PanMetics.com Presentation for Website

1. PanMetics
For Additional Information:
Neil Goldstein, Ph.D.
Chief Scientific Officer
info@panmetics.com
Website: www.panmetics.com
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2. Strategic Goals
• PanMetics is a newly formed biotechnology company developing
a powerful array of novel, targeted therapeutic leads against
cancers with high mortality rates and poor therapeutic options
such as Pancreatic Cancer.
• PanMetics has an exclusive license to develop a novel scaffold,
PanM-429, as a drug lead and as a vehicle for delivery of
therapeutic payloads.
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3. Company Overview
•Cancers such as Pancreatic are unmet medical needs with poor survival rates.
•IGF-1R is a validated target for Pancreatic and other cancers.
•PanM-429 is Mini-protein which acts as an IGF-1R antagonist and inhibits the
growth of established human pancreatic cancer tumors in animal models.
•PanM-429 is also a “core scaffold” used to generate other therapeutic drug
leads including Bi-specifics, which inhibit multiple targets, and as a delivery
vehicle for payloads such as small molecule drugs, siRNA and other biological
therapeutics (Cell Penetrating Peptides [CPPs]).
•With a $10M tranched investment, PanMetics will complete Phase 1 clinical
trials for at least 2 drug leads over a 3 year timeframe.
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4. Cost Basis & Rationale
•PanMetics is looking for an initial investment $10M for 3 years to complete the
following:
• Complete a Phase 1 trial for PamM-429 alone or in combination with approved drugs
•Generate and characterized PanM-429 derivatives (Bi-specifics and CPPs)
•Identify 1-2 PanM-429 derivatives for clinical development
•Complete 2nd Phase I trial for a PanM-429 derivative with an approved drug
•The investment can be paid in tranches and additional funding be based on
•Go/No Go decisions
•PanMetics believes that the drug leads generated from these studies are valuable
commodities and will generate strong interest from pharmaceutical companies
who are constantly looking for novel drug leads and ways to deliver their own
products in a highly specific manner.
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5. Exit Strategy
•PanMetics believes that its focused drug development strategy
will be amply rewarded through investment from both the
financial community and pharmaceutical licensing deals.
•Expected exit strategies include:
•Buyout by a large pharma or biotech company
•M&A with a biotech with synergistic technologies (e.g., siRNA delivery)
•IPO/Reverse Merger under the appropriate conditions
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6. The Medical Opportunity
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7. The Target: IGF-1R
• The Insulin-like growth factor (IGF) signaling axis is a focus for developing
targeted drugs for treatment of indications including cancer.
• Preclinical research and clinical investigations have implicated the IGF type
1 receptor (IGF-1R) and its ligands IGF-I and IGF-II in the development and
progression of a number of human cancers including pancreatic, ovarian,
colorectal, prostate and hematopoietic tumors.
• Targeting the IGF-1R receptor represents an important new approach in
cancer therapy. PanMetics intends to use its PanM-429 core scaffold to
generate drug leads which will inhibit the IGF-1R cancer axis.
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8. PanM-429 is a Novel IGF-1R Antagonist
• PanM-429 is a member of a class of novel, highly specific bioactive Mini-
Proteins called Peptimetics which act as agonists or antagonists and can
be generated for any disease indication.
• PanM-429 is an IGF-1R antagonist with high affinity and selectivity
• Because of its high specificity and biological activity, PanM-429 can be
used as a therapeutic in its own right as well as in combination with
approved drugs for Pancreatic and other cancers.
• In addition to its value as a drug lead, PanM-429 can also be used to
generate novel derivatives such as Bi-specifics and CPPs to deliver
payloads such as small molecule and biological drugs.
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9. PanMetics’ R&D Goals
•Fully characterize PanM-429 as a therapeutic lead in animal models alone and
in combination with approved drugs such as gemcitabine (Gemzar) and Tacerva
•Generate novel derivatives of PanM-429 including Bi-specific and CPPs.
