- |||||||||| Apocept (asunercept) / Apogenix
Review, Journal, CAR T-Cell Therapy: The role of CD95 in modulating CAR T-cell therapy: Challenges and therapeutic opportunities in oncology. (Pubmed Central) - Dec 13, 2024 Furthermore, we characterize the therapeutic potential of CD95 targeted approaches, including CD95L inhibition (APG101) and alterations in CAR T cell manufacturing (tyrosine kinase inhibitors to mitigate fratricide). In this review, we highlight the importance of multi-path way strategies combining CD95 modulation with CAR T cell engineering to overcome resistance, specifically to target tumor cells better and sustain CAR T cell persistence to enhance treatment efficacy in solid tumors.
- |||||||||| Apocept (asunercept) / Apogenix
P2 data, Journal: Efficacy and safety of asunercept, a CD95L-selective inhibitor, in hospitalised patients with moderate-to-severe COVID-19: ASUNCTIS, a multicentre, randomised, open-label, controlled, phase 2 trial. (Pubmed Central) - Nov 15, 2024 P2 The compound was safe and well tolerated. Apogenix GmbH, Heidelberg, Germany.
- |||||||||| Trial completion, Enrollment change, Trial completion date, Trial primary completion date: NCT Neuro Master Match - N (clinicaltrials.gov) - Sep 28, 2023
P1/2, N=228, Completed, Our results suggest that APG101 could be efficacious in reducing clone sizes of mutated hematopoietic cells in the bone marrow of Myelodysplastic Neoplasms, which warrants further investigation. Recruiting --> Completed | N=350 --> 228 | Trial completion date: Sep 2024 --> Feb 2023 | Trial primary completion date: Sep 2023 --> Feb 2023
- |||||||||| Apocept (asunercept) / Apogenix
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: ASUCOV: Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease (clinicaltrials.gov) - Aug 29, 2023 P3, N=34, Terminated, Recruiting --> Completed | N=350 --> 228 | Trial completion date: Sep 2024 --> Feb 2023 | Trial primary completion date: Sep 2023 --> Feb 2023 N=636 --> 34 | Trial completion date: Nov 2023 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2023 --> Aug 2023; Lack of patients
- |||||||||| Apocept (asunercept) / Apogenix
Trial completion: ASUNCTIS: Asunercept in Patients With Severe COVID-19 (clinicaltrials.gov) - Jan 14, 2022 P2, N=438, Completed, Adding asunercept to standard RT/TMZ was safe and well tolerated in patients with newly-diagnosed glioblastoma and 400 mg/week resulted in encouraging efficacy.Trial registration NCT02853565, August 3, 2016. Recruiting --> Completed
- |||||||||| Apocept (asunercept) / Apogenix
Trial completion date, Trial primary completion date: ASUNCTIS: Asunercept in Patients With Severe COVID-19 (clinicaltrials.gov) - Jul 7, 2021 P2, N=400, Recruiting, Trial primary completion date: Jul 2021 --> Nov 2021 Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Jul 2021
- |||||||||| Apocept (asunercept) / Apogenix, Pentaglobin (human immune globulin IV 10%) / Grifols
Trial completion date, Trial primary completion date: ACOVACT: Austrian CoronaVirus Adaptive Clinical Trial (COVID-19) (clinicaltrials.gov) - Feb 1, 2021 P2/3, N=500, Recruiting, Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: Feb 2021 --> Jul 2021 Trial completion date: Dec 2020 --> Mar 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Apocept (asunercept) / Apogenix
Clinical, Journal: Clinical Response to the CD95-Ligand Inhibitor Asunercept Is Defined by a Pro-Inflammatory Serum Cytokine Profile. (Pubmed Central) - Dec 12, 2020 Furthermore, non-responding patients showed a distinct, pro-inflammatory serum cytokine profile which was persistent throughout the first half of the treatment phase and appeared unaffected by asunercept. Although prospective validation is required, our post hoc analysis suggests that serum cytokine profiling based on IL-18, S100A9 and soluble p53 may represent an approach to identify and select low-risk MDS patients most likely to benefit from asunercept treatment.
