corporate presentation november 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · this...
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![Page 1: Corporate Presentation November 15, 2017filecache.investorroom.com/mr5ir_agenus/159... · This presentation contains forward-looking statements. These forward-looking statements are](https://reader033.vdocuments.us/reader033/viewer/2022050103/5f42449c45cf91000a716ff4/html5/thumbnails/1.jpg)
Corporate Presentation November 15, 2017
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This presentation contains forward-looking statements. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and made available on our website at www.agenusbio.com. When evaluating Agenus’ business and prospects, careful consideration should be given to these risks and uncertainties. These statements speak only as of the date of this presentation, and Agenus undertakes no obligation to update or revise these statements. This presentation and the information contained herein do not constitute an offer or solicitation of an offer for sale of any securities.
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Forward-Looking Statements
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Agenus: driving success in I-O
Record of speed and efficiency in advancing I-O portfolio to clinic
Optimal pipeline of leads for effective combinations
Enabling partnerships for validated & novel agents and cGMP product for clinical/pivotal trials*
Fully integrated capabilities from discovery to GMP manufacturing
Separate cell therapy business advancing; designed to unlock shareholder value
Highly experienced team
*AGEN1884 (CTLA-4) and AGEN2034 (PD-1)
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Agenus I-O 1.0 Pioneer Cancer Vaccines QS-21 Stimulon® Adjuvant
1994 – 2007
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2008 – 2013
Agenus I-O 2.0 Cancer Experience & Endurance
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2014 – 2017
Agenus I-O 3.0 Growth with a Complete Arsenal Neoantigen Vaccines, Checkpoint Antibodies Cell Therapy, QS-21 Stimulon® Adjuvant
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FUTURE
Agenus I-O 4.0 Combination and Speed Speed of discovery and development Optimizing the activity of leads
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We successfully integrated strategic building blocks
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Capabilities
Key Acquisitions
• Aquila (2000) adjuvants
• 4-AB (2014) checkpoints
• PhosImmune (2015) novel neoantigens
• XOMA (2015) antibody manufacturing
Platforms/Products
• 5 platforms
• GMP manufacturing
• 5 clinical candidates*
Partnerships
• GlaxoSmithKline
• Incyte
• Amgen
*Includes 2 programs partnered with INCY
• Merck
• UCB
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Close on near-term revenue opportunities
Licensing & Partnerships
Innovation drives business sustainability
Prioritize for partnering & investment
Operational excellence
Funding our business
Monetization and BD activities
Path to Commercial*
AGEN1884 + Keytruda: 1L NSCLC PD-L1+++ AGEN2034 + AGEN1884: 1L NSCLC PD-L1+++, 2L Cervical AGEN2034 Monotherapy: CSCC, 2L Cervical
Fastest path to
commercialization to
Fuel innovation
Our plan: Integrating combinations, speed & partnerships
*Potential path to BLA
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5 INDs^ filed in 2016 - 2017
4 Therapeutic modalities
6 Technology platforms
5 Ongoing/planned trials^
5 Partnerships
Since entering the I-O space, we have made substantial progress
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I-O Capabilities & Portfolio
Speed & Efficiency
Validated targets CTLA-4 and PD-1
Effective Combinations for Patients
CPMs, Vaccines, Cell Therapy*, Adjuvants
Mammalian, Yeast, Phage, Bispecific, PTTs, TCR* Manufacturing Commercial yields (>4g/L)
Pipeline >12 pipeline products
CPM + Vaccine CTLA-4 + AutoSynVax
CPM + CPM Novel CPM + CTLA-4 + PD-1
*Program expected to advance through a separate subsidiary, AgenTus Therapeutics ^Includes 2 programs partnered with INCY
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1
2
3
4
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7
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Roche AZ Pfizer Incyte Merck BMS Agenus Novartis
Our speed to clinic places us solidly among the leaders in I-O
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Number of I-O programs with US Phase I trials initiated since 2H2015
2 programs partnered
with Agenus
5 programs into clinic
in 2 years*
*Includes 2 programs partnered with INCY
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Broad I-O portfolio ranges from early- to late-stage programs
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AGEN1884 and AGEN2034 are being evaluated in 2L cervical cancer, advanced cutaneous squamous cell carcinoma, and non-small cell lung carcinoma AGEN1884 and AGEN2034 are partnered with Recepta for certain South American rights * Phase 2 recruiting in Australia
