On May 24, 2019 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the immediate launch of its therascreen PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis (Press release, Qiagen, MAY 24, 2019, View Source [SID1234536580]).

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The therascreen PIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use in any cancer indication for detection of activating mutations in the PIK3CA gene. It is also the first FDA approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA mutations, which are estimated to be present in approximately 40% of hormone receptor-positive (HR+) advanced or metastatic breast cancer patients. The real-time qualitative PCR kit is processed on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions. The test leverages QIAGEN’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

QIAGEN’s therascreen PIK3CA Kit was co-developed in collaboration with Novartis and co-approved with PIQRAY (alpelisib) by the FDA. The Novartis drug is indicated in combination with fulvestrant for the treatment of postmenopausal women and men ,with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Further detail about the Kit is available at www.qiagen.com/PIK3CA.

On May 24, 2019 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, reported that the company will present at the 5th Annual Immuno-oncology BD&L and Investment Forum being held in Chicago, IL, May 31, 2019 (Press release, Immunomic Therapeutics, MAY 24, 2019, View Source [SID1234536579]). Sia Anagnostou, Immunomic’s Senior Director of Corporate Development, will present a company overview and will discuss ITI’s recently expanded, investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). ITI’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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Presentation details are as follows:

Title: Immunomic Therapeutics, Pioneering Vaccines That Transform Lives
Panel Date and Time: Friday, May 31, 2019 10:30 AM
Track & Room: PR Track C, Room Sinclair North
Place: Waldorf Astoria Chicago Hotel, Chicago, Illinois

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On May 24, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported that Aron Knickerbocker, Chief Executive Officer, is scheduled to present at the following two investor conferences (Press release, Five Prime Therapeutics, MAY 24, 2019, View Source [SID1234536577]):

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The Jefferies Healthcare Conference, on Thursday, June 6th at 9:30am ET / 6:30am PT
The 40th Annual Goldman Sachs Global Healthcare Conference on Wednesday, June 12th at 1:00pm ET / 10:00am PT
The presentations will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at: View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On May 24, 2019 NeoImmuneTech, Inc. (NIT), a T cell-focused immunotherapeutics company, reported that the U.S. Food and Drug Administration (FDA) has allowed the Center for Cancer Research, National Cancer Institute to proceed with an Investigational New Drug application (IND) application for Hyleukin-7, a long acting T cell amplifier, to begin a clinical trial aiming to enhance the immune reconstitution and vaccine responses in elderly cancer survivors following chemotherapy (Press release, NeoImmuneTech, MAY 24, 2019, View Source [SID1234536576]).

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The study’s principal investigator, Ronald Gress, M.D., Chief, Experimental Transplantation & Immunology Branch, Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health commented. "Our previous study with IL-7 in humans showed restoration of polyclonality in T cell populations; the question now is whether the restored clonality has functional benefit in response to antigen challenge."

Elderly cancer survivors are vulnerable to vaccine-preventable diseases and are known to have poor anti-vaccine-specific immune responses. Effective prevention of communicable diseases is important for cancer survivorship, especially in the elderly population. The cytokine Interleukin-7 (IL-7) may play a role in immune reconstitution and immune enhancement in various circumstances of immune insufficiency in older individuals following chemotherapy. This phase 1/1b study will test whether Hyleukin-7, a long acting human IL-7, can enhance specific immune responses to selected vaccines in older subjects following chemotherapy.

"As we continue to explore the potential of Hyleukin-7 in oncology and other therapeutic areas, including infectious disease, NIT and the world-renowned experts at the NCI are very encouraged by the strong scientific rationale supporting the combination of Hyleukin-7 with various vaccines to enhance immune responses," said NgocDiep Le, M.D., Ph.D., NIT’s Executive VP and Chief Medical Officer. "Our mission at NIT is to develop innovative therapeutic options to ultimately improve the survival and quality of life for cancer patients. Through an in-depth analysis of Hyleukin-7’s function on specific T cell subsets, both in quantitative and qualitative aspects in this clinical trial, we will be able to assess the potential of using Hyleukin-7 in combination with various vaccines in Infectious Disease and Oncology."

In the phase 1 trial in healthy subjects and multiple ongoing dose-escalation trials in cancer patients, Hyleukin-7 showed a well-tolerated safety profile and dose-dependent increases of CD4+ and CD8+ T lymphocyte counts. NIT has been also actively conducting and planning multiple proof-of-concept clinical trials to develop Hyleukin-7 as an immune-oncology (IO)-enabling drug in combination with other cancer therapeutics such as immune checkpoint inhibitors or chemo/radiotherapies.

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.

On May 24, 2019 Novocure (NASDAQ: NVCR) reported that Bill Doyle, Novocure’s Executive Chairman, will participate in the Jefferies 2019 Global Healthcare Conference on June 4, 2019, in New York City (Press release, NovoCure, MAY 24, 2019, View Source [SID1234536575]). Mr. Doyle’s presentation will begin at 9 a.m. EDT and will be followed by a Q&A session. Mr. Doyle will also participate in one-on-one meetings with investors throughout the day.

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A live audio webcast of the presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the events.

Novocure’s corporate presentation is updated periodically, and the current presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations.