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Pharma news roundup and Larvol updates

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Month: May 2020

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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Weekly Top News – Ovarian Cancer – May 18, 2020

May 18, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer (AstraZeneca Press Release) – May 11, 2020 – “Regulatory reviews are currently underway in the EU, Japan and other countries for Lynparza based on results from the PAOLA-1 trial.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Maintenance olaparib provides significant long-term OS benefit in relapsed ovarian cancer (Targeted Oncology) – May 14, 2020 – P3, N=327; SOLO2 (NCT01874353); Sponsor: AstraZeneca; “Maintenance treatment with olaparib (Lynparza) demonstrated an improved median overall survival (OS) of 12.9 months over placebo in patients with platinum-sensitive relapsed ovarian cancer harboring a BRCA1/2 mutation, according to final OS results from the phase III SOLO2/ENGOT-ov21 trial. Poveda presented updated survival results after approximately 5 years of follow-up in a press briefing ahead of the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting…At 5 years, 42.1% of patients in the olaparib group were still alive compared with 33.2% in the placebo group. However, 39% of patients in the placebo arm crossed over to receive PARP inhibition.”

 

mirvetuximab soravtansine (IMGN 853) / ImmunoGen
ImmunoGen announces initial data from FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in recurrent ovarian cancer, regardless of platinum status (Immunogen Press Release) – May 13, 2020 – P3, N=366; FORWARD II (NCT02631876); Sponsor: ImmunoGen; “ImmunoGen…announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program on May 29, 2020. Three “trial in progress” posters will also be presented during the meeting….In the overall patient population, objective responses were seen in 26 patients and the confirmed overall response rate (ORR) was 43% (95% CI, 31, 57).”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers (clinicaltrials.gov) – May 14, 2020 – P1/2; N=73; Suspended; Sponsor: Vanderbilt-Ingram Cancer Center; Trial completion date: Mar 2025 –> Sep 2025; Not yet recruiting –> Suspended; Trial primary completion date: Mar 2023 –> Sep 2023

 

Keytruda (pembrolizumab) / Merck (MSD); DPX-Survivac (EMD 640744) / IMV Inc
IMV Inc. provides clinical and operational update and announces first quarter 2020 financial results (Businesswire) – May 15, 2020 – “Translational and updated clinical response data from Phase 2 DeCidE1 study of DPX-Survivac in advanced ovarian cancer to be presented by Oliver Dorigo, MD, Ph.D., at the upcoming 2020 ASCO Virtual Scientific Program….Upcoming Milestones: Top line Phase 2 clinical results update in the DLBCL combination trial in 2020, Update on the Phase 2 clinical results in the ovarian monotherapy trial at ASCO 2020, Updated Phase 2 clinical results for Basket trial in 2H 2020.”

 

AZD4635 / AstraZeneca; Recentin (cediranib) / AstraZeneca; capivasertib (AZD5363) / Otsuka, AstraZeneca; tremelimumab (CP-675206) / AstraZeneca, Pfizer; Calquence (acalabrutinib) / AstraZeneca; gefitinib / Generic mfg.; Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
AstraZeneca advances the science of cancer medicine with practice-changing data at the ASCO20 Virtual Scientific Program (AstraZeneca Press Release) – May 13, 2020 – “AstraZeneca will present ground-breaking new results across its broad portfolio of cancer medicines during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to 31 May 2020. AstraZeneca will present 98 abstracts, including 19 oral presentations with one plenary and 10 late-breakers. Presentations will showcase the Company’s leadership in the treatment of early lung cancer with a late-breaking plenary presentation of the unprecedented results from the Phase III ADAURA trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Data from the DESTINY programme will highlight the transformative potential of Enhertu (trastuzumab deruxtecan) across HER2-driven tumours, including in lung, breast, gastric and colorectal cancers.”

 

Keytruda (pembrolizumab) / Merck (MSD); Tecentriq (atezolizumab) / Roche
Phase 1/2 Study of IMC-F106C in Advanced PRAME-Positive Cancers (clinicaltrialsregister.eu) – May 12, 2020 – P1/2; N=63; Ongoing; Sponsor: Immunocore Ltd.

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Imfinzi (durvalumab) / AstraZeneca, BMS
MEDIOLA: A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (clinicaltrials.gov) – May 12, 2020 – P1/2; N=427; Active, not recruiting; Sponsor: AstraZeneca; Recruiting –> Active, not recruiting
Clinical • Combination therapy • Enrollment closed • BARD1 • BRCA • BRIP1 • CHEK1 • CHEK2 • HER-2 •

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Myriad receives FDA approval of myChoice CDx as companion diagnostic for Lynparza (olaparib) in patients with advanced ovarian cancer (GlobeNewswire) – May 11, 2020 – “Myriad Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) approved the myChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab.”

