Recurrent Ovarian Cancer Phase 1b Results

Transcription

1 Recurrent Ovarian Cancer Phase 1b Results December 5 th, 2017

2 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect Immunovaccine s current expectations regarding future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause Immunovaccine s actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. The forward-looking statements in this presentation are also based on a number of assumptions which may prove to be incorrect. Forward-looking statements contained in this presentation represent views only as of the date of this presentation and are presented for the purpose of assisting potential investors in understanding Immunovaccine s business, and may not be appropriate for other purposes. Immunovaccine does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applicable securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read Immunovaccine s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at 2

3 Immunovaccine Overview Focusing on Immuno-oncology (IO) - DPX-Survivac: delivery platform (DepoVax TM ) and cancer target (survivin) - Prior Phase 1/1b with DPX-Survivac + metronomic oral cyclophosphamide completed in 56 patients - Combination trials and collaborations with lead checkpoints and key partners (Incyte, Merck, Dana-Farber Cancer Institute) - Clinical demonstration in recurrent ovarian cancer - Next step will be to develop path to market in ovarian cancer and expand to other indications Partnering strategy for all other applications of the platform (e.g. RSV, malaria/zika, DNA/mRNA delivery, allergies, etc.) Experienced management team with combination of oncology and vaccine expertise and successful biotech and pharma experience Solid financial position - Raised $26M in last 18 months 3

4 Immuno-oncology Pipeline Indication Product Trials Timing Partners Phase 1b Ovarian DPX-Survivac + mcpa + epacadostat Ongoing DPX-Survivac + mcpa + pembrolizumab Phase 2 Ongoing Phase 2 DLBCL DPX-Survivac + mcpa + pembrolizumab Ongoing HPV related cancer DPX-E7 + mpca Phase 2 Ongoing * metronomic cyclophosphamide (immune-modulating agent) 4

5 Phase 1b: Recurrent Ovarian Cancer DPX-Survivac, cyclophosphamide, and epacadostat in recurrent ovarian cancer Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer not eligible for otherwise potentially curative treatment or undergoing concurrent therapy Platinum-resistant or -sensitive after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy. Must have evidence of progressive disease with biochemical (i.e. rising CA-125) and/or radiologic progression Up to 40 subjects will receive 0.25 ml prime and 0.1 ml boosts with metronomic cyclophosphamide and epacadostat (INCB024360) - Dose escalation from 100 mg BID epacadostat to 300 mg BID Subjects will be treated for one year (to SD370) or until disease progression, whichever comes first 5

6 Phase 1b: Recurrent Ovarian Cancer Enrollment completed at 100 mg epacadostat dosing cohort - Reporting topline results on 10 evaluable patients who have completed at least 2 CT scans (between 3 to 14 months on treatment) Enrollment at the target 300 mg dose of epacadostat - Reporting preliminary results on first 3 evaluable patients after first scans at day 56 6

7 Best Response 100 mg cohort (10 patients enrollment completed) 70% Disease Control Rate (3 PR + 4 SD) 30% Overall Response Rate (3 PR) 300 mg cohort (3 patients so far enrollment ongoing) Two Stable Disease ongoing in first 3 patients in 300mg including a -25% tumor regression after first scan at day 56 Summary Five tumor regressions in 13 patients observed Three achieved Partial Responses (PRs) (defined as 30% decrease in tumor lesion size) Six subjects reached Stable Disease (SD) Two additional subjects withdrew Four subjects discontinued due to confirmed (2) and unconfirmed (2) disease progressions One patient in PR continuing after EOS due to clinical benefits as per the PI decision 7

8 Safety Overview Majority of reported adverse events have been grade 1. Approximately equally distributed between injection site reactions and other events. One potential DLT at 300 mg BID - Elevated lipase Five SAE: three unrelated, two unlikely related - Subject experiencing unrelated thromboembolic event passed away shortly thereafter, report expedited to FDA and Health Canada Two subjects experienced grade 3 fatigue and two subjects grade 2 fatigue Two subjects have experienced grade 3 rash, one subject a grade 2 rash, and a couple of grade 1 Three subjects have experienced elevated lipase (two grade 3, one grade 4) 8

