The Digest

Pharma news roundup and Larvol updates

Contact Us
Month: August 2020

ESMO – GI 2020

August 28, 2020

ESMO-GI 2020 Biomarker-Drug Associations

 

The goal of Veri’s data platform is to promote progress in precision oncology by collecting up to date predictive biomarkers of drug response. It collects expert-curated predictive associations (biomarker-cancer-drug) coming from multiple sources like publications, clinical trials or conferences, among others.

 

Recently, ESMO’s World Congress on Gastrointestinal Cancer (ESMO-GI) took place virtually bringing together the latest achievements in this field. Here, we present the advances made in the form of cancer-biomarker-drug associations, many of which had not been previously reported.

 

To discover more about ESMO-GI 2020 advances and ultimately the biomarker-drug associations, visit veri.larvol.com. You can access the full plot.ly chart here at: https://chart-studio.plotly.com/~larvol/1/#/

Read More …

Daily Top News – August 28, 2020

August 28, 2020

llllllllll low molecular weight dextran sulfate (ILB) / TikoMed
TIKOMED Granted Orphan Medicinal Drug Designation for ILB for the Treatment of Amyotrophic Lateral Sclerosis by the European Commission (Digital Journal) – Aug 28, 2020 – “TIKOMED…announced that the European Commission has granted Orphan Drug Designation to its lead drug candidate ILB® for the treatment of patients with amyotrophic lateral sclerosis (ALS)…”

 

llllllllll Ad26.COV2-S / J&J, BARDA
J&J’s Janssen to begin Phase II COVID-19 vaccine trials next week in Spain (Reuters) – Aug 28, 2020 – “Johnson & Johnson’s Janssen unit will begin Phase II trials for its COVID-19 vaccine in Spain, the Netherlands and Germany next week, Spanish health minister Salvador Illa announced on Friday….The trial will last two months and include 550 participants across the three countries, including 190 people in Spain, Illa told a news conference in Madrid.”

 

llllllllll Formalin-inactivated and alum-adjuvanted candidate vaccine + CpG 1018 / Dynavax, Sinovac; PiCoVacc / Sinovac, Bio Farma Indonesia
Sinovac’s Covid Vaccine Candidate Approved For Emergency Use In China: Report (NDTV) – Aug 28, 2020 – “China National Biotec Group (CNBG)…also said it had obtained emergency use approval for a coronavirus vaccine candidate….CNBG, which has two vaccine candidates in phase 3 clinical trials, did not say which of its vaccines had been cleared for emergency use.”

Read More …

Daily Top News – August 27, 2020

August 27, 2020

llllllllll Sirtex Medical and China Grand Pharmaceutical announce landmark drug registration milestone (Canada Newswire) – Aug 27, 2020 – “Sirtex Medical…announced…that Sirtex and its shareholders, China Grand Pharmaceutical and Healthcare Holdings Limited (CGP), have been issued a ‘Notice of Drug Clinical Trial Approval’ by the National Medical Products Administration (NMPA) of the People’s Republic of China…The notice confirms that SIR-Spheres® Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country….’This is a critical milestone toward allowing us to provide a valuable treatment option to people with liver cancer in China.'”

llllllllll namodenoson (CF102) / Can-Fite, China Medical System
Can-Fite Reports Second Quarter 2020 Financial Results & Provides Clinical Update (Businesswire) – Aug 27, 2020 – “Namodenoson Headed into Pivotal Phase III Liver Cancer Study in Europe and U.S. – Following a successful meeting with the European Medicines Agency (EMA) during the second quarter, and a prior End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA), Can-Fite completed its protocol for a pivotal Phase III study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. The study is designed to support a New Drug Application submission in the U.S. and a Marketing Authorization Application in Europe.”

llllllllll GB0139 / BMS, Galecto
Galecto, Inc. Receives U.S. and EU Orphan Drug Designations for GB0139 in Idiopathic Pulmonary Fibrosis (GlobeNewswire) – Aug 27, 2020 – “Galecto, Inc.,…today announced it has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for GB0139 in the treatment of Idiopathic Pulmonary Fibrosis (IPF). The EMA cited clinically relevant biomarker data in IPF patients as a justification for the ODD designation…’Our Phase 2b study in IPF is progressing well, and we look forward to bringing GB0139 further through clinical trials and potentially to market to address a significant unmet medical need.'”

