PanMetics Presentation


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PanMetics Presentation

  1. 1. PanMetics For Additional Information: Neil Goldstein, Ph.D. Chief Scientific Officer Website: ANTYRA Non-Confidential 1 The Next Generation of Biologicals
  2. 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. 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 thegrowth of established human pancreatic cancer tumors in animal models.•PanM-429 is also a “core scaffold” used to generate other therapeutic drugleads including Bi-specifics, which inhibit multiple targets, and as a deliveryvehicle for payloads such as small molecule drugs, siRNA and other biologicaltherapeutics (Cell Penetrating Peptides [CPPs]).•With a $10M tranched investment, PanMetics will complete Phase 1 clinicaltrials for at least 2 drug leads over a 3 year timeframe. ANTYRA Non-Confidential 3 The Next Generation of Biologicals
  4. 4. Cost Basis & Rationale•PanMetics is looking for an initial investment $10M for 3 years to complete thefollowing: • 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 valuablecommodities and will generate strong interest from pharmaceutical companieswho are constantly looking for novel drug leads and ways to deliver their ownproducts in a highly specific manner. ANTYRA Non-Confidential 4 The Next Generation of Biologicals
  5. 5. Exit Strategy•PanMetics believes that its focused drug development strategywill be amply rewarded through investment from both thefinancial 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
  6. 6. The Medical Opportunity ANTYRA Non-Confidential 6 The Next Generation of Biologicals
  7. 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. 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. 9. PanMetics’ R&D Goals•Fully characterize PanM-429 as a therapeutic lead in animal models alone andin 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. 10. PanM-429: A Drug Lead forTreating Pancreatic Cancer ANTYRA Non-Confidential 10 The Next Generation of Biologicals
  11. 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. 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. 13. PanM-429 as a Scaffold forNovel Therapeutic Derivatives ANTYRA Non-Confidential 13 The Next Generation of Biologicals
  14. 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. 15. PanM-429 as Bi-specific Cell Penetrating Peptide‣PanM-429 internalizes into various cell types including PancreaticCancer‣PanM-429 can be used to deliver therapeutic payloads such assiRNA, antisense, biologicals and small molecules.‣PanM-429 conjugated to a payload can be considered “Bi-specific”because both the Peptimetic and the payload have biologicalactivity. ANTYRA Non-Confidential 15 The Next Generation of Biologicals
  16. 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 chemistryPanM-429 is cationic and help shield net negative charge on siRNA and other biologicals ANTYRA Non-Confidential 16 The Next Generation of Biologicals
  17. 17. The Investment Opportunity ANTYRA Non-Confidential 17 The Next Generation of Biologicals
  18. 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 (withEGFR and FGFR1) • PK and ADMET Lead 1 • Lead 2  IND•Develop PanM-429 delivery •Lead 1  IND (Q4) •Complete Phase 1 for Lead 2 andconjugates 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 leadsconjugates 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 directedliposomes 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. 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. 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. 21. PanMetics Has the Therapeutic Edge•PanMedics believes that PanM-429 and its derivatives will be effectivealone and in combination with any approved drugs to increase thetherapeutic 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 increasingselectivity, potency and therapeutic index.•PanM-429 conjugated to small molecules and biologicals will be able totarget internal targets inaccessible to monoclonal antibodies ANTYRA Non-Confidential 21 The Next Generation of Biologicals
  22. 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. 23. PanMetics For Additional Information: Neil Goldstein, Ph.D. Chief Scientific Officer Website: ANTYRA Non-Confidential 23 The Next Generation of Biologicals
  24. 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 cancersPhase 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. Itis anticipated that this would be done in partnership with a largepharmaceutical/biotech company ANTYRA Non-Confidential 24 The Next Generation of Biologicals