ONCR Oncorus Inc.

27.34
-1.44  -5%
Previous Close 28.78
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  1. -- Preclinical findings show that ONCR-177's systemic antitumor immunity is driven by its five complementary immunomodulatory transgene payloads and retention of γ34.5 --

    -- Complete and durable tumor regression and protective antitumor memory observed in multiple syngeneic tumor models --

    -- Preclinical safety data and preliminary readout from the ongoing Phase 1 study support Oncorus' proprietary safety strategies --

    CAMBRIDGE, Mass. , Jan. 20, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, announced today the recent publication of preclinical data supporting the clinical development…

    -- Preclinical findings show that ONCR-177's systemic antitumor immunity is driven by its five complementary immunomodulatory transgene payloads and retention of γ34.5 --

    -- Complete and durable tumor regression and protective antitumor memory observed in multiple syngeneic tumor models --

    -- Preclinical safety data and preliminary readout from the ongoing Phase 1 study support Oncorus' proprietary safety strategies --

    CAMBRIDGE, Mass. , Jan. 20, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, announced today the recent publication of preclinical data supporting the clinical development of its lead oncolytic Herpes Simplex Virus (oHSV) clinical candidate, ONCR-177. In the paper, entitled, "ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity" (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models. The preclinical findings demonstrate that the activity of ONCR-177, an intratumorally administered viral immunotherapy engineered for systemic activity currently in a Phase 1 study, is driven by Oncorus' unique combination of five complementary immunomodulatory transgene payloads in addition to its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the presence of host antiviral immune responses. ONCR-177's safety strategies and their ability to enhance oHSV tolerability without impeding potency were previously characterized in a paper published by Oncorus in September 2020 in Molecular Therapy on ONCR-159, the unarmed version of ONCR-177, (Kennedy et al., 2020) titled, "Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety Modalities for Improved Tolerability."

    "We are pleased to share these encouraging preclinical findings, which supported our advancement of ONCR-177 into clinical development last year. These data give important insight into how our proprietary engineering of ONCR-177 may enable systemic activity without compromising safety, and position us to advance our mission to realize the full potential of this therapeutic class for cancer patients," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. "We believe viral immunotherapies as a class are a proven modality and represent the most promising approach in development today to activate multiple arms of the immune system and improve outcomes for cancer patients."

    Oncorus is conducting a Phase 1 study to evaluate the safety and tolerability of ONCR-177 as well as to evaluate preliminary antitumor activity in patients with solid tumors (NCT04348916) as a monotherapy and in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) via a clinical trial collaboration and supply agreement signed with Merck in July 2020. Oncorus expects to report initial interim data from the monotherapy dose escalation part of this trial in the second half of 2021 with addition data readouts through the second half of 2022.

    Christophe Quéva, Ph.D., Oncorus' Chief Scientific Officer and Senior Vice President, Research, commented, "We have designed our proprietary oHSV Platform to safely maximize the impact of viral immunotherapies to foster the development of a potent systemic antitumor activity. With our Phase 1 study of ONCR-177 now well underway, we look forward to the potential of these preclinical findings translating into improving patient outcomes."

    In addition to ONCR-177, Oncorus plans to nominate a second intratumorally administered oHSV clinical candidate to specifically target cancers of the central nervous system, including glioblastoma multiforme, in the second half of 2021 (ONCR-GBM). In the first half of 2021, Oncorus plans to nominate intravenously administered Synthetic Coxsackievirus A21 and Synthetic Seneca Valley Virus clinical candidates from its Synthetic Virus Platform for difficult-to-inject tumors such as those of the lung.

