PanMetics is a biotech company developing novel targeted therapies for cancers like pancreatic cancer. It has exclusive rights to PanM-429, a mini-protein that acts as an IGF-1R antagonist. In animal models, PanM-429 inhibits the growth of human pancreatic tumors alone and in combination with other drugs. PanMetics is seeking $10 million to complete two Phase 1 clinical trials of PanM-429-based drug leads within three years and develop derivatives like bi-specific proteins for additional targets. The company expects these drug candidates to attract interest from large pharmaceutical partners.
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All businesses have growth potential regardless of their size, where they are located or in what field they operate. The challenge is identifying their strengths and how to use them to gain or increase business volume. If you find yourself unable to unlock this potential, are just getting your business off the ground or are experiencing difficulties getting a division to generate sufficient revenue, we may be able to help you out.
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To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
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Pan metics non confidential 2-21-12
1. PanMetics
For Additional Information:
Neil Goldstein, Ph.D.
Chief Scientific Officer
info@panmetics.com
Website: www.panmetics.com
ANTYRA
Non-Confidential 1 The Next Generation of Biologicals
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.
ANTYRA
Non-Confidential 2 The Next Generation of Biologicals
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.
ANTYRA
Non-Confidential 3 The Next Generation of Biologicals
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.
ANTYRA
Non-Confidential 4 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 5 The Next Generation of Biologicals
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.
ANTYRA
Non-Confidential 7 The Next Generation of Biologicals
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.
ANTYRA
Non-Confidential 8 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 9 The Next Generation of Biologicals
10. PanM-429: A Drug Lead for
Treating Pancreatic Cancer
ANTYRA
Non-Confidential 10 The Next Generation of Biologicals
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)
ANTYRA
Non-Confidential 11 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 12 The Next Generation of Biologicals
13. PanM-429 as a Scaffold for
Novel Therapeutic Derivatives
ANTYRA
Non-Confidential 13 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 14 The Next Generation of Biologicals
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.
ANTYRA
Non-Confidential 15 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 16 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 18 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 19 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 20 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 21 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 22 The Next Generation of Biologicals
23. PanMetics
For Additional Information:
Neil Goldstein, Ph.D.
Chief Scientific Officer
info@panmetics.com
Website: www.panmetics.com
ANTYRA
Non-Confidential 23 The Next Generation of Biologicals
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
ANTYRA
Non-Confidential 24 The Next Generation of Biologicals