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EX-99.1 - EX-99.1 - ANAPTYSBIO, INC | d626999dex991.htm |
8-K - FORM 8-K - ANAPTYSBIO, INC | d626999d8k.htm |
Nasdaq:
ANAB Etokimab (Anti-IL-33) Program
Phase 2a Eosinophilic Asthma Clinical Trial
Interim Data Update September 24 th 2018 Exhibit 99.2 |
Safe
Harbor Statement 2
This presentation and the accompanying oral presentation contain
forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from
our clinical trials, including etokimabs Phase 2b clinical
trial in moderate-to-severe adult atopic dermatitis patients, etokimabs Phase 2 clinical trial in adult chronic rhinosinusitis with nasal polyps patients and ANB019s Phase 2 trials in GPP and PPP patients; the design of and our ability
to launch a Phase 2 clinical trial of etokimab in adult chronic
rhinosinusitis with nasal polyps patients, a Phase 2b clinical trial of etokimab in severe eosinophilic asthma patients and a Phase 2 clinical trial of ANB019 in PPP patients; the timing of detailed data presentation of
etokimabs Phase 2a clinical trial in severe adult
eosinophilic asthma patients; the timing of an IND filing for an anti-inflammatory checkpoint modulator; and the success of our partnership with TESARO and Celgene. Statements including words such as plan, continue,
expect, or ongoing and statements in the
future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those
expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that may cause the companys actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and
uncertainties related to the companys ability to advance
its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the companys ability to fund development activities and achieve
development goals, the companys ability to protect
intellectual property and other risks and uncertainties described under the heading Risk Factors in documents the company files from time to time with the Securities and Exchange Commission (SEC). These forward-looking statements speak only as of
the date of this presentation, and the company undertakes no
obligation to revise or update any forward-looking statements to reflect events or circumstances after the date
hereof. Certain information contained in this presentation may be derived from information provided by industry sources. The Company
believes such information is accurate and that the sources from
which it has been obtained are reliable. However, the Company cannot guarantee the accuracy of, and has not independently verified, such information. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be
construed as an endorsement of such products. |
Etokimab Eosinophilic Asthma Phase 2a: Top-line data today ANB019 Generalized Pustular Psoriasis Phase 2: Top-line data in early 2019 Etokimab Atopic Dermatitis Phase 2b: Top-line data in H2 2019 Etokimab Chronic Rhinosinusitis With Nasal Polyps Phase 2: Top-line data in H2 2019 ANB019 Palmoplantar Pustulosis Phase 2: Top-line data in H2 2019 AnaptysBio: Clinical-Stage Antibody Development Company Focused on Novel Antibody Medicines for Severe Inflammatory Diseases 3 TESARO Celgene Rapid Antibody Generation Platform Technology ~2.5 years Antibody Discovery Preclinical & Translational IND or Equivalent Filing Antibody Medicines For Severe Diseases Wholly-Owned Anti-Inflammatory Pipeline Etokimab (ANB020, Anti-IL-33) Atopic Dermatitis, Eosinophilic Asthma & Chronic Rhinosinusitis with Nasal Polyps
ANB019 (Anti-IL-36R)
Generalized Pustular Psoriasis & Palmoplantar Pustulosis
Checkpoint Modulator Inflammatory Diseases 4 Additional Efficacy Readouts Anticipated By End 2019 Validating Product Partnerships Generated ~$75MM* * As of June 30 th 2018 |
Wholly-Owned and Partnered Product Pipeline
6 AnaptysBio-Generated Antibodies Advanced to Clinic Since Q1 2016
All programs generated internally using AnaptysBios proprietary antibody generation
