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Page 1: Webinar Logistics - Cello Health BioConsulting
Page 2: Webinar Logistics - Cello Health BioConsulting

•  Webinar Logistics

•  Co-Sponsor Acknowledgements

•  Introduction of Our Moderator, Linda Pullan, PhD

•  Introduction of Our Panelists

•  Snapshot of Topics for Discussion

•  Panelist Discussion

•  Responding to Audience Q&A

•  Thank you and Wrap-up

AGENDA

Page 3: Webinar Logistics - Cello Health BioConsulting

•  The web panel discussion will run from 8-9:30a PT / 11-12:30p ET.

•  Contribute questions via the Questions box in the GoToWebinar control panel.

•  We will address questions intermittently or at the end. If we don’t get to your question, we will forward them to the panel for a direct response.

•  The web panel discussion is being recorded and we will notify you via email when it becomes available.

•  Copies of the slides will also be made available to all registrants.

•  We welcome your feedback after the web panel so we can improve others in the future!

LOGISTICS

Page 4: Webinar Logistics - Cello Health BioConsulting

•  World's largest trade association of biotechnology companies, academic institutions, state biotechnology centers and related organizations across the US and in more than 30 other nations

BIO CEO & Investor Conference

•  Takes place, February 12-13, 2018 in New York

•  International biotech investor conference focuses on early and established private companies as well as emerging public companies

•  Poised for another record-breaking year of one-on-one partnering meetings

•  Visit bio.org/ceo to register and for more details

BIOTECHNOLOGY INNOVATION ORGANIZATION

Page 5: Webinar Logistics - Cello Health BioConsulting

•  Founded over 25 years ago, Defined Health, a CELLO HEALTH business, is a leading biopharmaceutical business development strategy consulting firm whose clients include a mix of pharma, biotech and specialty pharmaceutical companies

•  Defined Health's consultants hold advanced degrees in science, medicine and business, and have industry experience in business development, commercial evaluation, finance, licensing, drug discovery and R&D

Cancer Progress by Defined Health

•  Takes place, May 8-9, 2018 in New York

•  The 29th Annual Cancer Progress Conference – “The Premier Cancer Conference for Industry Leaders”

•  Visit cancerprogessbydh.com to register and for more details

DEFINED HEALTH

Page 6: Webinar Logistics - Cello Health BioConsulting

•  Provides Life Sciences organizations the confidence to simply and securely share confidential documents with third parties

•  Is the ONLY solution of this kind with biopharma-specific features

•  Commonly used for Licensing / Partnering, Asset sales, Fundraising

and

•  For communicating with Scientific Advisory Boards, Board of Directors, CROs/CMOs, regulatory advisors, consultants and other external parties

•  For protecting documents subject to sponsor and regulatory agency audits

•  As a secure corporate repository

As a recognized leader in life sciences, the Biotechnology Innovation Organization and 49 national and regional Life Sciences Associations have chosen ShareVault as their preferred virtual data room provider.

SHAREVAULT

Page 7: Webinar Logistics - Cello Health BioConsulting

OUR MODERATOR

Linda M. Pullan, PhD Pullan Consulting

•  Over 20 years of industry experience, now a well-known partnering consultant for her firm, Pullan Consulting

•  Extensive knowledge and experience in licensing and business development from Amgen, AstraZeneca, Kosan and many others

•  Began in drug discovery, led teams that put Seroquel, a multi-billion dollar antipsychotic, along with other molecules into development

Page 8: Webinar Logistics - Cello Health BioConsulting

OUR PANELISTS

Sanket Argawal, MBA Executive Director,

Global Oncology, Amgen

Jeff Bockman, PhD SVP, Head of Oncology

Practice, Defined Health

Ezio Bonvini, MD SVP, Research and CSO, MacroGenics

Chris Hurff, MBA Sr Director, Business

Development, Takeda

Taylor Schreiber, PhD CSO, Shattuck Labs

Ali Tehrani, PhD President & CEO,

Zymeworks

Page 9: Webinar Logistics - Cello Health BioConsulting

Panelist Discussion

Page 10: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 11: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 12: Webinar Logistics - Cello Health BioConsulting

DEFINITION OF BISPECIFICS, MULTI-TARGETING

Multivalent Biologics: Immune Cell-

Mul;valentBiologics

BispecificsNon-An;body(e.g.,MolecularPartners’Pieris)

BispecificsAn;body-Based

ImmuneCellEngagers

T-cellEngagers(CD3)

(e.g.,Amgen/MicrometBiTEs,Macrogenics’

