On April 6, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn" or "the Company"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the appointment of Howard J. Federoff, M.D., Ph.D., as Chief Executive Officer and President and a director as of 16 April 2021 (Press release, Brooklyn ImmunoTherapeutics, APR 6, 2021, View Source [SID1234577636]). Dr. Federoff succeeds Ronald Guido who was serving as Interim CEO and will remain on Brooklyn’s management team as Chief Development Officer.

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"Dr. Federoff brings an unwavering focus on the patient as well as an outstanding record of clinical, academic and corporate achievement to Brooklyn ImmunoTherapeutics," said Charles Cherington, Director of Brooklyn. "Dr. Federoff’s unparalleled record of professional accomplishments and experience will be a tremendous asset to Brooklyn ImmunoTherapeutics as we advance the clinical development of IRX-2 as well as explore potential new opportunities. We look forward to working with Dr. Federoff to bring new treatment options to patients living with cancer and other serious diseases."

"Brooklyn’s IRX-2 product offers a significant opportunity to improve patient outcomes both as a monotherapy and in combination with other anti-cancer drugs including immune-oncology therapies," said Dr. Federoff. "My top priorities will be the clinical advancement of IRX-2 in solid tumor indications as well as seeking opportunities to in-license new therapeutic agents that can extend and enhance the lives of patients fighting cancer and other serious diseases. This is an exciting time in oncology drug development and I believe that Brooklyn ImmunoTherapeutics will be a leader in advancing patient care."

Dr. Federoff is a distinguished professor of neurology at the University of California, Irvine. He is the former CEO of UCI Health, vice chancellor for health affairs and dean of the UCI School of Medicine. Prior to joining UCI Health, Federoff was executive vice president of Health Sciences and executive dean at Georgetown University. Dr. Federoff has published more than 275 peer-reviewed and invited articles, and serves on editorial boards of five journals. He co-founded MedGenesis Therapeutix and Brain Neurotherapy Bio, both advancing therapeutics for neurologic diseases. He became CEO of the regenerative medicine company, Aspen Neuroscience, Inc, in San Diego. Aspen is developing an autologous iPSC drug product for Parkinson’s disease. Dr. Federoff chaired the NIH Recombinant DNA Advisory Committee, the NHLBI Gene Therapy Resource and the Board of the Association of the Academic Health Centers. He has served as an advisor/director for several companies. He is an elected Fellow of the American Association for the Advancement of Science and the National Academy of Inventors. He received his MD, MS and PhD in biochemistry from the Albert Einstein College of Medicine in New York. He completed his residency and clinical and research fellowships at Massachusetts General Hospital and Harvard Medical School.

On April 6, 2021 HiFiBiO Therapeutics reported that it will share with the scientific community preclinical data for novel monoclonal antibodies for clinical development as new cancer immunotherapeutic options (Press release, HiFiBiO Therapeutics, APR 6, 2021, View Source [SID1234577676]). Two of these programs, HFB3010 and HFB2003, are slated to enter Phase I clinical trials later this year.

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The team will present highlights in four poster sessions at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, April 10-15 and May 17-21, 2021. These four programs highlight the continual evolution of HiFiBiO Therapeutic’s robust pipeline and unique capability to develop novel antibodies to address unmet medical needs.

"We are excited to share the latest data from four of our programs with the oncology research community at AACR (Free AACR Whitepaper). These include our two most advanced oncology antibodies, HFB301001, a highly differentiated second-generation OX40 agonist, and HFB200301, a novel anti-TNFR2 agonist bridging innate and adaptive immunity. We also share the profile of antibody candidates against CXCR5 and Galectin-9 that hold exceptional promise for the treatment of hematological malignancies and solid tumors," said Francisco Adrian, Global Head of Research.

"Applying single-cell immuno-profiling insights from our groundbreaking DIS platform to our oncology trials is a step towards realizing one of greatest ambitions; to deliver significant benefit to patients through targeted immunotherapies. Our novel biomarker strategy by analyzing tumor immune profiles at the single cell level aims to enrich for responding patients in our upcoming HFB3010 and HFB2003 clinical studies," said Andreas Raue, PhD, Global Head of Drug Intelligent Science.

The four HiFiBiO Therapeutics pipeline programs being presented at AACR (Free AACR Whitepaper) are:

HFB3010 (OX40)

HFB301001 is a second-generation novel, fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile. In contrast to previous anti-OX-40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX-40L, does not result in reduced levels of OX-40 on T-cells, and leads to superior anti-tumor activity in a human OX-40 knock-in mouse model compared to a benchmark antibody. HiFiBiO is also applying a biomarker strategy by leveraging its DIS platform to select patients who may benefit the most from treatment.