- |||||||||| Apocept (asunercept) / Apogenix
Enrollment open: ASUNCTIS: Asunercept in Patients With Severe COVID-19 (clinicaltrials.gov) - Oct 14, 2020 P2, N=400, Recruiting, Although prospective validation is required, our post hoc analysis suggests that serum cytokine profiling based on IL-18, S100A9 and soluble p53 may represent an approach to identify and select low-risk MDS patients most likely to benefit from asunercept treatment. Not yet recruiting --> Recruiting
- |||||||||| Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
Review, Journal: Exploring Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitors for Organ Protection in COVID-19. (Pubmed Central) - Jul 3, 2020 This may imply novel therapies in clinical development (e.g., the Fas ligand trap asunercept), but uptake of repurposed drugs already in clinical use may be faster...Further, preclinical data support a beneficial effect for the lung. We now discuss the potential benefits and risks of SGLT2 inhibitors in COVID-19 and an ongoing clinical trial testing the impact of dapagliflozin on outcomes in COVID-19 patients with respiratory failure.
- |||||||||| Apocept (asunercept) / Apogenix
Neutralization of pro-apoptotic CD95L by Asunercept/APG101 does not impair anti-tumor immune responses (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2156; Our results suggest that APG101 does not impair CD8 T cell activation, but rather supports their proliferation by disrupting CD95/CD95L interaction with regulatory T cells. Importantly, the primary anti-tumor killing mechanisms is most likely CD95L-independent and remains unaffected by the presence of APG101.
- |||||||||| APG 101.10 / Allostera, Apocept (APG101) / Apogenix
Blockade of CD95/CD95L Death Signaling Enhances CAR T Cell Persistence and Antitumor Efficacy (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4423; CD95L blockade enhanced CAR T cell survival and promoted killing of tumor cells in vitro . Combining CAR T cell therapy with CD95L inhibitor might improve CAR T cell persistence in vivo and thus enhance the effect of CAR T cell therapy.
- |||||||||| APG 101.10 / Allostera, Apocept (APG101) / Apogenix
Journal: Asunercept as an innovative therapeutic approach for recurrent glioblastoma and other malignancies. (Pubmed Central) - Oct 1, 2019 Asunercept is a first-in-class recombinant glycosylated fusion protein, which has been designed to selectively bind to CD95L and therefore disrupt CD95/CD95L signaling. The current report provides a brief overview of the role of the CD95/CD95L signaling pathway in cancer pathogenesis and discusses how asunercept was designed to bind and neutralize CD95L and disrupt signaling thereby potentially improving outcomes in glioblastoma and other malignancies.
- |||||||||| Apocept (asunercept) / Apogenix
Trial completion, Enrollment change, Trial primary completion date: A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme (clinicaltrials.gov) - Nov 8, 2018 P1, N=10, Completed, Further clinical investigation is warranted, particularly in combination with erythropoiesis stimulating agents (ESAs). Recruiting --> Completed | N=15 --> 10 | Trial primary completion date: Oct 2017 --> Sep 2018
- |||||||||| Trial initiation date: NCT Neuro Master Match - N (clinicaltrials.gov) - Nov 1, 2017
P1/2, N=350, Not yet recruiting, Recruiting --> Completed | N=15 --> 10 | Trial primary completion date: Oct 2017 --> Sep 2018 Initiation date: Jul 2017 --> Jan 2018
- |||||||||| Apocept (asunercept) / Apogenix
Trial completion: APG101 in Myelodysplastic Syndrome (clinicaltrials.gov) - Aug 24, 2016 P1, N=20, Completed, Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| Apocept (asunercept) / Apogenix
Enrollment closed: APG101 in Myelodysplastic Syndrome (clinicaltrials.gov) - Jun 16, 2015 P1, N=18, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| Apocept (asunercept) / Apogenix
Trial completion, Trial primary completion date: APG101 in Glioblastoma (clinicaltrials.gov) - Jun 16, 2015 P2, N=84, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Jul 2012 --> Oct 2014
- |||||||||| Apocept (asunercept) / Apogenix
Trial primary completion date: APG101 in Myelodysplastic Syndrome (clinicaltrials.gov) - Jan 15, 2015 P1, N=18, Recruiting, Active, not recruiting --> Completed | Trial primary completion date: Jul 2012 --> Oct 2014 Trial primary completion date: Jun 2015 --> Nov 2015
- |||||||||| Apocept (asunercept) / Apogenix
Enrollment change: APG101 in Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 10, 2014 P1, N=18, Recruiting, Trial primary completion date: Jun 2015 --> Nov 2015 N=12 --> 18
- |||||||||| Apocept (asunercept) / Apogenix
Enrollment open: APG101 in Myelodysplastic Syndrome (clinicaltrials.gov) - Jan 30, 2013 P1, N=18, Recruiting, N=12 --> 18 Not yet recruiting --> Recruiting
- |||||||||| Apocept (asunercept) / Apogenix
Enrollment closed: APG101 in Glioblastoma (clinicaltrials.gov) - Sep 11, 2011 P2, N=83, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
|