Monopar Announces First Patient Dosed with its Novel Therapeutic Radiopharmaceutical MNPR-101-Lu
Monopar Therapeutics (Nasdaq: MNPR) has announced the first-ever patient dosing of MNPR-101-Lu, a novel therapeutic radiopharmaceutical. The treatment combines MNPR-101 antibody targeting uPAR with lutetium-177 radioisotope. The first patient, who has metastatic pancreatic cancer, received the treatment under a compassionate use protocol in the US. The intravenous infusion was well-tolerated with no serious adverse reactions reported.
Prior to treatment, the patient's cancer was imaged using MNPR-101-Zr, showing uPAR expression. The company is currently conducting two Phase 1 clinical studies in Australia, evaluating MNPR-101-Zr for imaging and MNPR-101-Lu for treatment of advanced solid tumors.
Monopar Therapeutics (Nasdaq: MNPR) ha annunciato la prima somministrazione a un paziente di MNPR-101-Lu, un nuovo radioterapico terapeutico. Il trattamento combina l'anticorpo MNPR-101, che colpisce uPAR, con il radioisotopo lutetio-177. Il primo paziente, affetto da cancro pancreatico metastatico, ha ricevuto il trattamento sotto un protocollo di uso compassionevole negli Stati Uniti. L'infusione endovenosa è stata ben tollerata e non sono stati segnalati gravi effetti avversi.
Prima del trattamento, il cancro del paziente è stato inquadrato utilizzando MNPR-101-Zr, mostrando l'espressione di uPAR. Attualmente, l'azienda sta conducendo due studi clinici di Fase 1 in Australia, valutando MNPR-101-Zr per l'imaging e MNPR-101-Lu per il trattamento di tumori solidi avanzati.
Monopar Therapeutics (Nasdaq: MNPR) ha anunciado la primera dosificación en pacientes de MNPR-101-Lu, un nuevo radiofármaco terapéutico. El tratamiento combina el anticuerpo MNPR-101 que dirige a uPAR con el radioisótopo lutecio-177. El primer paciente, que tiene cáncer pancreático metastásico, recibió el tratamiento bajo un protocolo de uso compasivo en los EE. UU. La infusión intravenosa fue bien tolerada y no se reportaron reacciones adversas graves.
Antes del tratamiento, el cáncer del paciente fue imagenado utilizando MNPR-101-Zr, mostrando la expresión de uPAR. La empresa actualmente está llevando a cabo dos estudios clínicos de Fase 1 en Australia, evaluando MNPR-101-Zr para imágenes y MNPR-101-Lu para el tratamiento de tumores sólidos avanzados.
모노파르 테라퓨틱스 (Nasdaq: MNPR)는 MNPR-101-Lu라는 새로운 치료용 방사선 제재의 첫 번째 환자 투여를 발표했습니다. 이 치료는 uPAR를 타겟으로 하는 MNPR-101 항체와 루테튬-177 방사성 동위원소를 결합합니다. 첫 번째 환자는 전이성 췌장암 환자로, 미국에서 연민의 사용 프로토콜에 따라 치료를 받았습니다. 정맥 주사는 잘 견디며 심각한 부작용이 보고되지 않았습니다.
치료 전에 환자의 암은 MNPR-101-Zr을 사용하여 이미징 되었으며, uPAR 발현이 나타났습니다. 회사는 현재 호주에서 고급 고형 종양 치료를 위한 MNPR-101-Lu와 이미징을 위한 MNPR-101-Zr를 평가하는 두 개의 1상 임상 연구를 진행하고 있습니다.
Monopar Therapeutics (Nasdaq: MNPR) a annoncé la première administration à un patient de MNPR-101-Lu, un nouveau radiopharmaceutique thérapeutique. Le traitement associe l'anticorps MNPR-101 ciblant uPAR avec le radioisotope lutécium-177. Le premier patient, atteint d'un cancer du pancréas métastatique, a reçu le traitement dans le cadre d'un protocole d'utilisation compassionnelle aux États-Unis. L'infusion intraveineuse a été bien tolérée et aucune réaction indésirable grave n'a été signalée.