DARTs))

NKCellEngagers(CD16)

CIT—CIT(e.g.,dualcheckpoint

inhibitors,Xencororf-star)

CPI-CPI CPI-Cos;m Other

Non-CIT—Non-CIT(e.g.,Macrogenics,Janssen,Roche)

Source: Defined Health §  CIT=Cancer Immunotherapy MOA; CPI=Checkpoint Inhibitors; Costim=Costimulatory Agonists;

Page 13: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 14: Webinar Logistics - Cello Health BioConsulting

~60% of Clinical-Stage Bispecific Pipeline Targets are CD3-Redirecting CD3-Redirecting also ~ 1/3 of Pre-clinical Target Types

2612

221

ClinicalStageBispecificPipelinebyTargetType(n=43)

CITCellRedirec,ng:TCell(CD3)

DualNonCIT

CITCellRedirec,ng:OtherCellTypes

Other

DualCIT

85

80

32

27

10952

Preclinical/ResearchStageBispecificPipelinebyTargetType(n=250)

UndisclosedCITRedirec,ng:TCellDualNon-CITDualCITCIT/Non-CITCombo

Source: Defined Health

CATAGORIES OF TARGETS THAT BENEFIT FROM MULTI-TARGETING

Page 15: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 16: Webinar Logistics - Cello Health BioConsulting

IgG

Knobs-in-holes,SEED,Triomab,other

AppendedIgG

DVD,Zybody,

other

Abfragments

Nanobody,Bites,DART,

other

FusionProtein

DockandLock,ImTac,other

Conjugates

IgG-IgG,Cov-X-body,scFv-peg-scFv

Adapted from Spies et Molecular immunology, 2015

FORMATS OF BISPECIFICS

Page 17: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 18: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 19: Webinar Logistics - Cello Health BioConsulting

Mostly Early, Mostly Cell Redirecting, Across Many Indications, Starting in Heme

§  Adis R&D Insight; Clarivate Analytics Cortellis; company websites; clinicaltrials.gov; DH Analysis

HemeMalignancies Solidtumor

ALL

AML

Mul;p

lem

yeloma

NHL

Hodgkin'slym

phom

a

DLBC

L

Hematologicalm

aligna

ncies

Cancer

Solid

tumor

Thyroidcancer

Breastcan

cer

Ovaria

ncancer

Periton

ealcan

cer

Fallo

pian

tube

can

cer

Prostatecan

cer

Colorectalcan

cer

NSCLC

Smallcelllun

gcancer

Lungcan

cer

Melan

oma

Ocularm

elan

oma

Pancrea;

ccancer

HCC/Livercan

cer

Gastrointes;n

alcan

cer

Gastriccan

cer

Overall M P1 P1/2 P2/3 P2 P2 P2/3 P1 P1/2 P1/2 P1/2 P2 P2 P2 P1 P2 P1/2 P1/2 P1 P1/2 P2 P2 P1 P1 P2

CITCellRedirec;ng:TCell(CD3) M P1 P1 P2/3 P2 P2/3 P1 P2 P2 P2 P1 P1 P1/2 P2 P1 P2

DualNonCIT P1/2 P1/2 P1 P1/2 P1 P1 P1 P1 P2 P1 P1 P2 P1

DualCIT P1

CITCellRedirec;ng:OtherCellTypes P2 P1

Other P1/2 P1/2 P2 P1/2 P1/2

Source: Defined Health

INDICATIONS

Page 20: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 21: Webinar Logistics - Cello Health BioConsulting

Source: Linda Pullan, raw data from GlobalData

Deals mentioning “bispecific” are going up in number and value

DEALS

Page 22: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 23: Webinar Logistics - Cello Health BioConsulting

COMPETITION WITH BISPECIFICS

Bispecifics Competing with Adaptive Cell therapy, ADCs, vaccines, etc

§  Adis R&D Insight; Clarivate Analytics Cortellis Source: Defined Health

Page 24: Webinar Logistics - Cello Health BioConsulting

COMPETITION WITH BISPECIFICS

Fierce IO competition. (US IO Pipeline Heat Maps – Common Solid Tumors)

