INTRODUCTION TO LLS THERAPY ACCELERATION PROGRAM · 2019. 9. 9. · Strategic initiative...

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INTRODUCTION TO LLS THERAPY ACCELERATION PROGRAM August 2019

Transcript of INTRODUCTION TO LLS THERAPY ACCELERATION PROGRAM · 2019. 9. 9. · Strategic initiative...

Page 1: INTRODUCTION TO LLS THERAPY ACCELERATION PROGRAM · 2019. 9. 9. · Strategic initiative established in 2007 ... (PTCL)4 LTherapy Acceleration Program (TAP) Supports Emerging New

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