REPL Replimune Group Inc.

35.44
+0.39  (+1%)
Previous Close 35.05
Open 34.54
52 Week Low 17.5
52 Week High 54.85
Market Cap $1,647,728,470
Shares 46,493,467
Float 22,280,608
Enterprise Value $1,169,743,018
Volume 145,395
Av. Daily Volume 387,047
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Upcoming Catalysts

Drug Stage Catalyst Date
RP2 and nivolumab
Solid tumors
Phase 1
Phase 1
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RP1 (ARTACUS)
Liver and kidney transplant recipients with recurrent Cutaneous squamous cell carcinoma
Phase 1
Phase 1
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RP3
Solid tumors
Phase 1
Phase 1
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RP1 and Opdivo (nivolumab) - (IGNYTE)
Melanoma / NSCLC
Phase 1/2
Phase 1/2
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RP1 and Libtayo (cemiplimab) - CERPASS
Cutaneous squamous cell carcinoma (CSCC)
Phase 2
Phase 2
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Latest News

  1. WOBURN, Mass., May 10, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced the strengthening of its executive team with the appointment of Tanya Lewis to a newly created position of Chief Development Operations Officer effective May 10, 2021. Ms. Lewis previously served on Replimune's board of directors and resigned on May 7th in order to join the executive team.

    Ms. Lewis joins from Karyopharm Therapeutics, a publicly traded biopharmaceutical company, where she served as Executive Vice President, Chief Regulatory Strategy and Strategic Operations Officer and was responsible for project management and portfolio…

    WOBURN, Mass., May 10, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced the strengthening of its executive team with the appointment of Tanya Lewis to a newly created position of Chief Development Operations Officer effective May 10, 2021. Ms. Lewis previously served on Replimune's board of directors and resigned on May 7th in order to join the executive team.

    Ms. Lewis joins from Karyopharm Therapeutics, a publicly traded biopharmaceutical company, where she served as Executive Vice President, Chief Regulatory Strategy and Strategic Operations Officer and was responsible for project management and portfolio review including navigating the approval of XPOVIO®. Prior to joining Karyopharm, Ms. Lewis held leadership positions at several companies, including Tesaro and Millennium, where she developed approval strategies and led interactions with U.S. and European regulators. Tanya's past accomplishments include the successful negotiations for registration trial designs, approval, and/or commercialization of VELCADE®, VARUBI®, INTEGRILIN®, and ZEJULA®.

    As Chief Development Operations Officer, Ms. Lewis will work with Replimune's senior leadership team to execute an integrated clinical, regulatory and CMC strategy to facilitate multiple potential BLA filings and product registrations.

    "Our vision extends well beyond our initial lead indications in skin cancer, with the broader aim of becoming a cornerstone of immuno-oncology treatments across a wide spectrum of tumor types. This will necessitate conducting multiple later stage clinical trials in parallel, intended to result in multiple regulatory filings for product approvals across geographies. The creation of this role is intended to provide the operational organizational oversight, direction and bandwidth to fulfill this ambition. We have had the great pleasure of working with Tanya and benefiting from her insights in her role as a non-executive Director on our Board and are excited that Tanya will now join our executive leadership team where her deep experience in shepherding multiple high profile drugs through to regulatory approval in the US and EU will be invaluable," said Philip Astley-Sparke, Chief Executive Officer of Replimune.

    Tanya Lewis commented: "The potential of Replimune's pipeline of oncolytic immuno-gene therapies has become ever more apparent during my time serving on the Board of Directors. I am honored to be able to assist such an experienced and dedicated team in creating an expansive product development program focused on bringing these novel treatments to a broad range of patients with cancer."

    Tanya holds a Bachelor of Science degree in Biology from Northeastern University and a Master of Science degree in Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy and Health Sciences.

    About Replimune

    Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune's Immulytic® platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications. For more information, please visit www.replimune.com.