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Weekly Top News – IBD – May 18, 2020

May 18, 2020

brazikumab (AMG 139) / AstraZeneca
AstraZeneca recovery of global rights to brazikumab (MEDI2070) from Allergan completed (AstraZeneca Press Release) – May 11, 2020 – “AstraZeneca has completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. AstraZeneca and Allergan have terminated their previous license agreement and all rights to brazikumab have therefore now returned to AstraZeneca….Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab for Crohn’s disease (CD) and ulcerative colitis (UC), including the development of a companion diagnostic.”

 

brazikumab (AMG 139) / AstraZeneca
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrialsregister.eu) – May 12, 2020 – P3; N=1000; Sponsor: Allergan Limited

 

AK101 / Akesobio
Akeso gets approval for AK101 investigational New Drug Application in China (Reuters) – May 15, 2020 – “Announces approval for AK101 Investigational New Drug Application for ulcerative colitis in China”

 

PL8177 / Palatin Technologies
Palatin Technologies, Inc. reports third quarter fiscal year 2020 financial results and recent business highlights (PRNewswire) – May 12, 2020 – “A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first half of calendar year 2021, with data readout in the first half of calendar year 2022.”

 

Stelara (ustekinumab) / J&J
SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (clinicaltrials.gov) – May 14, 2020 – P3b; N=386; Active, not recruiting; Sponsor: Janssen Scientific Affairs, LLC; Trial primary completion date: Apr 2020 –> Dec 2020

 

LC51-0255 / LG Chem
LG Chem Life Sciences Innovation Center announces data from phase I study of its ulcerative colitis treatment LC51-0255 (Businesswire) – May 14, 2020 – “P1,N=110; NCT03174613; Sponsor: LG Chem; Positive topline results of oral LC51-0255 presented at virtual Digestive Disease Week (DDW) 2020 as ePoster…was well-tolerated in healthy subjects using once-daily oral administration for up to 21 days….We are delighted to be moving LC51-0255 into Phase II this year.”

 

Stelara (ustekinumab) / J&J
PROUST: A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab (clinicaltrials.gov) – May 14, 2020 – P=N/A; N=221; Completed; Sponsor: Janssen Cilag S.A.S.; Active, not recruiting –> Completed

 

KB295 / Kaleido
Kaleido Biosciences provides corporate update and reports first quarter 2020 financial results (GlobeNewswire, Kaleido Biosciences) – May 14, 2020 – “Initiating a clinical study later this year evaluating a new MMT candidate, KB295, in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Top-line results are expected in mid-2021.”

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Weekly Top News – Psoriasis – May 18, 2020

May 18, 2020

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Data from P3 OASIS-1 trial (NCT03482011) for psoriasis in H2 2020 (Eli Lilly, Bank of America Merrill Lynch Global Healthcare Conference 2020) – May 15, 2020

 

ABY-035 / Affibody
Affibody and Inmagene announce strategic partnership to develop ABY-035 – a phase 2 drug candidate with best-in-class potential for auto-immune diseases (Cision) – May 16, 2020 – “Affibody AB (‘Affibody’) and Inmagene Biopharmaceuticals (‘Inmagene’) today announced a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (clinicaltrials.gov) – May 12, 2020 – P3; N=964; Active, not recruiting; Sponsor: AbbVie; Recruiting –> Active, not recruiting; Trial primary completion date: Jan 2021 –> Oct 2020

 

EDP1815 / Evelo Biosci
Evelo Biosciences reports first quarter financial results and business highlights (GlobeNewswire) – May 11, 2020 – “Selected enteric capsule formulation of EDP1815 for Phase 2 dose ranging trial in psoriasis; trial initiation now expected in 3Q 2020, with interim data in mid-2021….This study will evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in approximately 225 individuals with mild to moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks….Evelo also announced interim data from cohorts of individuals with either mild to moderate psoriasis…who were treated with the newer, alternate formulation of EDP1815 in the ongoing Phase 1b studies. Meaningful clinical responses were not observed in either cohort. Based on these data, Evelo is discontinuing development of the alternate formulation.”

 

GSK2831781 / GSK
GSK2831781: Proof-of-concept data from P1 trial (NCT03965533) for psoriasis in H2 2020 (Immutep) – May 14, 2020 – NWR Virtual Small Cap Health Conference

 

Stelara (ustekinumab) / J&J
PROUST: A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab (clinicaltrials.gov) – May 14, 2020 – P=N/A; N=221; Completed; Sponsor: Janssen Cilag S.A.S.; Active, not recruiting –> Completed

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COVID-19 | Status of Scientific Conferences 2020

May 18, 2020

Over 400 healthcare and pharma conferences have changed or cancelled their upcoming meetings because of COVID-19.  We have compiled an updated list on the current status of these conferences.

