Helix BioPharma Corp. · TSX:HBP
Helix BioPharma — Investor Presentation (March 2015)
29 slides from Helix BioPharma's investor presentation, March 2015
Slide 1: New Advances in Cancer Treatments
New Advances in Cancer Treatments March 2015
Slide 2: Safe Harbour Statement
Safe Harbour Statement This presentation document contains certain forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable securities laws. Forward-looking statements are statements and information that are not historical facts but ins
Slide 3: Corporate Goal
Corporate Goal • Helix is a leader in the development of novel therapeutics in the field of oncology • Our proprietary technology represents a novel approach to the treatment of cancer, which we believe can be applied to multiple cancer types • The company intends to advance this technology and the
Slide 4: The DOS Technology
The DOS Technology • Tumours have a much different local environment (much lower pH) than normal tissue • This is caused by the high metabolism of tumours leading to the creation of acid surrounding the tissue • This highly acidic environment is linked to several issues in the treatment of cancer, i
Slide 5: The DOS Technology
The DOS Technology • Urease is an enzyme that can convert urea (found in all tissue) to ammonia and can be used to increase pH in tissue • Helix creates antibody conjugates (DOS47 compounds) by coupling urease to a targeting antibody • DOS47 candidates specifically bind to cancer cell surfaces and e
Slide 6: The DOS Technology
The DOS Technology DOS47 compounds act against solid tumours by: 1. Specific attachment to the cell surface of solid tumours 1. Direct cytotoxic effect against tumours with the generation of ammonia 2. Adjust the pH to work synergistically with other cancer therapeutics 7
Slide 7: DOS47 - Novel Treatment of Solid Tumours
DOS47 - Novel Treatment of Solid Tumours
Slide 8: DOS47 Platform Advantages
DOS47 Platform Advantages No need to internalize the drug • Action is at the tumour surface to manipulate microenvironment • Delivers cytotoxic ammonia directly to tumour while changing pH Can use antibodies that have no activity, only need specificity • No need to target biologically relevant p
Slide 9: DOS Platform Development
Pipeline Research Preclinical Phase I Phase II Phase III Non-small Cell Lung Cancer - Monotherapy DOS Platform Development Non-small Cell Lung Cancer – L-DOS47 Combination Ductal Breast Cancer Colon Cancer v-DOS Solid Tumour p-DOS Pancreatic Cancer BiPhasix TIFN HPV-mediated Cervical Lesions 12
Slide 10: L-DOS47 Lead Candidate
L-DOS47 Lead Candidate • Lead candidate is L-DOS47 for the treatment of non-squamous non- small cell lung cancer (NSCLC) • Uses a camelid antibody specific to CEACAM-6, which is highly expressed in lung, colon, breast and pancreatic cancers • Pre-clinical testing in cell and animal models showed pot
Slide 11: Specific to tumours
Specific to tumours L-DOS47 distributes to tumour preferentially Tumour specific localization Full Body Scan A549 tumour (8 x 7 mm) L-DOS47-Cy5.5 Filtered Scan L-DOS47-Cy5.5 Cy5.5 emission max @710nm
Slide 12: Direct effect on Tumours
Direct effect on Tumours L-DOS47 stays on tumour persistently and retards growth 120 Normalized Fluorescence Intensity 350 100 Vehicle 12hrs 300 %Change in Tumor 24hrs Cisplatin 80 48hrs 250 L-DOS47 (35U/kg) Volume 72 hrs 200 L-DOS47 (20U/kg) 60 150 L-DOS47 (10U/kg) 40 100 50 20 0 0 5 10 15 20 0 D
Slide 13: Enhances Other Chemotherapeutics
Enhances Other Chemotherapeutics L-DOS47 enhances chemo drugs The cytotoxic effect of weakly basic drugs is directly related to the solution pH (left panel). At an acidic tumour pH (<6.8), the effectiveness of these drugs is significantly reduced. L-DOS47 can dramatically raise the effectiveness o
Slide 14: L-DOS47 Phase I / II Trial
L-DOS47 Phase I / II Trial • Conducted in 5 Centers in Poland to assess safety (phase I) and then preliminary efficacy (phase II) • It is a monotherapy treatment protocol in NSCLC patients that have not responded to other treatments – Stage IIIb / IV, metastatic, and progression after several lines
Slide 15: L-DOS47 Phase I / II Trial
L-DOS47 Phase I / II Trial • Second Interim Data Review completed Sept 30th, 2014 • Reviewed PK, safety, toxicology, and radiological assessments of first 24 patients from cohorts 1-8 15
Slide 16: L-DOS47 Phase I / II Interim Review