    Preclinical Data Highlights

    Highlights from Oncorus' preclinical data described in these papers include:

    • The murine version of ONCR-177 (mONCR-171) demonstrated durable complete tumor regressions and abscopal activity in four syngeneic tumor models: A20, MC38, CT26 and B16F10N1.
    • Durable survival was achieved in both A20 and CT26 models versus the unarmed version of ONCR-177 (i.e., ONCR-159), specifically demonstrating the impact that ONCR-177's arming strategy has in driving systemic activity in these in vivo models of cancer. Re-challenge experiments in long term responders to mONCR-171 demonstrated that tumor antigen-specific protective memory responses were achieved.
    • The retention of a gene coding for γ34.5 demonstrated more robust replication in the presence of interferon-γ versus viruses that do not contain this gene. Of note, ONCR-159, which also retains γ34.5 expression, demonstrated statistically significant improvement in an in vivo bi-lateral CT26 model of survival.
    • The addition of systemic anti-PD-1 augmented the activity of mONCR-171, particularly for un-injected tumors, suggesting that utilizing systemic anti-PD-1 immunotherapy may augment the systemic antitumor effect of ONCR-177.
    • Directional viral promoters, CAG and MND, were shown to elicit strong transgene expression in injected tumors. Furthermore, the addition of the five complementary immunomodulatory transgenes and other modifications in ONCR-177 remain potently oncolytic in vitro in cancer cell lines. The oncolytic activity of ONCR-177 is on par with what has been reported for talimogene laherparepvec (IMLYGIC®), which is commonly referred to as "T-VEC".1
    • In vivo biodistribution analyses suggest that viral DNA and transgene expression were relegated primarily to the injected tumor. As previously disclosed, no dose limiting toxicities were observed in the first four patients dosed with ONCR-177 suggesting that the safety strategies incorporated into ONCR-177 are working as intended.

    About ONCR-177

    ONCR-177, Oncorus' lead viral immunotherapy candidate, is designed to mount a multidimensional attack on cancer. It induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response.

    Five Complementary Immunomodulatory Transgene Payloads to Recruit Multiple Arms of Immune System

    ONCR-177 is armed with five complementary transgenes with strong clinical and preclinical validation, IL-12, FLT3LG, CCL4, anti-PD-1 and anti-CLTA-4, which were selected by Oncorus to comprehensively drive the Cancer-Immunity Cycle2 at multiple nodes:

    • IL-12 is known to activate and expand CD8, CD4 TH1 and natural killer (NK) cells.
    • FLT3LG is well understood to expand antigen cross-presenting classical dendritic cells, and CCL4 is known facilitate dendritic and CD8 T cell recruitment.
    • ONCR-177's local expression of agonists to PD-1 (via a proprietary PD-1 nanobody) and CTLA-4 (using the ipilimumab sequence) is intended to counteract compensatory upregulation of key immune checkpoints.

    γ34.5 Retention to Enable Resistance to Host Antiviral Immune Responses and Additional Innovations

    ONCR-177 also retains a copy of γ34.5 to enable resistance to host antiviral interferon responses. γ34.5 is known to play a more central role in inhibition of antiviral response than US11.3 Furthermore, ONCR-177 contains a gB:N/T mutation in a surface fusion protein shown to broaden tropism beyond Herpesvirus entry mediator (HVEM) and nectin-1 to include nectins-2, 3 and 4 and enhance infectivity.4 Lastly, ONCR-177 contains inactivating null mutations in ICP47 intended to improve antigen presentation.5

    Orthogonal Safety Strategies to Enable Selective Attenuation and Retention of γ34.5

    Oncorus' oHSV platform incorporates two complementary and proprietary approaches to limit viral replication in normal tissues. First, Oncorus' microRNA attenuation strategy leverages the known differential expression of certain microRNA in tumors versus normal tissues to allow unencumbered viral replication in tumor cells, while preventing replication in healthy tissues. This microRNA attenuation strategy allows ONCR-177 to retain the ability to express the gene encoding for γ34.5, a feature unique among oHSV-based therapies such as T-VEC and others in development today. In addition, ONCR-177 also has engineered proprietary mutations into UL37 to eliminate the virus' ability to transport, replicate and establish latency inside neurons.6

