LKA651 / Novartis - LARVOL DELTA

A randomized, active-controlled, patient and investigator-masked, multiple dose Ph2 study of intravitreal LKA651, an anti-erythropoietin (EPO) antibody fragment, in patients with diabetic macular edema (ARVO 2024) - "Anti-EPO is a novel mechanistic approach to the treatment of DME. Positive safety and tolerability was observed for IVT doses of LKA651 monotherapy or LKA651 dosed in combination with Lucentis® in patients with DME. Treatment with IVT LKA651 showed clinically meaningful efficacy data with improvement in BCVA and CSFT from baseline and a positive safety and tolerability profile."

Clinical • Diabetic Macular Edema • Ophthalmology

Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=93 | Completed | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

"Please come by and check out our poster! P198.07: Neuronal cell cycle re-entry mice and their relevance to late-onset Alzheimer’s disease Video Chat: Nov 9, 9:30a-10:30a CST @RaviSPandey15 @gwcarter @nanostringtech #SFN21" (@DrKevinpark)

Preclinical • Video • Alzheimer's Disease • CNS Disorders

"$ATNM $170M MCAP major catalysts next week. 1) 3rd QTR earnings 2) #ASH21 3-5 abstracts release Nov 4 3) #SITC21 2 abstracts release Nov 9 $ISEE $PDSB $PAVM $CLDX $MGNX $HALO $SGMO $SPRT $CLOV $AMC $GME $CYTK $SLS $INO $ALXO $IMAB $tril $bmy $tgtx $BNTX $DVAX $EXEL $CRTX" (@ej23ny)

Oncology

"The mRNA conference in Berlin Nov9-10 is in person. Not sure though whether a JNJ adeno vaccinee like me will be admitted though. https://t.co/kG1z11RMSp" (@RNAiAnalyst)

Clinical

Antibiotics for lower respiratory tract infection in children presenting in primary care in England (ARTIC PC): a double-blind, randomised, placebo-controlled trial. (PubMed, Lancet) - "Amoxicillin for uncomplicated chest infections in children is unlikely to be clinically effective either overall or for key subgroups in whom antibiotics are commonly prescribed. Unless pneumonia is suspected, clinicians should provide safety-netting advice but not prescribe antibiotics for most children presenting with chest infections."

Clinical • Journal • Infectious Disease • Pneumonia • Respiratory Diseases

[VIRTUAL] Long-Term Efficacy and Safety (27 months) of the Biosimilar CT-P10 in Patients with Low Tumor Burden Follicular Lymphoma (ASH 2020) - "Between Nov 9, 2015 and Jan 4, 2018, 258 patients were randomised (130 CT-P10; 128 rituximab). (Figure A. OS; Figure B. PFS and Figure C. TTP) Over the study period, 114 (88%) and 104 (81%) patients in the CT-P10 and rituximab groups, respectively, experienced at least one treatment-emergent adverse event (TEAE) and 14 (11%) patients in each group experienced TE-serious adverse events (TESAEs). There were no unexpected safety findings observed during the second year of the maintenance period after single transition from rituximab to CT-P10."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CD20

"Coming Nov 9 Virtually @Lankenau: The first in a series of four minisymposia on #VTE with @DJC6998 @klinelab #mennohuisman @mainlinehealth @PERTConsortium @RosovskyRachel @connors_md @vic_tapson @ParthRali @SVM_tweets @chriskabrhel @PhillipJGaryMD @JayBishopMD @Erik_Klok_MD" (@DavidACohen3)

Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial primary completion date: Dec 2022 ➔ Jul 2022

Clinical • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Nov 2021 ➔ Dec 2022; Trial primary completion date: Nov 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Genomic characteristics and clinical effect of the emergent SARS-CoV-2 B.1.1.7 lineage in London, UK: a whole-genome sequencing and hospital-based cohort study. (PubMed, Lancet Infect Dis) - "Emerging evidence exists of increased transmissibility of B.1.1.7, and we found increased virus load by proxy for B.1.1.7 in our data. We did not identify an association of the variant with severe disease in this hospitalised cohort."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Smoking history and the efficacy of immune checkpoint inhibitors in patients with advanced non-small cell lung cancer: a systematic review and meta-analysis. (PubMed, J Thorac Dis) - "The deadline of search was Nov 9, 2019...The difference can be explained by several factors such as insufficient sample size of non-smokers, and confounding factors. We suggest that smoking history cannot be recognized as a predictor of immune therapy in advanced NSCLC."

