On October 27, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, report financial results for the quarter ended September 30, 2017 before the open of the U.S. markets on Thursday November 2, 2017 (Press release, Adaptimmune, OCT 27, 2017, View Source [SID1234521255]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EDT (12:00 p.m. GMT) on the same day at which time management will provide a business update and discuss the financial results for the third quarter of 2017.

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, if preferred, please dial (877) 280-1254 (U.S.) or 44(0)20 3450 9987 or 0800 279 4992 (United Kingdom). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (3625348).

On October 27, 2017 Unum Therapeutics Inc., a clinical stage biopharmaceutical company developing a universal cellular immunotherapy to treat multiple cancers, reported that the Company will be presenting on its Antibody-Coupled T cell Receptor (ACTR) platform at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which is being held in Philadelphia, PA on October 27-30, 2017 (Press release, Unum Therapeutics, OCT 27, 2017, View Source [SID1234521229]). The first poster presentation will highlight data from non-clinical studies on effective targeting of HER2-amplified cancers with trastuzumab used in combination with ACTR707, a novel Antibody-Coupled T cell Receptor (ACTR). The second poster will provide data from non-clinical studies on ACTR707 used in combination with rituximab, a novel T cell therapy for the treatment of relapsed or refractory CD20+ B cell lymphoma.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The accepted abstracts are listed below and are available online on the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC conference website: View Source
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Presentation Details:
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Title: Effective targeting of HER2-amplified Cancers with trastuzumab in combination with T cells expressing a novel Antibody-Coupled T cell Receptor (ACTR)
Authors: Katie M. O’Callaghan, John Shin, Eugene Choi, Greg Motz, Casey B. Judge, Heather A. Huet, Birgit C. Schultes, Seth A. Ettenberg
Authors’ Affiliation: Unum Therapeutics
Presenter: Katie M. O’Callaghan, Senior Scientist, Unum Therapeutics
Session: PO.A18 – EGFR/Her2
Session Date and Time: October 28, 2017, 12:30 – 4:00 PM
Location: Hall E, Pennsylvania Convention Center
Poster #: A163
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Title: ACTR707: a novel T cell therapy for the treatment of relapsed or refractory CD20+ B cell lymphoma in combination with rituximab
Authors: Greg Motz, Kathleen Whiteman, John Shin, Tapasya Pai, Casey Judge, Anthony Barnitz, James Hemphill, James Kim, Ann Ranger, Heather Huet, Kathleen McGinness, Birgit Schultes, Geoffrey Hodge, Michael Vasconcelles, Seth Ettenberg
Authors’ Affiliation: Unum Therapeutics
Presenter: Greg Motz, Principal Scientist, Unum Therapeutics
Session: PO.B19 – Therapeutic Agents: Biological
Session Date and Time: October 29, 2017, 12:30 – 4:00 PM
Location: Hall E, Pennsylvania Convention Center
Poster #: B105
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The posters will be posted on Unum’s website following the presentations.
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About Antibody-Coupled T cell Receptor (ACTR) Technology
Unum’s proprietary ACTR is a chimeric protein that combines components from receptors normally found on two different human immune cell types – natural killer (NK) cells and T cells – to create a novel approach to cancer cell killing. T cells bearing the ACTR receptor protein can be directed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface.
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In contrast to other T cell therapy approaches for cancer that are limited to a single cancer cell surface target and, therefore, treat a narrow set of tumors, Unum’s approach is not restricted by a specific tumor cell antigen and, thus, may have applications for treating many different types of cancers when combined with the right antibodies.
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Unum is developing ACTR in combination with a range of tumor-targeting antibodies for use in both hematologic and solid tumor indications. ACTR087 used in combination with rituximab, an anti-CD20 antibody, is Unum’s most advanced product candidate, currently in Phase I clinical testing for the treatment of adult patients with relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma. The Company has two additional product candidates on track for imminent clinical testing under Investigational New Drug Applications (INDs) in effect with the FDA, ACTR707 used in combination with rituximab for the treatment of adult patients with relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma, and ACTR087 in combination with SEA-BCMA for the treatment of adult patients with relapsed/refractory multiple myeloma.

