PHASE 2

SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination with Cetuximab

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Thursday, January 19, 2023
Teaching hospital, Colorectal cancer, PPF (company), Trial of the century, PHASE 2, Safety, University Hospital (Newark, New Jersey), Gastrointestinal tract, Patient, RAS, Cetuximab, Extrapyramidal system, Pembrolizumab, Pharmaceutical industry

BASEL, Jan. 19, 2023 (GLOBE NEWSWIRE) -- SOTIO Biotech , a clinical stage immuno-oncology company owned by PPF Group, announced today that the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and cetuximab in patients with colorectal cancer.

Key Points: 
  • BASEL, Jan. 19, 2023 (GLOBE NEWSWIRE) -- SOTIO Biotech , a clinical stage immuno-oncology company owned by PPF Group, announced today that the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and cetuximab in patients with colorectal cancer.
  • “The initiation of this Phase 2 study is an important step in the clinical development of nanrilkefusp alfa.
  • In addition to our previous and ongoing studies to determine the efficacy of nanrilkefusp alfa in combination with checkpoint blockers, we now aim to determine its ability to enhance the antibody dependent cellular cytotoxicity exerted by cetuximab,” said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO.
  • The first patient was dosed at the Gent University Hospital (Belgium), under the supervision of Professor Karen Geboes, head of the Department of Gastrointestinal and Intestinal Diseases.

Investment Deal Signed with Zijin; Pathway to Kharmagtai Production

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Wednesday, December 21, 2022
Strategic partnership, Documentation, FIRB, Extraordinary general meeting, Partnership, Zindagi 50-50, SOFR, Economics, ASX, TSX, Mineral, PHASE 2, Jefferies, XAM, Metallurgy, Risk, PFS, Sell, National instrument, Exercise, FID, Resource management, EGM, Appendix, Joint venture, Rare-earth element, Mining, Security (finance), Renewable energy, Retail, Bank, Pharmaceutical industry, Khüiten Peak, JV, PRC

Ltd. (Khuiten), which holds a 76.5% effective interest in the Kharmagtai copper-gold project (Kharmagtai).

Key Points: 
  • Ltd. (Khuiten), which holds a 76.5% effective interest in the Kharmagtai copper-gold project (Kharmagtai).
  • The significant cash investment by Zijin provides funding for the Pre-Feasibility Study for Kharmagtai (Kharmagtai PFS) which will commence in early 2023 and take the project to a potential Final Investment Decision (FID) as early as 2024.
  • The US$35 million will be used to complete the Kharmagtai PFS, continue exploration and support associated expenditure on the project’s development.
  • Upon delivery of the Kharmagtai PFS, Xanadu will have certain rights to partially or fully selldown its project interest in Kharmagtai to Zijin.

Apollo Reports First Assay Results From Phase 2 Drilling

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Thursday, December 1, 2022
Marketing, Perception, Laboratory, ICP-AES, Legislation, Apollo, Lead, COG, Element, TSX Venture Exchange, QA/QC, Canadian Securities Administrators, Nature, Mojave Desert, Project, Insurance, Langtry, Canadian Institute of Mining, Metallurgy and Petroleum, Basin, ALS, Zinc, MRE, Silver, COVID-19, Copper, Strike, PHASE 2, NI, News, Public expenditure, Quality control, ICP-MS, Resource management, Regulation, Photography, Cryptocurrency, Risk management, Mining, Gold, Calico, Miocene

Drilling was undertaken by Cooper Drilling LLC, of Monte Vista, Colorado.

Key Points: 
  • Drilling was undertaken by Cooper Drilling LLC, of Monte Vista, Colorado.
  • Figure 1: Locations of drill hole collars for results reported December 1, 2022, for Phase 2 of the Calico Project 2022 Drill Program.
  • Figure 2: Assay results for drill holes W22-RC-043 and W22-RC-044 reported December 1, 2022, for Phase 2 of the Calico Project 2022 Drill Program.
  • Figure 3: Assay results for drill holes W22-RC-058 and W22-RC-059 reported December 1, 2022, for Phase 2 of the Calico Project 2022 Drill Program.

EQS-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports Third Quarter 2022 Financial Results and Highlights Operational Progress

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Sunday, November 27, 2022
National Institute on Aging, Data collection, KKR, Acute kidney injury, Inflammation, MCI, PHASE 2, Kohlberg Kravis Roberts, Cancer, Partnership, Therapy, ADCS, AD, Patient, Exercise, Protein, Homeostasis, Research, Q&A, Nature Communications, Monash University, VIVA, EUR, CET, Risk, Immunity, NIA, Fibrosis, Euronext Amsterdam, Clinical trial, Safety, EU, Probability, Security (finance), Pharmaceutical industry, Medical imaging, Renewable energy, Broadcasting

In the third quarter of 2022, we were very pleased to have strengthened our financial position with a successful private placement of up to EUR 30 million.

