camsirubicin (MNPR-201) / Monopar Therapeutics - LARVOL DELTA

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS (clinicaltrials.gov) - P1 | N=14 | Terminated | Sponsor: Monopar Therapeutics | N=21 ➔ 14 | Trial completion date: Jun 2025 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Oct 2023; lack of timely enrollment

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Monopar Therapeutics | Phase classification: P1b ➔ P1 | Trial primary completion date: Jun 2023 ➔ Jun 2025

Metastases • Phase classification • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

PHASE 1B TRIAL OF CAMSIRUBICIN, A NOVEL DOXORUBICIN ANALOG, WITH CONCOMITANT PEGFILGRASTIM IN SUBJECTS WITH ADVANCED SOFT TISSUE SARCOMA TO IDENTIFY A NEW MTD/RP2D (CTOS 2023) - ": Camsirubicin, a novel doxorubicin analog, when given with concomitant pegfilgrastim can be given at doses higher than the previously reported RP2D. The objective of this ongoing study is to continue to increase the dose and define a new MTD/RP2D in the presence of pegfilgrastim. The hypothesis is that higher per cycle and cumulative doses of camsirubicin will lead to an increase in tumor response and clinical benefit when compared to doxorubicin, where the cumulative dose is restricted."

Clinical • Metastases • P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Presents Data Showing Tumor Reduction Benefit of Camsirubicin from Ongoing Phase 1b at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting (GlobeNewswire) - P1b | N=21 | NCT05043649 | Sponsor: Monopar Therapeutics | "Monopar Therapeutics Inc...will present data from its ongoing Phase 1b open-label, dose-escalating clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) later today at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, which is bringing together the world’s leading sarcoma specialists....So far, 9 out of the 14 patients have had stable disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin treatment. All patients in the fourth and fifth cohorts achieved stable disease, including the three most recently treated patients, each of whom also experienced an ~20% tumor size reduction at last study scan. One of these patients had unresectable cancer at study entry, but after the tumor size reduction, the patient became eligible for resection and underwent successful surgical removal of their cancer with clear margins."

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Provides Encouraging Camsirubicin Clinical Data Update (GlobeNewswire) - P1 | N=21 | NCT05043649 | Sponsor: Monopar Therapeutics | "Monopar Therapeutics Inc...provided an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). Both patients treated to date at the 650 mg/m2 dose level have experienced tumor size reductions – of 18% and 20% respectively – after the first two cycles of camsirubicin treatment. Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction.... The best response seen prior to the current 650 mg/m2 dose level was at the immediately prior dose level (520 mg/m2), which was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment."

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A NOVEL ANTHRACYCLINE MNPR-202 DISPLAYS A DISTINCT IMMUNOMODULATORY PROFILE TO DOXORUBICIN IN DIFFUSE LARGE B CELL LYMPHOMA (ICML 2023) - "Although the combination therapy of rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) is curative, around 40% of patients relapse after first line treatment...Camsirubicin (MNPR-201; GPX-150; 5-imino-13-deoxydoxorubicin), a novel analog of dox, has not shown any irreversible heart damage to date in two Phase 1 trials and a Phase 2 trial...Finally, the drug screen revealed distinct differences in the synergy profile between dox and MNPR-202, e.g., with respect to volasertib... To conclude, dox and MNPR-202 have similar cytotoxic potencies, but likely work through different cellular pathways and have distinct drug synergies. Overall MNPR-202 appears to have greater immunomodulatory potential. Indeed, MNPR-202 ostensibly improves the anti-tumor response by exerting a stronger suppressive effect on M2-macrophage polarization."

Immunomodulating • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • NF-κβ • TNFA

Monopar Announces Encouraging Camsirubicin Phase 1b Trial Update (GlobeNewswire) - P1b | N=21 | NCT05043649 | Sponsor: Monopar Therapeutics | "Monopar Therapeutics Inc...announced an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS)....One patient at the 520 mg/m2 dose level, unresectable at study entry, was deemed eligible for tumor resection after several cycles of camsirubicin treatment and a corresponding 21% reduction in tumor dimensions....100% of patients (3 of 3) at the fourth dose-level (520mg/m2) achieved stable disease, and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug. Phase 1b data continue to show an improvement in median progression free survival from what was observed in the prior camsirubicin Phase 2 trial (265 mg/m2). This is supportive of our dose­-response hypothesis with camsirubicin. Two patients are currently enrolled in the fifth dose-­level cohort (650 mg/m2)..."

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

PHASE 1B TRIAL OF CAMSIRUBICIN, A NOVEL DOXORUBICIN ANALOG, WITH CONCOMITANT PEGFILGRASTIM FOR ADVANCED SOFT TISSUE SARCOMA TO IDENTIFY A NEW MAXIMUM TOLERATED DOSE/RECOMMENDED PHASE 2 DOSE. (CTOS 2022) - "Camsirubicin, a novel doxorubicin analog, can be given at doses higher than a previously reported RP2D when given with concomitant pegfilgrastim. The objective of this ongoing study is to continue to increase the dose and define a new MTD/RP2D in the presence of pegfilgrastim. The hypothesis is that higher per cycle and cumulative doses of camsirubicin will lead to an increase in tumor response and clinical benefit when compared to doxorubicin, where the cumulative dose is restricted."

P1 data • P2 data • Cardiovascular • Hematological Disorders • Neutropenia • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Announces Camsirubicin Clinical Program Update - Improved Side Effect Profile Seen to Date Compared to Doxorubicin (GlobeNewswire) - P1b | N=21 | NCT05043649 | Sponsor: Monopar Therapeutics | "Monopar Therapeutics Inc....announced the following update on its currently enrolling open-label Phase 1b camsirubicin Maximum Tolerated Dose (MTD) trial in patients with advanced soft tissue sarcoma (ASTS): Monopar has opened enrollment for the fifth dose level cohort, at an increased dose of 650 mg/m2, which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial. To date, no drug-related cardiotoxicity has been observed with camsirubicin treatment as evaluated by the industry standard left-ventricular ejection fraction (LVEF)....In addition to the initial Sarcoma Oncology Research Center clinical trial site in Santa Monica, CA, Monopar recently welcomed a second clinical trial site with Dr. Lee Cranmer and the Sarcoma Clinic at the Fred Hutchinson Cancer Center/University of Washington in Seattle, WA."

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Announces Projected Timeline of Upcoming Q1 2023 Data Events for Validive, Camsirubicin, and MNPR-101 RIT (GlobeNewswire) - "February 2023: Camsirubicin Phase 1b Clinical Trial Data Update - In addition to the previously reported improvement in median progression free survival over the prior camsirubicin Phase 2 study, Monopar plans to provide details of the Phase 1b trial’s improved toxicity and safety observed to date compared to doxorubicin. MNPR-101 Radioimmunotherapeutic (RIT) Preclinical Data Update - Monopar plans to report an update on recently generated preclinical data and anticipated next steps with partner NorthStar Medical Radioisotopes."

P1 data • Preclinical • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Announces Successful Advancement of Camsirubicin Phase 1b Clinical Trial Past Fourth Cohort, Escalates Next to 650mg/m2 (GlobeNewswire) - P1b | N=21 | NCT05043649 | Sponsor: Monopar Therapeutics Inc | "Monopar Therapeutics Inc....announced the positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m2) in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS). This decision was made following a review of safety data from the patients in the first four dose cohorts....'We continue to see a favorable safety profile compared to doxorubicin, and the Phase 1b data to-date shows an improvement in median progression free survival from what was observed in the prior camsirubicin Phase 2 trial (265mg/m2). We are looking forward to evaluating the 650 mg/m2 dose level, which is nearly 2.5x higher than the highest dose evaluated in any prior camsirubicin clinical trial.'"

P1 data • Trial status • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Pre-Clinical Evaluation of a Camsirubicin Analog Mnpr-202 in Diffuse Large B Cell Lymphoma (ASH 2022) - "Diffuse large B cell lymphoma (DLBCL) is the most common subtype of aggressive lymphoma, for which the standard-of-care treatment is rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP)...For example, a clear antagonistic effect on cell killing was seen between PLK1 inhibitor, volasertib, and doxorubicin, but between volasertib and MNPR-202, this antagonism was seen to a significantly lesser extent...These intracellular differences also influence drug synergies observed with the two chemotherapeutics, implying that in the context of certain combinatorial regimens, MNPR-202 may be superior to doxorubicin. Overall these findings suggest promise for further in vivo and clinical evaluation of MNPR-202 as a potentially effective yet non-cardiotoxic anthracycline derivative in lymphoma."

Preclinical • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • STING

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS (clinicaltrials.gov) - P1b | N=21 | Recruiting | Sponsor: Monopar Therapeutics | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Announces Encouraging Clinical Data from Ongoing Camsirubicin Phase 1b Trial (GlobeNewswire) - P1b | N=21| NCT05043649 | Sponsor: Monopar Therapeutics | "Monopar Therapeutics...released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients. The data is displayed in the poster Monopar will be presenting later today at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting....The Phase 1b clinical trial has enrolled 11 patients (8 female and 3 male) to-date ranging in age from 26 to 81 years (median = 49 years). 5 of 10 patients have exhibited stable disease (SD, as defined by RECIST 1.1 criteria) at 12 weeks. 1 patient met the criteria for SD at the first CT scan (6 weeks) but unfortunately died due to COVID-19 and was not evaluable at the 12-week CT scan. The ASTS subtype patients achieving stable disease on camsirubicin are in line with those also more likely to respond to doxorubicin."

