Entrepreneurship Bootcamp Session 2 - Project, Product or Company - - PowerPoint PPT Presentation

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Entrepreneurship Bootcamp Session 2 - Project, Product or Company - - PowerPoint PPT Presentation

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1 1 Entrepreneurship Bootcamp Session 2 - Project, Product or Company Mark A. Tepper, Ph.D. President & CSO Corbus Pharmaceuticals Inc. June 3, 2018 Developing Medicines which modulate the endocannabinoid system JB Therapeutics:

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Entrepreneurship Bootcamp

Session 2 - Project, Product or Company

Mark A. Tepper, Ph.D. President & CSO Corbus Pharmaceuticals Inc. June 3, 2018

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Developing Medicines which modulate the endocannabinoid system

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Market Focus

Targeted Cannabinoid Agonists and Antagonists for the treatment of:

  • Pain: ~$30 Billion Rx market
  • Obesity: ~$15 Billion Rx market
  • CNS disorders: ~$20 Billion market (PTSD, Anxiety,

neurodegenerative diseases)

Technology

  • Orally active non-psychotropic CB1/2 agonist for chronic pain
  • Peripheral CB1 Antagonist for Obesity
  • CB2 Agonist for Inflammatory Pain
  • FAAH inhibitor for Neurodegenerative disease
  • Oral Endocannabinoid mimetics

Development Strategy

  • Advance programs to Phase II POC
  • Partner out select programs
  • Bring internal neurodegenerative disease programs to market.

Financing Plan

  • Seek funding of $5M to complete POC clinical studies with lead

CB1/CB2 agonist for pain

Leadership

  • Management team experienced in building biotech companies
  • 60+ yrs operating experience in drug discovery and development

JB Therapeutics: Highlights

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SLIDE 4

Mark Tepper, PhD – CEO

  • BMS, Serono
  • Former CEO - NKT Therapeutics, RXi

Pharmaceuticals, Arradial

Kollol Pal, PhD – SVP R&D

  • BIPI, Mitotix, Neogenesis, Satori
  • Former CEO, Rishi Pharma

Terry Plasse, MD – Clinical Consultant

  • Former Clinical developer of Marinol

Sumner Burstein, PhD

  • Prof. Emeritus, Biochemistry Umass

Medical School

  • Inventor of JBT-101

Robert Zurier, MD

  • Prof. of Medicine, Rheumatology

UMass Medical School

Paul Goldenheim, MD

  • Former CMO, Purdue Pharm
  • Analgesic Research

Nathan Katz, MD

  • CEO Analgesic Research
  • Advisor to FDA on analgesia

George Kunos, MD, PhD

  • NIH Section Head, Pain & Analgesia

Lynn Van Campen, PhD

  • Former VP, Inhale Therapeutics, BIPI
  • University of Wisconsin
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SLIDE 5

CB1 & CB2 Signaling Pathway

NRDD, 2008

CB2 CB2

PNS

EC EC

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Ki (nM) huCB1 huCB2 THC (Marinol)* 80.5nM 31.9nM DMH-THC* 0.27nM 0.20nM Nabilone (Cesamet)* 2.2nM 1.8nM JBT-101 5.7nM 56nM

Therapeutic Validation Cannabinoids have long history of human efficacy and safety in analgesia, emesis, MS spasticity, and neuropathic pain High Potency JBT-101 has > potency to natural and synthetic cannabinoid drugs on the market No Adverse Side- Effects JBT-101 has reduced penetration of BBB and therefore does not induce psychotropic side effects like Marinol, Nabilone or Sativex Potential Indications Chronic Pain, Chronic inflammatory diseases, GI disorders, angiogenesis, multiple sclerosis spasticity

Cannabinoids in Medicine

1981 1985 2005

*psychotropic

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  • Orally Active Non-psychotropic CB1/2 agonist
  • Effective in 15 animal models of Pain &

Inflammation

  • Analgesic effects: 1–10 mg/kg
  • Anti-inflammatory effects: 0.1-1 mg/kg
  • Modulate inflammatory mediators: PGJ, LXA4
  • Prevents inflammatory destruction
  • Suppress IL1β, IL6, IL8
  • Suppress MMP1, MMP3, MMP9
  • Clinical Studies
  • 150 patients/volunteers safely treated
  • Completed Phase I (US, Eu)
  • Completed Phase IIa in Neuropathic Pain

JBT-101 (Ajulemic Acid)

COOH OH O R R 1 3 8 9 11 1'

MW = 400.55 T1/2 = ~4 Hr Ki (CB1/2) = 5.7 nM/56 nM EC50 (CB1/2) = 11.6 nM/13.4 nM MTD > 100mg/kg ED50 = 0.5 - 5mg/kg

Dual Analgesic & Anti-inflammatory Drug

JBT-101

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Drug Analgesic Anti- Inflam No Side Effects

CNS CV Resp GI

No Abuse Potential JBT-101

      

Opiates

 X X  X X X

NSAIDs

     X 

Antidepressants Anticonvulsants

 X X  X X X

COX-2 Inhibitors

   X   

Unique Product Profile to Treat OA and Pain

JBT-101 safer than opiates, NSAIDs and Cox-2 Inh with potential to treat inflammation and pain

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JBT-101 Clinical Trials Summary

Phase I e I SAD D

  • 32 healthy vo

y volunteer eers

  • Single a

asc scending d dose

  • se desi

esign-10m 10mg

  • Endpoin

ints: P PK, Safety, Tole lerabili ility Phase I II Re Refra ract ctory Ch Chro ronic N c NP

