STING Program Update

STING Program UpdateJune 3, 2019

D I S C O V E R I N G & D E V E L O P I N G I M M U N O T H E R A P I E S F O R C H A L L E N G I N G D I S E A S E S

Note Regarding Forward-Looking Statements

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Today’s Presenters

Stephen T. IsaacsChairman, President and CEO

Dimitry Nuyten, MD, PhDChief Medical Officer

Funda Meric-Bernstam, MDMD Anderson Cancer Center

Andrea van Elsas, PhD Chief Scientific Officer

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Agenda

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Introduction Stephen T. Isaacs

Pipeline Update & Upcoming Catalysts Dimitry Nuyten, MD, PhD

Phase 1b Study of ADU-S100 (MIW815) + Spartalizumab Funda Meric-Bernstam, MD

Closing Andrea van Elsas, PhD

Q&A

Developing Therapies Targeting STING & APRIL Pathways for Oncology, Autoimmune & Inflammatory Diseases

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Financial StrengthStrategic Alliances

Domain ExpertiseImmunotherapy Focus

• Co-development and co-commercialization partnership with NVS

• Potential near-term development milestones

• $267M at end of Q1 2019• Operating capital into 2022

• Leaders in STING & APRIL pathway biology• Comprehensive preclinical characterization• Expertise in immuno-oncology R&D

• STING agonist in oncology• Anti-APRIL in IgA nephropathy• cGAS-STING inhibitors in autoimmune &

inflammatory diseases

Pipeline Update &Upcoming Catalysts

ADU-S100 (MIW815): STING Agonist “Partner of Choice” for Combination with Immune-Checkpoint Blockade

Indication Discovery Preclinical Phase 1 Phase 2 Current Status

ADU-S100 (MIW815)

IntratumoralSTING Agonist

Advanced/metastatic solid tumors or

lymphomas

• Single agent dose escalation completed

• No single agent expansion planned

+ spartalizumab(α-PD-1)


lymphomas

• Dose escalation & triple-negative breast cancer enrichment ongoing

+ ipilimumab(α-CTLA-4)

α-PD-1-relapsed-refractory melanoma • Enrollment ongoing

+ pembrolizumab(α-PD-1) 1st-line SCCHN • Pre-enrollment & site activation

cGAS-STING Pathway Inhibitors

Autoimmune & inflammatory

disorders• Advancing compounds

BION-1301Anti-APRIL Antibody

IgA nephropathy • First cohort of healthy volunteers cleared

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SCCHN = squamous cell carcinoma of the head and neck

Potential Upcoming Catalysts

Indication CatalystH1

2019H2

2019 2020

ADU-S100 (MIW815)

IntratumoralSTING Agonist

+ ipilimumab(α-CTLA-4)

α-PD-1-relapsed-refractory melanoma Initiate Ph 1 dose escalation study ✔

+ spartalizumab(α-PD-1)


lymphomas

Report initial Ph 1 dose escalation results ✔Report complete Ph 1 dose escalation & enrichment results

Initiate Ph 1 dose expansion

+ pembrolizumab(α-PD-1) 1st-line SCCHN

Initiate Ph 1b/2 study in 1L SCCHN

Report interim study results in 1L SCCHN

BION-1301Anti-APRIL Antibody

IgA nephropathyReport Ph 1 data in healthy volunteers

Report Ph 1 data in IgA nephropathy patients

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Expected Timing

Phase Ib study of MIW815 (ADU-S100) in combination with spartalizumab (PDR001) in patients with advanced/metastatic solid tumors or lymphomas (NCT03172936)Funda Meric-Bernstam,1 Shahneen Sandhu,2 Omid Hamid,3 Anna Spreafico,4 Stefan Kasper,5

Reinhard Dummer,6 Toshio Shimizu,7 Neeltje Steeghs,8 Nancy Lewis,9 Craig Talluto,10

Sinead Dolan,10 Andrew Bean,9 Robert J. Brown,11 Damian Trujillo,11 Nitya Nair,11 Jason J. Luke12

1Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, TX; 2Peter MacCallum Cancer Centre, Melbourne, Australia; 3The Angeles Clinic and Research Institute, Los Angeles, CA; 4Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada; 5Department of Medical Oncology, West German Cancer Centre, University Hospital Essen, Essen, Germany; 6University of Zurich, Zurich, Switzerland; 7National Cancer Center Hospital, Tokyo, Japan; 8Netherlands Cancer Institute, Amsterdam, The Netherlands; 9Novartis Pharmaceuticals Corporation, East Hanover, NJ; 10Novartis Institutes for BioMedical Research, Cambridge, MA; 11Aduro Biotech Inc., Berkeley, CA; 12The University of Chicago Medicine, Chicago, IL

