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Replimune Group, Inc. (REPL)

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Previous Close30.50
Open30.54
Bid30.14 x 800
Ask30.59 x 1200
Day's Range30.15 - 30.77
52 Week Range10.62 - 54.85
Volume19,755
Avg. Volume388,157
Market Cap1.424B
Beta (5Y Monthly)2.52
PE Ratio (TTM)N/A
EPS (TTM)-1.75
Earnings DateFeb 04, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est56.30
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  • GlobeNewswire

    Replimune to Present New Biomarker & Pre-clinical Data for Lead Oncolytic Immunotherapy Programs at the 2021 American Association for Cancer Research Annual Meeting

    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 samplesPre-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 StatementsThis 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 BrinzeyWestwicke, an ICR Company339.970.2843chris.brinzey@westwicke.com Media InquiriesLissette SteeleVerge Scientific Communications202.431.4116lsteele@vergescientific.com

  • 3 Biotech Stocks That Could Double In 12 Months
    Benzinga

    3 Biotech Stocks That Could Double In 12 Months

    Biotech stocks are risky investment bets that can swing an investor's fortunes in a big way. An investment decision backed by careful scrutiny and analysis — of a company's pipeline, collaborations, fundamentals, key make-or-break events and cash runway — can fetch disproportionate returns. Here are three biopharma stocks that have the potential to more than double from current levels: Immatics (NASDAQ: IMTX) FibroGen, Inc. (NASDAQ: FGEN) Replimune Group, Inc. (NASDAQ: REPL) Immatics: Immatics is a clinical-stage biopharma engaged in the discovery and development of T cell directing cancer immunotherapies. The shares of the German biotech were listed on the Nasdaq in July 2020 following its business combination with Arya Sciences Acquisition Corp, a SPAC sponsored by Perceptive Advisors. The Pipeline: The company's T cell receptor (TCR)-based immunotherapies offer a targeted therapy to patients with high medical need. It has two lead product classes, namely engineered Adoptive Cell Therapies, or ACTengine, and antibody-like TCR Bispecifics, or TCER. See also: Best Biotech Stocks Right Now ACTengine is based on genetically engineering patients own T cells — a type of blood cells that are key to the immune system — with a TCR to recognize the cancer target. This would program the T cells to attack the tumor. These engineered T cells are then multiplied in labs and reinfused into the patients to treat the tumor. The product candidates belonging to the class ACT are IMA201, IMA 202 and IMA203, which are in Phase 1 trials, as well as IMA204, which is in preclinical development. IMA301 is preclinical stage ACT allo product candidate. IMA401 and IMA402 are two preclinical TCR bispecifics candidates. The company has a string of partnerships with large biopharma companies such as Amgen Inc. (NASDAQ: AMGN), Bristol-Myers Squibb Company (NYSE: BMY) and GlaxoSmithKline plc (NYSE: GSK). "Overall, we view TCR approaches as potentially transformational for the solid tumor therapeutic space, with the ability to target a wide range of antigens not accessible by CAR-T or classical antibody approaches," SVB Leerink analyst Jonathan Chang said in a note. Although competition is steadily increasing, Immatics' comprehensive TCR-based immunotherapy approach will expand the potential utilization of TCRs across a broad range of tumor types and stages, the analyst said. Cash and cash equivalents as well as other financial assets stood at $303.6 million as of Sept, 30, 2020, providing cash runway into 2023. Upcoming Catalysts: Combined initial data readout from its ACTengine product candidates, IMA201 and IMA 202, in solid tumors and IMA203 in hematologic malignancies and solid cancers in the first quarter. Investigational new drug application filing for IMA204 in solid cancers in 2021. IND filing for IMA301 in hematological and solid cancers in 2022. IND filing for IMA-401 in solid cancers by year end 2022. FibroGen: FibroGen focuses on advancing treatment options for anemia, fibrotic disease and cancer, leveraging its expertise in fibrosis and hypoxia-inducible factor biology. HIF is a protein complex that plays a key role in the body's response to low oxygen concentrations and inflammation. The Pipeline: FibroGen's anemia drug roxadustat is being developed along with AstraZeneca PLC (NASDAQ: AZN). It is approved in China and Japan for chronic kidney disease-induced anemia, and awaits clearance in the U.S. and Europe for the same indication. It is also being evaluated for anemia in myelodysplastic syndrome patients and chemotherapy-induced anemia. FibroGen's fibrotic portfolio consists of pamrevlumab, which is being evaluated for multiple indications such as pancreatic cancer, Duchenne muscular atrophy, idiopathic pulmonary fibrosis and COVID-19. The company's announcement March 1 regarding the FDA's decision to hold an Adcom meeting ahead of the roxadustat