llllllllll Rizaport (rizatriptan oral film) / IntelGenx, Gensco Lab
IntelGenx and Exeltis Healthcare S.L. Expand RIZAPORT Commercialization Agreement to Include the European Union (GlobeNewswire) – Aug 27, 2020 – “IntelGenx Corp….today announced that it has granted Exeltis Healthcare, S.L. (‘Exeltis’) an exclusive license to manufacture and commercialize RIZAPORT®, a unique oral thin film for the treatment of acute migraines, in the European Union….Exeltis will pay IntelGenx prespecified royalties on net RIZAPORT® sales in the EU. In addition, IntelGenx has a right of first refusal to manufacture the Product for the EU market….’We are looking forward to continued collaboration with IntelGenx, and to launching RIZAPORT® in at least one major market early next year.'”

llllllllll Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche; BI-1808 / BioInvent; BT-001 / BioInvent, Transgene; BI-1206 / BioInvent
BioInvent Interim Report January 1 – June 30, 2020 (PRNewswire) – Aug 27, 2020 – “BioInvent and Transgene presented preclinical data at AACR Virtual Session II, demonstrating high cure rates in solid tumors of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus. Phase I clinical trial expected to start before the end of 2020…A clinical trial application was submitted to begin a Phase I/IIa, first-in-human study of BI-1808 for the treatment of solid tumors or cutaneous T-cell lymphoma. The trial is expected to start before the end of 2020….We are also progressing the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL) and are looking at the need to add additional sites to ensure good patient enrolment.”

Read More …

Daily Top News – August 26, 2020

August 26, 2020

llllllllll Enspryng (satralizumab) / Roche
Chugai Launches Enspryng (Satralizumab) Subcutaneous Injection 120 mg Syringe, the pH-Dependent Binding Humanized anti-IL-6 Receptor Monoclonal Antibody (Chugai Press Release) – Aug 26, 2020 – “Chugai Pharmaceutical Co., Ltd….announced the launch of Enspryng® Subcutaneous Injection 120 mg Syringe [generic name: satralizumab (genetical recombination)] (hereafter, Enspryng) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD) [including neuromyelitis optica (NMO)]….In Japan, the product received manufacturing and marketing approval on June 29, 2020, and was listed on the National Health Insurance (NHI) reimbursement price list today….’We are confident that Enspryng will contribute to the treatment of a wide range of people from adults to children both in terms of relapse prevention and convenience.'”

 

llllllllll asciminib (ABL001) / Novartis; Bosulif (bosutinib) / Pfizer
Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study (GlobeNewswire) – Aug 26, 2020 – P3, N=234; NCT03106779; Sponsor: Novartis Pharmaceuticals; “Novartis announced today that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib…in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs)…Data from the ASCEMBL trial will be submitted for presentation at an upcoming medical meeting, and results will be shared with regulatory authorities. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for asciminib.”

 

llllllllll CT-P59 / Celltrion
Celltrion Receives Korean MFDS Approval to Initiate Phase I Trial of COVID-19 Antiviral Antibody Treatment Candidate, CT-P59, in Patients (Businesswire) – Aug 26, 2020 – “Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59….Celltrion has initiated enrolment of patients with mild symptoms of SARS-CoV-2 infection….Celltrion anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe COVID-19, and the prevention clinical trial, by the end of the year.”

 

llllllllll Vafseo (vadadustat) / Akebia Therap, Otsuka, Mitsubishi Tanabe
Akebia Therapeutics Announces First Commercial Launch of VAFSEO (vadadustat tablets), a New Oral Treatment for Anemia Due to Chronic Kidney Disease, in Japan (PRNewswire) – Aug 26, 2020 – “Akebia…announced that vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™….The starting dose for VAFSEO is indicated at 300 mg with a maximum dose indicated at 600 mg.”

 

llllllllll stenoparib (2X-121) / Oncology Venture
Press Release Oncology Venture’s Novel PARP Inhibitor Stenoparib (formerly 2X-121) Shows Anti-Viral Activity Against Coronavirus in Pre-Clinical Studies (GlobeNewswire) – Aug 26, 2020 – “Stenoparib is currently being evaluated for the treatment of advanced ovarian cancer in a DRP®-guided Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.) using a DRP® companion diagnostic to guide patient enrollment and improve therapeutic outcome…the Phase 2 study (Denmark) of Stenoparib in heavily pretreated breast cancer (mBC) patients, that was initiated in 2018, will be terminated…the Company expects enrollment to restart in its Phase 2 ovarian cancer trial for Stenoparib…by late Q4 2020…the clinical validation of the DRP® companion diagnostic for Stenoparib has been published in the British Journal of Cancer…”

Read More …

Daily Top News – August 25, 2020

August 25, 2020

llllllllll Amondys 45 (casimersen) / Sarepta Therap
Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45 (GlobeNewswire) – Aug 25, 2020 – “Sarepta Therapeutics…today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) seeking accelerated approval for casimersen (SRP-4045) and provided a regulatory action date of February 25, 2021. The FDA has indicated it does not currently plan to hold an advisory committee to discuss the application….received conditional approval of AMONDYS 45 as the brand name for casimersen…The NDA included data from the casimersen arm of the ESSENCE study (also known as Study 4045-301)…”

 

llllllllll IMR-687 / Imara, Inc
Imara Receives Orphan Drug Designation from the European Commission for IMR-687 for the Treatment of Sickle Cell Disease (GlobeNewswire) – Aug 25, 2020 – “Imara…announced that the European Commission granted Orphan Drug designation to IMR-687 for the treatment of patients with sickle cell disease (SCD).”