9Dr Funda Meric-Bernstam

Stimulator of Interferon Genes (STING) pathway

• STING pathway senses intracellular DNA, triggering an immediate production of type I IFN1

• STING activation has wide-ranging impact on both the innate and adaptive immune response by inducing APC recruitment and priming and CD8+ T cells against tumor antigens2

• MIW815 (ADU-S100) is a synthetic cyclic dinucleotide (CDN), a first-in-class STING agonist3

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APC, antigen-presenting cell; IFN, interferon.1. Ishikawa H, Barber GN. Nature 2008;55:674–678; 2. Woo SR, et al. Immunity 2014;41:830–842; 3. Glickman LH, et al. Cancer Res 2016;76(14 Suppl):abst 1445; 4. Corrales L, et al. Cell Rep 2015;11:1018–1030.

Dr Funda Meric-Bernstam

• In mouse models, intratumoral injection of single-agent MIW815 (ADU-S100) resulted in tumor regression in both injected and non-injected lesions4

MIW815 (ADU-S100) demonstrates combination efficacy with PD-1 checkpoint inhibitors in mouse models

• Blockade of PD-1 may restore adaptive immunity through effector T-cell signaling, function, and proliferation1,2

• Combining the modulation of the tumor microenvironment provided by STING activation with the increase in T-cell activity provided by PD-1 blockade1–3 may further improve anti-tumor immunity

• Spartalizumab (PDR001) is an investigational monoclonal antibody that blocks the interaction between PD-1 and PD-L1/25

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*p < 0.05, **p < 0.01, ***p < 0.001.1. Pardoll DM. Nat Rev Cancer 2012;12:252–264; 2. Keir ME, et al. Annu Rev Immunol 2008;26:677–704; 3. Sivick KE, et al. Cell Rep 2018;25:3074–3085; 4. Sivick KE, et al. SITC 2018. Poster presentation:abstract P351; 5. Wirth L, et al. ASCO 2018. Poster presentation; abstract 6024.


• Combining MIW815 (ADU-S100) with systemic anti-PD-1 elicited near complete clearance of injected and non-injected tumors in mice3,4

Figure reproduced with permission from Sivick KE, et al. Cell Rep 2018;25:3074–3085.

Ph Ib MIW815 (ADU-S100) + spartalizumab in patients with advanced solid tumors or lymphomas

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NCT03172936IV, intravenous; MTD, maximum tolerated dose; PD, pharmacodynamics;

PK, pharmacokinetics, RDE, recommended dose for expansion; TNBC, triple negative breast cancer.


Dose ExpansionMTD/RDE

Data cut-off: April 5, 2019Primary objective: Safety and tolerabilitySecondary objectives: Preliminary anti-tumor activity, PK, and PD

MIW815 (ADU-S100) (intratumoral injection)

Weekly (3-weeks-on/1-week-off)+ spartalizumab (400 mg IV) monthly

Dose EscalationSolid tumors and lymphomas

Parallel non-randomized assignment

MIW815 (ADU-S100) (intratumoral injection) Monthly

+ spartalizumab (400 mg IV) monthly

MIW815 (ADU-S100)

dose

Key inclusion criteria: • Ability to undergo tumor biopsies of injected and

non-injected lesions• Injectable lesions are cutaneous,

subcutaneous, or nodal• Prior immunotherapy is permitted

• Patient population was enriched for TNBC and melanoma indications by allowing backfill of lower dose cohorts

Patient demographics and disease characteristics

All patients (N = 83)Median age, y (range) 61 (27–93)Sex, n (%)

MaleFemale

42 (50.6)41 (49.4)

ECOG PS, n (%)01

20 (24.1)63 (75.9)

Prior lines of therapy012≥3

2 (2.4)10 (12.0)19 (22.9)52 (62.7)

Prior immunotherapy, n (%)YesNo

60 (72.3)23 (27.7)

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Data cut-off: April 5, 2019ECOG PS, Eastern Cooperative Oncology Group performance status.


All patients(N = 83)

Primary diagnosis, n (%)MelanomaTNBCBreast cancer (not TNBC)LymphomaColorectal cancerSquamous cell carcinoma of skinHead and neck cancerMerkel cell carcinomaOvarian cancerSarcomaGastric cancerEsophageal cancerProstate cancerOther solid tumors

35 (42.2)11 (13.3)

6 (7.2)4 (4.8)3 (3.6)3 (3.6)3 (3.6)2 (2.4)2 (2.4)2 (2.4)1 (1.2)1 (1.2)1 (1.2)

9 (10.8)

Patient disposition

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*For patients with progressive disease that was not confirmed by imaging, sites were asked to enter the reason for discontinuation as physician decision.

