Index (publishing)

Indaptus Therapeutics Activates Morristown Medical Center as Trial Site in INDP-D101, Its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors

Retrieved on: 
Tuesday, February 7, 2023
Atlantic Health System, Safety, Morristown Medical Center, Therapy, MTD, Patient, Incidence, Index (publishing), Pharmaceutical industry

INDP-D101 is the Company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors.

Key Points: 
  • INDP-D101 is the Company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors.
  • Patient screening at the Morristown, NJ hospital is expected soon.
  • The Phase 1 study will begin with a single dose escalation part followed by an expansion part with continuous administration of Decoy20.
  • The study will enroll patients with advanced/metastatic solid tumors, who have exhausted the other known treatment options.

Mullen Announces Result of Special Meeting of Shareholders

Retrieved on: 
Wednesday, January 25, 2023
8-K, Index (publishing), Russell, Auction, Shareholder

BREA, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) -- via InvestorWire -- Mullen Automotive, Inc. (NASDAQ: MULN ) (“Mullen” or the “Company”), an emerging electric vehicle (“EV”) manufacturer, announces today after its reconvened Special Meeting of Stockholders, that all proxy proposals have been approved.

Key Points: 
  • BREA, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) -- via InvestorWire -- Mullen Automotive, Inc. (NASDAQ: MULN ) (“Mullen” or the “Company”), an emerging electric vehicle (“EV”) manufacturer, announces today after its reconvened Special Meeting of Stockholders, that all proxy proposals have been approved.
  • The Company  has until March 6, 2023 to meet the Nasdaq minimum bid requirement of $1.00.
  • Mullen is also a member of the Russell 2000 Index through June of 2023, which requires a minimum stock price of $1.00 for inclusion.
  • Additional details can be found on the Company’s recently filed SEC Form 8-K and subsequent 8-K filed post Special Meeting of Shareholders Jan. 25, 2023.

Cyteir Therapeutics Announces Prioritization of CYT-0851 Development and Extended Cash Runway

Retrieved on: 
Thursday, January 19, 2023
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, DNA, Capecitabine, Workforce, Safety, Platinum, MTD, MD, Patient, Index (publishing), Therapy, Ovarian cancer, Pharmaceutical industry

Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT) today announced the strategic prioritization of clinical development of CYT-0851, an investigational monocarboxylate transporter inhibitor, as a potential combination therapy for the treatment of ovarian cancer.

Key Points: 
  • Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT) today announced the strategic prioritization of clinical development of CYT-0851, an investigational monocarboxylate transporter inhibitor, as a potential combination therapy for the treatment of ovarian cancer.
  • In conjunction with focusing clinical activities on ovarian cancer, Cyteir is reducing headcount by approximately 70% and deferring research and development in other areas, which is expected to extend Cyteir’s cash runway into 2026.
  • Based on current estimates, including assumptions for continuation of clinical development of CYT-0851 towards registration as a combination therapy, Cyteir expects that these actions will extend its cash runway into 2026.
  • As of December 31, 2022, on an unaudited basis, Cyteir had approximately $147 million in cash and cash equivalents.

Avacta Announces Successful Completion of Fourth Dose Escalation in AVA6000 Phase 1 Clinical Study

Retrieved on: 
Tuesday, January 17, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Nausea, Mucositis, MTD, Index (publishing), AIM, Safety, Toxic leukoencephalopathy, Doxorubicin, Hair, Cardiotoxicity, Patient, Cancer, Vomiting, Clinical trial, Aplastic anemia, Neoplasm, Incidence, Medical imaging, Pharmaceutical industry

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics announces that AVA6000 continues to show a very favourable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial.

Key Points: 
  • Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics announces that AVA6000 continues to show a very favourable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial.
  • Nineteen patients with a range of advanced and/or metastatic solid tumours enrolled across four cohorts, have been administered AVA6000 to date.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group plc commented: “We’re delighted with the very positive data emerging from the dose escalation study of our lead pre|CISION™ tumour targeted therapy AVA6000.
  • “We are now in a position to proceed beyond the fourth cohort in the dose escalation study to even higher doses than originally anticipated, which is an unexpected and very positive development.

EQS-News: Defence Therapeutics Inc.: DEFENCE’S LUNG CANCER GLP TOX STUDY ON ITS INTRANASAL ACCUTOXTM FORMULATION ADVANCES

Retrieved on: 
Thursday, February 2, 2023
Toxicity, Kinetics, MTD, Index (publishing), Lymphoma, Therapy, Lung cancer, Melanoma, Endoplasmic reticulum stress in beta cells, DNA, Dog, Safety, PK, Breast, Plasma, Human, Patient, Toxicology, Mouse, Research, Cancer, Clinical trial, GLP, USD, RATS, Pharmaceutical industry, Vaccine, Defense

Vancouver, BC, Canada, January 31st, 2023 - Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies is pleased to announce the start of its GLP studies on a new intranasal AccuTOXTM formulation.

Key Points: 
  • Vancouver, BC, Canada, January 31st, 2023 - Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies is pleased to announce the start of its GLP studies on a new intranasal AccuTOXTM formulation.
  • This milestone is crucial to initiate a Phase I trial for this drug in the context of lung cancer.
  • Building upon this success, Defence designed a new non-invasive formulation allowing the drug to be delivered intranasally to reach lung-established tumors.
  • Lung cancer is the deadliest cancer worldwide, accounting for 1.79 million deaths in 2020.

