Tetralogic Pharmaceuticals Corp · OTC:TLOG
Tetralogic Pharmaceuticals — Investor Presentation (April 2014)
27 slides from Tetralogic Pharmaceuticals's investor presentation, Apr 8, 2014
Slide 1: Corporate Presentation April 2014
2.60 1.80 2.15 3.30 3.75 5.10 0.15 5.10 4.50 - logo Corporate Presentation April 2014 0.15
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. These statements are not guarantees of future performance and involve a number of unknown risks, assumptions, trends, uncertainties and factors that are beyond our control. Given these risks, assumptions and uncertaint
Slide 3: TetraLogic: Novel Therapies for Cancer and Infectious Diseases
TetraLogic: Novel Therapies for Cancer and Infectious Diseases Drug discovery program focused on programmed cell death (“apoptosis”) and its role in cancer and infectious disease Fundamental mechanism to maintaining human health Enables abnormal cells, such as cancerous and virally infected cells, t
Slide 4: Diversified Oncology Therapeutic Opportunities
Diversified Oncology Therapeutic Opportunities (a) Acute Myeloid Leukemia / Myelodysplastic Syndromes / Acute Lymphoblastic Leukemia Pre-clinical Phase 1 Phase 2 Status Oncology AML / MDS / ALL(a) Birinapant alone Investigator-initiated Phase 1/2 clinical trial in progress Myelodysplastic Syndromes
Slide 5: Oncology - Clinical Development Programs - Birinapant
Oncology - Clinical Development Programs - Birinapant - SHAPE
Slide 6: Novel Mechanism of Action Relevant Across Several Diseases
SMAC SMAC XIAP Novel Mechanism of Action Relevant Across Several Diseases Mimics the Endogenous Protein SMAC cIAP-1 Standard of care agents SMAC is an endogenous protein that antagonizes IAPs and enables TNF to signal cancer cells to self-destruct ABNORMAL CELL SURVIVAL TNF Standard of care agents c
Slide 7: Birinapant's Novel Mechanism of Action
Birinapant (SMAC mimetic) Birinapant (SMAC mimetic) ABNORMAL CELL SURVIVAL Birinapant’s Novel Mechanism of Action Potential to Re-establish the Body’s Ability to Eliminate Abnormal Cells TNF cIAP-1 XIAP Standard of care agents Birinapant blocks the amplified IAPs and thus re-establishes the TNF apop
Slide 8: Birinapant is Generally Well-Tolerated
Birinapant is Generally Well-Tolerated Well-tolerated at pharmacologically active doses Tested in >275 subjects with solid and hematological cancers Several subjects have continued >12 months Dose-limiting toxicities: Elevated serum amylase & lipase, Bell’s Palsy Occurred above Recommended Phase 2 D
Slide 9: Birinapant Has TNF-Dependent Combination Activity with Azacitidine
Combination activity is TNF dependent (HL-60 AML Cell Line) Birinapant and Azacitidine are synergistic in AML Stem Cells Birinapant Has TNF-Dependent Combination Activity with Azacitidine Cl = 0.57+/- 0.10 CD34+38-, N=10 BIR AZA BIR + AZA 0 50 100 200 400 800 0 50 100 200 400 800 AZA BIR 0 25 50 75
Slide 10: AML / MDS: Phase 1 Dose Escalation Studies
AML / MDS: Phase 1 Dose Escalation Studies Phase 1 study of single agent birinapant in elderly relapsed / refractory AML patients Evidence of inhibition of cIAP1 and NF- ҡ B in circulating AML blasts Evidence of hematological activity in some subjects Decreases in peripheral blast counts In one subj
Slide 11: Randomized Phase 2 Trial Design: 1st Line Higher Risk MDS
1:1 randomization (n = 148) RR RR azacitidine birinapant + azacitidine Commence trial 1H 2014 Assumptions: Primary Endpoint: Response Rate (RR) Overall Alpha = 5.0%, 1-Sided (Show improvement in RR from 29% to 49% with 80% power) Interim analysis will be conducted after 75 subjects complete 4 cycles
Slide 12: Amgen Collaboration
Amgen collaboration Pre-clinical evaluation of birinapant plus their TRAIL-agonist antibody (conatumumab) Open-label combination study in ovarian cancer commenced in December 2013 OVCAR3 Birinapant plus DR5-Agonist Antibodies Clinical Collaboration with Amgen Data and implications TRAIL agonist anti
Slide 13: Birinapant in 3rd Line CRC
