Author: [email protected]

Loxo Oncology to Present Updated LOXO-101 Adult Phase 1 Data at the European Society for Medical Oncology (ESMO) Asia Congress

On December 12, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the abstract titled "Clinical safety and activity from a phase 1 study of LOXO-101, a selective TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions" has been accepted for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress, taking place December 16-19, 2016 in Singapore (Press release, Loxo Oncology, DEC 12, 2016, View Source [SID1234517040]). Data from this trial were last presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2016. The presentation will include an efficacy and durability update for enrolled patients with TRK fusions.

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The schedule for the presentation is as follows:

Presentation Session Date & Time: December 18, 2016, 4:30 p.m. to 6:00 p.m. SGT
Title: Clinical safety and activity from a phase 1 study of LOXO-101, a selective
TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions
Abstract Number: 150O
Session: Developmental Therapeutics, Proffered Paper Session (oral presentation)
Presenter: Todd Bauer, M.D., Associate Director, Drug Development; Principal Investigator, Sarah Cannon Research Institute

INTERIM ANALYSIS OF PHASE Ib/II STUDY OF ERIBULIN AND PEMBROLIZUMAB COMBINATION REGIMEN IN METASTATIC TRIPLE NEGATIVE BREAST CANCER PRESENTED AT SAN ANTONIO BREAST CANCER SYMPOSIUM

On December 12, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the results of an interim analysis of a global Phase Ib/II clinical study (Study 218) of its in-house discovered and developed anticancer agent eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven, "eribulin") in combination with the anti-PD-1 antibody pembrolizumab developed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada), in patients with metastatic triple-negative breast cancer have been presented at the 39th Annual San Antonio Breast Cancer Symposium held from December 6 to 10, 2016 (Press release, Eisai, DEC 12, 2016, View Source [SID1234517039]). Development of this combination regimen is being conducted jointly under the cooperation of both companies.

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Study 218 is a Phase Ib/II clinical study which examined the activity and safety of eribulin in combination with pembrolizumab in 95 patients with metastatic triple-negative breast cancer previously treated with 0 – 2 lines of chemotherapy in the metastatic setting. The primary objective of the Phase Ib part was safety and tolerability, and the primary objective of the Phase II part was objective response rate (ORR).

This presentation reported on the results of an interim analysis of 39 evaluable patients out of the 89 patients enrolled in the study as of July 2016. Eribulin (1.4 mg/m2 intravenously on Day 1 and Day 8) and pembrolizumab (200 mg intravenously on Day 1) were administered to patients over 21 day cycles. From the results of the study, ORR was 33.3% (1 patient experienced a complete response and 12 patients experienced a partial response). In addition, the ORR was similar between PD-L1 positive and negative cohorts.

In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 35%) in patients treated with the combination regimen were fatigue, nausea, peripheral neuropathy, neutropenia and alopecia, with Grade 3 or higher Treatment-Emergent Adverse Events (TEAEs) observed in 66.7% of patients. The most common Grade 3 or higher TEAEs (incidence greater than or equal to 7%) observed were neutropenia (30.8%) and fatigue (7.7%).

Eribulin is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. Recent non-clinical studies showed that eribulin is associated with increased vascular perfusion and permeability in tumor cores.1 Eribulin promotes the epithelial state and decreases the capacity of breast cancer cells to migrate and invade.2 It was first approved for use in the treatment of metastatic breast cancer in the United States in November 2010, and is currently approved for use in the treatment of patients with breast cancer in over 60 countries including Japan and countries in Europe, the Americas and Asia.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. As exemplified by this combination regimen, Eisai remains committed to providing further clinical evidence for eribulin aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

*Please refer to the following notes for the approved indications in the United States, Japan and Europe

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

< Notes to editors >

1. About eribulin mesylate (product name: Halaven, "eribulin")
Eribulin is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, recent non-clinical studies showed that eribulin is associated with increased vascular perfusion and permeability in tumor cores.1 Eribulin promotes the epithelial state and decreases the capacity of breast cancer cells to migrate and invade.2

Eribulin was first approved for use in the treatment of metastatic breast cancer in the United States in November 2010. Eribulin is currently approved for use in the treatment of breast cancer in over 60 countries worldwide, including Japan and countries in Europe, the Americas and Asia.
Furthermore, eribulin was first approved as a treatment for liposarcoma in the United States in January 2016, and is also approved for liposarcoma in countries in Europe and soft tissue sarcoma in Japan.