Disposition, n (%) MIW815 weekly (3-weeks-on/1-week-off)+ spartalizumab monthly

MIW815 monthly + spartalizumab

monthly

All patients

Patients treatedOngoingDiscontinued

n = 5316 (30.2)37 (69.8)

n = 306 (20.0)

24 (80.0)

N = 8322 (26.5)61 (73.5)

Primary reason for discontinuationDeathProgressive diseasePhysician decision*Patient decisionAEs

1 (1.9)20 (37.7)12 (22.6)

3 (5.7)1 (1.9)

0 (0)16 (53.3)4 (13.3)3 (10.0)1 (3.3)

1 (1.2)36 (43.4)16 (19.3)

6 (7.2)2 (2.4)


Data cut-off: April 5, 2019

Safety of MIW815 (ADU-S100) + spartalizumab

AEPatients (N = 83)

Any grade, n (%)Total 48 (57.8)Injection site pain 11 (13.3)Pyrexia 10 (12.0)Diarrhea 8 (9.6)Rash 5 (6.0)

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ALT, alanine aminotransferase; AST, aspartate aminotransferase.1. Meric-Bernstam F, et al. SITC 2018 poster presentation: abstract P309; 2. Naing A, et al. ASCO 2016 poster presentation: abstract 3060.


• No dose-limiting toxicities were reported in any of the dosing cohorts

• The AEs of the combination are no more frequent or severe than those reported in either single-agent trial1,2


AE Patients (N = 83)Grade 3/4, n (%)

Total 10 (12.0)Increased lipase 3 (3.6)Diarrhea 2 (2.4)Increased ALT 2 (2.4)Increased AST 2 (2.4)Fatigue 1 (1.2)Pyrexia 1 (1.2)Increased amylase 1 (1.2)Hyperthyroidism 1 (1.2)Dyspnea 1 (1.2)Hyponatremia 1 (1.2)Partial seizures 1 (1.2)Pneumonitis 1 (1.2)Maculo-papular rash 1 (1.2)

Most common (≥5% of patients) treatment-related AEs of any grade

All treatment-related Grade 3/4 AEs

Pharmacokinetics: Cohorts 50 to 800 µg

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C, cycle; D, day.


MIW815 weekly (3-weeks-on/1-week-off)+ spartalizumab

• Fast absorption of MIW815 (ADU-S100) to plasma was observed

• Maximum concentration reached at the end of intratumoral injection

• MIW815 (ADU-S100) was eliminated quickly with short plasma half-life ranging from 8 to 28 min

• No accumulation was observed after multiple dosing at C1D15 and C3D1

• Plasma exposure increases dose-proportionally from 50 to 800 μg

0 2 40.5 1 0 2 40.5 1 0 2 40.5 10.01

0.3

102050

100Cycle 1 Day 1 Cycle 1 Day 15 Cycle 3 Day 1

Time (hours)

MIW

815

Plas

ma

Conc

entr

atio

n (n

g/m

L)

MIW815 dose (μg) 50 200100 400 800

Systemic IFN-β concentrations as PD biomarker

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Data cut-off: April 25, 2019AUClast, area under the concentration–time curve from time zero to time of last measurable concentration;

IL-6, interleukin-6; IP-10, interferon gamma-induced protein 10; MCP-1, monocyte chemoattractant protein 1.

Change in IFN-β at 6 hours post-treatment versus pre-dose

PK/PD analysis of IFN-β concentration change from pre-dose by AUClast


• Systemic IFN-β levels appear to increase in a dose-dependent manner• Trend observed between IFN-β levels and systemic exposure • Other cytokines detected (IP-10, MCP-1, and IL-6) did not demonstrate significant dose dependency

and/or PK/PD relationships

IFN

-βco

nc c

hang

e (p

g/m

L)

3

2

1

0

50 ug 100 ug 200 ug 400 ug 800 ugMIW815 dose (+ spartalizumab)

MIW815 + spartalizumab (3-weeks-on/1-week-off) Cycle 1 Day 8

Cycle 1 Day 15Cycle 3 Day 1

Cycle 1 Day 1

AUClast (ng/mL*hr)

IFN

-βco

nc c

hang

e (p

g/m

L) MIW815 + spartalizumab (3-weeks-on/1-week-off) Cycle 1 Day 8

Cycle 1 Day 15Cycle 3 Day 1

Cycle 1 Day 1

0.1 10.0

2

1

0

Preliminary anti-tumor activity

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CRC, colorectal cancer; SCC, squamous cell carcinoma. Data cut-off: April 5, 2019


