Oncorus Announces Exclusive Licensing Agreement with Gaeta Therapeutics Ltd. for Use of Locally Delivered Interleukin-12 (IL-12) via Oncolytic Viral Expression in Combination with Immune Checkpoint Inhibitors

Rhea-AI Summary

Oncorus announced an exclusive licensing agreement with Gaeta Therapeutics for the use of Interleukin-12 (IL-12) combined with immune checkpoint inhibitors in cancer therapy. The agreement includes an upfront payment of $0.2M and potential milestone payments up to $7.5M. Oncorus's lead product, ONCR-177, is an oncolytic viral therapy targeting multiple solid tumors and is currently in a Phase 1 clinical trial. Initial data from this trial will be presented at the SITC Annual Meeting on November 12-14, 2021.

Positive

• Secured exclusive licensing agreement with Gaeta Therapeutics to enhance ONCR-177's development.
• Potential milestone payments of up to $7.5M could provide significant funding for clinical development.
• ONCR-177 is currently in a Phase 1 clinical trial, indicating ongoing progress in product development.

Negative

• None.

CAMBRIDGE, Mass., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced that it has signed an exclusive licensing agreement with Gaeta Therapeutics Ltd., related to the use of locally delivered Interleukin-12 (IL-12) via oncolytic viral expression in combination with immune checkpoint inhibitors, including CTLA-4, PD-1 or PD-L1 checkpoint blockade. Gaeta Therapeutics was founded by the University of Zurich in 2017 as a vehicle for the commercialization of its immune-oncology patent estate relating to the use of IL-12 in combination with checkpoint inhibitors in the treatment of cancer.

“Known to activate and expand CD8, CD4 T_H1 and natural killer cells, IL-12 is a transgene of notable interest in the immune-oncology space. IL-12 in combination with immune checkpoint blockade has demonstrated the ability to augment treatment response in certain patients versus immune checkpoint inhibitor treatment alone,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. “IL-12 is one of five immunomodulatory payloads in our lead viral immunotherapy product candidate, ONCR-177. This agreement with Gaeta is a strategic addition to our IP portfolio as we continue to advance ONCR-177 as a potential new therapeutic option for cancer patients, including in combination with pembrolizumab and other immunotherapies.”

Under the terms of the agreement, Gaeta will receive an upfront payment of $0.2M and is eligible to receive up to $7.5M in potential clinical and regulatory milestone payments on a product-by-product and indication-by-indication basis.

“We’re pleased to enter into this agreement with Gaeta, as it enhances our clinical development efforts for ONCR-177 and bolsters our future commercialization strategy and opportunities for this product candidate,” said Stephanie Duncanson, Ph.D., Vice President, Corporate Strategy and Business Development. “We’ll continue to seek additional strategic opportunities to differentiate our pipeline programs as we work to drive innovation and advance our mission to realize the full promise of viral immunotherapy for cancer patients.”   

Being developed for multiple solid tumor indications, ONCR-177 is an intratumorally administered oncolytic Herpes Simplex Virus (HSV)-based viral immunotherapy engineered to induce immunogenic cancer cell death and ignite innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to IL1-12, ONCR-177’s complementary transgene payload also includes FLT3LG, CCL4, anti-PD-1 and anti-CLTA-4. Oncorus is currently enrolling patients in a Phase 1 open-label, dose escalation and expansion clinical trial designed to evaluate the safety and tolerability of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. Oncorus will present initial data from its ongoing Phase 1 clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36^th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually.

About Oncorus
At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our oncolytic Herpes Simplex Virus (HSV) Platform and Synthetic viral RNA (vRNA) Immunotherapy Platform.

Designed to deliver next-generation viral immunotherapy impact, our HSV Platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead HSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which could limit systemic toxicities. Our pioneering Synthetic vRNA Immunotherapy Platform involves a highly innovative, novel combination of RNA- and oncolytic virus-based modalities designed to realize the potential of RNA medicines for cancer. Our lead IV-administered Synthetic vRNA Immunotherapy clinical candidates, ONCR-021 and ONCR-788, are both currently in IND-enabling studies.
Please visit www.oncorus.com to learn more.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of ONCR-177, including expectations regarding timing for reporting initial data from the ongoing Phase 1 clinical trial of ONCR-177, the product candidate’s therapeutic potential and clinical benefits and the utility and potential of Oncorus’ HSV Platform, and the strategic benefit of Oncorus’ license agreement with Gaeta Therapeutics. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Oncorus’ ability to obtain, maintain and protect its intellectual property; the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned clinical trials; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus’ ability to successfully demonstrate the safety, tolerability and efficacy of ONCR-177 and obtain regulatory approval thereof; Oncorus’ ability to obtain the requisite components for its product candidates manufactured in accordance with regulatory requirements; the expansion of Oncorus’ in-house manufacturing capabilities; and the adequacy of Oncorus’ cash resources and availability of financing on commercially reasonable terms. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 10, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the “SEC filings” page of the Investors section of Oncorus’ website at http://investors.oncorus.com. Any forward-looking statements represent Oncorus’ views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Media Contact:                                
Liz Melone
liz@scientpr.com
                
Investor Contact:
Stern Investor Relations
Julie Seidel
Julie.seidel@sternir.com

FAQ

What is the significance of Oncorus's licensing agreement with Gaeta Therapeutics?

The licensing agreement allows Oncorus to use Interleukin-12 (IL-12) with their lead product, ONCR-177, potentially increasing its effectiveness in cancer treatment.

What are the financial terms of the agreement with Gaeta Therapeutics?

Oncorus will pay Gaeta an upfront fee of $0.2M and may pay up to $7.5M in future milestone payments based on clinical and regulatory progress.

What is the current status of ONCR-177?

ONCR-177 is in a Phase 1 open-label clinical trial, evaluating its safety and tolerability, including its use with KEYTRUDA (pembrolizumab).

When will Oncorus present data from the ONCR-177 trial?

Initial data from the ongoing Phase 1 clinical trial of ONCR-177 will be presented at the SITC Annual Meeting from November 12-14, 2021.

What types of cancer is ONCR-177 targeting?

ONCR-177 is being developed for multiple solid tumor indications, including advanced and refractory conditions.