Monopar Initiates Clinical Trial of Novel uPAR-Targeted Radiopharmaceutical Therapy in Advanced Cancers
Monopar Therapeutics Inc. (Nasdaq: MNPR) has initiated a Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu in patients with advanced cancers. The open-label dose-escalation study will recruit patients with solid tumors, focusing on those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry trial. The first clinical site activated is the Melbourne Theranostic Innovation Centre (MTIC) in Australia.
MNPR-101 is Monopar's proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types. The company aims to deliver targeted radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Recent clinical and preclinical data have shown highly specific and durable tumor uptake of MNPR-101-Zr.
This trial may be the world's first uPAR-targeted therapeutic radiopharma clinical trial, with the goal of identifying tumors using MNPR-101-Zr and treating them with MNPR-101-Lu.
Monopar Therapeutics Inc. (Nasdaq: MNPR) ha avviato uno studio clinico di Fase 1a per il suo nuovo radiofarmaco terapeutico MNPR-101-Lu in pazienti con tumori avanzati. Lo studio a dosi crescenti e a livello aperto arruolerà pazienti affetti da tumori solidi, concentrandosi su coloro che partecipano all'attuale studio di imaging e dosimetria in Fase 1 con MNPR-101-Zr. Il primo sito clinico attivato è il Melbourne Theranostic Innovation Centre (MTIC) in Australia.
MNPR-101 è l'anticorpo proprietario di Monopar che colpisce il recettore dell'attivatore del plasminogeno urochinasi (uPAR), espresso in vari tipi di tumore. L'azienda mira a fornire una terapia radiopharma mirata che uccide le cellule cancerose riducendo al minimo i danni ai tessuti sani. Dati clinici recenti e preclinici hanno mostrato un'uptake tumorale altamente specifica e duratura di MNPR-101-Zr.
Questo studio potrebbe essere il primo trial clinico al mondo di radiopharma terapeutico mirato a uPAR, con l'obiettivo di identificare i tumori utilizzando MNPR-101-Zr e trattarli con MNPR-101-Lu.
Monopar Therapeutics Inc. (Nasdaq: MNPR) ha iniciado un ensayo clínico de Fase 1a para su nuevo radiofármaco terapéutico MNPR-101-Lu en pacientes con cánceres avanzados. El estudio de escalación de dosis abierto reclutará pacientes con tumores sólidos, centrándose en aquellos que participan en el ensayo de imagen y dosimetría en Fase 1 con MNPR-101-Zr. El primer sitio clínico activado es el Melbourne Theranostic Innovation Centre (MTIC) en Australia.
MNPR-101 es el anticuerpo patentado de Monopar que se dirige al receptor activador de plasminógeno uroquinasa (uPAR), el cual se expresa en varios tipos de tumores. La empresa tiene como objetivo ofrecer una terapia radiopharma dirigida que elimine las células cancerosas mientras minimiza el daño al tejido sano. Datos clínicos y preclínicos recientes han demostrado una captación tumoral altamente específica y duradera de MNPR-101-Zr.
Este ensayo podría ser el primer ensayo clínico de radiopharma terapéutica con objetivo a uPAR en el mundo, con el objetivo de identificar tumores utilizando MNPR-101-Zr y tratarlos con MNPR-101-Lu.
모노파 테라퓨틱스 주식회사(Nasdaq: MNPR)는 진행성 암 환자를 위한 새로운 치료 방사성 의약품 MNPR-101-Lu의 1a상 임상 시험을 시작했습니다. 개방형 용량 증가 연구는 고형 종양 환자를 모집하며, 현재 진행 중인 MNPR-101-Zr 1상 영상 및 복용량 측정 시험에 참여하는 환자에게 초점을 맞춥니다. 최초로 활성화된 임상 시험 사이트는 호주 멜버른 치료 혁신 센터(MTIC)입니다.
MNPR-101은 다양한 종양 유형에서 발현되는 urokinase plasminogen activator receptor (uPAR)를 표적으로 하는 모노파의 독점 항체입니다. 이 회사는 정상 조직에 대한 손상을 최소화하면서 암 세포를 죽이는 표적 방사약물 치료를 제공하는 것을 목표로 하고 있습니다. 최근의 임상 및 전임상 데이터는 MNPR-101-Zr의 매우 특정하고 지속적인 종양 섭취를 보여주었습니다.
이 임상 시험은 세계 최초의 uPAR 표적 치료 방사약물 임상 시험이 될 수 있으며, MNPR-101-Zr를 사용하여 종양을 식별하고 MNPR-101-Lu로 치료하는 것을 목표로 하고 있습니다.