Product Disease/Target Partner Preclinical Ph1 Ph2 Ph3 Filed Approved Checkpoint Antibodies AGEN1884 CTLA-4 (antagonist)* next-gen CTLA-4 CTLA-4 (antagonist) AGEN2034 PD-1 (antagonist)
CD-137 (agonist) TIGIT (antagonist) Bispecific (regulatory T cell depletion) Bispecific (TME conditioning) Undisclosed
INCAGN1876 GITR (agonist) INCAGN1949 OX40 (agonist)
TIM-3 (antagonist) LAG-3 (antagonist) Undisclosed
Vaccines ProphageTM Glioblastoma (newly diagnosed) AutoSynVaxTM Cancers PhosphoSynVaxTM Cancers Adjuvant QS-21 Stimulon® Shingles
Malaria
Agenus fully-owned programs Partnered programs
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Developing effective combinations
Jennifer S. Buell, PhD Chief Communications and External Affairs Officer
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Multi-platform I-O portfolio well positioned for effective combinations
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Checkpoints Antibodies Shape Immune response
Personalized Cancer
Vaccines Educate
Immune system
Adoptive Cell Therapy* Augment
Immune system
>12 programs • 3 mAb display platforms •
Bi-specific discovery • Cell line development •
GMP mAb manufacturing •
• 3 platforms including PTT antigens
• Adjuvants, QS-21 Stimulon®
• GMP vaccine manufacturing
• Unique targets and product format strategy
• Leverages other platforms- discovery to manufacturing
*Program expected to advance through a separate subsidiary, AgenTus Therapeutics
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Agenus development plan for sustained revenue generation
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PD-1/CTLA-4
PD-1+ CTLA-4
(+novel CPMs)
Neo-antigen vaccines (+CPMs)
Adoptive cell therapy (CPM/vaccine combo)
Checkpoint Monotherapy
Checkpoint Combinations
Neoantigen Vaccines + Checkpoints
Cell Therapy* (+ Checkpoints)
Pat
ient
Pen
etra
tion
with
Effe
ctiv
e Tr
eatm
ents
Develop, register, launch validated CTLA-4 & PD-1 in 2020
Expand market with novel target combos (Neo-antigen vaccine, TIGIT, CD137)
Expand strategic partnerships (GSK, Merck, Incyte, UCB, etc.)
ü ü ü
*Program expected to advance through a separate subsidiary, AgenTus Therapeutics
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2017
Q1 Q2 Q3 Q4 Q1
AGEN2034 2L Cervical cancer*
AGEN1884/AGEN2034 Pivotal trial launch**
AGEN1884 Ph 1
2018
Q2 Q3
2019
Q4 Q1 Q2 Q3
2020
Q4 Q1 Q2 Q3 Q4
*Potentially in combination with AGEN1884; **Projections ^Designed as potential pivotal trials 1=AGEN1884; 2=AGEN2034;
US filing ** US approval **
Q4
Q4 Q1 Q2 Q3 Q1
MFG ready to supply pivotal programs 1
• Develop, register, launch validated CTLA-4 & PD-1 • Selected indications de-risk path to BLA • Trials designed as pivotal for BLA filing as soon as 2H2019 • Global site participation AGEN2034 P1
AGEN1884 + Keytruda in 1L NSCLC
Path to BLA: AGEN2034 (anti-PD-1) & AGEN1884 (anti-CTLA-4)
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AGEN2034 Cutaneous squam cell*
Trials designed as registrational trials to support BLA filing as soon as 2H2019^
Ph1 accrual
Pivotal design
2
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2017 2018 2019 2020 2021 2022
We expect to submit our first BLA by 2H2019, followed by other product opportunities
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Number of Programs
PD-1
ASV
TIGIT
CD137
Multi-specific 2
Next-Gen CTLA-4
LEAD CPMs
CTLA-4/PD-1
Multi-specific 1
Novel mAb
Cell Therapy*
ASV
BLA IND
Potential novel
Potential novel
*Program expected to advance through a separate subsidiary, AgenTus Therapeutics
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2016 / 2017 2017 2018
Accomplishments • Five programs to clinic ‒ CTLA-4 (AGEN1884)* ‒ GITR (INCAGN1876)** ‒ OX40 (INCAGN1949)** ‒ PD-1 (AGEN2034)* ‒ Neoantigen vaccine (AutoSynVax™) in
clinic
• US FDA and Health Canada approval of GSK SHINGRIX containing Agenus QS-21 Stimulon® adjuvant
• CDC ACIP recommended Shingrix as preferred vaccine for prevention of shingles
Deliverables • Clinical results ‒ Optimal monotherapy dose for AGEN2034* ‒ Target dose to initiate combinations
AGEN2034* + AGEN1884*
• Clinical trials ‒ Initiate CTLA-4 + PD-1combination trials
• Clinical responses ‒ CTLA-4 & PD-1 preliminary clinical data ‒ ASV safety and proof-of-mechanism
• GMP MFG readiness to supply clinical CTLA-4 and PD-1
Clinical Activity & Readouts • Complete enrollment and
top-line data for pivotal cohorts+ cohort: ‒ Pharmacodynamic data ‒ Response rate ‒ Duration of response ‒ Safety and tolerability
• GMP MFG readiness to supply CTLA-4 and PD-1 pivotal trials (1H2018)
Our recent accomplishments and near-term milestones
* Partnered with Recepta for certain South American rights; ** Partnered with INCY; + planned data from 2LCC and/or CSCC 18
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Expanding benefit through first-in-class/best-in-class products
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*Clinically validated in viral dx setting and oncology compassionate use setting
AutoSynVax™ clinically validated* neoantigen vaccine platform