EQS-News: BREAKTHROUGH RESULTS: DEFENCE’S NOVEL ACCUTOXTM INTRANASAL REDUCED 50% OF CANCER NODULES ON ANIMALS WITH LUNG TUMORS

Retrieved on: 
Sunday, January 22, 2023
Lung cancer, Mouse, Therapy, Hope, USD, IC50, Animal, Patient, Safety, FDA, Lung, MTD, Index (publishing), Defense, Neoplasm, Pharmaceutical industry

The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals.

Key Points: 
  • The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals.
  • This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination.
  • The sum of these results paved the path to test the compound in another animal model of pre-established lung cancer delivered via the intranasal route.
  • When tested using this schedule on animals with lung tumors, AccuTOXTM decreased by over 50% the number of cancer nodules especially in the group combined with the anti-PD1 immune-checkpoint inhibitor.

EQS-News: Defence Therapeutics Inc.: BREAKTHROUGH RESULTS: DEFENCE’S NOVEL ACCUTOXTM INTRANASAL REDUCED 50% OF CANCER NODULES ON ANIMALS WITH LUNG TUMORS

Retrieved on: 
Sunday, January 22, 2023
Lung cancer, Mouse, Therapy, Hope, USD, IC50, Animal, Patient, Safety, FDA, Lung, MTD, Index (publishing), Defense, Neoplasm, Pharmaceutical industry

The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals.

Key Points: 
  • The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals.
  • This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination.
  • The sum of these results paved the path to test the compound in another animal model of pre-established lung cancer delivered via the intranasal route.
  • When tested using this schedule on animals with lung tumors, AccuTOXTM decreased by over 50% the number of cancer nodules especially in the group combined with the anti-PD1 immune-checkpoint inhibitor.

Vincerx Pharma Announces FDA Safe to Proceed Letter for Investigational New Drug (IND) Application for its αVβ3 Small Molecule-Drug Conjugate (SMDC) VIP236

Retrieved on: 
Tuesday, December 13, 2022
NE, Protein, PDX, Form 10-K, Renal cell carcinoma, Tumor microenvironment, Failure, Letter, Neoplasm, FDA, Food, TME, Safety, CPT, Cancer, 8-K, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SMDC, Drug Quality and Security Act, Workforce, Irinotecan, IND, Index (publishing), PALO, COVID-19, Tissue, Patient, Therapy, Pharmaceutical industry, Medical imaging, Risk management, Bayer

PALO ALTO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has provided a safe to proceed letter and cleared the IND application for VIP236, the Company’s front-runner SMDC for the treatment of advanced solid tumors.

Key Points: 
  • VIP236 is a first-in-class SMDC with a tailored design to efficiently treat patients with cancer with aggressive and metastatic disease.
  • VIP236 binds to activated αVβ3 integrin allowing specific homing to the tumor and is efficiently cleaved by neutrophil elastase (NE).
  • “We are excited to advance our lead SMDC, VIP236, to the clinic,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.
  • Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

Investigators Present Clinical Data on Salarius Pharmaceuticals’ Seclidemstat in Patients with MDS and CMML at the 2022 American Society of Hematology Annual Meeting

Retrieved on: 
Tuesday, December 13, 2022
Life, CMML, Cancer prevention, Azacitidine, Sarcoma, Clinical trial, Annual report, Effectiveness, Hematological Cancer Research Investment and Education Act, Salinicola salarius, Cancer Prevention and Research Institute of Texas, Food, MDS, FDA, Poster, Safety, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Exposition, Trial of the century, ASH, MD Anderson Cancer Center, SUSAR, Ewing's sarcoma, Drug development, Survival, Research, Society, Research institute, LSD1, Index (publishing), Biology, University, Patient, Pharmaceutical industry, IND

HOUSTON, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today announced that investigators in the Department of Leukemia at the University of Texas MD Anderson Cancer Center presented clinical data on seclidemstat in patients with MDS and CMML at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition underway in New Orleans and virtually.

Key Points: 
  • of the Department of Leukemia and is available in the Investors Events and Presentations section of Salarius’ website here .
  • As of October 2022, nine patients were enrolled with a median follow-up time of 3.9 months.
  • Typically, overall survival is four to six months for patients after failing therapy with hypomethylating agents.
  • The Phase 1 dose-escalation portion of this study will evaluate up to six dose levels of seclidemstat.

Indaptus Therapeutics Announces Initiation of First-In-Human, Open Label, Dose Escalation and Expansion Multicenter Phase 1 Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors

Retrieved on: 
Tuesday, December 13, 2022
Immunotherapy, Liver, Cell, Neoplasm, Annual report, MTD, Incidence, Inflammation, Therapy, Security (finance), Government, TLR, Spleen, Safety, Immunology, Science, HBV, Squamous cell carcinoma, Toxicity, Toxicology, HIV, Immune system, Infection, IND, Cancer, Risk, Index (publishing), Patient, Gram-negative bacteria, Pharmaceutical industry, Vaccine, Decoy

NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the initiation of INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors.

Key Points: 
  • NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the initiation of INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors.
  • We look forward to advancing to the expansion portion of the trial once the appropriate dose is identified,” said Boyan Litchev, M.D., Chief Medical Officer, Indaptus.
  • The Phase 1 study will begin with a single dose escalation part followed by an expansion part with continuous administration of Decoy20.
  • The study will enroll patients with advanced/metastatic solid tumors, who have exhausted the other known treatment options.