On April 3, 2019 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported it is presenting pre-clinical data from ongoing research of RGX-019, a monoclonal antibody that targets MERTK, for the treatment of advanced cancer (Press release, Rgenix, APR 3, 2019, View Source [SID1234534968]). In a presentation of a late-breaking abstract, "Characterization of the anti-cancer and immunologic activity of RGX-019, a novel pre-clinical stage humanized monoclonal antibody targeting the MERTK receptor," which was accepted for the 2019 American Association of Cancer Research Annual Meeting, Isabel Kurth Ph.D., Rgenix VP of Research, discussed data showing RGX-019 to be a potent and selective inhibitor of MERTK signaling, resulting in suppression of cancer growth and activation of the innate immune response.

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RGX-019 is a humanized monoclonal antibody that selectively targets MERTK, a receptor tyrosine kinase of the TYRO3/AXL/MERTK (TAM) family. MERTK is expressed in immune cells such as macrophages, dendritic cells and NK cells, and is also overexpressed in a wide variety of liquid and solid cancers.

Activation of MERTK on cancer cells via ligand binding activates several tumor-promoting signaling pathways, stimulating tumor proliferation, migration and angiogenesis, and decreasing apoptosis and chemosensitivity. When activated on macrophages, MERTK promotes an immune-suppressive M2 phenotype.

RGX-019 binds to human MERTK with high affinity and selectivity, without detectible binding to other related TAM kinases. RGX-019 has a unique mechanism of action that not only leads to blockade of ligand binding, but also to MERTK degradation via receptor internalization.

This novel mechanism of action leads to inhibition of cancer growth in vitro and in vivo as well as activation of M1 (pro-inflammatory) cytokine release from immune-suppressive M2 macrophages.

Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix, said, "We are excited to have an opportunity to reveal the pre-clinical data that demonstrates the positive progress we are making with the development of RGX-019, our third proprietary program. The ability of RGX-019 to selectivity degrade MERTK in cancers cells and M2 macrophages provides a distinct advantages over current small-molecule approaches to targeting MERTK which are hampered by off-target binding to other related kinases. This data provides a strong foundation for IND enabling studies."

Sohail Tavazoie, MD, PhD, and Chair of Rgenix’s Scientific Advisory Board, said, "RGX-019 shows great potential as a cancer therapeutic and its ability to selectively modulate both cancer growth and innate immune activation is illustrative of that possibility. We look forward to continuing our research on this antibody and its impact on various MERTK expressing cancers."

On April 3, 2019 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective miniature drug conjugates (Pentarins) for the treatment of patients with a wide range of solid tumors, reported that Drew Fromkin, President and Chief Executive Officer, will present at Needham & Company’s 18th Annual Healthcare Conference, occurring April 9-10, 2019 in New York City (Press release, Tarveda Therapeutics, APR 3, 2019, View Source [SID1234534967]). Tarveda presentation details:

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Date: Tuesday, April 9, 2019
Time: 1:10pm Eastern Time
Location: Westin Grand Central, New York, NY

On April 3, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Claus Møller, MD, Ph.D., Chief Executive Officer of Y-mAbs Therapeutics will provide an overview and update on the company’s business at the H.C. Wainwright Global Life Sciences Conference in London, United Kingdom (Press release, Y-mAbs Therapeutics, APR 3, 2019, View Source [SID1234534966]). The presentation will take place on Monday, April 8, 2019, at 9:50 AM GMT, and the presentation deck will be made available on the Company website at the time of presentation.

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On April 3, 2019 At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, GA, Varian (NYSE: VAR), in partnership with the University of Maryland School of Medicine’s Department of Radiation Oncology and the Maryland Proton Treatment Center, reported its publicly the first pre-clinical results of its research on ultra-high dose rate cancer treatments with protons (Press release, Varian Medical Systems, APR 3, 2019, View Source [SID1234534964]). Known as Flash therapy, it is a non-invasive therapy for cancer delivering high doses of radiation in ultra-high-speeds (less than 1 second) and represents the potential for a major breakthrough in the treatment of cancer. The preclinical Flash therapy results presented at AACR (Free AACR Whitepaper) showed reduced toxicity in healthy tissues and organs.