 

llllllllll berubicin (RTA 744) / CNS Pharma, WPD Pharma
CNS Provides FDA Update on IND Filing (PRNewswire) – Aug 25, 2020 – “CNS Pharmaceuticals, Inc…provided an update on the Company’s plans for its lead product candidate, Berubicin, which is being studied for the treatment of glioblastoma multiforme (GBM). The company has taken significant strides in designing Phase 2 clinical trials and anticipates submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) this year and initiating clinical trials in early 2021…In preparation for submitting the IND, CNS also has completed the Clinical Study Report, or CSR, for a Phase 1 study for which the Company holds the rights….’We believe our efforts optimally position us to submit an IND for Berubicin in the fourth quarter of this year.'”

 

llllllllll Tepmetko (tepotinib) / EMD Serono
FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations (PRNewswire) – Aug 25, 2020 – “EMD Serono…announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally-dosed tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, as detected by an FDA-approved test…The application is based on results from the pivotal ongoing, single-arm Phase II VISION study…”

 

llllllllll ivaltinostat (CG-745) / CrystalGenomics
CrystalGenomics’ anticancer candidate has FDA’s orphan drug status (Korea Biomedical Review) – Aug 25, 2020 – “CrystalGenomics said Monday that the U.S. Food and Drug Administration has designated its anticancer candidate Ivaltinostat as an orphan drug for liver cancer…The company plans to expand indications of Ivaltinostat for different types of cancers and enhance efficiency via combination therapy. It is preparing to conduct phase 1/2a trials of combined administration of Ivaltinostat and immune checkpoint inhibitors on patients with liver cancer in the U.S.”

Read More …

Weekly Top News – Ovarian Cancer – August 24, 2020

August 24, 2020

llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Regulatory decision in EU for 1L ovarian cancer (based on PAOLA trial) in H2 2020 (AstraZeneca) – Aug 21, 2020 – Post H1 Roadshow, Oslo: Regulatory decision in EU for 2L prostate cancer in H2 2020 
[Screenshot]

 

llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca
DCGI approves AstraZeneca Olaparib tablets for ovarian and breast cancer (Medicircle) – Aug 20, 2020 – “Drug firm AstraZeneca Pharma India today said it has received permission from the Drug Controller General of India (DCGI) to import and market olaparib tablets used for the treatment of ovarian and breast cancer…The permission from the DCGI is for olaparib (Lynparza) tablets in the strengths of 100 mg and 150 mg, AstraZeneca Pharma India said in a BSE filing.The tablets are a patented product of the AstraZeneca group…”

 

llllllllll Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Samsung Bioepis Receives European Commission Approval for AYBINTIO (Bevacizumab) (GlobeNewswire) – Aug 20, 2020 – “Samsung Bioepis Co., Ltd….announced that the European Commission (EC) has granted marketing authorization for AYBINTIO® (bevacizumab) for the treatment of the same types of cancer as reference bevacizumab, including metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer. “

Read More …

Weekly Biomarker & CDx News – August 24

August 24, 2020

Evidence Highlights (1) | Pan Tumor (3) | Liquid Biopsy and ctDNA (17) | Cervical (3) | Endometrial (3)

 

For full coverage, contact us at veri@larvol.com

 

EVIDENCE HIGHLIGHTS

 
Kadcyla (ado-trastuzumab emtansine) / Roche
Chugai Obtains Approval for Additional Indication of Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer (Chugai Press Release) – Aug 21, 2020 – “Chugai Pharmaceutical…announced today that it has obtained approval for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla® Intravenous Infusion 100 mg and 160 mg [generic name: trastuzumab emtansine (genetical recombination)] from the Ministry of Health, Labour and Welfare for an additional indication of HER2-positive postoperative breast cancer….This approval is based on the results from an open-label, randomized, global phase III KATHERINE study.”
 
