Cancer treatments

InflaRx Doses First Patient in Multicenter Phase II Clinical Trial in Cutaneous Squamous Cell Carcinoma with Vilobelimab

Retrieved on: 
Tuesday, June 8, 2021

The Phase II clinical trial is expected to enroll approximately 70 patients at sites in Europe, the U.S. and elsewhere.

Key Points: 
  • The Phase II clinical trial is expected to enroll approximately 70 patients at sites in Europe, the U.S. and elsewhere.
  • The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab.
  • Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx, said: We are pleased to initiate the first clinical trial to evaluate vilobelimab in cancer.
  • Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated.

Vaccinex Announces Activation of Clinical Sites to Enroll Patients in Studies of Pepinemab as Single Agent in Alzheimer’s Disease and in Combination with KEYTRUDA® in Advanced, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Retrieved on: 
Tuesday, June 8, 2021

The Company plans to activate at least 13 U.S. sites for the Alzheimer study and 18 U.S. sites for HNSCC.

Key Points: 
  • The Company plans to activate at least 13 U.S. sites for the Alzheimer study and 18 U.S. sites for HNSCC.
  • The Alzheimers proof-of-concept study is expected to enroll at least 40 patients with key efficacy endpoints that include measures of cognition and brain imaging.
  • This study has received funding support from the Alzheimers Drug Discovery Foundation and the Alzheimers Association.
  • KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Biomarker Uncovered by Roswell Park Team Identifies NET Patients Likely to Have Blood Side Effects from PRRT

Retrieved on: 
Tuesday, June 8, 2021

While PRRT has been shown to be beneficial for patients with neuroendocrine tumors, it sometimes causes hematologic side effects that can be permanent.

Key Points: 
  • While PRRT has been shown to be beneficial for patients with neuroendocrine tumors, it sometimes causes hematologic side effects that can be permanent.
  • The researchers analyzed patients' blood samples before and after PRRT, looking for clonal mutations that may help characterize the selective pressures this therapy puts on stem cells.
  • Using genomic sequencing to track these mutations, the team uncovered the presence of expanding all elic fractions of DDR clones following PRRT.
  • Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York.

Polyphor Hosting Key Opinion Leader Roundtable on Covid-19: The Need for Novel Therapies for Severe Infections and the Potential Role of Balixafortide, a Selective CXCR4 Antagonist

Retrieved on: 
Tuesday, June 8, 2021

Klimkait, Shorr, and Ghosn will be available to answer questions following the formal presentations.

Key Points: 
  • Klimkait, Shorr, and Ghosn will be available to answer questions following the formal presentations.
  • Polyphor's management team will then discuss novel research findings of balixafortide relevant for COVID-19 infections.
  • Balixafortide is a potent, selective CXCR4 antagonist which is currently also in Phase III development in combination with eribulin in patients with metastatic HER-2 negative breast cancer.
  • is Head, Pulmonary and Critical Care Medicine at Medstar Washington Hospital Center and a Professor of Medicine at Georgetown University.

Live from ASCO 2021 | Ascentage Pharma Presents Updated Results of MDM2-p53 Inhibitor Alrizomadlin (APG-115) Demonstrating an ORR of 24.1% Including Complete Response in Combination with Pembrolizumab in Patients with Advanced Melanoma Resistant or Refrac

Retrieved on: 
Tuesday, June 8, 2021

The ORR and DCR in the melanoma cohort were 24.1% (7/29) and 55.2% (16/29), respectively.

Key Points: 
  • The ORR and DCR in the melanoma cohort were 24.1% (7/29) and 55.2% (16/29), respectively.
  • In the PD-1/PD-L1 inhibitor-resistant NSCLC (n=15) and urothelial carcinoma (n=8 evaluable) cohorts, 1 patient in each cohort achieved confirmed PR.
  • These preliminary results have established proof of concept clinically that the combination regimen has antitumor activity in patients with IO relapsed/refractory metastatic melanoma, (including uveal melanoma, mucosal melanoma, or cutaneous melanoma).
  • In addition, this combination therapy also showed promising antitumor activity in patients with MPNST or liposarcoma for which pembrolizumab has no approved indications.

Seven and Eight Biopharma’s BDB001 in Combination with Pembrolizumab Shows Favorable Safety and Clinical Responses in Interim Phase 1 Data Presented at the 2021 ASCO Annual Meeting

Retrieved on: 
Monday, June 7, 2021

Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 as monotherapy showed favorable tolerability and robust systemic immune activation leading to durable clinical responses.

