Tumor necrosis factor alpha

Alternate Mechanism Biologics and Adalimumab Biosimilar Prescribing Increases at the Expense of AbbVie's Humira in the EU5 Inflammatory Bowel Disease Market, Despite the Significant Impact of COVID-19 on Gastroenterology Practitioners

Retrieved on: 
Monday, July 20, 2020

Both therapies have experienced growth in prescribing in the US and EU markets over the past year, as gastroenterologists migrate away from traditional anti-TNF therapy use.

Key Points: 
  • Both therapies have experienced growth in prescribing in the US and EU markets over the past year, as gastroenterologists migrate away from traditional anti-TNF therapy use.
  • As such, Takeda will be tasked with building on that momentum with appropriate targeting and messaging in the very challenging COVID-19 environment.
  • Though the rate of growth has slowed slightly since 2019, a significant majority of EU gastroenterologists expect their adalimumab biosimilar prescribing to further increase in the future.
  • A companion service, RealTime Dynamix: Inflammatory Bowel Disease (US) , tracks the evolution of the IBD market in the US through a quarterly report series.

INmune Bio, Inc. Announces Interim Phase Ib Data Demonstrating That XPro1595 Decreases Neuroinflammation in Patients with Alzheimer’s Disease

Retrieved on: 
Monday, July 13, 2020

XPro1595 could have beneficial effects in patients with Alzheimers disease by decreasing neuroinflammation.

Key Points: 
  • XPro1595 could have beneficial effects in patients with Alzheimers disease by decreasing neuroinflammation.
  • XPro1595 is currently being evaluated in Phase Ib clinical trial in Alzheimers disease patients who have biomarkers of inflammation to determine if neutralizing soluble TNF can decrease those biomarkers of neuroinflammation.
  • The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.
  • The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patients NK cells to eliminate minimal residual disease in patients with cancer.

INmune Bio, Inc. to Announce Interim Data from Phase Ib Clinical Study of XPro1595 in Patients with Alzheimer’s Disease Prior to Start of AAIC 2020

Retrieved on: 
Thursday, July 9, 2020

XPro1595 could have substantial beneficial effects in patients with Alzheimers disease by decreasing neuroinflammation.

Key Points: 
  • XPro1595 could have substantial beneficial effects in patients with Alzheimers disease by decreasing neuroinflammation.
  • XPro1595 is currently being evaluated in a Phase Ib clinical trial in Alzheimers disease patients who have biomarkers of inflammation to determine if neutralizing soluble TNF can decrease those biomarkers of neuroinflammation.
  • The study will examine inflammatory and disease-related biomarkers before treatment, at the halfway point, and at the end.
  • The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.

EU5 Rheumatologists Expect the Introduction of Janssen's Tremfya in Psoriatic Arthritis to Blunt Anticipated Growth of Eli Lilly's Taltz, Novartis' Cosentyx, and Pfizer's Xeljanz

Retrieved on: 
Tuesday, June 23, 2020

According to the new Spherix report, TNF inhibitor use for the treatment of PsA across the EU5 remains widespread, accounting for two-thirds of all biologic/small molecule-treated patients.

Key Points: 
  • According to the new Spherix report, TNF inhibitor use for the treatment of PsA across the EU5 remains widespread, accounting for two-thirds of all biologic/small molecule-treated patients.
  • In fact, when assessing rheumatologists' six-month projected biologic/small molecule brand share in PsA, Taltz and Pfizer's Xeljanz are poised for the greatest growth.
  • Nonetheless, Tremfya (guselkumab), which is in Phase 3 clinical trials for treatment in PsA, is currently under EMA review for EU approval.
  • As a result, in a post-Tremfya world, EU5 rheumatologists predict continued erosion of the TNF inhibitors and a significant reduction in the projected growth for Taltz and Xeljanz.

Evelo Biosciences Announces EDP1815 to Advance into Phase 2/3 TACTIC-E COVID-19 Trial

Retrieved on: 
Monday, June 22, 2020

We have opted to investigate EDP1815 in this trial given the tolerability and the modulation of multiple inflammatory pathways observed in a Phase 1b clinical trial for psoriasis.