    About Oncorus

    At Oncorus, we are focused on driving innovation to deliver next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV Platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Oncorus' lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit us at 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:  expectations with respect to Oncorus' ability to advance its clinical and preclinical pipelines, including statements regarding the clinical development of ONCR-177 and timing and anticipated data read-outs for the ongoing Phase 1 clinical trial; Oncorus' expectations regarding upcoming milestones for its other potential product candidates, including the timing for nomination of clinical candidates from its two Synthetic Virus Platform development programs and its second oHSV Platform clinical candidate; and the therapeutic potential and clinical benefits of Oncorus' existing and potential product candidates. 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: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned preclinical studies and clinical trials; the risk that the preliminary results of preclinical studies or clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus' ability to successfully demonstrate the safety and efficacy of ONCR-177 and obtain regulatory approval and that Oncorus' other preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, 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.

    Investor Contact:                                                       

    Alan Lada                                

    Solebury Trout                                 

    617-221-8006                                

        
    Media Contact:                                

    Liz Melone                             

    ___________________________________________________  

    1 Moesta, et al, Cancer Research 2017

    2 Chen and Mellman, Immunity 2013

    3 Mulvey et al., J. Virol. 2004 and Peters et al., J. Virol. 2018

    4 Uchida, J. Virol. 2010

    5 Twumasi-Boateng, Nat. Rev. Cancer 2018

    6 Richards et al., PLoS Pathog. 2017 



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  2. -- 88,000 square foot state-of-the-art facility will support Oncorus' advancing, multi-product pipeline of intratumorally and intravenously administered viral immunotherapies

    -- Initial phase of site buildout anticipated to be completed in fourth quarter 2021 --

    -- Company anticipates site will be fully operational in early 2023 and expects to employ up to 100 Oncorus team members --

    CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, announced today that it has signed a 15-year lease to build a state-of-the-art, 88,000 square foot Good Manufacturing Practice (GMP) viral…

    -- 88,000 square foot state-of-the-art facility will support Oncorus' advancing, multi-product pipeline of intratumorally and intravenously administered viral immunotherapies

    -- Initial phase of site buildout anticipated to be completed in fourth quarter 2021 --

    -- Company anticipates site will be fully operational in early 2023 and expects to employ up to 100 Oncorus team members --

    CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, announced today that it has signed a 15-year lease to build a state-of-the-art, 88,000 square foot Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility in Andover, Mass.

    Oncorus is advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple cancer indications with significant unmet needs based on its oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. The company is currently conducting a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The company anticipates reporting interim data from this Phase 1 trial in the second half of 2021 through the second half of 2022. Oncorus plans to nominate its first intravenously administered synthetic virus clinical candidates (coxsackievirus A21 and Seneca Valley Virus programs) in the first half of 2021 and its second intratumorally administered oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021.

    "Last year was a year of tremendous progress for Oncorus. We initiated a first-in-human study of our lead viral immunotherapy program, ONCR-177, signed a clinical collaboration agreement and supply agreement with Merck for ONCR-177, made strides advancing multiple earlier stage programs, successfully completed an IPO, and continued to strengthen our team," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO at Oncorus. "Now we're thrilled to announce that we've signed a lease for our planned manufacturing facility, which will play a central role in enabling us to advance our mission to realize the full promise of viral immunotherapy for cancer patients. Operational and manufacturing scale-up will be a strategic priority for Oncorus going forward."

    The facility is intended to provide a comprehensive solution for Oncorus' Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling studies and clinical studies. Oncorus anticipates the first phase of the facility's buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023. Oncorus plans to continue partnering with contract manufacturing organizations to provide additional support and capacity.

    "The investment in this manufacturing facility demonstrates our commitment to growth and innovation," said Steve Harbin, Chief Operations Officer and Chief of Staff at Oncorus. "In addition to ramping up GMP activities to support our near-term development needs, we also plan to build robust process development and scale-up infrastructure, which is critical for future efforts, including potential commercial launch support. This facility will give us control over quality and output and enhanced flexibility as we develop our multiple oHSV- and synthetic virus-based viral immunotherapy programs."