Key Points: 
  • Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 as monotherapy showed favorable tolerability and robust systemic immune activation leading to durable clinical responses.
  • The poster discussion session at ASCO for Abstract #2512 revealed new interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with pembrolizumab in advanced solid tumors (NCT03486301).
  • The results show that BDB001 in combination with pembrolizumab was well tolerated, and induced robust immune activation leading to clinical responses.
  • These promising interim results show that BDB001 in combination with pembrolizumab represents a novel and viable treatment for advanced solid tumors.

IN8bio Completes Treatment of First Cohort in Phase 1 Clinical Trial with Gamma Delta T-Cell Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme

Retrieved on: 
Monday, June 7, 2021

INB-200 was co-administered to patients undergoing the standard-of-care therapy for GBM during the temozolomide (TMZ) maintenance treatment.

Key Points: 
  • INB-200 was co-administered to patients undergoing the standard-of-care therapy for GBM during the temozolomide (TMZ) maintenance treatment.
  • The Phase 1 clinical trial of INB-200 ( NCT04165941 ) is the first-in-human trial of a genetically modified gamma delta T-cell therapy.
  • The clinical program also cleared a data safety monitoring board (DSMB) review earlier in 2021 and enrollment for cohort 2 has been initiated.
  • Gamma delta T-cells are collected from the patient, expanded, activated and genetically modified with a proprietary process developed at IN8bio.

Acepodia Publishes Preclinical Data on Novel Off-the-Shelf Natural Killer Cell Therapy, ACE1702, for HER2-Expressing Solid Tumors Using Antibody-Cell Conjugation Technology in the Journal Cancers

Retrieved on: 
Monday, June 7, 2021

The article, titled A Novel off-the-Shelf Trastuzumab-Armed NK Cell Therapy (ACE1702) Using Antibody-Cell-Conjugation Technology, is available on the Acepodia corporate website at Acepodia.com/newsroom/publications .

Key Points: 
  • The article, titled A Novel off-the-Shelf Trastuzumab-Armed NK Cell Therapy (ACE1702) Using Antibody-Cell-Conjugation Technology, is available on the Acepodia corporate website at Acepodia.com/newsroom/publications .
  • Data from this study reinforce the potential of ACE1702 as a potent and safe off-the-shelf therapy against HER2-expressing cancers.
  • Preclinical results demonstrate that trastuzumab conjugation by ACC technology provides oNK cells with specific and enhanced cytotoxicity against HER2-expressing cancer cells.
  • Its lead product candidate, ACE1702, is the first antibody-conjugated NK cell therapy in clinical development for the treatment of HER2-expressing solid tumors.

Innovent Releases the Phase Ia/Ib Dose-Escalation Trial Results of IBI110 (anti-LAG-3) in Patients with Advanced Solid Tumors at ASCO Annual Meeting 2021

Retrieved on: 
Monday, June 7, 2021

The phase 1 study of IBI110is a dose-escalation trial evaluating IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in patients with advanced solid tumors refractory to standard of care therapy.

Key Points: 
  • The phase 1 study of IBI110is a dose-escalation trial evaluating IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in patients with advanced solid tumors refractory to standard of care therapy.
  • The study is comprised of Phase Ia, an IBI110 single-drug dose-escalation phase, and Phase Ib, the dose-escalation phase of IBI110 in combination with sintilimab (200mg).
  • At disease progression, cross over from IBI110 monotherapy to combo (IBI110+ sintlilimab) was allowed at the investigators' discretion.
  • No adverse event (AE) led to discontinuation of IBI110 or sintilimab and no treatment-related death was reported.

Iovance Biotherapeutics Announces 33-Month Follow Up Data for Lifileucel in Advanced Melanoma at ASCO 2021 Annual Meeting

Retrieved on: 
Sunday, June 6, 2021

The data were presented in an oral presentation at the ASCO 2021 Annual Meeting .

Key Points: 
  • The data were presented in an oral presentation at the ASCO 2021 Annual Meeting .
  • The long-term follow-up data for Cohort 2 in the C-144-01 clinical study continue to demonstrate durability and depth of lifileucel TIL therapy response.
  • Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
  • ET to discuss ASCO clinical data updates for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma.