On September 27, 2016 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that safety and preliminary efficacy phase 1 data evaluating DS-8201a, a novel HER2-targeting antibody drug conjugate, will be presented during a late-breaking poster discussion session during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress from October 7 -11 in Copenhagen, Denmark (Press release, Daiichi Sankyo, SEP 27, 2016, View Source [SID:SID1234515463]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are looking forward to presenting these results for DS-8201a to the scientific community at ESMO (Free ESMO Whitepaper)," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Additionally, for the first time we will be showcasing our innovative in-house antibody drug conjugate technology that was used to develop DS-8201a."

LBA17: Single Agent Activity of DS-8201a, a HER2-Targeting Antibody-Drug Conjugate, in Breast Cancer Patients Previously Treated with T-DM1: Phase 1 Dose Escalation
Results from part 1 (dose escalation) of a two-part phase 1 study of DS-8201a by Kenji Tamura, MD, PhD, Chairman, Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo will be presented on Sunday, October 9 at 4:30 pm CEST. The primary objective of the dose escalation part of the study was to examine the safety and tolerability of DS-8201a along with determining the maximum tolerated dose. Secondary objectives include evaluating the pharmacokinetics and efficacy of DS-8201a. Additional sub-group analyses of preliminary efficacy of DS-8201a in advanced or metastatic breast cancer patients previously treated with ado-trastuzumab emtansine (T-DM1) will be presented.

About DS-8201a
DS-8201a is an investigational antibody drug conjugate comprised of a humanized anti-HER2 antibody attached by a peptide linker to a novel topoisomerase I inhibitor, utilizing Daiichi Sankyo’s proprietary payload and linker-payload technology. It is currently in phase 1 clinical development for HER2 expressing advanced or metastatic breast cancer or gastric cancer and other HER2 expressing solid cancers.

The second part (dose expansion) of the phase 1 clinical trial evaluating the safety and efficacy of DS-8201a is currently underway, and will enroll patients in the United States and Japan into one of four treatment cohorts: patients with HER2+ breast cancer previously treated with T-DM1; patients with HER2+ gastric or gastroesphageal junction adenocarcinoma previously treated with trastuzumab; patients with HER2-low expressing breast cancer; and, patients with other solid cancers that express HER2. For more information about the study visit ClinicalTrials.gov.

On September 28, 2016 Zymeworks Inc., a clinical-stage biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics including bi-specific antibodies and drug conjugates for the treatment of cancer, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that they have entered into a cross-licensing and collaboration agreement to develop proprietary cancer immuno-oncology products (Press release, Daiichi Sankyo, SEP 28, 2016, View Source [SID:SID1234515462]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Daiichi Sankyo will acquire a license to Zymeworks’ Azymetric and Effector Function Enhancement and Control Technology (EFECT) platforms to develop a bi-specific antibody therapeutic, for which Zymeworks will receive an upfront technology access fee and research support. Zymeworks will also be eligible to receive payments upon the achievement of preclinical, clinical and commercial milestones, as well as up to double-digit tiered royalties on global product sales.

Additionally, Zymeworks will license immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop and commercialize multiple bi-specific products globally in exchange for royalties on product sales. Further financial details are not disclosed.

"We are very excited to enter into this cross-licensing agreement with Daiichi Sankyo," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "The in-licensing component of the transaction will enable Zymeworks to expand its therapeutic pipeline in the near term by accelerating a number of our immuno-oncology programs into the clinic and to ultimately provide more effective and targeted treatments to patients. Additionally, we believe that the licensing of Zymeworks’ platforms to Daiichi Sankyo further demonstrates the potential of the Azymetric and EFECT technologies for the discovery and development of next-generation multi-functional biologics."

"Targeting two drivers of disease with a single monoclonal antibody is a key scientific advance that may help change the standard of care for patients with cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We are looking forward to strengthening our expertise in bi-specific immuno-oncology by working closely with Zymeworks on this collaboration."

About the Azymetric Platform
Bi-specific antibodies developed using the Azymetric platform resemble conventional mono-specific antibodies while being able to simultaneously bind to two different targets resulting in additive or synergistic therapeutic responses. Azymetric antibodies spontaneously assemble into a single molecule with two different Fab domains comprising of unique heavy and light chain pairings. Azymetric antibodies are manufactured using conventional monoclonal antibody processes and can be easily adapted to rapidly screen target and sequence combinations for bi-specific activity in the final therapeutic format, thereby significantly reducing drug development timelines.

About the EFECT Platform
The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up and down-regulation of effector functions. This platform is compatible with traditional monoclonal and well as Azymetric bi-specific antibodies to further enable the customization of therapeutic responses for different diseases.