    Mr. Harbin, who recently joined Oncorus, is responsible for guiding operations and manufacturing at the company in addition to its Talent and Culture function. Previously, he held senior executive manufacturing and operations leadership roles in the U.S. and globally with Moderna, Inc., bioMérieux SA, and Eli Lilly and Company.

    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 and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV Platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit us at 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: expectations with respect to Oncorus' ability to advance its clinical and pre-clinical pipelines, including statements regarding the clinical development of ONCR-177 and timing of reporting interim data, expectations regarding upcoming milestones for its other potential product candidates, as well as the therapeutic potential and clinical benefits of Oncorus' product candidates; Oncorus' expectations with respect to its continued growth, including its ability to expand its infrastructure and organization and its ability to scale-up its platforms, buildout its manufacturing capabilities, including the anticipated timing for completion of the initial buildout phase and full operating capacity at Oncorus' newly leased manufacturing facility, and secure additional manufacturing capacity; the ability of the leadership team to execute Oncorus' strategy and support its future growth; and statements regarding the accomplishments, experience and capabilities of individual members of Oncorus' leadership team and the ability of such qualities to drive Oncorus' success. 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: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the development of its manufacturing capabilities and progression of its product candidates into the operational scale-up phase; the risk that the results of a clinical trial may not be predictive of future results in connection with future clinical trials; Oncorus' ability to successfully demonstrate the safety and efficacy of ONCR-177 and obtain regulatory approval; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, 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.

    Investor Contact:Media Contact:
    Alan LadaLiz Melone
    Solebury Trout
    617-221-8006 
    trout.com 



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  3. CAMBRIDGE, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, today announced the appointment of Scott Canute, M.B.A. to its Board of Directors. Mr. Canute has nearly 40 years of broad experience in the biopharmaceutical industry, including leading global manufacturing and operations strategy and execution for Genzyme Corporation and Eli Lilly and Company.

    "As we execute on our growth plans, including the buildout of our in-house manufacturing capabilities, we are delighted to welcome Scott Canute to our Board of Directors," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO of…

    CAMBRIDGE, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, today announced the appointment of Scott Canute, M.B.A. to its Board of Directors. Mr. Canute has nearly 40 years of broad experience in the biopharmaceutical industry, including leading global manufacturing and operations strategy and execution for Genzyme Corporation and Eli Lilly and Company.

    "As we execute on our growth plans, including the buildout of our in-house manufacturing capabilities, we are delighted to welcome Scott Canute to our Board of Directors," said Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO of Oncorus. "We look forward to leveraging Scott's breadth of experience and insights from leading operations and manufacturing for world-class biopharmaceutical organizations as we advance our pipeline of novel viral immunotherapies for cancer patients."

    Oncorus is advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on its oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Oncorus is currently conducting a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications.

    "I am thrilled to join Oncorus' Board and support Ted and the Oncorus team as they continue to advance ONCR-177 through the clinic and embark on an exciting period of growth and infrastructure development to support their expanding pipeline," said Mr. Canute. "Viral immunotherapies are increasingly gaining attention for their unique and clinically-validated approach against cancer. Oncorus' dual-platform approach positions the company as a leader in this space. I'm excited to have the opportunity to contribute to Oncorus' continued progression and patient-centric mission."   

    Mr. Canute previously served as President of Global Manufacturing and Corporate Operations at Genzyme from 2010 to 2011, where he was brought in specifically to lead a major turnaround in manufacturing to ensure the ongoing supply of the company's life-saving products. Prior to joining Genzyme, Mr. Canute spent 25 years at Lilly, where he held several operations and manufacturing roles of increasing responsibility, including ultimately serving as President, Global Manufacturing Operations from 2004 to 2007. In this role, Mr. Canute directed all manufacturing and supply chain activities for Lilly's global operations.

