On March 11, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will report fourth quarter and full year 2020 financial results on Thursday, March 18, 2021, prior to the open of the market (Press release, UroGen Pharma, MAR 11, 2021, View Source [SID1234576529]). The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

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Audio Webcast
The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On March 11, 2021 Purple Biotech Ltd. ("Purple Biotech" ", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported that additional preclinical data supporting the mechanism of action of NT219, a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3, will be presented in a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, taking place in virtual format, on April 10-15 and May 17-21, 2021 (Press release, Purple Biotech, MAR 11, 2021, View Source [SID1234576528]). These updated data expand on the previously reported results generated from the Company’s collaboration with Professor Ido Wolf, Head of the Oncology Division, Tel Aviv Sourasky Medical Center, and will be highlighted in a presentation titled, "Adaptation of colorectal cancer cells to the brain microenvironment: The role of IRS2."

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Colorectal cancer (CRC) represents the fourth most frequent cause of brain metastasis, which is the most common brain tumor. However, molecular mechanisms supporting the formation of these lesions from CRC are poorly defined. IRS2 is a known downstream effector of IGF-1 receptors, which regulate cell growth and proliferation. The updated in vitro and in vivo data show the importance of the expression of IRS2 in the development, survival and growth of CRC brain metastasis. Moreover, the increase in trophic effects of IRS2 on brain metastases was associated with increased mitochondrial oxidative phosphorylation. In addition, NT219, an inhibitor of IRS2, and the subject of the Company’s ongoing Phase 1/2 clinical trial for the treatment of multiple cancers, showed in preclinical studies significant and dose-dependent inhibition of CRC cell viability, associated with decreased beta-catenin levels that have been shown to be related to the immune oncology resistance phenotype.

"This important study is the first to demonstrate the significant role of IRS2 in promoting CRC brain metastases and suggests that NT219 could have potential in addressing this critical unmet medical need," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "We continue to be highly encouraged by the compelling mechanism of action data and preclinical results generated to date by NT219. We remain focused on enrolling patients in our ongoing Phase 1/2 clinical trial of NT219 as monotherapy for the treatment of solid tumors, followed by a dose escalation of NT219 in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer or colorectal adenocarcinoma. We continue to hope to receive top-line data from the first part of this study in the second half of this year."

On March 11, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that the company will present two posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held virtually April 10 – 15 and May 17 – 21 (Press release, aTyr Pharma, MAR 11, 2021, View Source [SID1234576527]).

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Details of the poster presentations are as follows:

Title: The Neuropilin-2 targeting antibody ATYR2810 inhibits non-small cell lung cancer tumor growth in monotherapy and combination therapy
Authors: Alison G. Barber, Zhiwen Xu, Justin Rahman, Hira Lal Goel, Arthur M. Mercurio, Christoph Burkart, Leslie A. Nangle. aTyr Pharma, San Diego, CA, UMass Medical School, Boston, MA.
Abstract Number: 5247
Session Category: Tumor Biology
Session Title: Human-in-Mouse Models of Human Cancer
Poster Number: LB234
Permanent Abstract Number: LB234
Date and Time: April 10 – 15 and May 17 – 21 (9:00AM – 6:00PM ET)

Title: A domain-specific antibody to NRP2 down-regulated epithelial-mesenchymal transition genes and enhanced efficacy of standard-of-care therapeutics for aggressive breast cancer
Authors: Zhiwen Xu, Christoph Burkart, Hira Lal Goel, Justin Rahman, Clara Polizzi, Matt Seikkula, Luke Burman, Arthur M. Mercurio, Leslie A. Nangle. aTyr Pharma, San Diego, CA, UMass Medical School, Boston, MA.
Abstract Number: 5316
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Poster Number: LB095
Permanent Abstract Number: LB095
Date and Time: April 10 – 15 and May 17 – 21 (9:00AM – 6:00PM ET)

About NRP2

Neuropilin-2 (NRP2) is a cell surface receptor that plays a key role in lymphatic development and in regulating inflammatory responses. In many forms of cancer, high NRP2 expression is associated with worse outcomes. NRP2 can interact with multiple ligands and co-receptors through distinct domains to influence their functional roles, making it a potential drug target with multiple distinct therapeutic applications. NRP2 interacts with type 3 semaphorins and plexins to impact inflammation and with forms of vascular endothelial growth factor (VEGF) and their receptors, to impact lymphangiogenesis. In addition, NRP2 modulates interactions between CCL21 and CCR7 potentially impacting homing of dendritic cells to lymphoid organs. aTyr is currently investigating NRP2 receptor biology, both internally and in collaboration with key academic thought leaders, as a novel target for new product candidates for a variety of diseases, including cancer and inflammation.

On March 11, 2021 Alkermes plc (Nasdaq: ALKS) reported that nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA) (Press release, Alkermes, MAR 11, 2021, View Source [SID1234576526]).

