Log in
Enquire now
‌

Oncoimmune Inc SBIR Phase I Award, April 2020

A SBIR Phase I contract was awarded to ONCOIMMUNE, LTD in April, 2020 for $400,000.0 USD from the U.S. Department of Health & Human Services and National Institutes of Health.

OverviewStructured DataIssuesContributors

Contents

sbir.gov/node/1912193
Is a
SBIR/STTR Awards
SBIR/STTR Awards

SBIR/STTR Award attributes

SBIR/STTR Award Recipient
ONCOIMMUNE, LTD
ONCOIMMUNE, LTD
0
Government Agency
0
Government Branch
National Institutes of Health
National Institutes of Health
0
Award Type
SBIR0
Contract Number (US Government)
1R44CA250824-010
Award Phase
Phase I0
Award Amount (USD)
400,0000
Date Awarded
April 3, 2020
0
End Date
September 30, 2020
0
Abstract

Summary A major paradigm in cancer immunotherapy is to use checkpoint inhibitors to break regulatory mechanisms that guard the host against autoimmune diseases. CTLA-4-targeting immunotherapy was the first example to establish this paradigm. However, the clinically tested anti-CTLA-4 antibodies exhibit suboptimal efficacy but high toxicity. Our preclinical study demonstrate that this outcome is predicated by inactivating the CTLA-4 checkpoint that plays important role in immune tolerance protecting body against autoimmune diseases. Importantly, our studies have demonstrated that immunotherapy-related adverse events (irAE) and the cancer immunotherapeutic effect (CITE) represent distinct and therapeutically separable activities of anti-CTLA-4 antibodies. The irAE is attributable to inactivation of CTLA-4 checkpoint, while the CITE is effective through selective depletion of regulatory T cells (Treg) in tumor microenvironment. We hypothesize that a safer and more effective CTLA-4-targeting immunotherapy should preserve rather than inhibit the CTLA-4 checkpoint while enhancing the efficacy and selectivity of Treg-depletion in tumor microenvironment. In preparation to test this ground-breaking hypothesis clinically, we have generated a new generation of anti- CTLA-4 antibodies that preserving CTLA-4 immune checkpoint by avoiding lysosomal degradation of CTLA-4. The new antibody, ONC-392, has dramatically lower irAEs in humanized mouse model and significantly higher potent activity in depleting tumor-infiltrating regulatory T cells, resulting in more effective CITE. We have conducted IND-enabling studies, including GMP-grade manufacturing and GLP toxicity in non-human primate. We have also sought FDA feedback on our clinical plan through a pre-IND meeting. These progresses allowed us to propose a Fast Track Phase 1/2 SBIR application to determine safety and efficacy of ONC-392 in human cancer patients. With the support of the SBIR grant, we will carry out an open label Phase I/II clinical study to test the safety, pharmacokinetics (PK), and efficacy of ONC-392 as a single agent and in combination with Pembrolizumab in advanced solid tumors and non-small cell lung cancer patients. Our proposed study will not only confirm safety of ONC-392, but also provide clinical proof-of-concept data for our new paradigm of CTLA-4 targeting cancer immunotherapy.Project Narrative A major paradigm in cancer immunotherapy is to use checkpoint inhibitors to break regulatory mechanisms that guard the host against autoimmune diseases. Here we presented our preclinical data to support a ground- breaking hypothesis that a safer and more effective CTLA-4-targeting immunotherapy should preserve rather than inhibit the CTLA-4 checkpoint while enhancing the efficacy and selectivity of Treg-depletion in tumor microenvironment. This Fast Track SBIR grant will support an open label Phase I/II clinical study to test the safety, pharmacokinetics (PK), and efficacy of a next generation anti-CTLA 4 antibody, ONC-392, as a single agent and in combination with Pembrolizumab in advanced solid tumors and non-small cell lung cancer patients.

Timeline

No Timeline data yet.

Further Resources

Title
Author
Link
Type
Date
No Further Resources data yet.

References

Find more entities like Oncoimmune Inc SBIR Phase I Award, April 2020

Use the Golden Query Tool to find similar entities by any field in the Knowledge Graph, including industry, location, and more.
Open Query Tool
Access by API
Golden Query Tool
Golden logo

Company

  • Home
  • Press & Media
  • Blog
  • Careers
  • WE'RE HIRING

Products

  • Knowledge Graph
  • Query Tool
  • Data Requests
  • Knowledge Storage
  • API
  • Pricing
  • Enterprise
  • ChatGPT Plugin

Legal

  • Terms of Service
  • Enterprise Terms of Service
  • Privacy Policy

Help

  • Help center
  • API Documentation
  • Contact Us
By using this site, you agree to our Terms of Service.