INTRODUCTION TO LLS THERAPY ACCELERATION PROGRAM · 2019. 9. 9. · Strategic initiative...
Transcript of INTRODUCTION TO LLS THERAPY ACCELERATION PROGRAM · 2019. 9. 9. · Strategic initiative...
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INTRODUCTION TO LLS
THERAPY
ACCELERATION
PROGRAM
August 2019
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BLOOD CANCERS
Every 3 minutes someone in the US is diagnosed
with a blood cancer.
More than one third of blood cancer patients do
not survive five years after diagnosis.
Despite improved outcomes, we need to do more!
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OUR MISSION
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LLS Research focuses on discovering and developing therapies to positively impact care for blood cancer patients
Discovery Development Commercialize
Patient Education,
Access & Advocacy
Research Grant
Programs
Therapy
Acceleration
Program®
Beat AML
Initiative
LLS PedAL
(Pediatric Acute Leukemia)
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Research by Funding Mechanism - FY18
TRP 32%
$52.6 Million
Canada 7%
MCL 4%
CDP 20%
TAP
12%
SCOR 18%
Other 5%
CDP – career development program
TRP – translational research program
SCOR – specialized center of research
SLP – screen to lead program
MCL – mantle cell lymphoma program
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Therapy Acceleration Program (TAP)
Strategic initiative established in 2007
Accelerate high-risk innovative blood cancer therapeutics
Meeting LLS Mission is first priority
Generating ROI to further fund LLS Mission is secondary
Biotechnology Accelerator Academic Concierge Co-funding up to 50% Funding up to 100%
LLS TAP
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>60 projects; >$120M invested to
date
18 active programs
3 FDA-Approved Therapies Vyxeos (AML)
Yescarta (DLBCL, tFL, PMBCL)
Elzonris (BPDCN)
Promising clinical data with CD47 mAb 5F9 (DLBCL and FL1, and
MDS2)
NK cell engager AFM13 (HL and CTCL)3
duvelisib (PTCL) 4
LTherapy Acceleration Program (TAP)
Supports Emerging New Therapies
1. Advani et al. 2018. NEJM. 379: 1711-1721
2. Sallman ASCO 2019
3. Ansell and Sawas ICML 2019
4. Horwitz et al. 2018. Blood. 131: 888-898
= new
www.lls.org/therapy-acceleration-program
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Development Stages of TAP Portfolio
Current Total
Development Phase
Phase II Reg / Phase III 3 7
Phase II (Non Registration) 7 11
Phase I 5 23
Preclinical 2 19
Clinical Trial Networks/
Patient Care1 4
TOTAL 18 64
Current Focus:Clinical Proof of Concept
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PAGESelect Active Projects in TAP Portfolio
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PAGELLS TAP Process
Open to funding application year round
All hematological indications
Focuses on therapeutics development in the clinic
Typically $2-6M dollars (co-funding for companies)
– equity or milestone based
Applicants fill out 1-page Inquiry Form to start the process
LLS Staff
Evaluation
External
Expert
Consultation
TAP
Committee
Review
Contract
Negotiation &
Execution
Project
Management
How to apply for TAP: www.lls.org/therapy-acceleration-program
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PAGELLS TAP Funding Is Competitive
Timeline: typically 3-6 months
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PAGELLS TAP Committee
Subcommittee of LLS National Board
Members consist of KOLs, IP lawyer, VC-investors in
biotech, Industry veterans
TAP Research performs S&E and recommends TAP
projects to the Committee
Company presents to the TAP Committee
The Committee may approve, conditionally approve or
reject company funding request
Committee approval provides Research BD to proceed
to Term Sheet and then formal Agreement
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Key Criteria
High Unmet Medical Need
Innovative Science
First-in-Class
Clinical PoC Study or Registration-Directed Study
Strong IP Position
Competent Management Team
Solid Corporate Finance
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Why Companies Come to TAPin addition to $$
Deep knowledge of blood cancer landscape
Expertise in hem/onc clinical development within LLS
and via KOLs
Connections to patients
Advocacy efforts for patients
Biotech companies leverage LLS approval to raise
additional funds
Track record of success
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PAGETAP is Bridging the Gap for Biotech
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We have one goal: A world without blood cancers
THANK YOU
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FY18 Research Spend by Disease
Research Budget: $52.6 Million
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PAGETAP Bull’s-Eye – All ProjectsAs of Aug 1, 2019