Shire has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Shire, 2017, OCT 27, 2017, View Source [SID1234521251]).

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On October 27, 2017 CureVac AG, a fully-integrated biotechnology company pioneering mRNA-based drugs, reported it has initiated a Phase I study assessing the intratumoral application of its novel RNAdjuvant technology in patients with superficial solid tumors that are easily accessible for repeated intratumoral injections (Press release, CureVac, OCT 27, 2017, View Source [SID1234521231]). RNAdjuvant is designed to amplify the scope and quality of an immune response when used alone or in combination with other immune therapies.

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The trial is designed to assess the safety, tolerability and immunomodulating effects of CV8102, a drug candidate developed with CureVac’s RNAdjuvant technology. The trial includes a dose escalation and several expansion cohorts, with plans to investigate CV8102 in combination with anti-PD-1 therapies.

CureVac’s RNAdjuvant (CV8102) is a potent immunomodulator designed to expand the effects of immuno-oncology treatments and prophylactic vaccines for the prevention of infectious diseases. In a previous Phase I study in healthy volunteers, CV8102 appeared safe and was shown to increase antigen-specific immune responses when combined with a licensed rabies vaccine.

Ulrike Gnad-Vogt, M.D., CMO of CureVac, commented, “The initiation of this study is a significant advancement for CureVac as it showcases our innovative approach to product development by leveraging our RNA platform. CV8102 has been shown to be an effective immunomodulator that results in significant, innate immune activation at the injection site ultimately facilitating tumor rejection. Given this, we believe CV8102 is ideally suited for treating tumors via direct, intratumoral injection. We are looking forward to testing CV8102 for the first time in cancer patients and establishing its ability to trigger systemic immune responses via local injection, in particular in combination with a systemic checkpoint blockade.”

The Phase I clinical study is targeting patients with superficially accessible tumors of several different histologies and is aiming to find a safe and tolerated dose with or without concomitant systemic checkpoint inhibition. As secondary and/or exploratory endpoints, the study will evaluate signals of objective tumor response, and changes in treatment-induced effects of CV8102 on systemic immune parameters, tumor immune cell infiltration and other peripheral biomarkers of interest.

On October 27, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) reported that its marketing authorisation application (MAA) for mogamulizumab, for the treatment of cutaneous T-cell lymphoma (CTCL) in adults who have received at least one prior systemic therapy, has been validated by the European Medicines Agency (EMA) and is now under review (Press release, Kyowa Hakko Kirin, OCT 27, 2017, View Source [SID1234521240]).

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This MAA is based on the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, the largest global randomised clinical trial of systemic therapy in CTCL.

“This is a significant milestone for our subsidiary, Kyowa Kirin Pharmaceutical Development,” said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. “I believe mogamulizumab has the potential to be an advance in therapy for patients with CTCL and we will keep working to make it available to patients as soon as possible.”

Mogamulizumab was first approved in Japan 2012 for other haematological malignancies and in 2014 for use in CTCL. Kyowa Hakko Kirin has also initiated discussions with regulatory authorities concerning plans for marketing authorisation applications for mogamulizumab in CTCL in other countries.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About Mogamulizumab
Mogamulizumab is a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL. Mogamulizumab was produced using Kyowa Hakko Kirin’s proprietary POTELLIGENT platform, which is associated with enhanced antibody-dependent cellular cytotoxicity (ADCC).

About MAVORIC
MAVORIC is a Phase 3 open-label, multi-centre, randomised study of mogamulizumab versus active comparator in patients with mycosis fungoides (MF) and Sézary syndrome (SS) who have failed at least one prior systemic treatment. The study was conducted in the US, Europe, Japan and Australia, and randomised 372 patients.

About CTCL (Cutaneous T-cell Lymphoma)
CTCL is a rare type of non-Hodgkin’s T-cell lymphoma. The two most common types of CTCL are MF and SS, and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera. In advanced stage CTCL is associated with significant morbidity and mortality.