• No patients achieved a response; however, six patients achieved a SD• Tumor types: Ovarian, breast, uveal melanoma, head and neck, and cutaneous melanoma• Four of whom maintained SD for ≥6 monthsM

IW81

5 (A

DU-S

100)

m

onth

ly

• Confirmed responses were achieved in five patients, one of which was a CR• Three of these responses (including the CR) were observed in patients with IO-naive TNBC; these patients

are continuing to receive treatment at time of data cut• Two of these patients with TNBC expressed PD-L1 levels of >1% at baseline (data from the third patient

are not available)• The two remaining responders had previously IO-treated melanoma

(of 35 melanoma patients enrolled across the whole study, 7 not yet reimaged)• An additional 12 patients achieved SD

• Tumor types: Sarcoma, melanoma, SCC skin, breast, lymphoma, and head and neck

MIW

815

(ADU

-S10

0)

3-w

eeks

-on/

1-w

eek-

off

Response and duration of exposure MIW815 weekly (3-weeks-on/1-week-off) + spartalizumab monthly

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Data cut-off: April 5, 2019CR, complete response; IO, immuno-oncology.


• The patient population was enriched for TNBC and melanoma indications by allowing backfill of lower-dose cohorts

Duration of exposure (months)

Dos

e of

MIW

815

(+ sp

arta

lizum

ab)

0 5 10 15 20 25

MelanomaCutaneous Melanoma

Non-Cutaneous MelanomaSarcoma

MelanomaCutaneous Melanoma

Cutaneous MelanomaTNBC

Cutaneous Melanoma

Lymphoma-Hodgkin’s disease

TNBCBreast CancerSquamous Cell Carcinoma of skin

Cutaneous MelanomaCutaneous Melanoma

TNBC

MelanomaMelanoma

Breast CancerTNBCTNBCTNBC

Lymphoma-Non-Hodgkin’s disease

Cutaneous MelanomaOther

MelanomaLymphoma-Non-Hodgkin’s disease

MelanomaTNBC

MelanomaColorectal cancer

Breast cancer

MelanomaBreast cancerNon-cutaneous melanoma

Cutaneous melanomaBreast cancer

TNBCOther

TNBC

OtherOther

Cutaneous melanomaMelanoma

Melanoma Melanoma

= Prior IOOngoing

Y

ResponseCRPRSDPD

Cutaneous MelanomaColorectal Cancer

OtherSarcoma

Gastric Cancer

Other

TNBC

1600

μg

800

μg40

0 μg

200

μg10

0 μg

50 μ

g

Response and duration of exposureMIW815 monthly + spartalizumab monthly

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Cutaneous melanoma

= Prior IOOngoing

Y

ResponsePRSDPD


Non-cutaneous melanomaOther

Ovarian cancerMelanoma

Squamous cell carcinoma of skin

Head and neck cancerMerkel cell carcinoma

Merkel cell carcinomaOther

Ovarian cancerLymphoma-non-Hodgkin’s disease

Colorectal cancerTNBC

Head and neck cancerCutaneous melanoma

Uveal melanoma Melanoma

Esophageal cancerMelanoma

Head and neck cancerCutaneous melanoma Cutaneous melanoma

Cutaneous melanoma Breast cancer

Prostate cancer

Cutaneous melanoma Melanoma Other

Squamous cell carcinoma of skin

0 5 10 15 20

Dose

of M

IW81

5 (+

spar

taliz

umab

)

1600

μg

800

μg40

0 μg

200

μg10

0 μg

50 μ

g

Percentage change from baselineSum of target lesion diameters (evaluable patients)

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MIW815 monthly + spartalizumab

OngoingResponse CRPRSDPD

MIW815 Dose Level (μg)501002004008001600

Perc

enta

ge ch

ange

from

bas

elin

e

-100

100

50

0

-30-50

2 4 6 140 8 10 12Time (months)

MIW815 weekly (3-weeks-on/1-week-off)

+ spartalizumab

Perc

enta

ge ch

ange

from

bas

elin

e

-100

100

50

0

-30-50

2 4 6 180 8 10 12 14 16Time (months)

CD8 IHC increased in responding patients with high PD-L1 at baseline

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*Tumor samples were stained using the PD-L1 IHC 22C3 pharmDx assay on the Dako autostainer and given a tumor positivity score by a pathologist.IHC, immunohistochemistry; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria In Solid Tumors; SD, stable disease; UNK, unknown. Data cut-off: April 25, 2019


• Two patients demonstrating best response (PR) had high levels of PD-L1* staining in their injected lesions at screening