Monopar Therapeutics Inc. (Nasdaq: MNPR) a lancé un essai clinique de phase 1a pour son nouveau radio-pharmaceutique thérapeutique MNPR-101-Lu chez des patients atteints de cancers avancés. L'étude ouverte d'escalade des doses recrutera des patients atteints de tumeurs solides, en se concentrant sur ceux participant à l'essai d'imagerie et de dosimétrie de phase 1 avec MNPR-101-Zr. Le premier site clinique activé est le Melbourne Theranostic Innovation Centre (MTIC) en Australie.
MNPR-101 est l'anticorps propriétaire de Monopar ciblant le récepteur de l'activateur du plasminogène urokinase (uPAR), exprimé dans divers types de tumeurs. L'objectif de l'entreprise est de fournir une thérapie radiopharma ciblée qui tue les cellules cancéreuses tout en minimisant les dommages aux tissus sains. Les données cliniques et précliniques récentes ont montré une prise en charge tumorale hautement spécifique et durable de MNPR-101-Zr.
Cet essai pourrait être le premier essai clinique au monde de radiopharma thérapeutique ciblé sur uPAR, visant à identifier les tumeurs en utilisant MNPR-101-Zr et à les traiter avec MNPR-101-Lu.
Monopar Therapeutics Inc. (Nasdaq: MNPR) hat eine klinische Studie der Phase 1a für ihr neuartiges therapeutisches Radiopharmazeutikum MNPR-101-Lu bei Patienten mit fortgeschrittenem Krebs initiiert. Die offene Dosis-eskalationsstudie wird Patienten mit soliden Tumoren rekrutieren und sich auf diejenigen konzentrieren, die an der laufenden Phase-1-Studie zur Bildgebung und Dosimetrie mit MNPR-101-Zr teilnehmen. Der erste aktivierte klinische Standort ist das Melbourne Theranostic Innovation Centre (MTIC) in Australien.
MNPR-101 ist der proprietäre Antikörper von Monopar, der den Urokinase-Plasminogen-Aktivator-Rezeptor (uPAR) angreift, der in verschiedenen Tumorarten exprimiert wird. Das Unternehmen hat sich zum Ziel gesetzt, eine gezielte Radiopharma-Therapie bereitzustellen, die Krebszellen abtötet und gleichzeitig Schäden an gesundem Gewebe minimiert. Jüngste klinische und präklinische Daten haben eine hochspezifische und langlebige Tumoraufnahme von MNPR-101-Zr gezeigt.
Diese Studie könnte die erste klinische Studie der Welt sein, die auf therapeutische Radiopharma mit Ziel-uPAR abzielt, mit dem Ziel, Tumoren mithilfe von MNPR-101-Zr zu identifizieren und sie mit MNPR-101-Lu zu behandeln.
- Initiation of Phase 1a clinical trial for MNPR-101-Lu in advanced cancers
- Potential to be the world's first uPAR-targeted therapeutic radiopharma clinical trial
- Recent clinical and preclinical data showing highly specific and durable tumor uptake of MNPR-101-Zr
- Trial launched months ahead of originally planned schedule
- None.
WILMETTE, Ill., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers.
The Phase 1a trial is an open-label dose-escalation study of MNPR-101-Lu in patients with solid tumors. The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial.
MNPR-101 is Monopar’s proprietary antibody that targets the urokinase plasminogen activator receptor (uPAR), which is expressed in numerous tumor types including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Both clinical (link) and preclinical (link) data to date have demonstrated highly specific and durable tumor uptake of MNPR-101-Zr (MNPR-101 conjugated to zirconium-89).
“We are very encouraged by the recently released human clinical data and preclinical efficacy results (link), and are thrilled to be launching this therapeutic trial months ahead of our originally planned schedule,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
“We believe this may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial,” commented Andrew Cittadine, Monopar’s Chief Operating Officer. “Our goal is to light up the tumors with MNPR-101-Zr and then treat them with MNPR-101-Lu.”
Further information about the MNPR-101-Lu trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Details about the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial are available at www.ClinicalTrials.gov under study identifier NCT06337084.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development-stage radiopharma programs against solid cancers. For more information, visit: www.monopartx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include: that by selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue; that Monopar believes MNPR-101-Lu may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial; and that Monopar’s goal is to light up the tumors with MNPR-101-Zr then treat it with targeted MNPR-101-Lu. The forward-looking statements involve risks and uncertainties including, but not limited to: that Monopar may not recruit and enroll patients in its MNPR-101-Lu therapeutic study; that the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield consistently satisfactory results; that future preclinical or clinical data may not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101-Lu may cause unexpected serious adverse effects or fail to be effective against the cancer tumors in humans; that Monopar may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Karthik Radhakrishnan
Chief Financial Officer
karthik@monopartx.com
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