Top↑
 

PAN TUMOR

 
An integrative pan-cancer investigation reveals common genetic and transcriptional alterations of AMPK pathway genes as important predictors of clinical outcomes across major cancer types. (PubMed, BMC Cancer) – Aug 19, 2020 – “Genetic and transcriptional aberrations in AMPK signaling have tissue-dependent pro- or anti-tumor impacts. Pan-cancer investigations on molecular changes of this pathway could uncover novel therapeutic targets and support risk stratification of patients in prospective trials.”
 
Sharing the initial experience of pan-cancer panel analysis in high-risk renal cell carcinoma in the Korean population. (PubMed, BMC Urol) – Aug 20, 2020 – “The pan-cancer panel comprised of RCC-related genes is a feasible and promising tool to evaluate genetic alterations in advanced RCC. However, large-scale studies and a focus on the clinical utility of this cancer panels is needed.”
 
A pan-cancer analysis of PBAF complex mutations and their association with immunotherapy response. (PubMed, Nat Commun) – Aug 22, 2020 – “In a series of 11 solid tumors (n = 2936), LOF mutations are not associated with improved OS in a stratified multivariate model (HR = 0.9, p = 0.7). In a current series of solid tumors treated with ICB, we are unable to demonstrate favorable response to ICB in patients with PBAF complex mutations.”
 
Top↑
 


 

LIQUID BIOPSY AND ctDNA

 
Label‐free liquid biopsy based on urine analysis using surface‐enhanced Raman spectroscopy for noninvasive gastric and breast cancer detection (Wiley Online Library) – Aug 21, 2020 – “The detection sensitivity for identifying gastric cancer versus healthy, breast cancer versus healthy, and gastric cancer versus breast cancer was 90.0%, 96.0%, and 62.0%, respectively. And the corresponding diagnostic specificities for each combination were 93.8%, 93.8%, and 81.4%, respectively. These results show that urine SERS technology based on Au nanoparticles holds promising potential to be a rapid, noninvasive, and label‐free clinical tool for both gastric and breast cancer detection.
 
A liquid biopsy to assess brain tumor recurrence: Presence of circulating Mo-MDSC and CD14+ VNN2+ myeloid cells as biomarkers that distinguish brain metastasis from radiation necrosis following stereotactic radiosurgery (Neurosurgery) – Aug 21, 2020 – “We report the utility of the previously reported HLA-Dr-Vnn2 Index or DVI to discriminate recurrent BM from RN using peripheral blood. The presence of CD14+ HLA-DRneg/low Mo-MDSC is significantly increased in the peripheral blood of patients with brain metastasis recurrence compared to RN (Average 61.5% vs 7%, n = 10 and n = 12, respectively, P < .0001)…In patients with biopsy confirmed recurrence of brain metastasis, the average DVI was 11.65, whereas the average DVI for RN patients was consistently <1 (Avg. of 0.17).”
 
Breast cancer liquid biopsy market investigated in the latest research (WhaTech) – Aug 20, 2020 – “According to the new market research report Breast Cancer Liquid Biopsy Market is expected to reach USD 411.1 million by 2022, at a CAGR of 23.1%.”
 
Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): Study protocol for a trial within a cohort study (BMC Cancer) – Aug 20, 2020 – “The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group.”
 
The potential use of urinary ctDNA profiling in the treatment of breast cancer (World Journal of Gynecology & Women’s Health) – Aug 20, 2020 – “Mutational profiling of urinary ctDNA might be prognostic for cancer relapse and could help to guide personalized treatment options and thus offering the most effective treatment for patients with breast cancer. Considering the aggressive tumor growth and increased resistance towards available chemotherapeutic options patients with triple negative tumors might particularly benefit from high frequency serial mutation profiling based on ctDNA from both blood and urine in an alternating manner.”
 
What’s driving, and blocking the liquid biopsy evolution in non–small cell lung cancer? (Targeted Oncology) – Aug 20, 2020 – “In the Noninvasive versus Invasive Lung Evaluation (NILE) study of 282 patients with previously untreated NSCLC who submitted pretreatment blood samples for circulating tumor DNA (ctDNA) testing, liquid biopsy utilization increased the rate of biomarker detection by 48% over tissue alone. In total, the blood-based test identified 77 patients with a guideline-recommended biomarker compared with only 60 patients who had tissue biopsies (P <.0001). It was also the NILE study that revealed swifter testing turnaround times were possible with liquid biopsies versus tissue biopsies.”
 
Multi-analyte liquid biopsies for treatment guidance in advanced refractory cancers: Findings of the LIQUID IMPACT trial (Research Square) – Aug 19, 2020 – “The present study demonstrated that refractory cancers have latent vulnerabilities which can be identified via non-invasive eLB to design personalized label- and organ-agnostic treatment regimens to yield meaningful treatment benefit.”
 