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 candidate antibody that binds potently and selectively to TNFR2, recognizes cyno TNFR2, and induces CD4 and CD8 T-cell activation and proliferation cooperatively with TNFα without requiring crosslinking. In vivo, HFB200301 demonstrates potent antitumor activity alone and combined with anti-PD-1. It is also well tolerated in mice and NHPs. HiFiBiO is also utilizing its DIS platform to implement a biomarker strategy for HFB2003.

HFB2009 (Gal-9)

Galactoside-binding lectin Galectin 9 (Gal-9) is a key pleiotropic immunosuppressive modulator present in the tumor microenvironment. HFB9-2, an anti-Gal-9 blocking antibody with demonstrated single agent anti-tumor activity in a mouse cancer model, offers improved survival in combination with anti-PD-1 therapy as compared to anti-PD-1 alone, and shows good tolerability in NHPs.

HFB1002 (GPCR)

CXCR5 is a GPCR expressed on B cells, as well as on follicular helper T cells. CXCR5 plays a key role in the migration of B cells to germinal centers and the production of autoantibodies. CXCR5 is implicated in autoimmune diseases, such as Sjögren syndrome, and in cancers such as B cell lymphomas and solid tumors, where it has been associated with metastasis and poor prognosis. HiFiBiO generated and characterized a novel anti-hCXCR5 blocker with potent ADCC activity to treat tumor and autoimmune diseases.

On April 6, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase I clinical trial to evaluate safety and tolerability of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin’s lymphoma (NHL) in China (Press release, Antengene, APR 6, 2021, View Source [SID1234577709]).

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As an orally bioavailable dual PAK4/NAMPT inhibitor, ATG-019 can lead to antitumor effects through energy depletion, inhibition of DNA repair, cell cycle arrest, inhibition of proliferation, and ultimately cell apoptosis. Hematological and solid tumor cells that are dependent on both PAK4 and NAMPT pathways may be susceptible to single-agent anti-tumor activity by ATG-019. ATG-019 has clear preclinical anti-tumor activity and a superior pharmacokinetics (PK) and safety profile making it an attractive novel drug candidate. Antengene has recently been conducting a Phase I clinical trial (TEACH) of ATG-019 in advanced solid tumors and NHL in Taiwan.

"The NMPA‘s approval of the IND application for ATG-019 indicates the potential of this drug to be applied to Chinese patients. We look forward to initiating the first clinical trial of ATG-019 in mainland China," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "ATG-019 is an orally available dual PAK4/NAMPT inhibitor that achieves synergistic antitumor effects through the co-inhibition of the two pathways. We believe that ATG-019, as a novel agent under investigation, can potentially provide an additional treatment option for patients with advanced solid tumor and NHL."

About ATG-019
ATG-019 is a global first-in-class oral dual PAK4/NAMPT inhibitor developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI). Antengene reached an exclusive agreement of cooperation and authorization with Karyopharm and obtained the exclusive development and commercialization rights of ATG-019 in multiple Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and ASEAN countries.

PAK4 is a signaling protein regulating numerous fundamental cellular processes, including intracellular transport, cellular division, cell shape and motility, cell survival, immune defense and the development of cancer. PAK4 interacts with many key signaling molecules involved in cancer development such as beta-catenin, CDC42, Raf-1, BAD and myosin light chain. NAMPT is a pleiotropic protein with intra- and extra-cellular functions as an enzyme, cytokine, growth factor, and hormone that can be found in a complex with PAK4 in the cell. In preclinical mouse models, ATG-019 in combination with anti-PD-1 therapies showed improved antitumor efficacy over anti-PD-1 monotherapy, indicating the potential of the combined therapy to treat anti-PD-1 resistant patients.

Antengene is conducting a Phase I clinical trial of ATG-019 in Taiwan in patients with advanced NHL and solid tumors and are planning to conduct clinical trials exploring its combination potential with other agents.

On April 6, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, has scheduled a conference call for Tuesday, May 4, 2021, at 8 a.m. (ET) reported its first quarter financial results for the period ending April 2, 2021 (Press release, Leidos, APR 6, 2021, View Source [SID1234577605]). The company plans to issue its quarterly earnings press release before the conference call on May 4, 2021.

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The details for the earnings conference call follow:

Replay:

A telephone playback of the first quarter earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on May 4, 2021, through 11:59 p.m. (ET) on May 11, 2021. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415), and entering conference ID 13718327.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source

On April 6, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer of Curis, will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 10:15 am ET (Press release, Curis, APR 6, 2021, View Source [SID1234577621]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for approximately 90 days following the event.