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• Potential best-in-class vaccine blueprint with QS-21 Stimulon® adjuvant for efficacy and manufacturing
• Clinically validated in viral setting*
• Long-term memory response (preclinical)
• MHC class I and II presentation
• Optimized delivery and peptide sparing
• End-to-end logistics: 20 years operational & FDA audited
AutoSynVaxTM Clinical Status
• Phase 1 ongoing • Safety and immunological readout expected 2017
Media (Negative Control)
Viral Peptides (Positive Control)
Neoantigen Peptide Pool
AutoSynVax™ promotes de novo immune recognition in clinic*
Post-Dose 3 Post-Dose 5
0 0 0
965 1035 1059
0 0 1
1096 1149 1161
278 307 318 31 44 45
Uduman et al. 2017 AACR
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Mechanism #1 Blockade of CD80 & CD86 binding to CTLA-4
Anti-CTLA-4 antibodies – advancing innovation
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Mechanism #2 Depletion of intratumoral Tregs via co-engagement of FcγRs
Mechanism #3 (Distinct)
Smyth M. et al., ICB 2014 Bulliard Y. et al., ICB 2014 Bulliard Y. et al., JEM 2013 Simpson et al., JEM 2013 Shelby et al., Can. Immunol. Res. 2013
Ligand blocking assay
Isotype Anti-CTLA-4 CD80
Isotype Anti-CTLA-4 CD86
CTLA-4 is a validated and foundational target with demonstrated clinical relevance
Agenus’ lead anti-CTLA-4 IgG1 is advancing in the clinic with combination trials planned in 4Q2017
Agenus is also advancing a novel IgG1 antibody that exhibits a distinct mechanism for CTLA-4 antagonism
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TIGIT modulates the innate and adaptive arms of the immune system to impair productive anti-tumor immunity
Antibody blockade of TIGIT combines effectively with other immune modulators (co-inhibitory and co-stimulatory antibodies) to promote tumor rejection in preclinical mouse tumor models. Example: PD-1/PDL-1 pathway
TIGIT: Potent novel negative regulator of immune synapse
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Prevention of CD226 co-stimulation
1
2
3
4
1
2
3
4 Induce immunosuppressive DCs (↑IL-10)
TIGIT-induced suppression of T and NK cells
Enhance Treg suppressive activity
Manieri et al., 2016
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Building value for our partners
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Our strategy builds value for Agenus, our partners, and patients
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Next generation Products
Efficacious Foundational CPMs Differentiated
x = Next
Generation
Bi-specifics TIGIT
CD137 vaccines
CTLA-4 PD-1
Validated
checkpoint targets
Expanded efficacy and market leadership
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Agenus is partnered with industry leaders
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• 1 undisclosed target • Lead selection complete; antibody advancing, milestone recently announced • Up to an additional $99 million in milestones
• Preclinical: LAG-3, TIM-3, 1 undisclosed ‒ Royalty rates are generally 6-12%
• Clinical: GITR, OX40 ‒ Royalty rate 15%
• Up to $510 million in milestones across all programs
• QS-21 Stimulon® adjuvant for Shingrix • Approved in US and Canada; Filed in EU, Japan, AUS • CDC's Advisory Committee on Immunization Practices recommended
Shingrix as preferred vaccine for prevention of shingles • Royalties partly monetized
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Cell Therapy Business Entity
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Bruno Lucidi – CEO AgenTus Therapeutics
• 30 years of industry experience • Vice President and Head of Pediatric Vaccines at GSK Biologicals
(developed $3bn global business) • Worldwide Vice-President Virology & Oncology at Johnson &
Johnson • Leadership at Bristol-Myers Squibb responsible for EU strategy and
launch of Videx® (didanosine), Zerit® (stavudine), Paraplatin® (carboplatin) and Taxol® (paclitaxel).
• Founding CEO of Idenix and the Chairman of Pharmasset where he laid the foundation for multi-billion dollar companies (acquired by MRK and GILD for $4bn and $11bn, respectively)
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Allogeneic Format
Allogeneic approach; “Off-the-shelf” Scalable, shorter diagnosis to treatment interval
T-Rx Mammalian Display - Direct selection for function Targets optimal balance between activity and specificity
Novel Targets
Proprietary target discovery and validation platforms Proprietary Phosphopeptide Tumor Targets
Precision Receptors
Differentiated cancer cell therapy
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Agenus: driving success in I-O
Record of speed and efficiency in advancing I-O portfolio to clinic
Optimal pipeline of leads for effective combinations
Enabling partnerships for validated & novel agents and cGMP product for clinical/pivotal trials*
Fully integrated capabilities from discovery to GMP manufacturing
Separate cell therapy business advancing; designed to unlock shareholder value
Highly experienced team
*AGEN1884 (CTLA-4) and AGEN2034 (PD-1)
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