§  Adis R&D Insight, Thomson Reuters Cortellis; DH Analysis

CountofAgentsinDevelopmentperModalitybyIndica,onP1->MRKT

Cancer

Solid

tumor

GBM

/Glio

ma

Head

and

neckcancer

Thyroidcancer

Breastcan

cer

Ovaria

ncancer

Prostatecan

cer

RCC/Re

nalcan

cer

Blad

dercan

cer

Colorectalcan

cer

NSCLC

Smallcelllun

gcancer

Lungcan

cer

Melan

oma

Pancrea;

ccancer

HCC/Livercan

cer

Esop

hagealcan

cer

Gastriccan

cer

Gastrointes;n

al

cancer

Sarcom

a

Carcinom

a

Cancerm

etastases

Cancervaccine 24 19 22 7 1 42 24 29 8 6 12 18 3 7 34 8 4 4 3 3 2CAR-Tcells 9 3 9 1 3 2 1 3 3 1Celltherapy 4 9 4 8 1 2 2 1 2 1 8 2 2 1 1 3Checkpoint 9 37 7 9 3 6 7 6 9 4 8 10 8 2 9 6 7 6 8 1 2 4Cos;m 4 16 2 3 1 2 2 1 1 4 1 1 1Cytokine 8 12 2 2 7 2 5 3 4 4 3 14 5 1 1InnateImmunity 3 6 1 3 3 2 1 5 2 1 5 2 1Oncoly;cvirus 7 14 10 10 1 6 11 9 2 3 10 5 1 3 10 6 6 2 3 2 2Othercelltherapy 1 OtherIO 6 20 3 2 2 5 3 1 2 3 1 1 3 2 1 1 1 1

HighestCountKey

1 20 50

Source: Defined Health

Page 25: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 26: Webinar Logistics - Cello Health BioConsulting

Zymework Perspective on Bispecific Platforms

Selec,onofanidealbispecific

plaaorm

FavorableCMCProfile(Manufacturability)

Reten,onofEffectorFunc,on

FavorablePK

FormatFlexibility

HowdoInvestorsandPharmaselectanidealBispecificAn;bodyFormat:•  “Toselectawellsuitedplaaorm…therearefour

factorsthatneedtobetakenintoconsidera,on:manufacturability,effectorfunc;on,PK/PDprofile,thenumberofbindingsitesrequiredandimportanceofvalency”-JoshuaE.Schimmeretal,PiperJaffrayResearch,2016

•  “TheBsAbformatisbestchosentomatchtheproposedmechanismsofac,onandthespecificclinicalapplica,on.IdeallyBsAbinseveralalterna1veformatsareconstructedandthefinalformatischosenajerinvitroandinvivofunc,onalcharacteriza,on.”-PaulCarteretal,DeptofAbEngineering,Genentech,2015

•  “DesigningBsAbtoincludeanFcregionisthemethodofchoicetosupporttargetdeple,onusingsecondaryfunc,onssuchasan,body-dependentcellularcytotoxicity(ADCC),complement-dependentcytotoxicity(CDC)andan,body-dependentcellularphagocytosis(ADCP).“-PaulCarteretal,DeptofAbEngineering,Genentech,2015

Page 27: Webinar Logistics - Cello Health BioConsulting

DEFINITIONOFBISPECIFICS,

MULTI-TARGETING

SNAPSHOT OF TOPICS

CATEGORIESOFTARGETSTHATBENEFITFROMMULTI-TARGETING

FORMATSOFBISPECIFICS

INDICATIONSCHALLENGESOFMAKINGBISPECIFICS

DEALS

COMPETITIONWITHBISPECIFICS

DATANEEDEDFORPARTNERSHIPS BUILDINGVALUE

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 28: Webinar Logistics - Cello Health BioConsulting

Please type your questions in the Questions box of the GoToWebinar control panel.

If we don’t get to your question, the panel may follow up with you directly.

Q&A

Page 29: Webinar Logistics - Cello Health BioConsulting

THANK YOU FOR JOINING US!

Linda Pullan, Moderator Pullan Consulting

Sanket Argawal Amgen

Jeff Bockman Defined Health

Ezio Bonvini MacroGenics

Chris Hurff Takeda

Taylor Schreiber Shattuck Labs

Ali Tehrani Zymeworks

Page 30: Webinar Logistics - Cello Health BioConsulting

•  The webinar has been recorded, and we will contact you when the recording becomes available. You’ll also receive an email explaining how to gain access to the presentation slides

•  You will be notified when a white paper based on this webinar has been published

•  We welcome feedback so we can improve future webinars and web panel discussions

REMINDERS

Page 31: Webinar Logistics - Cello Health BioConsulting

THANK YOU!

www.definedhealth.com

www.bio.org

www.sharevault.com

On behalf of our sponsors, our moderator and panelists, Thank you for being with us today.

www.pullanconsulting.com