Phases of clinical research

Edison Investment Research Limited: Scandion Oncology (SCOL): Initiation - Chemotherapy overcoming drug resistance

Retrieved on: 
Tuesday, June 21, 2022
FOLFIRI, Oncology, Phases of clinical research, Phase, Research, Pancreatic cancer, Oil, Thomas Edison

Scandion Oncology is a Danish biotechnology company that specialises in developing drugs to reverse chemotherapy resistance.

Key Points: 
  • Scandion Oncology is a Danish biotechnology company that specialises in developing drugs to reverse chemotherapy resistance.
  • Managements clinical programme is spearheaded by the Phase II CORIST study in FOLFIRI-resistant mCRC, from which we expect crucial proof-of-concept results in Q322.
  • Click here to view the full report or here to sign up to receive research as it is published.
  • About Edison: Edison is a leading research and investor relations consultancy, connecting listed companies to the widest pool of global investors.

Harbour BioMed Reports the Latest Progress of Next-Generation Fully Human Heavy-chain Antibody HBM4003 with Unique Treg Depletion Mechanism

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Wednesday, June 1, 2022
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The Treg depleting activity of HBM4003 offers a potential for clinical efficacy in indications hitherto unaddressed by first generation CTLA4 inhibitors.

Key Points: 
  • The Treg depleting activity of HBM4003 offers a potential for clinical efficacy in indications hitherto unaddressed by first generation CTLA4 inhibitors.
  • HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice.
  • The Company's proprietary antibody technology platforms Harbour Micegenerate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format.
  • Integrating Harbour Mice, HBICE with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.

EpiEndo: Successful Completion of Phase I Study for Lead Asset EP395

Retrieved on: 
Wednesday, May 18, 2022
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Phases of clinical research, Inflammation, Pharmacology, Patient, ClinicalTrials.gov, Phase, Pharmacokinetics, Reactive airway disease, Epithelium, Principal, University, Safety, Biomarker, Chronic obstructive pulmonary disease, Drug development, Lung, Therapy, Skin, Chronic Respiratory Disease, Pharmaceutical industry, Vaccine, COPD

EpiEndo will begin Phase Ib and Phase IIa studies with EP395 later this year, with top-level data to become available during 2023.

Key Points: 
  • EpiEndo will begin Phase Ib and Phase IIa studies with EP395 later this year, with top-level data to become available during 2023.
  • The Phase Ib study will be a proof of pharmacology study in healthy volunteers.
  • The Phase IIa study will assess the safety and tolerability of EP395 in patients with COPD, as well as assessing biomarkers for anti-inflammatory efficacy.
  • EpiEndos lead drug candidate, EP395, aims to be the first on-market oral, non-antibiotic, barrier strengthening and anti-inflammatory macrolide for the treatment of COPD.

Transcenta to Present Clinical Trial Data of TST001 and MSB0254 at 2022 ASCO Annual Meeting

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Friday, April 29, 2022
NK, Mab, Endothelium, CAPOX, Patient, FDA, ADCC, Pharmacokinetics, Orphan, High Affinity K+ transporter HAK5, Headquarters, Society, Capecitabine, HKEX, Suzhou Industrial Park, American Society of Clinical Oncology, Therapy, 2021 Essex County Council election, Ministry of Education (Malaysia), Process, CDC, Neoplasm, News, Research, Tolerability, Fucose, Nature, 2 Canadian Mechanized Brigade Group Headquarters and Signal Squadron, Stomach, Phases of clinical research, ICB, Discovery, Survival, Environment, Social conditioning, Pharmaceutical industry, Medical imaging, Vaccine, Safety, Oxaliplatin, McCormick Place

SUZHOU, China, April 28, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the abstracts of TST001 and MSB0254 have been accepted by the 2022 annual meeting of American Society of Clinical Oncology ("2022 ASCO Annual Meeting").

Key Points: 
  • SUZHOU, China, April 28, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the abstracts of TST001 and MSB0254 have been accepted by the 2022 annual meeting of American Society of Clinical Oncology ("2022 ASCO Annual Meeting").
  • The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific gathering of the clinical oncology community.
  • This year's ASCO Annual Meeting will take place both online and in-person (McCormick Place; Chicago, IL) on June 37, 2022.
  • Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001.