PDUFA date of March 20 led to a sell-off in shares. The stock has pulled back over 30% since the start of March. "At this reduced share price we believe that the market is still undervaluing FibroGen's anti-CTGF antibody pamrevlumab, which is in phase 3 studies for three large indications, as well as roxadustat in China and Japan," SVB Leerink analyst Geoffrey Porges said in a note. Even in the bear-case scenario of no approval for roxadustat in the U.S. and EU, FibroGen shares are worth $52/share, according to the analyst. This, the analyst said, is an unlikely scenario. Approval for the drug in both dialysis-dependent and non-dialysis-dependent patients could push the stock value up to $85, he said. The company recently initiated a Phase 3 study of pamrevlumab in combination with systemic corticosteroids in patients with ambulatory Duchenne muscular dystrophy. FibroGen expects to end 2021 with cash in the range of $660 to $670 million. Upcoming Catalysts: Phase 2 data for roxadustat in chemotherapy-induced anemia in the second-half of 2021. Data from the Phase 3 study of roxadustat in anemia of myelodysplastic syndromes in the first half of 2022. Resection data from the Phase 3 study of pamrevlumab in locally advanced pancreatic cancer in the second half of 2022. Data from the Phase 3 study of pamrevlumab in DMD in the second half of 2022. Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates Replimune: Replimune is a pursuing a novel approach in taking on cancer with its oncolytic immunotherapy. It uses viruses that have been modified to selectively replicate in tumor cells and kill them. In a two-pronged strategy, oncolytic viruses kill tumors at the site of injection and also activate immune system to kill cancer cells anywhere in the body. The company's lead candidate RP1 is being evaluated as a monotherapy as well as in combination with anti-PD1 antibodies such as Bristol-Myers Squibb's Opdivo and the Sanofi (NASDAQ: SNY)-Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) combo's Libtayo for multiple cancer types such as melanoma, non-melanoma skin cancer, micro instability-high cancers, non-small cell lung cancer, or NSCLC, and cutaneous squamous cell carcinoma, or CSCC. RP2 and RP2 are being studied as monotherapy option and in combination with anti-PD1 antibodies against solid tumors. "While the oncolytic virus landscape is competitive, we believe REPL has a lower risk profile given similarities between REPL's approach and the clinically validated T-Vec approach and the fact that REPL is being led by the same team that developed T-Vec," SVB Leerink analyst Chang said. The cash balance of $493.3 million as of Dec. 31, the company said, will fund its operating expenses and capital expenditure requirements into the second half of 2024. Upcoming Catalysts: Initial data for RP1 in new indications such as anti-PD1 failed NSCLC, anti-PD1 failed CSCC and CSCC solid organ transplant recipient patients due in 2021. Updates across all RP1 programs anticipated in 2021. Initial Phase 1 data for RP2 in combination with Opdivo due in 2021. Initial single-agent data for RP3 in 2021. Screening Criteria Used: Market cap of over $300 million. Average trading volume of over 100,000. Cash runway of two-plus years. Sell-side rating of Buy or above. Key upcoming catalysts. See more from BenzingaClick here for options trades from BenzingaWeek Ahead In Biotech (March 14-20): Update On Fibrogen-AstraZeneca's Anemia Drug, Earnings and Presentations© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • GlobeNewswire

    Replimune to Present at the American Association for Cancer Research Annual Meeting 2021

    WOBURN, Mass., March 11, 2021 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, today announced two poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021 being held virtually April 10-15, 2021 and May 17-21, 2021. 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 activationAbstract Number: LB180Session Title: Vaccines Session Date and Time: Saturday, April 10, 2021 at 8:30 am EDT 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 Number: 1917Session Title: Vaccines Session Date and Time: Saturday, April 10, 2021 at 8:30 am EDTThis is a collaborative presentation between Replimune and the Institute of Cancer Research, London, UK. The abstract for poster LB180 is embargoed until 12:01 a.m. ET on April 9, 2021. The abstract for poster 1917 is currently available at https://www.aacr.org/meeting/aacr-annual-meeting-2021/. Both full posters will be available for on-demand viewing on the AACR Annual Meeting 2021 website starting at 8:30 am ET on April 10, 2021 and will also be posted to the presentations section of the Replimune website at https://ir.replimune.com/events-and-presentations/presentations. 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. Investor Inquiries Chris BrinzeyWestwicke, an ICR Company339.970.2843chris.brinzey@westwicke.com Media InquiriesArleen Goldenberg Verge Scientific Communications917.548.1582agoldenberg@vergescientific.com