THE FUTURE OF VACCINES ASCO ANNUAL MEETING JUNE 4, 2016

Transcription

1 THE FUTURE OF VACCINES ASCO ANNUAL MEETING JUNE 4,

2 BAVARIAN NORDIC INVESTOR & ANALYST UPDATE & RECEPTION Welcome and Introduction to Bavarian Nordic s Cancer immunotherapy Programs Paul Chaplin, Ph.D. President & Chief Executive Officer, Bavarian Nordic A Clinical Overview of PROSTVAC as Monotherapy and Combination Therapy James L. Gulley, M.D., Ph.D. Chief, Genitourinary Malignancies Branch, Head, Immunotherapy Section, Director, Medical Oncology Service, CCR Office of the Clinical Director, National Cancer Institute Brachyury: A Novel Target with First in Man Data. Presentation of Clinical Data, Lessons Learned, and Potential Pathways Forward Christopher R. Heery, M.D. Associate Research Physician, Laboratory of Tumor Immunology and Biology, Director, Clinical Trials Group, National Cancer Institute 2

3 WELCOME AND INTRODUCTION TO BAVARIAN NORDIC S CANCER IMMUNOTHERAPY PROGRAMS PAUL CHAPLIN, PH.D. PRESIDENT & CHIEF EXECUTIVE OFFICER, BAVARIAN NORDIC 3

4 FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements regarding our short-term objectives and opportunities, financial expectations for the full year and financial preparedness as of year end, as well as statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. 4

5 MULTIPLE LAYERS OF VALUE 1 approved product 7 active programs Validated Platform Technology (NIH, BARDA, BMS, Janssen) 2 focus areas Infectious Disease & Oncology Expertise in T-Cell Stimulation & Antibody Response 3 Phase 3 Products Multiple near-term milestones Broad Pipeline & Late-Stage Candidates $1.2B in US government contracts $950M in revenues over past 10 years $975M BMS deal - PROSTVAC $358M Janssen deals Ebola and HPV Strong Revenue Base to Re-Invest in Clinical Pipeline 5

6 CLINICAL PIPELINE PRODUCT CANDIDATE INDICATION Infectious Disease IMVAMUNE / IMVANEX (LIQUID FROZEN) IMVAMUNE (FREEZE DRIED) Filo RSV HPV Vaccine Smallpox Smallpox Smallpox Ebola / Marburg RSV HPV Cancer Immunotherapy COMMERCIAL RIGHTS PRIMER / BOOSTER PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED STATUS / EXPECTED MILESTONES Approved in Canada and the European Union Phase 3 in US (non-inferiority) Complete enrollment in 2017 Manufacturing validation AdVac (a) Data from multiple trials in 2016 Approved in Canada and the European Union Phase 2 complete Fully enrolled Phase 1 trial data in 1H16 AdVac (a) Deal signed in December 2015 PROSTVAC CV mcrpc Localized Prostate Cancer Localized Prostate Cancer (neoadjuvant) Non-Metastatic Castration Sensitive Prostate Cancer mcrpc Metastatic Castration Sensitive Prostate Cancer Non-Metastatic Prostate Cancer Prostate Cancer Bladder Cancer Brachyury Solid Tumors (a) (c) (d) Vaccinia Vaccinia Three interim analyses likely starting in 1Q16 with top-line data in 2017 NCI enrolling Phase 2 trial Vaccinia NCI Phase 2 trial data in 2016 Vaccinia Vaccinia Vaccinia Vaccinia Vaccinia Vaccinia (c) PROSPECT fully enrolled + XTANDI (enzalutamide) + ADT and docetaxel + XTANDI (enzalutamide) ipilimumab An adenovirus primer from Janssen. BMS would have complete commercial rights to PROSTVAC, regardless of treatment setting, should they exercise their licensing agreement. Anticipated transition to MVA primer. Anticipated transition to booster. NCI enrolling Phase 2 trial NCI enrolling Phase 2 trial NCI enrolling Phase 2 trial NCI Phase 2 trial data in 1H16 NCI Phase 1 trial enrollment complete NCI enrolling Phase 2 NCI trial (d) Phase 1 data reported in 4Q15

7 COMMERCIAL MANUFACTURING CAPABILITIES Commercial Production Facility Inspected by the EMA and the FDA 28M doses of IMVAMUNE delivered to US national stockpile Over 2M doses of Filo (Ebola) delivered to Janssen Multi-Product Facility Highly scalable, fully integrated, reduces dependency on sub-contractors Fill/Finish established to support commercial launch of PROSTVAC Production of all clinical trial material Poxvirus Manufacturing Expertise Commercial partnerships in place with Janssen & BMS All manufacturing performed by BN Company has developed IP and extensive know-how in the production of poxvirus based vaccines 7

8 RECENT ONCOLOGY HIGHLIGHTS Interim analysis #1 of PROSTVAC Phase 3 confirmed that the study continue without modification Two new Phase 2 clinical studies of PROSTVAC initiated Combination with docetaxel Monotherapy Update of existing Phase 2 study: PROSTVAC Phase 2 of men undergoing active surveillance recruiting well (up to 66 men) potential to expand from 90 men up to 150 men. Brachyury Phase 1 shown to be safe and able to produce T-cells against Brachyury

