Monopar Announces Initial Data for First Patient Dosed in Radiopharma Phase 1 Clinical Trial of MNPR-101-Zr
Monopar Therapeutics Inc. (Nasdaq: MNPR) has announced initial data from the first patient dosed in its Phase 1 clinical trial of MNPR-101-Zr, a uPAR-targeted imaging radiopharmaceutical. The drug was well-tolerated with no serious adverse reactions reported. Preliminary analysis suggests low radiation dose to healthy tissue, aligning with preclinical data. Dosimetry analysis showed absorbed organ doses well below accepted safety limits, with red bone marrow radiation dose about 150 times less than the generally accepted limit. No unanticipated or excessive uptake was observed in critical organs. The study aims to include patients with cancers known for high uPAR expression to gain insight into MNPR-101-Zr's tumor uptake profile.
Monopar Therapeutics Inc. (Nasdaq: MNPR) ha annunciato i dati preliminari del primo paziente trattato nel suo studio clinico di fase 1 su MNPR-101-Zr, un radiotraghetto terapeutico mirato al uPAR. Il farmaco è stato ben tollerato, senza segnalazioni di reazioni avverse gravi. L'analisi preliminare suggerisce una bassa dose di radiazione ai tessuti sani, in linea con i dati preclinici. L'analisi dosimetrica ha mostrato che le dosi assorbite dagli organi erano ben al di sotto dei limiti di sicurezza accettati, con la dose di radiazione del midollo osseo rosso circa 150 volte inferiore al limite generalmente accettato. Non è stata osservata alcuna assunzione imprevista o eccessiva negli organi critici. Lo studio mira a includere pazienti con tumori noti per l'alta espressione di uPAR per ottenere informazioni sul profilo di assorbimento tumorale di MNPR-101-Zr.
Monopar Therapeutics Inc. (Nasdaq: MNPR) ha anunciado datos iniciales del primer paciente dosificado en su ensayo clínico de fase 1 de MNPR-101-Zr, un radiofármaco de imagen dirigido al uPAR. El fármaco fue bien tolerado y no se informaron reacciones adversas graves. El análisis preliminar sugiere una baja dosis de radiación en tejido sano, alineándose con los datos preclínicos. El análisis de dosimetría mostró dosis absorbidas en los órganos muy por debajo de los límites de seguridad aceptados, con una dosis de radiación en la médula ósea roja aproximadamente 150 veces menor que el límite generalmente aceptado. No se observó captación inesperada o excesiva en órganos críticos. El estudio tiene como objetivo incluir pacientes con cánceres conocidos por su alta expresión de uPAR para obtener información sobre el perfil de captación tumoral de MNPR-101-Zr.
모노파르 테라퓨틱스 Inc. (나스닥: MNPR)는 uPAR 표적 이미징 방사선약물인 MNPR-101-Zr에 대한 1상 임상시험에서 첫 번째 환자 투여에 대한 초기 데이터를 발표했습니다. 이 약물은 잘 견디는 것으로 보고되었으며, 심각한 부작용은 없었습니다. 초기 분석 결과는 건강한 조직에 대한 방사선량이 낮다고 제안하고 있으며, 이는 전임상 데이터와 일치합니다. 선량 분석 결과, 흡수된 장기의 방사선량은 수용 가능한 안전 한계보다 훨씬 낮았다고 하며, 적색 골수의 방사선량은 일반적으로 수용 가능한 한계보다 약 150배 낮았습니다. 중요한 장기에서 예상치 못한 또는 과도한 흡수는 관찰되지 않았습니다. 이 연구는 높은 uPAR 발현으로 알려진 암 환자를 포함하여 MNPR-101-Zr의 종양 흡수 프로필에 대한 통찰력을 얻는 것을 목표로 하고 있습니다.
Monopar Therapeutics Inc. (Nasdaq: MNPR) a annoncé des données préliminaires concernant le premier patient traité dans son essai clinique de phase 1 sur MNPR-101-Zr, un radio-pharmaceutique ciblant uPAR. Le médicament a été bien toléré, sans réactions indésirables graves signalées. L'analyse préliminaire suggère une faible dose de radiation pour les tissus sains, en accord avec les données précliniques. L'analyse dosimétrique a montré que les doses absorbées par les organes étaient bien en dessous des limites de sécurité acceptées, avec une dose de radiation pour la moelle osseuse rouge environ 150 fois inférieure à la limite généralement acceptée. Aucune absorption imprévue ou excessive n'a été observée dans les organes critiques. L'étude vise à inclure des patients atteints de cancers connus pour une forte expression de uPAR afin d'obtenir des informations sur le profil d'absorption tumorale de MNPR-101-Zr.