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Therapeutics Reports Third Quarter 2022 Financial Results and Recent Program Developments (GlobeNewswire) - "Validive – International Phase 2b/3 Trial, Interim Go/No-go Analysis on Track for Q1 2023....MNPR-202: Preclinical Data to be Presented at ASH 2022 in December....Early results from the open-label camsirubicin Phase 1b clinical trial will be presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting Conference being held on November 16-19, 2022 in Vancouver, BC."

P2/3 data • Preclinical • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Announces Timeline of Upcoming Data Events for Validive, Camsirubicin, and MNPR-202 (GlobeNewswire) - "Monopar Therapeutics Inc...will be presenting clinical data on camsirubicin and preclinical data on MNPR-202 in November and December, and is planning to report out the interim go/no-go analysis for its Validive Phase 2b/3 VOICE trial in Q1 2023."

Clinical data • P2/3 data • Preclinical • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

Monopar Announces Presentation Selected for 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting (GlobeNewswire) - "Monopar Therapeutics Inc...announced that its abstract on camsirubicin submitted to the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting has been selected for a poster presentation. CTOS 2022, held in Vancouver, Canada, brings together the world’s leading sarcoma specialists. Monopar’s poster will be the first formal release of data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma (ASTS) patients."

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Therapeutics Reports First Quarter 2022 Financial Results and Recent Program Developments (GlobeNewswire) - "Monopar Therapeutics Inc...today announced first quarter 2022 financial results and summarized recent program developments....Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting: The VOICE trial continues to enroll patients and add additional clinical sites, with the interim analysis anticipated to occur in 2H-2022....Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting: Monopar has cleared the third dose-level and is currently enrolling the fourth dose-level cohort. The fourth dose-level is approximately double the highest dose of camsirubicin ever tested in a prior trial. Early signs of clinical benefit have been observed with camsirubicin in this Phase 1b trial."

Enrollment status • P2/3 data • Inflammation • Leiomyosarcoma • Mucositis • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Advances Dosing of Camsirubicin to Higher Level Than Tested In Any Previous Clinical Trial (GlobeNewswire) - "Monopar Therapeutics Inc....announced the positive recommendation from its safety review committee to escalate to the second dose level in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS). This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial."

DSMB • Trial status • Oncology • Sarcoma • Soft Tissue Sarcoma

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments (GlobeNewswire) - "Cash and cash equivalents as of September 30, 2021, were $22.3 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through December 2022. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development beyond the Phase 1b clinical trial."

Commercial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Sarcoma • Soft Tissue Sarcoma

Monopar Announces First Patient Dosed in Phase 1b Trial Evaluating Camsirubicin for the Treatment of Advanced Soft Tissue Sarcoma (GlobeNewswire) - "Monopar Therapeutics Inc...announced that the first patient has been dosed in its open-label dose-escalation Phase 1b clinical trial evaluating camsirubicin for the treatment of advanced soft tissue sarcoma (ASTS)...An estimated 21 patients will be enrolled in the Phase 1b clinical trial, which is active and recruiting in the US."

Trial status • Oncology • Sarcoma • Soft Tissue Sarcoma

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS (clinicaltrials.gov) - P1b; N=21; Recruiting; Sponsor: Monopar Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS (clinicaltrials.gov) - P1b; N=21; Not yet recruiting; Sponsor: Monopar Therapeutics

Clinical • New P1 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Monopar Initiates Open-Label Phase 1b Clinical Trial Evaluating Camsirubicin in Patients with Advanced Soft Tissue Sarcoma (GlobeNewswire) - “Monopar Therapeutics Inc…announced its Phase 1b open-label dose-escalation clinical trial of camsirubicin in the US is active and recruiting patients. The trial is evaluating the safety and anti-tumor activity of increasing doses of camsirubicin in combination with growth factor support (pegfilgrastim/G-CSF) for the treatment of advanced soft tissue sarcoma (ASTS).”

New P1 trial • Oncology • Sarcoma • Soft Tissue Sarcoma

Monopar Announces FDA Clearance to Proceed with Camsirubicin Clinical Trial Targeting Advanced Soft Tissue Sarcoma (GlobeNewswire) - “Monopar Therapeutics Inc…announced clearance from the US Food and Drug Administration (FDA) to proceed under its IND with an open-label Phase 1b dose-escalation trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS). The Company anticipates dosing the first patient in the trial in the fourth quarter of this year.”

IND • New P1 trial • Oncology • Sarcoma • Soft Tissue Sarcoma