On September 27, 2016 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking and increase the ability for T-cells to track and destroy cancer, reported dosing of the first patient in its Phase 1b study of X4P-001 in patients with resectable Stage III and Stage IV melanoma (Press release, X4 Pharmaceuticals, SEP 27, 2016, View Source [SID:SID1234515440]). X4P-001 is the Company’s lead CXCR4 inhibitor drug candidate, and is also in clinical development for clear cell renal cell carcinoma (ccRCC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

This Phase 1b multi-center study in patients with resectable Stage III and Stage IV melanoma will evaluate the safety and tolerability of X4P-001 alone and in combination with the immuno-oncology therapy Keytruda (pembrolizumab), an approved PD-1 inhibitor for patients with advanced melanoma and certain other cancers. In addition, the study will include analyses of participants’ tumor biopsies to assess changes in the tumor microenvironment. Preliminary results from the study are expected in 2017.

"Immuno-oncology therapies have been a breakthrough for some melanoma patients. However, not all patients respond to the existing immuno-oncology approaches, and we believe that characteristics of the tumor microenvironment may be an important factor in response to treatment," said Robert Andtbacka, MD, a surgeon and investigator with the Huntsman Cancer Institute of the University of Utah, associate professor in the Division of Surgical Oncology at the University of Utah School of Medicine, and Principle Investigator of the X4P-001 study in melanoma. "This study will allow us to evaluate how inhibition of CXCR4 may alter the landscape of the microenvironment providing insights into improving immune surveillance and tumor response in melanoma."

"We are excited to be working with leading researchers in melanoma and immuno-oncology, led by Dr. Andtbacka, to undertake this innovative protocol to study changes in the tumor microenvironment with administration of X4P-001 and its potential benefit to patients with advanced melanoma," said Paula Ragan, PhD, President and CEO of X4. "Results from this study will allow us to assess the utility of X4P-001 alone and in combination with checkpoint modulators, opening the possibility to study X4P-001 in additional tumor types. X4 aims to further understand the mechanism and activity of X4P-001 in the hopes of advancing new therapies that substantially increase durable long term responses and overall survival in melanoma and other advanced cancers."

About X4P-001
X4P-001 is an oral, small molecule inhibitor of CXCR4, or C-X-C receptor type 4, the receptor for the chemokine CXCL12 (also known as stromal derived factor-1, or SDF-1). Recent studies demonstrate that CXCR4/CXCL12 is a primary receptor-ligand pair that cancer cells and surrounding stromal cells express and use to block normal immune function and promote angiogenesis through the trafficking of T-effector and T-regulatory cells, as well as myeloid derived suppressor cells (MDSCs), in the tumor microenvironment.1, 2 Pre-clinical studies have demonstrated X4P-001 activity alone and in combination with approved cancer therapies resulted in an increased tumor-specific immune response and significant inhibition of tumor growth. X4P-001 has been tested in over 70 subjects in four clinical trials in healthy volunteers and HIV-infected patients to date and was shown to be well tolerated.

About Melanoma
Cutaneous malignant melanoma is the fifth most common cancer in men and the sixth most common cancer in women in the United States. When discovered early, melanoma is highly curable with 10-year overall survival rates approaching 95% for stage I melanoma and 45-77% for stage II melanoma3. However, patients with stage III and IV melanoma, the prognosis is much worse. The 10-year survival rate for stage IV melanoma is 10-15%4. Adjuvant therapies for patients with resectable stage III melanoma include immunomodulating drugs, such as high dose interferon-α therapy and anti-CTLA-4 antibody therapy. Unmet needs remain to establish and improve overall survival in patients with advanced resectable melanoma, as well as improving objective response rates in patients who do not respond to existing treatments.

On September 27, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that the Company has initiated a Phase 2 clinical trial of Actimab-A in patients newly diagnosed with Acute Myeloid Leukemia (AML) who are over the age of 60 (Press release, Actinium Pharmaceuticals, SEP 27, 2016, View Source [SID:SID1234515434]). Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) program consists of the CD33 targeting monoclonal antibody, HuM195, and the alpha-emitting radioisotope, actinium-225.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited to have initiated the Phase 2 trial of Actimab-A for elderly patients who are newly diagnosed with AML and ineligible for 7+3 treatment. These older patients face a poor prognosis and have limited viable treatment options" said Sandesh Seth, Actinium’s Executive Chairman. "We are encouraged by the safety and efficacy signals we have seen thus far and look forward to the execution of this trial with an eye toward interim and top-line results which are both expected in 2017."