Eleven‐marker 10‐color flow cytometric assessment of measurable residual disease for T‐cell acute lymphoblastic leukemia using an approach of exclusion (Wiley Online Library) – Aug 19, 2020 – “We described an 11‐marker 10‐color MFC‐based highly sensitive MRD assay in T‐ALL using an approach of exclusion. The addition of CD4 and CD8 to the pan‐T‐cell markers in a 10‐color assay is highly useful in T‐ALL MRD assessment and extends its applicability to almost all T‐ALL patients.”
 
Genosity receives CLIA approval for AsTra Profile™ and AsTra Next™ to enable earlier detection of cancer relapse through patient-specific liquid biopsy monitoring (Businesswire) – Aug 18, 2020 – “Genosity Inc., announced today that it has received CLIA approval for its tumor exome and liquid biopsy cancer monitoring platform, AsTra (Assessment and Tracking), designed to identify a patient’s unique tumor molecular profile that can be used for ongoing, personalized Minimal Residual Disease (MRD) monitoring.”
 
Clinical activity of pembrolizumab in metastatic prostate cancer with microsatellite instability high (MSI-H) detected by circulating tumor DNA (Urotoday) – Aug 17, 2020 – “The use of liquid biopsy to identify metastatic prostate cancer patients with MSI-H is feasible in clinical practice and may overcome some of the obstacles associated with prostate cancer tumor tissue testing. The robust activity of pembrolizumab in selected patients supports the generalized testing for MSI-H.”
 
Enthusiasm is building for a liquid biopsy That may replace bone marrow biopsies (Patient Worthy) – Aug 17, 2020 – “BioFluidica recently issued an announcement that put the spotlight on its patented technology, Liquid Scan®. The new cartridge technology is designed to replace the invasive and painful bone marrow biopsy… BioFluidica’s small study focusing on replacing bone marrow biopsies has been well received and will be continued with the ongoing involvement of AML patients…The researchers will also be actively searching for signs of a relapse after therapy. The success of the study depends on the Liquid Scan® technology detecting relapse.”
 
Liquid biopsy in colon cancer utilizing exosomal miRNA biomarkers: An initial analysis (Clin Cancer Res) – Aug 16, 2020 – “In summary, highly abundant miRNA found in serum exosomes of patients with metastatic colon cancer demonstrate a different pattern of expression than miRNA found in the primary colon cancer itself. Further analysis of these miRNA patterns from serum exosomes of colon cancer patients with non-metastatic disease, visceral metastases and PC compared to normal volunteers will aid in the development of a serum exosomal miRNA signature.”
 
Importance of MSI using liquid biopsy for studying immunotherapy (Labroots) – Aug 16, 2020 – “Sep 30, 2020, 9:00 AM, “In our experience, liquid biopsy MSI has a higher incidence than tissue MSI in lung cancers and is associated with high tumor mutational burden (TMB) than microsatellite stable (MSS) cancers…Discuss the future research and potential clinical utility of liquid biopsy MSI.”
 
Investigating circulating tumor DNA as a biomarker of cancer progression and recurrence in sarcoma (Clin Cancer Res) – Aug 16, 2020 – “Of the 60 patient samples analysed to date, the majority were positive for cfDNA. Quality assessment of 41cfDNA by capillary electrophoresis showed peaks approximately 170 bp in size, characteristic of cfDNA. WES of 6 patients’ matched tumor-blood samples identified many tumor specific variants. Six of those sequence variants on SMAD4, COL19A1, DDX3X, ADGRG4, HECW1 and FOXR2 genes were used to design primers and probes to detect the tumour specific alterations in the corresponding ctDNA using dd PCR. We observed the presence tumour specific mutations in all corresponding ctDNAs tested in this study.”
 
Predictive and prognostic value of circulating tumor DNA (ctDNA) compared to circulating tumor cells (CTC) in a prospective cohort of metastatic breast cancer patients: The UCBG COMET trial (Clin Cancer Res) – Aug 16, 2020 – “Early decrease of CTC and/or ctDNA after one cycle of chemotherapy are independent predictive markers of favorable outcome. Compared to CTC, ctDNA allows monitoring of tumor burden during chemotherapy and specific detection of targetable mutations as PI3KCA, HER2 or BRCA.”
 
Detection of PIK3CA E545A mutation in circulating tumor DNA of a patient affected by uterine carcinosarcoma (Wolters Kluwer) – Aug 16, 2020 – “Here, we describe a case report of an 83-year-old woman with carcinosarcomas, stage T3aN0M0. Cancer cells did not express estrogen nor progesterone receptors, while p53 and p16 were positive. Molecular characterization of ccfDNA and of ctDNA was performed by quantitative PCR, amplification-refractory mutation system technology. The presence of phosphatidylInositol-4,5-bisphosphate 3-Kinase catalytic subunit alpha p.E545A mutation was detected in plasma. This approach may suggest the use of liquid biopsy and the development of specific targeted therapy for precision personalized medicine even in rare carcinosarcomas.”
 
Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study (Clin Cancer Res) – Aug 16, 2020 – “ctDNA is an adjuvant biomarker capable of both detecting MRD following surgery and defining the clonality of relapsing disease. These data pave the way for clinical trials predicated on escalation of adjuvant standard of care in NSCLC patients who exhibit MRD positive status following surgery.”
 
Top↑
 


 

 

CERVICAL

 

OC-001 / Ocellaris Pharma
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) – Aug 21, 2020 – P1b/2a; N=80; Recruiting; Sponsor: Ocellaris Pharma, Inc.; Not yet recruiting –> Recruiting
 
Yervoy (ipilimumab) / Ono Pharma, BMS
Immune activation in patients with locally advanced cervical cancer treated with ipilimumab following definitive chemoradiation (GOG-9929). (PubMed, Clin Cancer Res) – Aug 22, 2020 – “Our data indicate that CRT alone and combined with ipilimumab immunotherapy show immune modulating activity in women with locally advanced cervical cancer and may be a promising therapeutic option for the enhancement of anti-tumor immune cell function after primary CRT for this population at high-risk for recurrence and metastasis. Several key immune biomarkers were identified that were associated with clinical response.”
 
geptanolimab (GB226) / Apollomics
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive (clinicaltrials.gov) – Aug 21, 2020 – P2; N=80; Recruiting; Sponsor: Genor Biopharma Co., Ltd.; Trial completion date: Jul 2020 –> Jul 2021; Trial primary completion date: Jun 2020 –> Dec 2020

 

Top↑


 

ENDOMETRIAL

 
BAY1895344 / Bayer
First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas (clinicaltrials.gov) – Aug 17, 2020 – P2; N=241; Recruiting; Sponsor: Bayer; Trial completion date: Mar 2022 –> Feb 2023; Trial primary completion date: Feb 2022 –> Jan 2023
 
CFI-402411 / Treadwell Therap; Keytruda (pembrolizumab) / Merck (MSD)
Safety and Efficacy Study Of CFI-402411 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) – Aug 20, 2020 – P1/2; N=170; Not yet recruiting; Sponsor: Treadwell Therapeutics, Inc
 
Xtandi (enzalutamide) / Pfizer, Astellas
Evaluating the efficacy of enzalutamide and the development of resistance in a preclinical mouse model of type-I endometrial carcinoma. (PubMed, Neoplasia) – Aug 22, 2020 – “In conclusion, we show that enzalutamide induces apoptosis in EMC but has limited efficacy overall as a single agent. Induction of PR, a negative regulator of endometrial proliferation, suggests that adding progestin therapy to enzalutamide administration may further decrease tumor burden and result in a prolonged response.”

 

Top↑

Read More …

Weekly Top News – Psoriasis – August 24, 2020

August 24, 2020

llllllllll Otezla (apremilast) / Amgen
Long-term Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis Estudio a largo plazo de apremilast (CC-10004) en pacientes pediátricos de 6 a 17 años con psoriasis en placas de moderada a grave (clinicaltrialsregister.eu) – Aug 18, 2020 – P3; N=140; Ongoing; Sponsor: Celgene Corporation`Amgen Inc.

 

llllllllll Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Kangzhe Pharmaceutical (00867): Tiralizumab injection, a psoriasis drug, was approved for clinical trials [Google translation] (Eastmoney.com) – Aug 19, 2020 – “CMS…announced that the Chinese State Drug pull natalizumab injection for management of drug clinical Office on 18 August 2020 issued by approved test notification form agreeing to carry out the treatment of moderate to evaluate Tildrakizumab in Chinese population…on the efficacy and safety of patients with severe plaque psoriasis.”