Celsion and Medidata Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial at 2022 AACR Annual Meeting

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Thursday, April 14, 2022
Drug development, DNA, Clinical trial, Progression-free survival, Annual general meeting, Association, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NASDAQ, Research, U.S. Securities and Exchange Commission, Dassault Group, Immunotherapy, Food, Private Securities Litigation Reform Act, RNA, GLOBE, Patient, Phases of clinical research, SCA, Adaptive control, Vaccine, Severe acute respiratory syndrome coronavirus 2, Confidence interval, American Association, FDA, Disease, Ovarian cancer, Risk, AACR, Time, Pharmaceutical industry, Medidata Solutions

LAWRENCEVILLE, N.J., April 14, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN) a clinical-stage company focused on DNA-based immunotherapy and next generation vaccines and Medidata, a Dassault Systèmes company, today announced that they presented their findings on the use of a Synthetic Control ArmⓇ (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer (the OVATION 1 Study) at the Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, LA.

Key Points: 
  • A copy of the poster presentation is available on the investor portion of the Celsion website under Scientific Presentations .
  • The companys product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer.
  • Celsionalso has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies.
  • Celsionassumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Freya Pharma Solutions Announces Appointment of Dr. Jan van der Mooren as Chief Medical Officer, to guide its pivotal phase 3 clinical trial with Lybrido against FSIAD

Retrieved on: 
Tuesday, April 12, 2022
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AMSTERDAM, April 12, 2022 /PRNewswire/ -- Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women who have been diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the appointment of Jan van der Mooren MD, PhD, MSc (picture below) as Chief Medical Officer as per April 2022. Dr. Van der Mooren is a medical doctor with additional education in Gynaecological Endocrinology and Epidemiology. He has been involved in clinical research since 1990. Prior to his appointment he was Senior Director of the Danone Nutricia Research Center in Utrecht, the Netherlands. Jan will be in the lead of Freya's steering committee overseeing the upcoming phase 3 study of Lybrido to confirm its efficacy in women suffering from FSIAD.

Key Points: 
  • Dr. Van der Mooren is a medical doctor with additional education in Gynaecological Endocrinology and Epidemiology.
  • Jan will be in the lead of Freya's steering committee overseeing the upcoming phase 3 study of Lybrido to confirm its efficacy in women suffering from FSIAD.
  • Dr. Van der Mooren brings to Freya three decades of life sciences experience in clinical development and medical affairs in nutrition, epidemiology, obstetrics and gynaecology.
  • Freya Pharma Solutions plans to conduct the pivotal phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from FSIAD.

Freya Pharma Solutions Announces Appointment of Dr. Jan van der Mooren as Chief Medical Officer, to guide its pivotal phase 3 clinical trial with Lybrido against FSIAD

Retrieved on: 
Tuesday, April 12, 2022
VU University Medical Center, Female, American, Plasma, Phases of clinical research, Lists of diseases, Obstetrics, Research, Danone, Declaration of Helsinki, Clinical trial, No, DSM-5, Testosterone, Clinical research, CMO, PDE, American Psychiatric Association, Doctor of Philosophy, Person, Woman, Human sexual response cycle, Sexual dysfunction, EU, Senior, Saint Luke's Home for Destitute and Aged Women, Grammatical mood, Arousal, Knowledge, Safety, Master of Science, GCP, Good, Associate professor, EMA, Union, Communication, Lubrication, Department, GMP, Education, Science, Excellence, Patient, Pharmaceutical industry, Birth control, Freyja, Buspirone/testosterone, Nutricia, Epidemiology

AMSTERDAM, April 12, 2022 /PRNewswire/ -- Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women who have been diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the appointment of Jan van der Mooren MD, PhD, MSc (picture below) as Chief Medical Officer as per April 2022. Dr. Van der Mooren is a medical doctor with additional education in Gynaecological Endocrinology and Epidemiology. He has been involved in clinical research since 1990. Prior to his appointment he was Senior Director of the Danone Nutricia Research Center in Utrecht, the Netherlands. Jan will be in the lead of Freya's steering committee overseeing the upcoming phase 3 study of Lybrido to confirm its efficacy in women suffering from FSIAD.

Key Points: 
  • Dr. Van der Mooren is a medical doctor with additional education in Gynaecological Endocrinology and Epidemiology.
  • Jan will be in the lead of Freya's steering committee overseeing the upcoming phase 3 study of Lybrido to confirm its efficacy in women suffering from FSIAD.
  • Dr. Van der Mooren brings to Freya three decades of life sciences experience in clinical development and medical affairs in nutrition, epidemiology, obstetrics and gynaecology.
  • Freya Pharma Solutions plans to conduct the pivotal phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from FSIAD.

