Monopar Therapeutics Inc. · NASDAQ:MNPR
Monopar Therapeutics — MASCC/ISOO Annual Meeting 2021
18 slides from Monopar Therapeutics's conference presentation, Jun 24, 2021
Slide 1: Andrew P. Mazar, Ph.D., Chief Scientific Officer
Andrew P. Mazar, Ph.D. Chief Scientific Officer Monopar Therapeutics, Inc. 2@? 1 etal tes Annual Meeting Followus on Twitter | OD @ ) JUNE » SUPPORTIVE CARE IN CANCER @CancerCareMASCC | #MASCC21
Slide 2: Disclaimer, Forward-Looking Statements
Disclaimer, Forward-Looking Statements
Slide 3: WHO Oral Mucositis (OM) Scale
WHO Oral Mucositis (OM) Scale Grade O | Grade 2 | Grade 3 No change Soreness/ Erythema/ulcers Ulcers/No solid Oral alimentation erythema Caneat solid food food, liquid diet not possible only * Most common a fe Estimated oropharyngeal cancer (OPC) de effect of chemoradiotherapy (CRT) diagnoses (2020)
Slide 4: Validive (Clonidine Mucobuccal Tablet; Clonidine MBT) Overview
Validive (Clonidine Mucobuccal Tablet; Clonidine MBT) Overview The active ingredient of Validive®, clonidine, is the most potent currently marketed selective a 2-adrenergic receptor agonist, and has a well-established safety profile Clonidine MBT is a tasteless muco-adhesive buccal tablet (MBT) admi
Slide 5: Phase 1 study comparing pharmacokinetics of oral clonidine to Clonidine MBT
Phase | study comparing pharmacokinetics of oral clonidine (Catapres) to Clonidine MBT * Phase | PK study in healthy volunteers (Vasseur et al., 2017) + 36 patients randomized to two doses of clonidine MBT or Catapres (clonidine oral tablet; OT) * Daily clonidine dose for hypertension is 200-600 1g
Slide 6: Radiation treatment of OPC leads to local release of cytokines
Radiation treatment of OPC leads to local release of cytokines Enhanced by addition of chemotherapy (CRT) Local expression of cytokines triggers destruction of oral mucosa leading to SOM Pro-inflammatory cytokines are elevated in the saliva of patients with SOM Increased salivary cytokines correlate
Slide 7: Relative risk of developing mucositis in response to CRT by HNC site
Relative risk of developing mucositis in response to CRT by HNC site AnyOMvs.none Moderate/severe OMvs.none Severe OMvs. none (n=348) (n=269) (n=123) Larynx 1 0 10 Hypopharynx 11 (04 210 2.0(0.6- Oral cavity (OC) 0 6.2 (23-68) Nasopharynx 10.1 (2.1-49.9) Oropharynx 4.4 (17-112) 4.0 (1.6-9.9) 6.9 (2.
Slide 8: Validive Phase 2 Data Supports Further Development of the Product Candidate
Validive Phase 2 Data Supports Further Development of the Product Candidate * International randomized, double-blind, placebo controlled three-arm study (BA2009/28/01) of all HNC, regardless of anatomical location of disease (N=183) (Giralt et al., 2019) SOM developed in fewer patients receiving Val
Slide 9: Additional efficacy analysis in OPC-overview
Additional efficacy analysis in OPC-overview All secondary and exploratory endpoints collected in BA2009/028/01 were analyzed for trends in clinical benefit in patients with OPC OPC represented ~36% of the patients in this Phase 2 study and OC represented ~50% Results in the OPC subpopulation were c
Slide 10: Comparison of incidence in OC vs OPC in Phase 2
Comparison of incidence in OC vs OPC in Phase 2 Absolute incidence of SOM Risk of onset of SOM Placebo Validive® (S0pe) | Validive® Placebo | Validive™ | Validive®™ (100,12) (sone) (1008) sy 1 a > (pooled for two doses) (0.398 ; 1.223} | (0.493; 1353] confidence interval ‘Oral only 3.3% (n=30) 52% (
Slide 11: QoL: OMDQ and FACT-G in OPC patients
QoL: OMDQ and FACT-G in OPC patients OPC patient analy: falidive 100g MBT vs Placebo MBT OMDQ (MTS>2) FACT-G Mean Limitation in daily activity due to MTS score FACT-G mean score: Swallowing 2 vs4 Lack of energy 1.5 vs 1.9 Drinking 2.5 vs4 Nausea 0.7 vs 1.3 Eating 2.8 vs4 Meeting family 1.1vs 1.8 Tal
Slide 12: OMDQ patient-reported outcomes (severe limitations) for OPC in Phase 2
OMDQ patient-reported outcomes (severe limitations) for OPC in Phase 2 Time since first RT (days) Time since frst RT (days) Time since first RT (days) Time since frst RT (days) ce first RT (days)
Slide 13: OPC patient QoL assessments summary
MASCC OPC patient QoL assessments summary Exploratory or secondary endpoint ‘Risk of MTS>2 Phase 2 OPC only (Clonidine 100 ng dose vs placebo) Placebo (n=24) ‘Clonidine MET {n=19) 0.644 (p=0.394) Full phase 2 HNC population (Clonidine 100 ug dose vs placebo) Placebo (n ‘Clonidine | (n=65) 1.07 (p=0.
Slide 14: OPC patient QoL assessments
OPC patient QoL assessments Exploratory or Phase 2 OPC only (100 ng dose vs Full phase 2 HNC population (100 ug dose vs secondary placebo) placebo) endpoint Pracebo Clonidine MBT Pracebo (1-62) Tondine (n=24) {n=19) {n=65) Hospitalization 122 73 (p=0.335) 125 11 (p=0.626) (total days during treatmen
Slide 15: Opioid Use
Opioid Use? Full phase 2 HNC population (100 ug Fall phase 2 HNC population (Clonidine dose vs placebo), ACTIVE CRT 100 ug dose vs placebo), POST CRT Placebo (n=62) Cloniaine Mer Placebo (1-62) Clonidine MoT | (n=65) | (n=65) No opioids 32 34 (p=0.865) 7 3 (p=0.381) Total 76 (p=0.248) cumulative Dos
Slide 16: Feeding Tube Dependence
MASCC Feeding Tube Dependence Exploratory or secondary endpoint Feeding tube dependence (at start of CRT) Phase 2 OPC only (100 wg dose vs placebo) Pracebo (n=24) ‘Cloniaine MET (n=19) 6 2(p=0.27) Full phase 2 HNC population (100 ug dose vs placebo) Placebo ("=62) Tloname eT | (n=65) Bi Feeding Tube
Slide 17: Dry Mouth (xerostomia)
MASCC Dry Mouth (xerostomia) Exploratory or secondary endpoint Dysgé ‘Odynophagia Phase 2 OPC only (100 yg dose vs placebo) acebo (n=24) Tonidine MET (n=19) Full phase 2 HNC population (100 ug dose vs placebo) Pacebo (n=62) Conane Mer (n=65) 2 11 8 14 7 17
Slide 18: Conclusions
Conclusions A subgroup analysis comparing the effects of clonidine MBT on SOM in patients with OPC in a completed phase 2 all-HNC population was conducted The analysis was initiated based on a relatively higher risk of developing SOM in patients with OPC compared to other HNC and based on the origin
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