Avant le traitement, le cancer du patient a été imagé à l'aide de MNPR-101-Zr, montrant l'expression de uPAR. L'entreprise mène actuellement deux études cliniques de Phase 1 en Australie, évaluant MNPR-101-Zr pour l'imagerie et MNPR-101-Lu pour le traitement des tumeurs solides avancées.
Monopar Therapeutics (Nasdaq: MNPR) hat die erste Patientendosierung von MNPR-101-Lu, einem neuartigen therapeutischen Radiopharmazeutikum, angekündigt. Die Behandlung kombiniert den MNPR-101-Antikörper, der auf uPAR abzielt, mit dem Radioisotop Lutetium-177. Der erste Patient, der an metastasiertem Bauchspeicheldrüsenkrebs leidet, erhielt die Behandlung im Rahmen eines mitfühlenden Einsatzprotokolls in den USA. Die intravenöse Infusion wurde gut vertragen und es wurden keine schwerwiegenden unerwünschten Reaktionen gemeldet.
Vor der Behandlung wurde der Krebs des Patienten mit MNPR-101-Zr bildlich dargestellt, was die uPAR-Expression zeigte. Das Unternehmen führt derzeit zwei klinische Studien der Phase 1 in Australien durch, die MNPR-101-Zr für die Bildgebung und MNPR-101-Lu für die Behandlung fortgeschrittener solider Tumoren evaluieren.
- First successful patient dosing of MNPR-101-Lu with no serious adverse reactions
- Treatment well-tolerated in initial patient
- Two Phase 1 clinical trials actively enrolling participants
- Early-stage development with only one patient dosed so far
- data available on treatment efficacy
Insights
WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR), with the therapeutic radioisotope lutetium-177. uPAR is involved in tumor growth and metastasis, and is found in some of the most aggressive, deadly cancers, including pancreatic, ovarian, triple negative breast, and colorectal cancers.
The MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported. This patient, dosed under a compassionate use protocol in the US, has metastatic pancreatic cancer, and prior to dosing, the cancer was imaged using MNPR-101-Zr (a zirconium-89 imaging radioisotope conjugated to MNPR-101) with a PET/CT scanner and showed uPAR expression.
“As a result of encouraging biodistribution and dosimetry clinical data we recently reported (link) with our radiodiagnostic, MNPR-101-Zr, we have been eagerly looking forward to initiating treatment of patients with MNPR-101-Lu, hopeful it may provide an important therapeutic benefit to a group of cancer patients very much in need,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
“We are thrilled to have dosed this patient with MNPR-101-Lu, and believe this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical,” said Andrew Cittadine, Monopar’s Chief Operating Officer.
Monopar is actively enrolling participants in two Phase 1 clinical studies in Australia, evaluating MNPR-101-Zr for imaging and MNPR-101-Lu for treatment of advanced solid tumors. Further information about the MNPR-101-Lu Phase 1a trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Further information about the MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biotechnology company with ALXN-1840 for Wilson disease which has completed a Phase 3 trial, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced 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 statements concerning: the MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported; that as a result of recently reported encouraging biodistribution and dosimetry clinical data with Monopar’s radiodiagnostic, MNPR-101-Zr, the Company has been eagerly looking forward to initiating treatment and to seeing if the Company can bring an important therapeutic benefit to a group of cancer patients very much in need; and the Company believes this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical. The forward-looking statements involve risks and uncertainties including, but not limited to: that the patient may develop a serious adverse event in the future to MNPR-101-Lu; that radiation dosimetry analytics in the future may not be consistent with the estimated data generated thus far; that Monopar may not find enough patients to successfully enroll 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 the trials could result in a clinical hold should there be a Serious Adverse Event; Monopar’s ability to raise sufficient funds in order for the Company to support continued clinical, regulatory and commercial development of its programs and to make contractual future milestone payments, as well as its ability to further raise additional funds in the future to support any future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; uncertainties related to the regulatory discussions that Monopar intends to initiate related to ALXN-1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; 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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FAQ
What is MNPR-101-Lu and how does it work?
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