 

llllllllll serlopitant (JTS 661) / Menlo Therap
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) (clinicaltrials.gov) – Aug 18, 2020 – P3; N=558; Terminated; Sponsor: Menlo Therapeutics Inc.; Trial completion date: May 2021 –> Jun 2020; Active, not recruiting –> Terminated; Trial primary completion date: May 2021 –> Apr 2020; No longer pursuing development of serlopitant

 

llllllllll mirikizumab (LY3074828) / Eli Lilly
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2) (clinicaltrials.gov) – Aug 21, 2020 – P3; N=1484; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed; Trial completion date: Dec 2020 –> May 2020

 

llllllllll Cosentyx (secukinumab) / Novartis
MATURE: Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Aug 18, 2020 – P3; N=122; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed

 

llllllllll Enstilar (calcipotriene/betamethasone dipropionate) / LEO Pharma
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis). (clinicaltrials.gov) – Aug 19, 2020 – P3; N=494; Completed; Sponsor: Glenmark Pharmaceuticals Ltd. India; Recruiting –> Completed; Trial completion date: Oct 2019 –> Mar 2020; Trial primary completion date: Oct 2019 –> Mar 2020

 

llllllllll BMS-986020 / BMS
[VIRTUAL] Discovery of BMS-986202, a clinical Tyk2 JH2 inhibitor for the treatment of autoimmune and inflammatory diseases (ACS-Fall 2020) – Aug 20, 2020 – Abstract #MEDI 33; Pres time: Aug 17, 2020; 08:00 AM – 11:40 AM; Location: On Demand Oral; “We have previously reported that targeting the Tyk2 pseudokinase domain (JH2) is an innovative and effective approach to selectively mediating the Tyk2-dependent signaling cascade, leading to a compound currently in phase III clinical development for the treatment of psoriasis. We now report the discovery and pre-clinical studies of the clinical backup Tyk2 JH2 inhibitor BMS-986202.”

Read More …

Weekly Top News – IBD – August 24, 2020

August 24, 2020

llllllllll ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 306) (clinicaltrials.gov) – Aug 19, 2020 – P3; N=1032; Active, not recruiting; Sponsor: Shire; Trial completion date: Aug 2021 –> Aug 2020; Trial primary completion date: Aug 2021 –> Aug 2020

 

llllllllll Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
Highmark Forges Outcomes-Based Contract with UCB for Anti-Inflammatory Drug CIMZIA (certolizumab pegol) (PRWeb) – Aug 18, 2020 – “Highmark announced that it has entered an outcomes-based agreement with UCB, Inc. (‘UCB’) for UCB’s medication CIMZIA® (certolizumab pegol)…for adult patients with chronic inflammatory conditions that include Crohn’s disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis….With outcomes-based agreements between a pharmaceutical drug manufacturer and payer, reimbursement for a drug is based in part on its clinical effectiveness for those patients using the drug. If clinical outcomes are not met, the pharmaceutical drug manufacturer typically refunds part of the original purchase to the payer.”

 

llllllllll ontamalimab (SHP647) / Takeda
FIGARO UC 302: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Aug 19, 2020 – P3; N=740; Active, not recruiting; Sponsor: Shire; Trial completion date: Jul 2024 –> Oct 2020; Trial primary completion date: Jul 2024 –> Oct 2020

 

llllllllll ontamalimab (SHP647) / Takeda
FIGARO UC 301: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Aug 19, 2020 – P3; N=740; Active, not recruiting; Sponsor: Shire; Trial completion date: Jul 2024 –> Oct 2020; Trial primary completion date: Jul 2024 –> Oct 2020

 

llllllllll ontamalimab (SHP647) / Takeda
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn’s Disease (CARMEN CD 305) (clinicaltrials.gov) – Aug 19, 2020 – P3; N=1032; Active, not recruiting; Sponsor: Shire; Trial completion date: Aug 2021 –> Oct 2020; Trial primary completion date: Aug 2021 –> Oct 2020

 

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn’s Disease (clinicaltrials.gov) – Aug 19, 2020 – P3; N=1250; Recruiting; Sponsor: AbbVie; Trial primary completion date: Oct 2025 –> May 2026

Read More …

COVID-19 Top News – August 24, 2020

August 24, 2020

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results (GlobeNewswire) – Aug 19, 2020 – “CytoDyn Inc….announced today the Company provided its Top-line Report from its recently completed Phase 2 clinical trial…to Medicines and Healthcare Products Regulatory Agency….Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial….’We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August.'”

 

favipiravir / Generic mfg.
Dr Reddy’s launches antiviral drug Avigan in India, to launch remdesivir in September (The Economic Times) – Aug 19, 2020 – “Generic drugmaker Dr Reddy’s Laboratories launched antiviral drug Avigan (favipiravir) tablets….Company’s US arm is currently taking up a multi-centre, randamised, double blind, placebo controlled clinical trials to further evaluate the efficacy and safety of favipiravir….The study in collaboration with GRA obtained approval for the protocol to be initiated this month, beginning the study on the first patient on Wednesday. The generic drugmaker hopes to complete the multi-ethnic trials on over 700 patients during the 10-12 weeks….Pricing Avigan in 200mg dosages at Rs 99 a tablet in a complete therapy pack of 122 tablets with a two-year shelf life….Dr Reddy’s will initiate phase-IV study for Avigan in India to further establish its efficacy….The company is also looking at coming up with Avigan in 400mg dosages for the benefit of patients.”