Key Points: 
  • We have opted to investigate EDP1815 in this trial given the tolerability and the modulation of multiple inflammatory pathways observed in a Phase 1b clinical trial for psoriasis.
  • If the Phase 2/3 data are positive, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration.
  • In a prior clinical trial in psoriasis, EDP1815 was well tolerated with no overall difference in safety findings from placebo.
  • In a Phase 1b clinical trial in psoriasis, EDP1815 limited the production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1b.

Denali Therapeutics Provides Broad Update on Its RIPK1 Program Partnered With Sanofi

Retrieved on: 
Tuesday, June 9, 2020

RIPK1, receptor-interacting serine/threonine-protein kinase 1, is a critical signaling protein in the TNF receptor pathway, which regulates inflammation and cell death in tissues throughout the body.

Key Points: 
  • RIPK1, receptor-interacting serine/threonine-protein kinase 1, is a critical signaling protein in the TNF receptor pathway, which regulates inflammation and cell death in tissues throughout the body.
  • Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the BBB for neurodegenerative diseases.
  • The forward-looking statements in this press release are based on information available to Denali as of the date hereof.
  • Denali disclaims any obligation to update any forward-looking statements, except as required by law.

Aclaris Therapeutics Announces Publication of an Abstract of the Phase 1 Clinical Trial Results for ATI-450, an Investigational Compound, at the EULAR 2020 E-Congress

Retrieved on: 
Wednesday, June 3, 2020

ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development.

Key Points: 
  • ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development.
  • This mechanism leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals.
  • Key inflammatory cytokines driven by this mechanism include tumor necrosis factor (TNF) and interleukin-1, -1, -6 and -8 (IL1, IL1, IL6 and IL8).
  • These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

BioInvent Expands Anti-TNFR2 Program by Selecting Second Monoclonal Antibody for Further Development

Retrieved on: 
Friday, May 15, 2020

Targeting TNFR2 demonstrates compelling therapeutic effects in syngeneic solid cancer models spanning "hot" and "cold" tumors.

Key Points: 
  • Targeting TNFR2 demonstrates compelling therapeutic effects in syngeneic solid cancer models spanning "hot" and "cold" tumors.
  • Careful mechanistic dissection and matching of the human lead clinical candidates and mouse surrogate antibodies enables thorough understanding of TNFR2-targeting and critical guidance of clinical development.
  • The exciting translational data package will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24.
  • Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020.

BioInvent Expands Anti-TNFR2 Program by Selecting Second Monoclonal Antibody for Further Development

Retrieved on: 
Friday, May 15, 2020

Targeting TNFR2 demonstrates compelling therapeutic effects in syngeneic solid cancer models spanning "hot" and "cold" tumors.

Key Points: 
  • Targeting TNFR2 demonstrates compelling therapeutic effects in syngeneic solid cancer models spanning "hot" and "cold" tumors.
  • Careful mechanistic dissection and matching of the human lead clinical candidates and mouse surrogate antibodies enables thorough understanding of TNFR2-targeting and critical guidance of clinical development.
  • The exciting translational data package will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24.
  • Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020.

Kiadis announces new data validating and enhancing its PM21 K-NK-cell platform presented today at the ASGCT virtual annual meeting

Retrieved on: 
Tuesday, May 12, 2020

The first set of data (abstract #427) demonstrates similarity between K-NK cells produced using Kiadis feeder cell technology (FC21) and K-NK cells produced using Kiadis membrane particle technology (PM21).

Key Points: 
  • The first set of data (abstract #427) demonstrates similarity between K-NK cells produced using Kiadis feeder cell technology (FC21) and K-NK cells produced using Kiadis membrane particle technology (PM21).
  • The second set of data (abstract #765) relate to an enhanced K-NK cell production platform called PM21.Fc.
  • The data presented compare lab scale and industrial scale K-NK cells generated with FC21 and PM21 on expansion yield, cytotoxicity, cytokine production (IFN and TNF) and expression of key receptors.
  • K-NK cells produced at industrial scale with PM21 showed further improved expansion rates upon implementation of optimized process conditions.