Study Population All Subjects N = 71 Subjects who Failed Immediately Prior Irino Therapy N = 22 KRAS Mutant N = 37 4 month PFS 34% 32% 38% 6 month PFS 21% 18% 24% Median PFS (mo) 2.2 3.0 3.0 Response Rate 8% 14% 8% Disease Control Rate [PR + SD] 63% 59% 68% Historically irinotecan re-treatment has b
Slide 14: Oncology - Clinical Development Programs - SHAPE
Oncology - Clinical Development Programs - Birinapant - SHAPE
Slide 15: SHAPE is Differentiated from Currently-Marketed HDAC Inhibitors
SHAPE is Differentiated from Currently-Marketed HDAC Inhibitors Novel Tissue-Targeted Design Inhibits HDAC1, 2, 3, & 6 isoforms, similar to Zolinza® HDAC-inhibition locally in skin but without systemic exposure Stable in a gel formulation, allowing for convenient topical application Issued US compos
Slide 16: SHAPE Shows Desired Pharmacokinetic and Pharmacodynamic Profile
PD demonstrates localized dermal acetylation Ethanol-based Vehicle 0.5% SHAPE (3.5 mg/mL) PK demonstrates tissue-targeting with lack of systemic exposure SHAPE Shows Desired Pharmacokinetic and Pharmacodynamic Profile Human Blood vs. Human Skin Homogenate Time (min.) Fraction Remaining (%) Acetylati
Slide 17: SHAPE Phase 1 Trial in Early-Stage CTCL
SHAPE demonstrated clinical activity in early-stage CTCL in randomized, double-blind, placebo-controlled Phase 1 trial 5:1 randomization (n = 18) RR RR 1% SHAPE or Placebo 0.1% SHAPE or Placebo Disease: CTCL Stage IA-IIA Treatment duration: Maximum 28 days, 2 week follow up Dosing frequency: BID (tw
Slide 18: One Month Treatment with SHAPE Led to Cutaneous Responses
Phase 1 Clinical Trial Results Visit 2 – Pre-Dose Visit 4 – 2 weeks Visit 6 – 4 weeks Four subjects (~27%) demonstrated PRs by 50% reduction in CAILS score from baseline at Days 28 or 42 Subjects on placebo demonstrated no significant improvements No significant safety events observed: no SAEs, no d
Slide 19: Proposed Phase 2 Trial Design: 1st Line CTCL
1:1 randomization (n = 60) RR RR SHAPE (1.0%) SHAPE (0.5%) Commence trial 4Q 2014 Assumptions: Evaluate dose, efficacy at 6 months (vs 1 month), time to response and tolerability of treatment of >5% body surface area Determine treatment effect to design registration study (comparison to Valchlor) Pr
Slide 20: CTCL: Unmet Need Remains for Early-Stage Disease
Cutaneous T-Cell Lymphoma (CTCL) Unmet Need Remains for Early-Stage (IA-IIA) Disease
Slide 21: Infectious Diseases - Birinapant
Infectious Diseases - Birinapant
Slide 22: Birinapant Clears Hepatitis B Virus In Vivo
Birinapant Clears Hepatitis B Virus In Vivo Decrease in Circulating HBV-DNA with Birinapant TNF is Required for Birinapant’s Efficacy TNF is required for birinapant's effect; consistent with the anti-cancer mechanism of action Birinapant collaborates with polymerase inhibitors such as entecavir Note
Slide 23: Entecavir does not cause this decline
Entecavir does not cause this decline, implying a fundamental difference in mechanism Intend to start a Phase 1 clinical trial in Hepatitis B late 2014 Note: Studies conducted in lab of Dr. Marc Pellegrini, Walter and Eliza Hall Institute of Medical Research, Australia Day 0 - 8 Entecavir daily (ora
Slide 24: Potential broad applicability in other viral and mycobacterial infections
Potential broad applicability in other viral and mycobacterial infections Induced apoptosis in HIV-infected CD4+ cells Decreased Reverse Transcriptase Activity (24h) Donor 1 Donor 2 Donor 3 Reduction in lung burden after 3 doses Control (n=15) Birinapant (n=17) (0.33 Log10 CFU/lung; p = 0.012) HIV A
Slide 25: Near Term Catalysts
Near Term Catalysts 2014 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Oncology Randomized Phase 2 higher risk MDS Birinapant plus azacitidine Phase 1/2 Ovarian Cancer Birinapant plus conatumumab Randomized Phase 2 CTCL SHAPE Infectious Disease Phase 1 Hepatitis B Birinapant
Slide 26: Investment Highlights
Investment Highlights Novel therapeutic approaches Strong clinical data Expanding into infectious diseases Multiple value-creating milestones Proven management team
Slide 27: 2.60 1.80 2.15 3.30 3.75 5.10 0.15 5.10 4.50 - logo 0.15
2.60 1.80 2.15 3.30 3.75 5.10 0.15 5.10 4.50 - logo 0.15
TetraLogic Pharmaceuticals — Investor Presentation (April 2014) on 6ix