Paul J. Hastings Chairman and CEO. October 2013

Transcription

1 Targeting Cancer Stem Cells Paul J. Hastings Chairman and CEO October 2013

2 Safe Harbor Statement These slides and accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides and accompanying oral presentation are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as may, could, will, would, should, expect, plan, anticipate, i t believe, estimate, t intend, predict, seek, contemplate, t potential or continue or the negative of these terms or other comparable terminology. Forward-looking statements in these slides and accompanying oral presentation include, but are not limited to, statements about: the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our ability to advance product candidates into, and successfully complete, clinical trials; our collaborators exercise of their license options; the commercialization of our product candidates; the implementation of our business model, strategic plans for our business, product candidates and technology; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; estimates of our expenses, future revenues, capital requirements and our needs for additional financing; the timing or likelihood of regulatory filings and approvals; our ability to maintain and establish collaborations or obtain additional government grant funding; our use of proceeds from this offering; our financial performance; and developments relating to our competitors and our industry. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; our dependence on our collaboration partners, including GSK and Bayer, for the funding of our partnered programs; our ability to raise additional capital to support the development of our unpartnered programs; our dependence on the development and marketing efforts of our partners for the commercial success of our partnered product candidates; our reliance on third parties to conduct certain preclinical studies and all of our clinical trials; our reliance on single source third-party contract manufacturing organizations to manufacture and supply our product candidates; our ability to validate, develop and obtain regulatory approval for companion diagnostics; our ability to achieve market acceptance and commercial success of our product candidates once regulatory approval is achieved; our ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; our dependence on our Chairman and Chief Executive Officer, our Chief Scientific Officer, our Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate our patents or proprietary rights; and the ability of our proprietary rights to protect our technologies and product candidates. Other factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Risk Factors or otherwise described in our Prospectus filed with the Securities and Exchange Commission (SEC) on July 18, 2013 and our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013, filed with the Securities and Exchange Commission on September 3, Any forward-looking statement you see or hear during this presentation reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forwardlooking statements for any reason, even if new information becomes available in the future. 2

3 Disclaimer The information contained in this corporate presentation is time-sensitive and accurate as of the date indicated on such presentation. Such information is subject to change, and OncoMed does not have a duty to update the corporate presentation and will not necessarily inform you of such changes. The information contained in this corporate presentation may be updated, amended, supplemented or otherwise altered by subsequent presentations, reports and/or securities filings by OncoMed. 1

4 OncoMed Pharmaceuticals Inc. A Leading Cancer Stem Cell Company Novel Discovery Engine / Proprietary Technologies Pipeline of Potential First-in-Class Anti-Cancer Stem Cell Agents All Discovered at OncoMed Targeting Critical Oncology Pathways: Notch, WNT, RSPO Novel Predictive Biomarkers Cutting Edge Clinical i l Development Five Potential First-in-Class Clinical Programs (>265 pts treated) Programs Advancing to Ph2 Proof-of-Concept Trials Evidence of Clinical Activity and CSC Pathway Inhibition Potential for 11 Randomized Ph2 in Successful Financial Management Robust Partnerships with GSK and Bayer $2B+ in Future Milestones, Non-Dilutive Financing Unpartnered Clinical and Preclinical Assets Large Market Opportunity 3

5 Why Target Cancer Stem Cells? Cancer Stem Cells (CSCs) are the sub-population of cells that drive tumor growth, recurrence, and metastasis CSCs are not reduced by standard chemotherapy, radiation, and targeted therapies. Thus, tumors progress, recur and metastasize Novel anti-csc therapy has vast potential for more durable clinical outcomes when combined with chemotherapy, radiation, immunotherapy, or targeted agents Therapeutic Objectives Block CSC self-renewal Force differentiation 4

6 Signaling Pathways in Cancer OncoMed Area of Focus Self-Renewal/ CSC Pathways Modulate Differentiation and Differentiation Self-Renewal Notch Wnt RSPO New Pathway Pathway Pathway Pathways Reduce CSC Frequency Kinases Her2* EGFR Met VEGFR* ETC. B-Raf* PI3K Abl ALK Cytotoxics Taxanes* Alkylating agents* Anti metabolites* Anti-metabolites* Topoisomerase inh.* ETC. *Do not reduce CSC Frequency 5