Specifically, eribulin is approved for the following indications.
In the United States for the treatment of patients with:
Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
In Japan for the treatment of patients with:
Inoperable or recurrent breast cancer
Soft tissue sarcoma
In Europe for the treatment of adult patients with:
Locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
2. About the Phase Ib/II Study (Study 218)
Study 218 is a multicenter, single-arm, open-label Phase 1b/II clinical study which examined the activity and safety of eribulin in combination with pembrolizumab in 95 patients (12 patients for the Phase Ib part, 83 patients for the Phase II part) with metastatic triple-negative breast cancer previously treated with 0-2 lines of chemotherapy in the metastatic setting. Eribulin (1.4 mg/m2 intravenously on Day 1 and Day 8) and pembrolizumab (200 mg intravenously on Day 1) were administered to patients over 21 day cycles. The primary objective of the Phase Ib part was safety and tolerability, and the primary objective of the Phase II part was ORR. Progression-free survival was assessed as a secondary objective.

In this interim analysis of 39 patients, 22 patients were previously treated with 1 to 2 lines of chemotherapy in the metastatic setting. The ORR was similar between PD-L1 positive (17 patients, ORR 29.4%) and negative (18 patients, ORR 33.3%) cohorts and it was 50% for PD-L1 unknown cohorts. Pembrolizumab alone demonstrated the tendency to increase the antitumor activity with PD-L1 positive in triple-negative breast cancer patients (KEYNOTE-012 study)3
In this study, eribulin in combination with pembrolizumab is expected to show similar antitumor activity regardless of PD-L1 status.

3. About triple-negative breast cancer
Triple-negative breast cancer is a type of breast cancer where the cancer cells tested negative for expression of estrogen receptors, progesterone receptors and HER-2 receptors. Since the tumor cells lack the necessary receptors, common treatments like hormone therapy and drugs that target HER-2 are ineffective. This remains a disease with significant unmet medical need. Therefore, the development of new medicines is necessary to advance the treatment of triple-negative breast cancer.

4. About non-clinical research related to the mechanism of action for eribulin in combination with pembrolizumab
Eribulin contributes to maintaining or increasing the activity of cytotoxic T lymphocytes (CTLs), which play a leading role in attacking cancer cells, via reduction of immune suppressive Treg cells and M2 tumor macrophages4. The anti-PD-1 antibody pembrolizumab maintains or activates CTLs via its immune-checkpoint blockade. Eribulin in combination with pembrolizumab is expected to work synergistically in cancer immunotherapy.

Pioneers in Oncolytic Virus and Gene Therapy Fields Announce Formation of IGNITE Immunotherapy Inc., a Company Focused on Oncolytic Cancer Vaccine Discovery and Development

On December 12, 2016 IGNITE Immunotherapy Inc. (IGNITE), a new company focused on oncolytic virus vaccine design, discovery and development reported its formation (Press release, IGNITE Immunotherapy, DEC 12, 2016, View Source [SID1234518751]).

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Along with strategic collaborative partner and lead investor Pfizer Inc. (NYSE: PFE), IGNITE will focus on the discovery and development of targeted and proprietary next-generation intravenous oncolytic (cancer cell lysing) virus vaccines for the immunotherapy of cancer. These biotherapeutics may be optimized for use in combination with immune checkpoint inhibitors. IGNITE is developing a robust and proprietary vector discovery platform, Oncolytic Vaccine Evolution, to potentially discover novel vectors for use in its lytic cancer vaccine products.

Key terms of the agreement with Pfizer include Pfizer holding a 50 percent equity investment in IGNITE, Pfizer providing full research and development funding for three years, and Pfizer having an exclusive option to acquire IGNITE after the initial research program is completed. Pfizer also has two seats on IGNITE’s board of directors. Financial terms were not disclosed.

"We are excited to announce the formation of IGNITE Immunotherapy, which we hope will emerge as a leader in the oncolytic virus cancer vaccine and immunotherapy fields. Our founding scientific team has deep expertise in the fields of oncolytic virus design and development, cancer immunotherapy, gene therapy and biotech entrepreneurship", said Dr. David Kirn, co-founder and Executive Chairman of IGNITE. "I’m thrilled and honored to be working with my co-Founders and internationally-recognized scientific leaders Dr. David Schaffer and Dr. Douglas Hanahan. Together with our collaborators at Pfizer, we have highly complimentary skill sets that will help enable our success in this complex and promising field. Our mission is to create intravenous oncolytic cancer vaccines that will be safe and highly effective in combination with immune checkpoint inhibitors, which we hope will ultimately cure patients with metastatic cancers."