    Mr. Canute currently serves as a director of Flexion Therapeutics. He previously served as a member of the Board of Directors of Immunomedics Inc., Akebia Therapeutics, Inc., Proteon Therapeutics, Inc., AlloCure, Inc., Inspiration Biopharmaceuticals, Inc., Oncobiologics, Inc., and the National Association of Manufacturers and the Indiana Manufacturers Association.

    Mr. Canute earned a B.S. in chemical engineering from the University of Michigan and an M.B.A. from Harvard Business School.

    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 and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV Platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit us at 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: expectations with respect to Oncorus' ability to advance its clinical and pre-clinical pipelines, including statements regarding the clinical development of ONCR-177, expectations regarding upcoming milestones for its other potential product candidates, as well as the therapeutic potential and clinical benefits of Oncorus' product candidates; Oncorus' expectations with respect to its continued growth, including its ability to expand its infrastructure and organization and its ability to scale-up its platforms and buildout its manufacturing capabilities; the ability of the leadership team to execute Oncorus' strategy and support its future growth; and statements regarding the accomplishments, experience and capabilities of individual members of Oncorus' leadership team and the ability of such qualities to drive Oncorus' success. 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: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the development of its manufacturing capabilities and progression of its product candidates into the operational scale-up phase; the risk that the results of a clinical trial may not be predictive of future results in connection with future clinical trials; Oncorus's ability to successfully demonstrate the safety and efficacy of ONCR-177 and obtain regulatory approval; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, 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's 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.

    Investor Contact:Media Contact:
    Alan LadaLiz Melone
    Solebury Trout
    617-221-8006 
     

     

                  

     



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  4. CAMBRIDGE, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, today announced the appointment of Steve Harbin as Chief Operating Officer and Chief of Staff.

    "I am thrilled to welcome Steve to the Oncorus team. He is uniquely qualified to help steer the strategic growth of our company at this pivotal timepoint," said Theodore (Ted) Ashburn, M.D. Ph.D., President and CEO of Oncorus. "We continue to advance the Phase 1 study of our lead viral immunotherapy candidate, ONCR-177, and progress our earlier stage viral immunotherapy candidates toward candidate nomination, including our innovative…

    CAMBRIDGE, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a clinical stage biopharmaceutical company developing next-generation viral immunotherapies to transform outcomes for cancer patients, today announced the appointment of Steve Harbin as Chief Operating Officer and Chief of Staff.

    "I am thrilled to welcome Steve to the Oncorus team. He is uniquely qualified to help steer the strategic growth of our company at this pivotal timepoint," said Theodore (Ted) Ashburn, M.D. Ph.D., President and CEO of Oncorus. "We continue to advance the Phase 1 study of our lead viral immunotherapy candidate, ONCR-177, and progress our earlier stage viral immunotherapy candidates toward candidate nomination, including our innovative synthetic virus candidates. We believe that our infrastructure, organization and internal processes are poised for significant expansion in the coming months. Having Steve architect this evolution is an obvious choice."

    Mr. Harbin commented, "I am excited to join the Oncorus team at this exciting time in the company's journey. It takes good science, good people and good business to develop and grow a leading biotech, and I have found them all here at Oncorus. The promise of Oncorus' two novel viral immunotherapy platforms is now transitioning to a key operational scale-up phase as the company's pipeline advances. I believe I can make a significant impact and execute the ambitious growth strategy Ted and the Oncorus Board have articulated, including the buildout of the company's manufacturing capabilities."

    Mr. Harbin brings more than 30 years of diverse operational experience in biotech, pharmaceuticals and in-vitro diagnostics. He has served in a variety of senior business and operational leadership roles, including 15 years at the executive committee level, for both publicly and privately held companies based in Europe and the U.S. Most recently, Mr. Harbin served as a consultant to several early stage biotech companies in the Cambridge community, providing strategic counsel related to operational scale-up challenges.

