Pieris Pharmaceuticals Presents Preclinical Data for GPC3/4-1BB Bispecific PRS-342 at the 2019 American Association for Cancer Research (AACR) Annual Meeting

On April 2, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported the presentation of preclinical data for PRS-342, a GPC3/4-1BB immuno-oncology bispecific drug candidate, at a poster session at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Pieris Pharmaceuticals, APR 2, 2019, View Source [SID1234534885]).

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The poster, titled "Costimulatory T-cell engagement by PRS-342, a GPC3/4-1BB bispecific molecule, leads to activation of T cells and tumor growth inhibition in a HCC humanized mouse model," demonstrated that T-cell activation by PRS-342 led to NF-kB activation, increased production of IL-2 and dose-dependent cytolysis of GPC3-expressing tumor cells. PRS-342 also demonstrated a localized increase of tumor-infiltrating lymphocyte (TIL) levels in a humanized hepatocellular carcinoma (HCC) xenograft mouse model. The data presented suggest potent T-cell activation that is strictly dependent on the presence of GPC3-positive tumor cells. A copy of the poster presentation is available on the publications section of the Pieris website.

Heat Biologics Delivers Poster Presentation at the AACR Annual Meeting 2019

On April 2, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that it delivered a poster presentation yesterday, April 1, 2019, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Heat Biologics, APR 2, 2019, View Source [SID1234534901]). The Company’s presentation, entitled, ”Generation of a novel, allogeneic cell-based, Gp96-Ig/OX40L cancer vaccine, improves anti-tumor immunity and long-term memory T-cell generation,” is available online here.

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The poster presentation featured the Company’s next generation cellular vaccine platform, ComPACT (COMbination Pan-Antigen Cytotoxic Therapy), which incorporates a tumor antigen chaperone (gp96-Ig) with T-cell costimulation (OX40L-Ig), simulating a single tumor cell line source that secretes both products. The presentation modeled how the addition of human HS-130, which secretes OX40L-Ig, to HS-110 may ImPACT anti-tumor immune responses. This combination generated a three-fold increase in CD8+ T-cell expansion, increased numbers of long-lived tumor-specific T-cells, and potent short-lived killer T-cells required for tumor growth control.

Matt Seavey, Ph.D., Heat’s Senior Director of Research, commented, ”We are highly encouraged by these preliminary results in a mouse model, which demonstrate that the combination of HS-110 with OX40L co-stimulation has the potential to dramatically enhance anti-tumor immune responses. Moreover, this study further informed our selection of the ideal ratio of gp96 to OX40L, which will be helpful as we prepare to file an IND for our HS-130 ComPACT trial later this quarter.”

About AACR (Free AACR Whitepaper) Annual Meeting 2019

The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research – from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy – and highlights the work of the best minds in research and medicine from institutions all over the world.

PureTech Health Announces Presentation of Internal Immuno-Oncology Programs at American Association for Cancer Research (AACR) Annual Meeting

On April 2, 2019 PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, reported the presentation of two scientific posters at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia (Press release, PureTech Health, APR 2, 2019, View Source [SID1234534918]).

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Joseph Bolen, PhD, chief scientific officer at PureTech Health, said: "PureTech Health has built a leading position in BIG therapeutic development through its affiliate technologies and is now capitalizing on this critical mass of expertise through multiple internal development programs that are delivering clinical candidates. We’re proud to present data on these programs at AACR (Free AACR Whitepaper), one of the premiere scientific meetings focused on cancer research. Galectin-9 and γδ1 T cells represent powerful immunosuppressive mechanisms across both innate and adaptive immunity. We have moved quickly to advance development of compelling candidates that could act as both monotherapies and combination therapies against cancers that currently do not respond well to approved immunotherapies. In addition to our programs targeting the body’s immune cell trafficking highway – the lymphatic system – these immuno-oncology programs round out an exciting pipeline of therapeutics targeting important regulators of the immune system."

The posters detail the Company’s development of first-in-class, fully-human monoclonal antibodies (mAbs) targeting Galectin-9 (LYT-200) and immunosuppressive γδ1 (gamma delta) T cells (LYT-210). LYT-200 and LYT-210 are unique mAbs targeting foundational, novel mechanisms of tumoral immune escape and immunosuppression in cancer, and have been tested as single agents, as well as in combination with anti-PD1 in preclinical murine and human-derived ex vivo models. As such, they represent novel additions to the armamentarium of immuno-oncology agents, with potential across multiple solid tumors including malignancies that have historically proved difficult to treat. The AACR (Free AACR Whitepaper) posters describe their development, lead candidate characterization, and pre-clinical efficacy models.

