On October 27, 2017 Kura Oncology, Inc. (Nasdaq:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported presented updated preliminary results from its Phase 2 open-label trial of tipifarnib, a farnesyltransferase inhibitor, in patients with head and neck squamous cell carcinomas (HNSCC) with HRAS mutations (Press release, Kura Oncology, OCT 27, 2017, View Source [SID1234521243]).

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The results were featured in a late-breaking, oral presentation by Dr. Alan Ho of Memorial Sloan Kettering Cancer Center at the Spotlight on Proffered Papers Session 1 at the 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), taking place today in Philadelphia.

Four out of six evaluable HRAS mutant HNSCC patients enrolled in the study achieved a confirmed partial response, as defined by standard RECIST criteria. In addition, as of the data cutoff date of October 4, 2017, four HRAS mutant HNSCC patients remained on study in cycles 21, 7, 5 and 3. The patients in cycles 21, 7 and 5 had all experienced partial responses while the patient in cycle 3 experienced stable disease as of the first response assessment in cycle 2. One HRAS mutant HNSCC patient with a confirmed partial response remained on study through cycle 20 and withdrew in cycle 21 with progressive disease. Another HRAS mutant HNSCC patient experienced a best response assessment of stable disease and withdrew from the study in cycle 8.

Tipifarnib has demonstrated clinical activity in previously treated patients, including those who have progressed on chemotherapy with or without cetuximab or immune therapy. The majority of adverse events reported by the investigators have been mild to moderate and are consistent with the adverse event profile previously reported for tipifarnib.

“The responses, durability and safety data with tipifarnib clearly suggest this is an important drug candidate for patients with HRAS mutant head and neck cancers,” said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and presenter of the tipifarnib oral presentation. “We are excited to continue to follow these patients and treat additional HRAS mutant patients in the ongoing Phase 2 trial.”

“The consistent clinical activity of tipifarnib in HNSCC patients with HRAS mutations is very encouraging,” said Antonio Gualberto, M.D., Ph.D., chief medical officer of Kura Oncology. “Based on these positive results, we continue to explore available options to rapidly advance the development of tipifarnib and subject to input from regulatory authorities, we plan to initiate a registration-enabling study in HRAS mutant HNSCC in 2018.”

About HRAS Mutant HNSCC

Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, with squamous cell carcinomas accounting for most head and neck cancers. Response rates for the three agents approved for treatment of HNSCC in the second line, including cetuximab and immune therapy agents, are in the range of 13-16%, and median overall survival is up to 7.5 months. HRAS is a proto-oncogene that has been implicated in the development and progression of HNSCC and has been established to be uniquely farnesylated.

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.

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 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 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.