Monopar Therapeutics Inc. - MNPR STOCK NEWS

Monopar Therapeutics Inc. (Nasdaq: MNPR) announced the completion of a pre-specified interim analysis for its Phase 2b/3 VOICE trial, which aimed to prevent severe oral mucositis in patients with oropharyngeal cancer undergoing chemoradiotherapy. The independent Data Safety Monitoring Board reported that the trial did not meet the pre-defined efficacy threshold of a 15% absolute difference in SOM prevention between Validive and placebo, leading to the discontinuation of the study and Validive's development. Monopar plans to redirect resources towards advancing its Phase 1b camsirubicin trial and MNPR-101 radiopharmaceutical program, stating it has sufficient funds to support activities beyond Q1 2024.

Monopar Therapeutics (Nasdaq: MNPR) announced its financial results for Q4 and full year 2022. As of December 31, 2022, cash and investments totaled $13.1 million, expected to fund ongoing trials. The VOICE trial anticipates an interim analysis by next week to determine continuation. The camsirubicin Phase 1b trial has begun enrolling at a higher dose level, showing promising data in progression-free survival and lower toxicity than doxorubicin. Recent preclinical studies on MNPR-101 and MNPR-202 indicate potential advancements. However, a net loss of $10.5 million was reported for 2022.

Monopar Therapeutics (Nasdaq: MNPR), a biopharmaceutical company dedicated to cancer therapeutics, announced that CEO Chandler Robinson will participate in a fireside chat at the 35th Annual Roth Conference.

Event Details:
Date: March 13, 2023
Time: 12:30-1:00 pm PT
Location: The Ritz Carlton, Laguna Niguel, Dana Point, California.

Monopar's pipeline includes Validive® (Phase 2b/3) for severe oral mucositis, camsirubicin (Phase 1b) for soft tissue sarcoma, and MNPR-101 & MNPR-202 for advanced cancers. For more information, visit www.monopartx.com.

Monopar Therapeutics (Nasdaq: MNPR) and NorthStar Medical Radioisotopes have expanded their collaboration in the radiopharmaceutical sector, introducing a new imaging candidate, MNPR-101-Zr. Preclinical results indicate high uptake of MNPR-101-Zr in various tumors, supporting plans for a first-in-human imaging study by year-end. MNPR-101-Zr is a zirconium-89 labeled form of MNPR-101, targeted at the urokinase plasminogen activator receptor (uPAR). The partnership aims to leverage MNPR-101 for both imaging and therapeutic applications, highlighting the potential of personalized medicine in cancer treatment.

Monopar Therapeutics Inc. (Nasdaq: MNPR) has announced an update on its Phase 1b trial of camsirubicin for advanced soft tissue sarcoma (ASTS). Enrollment has begun for the fifth dose cohort at 650 mg/m², nearly 2.5 times the highest dose previously evaluated. Notably, there has been no drug-related cardiotoxicity observed, in contrast to doxorubicin, the current standard treatment. Additionally, lower rates of hair loss and oral mucositis have been reported in patients treated with camsirubicin compared to those on doxorubicin. A second clinical trial site has also been established at the Fred Hutchinson Cancer Center in Seattle.

Monopar Therapeutics Inc. (Nasdaq: MNPR) announced plans to report key clinical updates over the next two months, focusing on:

• Interim analysis for the Validive Phase 2b/3 VOICE trial
• Clinical data from the camsirubicin Phase 1b trial
• Preclinical progress on the MNPR-101 RIT program

Notably, the camsirubicin Phase 1b trial has shown improved safety compared to doxorubicin, while enrollment for Validive's trial continues ahead of its expected analysis in March 2023. These updates are crucial for assessing the company's therapeutic pipeline aimed at improving cancer patient outcomes.

Monopar Therapeutics Inc. (Nasdaq: MNPR) received a positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m²) in its camsirubicin Phase 1b trial for advanced soft tissue sarcoma (ASTS). This decision follows safety reviews from prior doses, indicating the drug's favorable safety profile compared to doxorubicin. The trial aims to improve progression-free survival, showing promise based on earlier studies. Camsirubicin, a novel analog of doxorubicin, has not shown the cardiotoxicity linked to the original drug in earlier trials, making it a significant advancement in treatment options for ASTS.

Monopar Therapeutics Inc. (Nasdaq: MNPR) announced promising preclinical data for its drug candidate MNPR-202, developed in collaboration with the Cancer Science Institute of Singapore. MNPR-202, a DNA Damaging Response drug akin to doxorubicin, demonstrates comparable cytotoxic potency while evading resistance in certain tumors. The findings, showcased at the ASH Annual Meeting, suggest that MNPR-202 may enhance immune activation and offer superior results in combination regimens. This positions MNPR-202 as a potential disruptor in the chemotherapy landscape for various cancers.

Monopar Therapeutics (MNPR) announced promising results from its ongoing Phase 1b trial of camsirubicin for advanced soft tissue sarcoma, presented at the CTOS Annual Meeting. The trial has enrolled 11 patients, with 5 of 10 showing stable disease at 12 weeks. Camsirubicin aims to enhance efficacy while minimizing cardiac damage compared to doxorubicin, the current standard. The trial is currently escalating doses, with no drug-related cardiotoxicity observed so far, emphasizing its potential for improved patient outcomes.