Galectin-9 is a master immunosuppressor that affects multiple cell types (e.g., regulatory and effector T cells, myeloid-derived suppressor cells, and macrophages) to induce and maintain a tumor-permissive microenvironment. As it can be both expressed by cancer cells and present in cancer tissue, and it can also be secreted into the circulation of cancer patients, targeting Galectin-9 can enable multiple anti-tumor effects. PureTech’s anti-Galectin-9 antibody, dubbed LYT-200, is being developed for difficult-to-treat malignancies, including pancreatic, cholangiocarcinoma, and certain types of colorectal and liver cancers, which remain insufficiently responsive or resistant to currently approved checkpoint inhibitors. The research presented today details the development and comprehensive characterization of LYT-200 and its efficacy in preclinical human-derived ex vivo models and a murine model. The work demonstrates efficacy to reduce tumor growth, as well as the ability of LYT-200 to reactivate human effector T cells in patient-derived tumor culture models.

Gamma Delta 1 (γδ1) T cells are an immunosuppressive subset of the γδ T cell family of immune cells, which are upregulated in multiple solid tumors including breast cancer, glioblastoma, melanoma, and pancreatic cancer. Notably, an abundance of circulating γδ1 T cells has been associated with poor response to checkpoint therapy in melanoma patients. γδ1 T cells harbor a distinct phenotype characterized by expression of the δ1 chain in the T cell receptor. Immunosuppressive γδ1 T cells function to block effector T cells, restrict anti-tumoral γδ2 T cell subset, hinder antigen-presenting dendritic cells, and attract tumor-associated macrophages and myeloid-derived suppressor cells to enhance immunosuppression in cancer. Targeting γδ1 T cells therefore has the capacity to modulate both innate and adaptive immunity, and their distinct phenotypic and functional properties make them excellent therapeutic targets in cancer. The research presented today focuses on PureTech’s leading antibody candidate aimed at depleting γδ1 T cells, showing high specificity (e.g., binding to δ1 but not the δ2 chain present on cytotoxic γδ T cells), excellent binding affinity to both human and non-human primate δ1 chains, as well as functional properties to increase T cell effector activity in human derived ex vivo models. PureTech Health believes its anti-δ1 mAb program is the only one of its kind, and the Company is now finalizing the program’s lead clinical candidate selection.

The company anticipates filing an Investigational New Drug Application (IND) for LYT-200, which targets Galectin-9, in 2020 and anticipates continuing to advance the lead clinical candidate of the γδ1 program, LYT-210, into development

MEI Pharma to Present at the 18th Annual Needham Healthcare Conference

On April 2, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., president and chief executive officer, will present at the 18th Annual Needham Healthcare Conference on Tuesday, April 9, 2019 at 10:40 a.m. ET (Press release, MEI Pharma, APR 2, 2019, View Source [SID1234534953]). The conference will take place April 9-10, in New York, N.Y.

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A live audio webcast of the event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source

An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

Sumitomo Dainippon Pharma Submits an Application of RETHIO for an Additional Indication of Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation for Malignant Lymphoma

On April 2, 2019 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura hereinafter called "Sumitomo Dainippon Pharma") has reported that on March 29 the company applied for a partial change in the marketing approval previously acquired in Japan for RETHIO 100 mg for I.V. infusion (generic name, thiotepa; hereinafter called "RETHIO") (Press release, Sumitomo Dainippon Pharma, FEB 2, 2019, View Source [SID1234605564]). The change applied for this time involves an additional indication of RETHIO for conditioning treatment prior to autologous hematopoietic stem cell transplantation (auto-HSCT) for malignant lymphoma.

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RETHIO is a drug indicated for conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors. Sumitomo Dainippon Pharma obtained the marketing approval for this drug on March 26, 2019 and plans to launch it after NHI drug price listing.

Malignant lymphoma, a hemocytes-derived cancer, is a disease that lymphocytes, a subpopulation of leukocytes (white blood cells), become cancerous. This disease occurs typically in lymphoid tissues, such as lymph nodes, spleens, and tonsils, but it also often develops in other sites. It has been reported that the incidence of malignant lymphoma is around ten in 100,000 persons in Japan annually, the most common hematapostema in Japanese adults. As with conditioning treatment prior to autologous HSCT for pediatric malignant solid tumors, the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs of the Ministry of Health, Labour and Welfare (MHLW) determined similarly high medical need in conditioning treatment prior to auto-HSCT for malignant lymphoma. Thus, Sumitomo Dainippon Pharma conducted Phase 1 trials in Japan and subsequently applied for the additional indication.

Sumitomo Dainippon Pharma believes that, upon approval of its additional indication, this drug will contribute to improved healthcare as a new treatment option for patients indicated for conditioning treatment prior to auto-HSCT for malignant lymphoma, a therapeutic area with high unmet medical need.

About autologous hematopoietic stem cell transplantation (auto-HSCT)
Autologous hematopoietic stem cell transplantation is a therapy that aims to reconstruct hematopoietic capacity via intravenous transfusion of normal hematopoietic stem cells of the patient himself/herself after eradicating intractable cancers by conditioning myeloablative treatment prior to transplantation using maximum levels of anti-cancer drugs or radiation.

About the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs
The Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs is a committee established to promote the development of unapproved or off-label drugs by pharmaceutical companies that are approved for use in Europe and the United States, etc., but not approved in Japan. It is organized under the Ministry of Health, Labour and Welfare of Japan and consists of academic experts in medical and pharmaceutical fields.