On October 27, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that it will host a conference call on Thursday, November 2, 2017 at 2:00 p.m. Eastern Time to discuss corporate updates and financial results for the third quarter ended September 30, 2017 (Press release, Sunesis, OCT 27, 2017, View Source [SID1234521247]).

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The call can be accessed by dialing (844) 269-7720 (U.S. and Canada) or (574) 990-1148 (international), and entering passcode 1071001.

To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at View Source The webcast will be recorded and available for replay on the company’s website for two weeks.

On October 27, 2017 Sandoz, a Novartis Division, and the global leader in biosimilars, reported that its biosimilar to EU-authorized Neulasta* (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review (Press release, Novartis, OCT 27, 2017, View Source [SID1234521227]).

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Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine.

"Our goal is to improve patient access to important biologic medicines and the EMA file acceptance of our biosimilar pegfilgrastim is a move towards doing just that," said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals.

"At Sandoz, oncology is a key area of focus and, with our biosimilar and generic oncology medicines, we have a leading portfolio in this therapy area. If approved, we look forward to supporting cancer patients, healthcare professionals and payors with our biosimilar pegfilgrastim."

The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.

The clinical development program for Sandoz biosimilar pegfilgrastim includes data from Phase I pharmacokinetic and pharmacodynamic studies in healthy volunteers, as well as Phase III confirmatory safety and efficacy studies in breast cancer patients.

Sandoz is committed to increasing patient access to high-quality biosimilars. As the global leader in biosimilars, Sandoz has five biosimilars marketed worldwide, as well as a leading global pipeline. We currently have three proposed biosimilars under review by the EMA: pegfilgrastim, adalimumab and infliximab.

Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

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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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.

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.