L-DOS47 Phase I / II Interim Review • No safety issues beyond those observed in pre-clinical toxicology studies or expected in the population of patients being studied • No Dose Limiting Toxicities • Pharmacokinetic data supports continued dose escalation • Immunogenicity consistent with what was ob
Slide 17: L-DOS47 Phase I / II Interim Review
L-DOS47 Phase I / II Interim Review For the first 24 patients treated: • Twelve (12) or 50% of patients treated with LDOS-47 had an radiological assessment of stable disease as compared to their baseline radiology before treatment following at least two cycles • Two (2) patients completed six (6) do
Slide 18: L-DOS47 Summary
L-DOS47 Summary • Given the safety profile and the information from the interim analysis, Helix has been approved for combination studies by the US FDA • We are exploring the application of L-DOS47 in other indications (breast, colon, pancreatic) as a second market for the product • Helix expects to
Slide 19: L-DOS47 Clinical Development Plan
L-DOS47 Clinical Development Plan Phase I with expansion cohort to Pathway to approval in First-line with assess preliminary efficacy most popular combination; Most direct Combination (Pem/Carbo) First-line reg. approval and market acceptance therapy in non-squamous NSCLC Phase II Monotherapy Pathwa
Slide 20: Topical Interferon (TIFN)
Topical Interferon (TIFN) Study IFN002/HPV001 Pap Smear Resolution CIN Two Phase II studies completed: 70.0% Resolution (Pap IIID Cohort) 60.0% Study IFN002/HPV001 50.0% Safety/efficacy study 40.0% 41 patients (Tx vs. observational control) 30.0% 18-doses TIFNα2b + 6 week follow-up 20.0%
Slide 21: Strategic Plan
Strategic Plan • We intend to maximize corporate value by developing L-DOS47 and other candidates to Phase II clinical status • Value is achieved in 2016 through the partnering of candidates at Phase II to large pharma companies (either product-by-product or acquisition of company) AND through IPO i
Slide 22: Strategic Plan
Strategic Plan • Continued development of lead candidates - Helix expects that opportunities for partnering, licensing, or acquisition will come near or very soon after Phase II results in 2016 • Enter into strategic R&D collaborations in 2015 for new pipeline candidates from DOS platform • Explore
Slide 23: Strategic Plan Summary
Strategic Plan Summary Build Internal Pipeline • LDOS-47 clinical studies • New pre-clinical programs Build liquidity and valuation into shares Licensing or Acquisition of New Product Opportunities • US listing eg Helix candidates NASDAQ • Licensing / Acquisition • Access to • Increase value • Reali
Slide 24: Strategic Plan Execution: Phase I Poland (LDOS002 Trial)
Strategic Plan Execution Developing L-DOS47 to Phase II Phase I Poland (LDOS002 Trial) Phase I Topline Results Q2-3 2015 Phase II Topline results early 2016 Final report H2 2016 27
Slide 25: Strategic Plan Execution: US Combination Study (LDOS001 Trial)
Strategic Plan Execution Developing L-DOS47 to Phase II US Combination Study w/ Pem/Carbo (LDOS001 Trial) Dose Escalation Complete enrollment in Q4 2015 Interim Analysis before end of 2015 Expansion Group Complete Enrollment by Q2-3 2016 Topline results Q3 2016 28
Slide 26: Strategic Plan Execution: Phase I/IIa Canada/EU (LDOS003 Trial)
Strategic Plan Execution Developing L-DOS47 to Phase II Phase I/IIa Canada/EU (LDOS003 Trial) Developing new protocols based on feedback / data from Polish Study Dose Escalation Interim Analysis late 2015-early 2016 Expansion Group Complete Enrollment by Q3 2016 Topline results Q3-4 20
Slide 27: Strategic Plan Execution
Strategic Plan Execution Enter Strategic Research Collaborations in 2015 • Current discussions with multiple companies for initial research collaborations • Focussed on new DOS candidates and other related research • Benefits Helix through the creation of new clinical candidates, external validation
Slide 28: Strategic Plan Execution
Strategic Plan Execution Explore Acquisition / Licensing Opportunities • Build pipeline non-organically • Identify and acquire companies / products that broaden pipeline and diversify product risk at different stages of development • Concentrating on acquiring Phase II or other novel opportunities •
Slide 29: Strategic Plan Summary
Strategic Plan Summary Build Internal Pipeline • LDOS-47 clinical studies • New pre-clinical programs Build liquidity and valuation into shares Licensing or Acquisition of New Product Opportunities • US listing eg Helix candidates NASDAQ • Licensing / Acquisition • Access to • Increase value • Reali