•Bi-specifics which inhibit multiple targets such as IGF-1R/EGFR & IGF-1R/FGFR1
•Cell Penetrating Peptides to deliver a vast array of therapeutics including small
molecules and biologicals such as, but not limited to, siRNA and antisense
oligonucleotides
•Characterize these entities in vitro and in the appropriate animal models
•Identify 2 drug leads for clinical development (manufacturing, PK/ADMET)
•Complete two Phase 1 clinical trials by the end of Year 3 for these 2 drug leads
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10. PanM-429: A Drug Lead for
Treating Pancreatic Cancer
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11. PanM-429: A Mini-Protein which
Inhibits the IGF-1R
• Affinity = ~300nM = ligand (IGF-1)
• In vitro properties
– Blocks IGF-I induced phosphorylation of IGF-IR
– Inhibits IGF-IR/IR hybrid receptors
– Specificity for IGF-1R vs IR
– Inhibits IGF-I induced proliferation in cell assays
• Inhibits tumor growth in vivo
• Predicted to weakly immunogenic (by analysis)
• Indication: Pancreatic Cancer (& other cancers)
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12. PanM-429 inhibits the Growth of
Pancreatic Cancer Cells in Animals
Tumor Growth Tumor Weight
2.5
3000
2.0 Control
2500 Control 429 300
Vehicle
ANT-429 300
Tumor Weight (g)
Tumor Volume (mm3)
2000 ANT-429 50
429 50
ANT-G12 300 1.5
1500
1.0
1000 Established Tumors
>100mm3
0.5
500
0 * *
0 5 10 15 20 25 30
0.0
Control
Control
Vehicle
Vehicle
5-FU *
429-300
429 300
429-50
429 50
G12-300
DAYS
Injections (ROI = SC): 4/week x 3
PanM-429 inhibits the growth of established MiaPaCa tumors growing in nude mice
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13. PanM-429 as a Scaffold for
Novel Therapeutic Derivatives
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14. Generation of Bi-specifics with PanM-429
429 Sequence 5mer Linker 15mer Random Sequence
Pan vs. 2nd Target (EGFR, FRGR1, etc.)
429 Sequence 5mer Linker Target Binding Sequence
Screen
•Screen in ELISA vs IGF-1R & 2nd Target
•Move to secretory vector for transfections studies
•Synthesize HP and test in cell-based assays
•Determine efficacy in animal models
•Library can be used for any 2ary target
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15. PanM-429 as Bi-specific Cell Penetrating
Peptide
‣PanM-429 internalizes into various cell types including Pancreatic
Cancer
‣PanM-429 can be used to deliver therapeutic payloads such as
siRNA, antisense, biologicals and small molecules.
‣PanM-429 conjugated to a payload can be considered “Bi-specific”
because both the Peptimetic and the payload have biological
activity.
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16. PanM-429 Conjugated to a Payload
Chemical Linker
PanM-429 [Stable or Cleavable ]
• Enzymatic • siRNA (single or ds)
• Chemical • Antisense
• Endosomal •Small Molecule Drugs
•Biologicals
5’ or 3’ linkage to PanM-429
Utilize well established chemistry
PanM-429 is cationic and help shield net negative charge on siRNA and other biologicals
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17. The Investment Opportunity
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18. PanMetics’ Business Strategy
Year 1 Year 2 Year 3
$10M Seed Investment: Tranched based on milestones
• Full Characterization of PanM-429 • Continue animal studies with PanM- • Complete Phase 1 for Lead 1
429 and derivatives and full data package (Q3)
• Develop PanM-429 Bi-specifics (with
EGFR and FGFR1) • PK and ADMET Lead 1 • Lead 2  IND
•Develop PanM-429 delivery •Lead 1  IND (Q4) •Complete Phase 1 for Lead 2 and
conjugates with gemcitabine & cis- full data package (Q4)
platin •Begin Manufacturing Lead 2
• Business Development :
•Develop PanM-429 delivery •Develop a full pre-clinical package for partnering deal(s) for drug leads
conjugates with Kras antisense partnering and licensing discussions 1&2 and/or other PanM-429
with pharma/biotech companies derivatives in pre-clinical
•Develop PanM-429 directed
liposomes with Kras siRNA  Business Development opportunities •Pre-clinical development of
additional leads
•Animal studies with PanM-429
•Begin Manufacturing Lead 1
•SBIRs to supplement investor funding
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19. Business Development: Risks & Potential
Risks:
 Unanticipated technical issues/delays
 Slower than forecasted development timelines
 Slower than expected BD licensing deals
Potential:
 Faster than expected development timelines for PanM-429 &
derivatives
 Rapid characterization of Lead 1: e.g., PanM-429
 Rapid development of Lead 2: e.g., PanM-429 –gemcitabine
conjugate
 Identification of additional leads with therapeutic potential
 Early licensing/partnering deal brings non-dilutional funds
and clinical expertise into company
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20. Competitive Landscape for IGF-1R Cancer
Drugs
Drug Company Clinical Trial Cancer(s) Target(s) Type Continuing?
