Bio Latin America Conference October 15, 2015

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1 Bio Latin America Conference October 15, 2015

2 About RuiYi and BioReal RuiYi, Inc. La Jolla, CA Innovative antibodies with upsized development potential BioReal Brazil (wholly owned subsidiary of RuiYi) Mission: to develop and commercialize Gerilimzumab for Brazil Top Tier Global Investors $50+M USD invested to date 2

3 Gerilimzumab Novel Antibody Targeting IL-6 Cytokine for the Treatment of Rheumatoid Arthritis (RA) 3

4 Antibody Therapies for RA Therapeutic antibodies provide tremendous efficacy and dramatically improved safety vs. small molecule drugs Medical care for RA patients is more established, resulting in an increasing impact on healthcare expenditures With patents of the leading anti-tnf agents expiring, Brazil is expected to be one of the most advanced biosimilar markets 4

5 RA Patients and Use of Biologic Therapies Europe (5EU) 2.5M RA 19% biologic US 1.4M RA 50% biologic China 4.6M RA < 2% biologic Brazil 1.3M RA 3% biologic Africa est. 3M RA < 1% biologic India 6.2M RA < 1% biologic Australia 0.4M RA 30% biologic Brazil represents the fourth largest country for RA and minimal adoption to date of antibody therapies 5

6 The Need for RA in Brazil goes Beyond Biosimilars 1.3M RA patients total 62% (800,000) moderate to severe 35% (300,000) will not respond to anti-tnf IL-6 pathway has been proven effective in patients who are non responsive to anti-tnf Gerilimzumab has a large opportunity to treat RA patientis in Brazil, including those who fail anti-tnf 6

7 Gerilimzumab A Competitively Differentiated Antibody Feature Profile Comment Target IL-6 Cytokine (vs IL-6R, e.g. Actemra) anti IL-6R (Actemra) requires increased dosing and dose frequency Potency IC pm IL-6 growth dependent B cell line Compared to 0.2 pm Sirukumab (J&J P3 anti IL-6 antibody) Half-life 20 days (cyno) Compared to 7 days Sirukumab Bioavailability Expected dose frequency Annual product need 100% for 1mg/kg and 65% for 10mg/kg SC (cyno) 10 mg SC q4w or q8w 120 mg/patient/year Expected Gerilimzumab dose is 10 mg SC Humira SC 40mg q2w Remicade IV 3mg/kg q8w Enbrel SC 50 mg q1w Actemra SC 162 mg q1w-q2w Humira 1.04 g Remicade g Enbrel 2.6 g Actemra 8.4 g 7

8 Proliferation [%] In Vitro Superiority of Gerilimzumab Gerilimzumab targets the IL-6 cytokine, well validated by drugs such as Actemra and Sirukumab (CNTO136) 100 mab (IgG) Potency [pm] H7 CNTO136 CAT 6001 UCB124.g1 Gerilimzumab ARGX-109 B-E conc.[pm] B-E8 7.7 UCB124.g H CNTO CAT Gerilimzumab

9 Concentration [ug/ml] Half-life Superiority of Gerilimzumab Combined with best in class potency, Gerilizumab also has an extended halflife resulting in high patient convenience for dosing and lowest cost of goods D3-WT 5 mg/kg I.V. single dose 129D3-HN = Gerilimzumab WT: wild type HN: argen-x mutations in Fc for half-life extension present in Gerilimzumab 10 1 WT: 15 HN: 25 t 1/2 [d] Time [days] 9

10 Gerilimzumab Clinical Development in Brazil Introduced at the Congress by Dr. Morton Scheinberg 10

11 Gerilimzumab Advisory Board Mark Genovese MD James W. Raitt Professor of Medicine, Division of Immunology and Rheumatology, Stanford University Morton Scheinberg MD Scientific Director of the Research Clinic at the Centro Hospitalar Abreu Sodré-AACD Professor of Immunology at the University of São Paulo, Brazil Geraldo Pinheiro MD, PhD Head of Rheumatology Division, Faculty of Medical Sciences, State University of Rio de Janeiro President of the Brazilian Society of Rheumatology ( ) Valderillo Azavedo MD Professor of Rheumatology at the Federal University of Paraná, Brazil Scientific Director of Edumed Biotec Cristiano Zerbini, MD Founder and Director of the Paulista Center for Clinical Research (CEPIC) 11

