Validive (clonidine MBT) / Valerio Therap, Monopar Therap - LARVOL DELTA

VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - P2b | N=190 | Terminated | Sponsor: Monopar Therapeutics | N=330 ➔ 190 | Trial completion date: Dec 2025 ➔ May 2023 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2024 ➔ May 2023; Interim Analysis did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis

Monopar Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis (GlobeNewswire) - P2/3 | N=330 | VOICE (NCT04648020) | Sponsor: Monopar Therapeutics | "Monopar Therapeutics...announced completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC)....The DSMB also reported that there were no safety concerns attributed to Validive. Based on not meeting the pre-specified efficacy threshold, Monopar announced today that it will be discontinuing the study along with the active development of Validive."

P2/3 data • Mucositis • Oncology • Oropharyngeal Cancer

Monopar Announces Projected Timeline of Upcoming Q1 2023 Data Events for Validive, Camsirubicin, and MNPR-101 RIT (GlobeNewswire) - "March 2023: Interim Go/no-go Analysis for Validive Phase 2b/3 VOICE Trial - Monopar expects to have the interim analysis completed and to report out the go/no-go decision during March 2023; in the intervening time, patient enrollment and addition of new sites continue in preparation for a potentially positive interim."

P2/3 data • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer

VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - P2b | N=330 | Recruiting | Sponsor: Monopar Therapeutics | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis

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

[VIRTUAL] Rationale and design of the phase IIb/III VOICE trial of clonidine MBT for the prevention of severe oral mucositis in patients with OPC receiving chemoradiotherapy (ESMO 2021) - P2b | "2021. Approximately 50 US and EU sites are planned with completion of patient enrollment scheduled to finish in late 2022."

Clinical • P2/3 data • P2b data • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

Monopar Announces Completion of Phase 2b Enrollment and Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis (GlobeNewswire) - "Monopar Therapeutics Inc...announced an update on its actively enrolling Validive Phase 2b/3 VOICE clinical trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer. This is an indication for which there is currently no FDA-approved preventative or treatment....Monopar announced it has enrolled greater than 130 patients, has completed enrollment for the Phase 2b portion of the trial, has activated a total of 68 sites, has recently expanded the trial to include sites in Germany and Poland, and has commenced enrollment for the Phase 3 portion of the trial....This analysis should be complete with interim results announced during Q1 2023."

P2/3 data • Trial status • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer

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 Announces Clinical and Preclinical Program Updates (GlobeNewswire) - "Monopar is evaluating Validive in this patient population in the international Phase 2b/3 VOICE study. Updated highlights of this trial include: 43 clinical sites opened to date, active and enrolling patients in both the US and Europe, Interim analysis is currently anticipated to be reached in mid-2022."

P2/3 data • Trial status • Head and Neck Cancer • Oncology • Oropharyngeal Cancer

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 Expands Phase 2b/3 VOICE Clinical Trial to Europe (GlobeNewswire) - "Monopar Therapeutics Inc...announced it has received authorization to proceed with the Phase 2b/3 VOICE clinical trial in France. The trial, which began earlier this year in the US, is evaluating Validive® (clonidine HCl MBT) to prevent the onset of severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients treated with chemoradiotherapy. The trial’s rationale and design will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress 2021. Monopar anticipates reaching the interim of the Phase 2b/3 VOICE trial in the first half of 2022."

New P2 trial • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer

Monopar Reaches Target Number of Clinical Sites in Phase 2b Portion of 2b/3 Validive VOICE Trial (GlobeNewswire) - "Monopar Therapeutics Inc...today announced it has successfully reached its target of 20 activated clinical trial sites in the Phase 2b portion of the VOICE trial...Monopar anticipates reaching the interim analysis of the Phase 2b/3 Validive® VOICE trial in the first half of 2022."

Trial status • Gastrointestinal Cancer • Head and Neck Cancer • Inflammation • Mucositis • Oncology • Oropharyngeal Cancer

Monopar to Present Results from Analysis of Oropharyngeal Cancer Patients in Completed Phase 2 Validive Trial at MASCC/ISOO (GlobeNewswire) - "Monopar Therapeutics Inc...announced that it will present its oropharyngeal cancer (OPC) patient population analysis of the Phase 2 Validive® (clonidine HCl MBT) trial for the prevention of chemoradiotherapy-induced severe oral mucositis in head and neck cancer at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2021 annual meeting. This analysis provided the rationale for the design of Monopar’s Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US."

Enrollment open • P2 data • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer

Monopar Announces First Patient Dosed in its Phase 2b/3 VOICE Trial Evaluating Validive for the Prevention of Chemoradiotherapy-Induced Severe Oral Mucositis (SOM) in Oropharyngeal Cancer (OPC) (GlobeNewswire) - “Monopar Therapeutics Inc…announced it has dosed the first patient in its Phase 2b/3 VOICE trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE)… Up to approximately 260 patients will be enrolled in the current multi-center, randomized, double-blind, placebo-controlled, adaptive design Phase 2b/3 VOICE trial.”

Trial status • Head and Neck Cancer • Oncology • Oropharyngeal Cancer

VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - P2b; N=260; Recruiting; Sponsor: Monopar Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis

VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - P2b; N=260; Not yet recruiting; Sponsor: Monopar Therapeutics

Clinical • New P2b trial • Head and Neck Cancer • Mucositis • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis

Monopar Announces Initiation of its Phase 2b/3 (VOICE) Trial to Evaluate Validive for the Prevention of Chemoradiotherapy-Induced Severe Oral Mucositis (SOM) in Oropharyngeal Cancer (OPC) (GlobeNewswire) - "Monopar Therapeutics Inc...announced that its Phase 2b/3 clinical trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE) is active and recruiting patients....Up to approximately 260 patients will be enrolled in this multi-center, randomized, double-blind, placebo-controlled, Phase 2b/3 clinical trial. The trial includes an interim analysis, which is anticipated to be reached approximately twelve months after the first patient is dosed."

Trial status • Head and Neck Cancer • Oncology • Oropharyngeal Cancer

Monopar Therapeutics Reports Third Quarter 2020 Financial Results and Business Update (GlobeNewswire) - "Monopar’s Phase 2b/3 clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy for oropharyngeal cancer (OPC) is on track to commence before year-end; The Phase 2 clinical trial of camsirubicin is anticipated to begin at the end of 2020 or in early 2021. Monopar has partnered with Grupo Español de Investigación en Sarcomas (GEIS), which will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS)."

Trial initiation date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Sarcoma

"Monopar Therapeutics gains WW rights to Onxeo's Validive for oral severe mucositis. Potential deal worth up to $109m https://t.co/KHrkpH74cH" (@Cortellis)

Biosimilar • Immunology