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January 29, 2018 | Author: Anonymous | Category: Science, Health Science, Immunology
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ImmuMed A Therapeutic Antibody Company

Corporate Overview August 2013 Private and Confidential

ImmuMed Inc.© 2013

Confidential

ImmuMed Profile 

Private therapeutic antibody company



Mission: To utilize our proprietary therapeutic antibody platform and build a leading organ transplantation business and transform the field by expanding recipient eligibility and enabling universal organ donor transplants



Established Lead product: Anti-Lymphocyte Globulin (ALG)

– Historical use in 52,000 in organ transplant recipients at over 281 transplant centers across the U.S., Canada and parts of Europe – Primary indication: Induction Therapy (Prevention of Acute Rejection) – Published scientific record of efficacy and safety, support from KOLs in transplant



Antibody Platform and Pipeline Portfolio targeting antibody markets > $3B

ImmuMed Inc.© 2013

Confidential

3

Investment Thesis – ROI vs R&D process mitigates risk 

Initial transplant antibody market size estimated at $470M W/W

- 85% of revenue earned from Induction Therapy ** 

Opportunity to revive proven product used in over 52,000 patients – Task: update mfg. and reproduce historical tox data to satisfy FDA IND requirement



$30M investment to market-rollout first product – $10M to kick-off Ph III and potential IPO



Projected $250M+ in revenue within 5 years



Competitor with $79M in revenue sold for $600M in 2003 (8X multiple)



Additional revenue from pipeline development funded by product sales ** Induction Therapy is a drug protocol employing the administration of therapeutic antibodies to prevent rejection immediately following organ transplantation

ImmuMed Inc.© 2013

Confidential

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Market Value Proposition 

Growing organ transplantation industry – Increasing demand for organ transplants (W/W) – Global Shortage of Donor Organs (growing waiting lists) – Increasing Use of High-Risk Donor Organs (must use polyclonal antibody)



Fragmented market without a clear leader – Multiple products are sold into the field on a fragmented basis



Clear unmet transplantation medical need – No product enables universal organ donation

– No polyclonal antibody currently licensed for induction therapy – No product addresses sensitized recipients – Key anti-rejection products are marginally effective or sold “off-label”



ImmuMed well positioned for: – Market expansion by enabling universal organ transplants

– Capture the sales of current products now being used off-label – Consolidation of existing products and businesses – Market leadership to Establish Induction Therapy as Standard of Care ImmuMed Inc.© 2013

Confidential

5

Competitive Landscape for Induction Therapy Antibody-based Immunosuppressive Drugs 

Monoclonal Antibodies (Low Risk Recipients)

5% US Revenue Share

– Single antigenic site with high specificity – Two (Simulect,® Zenapax®) approved to prevent rejection – One (OKT3) approved to treat acute rejection



Polyclonal Antibodies (High Risk Recipients)

95% US Revenue Share

- Multiple antigenic sites – cytotoxic activity – None approved for prevention of rejection – Two approved (Thymoglobulin® , Atgam®) to treat acute rejection – Treatment of Acute Rejection by antibodies – occurs in 4% of transplants – Antibody revenues (Induction Therapy) now driven by Off-Label Use – See IALG advantages vs. Thymoglobulin – More efficient production at higher margins

– Absence of 10% microaggregates  less safety concerns ImmuMed Inc.© 2013

Confidential

6

2012 Global Antibody Sales Approved Polyclonal & Monoclonal Antibodies Product Name Thymoglobulin® (Rabbit)

Type of Product

Polyclonal

Manufacturer

Genzyme

Indication

$$ Sales ($Millions)

% Change vs. PY

Rx AR

$320

12.0 %

Simulect® (Murine)

Monoclonal

Novartis

Induction

$110

4.5 %

rATG * (Rabbit)

Polyclonal

Fresenius

Rx AR

$ 40

8.0 %

* Not sold in U.S.