12 Gerilimzumab Phase 1 Clinical Plan Split single dose and multi-dose arms into individual studies Single dose escalation SC in healthy volunteers Four cohorts with 6+2 design (6 subjects RYI-008, 2 placebo per cohort/dose) 1 mg, 5 mg, 15 mg, 30 mg single dose SC Completion including final report by end of year Multi-dose escalation SC in healthy volunteers 5 mg multi-dose SC q4w, 3x 20 mg multi-dose SC q4w, 3x Completion of dosing in 2015, final report early March 2016 Monitor standard safety parameters, PK, ADA with 4 week follow-up 12

13 Gerilimzumab Phase 2 Clinical Plan (Brazil) Five arm study: RA patients inadequately controlled by methotrexate RYI-008 (Dose 1) + Methotrexate n = 50 RYI-008 (Dose 2) + Methotrexate n =50 RYI-008 (Dose 3) + Methotrexate n = 50 RYI-008 (Dose 4) + Methotrexate n = 50 Placebo +Methotrexate n = 50 SC repeat dosing q4w, three (3) months dosing Read-out: ACR20, 50, 70 at week 12; DAS 28 through week 12 ~ 20 g material (minimal manufacturing requirements) 13

14 Gerilimzumab Phase 3 Pivotal Trial (Brazil) Two arm study: RA patients inadequately controlled by methotrexate RYI Methotrexate n = 300 Placebo + Methotrexate n = 300 for 12 weeks, rescue to RYI-008 for ACR20 nonresponders, others continue through week 24 SC repeat dosing q4w, six (6) months dosing Primary Endpoint: DAS 28 at week 12 Secondary Endpoints: ACR20, ACR 50, 70 at week 12 and week 24 and DAS 28 through week 24 14

15 Gerilimzumab Local Manufacturing in Brazil High potency and long half-life = reduced manufacturing requirements Pre-validated container-based single use bio reactor system to be installed 15

16 Summary of BioReal Opportunity in Brazil Gerilimzumab has best in class potential amongst well validated class of drugs (anti IL-6) Potency and half-life = Low COGs Infrequent subcutaneous dosing ideal for cost effective, convenient patient care. Pricing flexibility dramatically expands patient access to advanced care >800,000 moderate-severe RA patients 16

17 Funding Activity Significant investment to date (from the US parent corporation) to reach Phase 2 Active discussions with strategic investors to fund Brazil clinical trials Domestic or multi-national financial or strategic entities looking for innovative relationship for RA 17

18 Management Paul Grayson, President & CEO CEO, Fate Therapeutics; Founding Chairman and CEO, Senomyx Managing Director, Sanderling Ventures Ray Stevens, PhD, RuiYi Founder and Executive Supervisor Provost Prof., Biological Sciences and Chemistry, University of Southern California Founder of Syrrx (Acquired by Takeda), MemRx, Receptos Founder and Director of the ihuman Institute at Shanghai Tech University Alan Glicklich, MD, CMO VP, Clinical Development, Arena Pharmaceuticals Medical lead for BMS Ibipinibant Senior Director, Medical Affairs at Sanofi (Rimonabant) Mark Saad, CFO CFO, Cytori Therapeutics Executive Director UBS Investment Bank Anke Kretz-Rommel, PhD, Sr. VP Biology and Pharmacology Alexion Antibody Technologies Scripps Research Institute; ETH-Zurich 18

19 Thank You

20 Gerilimzumab Best in Class Biologic Therapy for Brazil Differentiated Profile High Potency & Long Half-life Development Strategy IL-6 Biology Clinically Validated Strong Commercial Value Significant Unmet Medical Need Infrequent Subcutaneous (SC) dosing Biologic Naïve Patients Unique Affordability Lowest Cost of Goods Development & Manufacturing In Brazil for Brazil Drive Increase in Patient Access 20