 

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval (GlobeNewswire) – Aug 17, 2020 – “CytoDyn Inc….has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients…to the U.S. Food and Drug Administration (FDA), and requested emergency use approval. In addition, CytoDyn has sent…to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines….The Company is preparing a Phase 3 protocol and will file it as soon as possible.”

 

FDA’s emergency approval of blood plasma as COVID-19 treatment on hold – NYT (Reuters) – Aug 19, 2020 – “The emergency approval of blood plasma as a potential COVID-19 treatment by the U.S. Food and Drug Administration has now been put on hold….A group of top federal health officials including Anthony Fauci have argued that the emerging data on the treatment was too weak the report said, adding that an emergency approval could still be granted in the near future. The authorization is on hold for now…”

 

ArtemiC / MGC Pharma
MGC Pharmaceuticals interim results of ArtemiC in Phase II trial on COVID-19 infected patients meet all primary objectives (Proactiveinvestors) – Aug 19, 2020 – P2, N=50; NCT04382040; Sponsor: MGC Pharmaceuticals d.o.o; “The Phase II double-blind, placebo-controlled clinical trial has met all the primary objectives, with all 10 patients showing significant improvement. Shares jumped 43% on release of the news to A$0.037 and are up from A$0.021 at the market close on July 31….The statistically proven results show two important clinical outcomes: A significant improvement in the clinical parameters of patients in the treatment group; and; No adverse events occurred, demonstrating the safety of the treatment.”

 

azithromycin / Generic mfg.
COVID-19 pandemic ‘could be quite damaging’ to efforts to end other diseases (Healio) – Aug 21, 2020 – “According to Peter J. Hotez, MD, PhD…Because of the COVID-19 pandemic, however, Hotez worries these efforts may be slowed, interrupted or halted. ‘The Mass Drug Administration’s program is huge in continuing eradication efforts toward lymphatic filariasis, river blindness and trachoma. It’s really important,’ Hotez said. ‘Now we’re finding it extends to yaws, scabies and some of the others. So, continuing those programs of preventive treatment for the Mass Drug Administration is a top priority’….Hotez named azithromycin, a common antibiotic for strep throat and sinusitis that can also be used for trachoma, as an example. However, efforts to use this drug may be slowed because of the pandemic, he said.”

 

Dr. Fauci: Long-term effects of COVID-19 ‘really troublesome’ (The Denver Channel) – Aug 18, 2020 – “Dr. Anthony Fauci has a warning for young adults who think they will bounce back from COVID-19….’We’d better be careful when we say ‘Young people who don’t wind up in the hospital are fine, let them get infected, it’s OK.’ No, it’s not OK,’ Dr. Fauci said during the briefing….He called these findings ‘really troublesome’ because they are constantly evolving as the world learns more about COVID-19 and the long-term impacts on the human body.”

 

Coronavirus: Vaccine will not be mandatory in US, says health expert Anthony Fauci – Aug 20, 2020 – “United States’ top infectious disease expert Dr Anthony Fauci on Wednesday said any future coronavirus vaccine would not be mandatory for the general public in the America, AFP reported. He, however, said that states can make it obligatory for some groups. ‘You can mandate [the vaccine] for certain groups of people like health workers, but for the general population you can’t,’ he said. Fauci, who was speaking at a video conference organised by the George Washington University, added that at the National Institutes of Health, health workers need to have a flu shot before they can treat patients.”

 

WHO hopes COVID-19 pandemic ends within 2 years, says chief Tedros Adhanom Ghebreyesus – Aug 22, 2020 – “Tedros Adhanom Ghebreyesus described COVID-19 as a once-in-a-century health crisis and said that while globalisation had allowed the virus to spread quicker than the flu did in 1918, there was also now the technology to stop it that hadn’t been available a century ago….’We hope to finish this pandemic (in) less than two years, especially if we can pool our efforts,’ he said during a press briefing on Friday.”

 

COVID-19: Herd immunity requires effective vaccine, says WHO (The Tribune) – Aug 18, 2020 – “WHO’s emergencies chief Dr Michael Ryan largely dismissed that theory at a press briefing on Tuesday, saying we should not live ‘in hope’ of achieving herd immunity. ‘As a global population, we are nowhere close to the levels of immunity required to stop this disease transmitting,’ he said. ‘This is not a solution and not a solution we should be looking to.’ Most studies conducted to date have suggested only about 10 per cent to 20 per cent of people have antibodies.”

Read More …
« Older Entries