Email : info@nexusalliancebiopharma.com
Contact : (321) 445-1969

AI-IO-SCP-Oncology

ORIXA THERAPEUTICS

Our Goal

Faster Commercialization of True Personalized Cancer Therapies that are Safe, Effective, Beneficial and Feasible

Our Goal

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.

Benefits

  • Faster to Market
  • Less Expensive
  • Mitigated Risks
Treatment:

combining Genomics, Artificial Intelligence, and Individual Biopsies to identify the true personalized cancer treatment.

Benefits

Technology 1:

11 Repurposed drugs (STAT3 Inhibitors)

OT-805

Ready: re-engineered, patented

Technology 2: (SCP Nanotechnology)

Re-engineered Chemotherapeutics

SCP- Cisplatin
SCP- Paclitaxel

SCP- Doxorubicin
SCP- Docetaxel



Cancer Types Selected

  • Glioblastoma: Adult & Children
  • Pancreatic Cancer
  • Cholangiocarcinoma
  • 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

Winning Team

  • 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.