BTX Brooklyn ImmunoTherapeutics Inc.

18.75
-2.85  -13%
Previous Close 21.6
Open 20.2
52 Week Low 1.88
52 Week High 80.67
Market Cap $779,288,231
Shares 41,562,039
Float 1,724,410
Enterprise Value $897,740,042
Volume 5,157,629
Av. Daily Volume 6,821,744
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Upcoming Catalysts

Drug Stage Catalyst Date
IRX-2 - INSPIRE
Head and neck squamous cell cancer
Phase 2b
Phase 2b
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IRX-2 and Imfinzi (Durvalumab) - MHN-102
Head and Neck cancer
Phase 1
Phase 1
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IRX-2 and Keytruda (Pembrolizumab) - GI-106
Gastric or Gastroesophageal Junction Cancer
Phase 1/2
Phase 1/2
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IRX-2 and Opdivo - HCC-107
Hepatocellular carcinoma (HCC)
Phase 1
Phase 1
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IRX-2 (CIN-201)
Cervical Squamous Intraepithelial Neoplasia 3
Phase 2
Phase 2
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IRX-2 and Opdivo - BAS-104
Solid Tumors
Phase 1
Phase 1
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IRX-2 and Keytruda (Pembrolizumab) - BR-202
Breast Cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
IRX-2
Neoadjuvant breast cancer
Phase 1
Phase 1
Phase 1 trial completed.

Latest News

  1. Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, today announced the appointment of Christopher Rohde, Ph.D. to the Company's Scientific Advisory Board, effective May 13, 2021.

    Dr. Rohde is Co-Founder and Chief Technology Officer at Factor Bioscience. Dr. Rohde is also Co-Founder and President of Novellus Therapeutics. Brooklyn ImmunoTherapeutics acquired an exclusive license for the mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics Limited. Dr. Rohde is currently leading Factor's efforts to apply their RiboSlice™ gene-editing…

    Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, today announced the appointment of Christopher Rohde, Ph.D. to the Company's Scientific Advisory Board, effective May 13, 2021.

    Dr. Rohde is Co-Founder and Chief Technology Officer at Factor Bioscience. Dr. Rohde is also Co-Founder and President of Novellus Therapeutics. Brooklyn ImmunoTherapeutics acquired an exclusive license for the mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics Limited. Dr. Rohde is currently leading Factor's efforts to apply their RiboSlice™ gene-editing technology, and FactorStem™ cell-reprogramming and differentiation technologies to the development of new research models, including high-throughput screening-compatible human cell libraries. His work is described in numerous peer-reviewed publications, and has been covered by Technology Review, Nature, Bioscience Magazine, Analytical Chemistry, The Economist, and many other publications. Chris Rohde earned his Ph.D. from the Massachusetts Institute of Technology (MIT) in 2011.

    "As Co-founder and Chief Technology Officer at Factor Bioscience, Dr. Rohde brings a unique and unparalleled understanding of the gene editing and cell therapy technology which Brooklyn has in-licensed to our Scientific Advisory Board," said Howard J. Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "His in-depth knowledge and perspective will allow us to target disease at the molecular level. This is a very exciting time at Brooklyn and we are looking forward to working with Chris to rapidly advance our potential treatments for oncology, blood disorders and monogenic diseases."

    "Brooklyn ImmunoTherapeutics is well-positioned to become a leader in gene editing and cell reprograming using Factor's RiboSlice™ gene-editing technology, and FactorStem™ cell-reprogramming and differentiation technologies," said Dr. Rohde. "I look forward to working with colleagues on the Scientific Advisory Board to optimize this leading edge technology to develop new therapies for patients living with cancer and blood disorders."

    About Brooklyn ImmunoTherapeutics

    Brooklyn is exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance oncology, blood disorder, and monogenic disease therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus.

    Brooklyn's most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

    For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.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, concerning Brooklyn's expectations, anticipations, intentions, beliefs or strategies regarding the future that are not statements of historical fact, including statements in the fourth and fifth paragraphs related to potential future development and growth. These statements are based upon the current beliefs and expectations of Brooklyn's management and are subject to significant risks, uncertainties, and other factors. Brooklyn's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors, including, but not limited to: (i) Brooklyn's ability to successfully, cost-effectively and efficiently develop its technology and products; (ii) Brooklyn's ability to successfully commence clinical trials of any products on a timely basis or at all; (iii) Brooklyn's ability to successfully fund and manage the growth of its development activities; (iv) Brooklyn's ability to obtain regulatory approvals of its products for commercialization; and (v) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of the BR-202 clinical trial. Additional factors and risks are described in Brooklyn's periodic reports filed with the Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to Brooklyn on the date of this press release, and Brooklyn assumes no obligation to update the information contained in this press release.

