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ImmunoGen to Present Full Data from Phase 3 FORWARD I Study of Mirvetuximab Soravtansine and Initial Data from Phase 1b FORWARD II Triplet Cohort at ESMO

On September 17, 2019 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that full data and additional exploratory analyses from the Phase 3 FORWARD I study evaluating mirvetuximab soravtansine compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer will be presented during an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress to be held from September 27 to October 1, 2019 in Barcelona, Spain (Press release, ImmunoGen, SEP 17, 2019, View Source [SID1234539573]). Initial safety and overall response rate data from the Phase 1b FORWARD II triplet study evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) in patients with recurrent platinum-sensitive ovarian cancer will also be featured in a poster at the congress.

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Oral Presentation Details

Title: "FORWARD I (GOG 3011): A Phase III study of mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), versus chemotherapy in patients (pts) with platinum-resistant ovarian cancer (PROC)" (Abstract #992O)
Date:September 29, 2019
Time:8:30 a.m. CEST/2:30 a.m. EDT
Lead Author:Kathleen Moore M.D., University of Oklahoma Health Sciences Center, Oklahoma City, OK
Poster Details

Title: "Mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), in combination with carboplatin and bevacizumab: Initial results from a Phase 1b study in patients with ovarian cancer" (Abstract #1028P)
Date:September 29, 2019
Time: 12:00 p.m. CEST/6:00 a.m. EDT
Lead Author: David M. O’Malley M.D., James Cancer Center and The Ohio State University Wexner Medical Center, Columbus, OH
Additional information and full abstracts can be found at www.esmo.org.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call at 8 a.m. ET on Monday, September 30, 2019. Dial-in details to follow.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

Ayala Pharmaceuticals to Present at 2019 Ladenburg Thalmann Healthcare Conference

On September 17, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to developing targeted cancer therapies for people living with genetically defined cancers, reported that Roni Mamluk, Ph.D., Chief Executive Officer of Ayala, will present at the 2019 Ladenburg Thalmann Healthcare Conference on Tuesday, September 24, 2019 at 10:30am ET in New York, NY (Press release, Ayala Pharmaceuticals, SEP 17, 2019, View Source [SID1234539542]).

Oncoheroes Biosciences Inc. and Boehringer Ingelheim International GmbH sign exclusive licensing agreement for volasertib

On September 16, 2019 Oncoheroes Biosciences Inc ("Oncoheroes") and Boehringer Ingelheim International GmbH ("Boehringer Ingelheim") reported that have signed a worldwide, exclusive licensing agreement for volasertib, an investigational anti-cancer compound that was originally discovered and developed by Boehringer Ingelheim (Press release, Oncoheroes Biosciences, SEP 16, 2019, View Source [SID1234568288]). Under the terms of this agreement Boehringer Ingelheim assigns to Oncoheroes the intellectual property of volasertib, with exclusive rights to research, develop, sell and sublicense the compound. Oncoheroes is committed to further develop and commercialize volasertib for pediatric cancer indications.

Volasertib is an inhibitor of Polo-like-kinase 1 (PLK1), an enzyme known to be involved in cancer progression in a number of diseases. The compound was being developed by Boehringer for the treatment of a specific form of leukemia but clinical development activities were halted after a large Phase III study with adult patients failed to meet its primary endpoints. Meanwhile, independent academic groups had generated strong data in support of further developing the drug for rhabdomyosarcoma and a few other pediatric cancer indications. By signing this licensing agreement, Oncoheroes and Boehringer Ingelheim make it possible to continue the clinical development of volasertib to the benefit of younger cancer patients.

Oncoheroes is a Boston-based biotech company exclusively focused on the development of innovative medicines to treat cancer in children and adolescents. The company was co-founded by Ricardo Garcia and Cesare Spadoni, two parents touched by childhood cancer and determined to change the outlook for these young patients.

"This is probably the first example of an investigational compound being specifically repurposed to investigate it as a treatment for a form of childhood cancer. We are committed to identify more such opportunities and also develop our own innovative treatments for children and adolescents with cancer", jointly stated Ricardo Garcia and Dr Cesare Spadoni, Oncoheroes’ Chief Executive Officer and Chief Operating Officer, respectively.

The financial details of this deal are not disclosed. Oncoheroes has already established links with international pediatric oncology networks and is actively working to start clinical development activities as soon as possible.

Genprex is Defining a New Immunogene Therapy that Could Change the Course of Cancer

On September 16, 2019 Genprex, a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients, reported raising the standard in cancer treatment by developing what it calls an "immunogene therapy," which harnesses the power of immunotherapy’s immunomodulation through the delivery of a gene therapy (Press release, Genprex, SEP 16, 2019, https://www.genprex.com/news/genprex-is-defining-a-new-immunogene-therapy-that-could-change-the-course-of-cancer/ [SID1234551276]).

Gene therapies and immunotherapies are two different types of treatment. Simply put, gene therapies insert a gene into a patient’s cells1while immunotherapies boost the body’s natural defenses to fight diseases, such as cancer.2 Genprex’s cancer fighting drug candidate for non-small cell lung cancer (NSCLC), Oncoprex immunogene therapy, is a gene therapy that also has immunomodulatory effects.

