesivir) / Gilead
EMA recommends expanding compassionate use of Gilead’s Covid-19 drug (TODAYonline) – May 12, 2020 – “The European Medicines Agency (EMA)…recommended that the compassionate use of Gilead Sciences Inc’s…experimental drug remdesivir be expanded so that more patients with severe COVID-19 can be treated….The agency, which last month started a rolling review of data on the use of remdesivir for COVID-19 treatment, said it also introduced a five-day course of the drug, alongside the longer 10-day course, for patients not requiring assisted ventilation.”

 

mosedipimod (EC-18) / Enzychem Lifesciences
Enzychem Lifesciences to start P2 trial of Covid-19 treatment (Korea Biomedical Review) – May 13, 2020 – “Enzychem Lifesciences said that the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application to conduct phase 2 clinical trials of EC-18, a treatment candidate for Covid-19….Enzychem plans to speed up efforts to make a similar application to the U.S. Food and Drug Administration. The company will begin clinical trials to demonstrate the efficacy of EC-18 with several clinical institutions, including Chungbuk National University Hospital. The trial on 60 patients will be a double-blinded placebo-controlled trial to increase the value of efficacy data.”

 

mRNA-1273 / Moderna Therapeutics
Moderna receives FDA Fast Track designation for mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) – May 12, 2020 – “Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020….Moderna, Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2)….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.”

 

VERU-111 / Veru Inc
Veru Secures FDA Agreement to Initiate Phase 2 Study of VERU-111, Novel Microtubule Depolymerization Drug to Combat COVID-19 (GlobeNewswire, Veru Healthcare) – May 12, 2020 – “Veru Inc….today announced that it has received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111, a microtubule depolymerization agent, in combating COVID-19….The Company met with FDA and received agreement on the clinical development program for VERU-111 as a potential dual antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program….The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients….The primary efficacy endpoint will be the proportion of patients that are alive and without respiratory failure at Day 29….The study is expected to commence in the next 2 weeks.”

 

Cuba works on new product to fight “Cytokine Storm” produced by Covid-19 (Escambray) – May 14, 2020 – “The Center of Molecular Immunology (CIM by its Spanish acronym) is working to obtain an antagonist of interleukin-6, a product that can be used to inhibit the so-called ‘cytokine storm’….The project is in its initial phase….Three of the drugs that make up the Cuban protocol for the treatment of COVID-19 are developed by the Center for Molecular Immunology: the monoclonal antibody Itolizumab, created to combat leukemias and lymphomas; the recombinant human erythropoietin, of proven efficacy in people with renal failure and, finally, the stem cell generating factor LeukoCIM.”

 

FDA approves Covid-19 trial after successful emergency use of umbilical stem cells from RESTEM (PRNewswire) – May 14, 2020 – “RESTEM…announced today it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the U.S….The randomized, placebo-controlled and blinded study will look at whether this may be a safe and effective treatment for patients hospitalized with severe cases of COVID-19….The study is expected to start enrolling patients from Baptist Health South Florida and Sanford Health this week….Sanford Health will also be a key strategic partner for this study.”

 

Dr. Anthony Fauci says there’s ’virtually no chance’ that COVID-19 will be eradicated (Business Insider) – May 12, 2020 – “Dr. Anthony Fauci said that there’s little chance that the novel coronavirus, which causes the disease COVID-19, will be completely eradicated in an interview with NBC Sports….’It is so transmissible, and it is so widespread throughout the world, that even if our infections get well-controlled and go down dramatically during the summer, there is virtually no chance it will be eradicated,’ Fauci said of the novel coronavirus.”

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