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  2. Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, today announced a publication in Breast Cancer Research that demonstrates how multiplex immunofluorescence (mIF) may be used to characterize the immunological activity of IRX-2 in early stage breast cancer. The publication, entitled "Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer," describes a methodology for mIF in conjunction with statistical modeling applied in a clinical trial collaboration between Providence Cancer Institute in Portland…

    Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, today announced a publication in Breast Cancer Research that demonstrates how multiplex immunofluorescence (mIF) may be used to characterize the immunological activity of IRX-2 in early stage breast cancer. The publication, entitled "Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer," describes a methodology for mIF in conjunction with statistical modeling applied in a clinical trial collaboration between Providence Cancer Institute in Portland, Oregon, and Brooklyn.

    "Multiplex immunofluorescence combined with hierarchical linear modelling resulted in more precise estimates of treatment-related increases in stromal tumor infiltrating lymphocytes, PD-L1, and other metrics such as CD8+ tumor nest infiltration compared to conventional testing," said study principal investigator David Page, MD, medical oncologist and assistant member, Earle A. Chiles Research Institute, a division of Providence. "Hierarchical linear modeling can mitigate the effects of intratumoral heterogeneity on immune cell count estimations, allowing us to more efficiently detect treatment-related pharmocodynamic effects of an anticancer drug such as IRX-2. This may allow us to more effectively demonstrate treatment activity, and ultimately patient benefit, in the context of immunotherapy clinical trials."

    IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system associated with activation of the entire tumor microenvironment. The paper illustrates that IRX-2 increases immune cell infiltration and PD-L1 expression, suggesting that IRX-2 may hold promise in combination of PD-L1-targeted therapy in early stage breast cancer.

    "We are excited to receive this validation for IRX-2 from an unbiased detection technology," said Howard Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "We recently initiated a combination trial evaluating IRX-2 with an immunotherapy that targets PD-1, in triple negative breast cancer, and we hope to explore additional combination approaches in various indications."

    About the Phase 2 Trial

    The Phase 2 randomized, open-label trial is designed to assess the efficacy and safety of IRX-2 in patients with triple negative breast cancer (TNBC). Approximately 30 patients in total are expected to be enrolled. Patients with locally confirmed stage II-III TNBC are eligible. Patients will receive alternating regimens of the PD-1 inhibitor plus chemotherapy and subcutaneous IRX-2 injections twice a day for 10 days as neoadjuvant therapy prior to surgery. The primary efficacy endpoint is pathological complete response rate, evaluated at the time of definitive surgery. For additional clinical trial details, refer to www.clinicaltrials.gov (NCT04373031).

    This study is being supported in part by a multinational pharmaceutical company.

    About Brooklyn ImmunoTherapeutics

    Brooklyn is exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance oncology and blood disorder therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus.

    Brooklyn's most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

    For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.

    About Providence Cancer Institute

    Providence Cancer Institute, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. Investigators lead more than 400 active clinical trials in key areas such as cancers of the: breast, colon/rectum, prostate, lung, esophagus, liver and pancreas, head and neck, ovary, skin and blood. Other studies are investigating treatments for COVID-19. Learn more at providenceoregon.org/cancer.

    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, concerning Brooklyn's expectations, anticipations, intentions, beliefs or strategies regarding the future that are not statements of historical fact, including statements in the fourth and fifth paragraphs related to potential future development and growth. These statements are based upon the current beliefs and expectations of Brooklyn's management and are subject to significant risks, uncertainties and other factors. Brooklyn's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors, including, but not limited to: (i) Brooklyn's ability to successfully, cost-effectively and efficiently develop its technology and products; (ii) Brooklyn's ability to successfully commence clinical trials of any products on a timely basis or at all; (iii) Brooklyn's ability to successfully fund and manage the growth of its development activities; (iv) Brooklyn's ability to obtain regulatory approvals of its products for commercialization; and (v) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of the BR-202 clinical trial. Additional factors and risks are described in Brooklyn's periodic reports filed with the Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to Brooklyn on the date of this press release, and Brooklyn assumes no obligation to update the information contained in this press release.

