Toxic leukoencephalopathy

Plus Therapeutics Announces First Patient Dosed in ReSPECT-GBM Phase 2b Trial of Rhenium (186Re) Obisbemeda for Treatment of Recurrent Glioblastoma

Retrieved on: 
Wednesday, January 18, 2023

This Phase 2b multi-center trial is designed to evaluate the safety, tolerability, distribution and efficacy of rhenium (186Re) obisbemeda infused directly into the tumor via convection-enhanced delivery catheters in patients with recurrent GBM progressing after conventional treatment.

Key Points: 
  • This Phase 2b multi-center trial is designed to evaluate the safety, tolerability, distribution and efficacy of rhenium (186Re) obisbemeda infused directly into the tumor via convection-enhanced delivery catheters in patients with recurrent GBM progressing after conventional treatment.
  • “The treatment of our first patient went well with excellent targeted tumor delivery of high dose rhenium (186Re) obisbemeda, similar to that seen at this same dose in our Phase 1/2a trial.
  • Moving forward this year, our focus will be to expand the trial sites and ramp up enrollment to accelerate clinical development of this novel treatment option.”
    Figure: Initial treatment imaging from first patient treated in the ReSPECT-GBM Phase 2b trial.
  • The U.S. FDA granted both Orphan Drug designation and Fast Track designation to rhenium (186Re) obisbemeda for the treatment of GBM.

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

Retrieved on: 
Tuesday, January 17, 2023

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.

Kymera Therapeutics Shares Key 2023 Goals to Support its Evolution into a Fully Integrated Degrader Medicines Company

Retrieved on: 
Tuesday, January 10, 2023

WATERTOWN, Mass., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today announced its research, development and corporate goals for 2023.

Key Points: 
  • WATERTOWN, Mass., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today announced its research, development and corporate goals for 2023.
  • Initial Phase 2 clinical trials of KT-474 will investigate its potential in HS and AD, with the first study initiating in 2023.
  • In December 2022 Kymera announced that Dose Level (DL) 1 had been completed with a total of 4 patients enrolled.
  • Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera, will provide an overview of the Company’s progress and 2023 goals.

4D Molecular Therapeutics Announces Updates on Clinical Pipeline and Additional Preclinical Programs

Retrieved on: 
Monday, January 9, 2023

The doses to be evaluated in DME are expected to be similar to those used in the 4D-150 wet AMD clinical trial.

Key Points: 
  • The doses to be evaluated in DME are expected to be similar to those used in the 4D-150 wet AMD clinical trial.
  • It is estimated that there are over one million individuals with GA in the United States according to published data.
  • In addition, I’m excited by the potential of 4D-175, the new preclinical product candidate utilizing the same R100 vector.
  • Cardiac clinical endpoint data (MRI, echocardiography, cardiopulmonary exercise testing [CPET] and QOL assessment) from evaluations at baseline and 12 months after treatment were assessed.

Theriva Biologics Announces Dosing of First Patient in the Investigator Sponsored Phase 1 Trial of VCN-01, an Intravenous Oncolytic Adenovirus, in Patients with Brain Tumors

Retrieved on: 
Monday, January 9, 2023

ROCKVILLE, Md., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the first patient has been dosed in the Phase 1 investigator sponsored clinical trial of VCN-01, an intravenous oncolytic adenovirus, for patients with high-grade brain tumors who are scheduled for surgical resection.

Key Points: 
  • “We are pleased to dose the first patient and evaluate the ability of our lead oncolytic adenovirus, VCN-01, to enter brain tumors following systemic administration,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
  • “This design builds on the data that we obtained from previous trials of systemically delivered VCN-01 for treating metastatic pancreatic cancer, another difficult to treat disease.
  • Dr. Samson commented, “Patients with recurrent high-grade primary brain tumors typically have a poor prognosis, and often have to undergo one or more surgical interventions to remove their tumors.
  • This could provide a more effective and less invasive therapeutic option for these patients.”