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Conducted on a clinical device capable of translation to humans, the Flash therapy preclinical tests, compared to conventional proton treatments, displayed 25-30 percent less damage to lung tissue, resulting in less fibrosis of the lung, and an average of 35 percent reduction in skin dermatitis during treatment.

"Since announcing in October 2018 the ongoing research programs of our Global Translational Science team on Flash therapy and the formation of the FlashForward Consortium, we have received strong interest from across the cancer community to learn more about this potential new treatment and our preclinical results," said Dee Khuntia, MD, chief medical officer, Varian. "Previously released studies on ultra-high dose rate treatments were done using experimental radiotherapy equipment. It is exciting to share for the first time, preclinical results of proton Flash therapy on a clinical device and offer a clearer picture of this possible major breakthrough in cancer treatment."

The FlashForward Consortium, comprised of 14 cancer centers, is focused on preclinical research, clinical implementation and advocacy efforts of Flash therapy. Working groups in the FlashForward Consortium are identifying preclinical study design for understanding this therapy, developing and sharing protocols that will enable a safe and quality clinical start for new users, and assist with regulatory and advocacy efforts.

"Partnering with Varian’s Global Translational Science team on the first proton Flash pre-clinical study, and being one of the founding members of the FlashForward Consortium, is a significant step in building a foundation of research and bridging the gap to patient benefits in this potentially game-changing therapy," said William F. Regine, MD, The Isadore & Fannie Foxman Chair and Professor, Department of Radiation Oncology at the University of Maryland School of Medicine, and Executive Director of the Maryland Proton Treatment Center. The pre-clinical study was led by Zeljko Vujaskovic, MD, PhD, Professor of Radiation Oncology and Director of the Division of Translational Radiation Services, and Lauren Jackson, PhD, Associate Professor of Radiation Oncology and Deputy Director of Translational Radiation Sciences.

On April 3, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, reported data from its preclinical program for TP-2846, the Company’s new pipeline candidate for acute myeloid leukemia (AML) discovered using Tetraphase’s proprietary total synthesis platform (Press release, Tetraphase, APR 3, 2019, View Source [SID1234534963]). The data were presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29-April 3 at the Georgia World Congress Center in Atlanta. The posters showed results from preclinical in vitro and in vivo studies demonstrating the activity, potency and unique mechanism of action (MOA) of TP-2846.

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"Preclinical testing has characterized TP-2846 as a novel, potent, synthetic tetracycline with activity across multiple in vitro and in vivo cancer models," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "We are very encouraged by these early data, which suggest that TP-2846 holds the potential to benefit AML patients regardless of their mutation status. Further, these data show that because of its unique MOA, TP-2846 may have antileukemic activity in patients whose cancer has progressed while on different treatment regimens."

"TP-2846 has a new MOA that has never before been fully explored clinically as a viable approach to treating AML," said Jacques Dumas, Chief Scientific Officer of Tetraphase. "Our preclinical data demonstrated high potency across multiple AML cell lines, along with in vivo tumor responses at well-tolerated doses. These early data are very encouraging and support the continued preclinical evaluation of TP-2846 as a potential new antileukemia agent."

TP-2846 binds to the mitochondrial ribosome, inhibiting protein translation and inducing apoptosis. Mechanistic assays demonstrated changes in protein and gene expression – all consistent with disruption of mitochondrial translation.

TP-2846 showed antiproliferative activity against cultured AML cell lines in vitro, as well as bone marrow samples derived from AML patients in ex vivo assays. The data available to date also suggest that TP-2846’s activity is independent of p53 status. Because of its novel MOA, TP-2846 maintained antiproliferative activity in cell lines that are resistant to anthracyclines, cytarabine and venetoclax, which are currently approved treatments for AML.

In vivo efficacy studies were also performed, comparing TP-2846 to cytarabine and tigecycline, a tetracycline antibacterial, in two AML mouse xenograft models. In these studies, TP-2846 demonstrated potent, dose-dependent in vivo efficacy, including greater than 50 percent tumor shrinkage in 19 out of 20 animals treated with TP-2846, while none in the comparator treatment groups achieved a tumor response in the same studies. TP-2846 was well tolerated in both models.