This Phase 2 clinical trial is a multicenter, open-label study that will enroll 53 patients. Patients will receive 2.0 µCi/kg/fractionated dose of Actimab-A via two injections given at day 1 and day 7. The Phase 2 trial is designed to evaluate complete response rates at up to day 42 after Actimab-A administration, where complete response is defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRp). A formal interim analysis is expected to occur in mid-2017 with topline results expected in the second half of 2017. The Phase 2 trial will include peripheral blast burden as an inclusion criteria and in patients with high peripheral blast (PB) burden, the use of Hydroxyurea will be mandated with the goal of bringing PB burden below a key threshold number that the Company has identified from two previously complete Phase 1 clinical trials totaling 38 patients. In addition, the use of granulocyte colony-stimulating factors (GCSF) will be mandated. Low dose cytarabine has been eliminated from the protocol and the Phase 2 clinical trial will evaluate Actimab-A as a monotherapy. The secondary endpoint of the Phase 2 trial will be overall survival.

Dr. Joseph Jurcic, Principal Investigator of the Actimab-A Phase 2 trial and Director of Hematologic Malignancies; Professor of Medicine at Columbia University Medical Center said, "Actimab-A has been studied in two clinical trials thus far in patients with AML ranging in age from 18-87 who had a wide array of genetic risk factors that were at various stages of disease progression. Actimab-A has shown a promising safety and efficacy profile thus far that we believe differentiates Actimab-A from other CD33 targeting drug candidate, which is an exciting space in AML. Our PB burden hypothesis indicates that of all factors related to AML including age, stage of disease and genetic factors, peripheral blast burden showed to be the most relevant. With PB burden serving as an inclusion criteria in this Phase 2 trial and the use of Hydroxyurea being mandated in patients with PB burden above a key threshold we look forward to conducting this clinical trial in this older patient population that has a great unmet medical need."

The Company will host a webinar Tuesday, September 27, 2016 at 9:00 AM ET to discuss the Phase 2 clinical trial. Details for the webinar are as follows:

Date: Tuesday, September 27, 2016
Time: 9:00 AM ET
Webinar Link: View Source
Speakers: Joseph Jurcic, M.D., Director of Hematologic Malignancies; Professor of Medicine at Columbia University Medical Center. Actimab-A Principal Investigator
Sandesh Seth, Executive Chairman, Actinium Pharmaceuticals
Dragan Cicic, M.D., Chief Medical Officer, Actinium Pharmaceuticals

About Actimab-A

Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) program, is in a multicenter, open-label, Phase 2 clinical trial for patients newly diagnosed with Acute Myeloid Leukemia (AML) over the age of 60. Actimab-A is being developed as a first-line therapy and it has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile. Actimab-A consists of the monoclonal antibody, HuM195, and the radioisotope, actinium-225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. HuM195 is the humanized version of M195 and is a monoclonal antibody that targets CD33, which is abundantly found on myeloid leukemia cells. Both the alpha particle technology and HuM195 were initially developed at Memorial Sloan Kettering Cancer Center. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which has now been studied in almost 90 patients in four clinical trials.

On September 27, 2016 Incyte Corporation (Nasdaq: INCY) reported that its first-in-class JAK1/JAK2 inhibitor, Jakafi (ruxolitinib), has been included as a recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for myelofibrosis (MF) (Press release, Incyte, SEP 27, 2016, View Source [SID:SID1234515428]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Jakafi is the first FDA-approved treatment for patients with intermediate or high-risk MF, representing an important advancement for patients," said Peg Squier, M.D., Ph.D., Incyte’s Head of U.S. Medical Affairs. "We are pleased that Jakafi has been recommended in the first set of NCCN treatment guidelines for MPNs, which will help inform healthcare providers’ treatment decisions for patients with MF. We believe that this underscores the important and long-term clinical benefits seen in patients treated with Jakafi."

MF is part of a group of related rare blood cancers known as myeloproliferative neoplasms (MPNs). In MF, a patient’s bone marrow can no longer produce enough normal blood cells, causing the spleen and or liver to become enlarged.1 MF is a progressive disease, which leads to bone marrow scarring and significant debilitating disease-related symptoms such as anemia, fatigue, and itching which can result in a poor quality of life.2 Patients with MF have a decreased life expectancy, with an average survival of approximately five to six years.3 The cause of MF is unknown but is linked to genetic mutations—between 50% and 60% of people with MF have a specific mutation of the Janus Kinase 2 gene (JAK2).4
The new NCCN Guidelines are available online at www.nccn.org.

About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is also indicated for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

About National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.