Key Points: 
  • In the third quarter of 2022, we were very pleased to have strengthened our financial position with a successful private placement of up to EUR 30 million.
  • Vivoryon now expects to report full data, including additional follow-up data, in the first quarter of 2024.
  • A Q&A session will follow the presentation of the third quarter results and operational progress.
  • Certain risk factors that may affect the Companys future financial results are discussed in the published annual financial statements of the Company.

CORRECTION – Istation Reading, Math, and Lectura added to Colorado state assessment list

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Wednesday, November 9, 2022
GLOBE, Review, Data collection, Learning, School, KSR, CDE, Knowledge, Environment, Colorado Department of Education, Implement, PHASE 2, Colorado State Board of Education, Time, Education, Student, Imagination, Tutoring, ISTAT

Istation has been moved to Phase 2 for consideration by the Colorado Department of Education for the Kindergarten School Readiness (KSR) initiative.

Key Points: 
  • Istation has been moved to Phase 2 for consideration by the Colorado Department of Education for the Kindergarten School Readiness (KSR) initiative.
  • The CDE is still in the process of reviewing assessments for the purpose of measuring kindergarten school readiness.
  • After the review, the Colorado State Board of Education will be presented with the results and will decide which assessments to approve for use in schools across Colorado.
  • Istation is presently in Phase 2 of the Kindergarten School Readiness (KSR) initiative, and the CDE will release final decisions in 2023.

EQS-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports H1 2022 Financial Results and Highlights Operational Progress

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Friday, September 30, 2022
Nervous system, Safety, National Medical Products Administration, Center, Research, Hospital, Achievement, EU, Patient, Clinical trial, Exercise, PHASE 2, AAIC, EUR, Cone Health Women's Hospital, National Institute, DSMB, Center for Drug Evaluation and Research, Kohlberg Kravis Roberts, Company, University of California, San Diego, CDE, VIVA, NIA, AES, Lists of diseases, Doctor of Philosophy, UC, Associate, NMPA, Skin, Annual general meeting, MD, Data monitoring committee, CMO, ADCS, CEO, MCI, Simcere Pharmaceutical, Comprehensive income, Conference, Șaeș, National Institute on Aging, Therapy, Protein, Euronext Amsterdam, Harvard Medical School, BID, Security (finance), Pharmaceutical industry, Medical device, Medical imaging, Health insurance, Neuroscience, Amyloid beta, Neurology

Firstly, we have been able to further de-risk clinical development of varoglutamstat with extremely encouraging safety results from our VIVIAD Phase 2b study.

Key Points: 
  • Firstly, we have been able to further de-risk clinical development of varoglutamstat with extremely encouraging safety results from our VIVIAD Phase 2b study.
  • Vivoryon presented detailed safety data from the VIVIAD study at the Alzheimers Association International Conference (AAIC) in San Diego (July 31 to August 4, 2022).
  • On June 22, 2022, Vivoryon held its Annual General Meeting where all voting items were approved with a large majority.
  • Condensed Statements of Profit or Loss and Other Comprehensive Income for the six months ended June 30, 2022 and 2021

EQS-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics Announces Successful Private Placement of up to EUR 30 Million

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Friday, September 30, 2022
Qualifying investor alternative investment fund, Person, AMERICA, Achievement, Patient, European Economic Area, Investment, Exercise, Urban economics, PHASE 2, Drug development, Ecosystem, EUR, Financial services, Financial Services and Markets Act 2000, Research, Inflammation, Communication, Disease, Council, Market share, Fibrosis, Sale, Securities Act of 1933, Kohlberg Kravis Roberts, Company, Growth, European Union (Withdrawal) Act 2018, KKR, Prospectus, AFRICA, Issuer, CEO, Security (finance), European Parliament, Article, Relevance (Person of Interest), Financial market, Therapy, Risk, Cancer, Offering, Protein, Euronext Amsterdam, Caregiver, Pharmaceutical industry, EU

Vivoryon is pioneering a unique therapeutic approach to overcoming the challenges in Alzheimers disease (AD) drug development.

