On June 22, 2020 Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, reported the appointment of Allen Melemed, M.D., M.B.A., as Chief Medical Officer (Press release, Chimerix, JUN 22, 2020, View Source [SID1234561433]).

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"We are delighted to welcome Dr. Melemed as a key member of our management team. We look forward to leveraging his considerable clinical and regulatory experience as a distinguished pharmaceutical executive. His vast experience bringing oncology therapeutics through development and approval across multiple modalities will be invaluable as we initiate our dociparstat sodium (DSTAT) Phase 3 trial in first line acute myeloid leukemia (AML), our ongoing Phase 2/3 trial to combat acute lung injury (ALI) in COVID-19 patients, and finalize our rolling New Drug Application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox," said Mike Sherman, Chief Executive Officer of Chimerix.

"I am particularly pleased to be joining Chimerix at such an important juncture in its growth trajectory. DSTAT’s potential to improve survival in newly-diagnosed AML patients is critically important in a disease where five-year survival rates remain far too low, particularly in older populations. Furthermore, DSTAT’s broad mechanism to manage inflammation and hematologic disorders offers promise to treat ALI in COVID-19 patients and underpins its mechanism of action in ALI beyond the current pandemic. I look forward to working with the team to advance our pipeline of important therapies and to bringing these life-saving treatments to patients in need," said Dr. Melemed.

Dr. Melemed joins Chimerix from Eli Lilly and Company, where he spent more than 20 years dedicated to the clinical development and approval of oncology medicines across a broad range of tumor types including VERZENIO, CYRAMZA, LARTRUVO , ALIMTA and RETEVMO among others. Most recently, he served as a Distinguished Medical Fellow and Senior Director of Regulatory Affairs Oncology, North America. In addition to his role at Eli Lilly, Dr. Melemed was an attending physician in pediatric oncology at Indiana University (IU) School of Medicine, Riley Children’s Hospital from 1996 to 2012.

Dr. Melemed holds a B.S. in Genetics and Cell Biology from the University of Minnesota and a M.D. from the University of Minnesota School of Medicine. In addition, he completed his residency in pediatrics at the University of Wisconsin, Madison and fellowship in pediatric hematology/oncology at IU School of Medicine. He earned an M.B.A. from the University of Chicago Booth School of Business. Dr. Melemed has authored dozens of scientific and clinical publications.

On June 22, 2020 Ankrin Therapeutics has been awarded 2.4 million DKK from Innovation Fund Denmark’s ‘Innobooster’ program (Press release, Ankrin Therapeutics, JUN 22, 2020, View Source [SID1234572466]). The Grant will support Ankrin’s discovery programs targeting so-called homologous recombination (HR), a critical DNA damage response (DDR) mechanism in cancer cells. Ankrin’s novel concept provides a new approach to inhibit HR with potential to treat a broad spectrum of cancers.

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On June 22, 2020 Grey Wolf Therapeutics reported that it will present an e-poster and accompanying audio description at AACR (Free AACR Whitepaper) 2020 (Virtual Annual Meeting II) (Press release, Grey Wolf Therapeutics, JUN 22, 2020, View Source [SID1234561270]).

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The company has generated potent oral ERAP1 inhibitors that modify the immunopeptidome in vivo and represent novel immunotherapy agents.

Visit the American Association for Cancer Research (AACR) (Free AACR Whitepaper) website and head to e-poster 5551 for more information. The virtual event will run from June 22 – June 24.

On June 22, 2020 Alkermes plc (Nasdaq: ALKS) and Clovis Oncology, Inc. (Nasdaq: CLVS) reported positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis’ investigational angiogenesis inhibitor (Press release, Clovis Oncology, JUN 22, 2020, View Source [SID1234561298]). The data will be presented during a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, taking place June 22-24, 2020.

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The study evaluated the antitumor efficacy and mechanism of action of mALKS 4230, a mouse ortholog of ALKS 4230, and lucitanib as monotherapies and in combination in a preclinical syngeneic mouse model of colon cancer. The combination of mALKS 4230 with lucitanib resulted in dose-dependent, durable complete responses (absence of any detectable tumor) and enhanced survival compared with monotherapy treatment with mALKS 4230 and lucitanib.

"Combining treatments with complementary mechanisms may offer synergistic clinical benefit and expand treatment options for a broader set of patient populations," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "These compelling preclinical data provide a foundational rationale to further explore novel combination options, such as an angiogenesis inhibitor, for ALKS 4230, with the goal of bringing improved therapeutic outcomes to patients across multiple tumor types."