"This partnership with IGNITE represents a significant advancement in Pfizer’s investment in oncolytic viruses, which we believe strengthens our position as a leader in next-generation immuno-oncology," said James Merson, Ph.D., Chief Scientific Officer, Vaccine Immunotherapeutics at Pfizer and a member of IGNITE’s scientific advisory board and board of directors. "Pfizer has a strong and growing portfolio of immuno-oncology assets, and we remain committed to developing unique cancer therapies and novel combination therapies that may benefit patients around the world.

About the Senior Scientific co-Founders and Board of IGNITE Immunotherapy Inc.

David Kirn, MD: co-Founder & Executive Chairman
Dr. Kirn is a physician-scientist, biotech entrepreneur and pioneer in oncolytic virus design, research and development with over 20 years in the field. IGNITE is his 4th start-up company in the field. He is also currently co-founder, Chairman and CEO of 4D Molecular Therapeutics, an AAV gene therapy company, and adjunct Professor of Bioengineering at UC Berkeley. Dr. Kirn has led the preclinical or clinical development of over 10 oncolytic virus therapeutics, including clinical trials involving over 800 patients in first-in-man through Phase 3 trials (including products from Onyx, Jennerex & Novartis/Cell Genesys). He has co-authored over 100 publications in the field. He has degrees from UC Berkeley (BA), UCSF (MD; Clinical Research & Biostatistics), and Haas Business School at UC Berkeley, and trained in internal medicine at Harvard (Brigham & Women’s Hospital) and in oncology at UCSF.

Dave Schaffer, PhD: co-Founder & SAB co-Chair
Dr. Schaffer is a leader in viral vector gene therapy and stem cell discovery, research and development. IGNITE is his 2nd start-up company in the field. At UC Berkeley, he is Professor of Chemical and Bioengineering, and Director of the Stem Cell Center. He is also currently co-founder & acting CSO of 4D Molecular Therapeutics, an AAV gene therapy company developing his directed vector evolution discovery platform. He has co-authored over 100 publications. He has degrees from Stanford (BS) and MIT (PhD), and his post-doctoral training was at The Salk Institute with Rusty Gage.

Doug Hanahan: co-Founder & SAB co-Chair
Dr. Hanahan is a leader in cancer research with over 25 years of experience in the fields of cancer biology, mouse tumor models, tumor resistance mechanisms and experimental therapeutics (including oncolytic viruses). IGNITE is his 3rd start-up company in the field (previous SAB member at Jennerex and Onyx). He is Director of the Swiss Institute for Cancer Research (ISREC), and Professor at EPFL (Lausanne, Switzerland); he previously was on the faculty at UCSF Medical School. He has co-authored over 100 publications, including the seminal Cell paper "The Hallmarks of Cancer" with Robert Weinberg (2000 and 2011). He serves on the cancer advisory board for Pfizer. He has degrees from MIT (BS) and Harvard (PhD), and post-doctoral training at Cold Spring Harbor.
Theresa Janke: co-Founder & Board member
Ms. Janke has over 15 years of clinical research and operations, alliance and program management, and business operations start-up experience in the biopharmaceutical industry, including work in immunotherapy, gene therapy and oncolytic virus therapy. She is currently SVP of Operations and Alliance/ Program Management at 4D Molecular Therapeutics.

James Merson: Board member
James Merson, Ph.D. is Senior Vice President and Chief Scientific Officer of the Vaccine Immunotherapeutics Research Unit at Pfizer. Prior to his current role, Dr. Merson was Chief Scientific Officer of Pfizer’s Vaccine Research Unit, Head of the Antivirals Therapeutic Area, and leader of Pfizer’s first efforts into immuno-gene therapy. Dr. Merson received his B.A. in Biology from Bellarmine College in Louisville, Kentucky, and his Ph.D. in Microbiology and Immunology from Baylor College of Medicine in Houston, Texas. He is a member of the British Society for Immunology, International Society of Vaccines, and is an adjunct professor at the Scripps Research Institute.