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"This orphan drug designation is an important milestone for the nemvaleukin alfa program and underscores nemvaleukin’s potential clinical utility in mucosal melanoma, a particularly aggressive form of melanoma for which treatment options remain limited," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "The accumulating data from the nemvaleukin program have continued to support the clinical profile we anticipated in targeting the IL-2 pathway, and we look forward to continuing our momentum with the ARTISTRY development program this year."

Under the Orphan Drugs Act (ODA), the FDA may grant orphan drug designation to drugs and biologics that are intended to treat diseases or conditions affecting fewer than 200,000 people in the U.S. Orphan drug designation qualifies the drug developer for a variety of development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and seven years of market exclusivity, if approved. For more information on orphan drug designation, please visit the FDA website, available at View Source

About nemvaleukin alfa
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin in patients with advanced solid tumors.

ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days. In ARTISTRY-2, nemvaleukin is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of nemvaleukin monotherapy administered intravenously on the tumor microenvironment of a variety of advanced, malignant solid tumors.

On March 11, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that preclinical feasibility data supporting an Actinium-225-based CD45-targeted Next-Generation conditioning agent has been accepted for poster presentation at the American Association of Cancer Research (AACR 2021) annual meeting being held virtually April 10th – 15th, 2021 (Press release, Actinium Pharmaceuticals, MAR 11, 2021, View Source [SID1234576525]). The data to be presented includes initial dose escalation, safety, tolerability, and conditioning experiments of an Ac-225-based CD45 ARC or antibody radiation conjugate. Dosimetry results with this Ac-225-based alpha emitting ARC showed selective accumulation in immune cell target organs such as bone marrow, spleen, and liver with the potential for lower exposure to non-target tissues from longer path length beta emitter radioisotopes like Iodine-131 and Lutetium-177. The data to be presented demonstrate that conditioning with this Ac-225-based CD45-targeting agent result in depletion of peripheral immune cells and hematopoietic progenitor cells, thereby enabling engraftment of donor cells. A dose dependent response was observed with low doses depleting white blood without effecting hematopoietic progenitor cells, representing a lymphodepletive dose that is relevant for adoptive cell therapies such as CAR-T, while higher doses eliminated peripheral immune cells and hematopoietic progenitor cells, which is applicable to ex vivo gene therapies and BMT or bone marrow transplant.

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This program further augments Actinium’s targeted conditioning portfolio that is led by Iomab-B, an ARC consisting or the radioisotope Iodine-131 and the CD45 targeting antibody apamistamab. In total, apamistamab has been studied in several hundred patients. Iomab-B is currently being studied in the pivotal Phase 3 SIERRA trial for BMT conditioning in patients with active relapsed or refractory acute myeloid leukemia age 55 and above that is expected to complete enrollment in 2021.

Details of the poster presentation at AACR (Free AACR Whitepaper) are as follows:

Dr. Dale Ludwig, Actinium’s Chief Scientific and Technology Officer said, "We are excited to present this data supporting an Ac-225 antibody radiation-conjugate at AACR (Free AACR Whitepaper) and to have the opportunity to develop potentially safer and better targeted chemotherapy-free conditioning agents. Recent cases of secondary malignancies potentially tied to toxic chemotherapy regimens highlight the urgent need for improved conditioning to enable the very promising cell and gene therapy strategies to treat diseases such as Sickle Cell Disease and Beta-Thalassemia. As advances in cell and gene therapies address more disease indications and thus a larger overall patient population, our commitment to developing targeted conditioning agents to improve patient access to the these potentially curative therapies and patient outcomes grows stronger. We look forward to further optimizing this construct to enable advancement into the clinic."

Actinium is developing the only multi-target, multi-indication, clinical-stage pipeline for targeted conditioning and the only ARC based targeted conditioning regimens in development. This Ac-225-CD45 construct to be highlighted at AACR (Free AACR Whitepaper) resulted from Actinium’s AWE or Antibody Warhead Enabling technology platform. AWE encompasses Actinium’s intellectual property of over 140 patents, know-how, and clinical experience including nearly 150 patients treated with alpha emitters like Ac-225 for which Actinium is an industry leader. Specific to Ac-225, Actinium has gold-standard linker technology with a strong stability and safety profile and patents covering composition of matter, formulations, methods of use and methods of manufacturing the radioisotope Actinium-225 in a cyclotron. In addition to fueling Actinium’s R&D efforts, AWE is being utilized in collaborative research partnership with Astellas Pharma, Inc. who is focused on the development of theranostics for solid tumors.

Sandesh Seth, Actinium’s CEO, said "This new program and initial data is yet another example of the potential of Actinium’s AWE platform technology and our team’s ability to create disruptive agents for oncology therapeutics and cell and gene-based therapies. It also exemplifies Actinium’s strong commitment to advancing and increasing access to life-changing and potentially curative therapies. With 2021 expected to be a transformational year for Actinium marked with key clinical milestones including completion of the SIERRA trial it is also exciting to see our R&D efforts delivering tangible results that will position us for continued future success."