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities

Retrieved on: 
Thursday, January 5, 2023

SOUTH SAN FRANCISCO, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced its 2023 company priorities and provided a pipeline update which included anticipated milestones for 2023, recent progress and achievements in its wholly owned and collaboration pipeline, and a data update for the Phase 2, CX-2029 cohort expansion study. The company will host a call with investors today to review the CX-2029 cohort expansion study data and potential key pipeline events for 2023.

Key Points: 
  • The company plans to rapidly advance this potentially best-in-class program towards clinical evaluation with an IND filing targeted for the second half of 2023.
  • The company anticipates filing an IND for this novel ADC in the second half of 2023.
  • CytomX enters 2023 in a strong strategic position and with significant momentum in its pipeline.
  • CytomX management will host a conference call and a simultaneous webcast today, January 5th 2023 at 5 p.m.

IN8bio Provides INB-200 Clinical Update and Outlines 2023 Pipeline Goals

Retrieved on: 
Thursday, January 5, 2023

Company-sponsored Phase 2 multi-center clinical trial of autologous INB-400 gamma-delta T cells in newly diagnosed GBM patients to start enrollment by Q3 2023.

Key Points: 
  • Company-sponsored Phase 2 multi-center clinical trial of autologous INB-400 gamma-delta T cells in newly diagnosed GBM patients to start enrollment by Q3 2023.
  • Announcement of a new solid tumor indication with relevant data at a scientific conference in 1H 2023.
  • NEW YORK, Jan. 05, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced a clinical update from the ongoing Phase 1 trial evaluating INB-200 in patients with newly diagnosed GBM and provided pipeline goals for 2023.
  • New solid tumor indications: Announce and present relevant data at a scientific conference in 1H 2023.

iOnctura provides development update on first-in-class semi-allosteric PI3Kδ inhibitor program

Retrieved on: 
Thursday, January 5, 2023

This grants certain benefits during development and commercialization.

Key Points: 
  • This grants certain benefits during development and commercialization.
  • As of December 2022, 38 patients (including 23 with metastatic uveal melanoma and eight patients with follicular lymphoma) have been treated with IOA-244.
  • Catherine Pickering, Chief Executive Officer of iOnctura, said: "We are delighted to provide these positive updates on IOA-244, our lead clinical program.
  • These data demonstrate for the first time that a semi-allosteric inhibitor of PI3Kδ can be given to patients safely for long durations with no serious adverse events.

iOnctura provides development update on first-in-class semi-allosteric PI3Kδ inhibitor program

Retrieved on: 
Thursday, January 5, 2023

This grants certain benefits during development and commercialization.

Key Points: 
  • This grants certain benefits during development and commercialization.
  • As of December 2022, 38 patients (including 23 with metastatic uveal melanoma and eight patients with follicular lymphoma) have been treated with IOA-244.
  • Catherine Pickering, Chief Executive Officer of iOnctura, said: "We are delighted to provide these positive updates on IOA-244, our lead clinical program.
  • These data demonstrate for the first time that a semi-allosteric inhibitor of PI3Kδ can be given to patients safely for long durations with no serious adverse events.

NanOlogy Publishes Results From a Clinical Trial of Intracystic LSAM-PTX in Mucinous Pancreatic Cysts

Retrieved on: 
Tuesday, December 20, 2022

Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer.

Key Points: 
  • Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer.
  • Results from the trial are intended to support future research in this patient subset to evaluate whether intracystic LSAM-PTX can decrease the rate of progression.
  • The treatment is covered by a recently issued US patent ( 11,523,983 ) entitled Treatment of Epithelial Cysts by Intracystic Injection of Antineoplastic Particles.
  • Enrollment is also complete (n=54) in a NanOlogy-sponsored clinical trial of intratumoral (IT) LSAM-PTX with systemic chemotherapy in locally advanced pancreatic cancer (LAPC).