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NeoImmuneTech Announces that the FDA has Allowed the Center for Cancer Research, National Cancer Institute to Proceed with an Investigational New Drug Application to Initiate a Clinical Trial for Hyleukin-7™ with Vaccines in Elderly Cancer Survivors

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.

Novocure to Participate in the Jefferies 2019 Global Healthcare Conference

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.

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.

MEDIGENE PRESENTED PRECLINICAL DATE ON DIFFERENT TCR CANDIDATES AT CIMT

On May 24, 2019 Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that two scientific posters with preclinical data on an HA-1-specific T-cell receptor and a NY-ESO-1/LAGE-1-specific T-cell receptor were shown on 21 May 2019 during the CIMT (Free CIMT Whitepaper) Annual Meeting in Mainz. Prof. Dolores Schendel also gave a presentation on 23 May on the topic: "Matching future needs for world patient populations needing TCR-T therapies with different antigen specificities and HLA restrictions" (Press release, MediGene, MAY 24, 2019, View Source [SID1234536574]).

The first poster was entitled: "HA-1-specific T-cell receptors for the treatment of hematological malignancies" and showed how a minor histocompatibility antigen like HA-1 can play an important role in the graft versus leukemia effect after an allogenic hematopoietic stem cell transplantation. As the expression of HA-1 is restricted to the hematopoietic system., it is a promising target for the treatment of malignancies resulting from these cells. If donor and patient have the right mismatch in HA-1, adoptive T cell immunotherapy targeting HA-1 can theoretically be used after allogenic stem cell transplantation to prevent relapse or as treatment for relapse. To not be limited to the T cell receptor (TCR) repertoire of a stem cell donor, Medigene used its TCR platform to isolate HA-1-specific TCRs from healthy donors. In summary, Medigene was able to efficiently isolate and characterize TCRs specific for the minor histocompatibility antigen HA-1, that can be considered for TCR-T immunotherapy.

Medigene plans to conduct a Phase I clinical trial with Medigene’s T cell receptor (TCR) modified T cell therapy MDG1021 targeting the HA-1 antigen. The study is scheduled to start in 2020 as Medigene’s second company-sponsored clinical TCR-T trial.

The second poster reported on "A safe and highly active NY-ESO-1/LAGE-1-specific TCR for adoptive T cell therapy of cancer". In summary, Medigene’s proprietary technology enabled the identification of a TCR lead candidate for a NY-ESO-1/LAGE-1-derived SLLMWITQC peptide (NY-ESO-1/LAGE-1157-165) presented on HLA-A*02:01 molecules. It demonstrated high natural affinity and potent preclinical efficacy. Moreover, its favorable preclinical in vitro safety profile proves the technology valuable for obtaining TCRs with properties qualifying for clinical application.

The Association for Cancer Immunotherapy CIMT (Free CIMT Whitepaper) is a member-based information and education platform that facilitates the knowledge exchange between academic and industry scientists, physicians and regulatory authorities who research and develop cancer immunotherapies. Every year, CIMT (Free CIMT Whitepaper) organizes the largest and most influential international cancer immunotherapy meeting in Europe.

Surface Oncology Presents Preclinical Data Further Supporting Anti-Tumor Mechanism of CD73 and CD39 Programs at Brisbane Immunotherapy 2019

On May 24, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment (TME), reported the presentation of updated preclinical findings regarding the anti-tumor effects of increasing inflammation and reducing extracellular adenosine in the TME (Press release, Surface Oncology, MAY 24, 2019, View Source/news-releases/news-release-details/surface-oncology-presents-preclinical-data-further-supporting" target="_blank" title="View Source/news-releases/news-release-details/surface-oncology-presents-preclinical-data-further-supporting" rel="nofollow">View Source [SID1234536573]). The data highlight the mechanisms of targeting CD73 and CD39, which are distinct targets in the adenosine axis and focal points of the Surface Oncology pipeline. The podium presentation, "Targeting the Adenosine Axis to Treat Cancer", was given by the Company’s vice president of cancer biology, Pamela Holland, Ph.D., at Brisbane Immunotherapy 2019 in Brisbane, Australia.

"These data are supportive of our multi-faceted approach to targeting the adenosine axis. Pam’s presentation highlights additional validating data of the NZV930 program candidate, a highly potent enzymatic inhibitor of CD73, and its ability to block the production of extracellular adenosine in the TME," said Vito Palombella, Ph.D., chief scientific officer of Surface. "For CD39, this new in vivo data demonstrates that inhibition of CD39 upregulates inflammation in the TME, leading to an influx of innate immune cells to tumors, a compelling addition to the significant supporting evidence behind this program. Also, by reducing adenosine, in a manner similar to NZV930, we see increased proliferation of tumor-targeting T cells. These data show a dual mechanism of action for this monoclonal antibody candidate, whereby it invokes both the innate and adaptive arms of the immune system. We look forward to advancing our lead CD39 antibody, SRF617, into the clinic later in 2019."

Dr. Holland’s presentation is accessible on the Investors page of the Surface website at View Source

Medtronic Chairman and CEO Omar Ishrak to Speak at Bernstein Strategic Decisions Conference

On May 24, 2019 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported that it will participate in the Bernstein 35th Annual Strategic Decisions Conference on Wednesday, May 29, 2019, in New York City (Press release, Medtronic, MAY 24, 2019, View Source;p=RssLanding&cat=news&id=2399696 [SID1234536572]).

Omar Ishrak, chairman and chief executive officer of Medtronic, will make a presentation and will answer questions about the company beginning at 10:00 a.m. EDT (9:00 a.m. CDT).

A live audio webcast of the presentation will be available on May 29, 2019, by clicking on the Investor Events link at View Source, and an archive of the session will be available on the same webpage later in the day.