webinar logistics - cello health bioconsulting
TRANSCRIPT
• 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
• 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
• 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
• 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
• 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
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
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
Panelist Discussion
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
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
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;
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
~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
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
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
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
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
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
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
Source: Linda Pullan, raw data from GlobalData
Deals mentioning “bispecific” are going up in number and value
DEALS
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
COMPETITION WITH BISPECIFICS
Bispecifics Competing with Adaptive Cell therapy, ADCs, vaccines, etc
§ Adis R&D Insight; Clarivate Analytics Cortellis Source: Defined Health
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
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
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
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
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
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
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REMINDERS
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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