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the advancement of our clinical trials, our plans to initiate new clinical trials, our goals to develop and commercialize our product candidates, the breadth and applicability of our technology, product candidates and potential product candidates, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

    Investor Inquiries

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    Westwicke, an ICR Company

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  2. WOBURN, Mass., May 05, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced a clinical development update for CERPASS, its registration-directed global randomized Phase 2 clinical trial of RP1 in combination with Libtayo® (cemiplimab) versus Libtayo for the treatment of cutaneous squamous cell carcinoma (CSCC), and for IGNYTE, its registration-directed single arm clinical trial in combination with Opdivo® (nivolumab) for the treatment of anti-PD1 failed melanoma.

    CERPASS

    "Based on the depth and durability of responses and the manageable safety profile we have seen in patients with non-melanoma skin cancers treated…

    WOBURN, Mass., May 05, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced a clinical development update for CERPASS, its registration-directed global randomized Phase 2 clinical trial of RP1 in combination with Libtayo® (cemiplimab) versus Libtayo for the treatment of cutaneous squamous cell carcinoma (CSCC), and for IGNYTE, its registration-directed single arm clinical trial in combination with Opdivo® (nivolumab) for the treatment of anti-PD1 failed melanoma.

    CERPASS

    "Based on the depth and durability of responses and the manageable safety profile we have seen in patients with non-melanoma skin cancers treated with RP1 in combination with Opdivo to date, we are amending the clinical trial protocol for our Phase 2 CERPASS clinical trial to include complete response (CR) rate as a primary endpoint in addition to overall response rate (ORR), and to reduce target enrollment to 180 patients," said Robert Coffin, Ph.D., President and Chief Research and Development Officer of Replimune. "Incorporating CR as an independent additional primary endpoint should ensure a robust assessment of the clinical meaningfulness of adding RP1 to Libtayo in the primary data analysis upon which a BLA submission and FDA's assessment for approval will be based."

    Under the modified clinical trial protocol for CERPASS, Replimune plans to add CR rate as an additional independent primary endpoint, in addition to ORR, and to reduce target enrollment from 240 patients to 180 patients. Secondary endpoints will continue to include duration of response, progression-free survival (PFS), and overall survival (OS). Replimune is maintaining its guidance to expect initial data in 2022.

    Replimune plans to submit the amended CERPASS clinical trial protocol to the U.S. Food and Drug Administration (FDA) in the first half of the year.

    Libtayo® is a registered trademark of Regeneron.

    IGNYTE

    Replimune recently held a Type B meeting with the FDA to discuss the design of the 125-patient, single-arm cohort in the IGNYTE clinical trial which is currently enrolling patients with anti-PD1 failed cutaneous melanoma, with registrational intent. The FDA expressed that while a randomized controlled trial would always be preferred to support licensure, that in this population if the data generated were sufficiently compelling, then the data could be considered for submission by the FDA under the accelerated approval pathway. The FDA also confirmed that a confirmatory trial would be needed as is required under the accelerated approval pathway. The design of the confirmatory trial is intended to be discussed with the FDA prior to a Biologics License Application (BLA) submission.

    Dr. Coffin commented: "The discussion with the FDA at the Type B meeting provides clarity on the appropriate regulatory pathway to potential approval for RP1 in combination with Opdivo in anti-PD1 failed melanoma based on the data intended to be generated from our ongoing clinical trial. We look forward to releasing initial data from this study during 2022."

    Opdivo® is a registered trademark of Bristol Myers Squibb.

    About CERPASS

    CERPASS is Replimune's registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune's investigational oncolytic immunotherapy RP1. The clinical trial will enroll 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD1 therapy. The trial will evaluate complete response (CR) rate and objective response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as its secondary endpoints. The study is being run under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.