Bob Smith: Board member
Bob Smith is Pfizer’s Senior Vice President, Gene Therapy Business and Early Commercial Development, Rare Disease, for Pfizer’s Innovative Health Business. Prior to his current role, Bob was SVP of Business Development for Pfizer’s Worldwide Research and Development organization, and SVP of Global Business Development and Mergers & Acquisitions at Wyeth. Bob received his B.S. in Neuroscience from the University of Rochester, NY, and his M.B.A. in Finance and Corporate Accounting from the William E. Simon Graduate School of Business Administration at the University of Rochester, NY.

For more information on IGNITE and its product design and discovery efforts, please visit www.igniteimmunotherapy.com.

About IGNITE Immunotherapy Inc.
IGNITE is focused on the discovery and development of targeted oncolytic virus vaccines for the intravenous immunotherapy of cancer. IGNITE’s founding team, led by Drs. David Kirn (Executive Chairman), David Schaffer (SAB co-Chair) and Douglas Hanahan (SAB co-Chair), has deep expertise in oncolytic virus design and development, cancer immunotherapy, gene therapy vector discovery, experimental cancer therapeutics and biotech entrepreneurship. Our discovery platform, termed Oncolytic Vaccine Evolution, is designed to discover optimized gene and immunotherapy delivery vehicles to target cancer cells in diverse patient populations with common metastatic tumor types. These products may be designed for intravenous administration, antibody resistance, tumor-specificity and combination efficacy with immune checkpoint inhibitors.

About IGNITE’s Oncolytic Vaccine Evolution
Oncolytic virus cancer vaccines have demonstrated promising antitumoral activity and tolerability, and the oncolytic virus IMLYGIC (Amgen; talimogene laherperepvec) was approved by the US FDA in 2015 for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. While oncolytic viruses represent a promising new approach to cancer immunotherapy, hurdles to this approach still exist. First, IMLYGIC and many other clinical-stage agents require direct intratumoral injection, a method with significant disadvantages versus standard intravenous (IV) infusions that are used for blockbuster cancer biotherapeutics such as monoclonal antibodies (e.g. most patients with metastatic cancer have tumor metastases that are not directly injectable in the clinic). Second, if administered IV, many of these immunotherapeutic viruses are rapidly cleared by the immune system (e.g. by antibodies and/or complement). Finally, the number of immune-activating transgenes that can be expressed from the vector is limited by these viruses’ transgene-encoding capacities. Novel oncolytic vaccine vectors are needed for the IV delivery of diverse immunostimulatory transgenes to metastatic cancers.

IGNITE Immunotherapy is advancing the field of oncolytic cancer vaccines by taking advantage of evolution to help discover vectors that are designed to efficiently and selectively target cancer cells after IV administration. Our Oncolytic Vaccine Evolution platform empowers us to potentially discover and engineer optimized and proprietary oncolytic vectors for use in cancer immunotherapy. The resulting products may be evolved and designed for intravenous infusion, resistance to immune-mediated clearance (e.g. by antibodies, complement), tumor-specific replication and cell lysis, and immune-activating transgene expression.

MorphoSys Starts Phase 2 Trial of MOR208 in Combination with Idelalisib in Patients with Relapsed or Refractory CLL or SLL Previously Treated with a BTK Inhibitor

On December 13, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that the first patient was dosed in a Phase 2 combination trial of MOR208 with idelalisib (Zydelig) (Press release, MorphoSys, DEC 12, 2016, View Source [SID1234517058]). The trial, which has been named COSMOS (CLL patients assessed for ORR & Safety in MOR208 Study), is designed to evaluate the safety and efficacy of MOR208 in combination with the PI3K delta inhibitor idelalisib in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Patient enrolled must have been refractory or shown relapse or intolerance to a prior, most recent, therapy with a Bruton’s Tyrosine Kinase (BTK) inhibitor (e.g. ibrutinib). MOR208 is an investigational Fc-engineered monoclonal antibody targeting CD19 that is being developed for the treatment of patients with B cell malignancies. CLL is the most common type of leukemia in Western populations.

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"We are pleased to kick off the COSMOS trial. This is the third in a series of clinical studies we have initated this year investigating combination therapies with our CD19 antibody MOR208 in hemato-oncological indications", commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "There is a particularly high medical need for chronic lymphocytic leukemia (CLL) patients, especially following discontinuation of a BTK inhibitor therapy. We look forward to exploring the potential of MOR208 in this indication in combination with idelalisib. In addition, we are also planning to investigate MOR208 with a second combination partner in this patient population and will provide more details soon."

