Modified Soluble CD23 for the Treatment of IgE- Mediated Diseases

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1 Modified Soluble CD23 for the Treatment of IgE- Mediated Diseases Boston University Office of Technology Development April Effort Director Business Development, Life Sciences Phone:

2 Outline Research team Research background Competitive Landscape Xolair High level non-confidential findings Value Proposition Target Product Profile Lifecycle planning additional indications Opportunities for Collaboration 2

3 Research Team Ganley-Leal, Lisa, Ph.D. Dr. Lisa Ganley-Leal s primary research focus is on defining the bona fide role of IgE in human immunity. IgE has been primarily studied in allergic disease where the antibody plays a role in generating the chronic inflammation. However, in parasitic disease, IgE has a beneficial role, namely in host resistance to infection with worms. Thus, the laboratory is focused on defining immune correlates of protection in human schistosomiasis including mechanisms by which IgE and IgE receptors play a role in generating protection. Her studies in this area are in collaboration with the Centers for Disease Control and Prevention and the Kenya Medical Research Institute. To establish a mechanistic understanding of field clinical data, her laboratory developed a model system using human cells to recapitulate the inflammatory milieu of parasitic helminth disease. The laboratory has recently published papers describing novel roles of IgE in human immunity n highlighted articles. By understanding the beneficial roles of IgE and immune regulation in parasitic disease, Dr. Ganley-Leal hopes to develop effective treatments for IgE-mediated diseases, such as allergy. 3

4 Research Team Connor, John, Ph.D. Dr. Connor trained as a molecular biochemist in the Department of Pharmacology at Duke University. At Duke, his work focused on structure-based mutational analysis of protein-protein interactions. Through his work there he co-authored more than a dozen papers and facilitated the sale of recombinant phosphatase-inhibitors to the biotechnology company Upstate Biotech. Dr Connor then moved to Wake Forest, where his work in structure-based mutational analysis continued, but with a focus on virus/host interactions. Since starting-up his own laboratory, Dr. Connor has maintained an interest in analyzing proteins with known atomic structures for potential improvement. ET523 design and improvement lies within this interest. Outside his work with Epsilon, Dr. Connor heads a research laboratory in the Microbiology department at Boston University School of Medicine. The laboratory has a current annual research budget of approximately $1 million from NIH and Defense Department funding. This allows Dr. Connor to determine critical interaction points of the virus/host infection and drugdevelopment from the single-cell level to the organismal level. He has co-authored more than three dozen papers. 4

5 Research Background Allergy Allergy is a chronic inflammatory disease that encompasses a broad range of manifestations including allergic rhinitis (AR), eczema, and asthma 1 25% (75 million) of the US population suffers from some form of allergy 9% (27 million) in the USA have asthma 19% (60 million) Americans suffer from AR Research Focus IgE is class of antibody that mediates allergic response Discovered a polypeptide of soluble CD23 (scd23) that binds and sequesters IgE to prevent allergic responses Could treat conditions linked to increased IgE levels 5 1 Ganley-Leal, Lisa, Connor, John. Treatment of IgE-Mediated Disease. Patent WO June 9, 2011.

6 Role of IgE in mediating allergic responses IgE binds to receptors on the surface of mast cells and basophils Allergen binds to the IgE on the IgEcoated cells Cross-linking of the IgE and Fc receptors activates the cells Cells release inflammatory chemical mediators Airways or inside Airways or inside intestines intestines Allergen (pollen, peanut) (Pollen, peanut) Airways or inside intestines Airways or inside intestines Airways or inside Airways or inside intestines intestines IgE IgE IgE IgE IgE cross-linking IgE cross-linking Mast cell Eosinophil Mast cell Eosinophil for pollen Specific for pollen Specific for for peanuts peanuts Hypersensitivity reaction Mast cell Eosinophil Mast cell Eosinophil Allergic disease Mast cell degranulation Mast cell degranulation Allergic symptoms Allergic symptoms 2 Ganley-Leal, Lisa, Connor, John. Treatment of IgE-Mediated Disease. Patent WO June 9,