    About IGNYTE

    IGNYTE is Replimune's multi-cohort Phase 1/2 trial of RP1 plus Opdivo®. There are 4 tumor specific cohorts currently enrolling in this trial including a 125-patient extension cohort of RP1 combined with Opdivo in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same trial of approximately 30 patients with melanoma. The additional thirty patient cohorts are studying RP1 in combination with Opdivo in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in microsatellite instability high, or MSI-H/dMMR tumor types and anti-PD-1 failed non-small cell lung cancer, or NSCLC. This trial is being done under a collaboration and supply agreement with Bristol Myer Squibb.

    About RP1

    RP1 is Replimune's lead Immulytic® product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response through the expression of a GALV-GP R- fusogenic protein and GM-CSF.

    About Replimune

    Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune's Immulytic® platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications. For more information, please visit www.replimune.com.

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the design and advancement of our clinical trials, the sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, the potential impact of COVID-19 on our operations and milestones, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

    Investor Inquiries

    Chris Brinzey

    Westwicke, an ICR Company

    339.970.2843

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    Verge Scientific Communications

    202.431.4116

     



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  3. WOBURN, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced it will host an investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo® and data from its Phase 1 study of RP2 alone and in combination with Opdivo. The event will include presentations by Philip Astley-Sparke, Chief Executive Officer of Replimune, Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology…

    WOBURN, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced it will host an investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo® and data from its Phase 1 study of RP2 alone and in combination with Opdivo. The event will include presentations by Philip Astley-Sparke, Chief Executive Officer of Replimune, Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford.

    The event will begin at 8:00 a.m. Eastern Time on Thursday, June 3, 2021. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company's website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune's website.

    Opdivo® (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.

    About Replimune

    Replimune Group Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of "oncolytic immune-gene therapies" for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. The Company's Immulytic platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action. For more information, please visit www.replimune.com.

    Investor Inquiries

    Chris Brinzey

    Westwicke, an ICR Company

    339.970.2843

    Media Inquiries

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    Verge Scientific Communications

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  4. WOBURN, Mass., April 21, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, today announced the strengthening of its executive team with the appointment of Sushil Patel, Ph.D. as Replimune's Chief Commercial Officer effective May 3, 2021. Sushil joins from Genentech, a member of the Roche Group, where he was global oncology franchise head for lung cancer, skin cancer and rare / agnostic tumor types and was previously lifecycle leader and "CEO for the molecule" in lung cancer for the multi-billion-dollar checkpoint blockade drug Tecentriq.

    "We are thrilled to welcome Sushil to our leadership team," said Philip Astley-Sparke…

    WOBURN, Mass., April 21, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, today announced the strengthening of its executive team with the appointment of Sushil Patel, Ph.D. as Replimune's Chief Commercial Officer effective May 3, 2021. Sushil joins from Genentech, a member of the Roche Group, where he was global oncology franchise head for lung cancer, skin cancer and rare / agnostic tumor types and was previously lifecycle leader and "CEO for the molecule" in lung cancer for the multi-billion-dollar checkpoint blockade drug Tecentriq.

    "We are thrilled to welcome Sushil to our leadership team," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "Sushil brings a wealth of experience in immuno-oncology and an incredible track record of success in defining and implementing launch strategies. He is well suited to both spearhead the development of Replimune's commercial capabilities and help guide our indication expansion and prioritization strategy as we seek to expedite the development of our pipeline to benefit as many patients as possible."

    Sushil Patel commented, "Replimune's broad pipeline of oncolytic immuno-gene therapies could become the next cornerstone of immuno-oncology treatment regimens. With RP1 in two registration-directed trials in CSCC and melanoma, it is now time to build an innovative and comprehensive commercial strategy and assemble a world-class team to advance these first-in-class therapies to patients. I am excited to be joining such a dynamic organization and look forward to doing my part to deliver on the full promise of the Company's leading immuno-oncolytic platform."