    Prior to that, Mr. Harbin served in several executive committee roles at Moderna, Inc. for six years as a Senior Vice President, joining the company when it was still at an early phase. Throughout his tenure at Moderna, Mr. Harbin was a key driver of the company's successful growth strategy, overseeing clinical and non-clinical manufacturing operations, supply chain, facilities and human resources. Mr. Harbin retired from Moderna in 2019, shortly after the company's initial public offering.

    Before joining Moderna, Mr. Harbin was based in France and held the position of Senior Vice President, Global Operations at bioMérieux SA, where he managed over 3,500 employees responsible for multiple highly-regulated global functions, including regulatory, information technology, internal control and quality, and all 15 of the company's global manufacturing sites. In addition to his operational duties, Mr. Harbin also held two board-level positions in joint ventures in Japan and China.

    Earlier in his career, Mr. Harbin held multiple leadership roles within Eli Lilly and Company globally, where his responsibilities spanned a variety of business and operations functions, including finance, manufacturing, sales, human resources and people development.

    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 and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV Platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit us at 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: expectations with respect to Oncorus' ability to advance its clinical and pre-clinical pipelines, including statements regarding the clinical development of ONCR-177, expectations regarding upcoming milestones for its other potential product candidates, as well as the therapeutic potential and clinical benefits of Oncorus' product candidates; Oncorus' expectations with respect to its continued growth, including its ability to expand its infrastructure and organization and its ability to scale-up its platforms and buildout its manufacturing capabilities; the ability of the leadership team to execute Oncorus' strategy and support its future growth; and statements regarding the accomplishments, experience and capabilities of individual members of Oncorus' leadership team and the ability of such qualities to drive Oncorus' success. 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: the impact of COVID-19 on Oncorus' operations and the timing and anticipated results of its ongoing and planned clinical trials; the development of its manufacturing capabilities and progression of its product candidates into the operational scale-up phase; the risk that the results of a clinical trial may not be predictive of future results in connection with future clinical trials; Oncorus's ability to successfully demonstrate the safety and efficacy of ONCR-177 and obtain regulatory approval; and Oncorus' ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, 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's 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.

    Investor Contact:  Media Contact:
    Alan LadaLiz Melone
    Solebury Trout 
    617-221-8006 
    trout.com 

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1a8a7d16-f4b6-4a61-ae9f-50b332d79f23



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  5. CAMBRIDGE, Mass., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, announced today that Theodore (Ted) A. Asbhurn, M.D., Ph.D., President and Chief Executive Officer, will participate in fireside chats at two upcoming investor conferences.

    32nd Annual Piper Sandler Annual Virtual Healthcare Conference
    Dates: December 1 - December 3, 2020
    Webcast: The pre-recorded fireside chat is now available in the Investors & Media section of Oncorus' website at https://investors.oncorus.com/events-and-presentations. The presentation will be archived on the company's site for 90 days.

    3rd Annual Evercore ISI HealthCONx Conference
    Date…

    CAMBRIDGE, Mass., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Oncorus, Inc. (NASDAQ:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, announced today that Theodore (Ted) A. Asbhurn, M.D., Ph.D., President and Chief Executive Officer, will participate in fireside chats at two upcoming investor conferences.

    32nd Annual Piper Sandler Annual Virtual Healthcare Conference

    Dates: December 1 - December 3, 2020

    Webcast: The pre-recorded fireside chat is now available in the Investors & Media section of Oncorus' website at https://investors.oncorus.com/events-and-presentations. The presentation will be archived on the company's site for 90 days.

    3rd Annual Evercore ISI HealthCONx Conference

    Date: December 3, 2000

    Time: 9:40 a.m. ET

    Webcast: A live webcast of the presentation will be available in the Investors & Media section of Oncorus' website at https://investors.oncorus.com/events-and-presentations. A replay of the presentation will be archived on the company's site.

    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 and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Our lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit www.oncorus.com to learn more.

    Investor Contact:Media Contact:
    Alan LadaLiz Melone
    Solebury Trout
    617-221-8006 
     





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