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NeoImmuneTech, Genexine, SNUH and POSTECH researchers Announce Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2019

On April 3, 2019 NeoImmuneTech, Inc. (NIT), a T cell-based therapeutics company, reported the presentation of new research at the AACR (Free AACR Whitepaper) Annual Meeting, being held March 29 – April 3, 2019 in Atlanta, GA (Press release, NeoImmuneTech, APR 3, 2019, View Source [SID1234534970]). Study results regarding Hyleukin-7 (Interleukin-7-hyFc), developed jointly with Korean affiliate company Genexine, Inc. (Genexine), will be presented in two posters.

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Presentation Details:

Title: CT045. Hyleukin-7, a long-acting interleukin-7, increased absolute lymphocyte counts after subcutaneous and intramuscular administration in healthy subjects
Date: April 1, 2019

This poster details Hyleukin-7’s safety profile and T cell boosting effects from the first-in-human study in healthy subjects. Hyleukin-7 administration was well-tolerated, exhibited dose-dependent increases in T cells, and significantly increased killer and memory T cells, which are crucial for effective anti-tumor response. Additionally, the poster reports that dose escalation of Hyleukin-7 in multiple ongoing clinical trials in cancer patients has shown similar safety profiles to the first-in-human study, and also demonstrated dose-dependent increases of killer T cells. The study was led by professor Howard Lee of Seoul National University Hospital (SNUH).

Title: 4991. Hyleukin-7, the Fc-fused interleukin-7, generates anti-tumor activity by modulating both adaptive and innate immune cells in the tumor microenvironment
Date: April 3, 2019

Data shown here focuses on the anti-cancer mechanism of Hyleukin-7 from preclinical studies. Hyleukin-7 affected the immune cells not only in the peripheral blood but also in the tumor microenvironment (TME). This study, led by professor Seung-Woo Lee of Pohang University of Science and Technology (POSTECH), Korea, demonstrated that administration of Hyleukin-7 in an animal cancer model significantly increased the quantity of killer T cells. Most importantly, within the TME killer T cells drastically increased while regulatory T cells and myeloid lineage cells (immune suppressor cells) such as myeloid-derived suppressor cells (MDSC) substantially decreased, resulting in significant anti-tumor activity.

"This research is the first to demonstrate that a long-acting IL-7 effectively modulates the TME, significantly amplifying anti-tumor T cells and reducing immune-suppressive cells such as MDSCs in the tumor," said professor Seung-Woo Lee. "These data allow us to envision Hyleukin-7 as a potential next-generation cancer immunotherapy with a differentiated function."

"Having recently raised $92 million in Series D funding round, we aim to use the funds to continue confirming the anti-tumor effects and mode of action of Hyleukin-7 through multiple monotherapy and combination therapy clinical trials in various tumor types," added Se Hwan Yang, Ph.D., Chief Executive Officer of NIT.

NIT and Genexine are currently conducting dose-escalation studies to identify an optimal Hyleukin-7 dosing regimen in advanced solid tumors and brain cancer (glioblastoma) patients. NIT and Genexine are also collaborating with global pharmaceutical companies to combine Hyleukin-7 with anti-PD-1/anti-PD-L1 therapies in clinical trials in high-risk skin cancers and triple-negative breast cancer patients in the United States and Korea, respectively.

About Hyleukin-7
Hyleukin-7 (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell growth factor composed of a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc. IL-7 is known to be a critical factor for T cells homeostasis, acting to increase both the number and functionality of T cells. Hyleukin-7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy as well as next generation IO therapeutics.

Veracyte to Release First Quarter 2019 Financial Results on April 30, 2019

On April 3, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the first quarter 2019 after the close of market on Tuesday, April 30, 2019 (Press release, Veracyte, APR 3, 2019, View Source [SID1234534969]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

The conference call will be webcast live from the company’s website and will be available via the following link View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free): (855) 541-0980
International participant dial-in number: (970) 315-0440
Conference I.D.: 9289499

Rgenix Presents Pre-Clinical Data on RGX-019 at the 2019 AACR Annual Meeting

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.

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."

Tarveda Therapeutics to Present at Needham & Company’s 18th Annual Healthcare Conference

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:

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

Y-mAbs Therapeutics To Present At The H.C. Wainwright Global Life Sciences Conference in London

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.