    As Chief Commercial Officer, Sushil will lead Replimune's commercial team including launch readiness initiatives and play a key role in the development and execution of the Company's "go to market" strategy. Sushil brings more than 20 years of oncology experience with pertinent skills in strategy, US and international oncology marketing and sales, and clinical development. He most recently served as Franchise Head in Global Product Strategy for Genentech. In this role, he was responsible for directing the company's lung and skin cancer franchise with responsibility for multiple blockbuster drugs, generating in excess of $3.5 billion in annual global sales.

    Prior to his career in biotechnology, he worked as a strategic management consultant and at IMS Health in their Pharma Strategy Group. Sushil received a Doctor of Philosophy in Molecular Biology and a Master of Sciences in Biotechnology, both from the Imperial College of Science Technology and Medicine, University of London.

    In connection with his appointment, Replimune will grant Sushil a stock option to purchase 125,000 shares of its common stock with an exercise price equal to the closing price of Replimune's common stock on the grant date. The stock option will have a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the grant date and the remainder vesting monthly for three years thereafter. Replimune will also grant Sushil restricted stock units, representing 88,333 shares of its common stock. The restricted stock units will vest in approximately four equal annual installments beginning on May 15, 2022.

    The stock option and restricted stock units (the "equity awards") will be granted subject to and effective upon the commencement of Sushil's employment on May 3, 2021. The equity awards will be granted outside of Replimune's 2018 Equity Incentive Plan, but will have terms and conditions consistent with those set forth under the plan. The equity awards were approved by the compensation committee of Replimune's board of directors in reliance on the employment inducement exception under Nasdaq Listing Rule 5635(c)(4).

    About Replimune

    Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune's Immulytic™ platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications. For more information, please visit www.replimune.com.

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the advancement of our clinical trials, our plans to initiate new clinical trials, our goals to develop and commercialize our product candidates, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

    Investor Inquiries

    Chris Brinzey

    Westwicke, an ICR Company

    339.970.2843

    Media Inquiries

    Lissete Steele

    Verge Scientific Communications

    202.930.4762



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  5. Data confirms potent anti-tumor activity & activation of robust systemic immune responses by RP1 and RP2

    • Increased infiltration of CD8+ T cells and PD-L1 expression for patients dosed with RP1 in combination with Opdivo® (nivolumab) and single agent RP2 in human biomarker samples
    • Pre-clinical evidence of innate immune activation mediated by GALV-GP R- expression
    • Gene expression profiling supportive of broad immune activation in both humans & mice
    • Further pre-clinical demonstration of potent lytic activity in tumors

    WOBURN, Mass., April 12, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced additional data supporting…

    Data confirms potent anti-tumor activity & activation of robust systemic immune responses by RP1 and RP2

    • Increased infiltration of CD8+ T cells and PD-L1 expression for patients dosed with RP1 in combination with Opdivo® (nivolumab) and single agent RP2 in human biomarker samples
    • Pre-clinical evidence of innate immune activation mediated by GALV-GP R- expression
    • Gene expression profiling supportive of broad immune activation in both humans & mice
    • Further pre-clinical demonstration of potent lytic activity in tumors

    WOBURN, Mass., April 12, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced additional data supporting the multiple mechanisms of action for its lead programs, RP1 and RP2, during two presentations at the American Association for Cancer Research (AACR) Annual Meeting 2021 being held virtually April 10-15, 2021 and May 17-21, 2021.

    "We developed Replimune's Immulytic platform with the intention of developing therapies with both enhanced tumor killing potency and with an enhanced ability to initiate a systemic anti-tumor immune response. This pre-clinical and clinical biomarker data provides further evidence that these objectives are being achieved, and that RP1 and RP2 are able to initiate a potent systemic immune response against a patient's cancer," said Robert Coffin, PhD, President and Chief Research and Development Officer, Replimune.