20

10

0

30

CD8

perc

ent m

arke

r are

a

20

10

0

30

50 100 200 400 800

Injected lesion

Non-injected

lesion

MIW815 (3-weeks-on/1-week-off) + spartalizumab

PD-L

1 pe

rcen

t pos

itive

tum

or

75

250

100

50

75

250

100

50

Injected lesion

Non-injected lesion

MIW815 dose (μg):

Best overall response

per RECIST v1.1 or Cheson 2014 for

Lymphoma (with confirmation)

PRSDPDUNK

Response and duration of exposure in patients with TNBC

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*Tumor samples were stained using the PD-L1 IHC 22C3 pharmDx assay on the Dako autostainerand given a tumor positivity score by a pathologist; †3-weeks-on/1-week-off.NA, data not available. Data cut-off: April 5, 2019


• Three patients had durable PR/CR, five patients had radiographic or clinical PD, one patient had pneumonitis, and the two remaining patients are too early for assessment

Ongoing

Response CRPRPD

MIW815 dose level (+ spartalizumab)

50 μg200 μg400 μgPe

rcen

tage

chan

ge fr

om b

asel

ine

-100

100

-50-30

50

0

2 4 60 8 10 12 14 16 18Time (months)

5 of the 11 patients with TNBC were radiographically evaluable for efficacy

0 5 10 15 20

NANANANANANA

>1%NA

>1%NA

>50%

PD-L1 % positive tumor*

= Prior IOOngoing

Y

50 μg weekly†

100 μg weekly†

200 μg weekly†

400 μg weekly†

800 μg weekly†

200 μg monthly

MIW815 dose level (+ spartalizumab)

ResponseCRPRPD


Patient vignette

• 64-year-old post-menopausal female diagnosed with stage I TNBC, now with metastases to the brain, axilla, lung, skin, and thigh

• Prior therapy: • S/P surgical resection and adjuvant cyclophosphamide, doxorubicin,

5-fluorouracil and paclitaxel, radiotherapy• S/P eribulin for metastatic disease• S/P radiotherapy to brain

• Remains on study 18+ months• Developed hyperthyroidism on study

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S/P, status post.


IHC of injected lesion, Sub-Q tissue - PR

25

Scre

enin

g C2

D18

* % biomarker area (image analysis).** % tumor-positive score (pathologist scored).

H&E CD8*CD163*PD-L1** (22C3)

Screening: Large numbers of macrophages throughout tumor nest Both macrophages and tumor cells appear positive for PD-L1On treatment: Tumor cells limited to areas of non-viable tissue and debris

100 11.79 0.63


Imaging


0.0 cm

4.4 x 4.3 cm

0.0 cm

3.6 x 2.6 cm 1.8 x 1.8 cm

0.5 x 0.3 cm

Baseline

Cycle 4Day 22

Conclusions

• MIW815 (ADU-S100) + spartalizumab was generally well tolerated in patients with solid tumors or lymphomas, with no dose-limiting toxicities reported as of the data cut-off

• The MTD has not been reached and dose-escalation is ongoing• MIW815 plasma exposure increases dose-proportionally• IFN-β concentrations appeared to increase with increasing exposure

to MIW815 (ADU-S100)• The combination has demonstrated anti-tumor activity in PD-1–naive

TNBC and PD-1–relapsed/refractory melanoma


Acknowledgments


Study sites• MD Anderson Cancer Center• Peter MacCallum Cancer Centre • Angeles Clinic and Research Institute • Princess Margaret Cancer Centre • University of Chicago Cancer Center• National Cancer Center Hospital Japan• Hospital Kliniken Essen-Mitte• Netherlands Cancer Institute • Melanoma Institute of Australia • Comprehensive Cancer Center Zürich • Institut Català d'Oncologia

Aduro• Andrea van Elsas• Sarah McWhirter• Thomas Mueller • Anthony Desbien• Leticia Corrales

Novartis• Jose Carlos Torres• Saero Park• Xinhui Heller Chen• Marc Pelletier• Helen Oakman• Fang Xiang• Jincheng Wu

• The authors would like to thank the patients who participated in the trial, and their families/caregivers

• This study was funded by Novartis Pharmaceuticals Corporation and Aduro Biotech

• Editorial assistance was provided by Zoe Crossman, PhD of ArticulateScience Ltd. and was funded by Novartis Pharmaceuticals Corporation and Aduro Biotech

Acknowledgements

Aduro would like to thank Dr. Funda Meric-Bernstam and the investigators as well as patients who participated in the trials of ADU-S100 (MIW815)

and their families/caregivers.Thank you for attending today’s update on Aduro’s STING program.

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