Key Points: 
  • Vivoryon is pioneering a unique therapeutic approach to overcoming the challenges in Alzheimers disease (AD) drug development.
  • Pursuant to the Offering, the Company will issue 2,054,796 ordinary shares at an offering price of EUR 7.30 per share, amounting to gross proceeds of EUR 15.0 million.
  • As a consequence, the Companys issued share capital will increase to EUR 24,105,278.00 on completion of the Offering, which is expected to occur on October 6, 2022.
  • Hauck Aufhuser Investment Banking acted as sole placement agent in the private placement.

United Energy Announces Major Corporate Advancements

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Friday, August 5, 2022
Oil, Gas, Energy, Carbon, Industry, Santa Rosa Integrated Terminal, Environment, Engineering, Acquisition, EXCEL, Safety, Mississippi River, PHASE 2, Â, Ownership, UNRG, Oil

United Energy Corporation today announced 100% acquisition of Integrity Terminals, LLC., adding to UNRGs previous minority ownership stake of 12%.

Key Points: 
  • United Energy Corporation today announced 100% acquisition of Integrity Terminals, LLC., adding to UNRGs previous minority ownership stake of 12%.
  • UNRG has also acquired the option to purchase a total of 686 acres of land located in Iberville Parish, Louisiana.
  • The world-class and technologically advanced, multi-functional facility will store, blend, and distribute petroleum products, crude oil, biofuel, green energy, and non-petroleum compounds.
  • In conjunction with the acquisition, UNRG also announces it has engaged EXCEL Midstream Solutions, Inc. of Houston, Texas as its strategic design, permitting, and engineering partner.

Eisai Presents New Findings on Lecanemab's Investigational Subcutaneous Formulation and Modeling Simulation of ApoE4 Genotype on Aria-E Incidence at AAIC 2022

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Thursday, August 4, 2022
BAN2401, Alzheimer's disease, Senior, PHASE 2, Brain, Disease, BLA, ARIA, Food, Review, PET, Biologics license application, Safety, FDA, AAIC, Genotype, Biogen, AD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Clarity, Prescription Drug User Fee Act, OLE, CA, IV, Neutralizing antibody, AUC, Incidence, Cmax, Conference, PDUFA, MCI, Caregiver, Pharmaceutical industry, Patient, Single, Apolipoprotein E, Eisai

Lecanemab PK for the 5 Japanese subjects was similar to that of the non-Japanese subjects following a single subcutaneous dose administration.

Key Points: 
  • Lecanemab PK for the 5 Japanese subjects was similar to that of the non-Japanese subjects following a single subcutaneous dose administration.
  • The modeling will be updated with data from Eisai's Phase 3 Clarity AD confirmatory study reading out in fall 2022."
  • This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety.
  • There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

Acrivon Therapeutics Receives FDA Clearance for Innovative Phase 2 Trial to Treat Ovarian, Endometrial and Urothelial Cancer Patients Based on Predicted Sensitivity to ACR-368

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Wednesday, June 22, 2022
Eli Lilly and Company, Cancer, FDA, Safety, DDR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Proteomics, Anal cancer, Â, Precision medicine, Probability, Company, CHK2, Investigational New Drug, PHASE 2, IND, AP3, Food, Patient, Therapy, GLOBE, Neoplasm, Pharmaceutical industry, Medical imaging

WATERTOWN, Mass., June 22, 2022 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary proteomics-based technologies driving a new era of precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for its lead asset ACR-368 in a Phase 2 master protocol trial to treat patients with ovarian, endometrial and urothelial cancer based on predicted ACR-368 sensitivity. ACR-368 is a potent, selective inhibitor of checkpoint kinase 1 and 2 (CHK1/2) which has previously shown durable monotherapy efficacy in a proportion of patients across several high unmet need solid tumor types. Acrivon will stratify patients for its trial into two treatment groups using its pioneering OncoSignature® proteomic companion diagnostic. OncoSignature®-positive patients will receive ACR-368 monotherapy in a Phase 2 Simon two-stage study design at the recommended Phase 2 dose, while OncoSignature®-negative patients will receive ACR-368 in combination with low-dose gemcitabine in a Phase 1b/2 study design.

Key Points: 
  • Acrivon will stratify patients for its trial into two treatment groups using its pioneering OncoSignature proteomic companion diagnostic.
  • The Phase 2, multicenter, open-label study will enroll patients with histologically confirmed, locally advanced or metastatic, recurrent platinum-resistant high-grade ovarian cancer, or endometrial adenocarcinoma, or platinum-resistant urothelial carcinoma.
  • Based on the results of the companys proprietary OncoSignature predictive test, patients will be allocated to one of two treatment arms.
  • Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation.