Faster Commercialization of True Personalized Cancer Therapies that are Safe, Effective, Beneficial and Feasible
Game-Changing Technology by RE-ENGINEERED Known Products
- Chemotherapeutics: SPC- An advanced Technology in bio- conjugates.
- STAT3 Inhibitors
- Immune Oncology combination therapy has proven the route to successful programs against the challenges in cancer treatment.
- Faster to Market
- Less Expensive
- Mitigated Risks
combining Genomics, Artificial Intelligence, and Individual Biopsies to identify the true personalized cancer treatment.
11 Repurposed drugs (STAT3 Inhibitors)
Ready: re-engineered, patented
Technology 2: (SCP Nanotechnology)
SCP- CisplatinSCP- Paclitaxel
SCP- DoxorubicinSCP- Docetaxel
Cancer Types Selected
- Glioblastoma: Adult & Children
- Pancreatic Cancer
- Malignant Ascites (Ovarian and other cancers)
Combinations into the Absolute Benefit
Cancer Development Program
11 Repurposed Drugs discovered to be STAT3 Inhibitors Licensed from the Dana Farber Cancer Institute
- OT-801 Clinical studies are used as Clinical Proof-of-Concept.
- OT-805 is a new salt/formulation of OT-801, for oral iv and intraperitoneal (ip) administration. A worldwide patent was filed in 2018. Will be studied alone and in combination; new fixed formulations will be developed and patented.
Immune Oncology Combination Therapy with Re- engineered Chemo's
A true Game-Changer and First in its mission
Risk Mitigation Developmental Plan
- OT-805 is a targeted therapeutic. Abnormal STAT3 (p-STAT3) is the target.
- Diagnostic tests are used to identify patients who have p-STAT3 and should be treated with OT-805
- Patient selection includes genetic and proteomic profiling to maximize efficacy, reduce number of patients needed for clinical trials, reduce cost and risk of failure
- Use FDA 505(b)(2) regulations to expedite/simplify development
- Use modern, adaptive clinical trial designs (parallel development, continuous development: phase II study continue into phase III trials in the same patients saving significant time).
Overall Action Plan
- Application of 505(b)(2) - engagement with the FDA
- First program: Brain Tumor, Adults, STAT3+ SCP (Temo.)+ SCP(Dexa.)
- Cost to Market: $35M
- Market Value: $350M yr1 and $57B gross of 7 years
- Second and Third programs will tackle similarly game changing spaces in Ovarian cancer and Cholangiocarcinoma
- Bench to Market up to 36 months
Why Us? Why Now?
- The first well proven immune oncology combination early stage development with the known late stage development results
- A winning team of known and successful professionals in the cancer treatment commercial space
- Strong IP, low cost to market, mitigated risks, and short timeline from bench to market
- Hector Gomez, MD, PhD. With 25 years in Biopharma, Multiple INDs,NDAs, successful IPO, 10 products in the market.
- Timothy Allen, MD, PhD. Hem. Onc. With 14 years of Biopharma, Multiple NDAs and 3 BLAs.
- Ghazaleh Shoja, MD. Hem. Onc. With 28 years of Clinical Practices and 9 years of Biopharma.
- Nepton Sheikh- Khoni. With 12 years of Clinical Practices and Biopharma.