7 First-in-Class Anti-Cancer Stem Cell Pipeline 5 Clinical Programs, 5+ Research Programs Therapeutic Preclinical IND Phase I Phase Ib Phase Ib/II Notch Pathway Wnt Pat thway Demcizumab (anti-dll4) DLL4/VEGF bispecific Anti-Notch2/3 (OMP-59R5) Anti-Notch1 (OMP-52M51) Vantictumab (anti-fzd7) Fzd8-Fc (OMP-54F28) Wnt biologic #3 Small Molecules (WNT inhibitors) Anti-RSPO-LGR Other Pathways Clinical Program Preclinical Program 6

8 Anti-CSC Therapies Reduce the Ability of Tumors to Grow Anti-DLL4 preclinical results shown. Similar results across our pipeline 19.8% CSC CD44 Breast Tumor TNBC mm 3 Tumor Volume, Control Ab+Taxol->Control Ab Anti-DLL4+Taxol->Anti-DLL4 Abs + chemo LDA Abs only Days Post Cell Injection 74.1 CD166 Transfer tumor cells post-treatment Tumor Volume, mm Limiting Dilution Assay (Day 75) CSC Frequency /74 1/184 1/30 1/ Hoey et al. CELL Stem Cell 5, , rol-50 Contr Contro ol-150 Contro ol-500 Anti-DLL L4-50 Anti-DLL Anti-DLL Tax xol-50 Taxo ol-150 Taxo ol-500 Taxol+Anti-DLL L4-50 Taxol+Anti-DLL Taxol+Anti-DLL

9 OncoMed Clinical Development Program Clinical Trials: Ph2: NSCLC+ # Ph2: Panc Ca+ # Over 265 patients treated to date The information contained in this table is derived from our business plans, which are used for internal financial and operational planning purposes. This OncoMed information should not be relied upon as projections. The timing of these programs is subject to the risks and uncertainties set forth under the caption Risk 8 Factors in our prospectus and quarterly report on Form 10-Q.

10 Major Pharma Alliances 2 Notch Programs 5 Wnt Programs $35M upfront 2 Biologic Programs Up to $344.5M and $349.5M in milestones respectively Royalties: Low double digit to high teens GSK option through Ph2 PoC trials GSK holds equity stake 9.4%* $40M upfront + $20M for 2011 IND 3 Biologic & 2 Small Molecule Programs Up to $387.5M milestones per biologic, $112M per small molecule Biologics royalties: Mid single digit to high teens Small Molecule royalties: single digits Bayer option through Ph1 trials * per most recent SEC filing $176M raised from partners to date Up to $160M additional milestones through 2016 Option deals provide significant cash, synergy, and long-term value creation. Partners committed to OncoMed success 9

11 Demcizumab Summary First-in-Class Anti-DLL4 Antibody Single agent activity in heavily pre-treated Ph1a patients Multiple solid tumor types Two ongoing Ph1b combination chemo studies First-line NSCLC and pancreatic cancers Enhanced response rate and durability (preliminary) Ph1b/2 recurrent ovarian cancer (DEM + Taxol) Study initiated at MDACC Additional Ph2 studies planned for 2014 Pancreatic Cancer NSCLC Studies employ novel truncated dosing regimen MDACC: MD Anderson Cancer Center 10

12 Demcizumab (Anti-DLL4) Ph1a Activity Dose Escalation (0.5 10mg/kg); g) Expansion (10Q2W) Waterfall Plot: Best Response Swim Lane Plot: Time on Tx First Tumor Assessment 30% target lesion reduction One Partial Response in Recurrent Pancreatic Cancer 17 of 55 (31%) Patients with Stable Disease for at least 3 months Solid Tumor Activity*: Panc Ca, NSCLC, CRC, Renal Cell, Ovarian Ca (570 days), Melanoma, H/N, Sarc, etc Low incidence of cardiopulmonary events with long term dosing: risk mitigation strategies implemented * Target Lesion decrease and/or PR or SD >3mos Update to EORTC-NCI-AACR Mol Targets & Cancer Therapeutics, Berlin