Oncoprex classifies as a gene therapy because it consists of a tumor suppressor gene that is injected intravenously and can specifically target cancer cells. As a gene therapy, Oncoprex works to fight off cancer by interrupting cell signaling pathways that cause replication and proliferation of cancer cells. It also stimulates apoptosis, or the death of cancer cells.

Oncoprex also works as an immunotherapy because it modulates the body’s immune response against cancer. The TUSC2 gene, which is the active agent in Oncoprex, has been shown to upregulate Natural Killer cells, or NK cells. These NK cells are known for their ability to kill tumor cells.3TUSC2 has also been shown to downregulate PD-L1, or programmed cell death ligand-1, receptors. These receptors, which are also known as immune checkpoint proteins, can sometimes help cancer evade detection. TUSC2 works to downregulate, or suppress them, which helps the body’s immune system to fight against the cancer.

Genprex’s immunogene therapy is unlike the approved targeted gene therapies and immunotherapies available today. Because Oncoprex is a gene therapy with immunotherapy characteristics, it is poised and positioned to help NSCLC patients who cannot benefit from today’s treatment options.

*Oncoprex is currently in development and is not FDA approved.

References:

(2019). What is gene therapy?. [online] U.S. National Library of Medicine. Available at: View Source [Accessed 5 Sep. 2019].
Cancer.org. (2019). Cancer Immunotherapy. [online] Available at: View Source [Accessed 5 Sep. 2019].
Eissmann, P. (2019). Natural Killer Cells | British Society for Immunology. [online] Immunology.org. Available at: View Source [Accessed 5 Sep. 2019].

INmune Bio Invited to Speak on Company’s Advancements in Cancer Treatments at the Targeting Innate Immunity Congress and MarketsandMarkets Next Gen Immuno-Oncology Congress

On September 16, 2019 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that RJ Tesi, M.D., Co-Founder and CEO, and Mark Lowdell, Ph.D., Co-Founder and Chief Scientific Officer, will present at the first ever Targeting Innate Immunity Congress, taking place in the biotech hub of Cambridge, Mass. from Sept. 23 through 25 (Press release, INmune Bio, SEP 16, 2019, View Source [SID1234539636]).

The conference is an opportunity for INmune Bio to showcase its two leading innate compounds in the hopes of improving the treatment of cancer to industry leaders, experts, academic researchers and clinicians in the field of innate immunity. In addition to presenting at the conference, Dr. Tesi and Dr. Lowdell will be instructing a course on the role of the tumor microenvironment (TME) in immunosuppression.

"This panel will bring together other experts from industry and academia to explore the role of the innate immune system in the TME and in cancer drug development," said Dr. Tesi.

In addition to speaking at the Targeting Innate Immunity Congress this month, Dr. Tesi will also take part in a speaking engagement at the second annual MarketsandMarkets Next Gen Immuno-Oncology Congress on Sept. 19 in Philadelphia.

Below is a schedule of upcoming presentations:

MarketsandMarkets Next Gen Immuno-Oncology Congress
Thursday, September 19 at 11:40 a.m.
"Reversing Trastuzumab Resistance in HER2+ Breast Cancer"
Dr. Tesi will discuss Mucin 4 (MUC4) protein and how it predicts trastuzumab resistance in HER2+ breast cancer, the role of soluble tumor necrosis factor (TNF) in MUC4 expression and how INmune Bio’s drug candidate, INB03 works in combination with trastuzumab to reverse resistance in MUC4/HER+ breast cancer.

Targeting Innate Immunity Congress
Monday, September 24 at 3:30 – 6:00 p.m.
Short Course: "Understanding and Modulating Tumor Microenvironment for Immunotherapy"
Dr. Tesi and Dr. Lowdell will instruct an interactive short course on the role of the tumor microenvironment (TME) in immunosuppression. They will discuss strategies to change the immunosuppressive nature of the TME to one that supports immune responses and enhances the impact of tumor immunotherapy. Those who attend will walk away with an understanding of the following:

•Role of the TME in immunosuppression
•Checkpoint inhibitor optimization
Targeting of regulatory cells
•Reprogramming of immunosuppressive cells
•Modulation of chemokines and cytokines in the TME
•Modification of tumor-reactive lymphocytes to evade the TME
Wednesday, September 25 at 11:40 a.m.
"Myeloid Derived Suppressor Cell (MDSC): The Queen Bee of the Tumor Microenvironment (TME)"
As part of the "Modulating Macrophages in the Tumor Microenvironment" panel, Dr. Tesi will discuss targeting myeloid derived suppressor cells (MDSCs) as an efficient way to reverse tumor microenvironment (TME) immunobiology. His discussion will address the complexity of TME and how it contributes to failure of therapy, as well as understanding how targeting soluble tumor necrosis factor (TNF) offers a solution to the resistance to therapy when part of combination therapy. Dr. Tesi will also discuss the results of the Phase I trial for INmune Bio’s drug candidate, INB03 in patients with advanced cancer.

Wednesday, September 25 at 1:45 p.m.
"What do Tumor Cells do to NK Cells? – Harnessing the Tumor-NK Interaction for Clinical Benefit"
Dr. Lowdell will participate in the "Advancing Innate Cell Therapies to the Clinic" portion of the conference to discuss how relapsed cancer cells evade natural killer (NK) cells, and how priming NK cells could effectively kill these cancer cells. Dr. Lowdell will also discuss INmune Bio’s INKmune drug candidate.