 

Click Here for Full Access

 

Last Updated: May 18, 2020

 

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Weekly Top News – Ovarian Cancer – May 11, 2020

May 11, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Olaparib Átlépéses vizsgálat olyan betegek számára, akik teljesítettek egy korábbi, olaparibra irányuló onkológiai vizsgálatot (clinicaltrialsregister.eu) – May 7, 2020 – P3; N=124; Ongoing; Sponsor: AstraZeneca AB

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza (olaparib) approved by FDA as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer (Merck (MSD) Press Release) – May 8, 2020 – “AstraZeneca and Merck…announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. The approval was based on a biomarker subgroup analysis of 387 patients with HRD-positive tumors from the Phase 3 PAOLA-1 trial…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer (AstraZeneca Press Release) – May 11, 2020 – “Regulatory reviews are currently underway in the EU, Japan and other countries for Lynparza based on results from the PAOLA-1 trial.”

 

Pemazyre (pemigatinib) / Incyte; Revlimid (lenalidomide) / BMS; INCB62079 / Incyte
Incyte reports 2020 first quarter financial results and provides updates on key clinical programs (Businesswire) – May 5, 2020 – “Delays in data collection and validation, caused by COVID-19 related disruption, mean that data from the FIGHT-201 clinical trial of pemigatinib in patients with bladder cancer are now expected to be presented at a medical conference in early 2021….In February, the FDA granted Priority Review for tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and set a PDUFA goal date of August 30, 2020….Incyte no longer plans to pursue the Phase 3 POD1UM-301 trial of retifanlimab in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III NSCLC….Based on emerging data from the FGFR4 inhibitor program, development of INCB62079 has been discontinued because of insufficient efficacy in the target patient population.”

 

Rubraca (rucaparib) / Clovis; lucitanib (E 3810) / Clovis, HaiHe Pharma, Servier
Clovis Oncology announces first quarter 2020 operating results (Clovis Oncology Press Release) – May 5, 2020 – “$42.6M in Rubraca® (rucaparib) global sales for Q1 2020; net product revenue up 8% over Q4 2019 and up 29% over Q1 2019….Following successful reimbursement negotiations, Clovis has launched Rubraca in each of Germany, United Kingdom, Italy, France and Spain, and over time expects to launch in additional smaller European markets….Supplemental NDA for Rubraca in patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer granted Priority Review by FDA with PDUFA date of May 15, 2020…Lucitanib combination studies enrolling; initial data anticipated at medical meetings in 2H 2020…Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020.”

 

Bavencio (avelumab) / EMD Serono, Pfizer; TG4050 / Transgene
Transgene reports Q1 2020 financial position and business update (Businesswire) – May 6, 2020 – “Summary of key ongoing clinical trials and expected milestones: TG4001+ Bavencio® (avelumab) Phase 2 Targets: HPV16 E6 and E7 oncoproteins HPV-positive cancers including oropharyngeal head and neck cancer…Interim Phase 2 results on track for 2Q 2020; myvac® TG4050 Phase 1 Targets: tumor neoantigens Ovarian cancer – after first-line surgery and adjuvant therapy…First data on track for 1H 2021; myvac® TG4050 Phase 1 HPV-negative head and neck cancer – after surgery and adjuvant therapy First data on track for 1H 2021 Data demonstrating high accuracy of AI-based neoantigen prediction for the design of TG4050 will be presented at AACR.”

 

Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; relacorilant (CORT125134) / Corcept Therap; Keytruda (pembrolizumab) / Merck (MSD)
Corcept Therapeutics announces first quarter 2020 financial results and provides corporate update (GlobeNewswire) – May 4, 2020 – “Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel (Abraxane®) to treat metastatic ovarian cancer enrolling patients at sites in the United States and Europe; results expected in first half 2021. Phase 3 trial of relacorilant plus nab-paclitaxel in metastatic pancreatic cancer (RELIANT) to start in second quarter 2020 Selection of optimum dose of exicorilant plus enzalutamide in castration-resistant prostate cancer expected by year-end, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab (Keytruda®) to treat patients with metastatic or unresectable adrenal cancer to start in third quarter 2020.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Myriad receives FDA approval of myChoice CDx as companion diagnostic for Lynparza (olaparib) in patients with advanced ovarian cancer (GlobeNewswire) – May 11, 2020 – “Myriad Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) approved the myChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab.”

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