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  3. Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer, blood disorders and monogenic diseases, today announced the appointment of Erich Mohr, Ph.D., ICD.D. to Brooklyn's Board of Directors, effective May 7, 2021.

    "Dr. Erich Mohr's distinguished career as a leader of life sciences companies, as well as in academic research, will serve as an important resource to Brooklyn," said Howard J. Federoff, M.D., Ph.D. Brooklyn ImmunoTherapeutics' Chief Executive Officer and President. "Dr. Mohr has a proven track record of creating value both as a Board member and as a senior executive in a number of life…

    Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer, blood disorders and monogenic diseases, today announced the appointment of Erich Mohr, Ph.D., ICD.D. to Brooklyn's Board of Directors, effective May 7, 2021.

    "Dr. Erich Mohr's distinguished career as a leader of life sciences companies, as well as in academic research, will serve as an important resource to Brooklyn," said Howard J. Federoff, M.D., Ph.D. Brooklyn ImmunoTherapeutics' Chief Executive Officer and President. "Dr. Mohr has a proven track record of creating value both as a Board member and as a senior executive in a number of life sciences companies. I am delighted to welcome Erich to our board."

    "I am excited to join Brooklyn's board at such a pivotal time in the company's growth," said Dr. Mohr. "I am drawn to Brooklyn by the progress of IRX-2, a cytokine-based drug candidate which is currently being studied in multiple clinical trials both as a monotherapy and in combination with other anti-cancer therapies. Brooklyn has also successfully licensed leading edge gene editing technology which could open the door to developing therapies to treat a variety of cancer and blood disorders. I look forward to supporting the company's clinical plans and business plans to help Brooklyn achieve its full potential."

    Dr. Mohr currently serves as Chairman of Oak Bay Biosciences as well as Chairman & Chief Executive Officer of MedGenesis Therapeutix Inc. Previously, he served as Chief Scientific Officer of PRA International and Chief Executive Officer of CroMedica International. He earned his Bachelors degree in Chemistry/Biology from the University of the Pacific and his Ph.D. in Neuropsychology from the University of Victoria.

    About Brooklyn ImmunoTherapeutics

    Brooklyn is exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance oncology, blood disorder, and monogenic disease therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus.

    Brooklyn's most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

    For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.

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  4. Brooklyn ImmunoTherapeutics LLC (NYSE:BTX) ("Brooklyn") today announced it has acquired an exclusive license for mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics Limited pursuant to an exercise of a previously announced option.

    The license includes use of an extensively patented process to develop gene editing compounds using mRNA, which preclinical data suggest demonstrate a high degree of efficiency, as well as being non-immunogenic and non-mutagenic.

    The licensed platform includes mRNA cell reprogramming, which is considered to be the highest efficiency and footprint-free technology that can be applied to both allogeneic and autologous cells, and is combined with mRNA-based gene editing…

    Brooklyn ImmunoTherapeutics LLC (NYSE:BTX) ("Brooklyn") today announced it has acquired an exclusive license for mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics Limited pursuant to an exercise of a previously announced option.

    The license includes use of an extensively patented process to develop gene editing compounds using mRNA, which preclinical data suggest demonstrate a high degree of efficiency, as well as being non-immunogenic and non-mutagenic.

    The licensed platform includes mRNA cell reprogramming, which is considered to be the highest efficiency and footprint-free technology that can be applied to both allogeneic and autologous cells, and is combined with mRNA-based gene editing – along with a proprietary gene editing protein – to eliminate off-target effects. It also includes the proprietary ToRNAdo lipid delivery system that provides efficient delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

    "As a result of the license acquisition, Brooklyn is now poised to become a key player among companies exploring gene editing for cell therapies. This mRNA gene editing technology has the potential to be disruptive given its high efficiency and relatively low manufacturing costs. We look forward to continuing the work begun by Factor Bioscience and Novellus with this platform and to reporting our progress as our products advance towards the clinic," commented Howard J. Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "Our licensing of this technology represents a significant advancement in our approach to treating cancers, blood and other disorders, and transforms us from a single therapeutic company with multiple potential indications to a platform company with multiple products in a pipeline of next-generation engineered cellular medicines."