9 Comparison with Ovarian Cancer IO Results Checkpoints and combinations have delivered limited success so far in recurrent ovarian cancer Average of 44% disease control rate (DCR) and 11% overall response rate (ORR) in 11 clinical trials Ovarian Cancer IO clinical trials Phase (nb patients) DCR (SD, PD and CR) ORR (PR and CR) References Checkpoint Immunotherapy Ipilumab-BMS (CTLA-4) P1 (9) 44% (1 PR + 3 SD) 11% (1 PR) Hodi F. S. et al Proc. Natl Acad. Sci. USA 105:3005 Epacadostat-Incyte (IDO1) P2 (20) 0% (1 CA 125 reduction) 0% Kristeleit et al Gynecol Oncol Sep;146(3): Pembrolizumab-Merck (PD-1) P1b (26) 35% (6 SD + 3PR) 12% (1 CR + 2 PR) Varga A et al. (2015) J Clini Oncol (Meeting Abstracts) 33): Nivolumab-BMS (PD-1) P2 (18) 44% (2 CR +1 PR + 5 SD) 17% (2 CR +1 PR) Hamanishi J et al. (2014) J Clin Oncol 32: 5511 Avelumab-Merck KgA (PD-L1) P1b (124) 54% (12 PR + 55 SD) 10% (12 PR) Disis ML et al. J Clin Oncol 34, 2016 (suppl; abstr 5533) BMS (PD-L1) P1 (17) 24% (1 PR + 3 SD) 6% (1 PR) Brahmer JR et al. N Engl J Med. 2012;366(266); Checkpoint + PARP inhibitor Durvalumab-AZ (PD-L1) + Olaparib (PARPi) P1/2 (12) 83% (2 PR + 9 SD) 17% (2 PR) Lee JM et al. J Clin Oncol Jul 1;35(19): Pembrolizumab + Niraparib (PARPi)* P2 (29) 52% (9 SD + 6 PR) 21% (6 PR) Tesaro 2017 ESMO Combination Immunotherapy Epacadostat + Pembrolizumab P2 (37) 35% (10 SD + 3 PR) 8% (3 PR) Lee S. Schwartzberg Post-ASCO Immunotherapy Highlights:June 27, 2017 Epacadostat 100mg + Nivolumab P1/2 (18) 28% (3 SD + 2 PR) 11% (2 PR) Lee S. Schwartzberg Post-ASCO Immunotherapy Highlights:June 27, 2017 Epacadostat 300mg + Nivolumab P1/2 (11) 36% (2 SD + 1 PR + 1 CR) 18% (1 PR + 1 CR) Lee S. Schwartzberg Post-ASCO Immunotherapy Highlights:June 27, 2017 Average 29 44% 11% DPX-Survivac+ Epacadostat 100mg P1b (10) 70% (3 PR + 4 SD) 30% (3 PR) * Study ongoing incomplete results 9

10 Historical Vaccine/T Cell Activation Results Tumor regressions historically inexistent or very low with vaccine /T cell activation Review Jacobs, John J.L. (2014) - 41 studies in prostate cancer 1100 patients - 3 tumor regressions: 1 CR, 2 PR reported in total More tumor regressions in our first 13 patients (5/13) than in the review of 41 trials (3/1100) including immunooncology combinations with co-stim and checkpoints inhibitors Review Klebanoff et Al (2011) - 3.7% response rate in 49 studies across all indications and cancer vaccine types 10

11 Summary of Early Findings Key milestone for Immunovaccine s clinical strategy: one of the first clinical demonstration that targeted T cell activation can trigger tumor regressions and improve the efficacy and number of patients benefiting from other immuno-modulators DPX-Survivac + epacadostat combination: early data indicates activity in recurrent ovarian cancer Response rate in the 100mg cohort compares favorably with other IO results including with combinations of pembrolizumab (Keytruda ) and nivolumab (Opdivo ) 11

12 Next Steps Significant milestone achieved for Immunovaccine - De-risking our value proposition - first clinical demonstration of our mechanism of action - Provides us with a solid foundation to continue and accelerate our growth Next steps - Multiple clinical milestones in 2018 (epacadostat 300mg and combinations with Merck pembrolizumab) - Path to market in recurrent ovarian cancer and expansion into additional indications 12

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