13 Demcizumab Ph1b: Pancreatic Cancer Efficacy: Response Rate and Duration Ongoing clinical trial First-Line Advanced Pancreatic Cancer Gemcitabine + demcizumab GEM/Abrax 2.5 Q2W N=6 treated Study Patients et Lesions in Tumor Targ % Change i Waterfall Plot (N=16 pts) 40 5 Q4W % target lesion reduction DEM: 2.5 or 5mg/kg Q2 or 4 Wks Partial Response (PR) Stable Disease (SD) GEM + DEM (N=16) GEM* 4 (25%) 7% 7 (44%) 44% PR + SD 11 (69%) 51% 2.5 Q4W 2.5 Q2W Days GEM mpfs: 104d Median PFS by DEM Dose (Kaplan-Meier) GEM (MPACT Trial*): 104d GEM+DEM (mg/kg): 2.5Q4W: 50d 2.5Q2W: 101d 5Q4W: 143d Preclinical Data: Pt-Derived Panc Ca: GEM/Abrax + DEM Truncated Dosing Data on File Tumor Assessments every 56 days * vonhoff ASCO GI

14 Demcizumab Ph1b: NSCLC Efficacy: Response Rate and Duration Ongoing clinical trial et Lesions in Tumor Targ % Change i First-Line Advanced NSCLC Carboplatin/Pemetrexed + demcizumab Waterfall Plot (N=22 pts) 30% target lesion reduction Partial Response (PR) 30% target tumor reduction DEM: 2.5 or 5mg/kg Q3Wks DEM: 2.5 or 5mg/kg Q3 Wks Carbo/PEM + DEM (N=22) Stable Disease 10 (45%) (SD) PR + SD 19 (86%) Platinum/PEM (Package Insert) 9 (41%) 27% 7.5 Q3W N=6 treated Study Patients 5Q3W (N=20) 2.5 Q3W Plt/PEM: mpfs: 139d Median PFS by DEM Dose (Kaplan-Meier) Platinum/PEM (PEM PI): 139d Carbo/PEM + DEM: 2.5Q3W: 129d 5Q3W: 160d Data on File Tumor Assessments every 56 days 13

15 Anti-Notch2/3 (OMP-59R5) Summary Potential GSK Opt-In Program Ph1a Study Completed Oral Plenary Presentation: Mol Targets and Cancer Therapeutics 2012 Safety: Well tolerated in refractory solid tumor patients Toxicity: on-target diarrhea Maximum tolerated dose (MTD) established for 3 dosing schedules (QW, Q2W, Q3W) Efficacy: Prolonged stable disease Triple Negative BC (JAG1 amplification), Liposarcoma, Adenoid Cystic Carcinoma, Rectal Cancer, Kaposi Sarcoma Two Proof-of-concept Phase 1b/2s Ongoing Personalized Medicine Program with Predictive Biomarker Pancreatic Cancer and Small Cell Lung Cancer Smith, Mol Targets Cancer Therapeutics, Dublin

16 Anti-Notch2/3 in Two Phase 1b/2 Trials SCLC and Pancreatic Cancer Ongoing POC Trials with Predictive Biomarkers Supportive Preclinical Patient-Derived Xenograft Data in SCLC C and Pancreatic Cancer tumor volum me (mm 3 ) Antibodies + chemo Abs only Days Control Ab+cisplatin->Control Ab Anti-Notch2/3+cisplatin ->Anti-Notch2/3 Tumor Volu ume, mm Days Post Treatment Control mab Anti-Notch2/3 (59R5) Gem+Abraxane Anti-Notch2/3 + Gem/Abrx 15