Checkpoint inhibition • Clinical • Journal • Retrospective data • Review • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacokinetic study of a novel oral formulation of S-adenosylmethionine (MSI-195) in healthy subjects: dose escalation, food effect and comparison to a commercial nutritional supplement product. (PubMed, BMC Pharmacol Toxicol) - P1 | "The overall conclusion was that MSI-195 was well tolerated and has markedly higher bioavailability compared with both the SAM-e Complete™ commercial product tested and, on a per mg basis, products reported in other literature."

Clinical • Journal • PK/PD data

[VIRTUAL] Cellphone Videos Change the Paradigm of Nonepileptic Seizure Diagnosis in the Era of COVID-19 (AES 2020) - "2004 Nov 9;63(9):1728-30 •Tatum WO, Hirsch LJ, Gelfand MA, Acton EK, LaFrance WC Jr, Duckrow RB, Chen DK, Blum AS, Hixson JD, Drazkowski JF, Benbadis SR, Cascino GD; OSmartViE Investigators... Forced by COVID-19 to become creative about outpatient differential diagnosis, we found that ictal cell phone video semiology can be paired with subsequent suggestion induction vEEG to establish a nonepileptic seizure diagnosis. Using this algorithm we managed to diagnose one patient with nonepileptic seizures, wean her off of antiseizure medication, and refer her to therapy. There are limitations of this algorithm."

CNS Disorders • Epilepsy • Infectious Disease • Novel Coronavirus Disease

Validating clinical practice guidelines for the management of children with non-blanching rashes in the UK (PiC): a prospective, multicentre cohort study. (PubMed, Lancet Infect Dis) - P=N/A | "Invasive meningococcal disease is a rare cause of non-blanching rashes in children presenting to the emergency department in the UK. Current NICE guidelines perform poorly when compared with tailored clinical practice guidelines. These findings suggest that UK national guidance could be improved by shifting towards a tailored approach."

Clinical • Clinical guideline • Journal • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Infectious Disease • Oncology • Pediatrics • Thrombocytopenic Purpura

"#ThursdayThanks to 🗳All who ✅ our survey & RT ! ⏱Tell us how we are doing👉🏼 https://t.co/5YjKEkou0A 🔥 #MNIBDtweetorial on new & emerging biologics for #UC @moss_md ☄️#CME partners @IntegrityCE @SoMeCME 📣Tune in Sat Nov 9.30 EST 🆓 #MNIBDwebinar @MaiaKayalMD @moss_md" (@MondayNightIBD)

"👇@mmPharmD Nov 9, 2020." (@minkeyw)

Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Feb 2021 ➔ Nov 2021; Trial primary completion date: Feb 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

"TAEMIN COMEBACK - IDEA: NOV 9 #TAEMIN_IDEA #NeverGonnaDanceAgain #ACT2 @SHINee https://t.co/tfqXHPO7XL" (@SHINeePearlAqua)

"TAEMIN COMEBACK - IDEA: NOV 9 #TAEMIN_IDEA #NeverGonnaDanceAgain #ACT2 @SHINee https://t.co/tfqXHPO7XL" (@SHINeePearlAqua)

"YES! Don't forget to log in your time by Nov 9. Happy running!🙌🏾" (@SophieBalzoraMD)

[VIRTUAL] ELEXACAFTOR/TEZACAFTOR/IVACAFTOR AND WORK: IMPROVED HEALTH AFFECTS EMPLOYMENT OPPORTUNITIES FOR PEOPLE WITH CF (NACFC 2020) - "Nov19 5% (37/802); Dec19 8% (69/829); Jan20 18% (119/671); Feb20 20% (126/638); Mar20 4% (72/1618); Apr20 2% (27/1624); May20 2% (34/1642); Jun20 4% (54/1219). As the number of individuals using EIT increased, the number of individuals considering a work attempt increased. Maintaining health benefits and access to CF therapies, sustaining health improvements, and preserving economic security during and after a work attempt remain high priorities."

Infectious Disease • Novel Coronavirus Disease

"$ONCS long term KEYNOTE 695 update for 50 patient out of 100 at #SITC2020 Nov 9-10 per BTIG presentation. (Last update was in 2018 for 10 patients)." (@wire_rx)

Clinical • Oncology

""If you lost a son in uniform in 1918, you were equally likely to lose him to the flu as to enemy bullets" [Nov 9, 2014] @cnn https://t.co/GtTO00b1O4 #Flu" (@mtmdphd)

""If you lost a son in uniform in 1918, you were equally likely to lose him to the flu as to enemy bullets" [Nov 9, 2014] @cnn https://t.co/GtTO00b1O4 #Flu" (@mtmdphd)