2016 VALUE DRIVERS & MILESTONES
(2nd-Half of 2016 is packed with VALUE DRIVING MILESTONES for INO, imo.)
1. ( MOST IMPORTANT ) Launch PHASE 3 VGX-3100 for Cervical Dysplasia
• Huge Milestone & INO could highly likely REPLICATE successful results from P2 again in P3, imo
• Post-Hoc Analysis showed most responders were COMPLETE RESPONDERS / COMPLETE REMISSIONS
• I like to see this milestone put a footing on INO's PPS at $40, imo
2. Launch VGX-3112 + Checkpoint Inhibitors (MEDI) COMBO for Cervical Cancer
• INO & MEDI seems to be focused on expedited path to approval, imo
• This can be a huge milestone & likely trigger significant amount of milestone payment, imo
3. ( MOST EXCITING NEW TRIAL ) Launch INO-5400 "Universal" Cancer Vaccine w/ Checkpoint Inhibitors
• INO is confident enough to go after one of the fastest progressing cancer indications after diagnosis w/ no alternatives, imo
• May strike MONUMENTAL SIZE new PARTNERSHIP/S, imo
4. ( MOST EXCITING MILESTONE ) Report Phase 1 INO-1400 hTERT "UNIVERSAL" Cancer Vaccine
interim data
• If the results are good, there can be huge partnership/s or buy-out FRENZY, imo
• hTERT cancer vaccine can be applicable to 85% of ALL cancers & allow INO to OWN the most comprehensive immino-oncology COMBO therapies, imo
• In general, INO sees hTERT as being a foundation antigen in multiple immunotherapies combining different antigens and checkpoint inhibitors.
• Expanded Cancer Indications to Total of 9 Tumor Types :
Original Umbrella Trials :
1. Pancreatic Cancer
2. Lung Cancer
3. Breast Cancer
Recently Expanded Trials :
4. Head & Neck Squamous Cell Cancer
5. Ovarian Cancer
6. Colorectal Cancer
7. Gastric Cancer
8. Heptocellular Cancer
9. Esophageal Cancer
*** If the Phase 1 data is positive, INO probably can make it work by combining its own DNA-based Immune Activators ( i,e DNA IL-12 ) + its own DNA-based Checkpoint Inhibitors ( to be unveiled in 2017 ) or with its collaborators' Checkpoint Inhibitors, imo
*** Seems like INO is liking what they are seeing from the "Open-Label" Phase 1 Human Trials to be expanding to 9 tumor types, imo.
5. Report INO 5150 for Prostate Cancer
• If the results are good, INO can strike another partnership for significant amount of money, imo
6. REPORTED SUCCESSFUL Ebola HUMAN Study results
• Achieved 100% Response rate ( via Skin EP )
• Achieved 100% Response rate ( via Intra-Muscular EP w/ DNA IL12 adjuvant )
••• Great indication INO can succeed Zika vaccine w/ similar fashion (100%), imo
••• Great indication INO can take chunk of the $50+ Billion ( estimated by 2019) Infectious Disease Vaccine Market, imo.
7. Zika can be the WILDCARD for INO in 2016
• Breezed through Vaccine Design & Pre-Clinical ( Small & Large Non-Human Primate Animals ) w/ 100% protection in just about 6 months.
• Received approval for first-in-man Zika vaccine clinical trial from FDA.
, Estimated to report interim data from Phase 1 HUMAN Trial later in 2016
• If things get desperate in U.S. this summer, FDA may invoke ANIMAL RULE, imo
• May strike PRV deal( worth between $100Million to $300+M), imo