17 ALPINE Ph1b: Best Radiographic Response Waterfall Plot (First N=12 Evaluable Pts) Ongoing clinical trial n Tumor Tar rget Lesions s Perce ent Change i A Predictive Biomarker analysis pending A PD 2/4 (50%) PR GEM/Abraxane + N2/3 5mg/kg GA5 G5 G5 G5 GA5 G2.5 G2.5 G2.5 G5 G2.5 GA5 GA5 30% target lesion reduction Cohort 1 (G 2.5): GEM + 59R5 2.5mg/kg Q2W (N=4) Cohort 2 (G 5): GEM + 59R5 5mg/kg Q2W (N=4) Cohort 3 (GA 5): GEM/Abrax + 59R5 5mg/kg Q2W (N=4) A A A: pts receiving GEM/Abraxane + anti-notch2/3 GEM/Abraxane + OMP-59R5 Patients Enrolled: 16 in three dose cohorts Data on File Tumor Assessments every 56 days 16

18 Anti-Notch1 in Phase 1 Potential GSK Opt-In Program Two Ongoing First-in-Human in Trials (With Companion Diagnostics) Hematologic Malignancies Dose Escalation and Expansion Efficacy Expansion: Biomarker pt selection Solid Tumors Dose Escalation and Expansion Efficacy Expansion: Biomarker pt selection Potential for Early POC Cancilla AACR 2013 Abstract highlighting First-in-Human Data submitted to Mol Tar Can Thera

19 Vantictumab (Anti-Fzd7, OMP-18R5 18R5) Potential Bayer Opt-in Program Preclinical Data: Patient-derived Pancreatic Cancer Model Believed to be 1 st Wnt pathway antagonist mab in clinic; binds Fzd 1,2,5,7,8 Strong preclinical synergy with chemotherapy and targeted agents Gurney et al Proc Natl Acad Sci USA 109,

20 Vantictumab (Anti-Fzd7, OMP-18R5) Phase 1 Clinical Data at ASCO 2013 Ongoing clinical trial Ph1a study: Ongoing N=29 (Dose levels: 0.5 to 15mg/kg) Safety: Vantictumab is well tolerated in refractory solid tumor patients 016 Bone protection strategy is effective 029 Vertical lines: tumor assessments Biomarker: PD modulation of Wnt pathway and CSC markers in Hair 001 Follicle surrogate tissue Efficacy: Single Agent Activity in 3/3 NET pts (pnet and Carcinoid) id) Phase Ph1b studies: Initiating 2H13 VAN + chemo in three solid tumor indications Predictive Biomarkers for Patient Selection Patients on Study = Active = Neuroendocrine tumor Days on study Smith ESMO

21 Fzd8-Fc Fc (OMP-54F28) in Phase 1 Potential Bayer Opt-in Program Inhibition of Ovarian Tumor Growth Tumor Vo olume, mm Days Post Treatment Control mab FZD8-Fc Taxol FZD8-Fc + Taxol OvarianTumor Metastatic Serous Carcinoma P53 mutation Hoey, AACR 2013 Fzd8-Fc: 2 nd Wnt Biologic; Decoy receptor Strong preclinical synergy with chemotherapy and targeted agents Ph1 single agent study ongoing (data expected in 2013) Three planned Ph1b studies: 54F28 + chemo in specific solid tumor indications in 2013/14 Abstract highlighting First-in-Human Data submitted to Mol Tar Can Thera

22 OMED: Preclinical Discovery Program Multiple INDs in 2014 and beyond DLL4/VEGF Bispecific Candidate Selection IND + Ph1a + Anti-RSPO/LGR Efficacy testing/ Lead optimization Candidate Selection Wnt Small Molecule Efficacy testing/ Lead optimization (Timing not disclosed) IND + Ph1a + Ph1b+ Ph1b+ Undisclosed Pathway Efficacy testing/ Lead optimization Candidate Selection Ongoing New Discovery/ Immunotherapy IND + Ph1a + 21