Source: Evaluate Pharma 2013

ImmuMed Inc.© 2013

Confidential

7

Technology Background • Therapeutic antibody technology acquired from U. Minnesota 1996 •

$66M R&D investment already done

• Lead product: ImmuMed Anti-Lymphocyte Globulin (“IALG”) •

Primary indication: prevent rejection after solid organ transplantation



52,000 patient administrations (Compassionate Use) at least 281 transplant centers across the U.S., Canada and parts of Europe Lack of sufficient data reporting on compassionate use caused FDA clinical hold University refused commercial drug production FDA issue with original inventor resolved

• • •

• Multiple pipeline products from common plasma inventory • • • •

Precondition donor tissue for bone marrow and stem cell transplants Aplastic anemia Autoimmune diseases Lymphomas (FAB2 form)

• Qualified strategic partners identified • • • •

CMO: Cangene and/or Therapure BioPharmaceutical CSO: Bio-Reliance and Apptec CSO: Lake Immunogenics CRO: Cato Research; Kendle; CTI

ImmuMed Inc.© 2013

Confidential

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Pipeline Common Manufacturing Platform PRODUCT PIPELINE Program

Indication

R&D

PC

** Phase I

Phase II

Phase III

Biological Antibodies ALG

Solid Organ Transplantation

IATG-BMT

Bone Marrow Transplantation

H. anti HIV

Adjuvant Therapy in HIV and AIDS

Recombinant Antibodies Fab2

Infectious Diseases

ISI Mab

Cancer Immunotherapy Additional Opportunities

** Of products in its portfolio, ImmuMed has prioritized the sequence in which to develop acquired compounds based on the current stage of clinical development listed below.

ImmuMed Inc.© 2013

Confidential

9

Pipeline Target Markets • Lead product: ImmuMed Anti-Lymphocyte Globulin (“IALG”) •

$470MM potential market oppty. based on existing drugs

• Target markets for follow on pipeline products (derivatives of common plasma inventory = truncated development pathway) • Graft versus Host disease in Bone Marrow Transplant ($80MM)

• Aplastic Anemia ($175MM) • Reduced viral loads in CMV and HIV infected patients ($750MM) • B-cell lymphoma ($30MM) • B-Cell Mediated Auto-Immune Diseases ($125MM) • IVIG ($1.4B)

ImmuMed Inc.© 2013

Confidential

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How Does IALG Work? - Adjuvant Immunosuppressive Drug Adjuvant = administration as add-on to background immunosuppressive regimens to improve outcomes

- Mechanism of Action Cytotoxic to lymphocytes (including those causing acute organ rejection ) Decreases: Recognition of Foreign Antigen Incidence of Acute Rejection Incidenceof Post-op dialysis events

- Degraded by Liver • Anti-IALG antibodies occasionally measured

ImmuMed Inc.© 2013

Confidential

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Clinical Development Summary Published Scientific Studies Human Studies

Sample Size

Major Findings

Phase I (1)

Pharmacokinetics (N = 104)

Depletion Circulating lymphocytes

Dose response in humans Phase II (2)

a) Skin grafts (N = 102) b) Renal grafts (N = 47)

Phase III

(3)

Study drug v. Placebo Renal grafts (N = 160)

Increased graft survival was dose related Therapeutic Benefit improved renal graft survival at 1 & 3 years ** No Safety Issues **

1) Buchman TE., et al; Transplantation. 55(5):1190-3, 1993 May. 2) Simmons RL. Moberg AW., et al: Surgery. 68(1):62-8, 1970 Jul. 3) Condie RM, et al, Transplantation proceeding 1985; XVII(1): 1304-1311.

ImmuMed Inc.© 2013

Confidential

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Phase III Trial Efficacy: Enhanced Graft Survival

ALG versus Placebo (Phase III study) Multicenter Efficacy Study for Induction Therapy Post-Transplant Event

ALG (n=81)

Albumin (n=79) P-Value

Efficacy Graft Survival: 1 year

48/81 (59%)

37/79 (47%)

p = 0.02

Graft Survival: 3 years

45/81 (56%)

18/79 (23%)

p
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