Monopar Therapeutics Inc. (Nasdaq: MNPR) hat erste Daten des ersten behandelten Patienten in seiner Phase 1-Studie zu MNPR-101-Zr, einem uPAR-gezielten bildgebenden Radiopharmazeutikum, bekannt gegeben. Das Medikament wurde gut vertragen, es wurden keine schweren Nebenwirkungen berichtet. Vorläufige Analysen deuten auf eine geringe Strahlendosis für gesundes Gewebe hin, was mit den präklinischen Daten übereinstimmt. Die Dosimetrie-Analyse ergab, dass die aufgenommenen Organ-Dosen deutlich unter den akzeptierten Sicherheitsgrenzen lagen, wobei die Strahlendosis des roten Knochenmarks etwa 150 Mal unter dem allgemein akzeptierten Limit lag. Es wurde keine unerwartete oder übermäßige Aufnahme in kritischen Organen beobachtet. Die Studie zielt darauf ab, Patienten mit Krebsen einzubeziehen, die für ihre hohe uPAR-Expression bekannt sind, um Erkenntnisse über das Tumoraufnahmeprofil von MNPR-101-Zr zu gewinnen.
- MNPR-101-Zr was well-tolerated with no serious adverse reactions
- Low radiation dose to healthy tissue aligns with preclinical data
- Absorbed organ doses were well below accepted safety limits
- No unanticipated or excessive uptake in critical organs
- The first patient has metastatic disease from a cancer type not known for high uPAR expression
Insights
The initial data from Monopar's Phase 1 trial of MNPR-101-Zr is promising. The radiopharmaceutical's safety profile and biodistribution align with preclinical expectations, which is important for advancing to therapeutic applications. The
However, it's important to note that this data is from a single patient with a cancer type not known for high uPAR expression. The true efficacy of MNPR-101-Zr in targeting uPAR-expressing tumors remains to be seen. Investors should watch for results from patients with high uPAR-expressing cancers to better gauge the potential of this radiopharmaceutical.
While the initial data is encouraging, it's important to maintain a measured perspective. This is a Phase 1 trial, primarily focused on safety and dosimetry. The path to market is still long, with efficacy and larger patient cohorts yet to be evaluated.
Monopar's focus on radiopharma aligns with a growing market trend, potentially positioning them well if MNPR-101-Zr proves successful. However, the company's financial stability and cash runway will be critical factors to monitor as they progress through clinical development. Investors should consider the risk-reward profile of early-stage biotech companies and the potential for dilution through future fundraising rounds to support ongoing research and development.
WILMETTE, Ill., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the successful dosing of the first patient in its open-label Phase 1 imaging and dosimetry clinical trial of its uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr.
MNPR-101-Zr was well-tolerated with no serious adverse reactions reported through the last imaging timepoint and the corresponding initial safety review. Preliminary analysis of MNPR-101-Zr’s pharmacokinetics and biodistribution suggests the low radiation dose to healthy tissue aligns with what was anticipated based on the previously presented MNPR-101-Zr preclinical biodistribution data. Dosimetry analysis showed absorbed organ doses were well below accepted safety limits; for example, the radiation dose to red bone marrow was about 14 mGy, which is around 150 times less than the generally accepted limit of 2-to-3 Gy. No unanticipated or excessive uptake of MNPR-101-Zr was observed in any critical organs through the end of the subject’s imaging period. The patient has metastatic disease from a cancer type not known for high uPAR expression. The study aims to include several patients with cancers known to express high levels of uPAR to gain insight into MNPR-101-Zr’s tumor uptake profile, in addition to patients with cancers of unknown uPAR expression.
“The safety profile observed thus far, along with the encouraging biodistribution data, gives us an increased confidence as we continue to advance our Phase 1 study and prepare to launch our therapeutic study,” said Andrew Cittadine, Monopar’s Chief Operating Officer.
Further information about the ongoing MNPR-101-Zr trial is 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 and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced cancers, as well as early development 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 statements concerning: that the study aims to enroll several patients with cancers known to express high levels of uPAR to gain insight into MNPR-101-Zr’s tumor uptake profile, in addition to patients with cancers of unknown uPAR expression; and that the safety profile observed thus far, along with the encouraging biodistribution data, gives Monopar an increased confidence as it continues to advance its Phase 1 study and launch its therapeutic study. The forward-looking statements involve risks and uncertainties including, but not limited to: the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield satisfactory results, if at all; that future preclinical or clinical data will not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101 conjugated to a therapeutic radioisotope may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; that Monopar may not advance its Phase 1 study and launch its therapeutic study; that Monopar may not regain compliance with Nasdaq listing standards within any extended Nasdaq deadline; 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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