    Details of the presentations are as follows:

    Abstract Title: Clinical biomarker studies with two fusion-enhanced versions of oncolytic HSV (RP1 and RP2) alone and in combination with nivolumab in cancer patients indicate potent immune activation – Abstract #: LB180

    • In patients dosed with RP1 in combination with nivolumab or single agent RP2 alone and in combination with nivolumab, immunohistochemistry for CD8 and PD-L1 from paired tumor biopsies demonstrated robust and increased infiltration of CD8+ T cells and PD-L1 expression across different tumor types, including reversal of T cell exclusion following prior combined treatment with ipilimumab and nivolumab in melanoma.
    • A significant increase in the expression levels of genes associated with innate and adaptive immune activation and genes previously reported to be associated with responsiveness to anti-PD1 therapy was demonstrated.
    • In patients dosed with RP2 monotherapy, an increase in CD8+ T cell infiltration as well as robust changes in expression of key tumor and immune cell signalling pathway genes was observed.
    • Peripheral blood T cell receptor (TCR) sequencing indicated the expansion of existing T cell clones and generation of new T cell clones.
    • Increased CD8+ T cell infiltration and PD-L1 expression, coupled with changes in TCR clonal expansion in PBMC samples, suggest systemic immune activation.

    This presentation is now available for on-demand viewing on the AACR Annual Meeting 2021 website linked here and also posted to the presentations section of the Replimune website and linked here.

    RP1 is Replimune's lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus (HSV) engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response through the expression of a GALV-GP R- fusogenic protein and GM-CSF. RP2 is a derivative of RP1 that expresses an anti-CTLA-4 antibody-like molecule intended to provide targeted and potent delivery to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

    Abstract Title: Immunomodulatory effects of a novel, enhanced potency gibbon ape leukemia virus (GALV) fusogenic membrane glycoprotein-expressing herpes simplex virus platform with increased efficacy combined with anti PD-1 therapy – Abstract #1917

    This poster presentation is a collaboration between Replimune and The Institute of Cancer Research, London, UK.

    • In a histological examination of tumors injected with RP1 or RP2, large areas of necrosis in syngeneic mouse tumours were observed, even in a model where GALV-GP R- is not functional. In models where GALV-GP R- is functional, including in human xenograft tumors in nude mice (which have no adaptive immune system, but retain innate, e.g. NK cell mediated, immune function), GALV-GP R- was observed to give anti-tumor activity in both injected and in uninjected tumors, whereas a virus without GALV-GP R- only exhibited anti-tumor activity in injected tumors. These effects in uninjected tumors were presumed to result from enhanced innate immune activation mediated by GALV-GP R-.
    • RP1 increased PD-L1 expression, particularly on neutrophils, and increased CD3 T cell infiltration in injected and contralateral tumors.
    • Profound effects on the gene expression profile were also seen in both injected and contralateral tumors which are consistent with potent and broad immune activation. These were significantly greater than that seen with single agent anti-PD1, and were further enhanced when RP1 was combined with anti-PD1.

    This presentation is now available for on-demand viewing on the AACR Annual Meeting 2021 website linked here and also posted to the presentations section of the Replimune website and linked here.

    "RP1 and RP2 represent attractive potential treatment modalities with the ability to self-amplify, kill through multiple mechanisms and promote anti-tumour immune responses," said Professor Kevin Harrington, PhD, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust ​in the UK. "These data show that RP1 increases PD-L1 expression, increases CD3 T cell infiltration in injected and contralateral tumors, and has profound effects on the gene expression profile in both injected and non-injected tumors which are consistent with potent and broad immune activation. These benefits are then further enhanced by treatment with anti-PD1 creating the potential for an attractive treatment option for patients with difficult to treat tumor types who are currently underserved."

    Opdivo® is a registered trademark of Bristol Myers Squibb.

    About Replimune

    Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune's Immulytic® platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications. For more information, please visit www.replimune.com.

    Forward Looking Statements

    This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

    Investor Inquiries

    Chris Brinzey

    Westwicke, an ICR Company

    339.970.2843

    Media Inquiries

    Lissette Steele

    Verge Scientific Communications

    202.431.4116



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