nendratareotide uzatansine (PEN-221) News

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Journal, CAR T-Cell Therapy: SSTR2 as an anatomical imaging marker and a safety switch to monitor and manage CAR T cell toxicity. (Pubmed Central) - Dec 4, 2022
Treatment with PEN-221 rapidly reduced the abundance of CAR T cells, decreasing the severity of xenogeneic graft-versus-host disease (GvHD), and prolonged survival. Our study supports the development of SSTR2 as a single genetic marker for CAR T cells that is readily applicable to humans both for anatomical detection of T cell distribution and an image-guided safety switch for rapid elimination of CAR T cells.

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[VIRTUAL] The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 Results () - Nov 15, 2021 - Abstract #NANETS2021NANETS_65;
Our study supports the development of SSTR2 as a single genetic marker for CAR T cells that is readily applicable to humans both for anatomical detection of T cell distribution and an image-guided safety switch for rapid elimination of CAR T cells. PEN-221 appears well tolerated at 8.8 mg/m2 q 3 weeks and has demonstrated efficacy exceeding its clinical efficacy goals with a CBR of 88.5% and a mPFS of 9 months.

|||||||||| nendratareotide uzatansine (PEN-221) / Tarveda Therap
[VIRTUAL] The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 results. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1522;
P1/2
PEN-221 appears well tolerated at 8.8 mg/m2 q 3 weeks and has demonstrated efficacy exceeding its clinical efficacy goals with a CBR of 88.5% and a mPFS of 9 months . A randomized trial of PEN-221 in GI mid-gut NET patients is now in development.

||||||||||  nendratareotide uzatansine (PEN-221) / Tarveda Therap
Trial completion, Metastases:  PEN-221-001: PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers (clinicaltrials.gov) -  Mar 11, 2021
P1/2, N=89, Completed,  Sponsor: Tarveda Therapeutics
A randomized trial of PEN-221 in GI mid-gut NET patients is now in development. Active, not recruiting --> Completed

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Journal: Somatostatin receptor 2 expression in nasopharyngeal cancer is induced by Epstein Barr virus infection: impact on prognosis, imaging and therapy. (Pubmed Central) - Jan 13, 2021
P=N/A
Furthermore, we reveal significant correlation of SSTR expression with increased rates of survival and report in vivo uptake of the SSTR2-binding Ga-DOTA-peptide radioconjugate in PET-CT scanning in a clinical trial of NPC patients (NCT03670342). These findings reveal a key role in EBV-associated NPC for SSTR2 in infection, imaging, targeted therapy and survival.

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Journal: Targeting the Somatostatin Receptor 2 with the Miniaturized Drug Conjugate, PEN-221: A Potent and Novel Therapeutic for the Treatment of Small Cell Lung Cancer. (Pubmed Central) - Jun 4, 2020
The unique attributes of the miniaturized drug conjugate allowed for deep tumor penetration and limited plasma exposure that may enable long-term dosing, resulting in durable tumor control. Collectively, these data suggest potential for antitumor activity of PEN-221 in patients with SSTR2-positive SCLC.

||||||||||  nendratareotide uzatansine (PEN-221) / Tarveda Therap
Enrollment closed, Metastases:  PEN-221-001: PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers (clinicaltrials.gov) -  May 22, 2020
P1/2, N=90, Active, not recruiting,  Sponsor: Tarveda Therapeutics
Collectively, these data suggest potential for antitumor activity of PEN-221 in patients with SSTR2-positive SCLC. Recruiting --> Active, not recruiting

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Preclinical, Journal: Discovery of an SSTR2-targeting maytansinoid conjugate (PEN-221) with potent activity in vitro and in vivo. (Pubmed Central) - Apr 10, 2020
PEN-221 targets high levels of DM1 to SSTR2-expressing xenograft tumors, which has led to tumor regressions in several SSTR2-expressing xenograft mouse models. The safety and efficacy of PEN-221 is currently under evaluation in human clinical trials.

||||||||||  nendratareotide uzatansine (PEN-221) / Tarveda Therap
Trial completion date, Trial primary completion date, Metastases:  PEN-221-001: PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers (clinicaltrials.gov) -  Aug 28, 2019
P1/2, N=90, Recruiting,  Sponsor: Tarveda Therapeutics
The safety and efficacy of PEN-221 is currently under evaluation in human clinical trials. Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jun 2019 --> Jun 2020

||||||||||  nendratareotide uzatansine (PEN-221) / Tarveda Therap
Enrollment open, Metastases:  PEN-221-001: PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers (clinicaltrials.gov) -  Nov 25, 2016
P1/2, N=120, Recruiting,  Sponsor: Tarveda Therapeutics
Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jun 2019 --> Jun 2020 Not yet recruiting --> Recruiting

||||||||||  nendratareotide uzatansine (PEN-221) / Tarveda Therap
New P1/2 trial, Metastases:  PEN-221-001: PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers (clinicaltrials.gov) -  Oct 17, 2016
P1/2, N=120, Not yet recruiting,  Sponsor: Tarveda Therapeutics



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