  • 21 p

21 pat atie ients w wit ith > > 6 6 months continuo nuous us N NP p pain

  • 20

20 mg => 40 m 40 mg, p , po, bid , bid, , x7 d 7 day ays

  • Endpoints: E

: Effic icac acy, S , Saf afety, T , Tolerability Phase I e I SAD/ D/MAD

  • 104 h

104 heal althy v volu lunteers

  • Sin

ingle d dose: 10, 20, 40, 10, 20, 40, 80, 120, 80, 120, 150, 150, 180, 180, o

  • r 280

280mg

  • Mult

ltiple d doses : : 20, 20, 40 40 & 80m 80mg, , tid id

  • Endpoints:

: PK, , AEs, S , Saf afety, M MTD

JBT-101 dosed orally in 150 patients/volunteers

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Cohort 1 Active vs Placebo Cohort 2 Active vs Placebo Primary Endpoint: VAS Reduction 31% vs 2%* 18% vs 5%* Secondary Endpoint: Responders (>30% pain reduction) VRS Reduction Allodynia Pressure Test 67% vs 10% 20% vs 4%** Variable 20% vs 10% 16% vs 1%** Variable

Global Impression Score (CGI) Clear improvement

Cohort 1 & 2 combined

11 patients NIDA Addiction Research Center Inventory- Marijuana (ARCI-M) No ∆ between active and placebo groups Safety & Adverse Events No safety issues No ∆ in AEs between active, placebo and baseline

  • p< 0.032; **p< 0.052
  • N=21 patients
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Timeline

Milestones: 2 Clinical trails + SR formulation

2H09 1Q10 2Q10 3Q10 4Q10 1Q11 2Q11 3Q11 4Q11 1Q12 2Q12 Bridge PK w/ SR (JBT)

Phase 2a JBT-101SR in NP File JBT IND Develop SR formulation CRO#1 Phase Ib Lupus Study (Feinstein-JBT SBIR Grant)

Generate Clinical Drug Product CRO#1

Clinical API Campaign CRO#2

200gm API (JBT)

Pre- IND Mtg

0.4Kg 5Kg

FDA required Non-Clinical Studies (if necessary)

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JBT-101 Patent Estate

199 1992 200 2008 200 2009 201 2010 201 2015 202 2020 203 2030 203 2031

US 5, 5,338 338,753 53 – JB JBT10 101 C Comp mp o

  • f matte

matter 201 2011– Met ethod of

  • f Use

e – JB JBT10 101 1 Fibr brotic Dise sease se 2010 2010– Comp mposi sition, Dose se & Sustai stained-rel elea ease

  • NCE data exc

xclu lusivi vity y & O Orphan D Drug g

JB JBT-101 F Franch chise C Cove vere red Through ~ ~ 2031 201 2011– Improved Pharma maceutic tical l Compositio ition & Meth thod of Synth thesis is

IP Couns unsel Landro ro & Anast stasi si Cla Clark & Elbin ing

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Market Opportunity- Franchise in a product

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Product

  • First non-psychotropic CB1/CB2 Agonist for treating pain and

inflammation

  • POC established in refractory neuropathic pain patients

Pipeline

  • 1 Phase 2, 1 Preclinical and 2 lead optimization programs

targeting endocannabinoid system

  • Multiple formats – sustained release, topical, patch
  • Multiple indications & combinations with NSAIDs, opioids

Market

  • Large unmet medical need-
  • Pain, Obesity, Neurodegenerative Disease- All $ billion markets

Investor Opportunity

  • Seeking Funding of $5 Million to complete Phase 2 POC studies

with SR formulation

  • Advance preclinical pipeline
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Corbus Pivots

Risks Original Current Product Single Asset, 1 large indication Single asset multiple indications IP Limited IP life with 5 yr NCE protection Issued IP to 2033 + ODD Team 2FTEs Mgmt + consultants 4 FTEs Mgmt w 120 yr experience -62 total FTEs Regulatory Repeat Tox study File new IND Phase 3 with multiple FDA/EMA mtgs with agreement on endpoints Market Large Market Niche/Orphan Financial Private/Angels Public- 45% institutions Competition Opiates, NSAIDs SSc, CF, DM, SLE (novel MOA)

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Corbus Funding History

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2009 2010 2011 2012 2013 2014 2015

Company Founding Seed Round Vendor Financing-API FDA pre-IND Mtg-NP Convertible Note Repeat Tox Study FDA Pre-IND Mtg- SSc Series A Round- $2M SSc Animal POC Mtf with BfArM Hire CEO & CFO $11M Private Placement- 6/14 Hire CMO $5M CFF Award NASDAQ Listing $11M Warrant Call CF ODD SSc ODD $27M Financing $37M Financing $25M CFF Award Mfg DS & DP File S-1 5/15 List on NASDAQ-5/15 $11M Private Placement- 6/14 SSc &DM P2 Trails Initiated CF P2 Trail Initiated SSc &DM P2 Trails Completed CF P2 Trail Completed SSc P3 Trail Initiated CF P2b Trial Initiated File IND S-1 Filing S-3 $200M S-3 $100M

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Thank You!

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Back Up Slides

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JBT-101: Analgesic Activity

Neurosci, 2000 Life Sci, 1998

100 10 1 .1

  • 1

1 3 5 7 9 11

DOSE of CT3 [mg/kg i.v.] RESPONSE [writhings]

JBT-101 iv in 10% Cremophor 0.02% phenylquinone

Formalin Test

4.6 mg/kg JBT-101 5% formalin sc in hindpaw Early phase: 0-15 min Late phase: 15-30 min

Analgesia Model

JBT-101 reversed PAF induced Allodynia, improved analgesia

Writhing Model Reduces Pain in Animal Models

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JBT-101: Anti-inflammatory Activity

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20 40 60 80 100 CONTROL CT3 TREATED

% JOINTS SHOWING ANKYLOSIS

Reduces Inflammation & Joint Damage in Arthritis Model