    Brooklyn intends to initiate pre-clinical development programs for sickle cell anemia, other inherited monogenic disorders, and solid and liquid tumors, with the intention of being at the Investigational New Drug (IND) stage for at least one of these disorders by 2024.

    About Brooklyn ImmunoTherapeutics

    Brooklyn is exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance oncology and blood disorder therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus.

    Brooklyn's most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

    For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.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, concerning Brooklyn's expectations, anticipations, intentions, beliefs or strategies regarding the future that are not statements of historical fact, including statements in the fourth and fifth paragraphs related to potential future development and growth. These statements are based upon the current beliefs and expectations of Brooklyn's management and are subject to significant risks, uncertainties, and other factors. Brooklyn's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors, including, but not limited to: (i) Brooklyn's ability to successfully, cost-effectively and efficiently develop its technology and products; (ii) Brooklyn's ability to successfully commence clinical trials of any products on a timely basis or at all; (iii) Brooklyn's ability to successfully fund and manage the growth of its development activities; (iv) Brooklyn's ability to obtain regulatory approvals of its products for commercialization; and (v) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of the BR-202 clinical trial. Additional factors and risks are described in Brooklyn's periodic reports filed with the Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to Brooklyn on the date of this press release, and Brooklyn assumes no obligation to update the information contained in this press release.

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  5. Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, today announced the appointment of Matthew During, M.D., Ph.D. to the Company's Scientific Advisory Board, effective April 26, 2021.

    Dr. During is a Harvard, MIT and Yale trained neuroscientist. He has served for 9 years as a member of the faculty of Yale as Professor of Neurosurgery, and as a Professor at Thomas Jefferson, Cornell, and Ohio State Universities. Dr. During was a pioneer in the use of viral vectors for neurological disorders, and was the first to carry out gene transfer into the brain of a human child. Dr. During was the Principal Investigator…

    Brooklyn ImmunoTherapeutics, Inc. (NYSE:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, today announced the appointment of Matthew During, M.D., Ph.D. to the Company's Scientific Advisory Board, effective April 26, 2021.

    Dr. During is a Harvard, MIT and Yale trained neuroscientist. He has served for 9 years as a member of the faculty of Yale as Professor of Neurosurgery, and as a Professor at Thomas Jefferson, Cornell, and Ohio State Universities. Dr. During was a pioneer in the use of viral vectors for neurological disorders, and was the first to carry out gene transfer into the brain of a human child. Dr. During was the Principal Investigator and the FDA sponsor for two pioneering gene therapy studies on neurodevelopmental and movement disorders and has published over 250 scientific articles, with many in the world's most prestigious journals including Nature, Science, Cell, Nature Medicine, Nature Genetics, the Lancet and Science Translational Medicine. Dr. During was a co-founder of Merlin Pharmaceuticals, Neurologix, Vector Neurosciences, Emrys Bio, Nightstar Therapeutics, and founder of Ovid Therapeutics where he previously served as President, Chief Scientific Officer and chair of the Scientific Advisory Board.

    "Dr. During brings a depth of experience to the Scientific Advisory Board of Brooklyn ImmunoTherapeutics which will be important as we develop IRX-2 and explore opportunities to license leading edge gene editing and cell therapy technologies," said Howard J. Federoff, M.D., Ph.D., Brooklyn ImmunoTherapeutics' Chief Executive Officer. "Dr. During has been a leader in drug development, particularly in the field of gene and cell therapies. He has a demonstrated ability to advance ground-breaking science into clinical advances that have the potential to change the way diseases are treated."

    "Brooklyn ImmunoTherapeutics is well-positioned to be a key player in the cancer field with IRX-2, its clinical stage cytokine-based therapy that is currently being evaluated both as a single agent and in combination with other anti-cancer agents in a number of solid tumor indications," said Dr. During. "In addition, I'm excited by the opportunity for Brooklyn to license leading edge gene editing technology that may provide an opportunity to develop a multitude of drugs for serious conditions including cancer and blood disorders. I look forward to working with the team at Brooklyn ImmunoTherapeutics at such an important time in its development."

    About Brooklyn ImmunoTherapeutics

    Brooklyn is focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance therapies using leading edge gene editing/cell therapy technology through its option agreement with Factor Bioscience/Novellus.

    Brooklyn's most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

    For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.

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