platform technology 4 |
IL-33 acts as a gatekeeper of allergic response with demonstrated activity in the initiation (activation of ILC2 cells) , propagation (activation of allergen-specific T and B cells) and amplification (degranulation of mast cells and basophils) . 5 Etokimab: First-in-Class Anti-IL-33 Antibody Broadly Applicable to Atopic Diseases IL-33 is an upstream driver of atopic disease Human genetics validate key role of IL-33 in atopic dermatitis and asthma Pro-inflammatory cytokine released upon allergen contact with epithelium Activates downstream release of IL-4, IL-5 and IL-13 Modulates IgE-mediated mast cell and basophil degranulation Etokimab is a potentially first-in- class anti-IL-33 cytokine antibody Phase I healthy volunteer trial completed without dose-limiting toxicities AnaptysBio pursuing development in moderate-to-severe atopic dermatitis, eosinophilic asthma and chronic rhinosinusitis with nasal polyps 1. Cayrol et al. Curr Opin Immunol (2014) 31:31 2. Peine et al. Trends Immunol (2016) 37(5):321 3. Saluja et al. Clin Transl Allergy (2015) 5:33 2 1 3 |
Eosinophilic Asthma Focus on Severe Patients Inadequately Controlled With ICS/LABA 6 Eosinophilic asthma is a debilitating, chronic atopic disease - Decreased lung function associated with poor quality-of-life and exacerbations - Often concomitant with other atopic diseases, such as chronic rhinosinusitis with nasal polyps and atopic dermatitis Significant unmet medical need - ~1.1 million US adults diagnosed with severe asthma and inadequately controlled with inhaled corticosteroids and long-acting-beta-agonists (ICS/LABA) - Approximately 50% estimated to be eosinophilic asthmatics |
Etokimab
Clinical Trials 7
Subjects Trial Trial Design Key Clinical Endpoint(s) Timing Healthy Volunteers Phase 1 n=96, SAD and MAD cohorts, IV and SC dosing, randomized, placebo-controlled Safety, PK and PD Top-line data announced October 2016 Detailed data presented at AAD and AAAAI 2017 Moderate-to-Severe Adult Atopic Dermatitis Phase 2a n=12, single IV dose Eczema Area & Severity Index (EASI) Top-line data announced October 2017 Detailed data presented at AAD and EAACI 2018 ATLAS Phase 2b n=300, SC multi-dose, randomized, placebo-controlled EASI Anticipate top-line data in H2 2019 Moderate-to-Severe Baseline Adult Peanut Allergy Phase 2a n=20, single IV dose, randomized, placebo-controlled Oral Food Challenge (OFC) Top-line data announced March 2018 De-prioritized for commercial reasons Eosinophilic Asthma Phase 2a n=25, single IV dose, randomized, placebo-controlled Forced Expiratory Volume in 1 Second (FEV1) Top-line data announced today Detailed data presentation anticipated in 2019 Phase 2b Undisclosed Undisclosed Anticipate initiation in 2019 Adult Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) ECLIPSE Phase 2 n=100, SC multi-dose, randomized, placebo-controlled Nasal Polyps Score (NPS); Sino- Nasal Outcome Test-22 (SNOT-22) Anticipate top-line data in H2 2019 |
8 Etokimab Eosinophilic Asthma Phase 2a Trial Single Dose of Etokimab or Placebo Administered on Day 1 Patient Population ClinicalTrials.gov: NCT03469934 Etokimab 300mg IV Single Dose + High Dose ICS/LABA n=12 Placebo Single Dose + High Dose ICS/LABA n=13 Adults with severe asthma (according to GINA 2016) Pre-bronchodilator FEV1 <80% of predicted Blood eosinophils 300 cells/microliter 1 asthma exacerbation in past year requiring rescue medication Stably maintained on ICS/LABA dose for at least 3 months prior to screening
Efficacy: % change in FEV1 relative to baseline
Biomarker: change in blood eosinophil levels
Safety Key Endpoints |
9 Key Baseline Parameters Average Baseline Parameters of Enrolled Patients (Day 1 Pre-Dose) Etokimab Arm Placebo Arm n 12 13 Blood Eosinophils per microliter 545 705 FEV1 (Liters) 2.5 2.5 % Predicted FEV1 65% 66% Age (years) 41 36 Male % 75% (9 of 12) 69% (9 of 13) |