Key findings presented in the poster include the following:

In the group that received the higher dose of mALKS 4230 (out of two doses tested) combined with lucitanib, 100 percent of the treated mice exhibited complete tumor regression and protection from new tumor growth upon re-challenge, an indication of the development of immunological memory.
The combination of mALKS 4230 with lucitanib resulted in an increase in intratumoral immune cells, including CD8+ T cells and dendritic cells, compared to monotherapy treatment, changes that are associated with anti-tumor immune responses.
The combination of mALKS 4230 with lucitanib elicited a distinct gene expression profile associated with anti-tumor activity, including increased immune cytolytic gene expression with decreased expression of genes with pro-angiogenic functions.
A virtual poster titled, "The Combination of a Mouse Ortholog of ALKS 4230, a Selective Agonist of the Intermediate-Affinity IL-2 Receptor, and the Angiogenesis Inhibitor Lucitanib Enhances Antitumor Activity," along with a pre-recorded audio presentation by Dr. Jared Lopes, Principal Scientist, Alkermes will be available on the AACR (Free AACR Whitepaper) website at View Source

About ALKS 4230

ALKS 4230 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 ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

On June 22, 2020 Ribon Therapeutics, a clinical stage oncology company developing first-in-class therapeutics targeting stress response pathways, reported new data to be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II, taking place from June 22-24, 2020 (Press release, Ribon Therapeutics, JUN 22, 2020, View Source [SID1234561315]).

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"PARP7 is a fundamental regulator of intrinsic stress support pathways and represents a novel cancer cell vulnerability," said Heike Keilhack, Ph.D., Senior Vice President of Biological Sciences, Ribon Therapeutics. "RBN-2397 is the first potent and selective inhibitor of PARP7 and exhibits potent anti-tumor activity as a monotherapy, as well as in combination with other therapies, including immune checkpoint inhibitors."

"The posters presented at AACR (Free AACR Whitepaper) provide a glimpse into Ribon’s unique ability to interrogate the complex biology of stress support pathways to identify novel therapeutic targets," said Kevin Kuntz, Ph.D., Senior Vice President of Molecular Discovery, Ribon Therapeutics. "The multi-dimensional, in silico mining tools and bespoke screening assays Ribon has developed were instrumental in the identification of PARP7 and RBN-2397 and are critical components of the platform, which we have assembled to validate new monoPARP and NADase targets and develop novel therapeutics."

Ribon will present the following from its development program and platform:

Abstract Title: PARP7 negatively regulates the Type I interferon response in cancer cells and its inhibition leads to tumor regression
Abstract ID: 3405
Session Type: Minisymposium (oral presentation)
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Mechanisms Enabled by Tool Molecules
Date/Time: June 23, 2020, 9:00 – 11:00 a.m. EDT
Presenter: Joseph M. Gozgit, Ph.D.
Summary:

Data demonstrate that cancer cells use PARP7 to suppress the Type I IFN response to cytosolic nucleic acids. RBN-2397, a first-in-class, potent and selective inhibitor of PARP7 is shown to restore Type I IFN signaling in the tumor and cause complete tumor regressions and adaptive immunity in murine models.
Targeting cytosolic nucleic acid sensing pathways and the Type I interferon (IFN) response is an emerging therapeutic strategy being explored in oncology. PARP7 expression is increased by cellular stress and aromatic hydrocarbons, and the PARP7 gene is amplified in cancers, especially in those of the upper aerodigestive tract. PARP7 has also been reported to negatively regulate the Type I IFN response by interacting with TBK1 during viral infection. PARP7 is identified as a novel negative regulator of cytosolic nucleic acid sensing in tumor cells.
Title: A bespoke screening platform to study mono(ADP-ribosylation)
Abstract ID: 506 / 2
Session Type: Poster Session
Session Title: Screening, Lead Identification, and Optimization
Date/Time: June 22, 2020, 9:00 a.m. – 6:00 p.m. EDT
Presenter: Tim J. Wigle, Ph.D.
Summary:

Development of robust, high-throughput biochemical and cellular monoPARP assays that overcome the lack of knowledge around the substrates and construction of a family-wide screening panel. These assays have been used in high-throughput screening campaigns, as well as in the development of potent and selective inhibitors of multiple monoPARP enzymes, including cell active chemical probes for PARP3, PARP7, PARP10, PARP12, PARP14 and PARP16.
Title: A multi-omic characterization of PARP enzymes in cancer to identify novel monoPARP drug targets
Abstract ID: 4381
Session Type: Poster Session
Session Title: Knowledge, Networks, Graphs, and Models for Discovery
Date/Time: June 22, 2020, 9:00 a.m. – 6:00 p.m. EDT
Presenter: Ryan Abo, Ph.D.
Summary:

The first pan-cancer in silico characterization of the PARP family, revealing a broad molecular and potential mechanistic diversity among the PARPs across cancer. Notwithstanding the lack of traditional oncogenic features, such as mutational hotspots, in the PARPs, analyses highlight several monoPARPs with potential oncogenic roles and further support our focus of targeting these in the clinic.
AACR Virtual Meeting II the second of two virtual meetings being held by AACR (Free AACR Whitepaper); the first, AACR (Free AACR Whitepaper) Virtual Meeting I, took place April 27-28, 2020. Presentations from Virtual Meeting I can be accessed at View Source