7 Anti-IgE Therapy Existing strategies to treat allergic diseases have limitations and consist of attempts to Desensitize the atopic individual to a given allergen or Ameliorate an ongoing allergic reaction. Treatments that selectively inhibit IgE activity can manage the allergic response An example is Xolair (omalizumab), a recombinant humanized IgG 1 monoclonal anti-ige antibody that binds to IgE at the same epitope as FcRI 3 Treatment with Xolair has several drawbacks including risk profile and high cost ($1,300/patient month) 4 3 Genentech Inc Pulmonary-Allergy Drugs Advisory Committee Meeting 15 May (BLA STN /0). Washington, DC: Food and Drug Administration. Accessed on Jan 5, Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J Allergy Clin Immunol Nov;120(5): Epub 2007 Sep 29. 7

8 Xolair Sales Xolair Sales US Dollars (MM) $1,600 $1,400 $1,200 $1,000 $800 $600 $400 $200 $0 ROW USA Currently approved for moderate to severe persistent allergic asthma(12 years of age and above) Under consideration for additional indications, can further increase value Pediatric allergic asthma (age 6-12) approved in Europe, but not US or UK Chronic idiopathic uticaria III (exp approval 2015) Xolair liquid formulation III Xolair with ICS and LABA moderate to severe asthma inadequately controlled with highdose ICS and LABA - III Allergy (Cat allergy) II Source: Medtrack 8

9 Xolair Efficacy Xolair is effective for 60-70% of patients 5,6,7 U.S. and Europe Indicated for patients who have a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids 8 Europe Physicians assess effectiveness of Xolair therapy after 16 weeks of treatment. If there is no improvement in symptoms, Xolair should be discontinued 7 There is a large unmet need for the treatment of severe allergic asthma in patients that do no respond to Xolair Therapeutics with a different biological target may work for Xolair non-responders 9 5 Humbert M, Berger W, Rapatz G, Turk F. Add-on omalizumab improves day-to-day symptoms in inadequately controlled severe persistent allergic asthma. Allergy May;63(5): Epub 2008 Mar Niven R, Chung KF, Panahloo Z, Blogg M, Ayre G. Effectiveness of omalizumab in patients with inadequately controlled severe persistent allergic asthma: an open-label study. Respir Med Oct;102(10): Epub 2008 Jul European Medicines Agency. Xolair : EPAR Product Information, Annex I. Jun, Xolair prescribing information. Accessed on Feb 21, 2012.

10 Xolair Safety Premarketing cases: Frequency of adverse events with Xolair (omalizumab) and placebo in asthmatic subjects 9,10 Adverse event Omailzumab (n = 2,076) Placebo (n = 1,383) Injection site reaction 45.0% 43.0% Virus infection 23.3% 26.3% Upper respiratory infection 20.0% 20.5% Sinusitis 16.5% 17.6% Headache 15.4% 15.6% Pharyngitis 10.7% 10.3% Bronchitis 8.8% 10.3% Back pain 6.9% 7.0% Arthraldia 4.7% 3.6% Diarrhea 4.3% 3.5% Dyspepsia 2.8% 4.5% Rash 3.3% 2.0% Fatigue 2.6% 1.2% Serious adverse events Anaphylaxis 3/4,127 0/2,236 Malignancies 0.5% (20/4,127) 0.2% (5/2,236) Xolair safety profile could be improved Postmarketing cases: 124 spontaneous case reports of anaphylaxis out of ~57,300 exposed to Xolair 7 Frequency of anaphylaxis attributed to Xolair estimated to be at least 0.2% of treated patients 89% reported pulmonary involvement, including bronchospasm, dyspnea, cough, or chest tightness 14% reported hypotension or syncope 15% of patients required hospitalization 10 9 Avila, Pedro C. Does Anti-IgE Therapy Help in Asthma? Efficacy and Controversies. Annu. Rev. Med : FDA Information for Healthcare Professionals: Omalizumab (marketed as Xolair). Washington, DC: Food and Drug Administration. Accessed on Jan 6, 2012