% FEV1
Improvement Relative to Baseline After Single Dose Rapid and Sustained FEV1
Improvement Post-Etokimab Administration 10
Timepoint Etokimab Placebo Net Day 1 (Baseline) 0% 0% 0% Day 2 12% 4% 8% Day 8 9% 5% 4% Day 22 16% 8% 8% Day 36 14% 8% 6% Day 64 15% 4% 11% |
Blood
Eosinophil Reduction Relative to Baseline After Single Dose Correlates with
FEV1 Improvement and Consistent With Phase 2a Atopic Dermatitis Trial
11 Timepoint Etokimab Placebo Net Day 1 (Baseline) 0% 0% 0% Day 2 -22% 9% -31% Day 8 -34% -15% -19% Day 22 -30% -10% -20% Day 36 -43% 1% -44% Day 64 -40% 6% -46% |
12 Eosinophilic Asthma Phase 2a Day 64 Interim Analysis Supports Advancement of Etokimab Into Phase 2b Eosinophilic Asthma Trial Interim Analysis Summary Etokimab demonstrated proof-of-concept in eosinophilic asthma Single dose of etokimab resulted in rapid and sustained improvement in FEV1 over placebo
Blood eosinophil biomarker reduction correlated with FEV1 improvement and is consistent
with prior etokimab Phase 2a atopic dermatitis trial
Etokimab was generally well-tolerated and no serious adverse events reported
- No treatment-emergent adverse events were deemed to be etokimab-related
- The most frequent treatment-emergent adverse events reported were single occurrences of moderate strep throat in two etokimab-dosed patients and single
occurrences of mild vomiting in two placebo-dosed patients
- No exacerbations or rescue therapy usage was reported Next Steps Complete ongoing Phase 2a trial and present detailed data at a medical conference in 2019
Initiate Phase 2b randomized, double-blinded, placebo-controlled, multi-dose trial of
etokimab in eosinophilic asthma during 2019 |
Anticipated Milestones 4 Additional Efficacy Readouts Anticipated By End 2019 Program Milestone Timing Etokimab (anti-IL-33) Moderate-to-Severe Adult Atopic Dermatitis Phase 2a Trial Top-line data announced October 2017 Detailed data presented at AAD and EAACI 2018 ATLAS: Moderate-to-Severe Adult Atopic Dermatitis Phase 2b Trial Initiated H1 2018 Top-line data anticipated in H2 2019 Severe Adult Eosinophilic Asthma Phase 2a Trial Top-line data presented today Detailed data to be presented in 2019 Eosinophilic Asthma Phase 2b Trial To be initiated in 2019 ECLIPSE: Adult Chronic Rhinosinusitis with Nasal Polyps Phase 2 Trial To be initiated by end 2018 Top-line data anticipated in H2 2019 ANB019 (anti-IL-36R) Healthy Volunteer Top-line Phase I Trial Top-line data announced November 2017 Detailed data presented at EAACI 2018 GALLOP: GPP Phase 2 Trial Initiated H1 2018 Top-line data anticipated in early 2019 POPLAR: PPP Phase 2 Trial Initiated H2 2018 Top-line data anticipated in H2 2019 Approximately $300MM in cash, cash equivalents and investments as of June 30 2018
13 th |
AnaptysBio: Clinical-Stage Antibody Development Company
Focused on Novel Antibody Medicines for Severe Inflammatory Diseases
14 TESARO Celgene Rapid Antibody Generation Platform Technology ~2.5 years Antibody Discovery Preclinical & Translational IND or Equivalent Filing Antibody Medicines For Severe Diseases Wholly-Owned Anti-Inflammatory Pipeline Etokimab (ANB020, Anti-IL-33) Atopic Dermatitis, Eosinophilic Asthma & Chronic Rhinosinusitis with Nasal Polyps
ANB019 (Anti-IL-36R)
Generalized Pustular Psoriasis & Palmoplantar Pustulosis
Checkpoint Modulator Inflammatory Diseases 4 Additional Efficacy Readouts Anticipated By End 2019 Validating Product Partnerships Generated ~$75MM* Etokimab Eosinophilic Asthma Phase 2a: Top-line data today ANB019 Generalized Pustular Psoriasis Phase 2: Top-line data in early 2019 Etokimab Atopic Dermatitis Phase 2b: Top-line data in H2 2019 Etokimab Chronic Rhinosinusitis With Nasal Polyps Phase 2: Top- line data in H2 2019 ANB019 Palmoplantar Pustulosis Phase 2: Top-line data in H2 2019 * As of June 30
2018 th |
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