WILMETTE, IL, USA I August 21, 2024 I Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu.
MNPR-101-Lu combines the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar’s proprietary first-in-class humanized monoclonal antibody MNPR-101, which is highly selective against the urokinase plasminogen activator receptor (uPAR). The MNPR-101-Lu Phase 1 clinical trial will enroll patients with advanced solid cancers and will be a therapeutic follow-on study to the currently ongoing MNPR-101-Zr imaging and dosimetry clinical trial.
The results from preclinical studies of MNPR-101-Lu are promising. In a 90-day efficacy study in a human pancreatic cancer xenograft mouse model (Figure 1, below) as an example, MNPR-101-Lu demonstrated durable antitumor effects after a single injection, achieving complete elimination of tumors that lasted the duration of the study.
The MNPR-101-Lu imaging data in a human pancreatic cancer xenograft mouse model presented in March (link, Figure 2 below) provides additional insight into the strong therapeutic effect observed after a single injection of MNPR-101-Lu. The imaging data demonstrates the high specificity and durable uptake of MNPR-101-Lu in the tumor relative to normal tissue.
“We are excited about the HREC clearance and encouraged by the potential of MNPR-101-Lu to provide a meaningful clinical benefit to patients with uPAR-positive tumors. Several of the most aggressive, deadly cancers express uPAR, including triple negative breast cancer and pancreatic cancer,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “We are looking forward to launching the trial as quickly as we can.”
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-Lu and MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development programs against solid cancers. For more information, visit: www.monopartx.com.
SOURCE: Monopar Therapeutics
Post Views: 2,094
WILMETTE, IL, USA I August 21, 2024 I Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu.
MNPR-101-Lu combines the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar’s proprietary first-in-class humanized monoclonal antibody MNPR-101, which is highly selective against the urokinase plasminogen activator receptor (uPAR). The MNPR-101-Lu Phase 1 clinical trial will enroll patients with advanced solid cancers and will be a therapeutic follow-on study to the currently ongoing MNPR-101-Zr imaging and dosimetry clinical trial.
The results from preclinical studies of MNPR-101-Lu are promising. In a 90-day efficacy study in a human pancreatic cancer xenograft mouse model (Figure 1, below) as an example, MNPR-101-Lu demonstrated durable antitumor effects after a single injection, achieving complete elimination of tumors that lasted the duration of the study.
The MNPR-101-Lu imaging data in a human pancreatic cancer xenograft mouse model presented in March (link, Figure 2 below) provides additional insight into the strong therapeutic effect observed after a single injection of MNPR-101-Lu. The imaging data demonstrates the high specificity and durable uptake of MNPR-101-Lu in the tumor relative to normal tissue.
“We are excited about the HREC clearance and encouraged by the potential of MNPR-101-Lu to provide a meaningful clinical benefit to patients with uPAR-positive tumors. Several of the most aggressive, deadly cancers express uPAR, including triple negative breast cancer and pancreatic cancer,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “We are looking forward to launching the trial as quickly as we can.”
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-Lu and MNPR-101-Ac225 for the treatment of advanced cancers, as well as early development programs against solid cancers. For more information, visit: www.monopartx.com.
SOURCE: Monopar Therapeutics
Post Views: 2,094
