SEATTLE, WA and HAMPTON, NJ, May 29, 2014 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) and Celldex Therapeutics, Inc., (NASDAQ: CLDX) today announced that they have agreed to collaborate on a combined clinical trial of ONT-10 and varlilumab. ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1. Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.
The planned trial is an open-label Phase 1b study of ONT-10 administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer. The primary objective of the trial is to determine the safety and tolerability of the combined therapy. Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses and anti-tumor effects.
"Recent advances in the immunotherapy of cancer have created new opportunities for evaluating the effectiveness of combination approaches," said Diana Hausman, M.D., Chief Medical Officer at Oncothyreon. "We believe the combination of a therapeutic vaccine with an agent which activates T-cells has the potential to be particularly exciting."
"The combination of an immunogenic tumor-targeted vaccine such as ONT-10 and a broad immune co-stimulator like varlilumab could create potent immunity that may result in anticancer activity, either together or in combination with a checkpoint inhibitor," said Tom Davis, M.D., Senior Vice President and Chief Medical Officer of Celldex. "We believe combination approaches represent the future of immuno-oncology and look forward to starting this study and gathering more information on the potential of varlilumab in combination with this promising MUC1 vaccine and other potentially complementary agents."The collaboration agreement provides that Oncothyreon will supply ONT-10 and Celldex will supply CDX-1127. The Phase 1b trial will be conducted and funded by Oncothyreon, which plans to submit a new Investigational New Drug (IND) application for the combination trial. Oncothyreon and Celldex will jointly own the data from the trial and will make any plans for potential future development of the combination therapy together. Under the agreement, neither company has granted the other a license, or any other rights, to its product candidate.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV