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Page 1: Bionest Immuno-Oncology Capabilitiesbionest.com/wp-content/uploads/2016/05/2016... · 2016 – Slide 3 IO Frenzy Raises Key Strategic Questions ... additional PD-1/L1 inhibitors as

1

Bionest Immuno-Oncology Capabilities

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ARE YOU POSITIONED FOR SUCCESS

IN NEXT-GENERATION IMMUNO-

ONCOLOGY?

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Bionest Immuno-Oncology Capabilities 2016 – Slide 3

IO Frenzy Raises Key Strategic Questions

PD-1 / PD-L1

Next-Gen

Checkpoints: IDO-1, OX-40, GITR,

LAG-3, TIM-3

2 approved

3 Ph. III

Ph. I-II = 10+ What combination strategy?

What opportunity for my early stage PD-(L)1?

Biomarker or no biomarker?

How to differentiate my PD-(L)1?

15+ in clinical trials

>40 pre-clinical

Novel-combo? PD-(L)1 combo? Mono?

What opportunities for my asset?

Biomarker or no biomarker?

How can I move quickly?

As IO moves beyond the first generation of Yervoy, Opdivo, and Keytruda, more companies are investing in IO…

…opportunities abound, but the field is moving fast and opportunities

will close quickly.

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Bionest Immuno-Oncology Capabilities 2016 – Slide 4

Keys to a Successful IO Strategy

DEFINE ALTERNATIVES TO ADDRESS HIGH

IMPACT OPPORTUNITIES

Evaluate when and where to leverage combinations, whether you need a biomarker / CDx strategy, and how to maximize your asset or portfolio value

KNOW THE OPPORTUNITIES

The IO space is becoming increasingly crowded, and opportunity windows may not remain open for long

BUILD A ROBUST IO PORTFOLIO…

OR BECOME PARTNER OF CHOICE

Developing an IO focused Corporate Development Strategy is critical, whether you plan to build internally, invest in external opportunities, or focus on

external collaborations

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Bionest Immuno-Oncology Capabilities 2016 – Slide 5

What Can Bionest Do For You?

DEFINE STRATEGIC

ALTERNATIVES

MAPPING

OPPORTUNITIES

CORPORATE

DEVELOPMENT STRATEGY

In-depth IO landscape assessment

Competitor strategies and future scenarios

Mapping & prioritization of opportunity areas

Future landscape and timing of opportunity windows

How to address high impact opportunities

Combination strategy

Biomarker / CDx strategy

How and when to leverage your internal PD-(L)1

Differentiating delivery / formulation strategy

Building a competitive IO portfolio

Search & Scout to identify external opportunities

Partnering strategy

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Bionest Immuno-Oncology Capabilities 2016 – Slide 6

Bionest has a Strong Track Record in Immuno-Oncology Multiple Big Pharma and Biotech Clients

Numerous Companies Have Trusted Bionest With IO-Related Projects

Bionest Has Worked Extensively in Immuno-Oncology

In Multiple Treatment Modalities... … And Across Various Therapeutic Areas

Checkpoint Modulators

CAR-T / TCR

BiTEs

Vaccines

Solid Tumors

Melanoma, NSCLC, RCC, H&N, Gastric, HCC, CRC,

Breast, Ovarian, Prostate, Glioblastoma etc.

Heme Malignancies

B and T Cell NHL, CLL, MDS, Multiple Myeloma,

Leukemia, etc.

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Bionest Immuno-Oncology Capabilities 2016 – Slide 7

Bionest has a Strong Track Record in Immuno-Oncology Selected Project Examples

Immuno-Oncology Portfolio Strategy Immuno-Oncology Combination Strategy

In-depth review of IO landscape and clear

understanding of opportunity areas, including

competition, timelines, and efficacy

requirements

Workshop session to prioritize opportunities

and define optimal strategy to maximize

success of the program

Recommended IO strategy including a

presentation for Sr. Management

Developed understanding of the evolving IO

combination landscape

Identified opportunities to enhance the value

proposition of each of the client’s therapies to

drive differentiation and gain leadership

Bionest prioritized potential combination

partners and provided rationales for a

mutually beneficial partnership

Company Strategies

Strategy for Opportunity Area #1

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Bionest Immuno-Oncology Capabilities 2016 – Slide 8

Bionest has a Strong Track Record in Immuno-Oncology Extensive Thought Leadership

“Immunotherapy: Big Pharma’s Seductive Embrace”

IN VIVO, Dec. 2014

“Companies are…setting up combination trials early in

clinical development…This notion of seeking synergy from

the get-go is a dramatic shift in how cancer drugs are

developed, with strong implications for partnering, pricing,

and life cycle management”

SEPTEMBER 2015

“Immuno-Oncology Brings New

Opportunities for Developers of

Targeted Cytotoxics”

Personalized Medicine in Oncology

Selected Articles and Presentations

To read these articles and more, visit http://bionest.com/publications/publications/

2016

“Time to be Savvy for

Next-Generation

Immuno-oncology”

Article in Progress

2016

“Can CDx Save the Next-

Generation of Immuno-

Oncology?”

Article in Progress

First-generation IO agents have, for the most part, been widely approved. After the

focus on precision medicine for molecular therapies, it has

failed to make its way into IO thus far. However, the IO space is poised to become increasingly

complex. Experts recognize that biomarker approaches will become increasingly important, but how this will play out and who will drive this remains to

be seen.

Opdivo and Keytruda have been approved and incorporated into

standard-of-care in several indications, with other

approvals on the horizon. Companies are capitalizing on

immuno-oncology’s (IO) success, pushing forward with

additional PD-1/L1 inhibitors as well as next-generation

therapies. These companies face a highly competitive and

complex market, where past strategies may prove obsolete and more savvy bets may drive

success.

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Bionest Immuno-Oncology Capabilities 2016 – Slide 9

Bionest is a Global Consulting Firm With an Experienced Management Team

Bionest Professional Staff: Majority of the team have a Ph.D. and / or MBA degree

Europe

Rachel Laing Manager Basel

Anne-Sophie Demange Manager Paris

Alain Gilbert Co-Chairman Paris

Asia

Yasuhiro Komatsu

Senior Advisor

Tokyo

Additional Strategic partner in China

America

Mary Koto Founder San Diego

Olivier Lesueur Managing Director New York

Bob Easton Co-Chairman New York

Additional Strategic partner in South America

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Bionest Immuno-Oncology Capabilities 2016 – Slide 10 10 10

19, rue du Général Foy 75008 Paris

France

Tel: +33 1 58 05 14 00

380 Lexington Ave, 43rd Floor New York, NY 10168

USA

Tel: +1 612 212 3030

[email protected]

www.bionest.com