XL228 Exelixis Two Phase 1s CML IGF-1R, src, Small Both Studies
(updated 2011) BCR-ABL molecule terminated?
OSI 906 OSI Phase I ACC IGFR, IR Small ongoing
Molecule
AMG-479 Amgen/Takeda Phase I/II Multiple solid IGFR MAB ongoing
Phase III (+ tumors
Gemzar) Pancreatic
R 1507 Roche Phase I Sarcoma IGFR MAB Stopped
development
Figitumumab Pfizer Phase I Multiple solid IGFR MAB Stopped
tumors development
BMS-754807 BMS Phase I Multiple solid IGFR, IR Small ongoing
tumors molecule
MK0646 Merck Phase I +/- Pancreatic IGFR MAB ongoing
Gemzar+/-
erlotinib
Cixutumumab Lilly (from Phase I + Multiple solid IGFR MAB ongoing
(IMC A12) ImClone) temsirolimus tumors
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21. PanMetics Has the Therapeutic Edge
•PanMedics believes that PanM-429 and its derivatives will be effective
alone and in combination with any approved drugs to increase the
therapeutic index for IGF-1R expressing cancers such as Pancreatic.
•PanM-429 is cheaper to produce than monoclonal antibodies and vaccines
(=decreased COGs).
•PanM-429 Bi-specifics will inhibit multiple targets thereby increasing
selectivity, potency and therapeutic index.
•PanM-429 conjugated to small molecules and biologicals will be able to
target internal targets inaccessible to monoclonal antibodies
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22. Assets and Capabilities
 PanM-429 has already shown efficacy in vivo
 PanM-429 Bi-specific and delivery modules are available &
tested in vitro
 Hugh pipeline potential
 Proven scientific approach
 Strong IP base, proprietary reagents and know-how poised
to move 2 Leads through clinical trials within 3 years
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23. PanMetics
For Additional Information:
Neil Goldstein, Ph.D.
Chief Scientific Officer
info@panmetics.com
Website: www.panmetics.com
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24. PanMetics: 5 Year Plan
•Primary Opportunities: Years 1-3
•Move 2 drug leads through Phase I Clinical Trials
•Secondary Opportunities: Years 1-3
•Continued pre-clinical development of additional PanM-429 derivatives for
partnering/licensing and downstream INDs
•Round B financing = $7.5M: Years 4-5
•Move additional drug leads into Phase I Clinical Trials (from PanM-429
derivative pool)
•Identify new targets for Pancreatic Cancer and generate novel Peptimetic
antagonists for pre-clinical development
•Develop antagonists for additional high mortality/untreatable cancers
Phase II Clinical study(s): With additional financing for Years 4-5 ($15-20M)
PanMetics would be able to move one of its drug leads into a Phase II trial. It
is anticipated that this would be done in partnership with a large
pharmaceutical/biotech company
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