23 Two Potential INDs in 2014 Novel Bi-specific: anti-vegf + anti-dll4 Proprietary bi-specific antibody technology Preclinical anti-tumor efficacy demonstrated Evidence for improved activity relative to anti-dll4 or anti-vegf Clinical candidate selected Key OncoMed discovery: RSPOs are the ligands for LGRs US Patent Nos. 8,158,757, 8,158,758 and 8,540,989 Original Filing Date: July 02, 2008 (priority to 2007) Assignee: ONCOMED PHARMACEUTICALS, INC. Broad claims covering therapeutic antibodies that disrupt this pathway have issued in the U.S. RSPO LGR Anti- VEGF Heavy chain Anti-DLL4 Heavy chain Beviglia AACR

24 OMED Financial Snapshot July IPO Proceeds: $94MM Extended Lock Up (18 months): Management and Investors July 31 ProForma Cash: $140MM $10 million milestone achieved in August Shares outstanding 27.8 million 23

25 Leadership Team Management Title Prior Experience Paul Hastings Chairman and CEO QLT, Axys, Chiron, Genzyme John Lewicki, Ph.D. EVP and Chief Scientific Officer Scios Jakob Dupont, M.D. SVP and Chief Medical Officer Genentech, MSKCC Sunil Patel SVP, Chief Business Officer Abgenix, McKinsey, BiPar Will Waddill SVP and Chief Financial Officer Ilypsa, Exelixis Austin Gurney, Ph.D. SVP, Molecular & Cellular Biology Genentech Tim Hoey, Ph.D. SVP, Cancer Biology Tularik, Amgen Alicia Hager, J.D., Ph.D. VP, General Counsel Morrison & Foerster 24

26 Upcoming Milestone Events Six trial initiations: late early 2014 Vantictumab: 3 Phase 1b trials (solid tumors, predictive biomarkers) Fzd8-Fc: 3 Phase 1b trials (solid tumors, predictive biomarkers) Medical meetings: Clinical trial data AACR/EORTC/NCI 2013: 5 abstracts submitted, inc. 2 abstracts with FIH data ASCO GI 2014: 2 abstracts submitted, Pancreatic Cancer trials Partnership milestone payments Clinical achievements Issued patents 25

27 Clinical Objectives and Milestones Program Event Program Event Demcizumab Ph1b NSCLC: results Vantictumab Ph 1a: results Ph1b Pancreatic Ca: results Ph 1b: indication #1: initiation & results Ph1b/2 Ovarian Ca: Ph1b: results Ph 1b: indication #2: initiation & results Ph1b/2 Ovarian Ca: Ph2 initiation iti & results Ph 1b: indication #3: initiation iti & results Anti-Notch 2/3 Ph 1b/2 ALPINE: Ph1b: results Fzd8-Fc Ph 1a: results Ph 1b/2 ALPINE: Ph2: initiation & results Ph 1b: indication #1: initiation & results Ph 1b/2 PINNACLE: Ph1b: results Ph 1b: indication #2: initiation & results Ph 1b/2 PINNACLE: Ph2: initiation & results Ph 1b: indication #3: initiation & results Anti-Notch 1 Ph 1a Heme: results Ph 1a Solid Tumor: results Ph 1b Heme: initiation & results Ph 1b Solid Tumor: initiation & results Ph 2 Heme: initiation & results Ph 2 Solid Tumor: initiation & results 26

28 OncoMed Pharmaceuticals Inc. A Leading Cancer Stem Cell Company Novel Discovery Engine / Proprietary Technologies Pipeline of Potential First-in-Class Anti-Cancer Stem Cell Agents All Discovered at OncoMed Targeting Critical Oncology Pathways: Notch, WNT, RSPO Novel Predictive Biomarkers Cutting Edge Clinical i l Development Five Potential First-in-Class Clinical Programs (>265 pts treated) Programs Advancing to Ph2 Proof-of-Concept Trials Evidence of Clinical Activity and CSC Pathway Inhibition Potential for 11 Randomized Ph2 in Successful Financial Management Robust Partnerships with GSK and Bayer $2B+ in Future Milestones, Non-Dilutive Financing Unpartnered Clinical and Preclinical Assets Large Market Opportunity 27

29 Thank You