Celsion and Medidata to Present Findings on Use of Synthetic Control Arm to Estimate Treatment Effect in Ovarian Cancer Trial

Retrieved on: 
Wednesday, April 6, 2022
Private Securities Litigation Reform Act, Drug development, Risk, NASDAQ, DNA, Dassault Group, Immunotherapy, Clinical trial, Vaccine, AACR, Research, Progression-free survival, American Association, Phases of clinical research, Confidence interval, RNA, Food, Ovarian cancer, SCA, Association, Annual general meeting, Time, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, U.S. Securities and Exchange Commission, Adaptive control, FDA, Patient, Disease, Data science, Pharmaceutical industry, Medical device, Medidata Solutions

LAWRENCEVILLE, N.J., April 06, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN) a clinical-stage company focused on DNA-based immunotherapy and next generation vaccines and Medidata, a Dassault Systèmes company, today announced that they will be presenting their findings on the use of a Synthetic Control ArmⓇ (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer (the OVATION 1 Study) at the Annual Meeting of the American Association for Cancer Research (AACR) being held on April 8-13, 2022 in New Orleans, LA.

Key Points: 
  • The Medidata Synthetic Control Arm provided reliable estimates of the efficacy endpoints, which allowed for a decrease in the number of patients needed to participate in the subsequent randomized Phase II trial.
  • In addition to decreasing the burden on patients, this helped to accelerate trial timelines and decrease costs, said Dr. Nicholas Borys, Chief Medical Officer at Celsion.
  • The companys product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer.
  • Celsionassumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Sen-Jam Pharmaceutical Partners with Leading Academic Medical Centers in Promising Novel Oral COVID-19 Therapeutic Clinical Trial

Retrieved on: 
Tuesday, February 22, 2022
Therapy, FACEP, Death, Duke–NUS Medical School, Name, Degenerative disease, Pain, Inflammation, MHSC, Steroid, Immune system, Immunity, Iversen, B cell, COVID-19, Clinical trial, Duke University School of Medicine, Phases of clinical research, Wefunder, Safety, Associate, Laboratory, Emergency medicine, Acute respiratory distress syndrome, Collateral damage, Patient, COVID, Merck, MD, Infection, Pharmaceutical industry, Vaccine, Research, Pfizer

The collaboration received official approval this past Friday from the Nepal Health Research Council and is now commencing Phase II Clinical Trials for a novel oral therapy to mitigate the symptoms and hospitalizations associated with COVID-19.

Key Points: 
  • The collaboration received official approval this past Friday from the Nepal Health Research Council and is now commencing Phase II Clinical Trials for a novel oral therapy to mitigate the symptoms and hospitalizations associated with COVID-19.
  • Jackie believes that this oral combination, SJP-002C, will be shown to be safe for home use alone or in conjunction with anti-viral therapies.
  • Sen-Jam's investigational therapeutic for the treatment of COVID-19, SJP-002C is scheduled to begin a clinical trial this month under a co-development agreement with Duke-NUS .
  • Sen-Jam repurposes small molecules to develop novel therapeutics for large unmet needs with a focus on improving clinical outcomes.

Vaccinex Reports Two Complete Responses in First Three Patients Enrolled in the Phase 1b/2 KEYNOTE-B84 Study of Pepinemab in Combination with KEYTRUDA (pembrolizumab) in Patients with Recurrent or Metastatic Head and Neck Cancer

Retrieved on: 
Wednesday, January 26, 2022
MSD, Neurodegeneration, RECIST, Nasdaq, SEMA4D, PD-L1, Pembrolizumab, Biomarker, Company, Cancer, CPS, Patient, Phases of clinical research, Neoplasm, GLOBE, Pharmaceutical industry, Medical imaging

Among the three patients enrolled in the Phase1b safety segment of the study, two patients have been observed to experience a complete response (CR), as per RECIST v.1.1.

Key Points: 
  • Among the three patients enrolled in the Phase1b safety segment of the study, two patients have been observed to experience a complete response (CR), as per RECIST v.1.1.
  • The trials Data Safety Monitoring Boarddetermined that the recommended phase 2 dose of pepinemab (20 mg/kg Q3W), in combination with KEYTRUDA (200 mg Q3W), appeared to be well-tolerated.
  • Two of these initial three patients have been observed to experience a complete response (CR), as per RECIST v.1.1.
  • The study report also indicated that pepinemab did not increase immune-related toxicities of BAVENCIO but increased penetration of cytotoxic T cells.