9 PROSTVAC CANCER IMMUNOTHERAPY PHASE 3 STUDY STATUS PROSPECT A Randomized, Double-blind, Global Phase 3 Efficacy Trial of PROSTVAC in Metastatic Castration-Resistant Prostate Cancer Randomization by region (N=1,297) Final data anticipated in 2017 Injections Interim Analysis #1 214 events 40% Interim Analysis #2 321 events 60% Interim Analysis #3 427 events 80% Final Analysis 534 events 100% Australia, Estonia, Israel, Poland, 25,7% Russia Rest of World (n=333) 9 38,2% Western Europe (n=497) Belgium, Denmark, France, Germany, Iceland, Netherlands, Spain, United Kingdom 18,4% North America Oncology (n=239) 17,7% North America Urology (n=229) USA, Canada Average was 6.1 injections 1 Randomized Phase 2 trial (n=122) had average of 5.4 injections 2 An increased number of injections is expected to improve the clinical outcome for patients receiving the active drug. 1) Subjects who have completed study treatment phase or have completed 7 th dosing visit. N=1,279 2) Kantoff et al., Journal of Clinical Oncology, January 2010

10 ENTRY CRITERIA Randomized Phase 2 PROSPECT Phase 3 ECOG < 2 No visceral metastases Asymptomatic (no cancer-related pain requiring narcotics) No prior chemotherapy Gleason score < 7 (from original biopsy) Removed Gleason score exclusion Gleason grade not associated with treatment effect in other phase 3 mcrpc trials (sip-t, ipilimumab) No alkaline phosphatase exclusion No LDH exclusion Changed to exclude patients with alk phos > 2 times ULN Excludes more advanced metastatic disease Changed to exclude patients with LDH > 2 times ULN Excludes more advanced metastatic disease No PSA doubling time (PSA-DT) exclusion Added exclusion for patients with PSA-DT < 1 month Excludes patients with fast growing tumors Minimum PSA value for determination of CRPC = 5 ng/ml (PCWG1) Minimum PSA value for determination of CRPC lowered to 2 ng/ml (PCWG2) 10

11 COMMERCIAL LICENSE WITH BMS Elements Value Upfront payment $60M License $80M Phase 3 data $50M Data-driven milestones $180M* Regulatory milestones $110M Sales milestones $495M Tiered royalties on future sales High teens up to mid-twenties * Based on Phase 2 data 11

12 ONGOING PROSTVAC STUDIES SPAN PROSTATE CANCER DISEASE LANDSCAPE mono (NCI) mono (NCI) mono (MUSC) hormonal combo (NCI) mono (NCI) hormonal combo (NCI) chemotherapy combo (NCI) hormonal combo (NCI) Phase 3 (BN) chemotherapy chemotherapy, radiation therapy death ipi combo (UCSF) ipi + nivo combo (NCI) surgery hormonal hormonal, immunotherapy Tumor volume Hormone dependent Nonmetastatic No pain Castration resistant Metastatic Pain 12

13 PROSTVAC COMBINATION TRIALS TWO NEW TRIALS PLANNED FOR INITIATION Further investigation of PROSTVAC in collaboration with BMS Two new investigator-sponsored trials planned for initiation Randomization 1:1:1 Phase 2 (n=75) Open label combination trial in localized prostate cancer using PROSTVAC and ipilimumab as neoadjuvant therapy. PROSTVAC ipilimumab PROSTVAC + ipi Sponsor: UCSF Clinicaltrials.gov NCT Phase 2 (n=28) Open label combination trial in prostate cancer using PROSTVAC, ipilimumab and nivolumab as neoadjuvant therapy PROSTVAC + ipi + nivo PROSTVAC + ipi Sponsor: NCI 13

14 CV-301 CANCER IMMUNOTHERAPY DESIGNED FOR THE TREATMENT OF MULTIPLE CANCERS New and improved vaccine construct based on TRICOM CEA + = MUC-1 CV-301 Lung, Breast, Colorectal, Ovarian, Gastric, Bladder, Liver and Renal cancer Leverage Existing Clinical Data CV-301 in Combination with Immune Checkpoint Inhibitors Preliminary evidence of efficacy generated in multiple clinical studies. Safety data with over 300 subjects treated NCSLC Bladder Colorectal BN sponsored Exploring combinations with PD-1/PD-L1 in company collaborations or with NCI

15 PHASE 2 CV301 & NIVOLUMAB COMBINATION IN NSCLC Safety CV301 single agent & combination with nivolumab N=20 Randomization CV301 + Nivolumab Nivolumab N=60 N=60 Prime CV301 2 vaccinations 4 wks apart Total 8 weeks Endpoints: 4 boosters 2 wks apart Total 8 weeks Boost FPV boosters 4 weeks apart 4 boosters 13 weeks apart Total 36 weeks Total 2 years Total 52 weeks Safety, tolerability Primary endpoint: OS Secondary endpoints: ORR, DOR, PFS, Immune effects Multi-center trial: Principle Investigators: 15 sites in USA Dr C. Heery & Dr J. Gulley at NCI 15

16 STRONG FOUNDATION FOR FURTHER DEVELOPMENT PROSTVAC prostate cancer Partnered with Bristol-Myers Squibb Phase 3 fully enrolled Phase 3 top-line data expected in 2017 Multiple clinical studies being advanced in earlier stages and in combination regimens IMVAMUNE Approved in EU & Canada 28 million doses delivered to US smallpox vaccine USD 233 million bulk vaccine order bridging to next-generation freeze-dried vaccine Recurrent orders from Canada Janssen partnership 2 license agreements in Ebola & HPV Moved Ebola vaccine from preclinical to Phase 3 in 9 months 2 million doses of Ebola vaccines produced Pipeline projects Advancing clinical development of RSV vaccine in elderly & children Advancing development of CV-301 in combination treatment for multiple cancers Supporting NCI in clinical development of Brachyury 16

17 This presentation includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.