11 Implications for Xolair Usage Xolair has restrictions on use and long-term safety concerns Anaphylaxis has occurred as early as the first dose of Xolair, and as late as after one year Therefore, FDA recommends that Xolair should only be administered to patients in a healthcare setting under direct medical supervision with the following guidelines Providers should be prepared to identify and treat anaphylaxis after Xolair treatment Providers should observe patients for an appropriate period of time following each Xolair injection Long-Term Safety 11 An ongoing observational study of Xolair suggests an increased number of cardiovascular and cerebrovascular adverse events (~5000 Xolair treated patients and ~2500 non-xolair treated patients) The interim data (2009) suggests a disproportionate increase in Ischemic heart disease Arrhythmias Cardiomyopathy and cardiac failure Pulmonary hypertension Cerebrovascular disorders Embolic, thrombotic, and thrombophlebitic events Estimated completion in FDA Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair). Washington, DC: Food and Drug Administration. Accessed on Jan 6, 2012

12 New BU Anti-IgE Treatment The research team observed that patients with schistosome (parasitic worm) infections do not develop allergic responses The worms cleave a molecule called CD23 into a specific polypeptide that acts as a decoy to the IgE receptor The polypeptide of soluble CD23 (scd23) binds and sequesters IgE to induce an antiinflammatory response However, earlier attempts at using scd23 as an allergy treatment were not successful Trimeric CD23, which is high affinity for IgE and the basis for many previous treatments, increases IgE production and inflammation Covered under Patent WO ; June 9, Depiction of cell bound CD23 cleavage to produce various polypeptides of soluble CD23. 12

13 scd23 Modification to Increase IgE Affinity Altered the IgE binding protein to increase IgE binding affinity without trimerization The CD23 fragment was mutated at a single amino acid (A258) This modified scd23 protein (ET523) is an ideal treatment for allergic diseases Found naturally in human blood after schistosome infection Potential for excellent safety profile because it originates in nature 13

14 In Vivo Testing Investigated whether ET523 can mediate acute allergic responses in an allergic mouse model Obtained transgenic mice expressing human IgE receptors Confirmed human IgE provoked allergic response in the mice Defined optimal reagents and time points to induce acute allergic response Found that ET523 + IgE reduced allergy score in the mice when compared to a control group that received only IgE 14

15 Mechanism of Action Xolair only works in only 60-70% of population, suggesting that Xolair may not recognize IgE in the non-responders 5,6 IgE has multiple isoforms, which differ in the amount of glycosylation at Region 3 Xolair binds at Region 3 and some isoforms may interfere with binding scd23 binds to Constant region 2 and 3, so it is expected to recognize most glyco-isoforms of IgE CD23 12 Hannah J. Gould & Brian J. Sutton. IgE in allergy and asthma today. Nature Reviews Immunology 8, (March 2008)

16 Value Proposition Early Target Product Profile Low anaphylaxis risk, scd23 doesn t form multimers like Xolair Different mechanism of action than Xolair; CD23 binds to IgE at region 2 and 3 instead of constant region 3 May work in 30-40% of patients unresponsive to Xolair because it binds to IgE at a different location and avoids the specific effect of glycosylation has on a monoclonal antibody recognition Potential for self administration at home via injector pen Expected to have fewer side effects and be better tolerated long term because mechanism of action comes from natural processes Greater potential utilization in children and adults Therapy may be developed to treat orphan and rare IgE-mediated diseases 16

17 Value Proposition Additional Indications BU technology is a potential therapeutic option for various allergic conditions including: Asthma Allergic rhinitis 14% of the adult population in the United States In selected pediatric populations may be present in up to 42% Eczema Chronic Urticaria (hives) Allergic bronchopulmonary aspergillosi Insect hypersensitivity Atopic dermatitis Eosinophilic Esophagitis Kopp, M. Omalizumab: Anti-IgE Therapy in Allergy. Curr Allergy Asthma Rep (2011) 11:

18 Opportunities for Collaboration Next Steps CDA to share more detailed data Establish MTA to test product in collaborator s models Conclude with industry partnership to continue development and commercialization 18

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