The single-arm, open-label, multicenter COSMOS study will enroll patients in Europe and in the USA. Patients will receive intravenous infusions of MOR208 for up to 24 cycles of 28 days each. Idelalisib is taken orally, 150 mg twice-daily for the study duration. The study will include a safety run-in phase consisting of a safety evaluation by an independent data monitoring committee (IDMC).

The study’s primary endpoint is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include progression-free survival (PFS), overall survival (OS) and duration of response (DoR), as well as an evaluation of the drug combination’s safety and pharmacokinetic parameters of MOR208.

Detailed information on the trial can be found on clinicaltrials.gov.

About CD19
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 enhances B cell receptor (BCR) signaling, which is important for B cell survival, making CD19 a potential target in B cell malignancies.

About MOR208
MOR208 (previously Xmab5574) is an Fc-engineered ("Fc-enhanced") monoclonal antibody targeting CD19. Fc-modification of MOR208 is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus possibly improving a key mechanism of tumor cell killing. Furthermore, MOR208 induces direct apoptosis by binding to CD19, which is a crucial component for B cell receptor (BCR) signaling.
MorphoSys is currently investigating MOR208 as an immunotherapeutic treatment option in several phase 2 combination studies in patients with B cell malignancies. A phase 2 study namend L-MIND (Lenalidomide-MOR208 IN DLBCL) is investigating the safety and efficacy of MOR208 in combination with lenalidomide in patients with relapsed or refractory DLBCL. A phase 2/3 study named B-MIND (Bendamustine-MOR208 IN DLBCL) is evaluating the safety and efficacy of MOR208 in combination with the chemotherapeutic agent bendamustine in comparison to rituximab plus bendamustine in patients with relapsed or refractory DLBCL. The B-MIND trial, which is currently in the safety part, is planned to be transitioned into a pivotal phase 3 part in 2017. A third trial namend COSMOS (CLL patients assessed for ORR & Safety in MOR208 Study) is investigating safety and efficacy of MOR208 together with idelalisib in patients with relapsed or refractory CLL or SLL after discontinuation of BTK inhibitor therapy.

Daiichi Sankyo and DarwinHealth Announce Strategic Partnership to Deploy a Quantitative Systems Biology Discovery Platform to Prioritize Daiichi Sankyo Cancer Enterprise Compounds for Development

On December 12, 2016 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and DarwinHealth reported a strategic partnership to use quantitative systems biology-based algorithms and novel, validated approaches focused on tumor checkpoints — a new class of cancer targets — to help prioritize investigational compounds in the Daiichi Sankyo Cancer Enterprise pipeline for clinical development (Press release, Daiichi Sankyo, DEC 12, 2016, View Source [SID1234517057]).

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Utilizing DarwinHealth’s proprietary, oncotecture-based technology, the vast majority of investigational compounds in the Daiichi Sankyo Cancer Enterprise portfolio will be evaluated and compared against an extensive repository of patient-derived tumor samples to measure their efficacy in disrupting the master regulator proteins that represent the most critical vulnerabilities of each specific tumor. These studies will provide a comprehensive readout of each compound’s potential clinical value, including its genome-wide mechanism of action, its tumor-specific biomarkers of sensitivity and resistance, and its ability to synergize with other drugs for combination therapy applications. Through quantitative modeling, the developmental trajectory of each potential treatment will be predicted to help Daiichi Sankyo design more effective, successful and focused clinical studies to leverage key opportunities that are currently being missed or may not be identified using traditional methodologies.

"As we begin to see quantitative science revolutionize the approach to clinical development, we are very excited about entering into this partnership with DarwinHealth," said Igor Matushansky, MD, PhD, Global Head Oncology Translational Development, Daiichi Sankyo. "These insights will help us to focus on compounds with a higher likelihood of success to ultimately ensure the best treatment options are reaching patients with cancer sooner."

"Genetics has been the basis of the development of precision medicine, but even more targeted and integrative approaches are now needed to deal with the complexity of cancer," explained Dr. Andrea Califano, Clyde and Helen Wu Professor and Chair of Systems Biology at Columbia University and co-founder of DarwinHealth. "The evolution of cancer research has expanded our universe from gene mutations to the ultimate effects these genomic alterations have on protein activity. Virtual, computation-based methods have finally achieved the accuracy necessary to systematically detect aberrantly activated proteins representing the master regulators of a cancer cell. We have created sophisticated tools, such as the VIPER algorithm, to identify tightly-knit modules of master regulator proteins – which we call tumor checkpoints – that represent a new class of actionable therapeutic targets in cancer."