On June 03, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its entire senior management team will attend the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 52nd annual meeting to be held June 3-7, 2016, at McCormick Place in Chicago (Press release, PharmaCyte Biotech, JUN 3, 2016, View Source [SID:1234512978]). The theme of this year’s meeting is "Collective Wisdom – The Future of Patient Centered Care and Research."

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Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, stated, "This year’s ASCO (Free ASCO Whitepaper) annual meeting will be invaluable as we head into the final preparations for our Phase 2b clinical trial in advanced pancreatic cancer. During ASCO (Free ASCO Whitepaper) we will host a medical and scientific discussion of our therapy for advanced pancreatic cancer among top oncologist investigators who have expressed interest in PharmaCyte’s technology and participation in our clinical trial. Joining me will be Dr. Gerald W. Crabtree, Dr. Matthias Löhr, Dr. Manuel Hidalgo, Prof. Dr. Walter H. Günzburg, Dr. Brian Salmons and Dr. Sanjay Batra. Presentations will be made by our Chief Scientific Officer, Dr. Günzburg, and Dr. Salmons – the co-developers of our Cell-in-a-Box live cell encapsulation technology. Presentations will also be made by Dr. Löhr and Dr. Hidalgo. Dr. Löhr is the Chairman of our Medical and Scientific Advisory Board (Board) and was the Principal Investigator of the two earlier clinical trials where our technology was found to be safe and effective in treating advanced pancreatic cancer. Dr. Hidalgo is a member of the Board and one of the principal architects of the design of our clinical trial."

ASCO is one of the largest organizations in the world devoted to the advancement of treatments for all types of cancer, and its annual meeting is the one of the largest educational and scientific meetings in the world. Over 32,000 individuals from around the globe have registered for this year’s meeting with over 50% of these from outside the United States. More than 26,000 of the total number of registrants are oncology professionals. Approximately 6,000 abstracts of presentations have been submitted for consideration by ASCO (Free ASCO Whitepaper). At this meeting, reports of studies on all types of cancer will be presented. For PharmaCyte, presentations on advanced pancreatic cancer and clinical trials will be of paramount importance.

In addition to scientists and clinicians, representatives from large and small pharmaceutical and biotech companies and Contract Research Organizations, all with an interest in cancer, will be in attendance. ASCO (Free ASCO Whitepaper)’s annual meeting provides representatives from all areas of the cancer spectrum the opportunity to interact and offers an unparalleled opportunity for the free exchange of information among meeting attendees.

On June 3, 2016 Eli Lilly and Company (NYSE: LLY) reported results from the MONARCH 1 Phase 2 study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (Press release, Eli Lilly, JUN 3, 2016, View Source [SID:1234512996]). The data, which were presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by Maura Dickler, M.D., of Memorial Sloan Kettering Cancer Center, showed that single-agent activity was observed in metastatic breast cancer patients, for whom endocrine therapy was no longer a suitable treatment option. The MONARCH 1 results (abstract #510) confirmed objective response (ORR), durability of response (DoR), clinical benefit rate (CBR) and progression-free survival (PFS).

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The single-arm study, designed to evaluate the safety and efficacy of abemaciclib monotherapy, enrolled 132 patients who were given 200 mg of abemaciclib orally every 12 hours until disease progression. Patients enrolled in the study were heavily pretreated, having experienced progressive disease on or after prior endocrine therapy, and had received prior chemotherapy with one or two chemotherapy regimens for metastatic disease. The primary objective of the trial was investigator-assessed ORR, with secondary endpoints of DoR, CBR and PFS.

"After endocrine therapies are no longer considered appropriate for HR+ metastatic breast cancer patients, when the disease is refractory or aggressive, chemotherapy is the only option. The side effects can be distressing and may be long lasting, limiting the options for patients," said José Baselga, M.D., Ph.D., physician-in-chief and chief medical officer, Memorial Sloan Kettering Cancer Center, and senior study author. "To see this level of anti-tumor activity, combined with the toxicity profile observed in MONARCH 1, is compelling."

At the final analysis of response (minimum of 12 months follow-up), patients treated with abemaciclib achieved an ORR of 19.7 percent (95% confidence interval (CI): 13.3 – 27.5%), with a median time to response of 3.7 months and a median DoR of 8.6 months. The median PFS was six months with a CBR (defined as patients who achieved complete response, partial response or stable disease for six months or longer) of 42.4 percent. Of the 13 patients who remained on treatment at the time of this analysis, nine were responders and four had stable disease (SD).

"In this population of heavily pretreated patients with a particularly poor prognosis, abemaciclib has shown promising single agent activity and tolerability," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "These data reinforce our belief in abemaciclib as a potential best-in-class CDK 4 and CDK 6 inhibitor and add to the growing body of evidence that sustained target inhibition can lead to improved patient outcomes."

The safety and toxicity profile of twice daily, continuously dosed abemaciclib was consistent with previous Phase 1 experience. The most common grade 3 non-laboratory treatment emergent adverse events (AEs) were diarrhea (19.7%) and fatigue (12.9%), with no grade 4 non-laboratory events reported. The most common laboratory AEs were neutropenia (22.3% grade 3, 4.6% grade 4) and leukopenia (27.4% grade 3) in this population; 7.6 percent of patients discontinued treatment due to AEs, one due to diarrhea.

Beyond MONARCH 1, Lilly has an active clinical development program studying abemaciclib in breast cancer. Abemaciclib is being evaluated in two Phase 3 clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant for treatment of HR+, HER2- advanced or metastatic breast cancer in postmenopausal women, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in HR+, HER2- locoregionally recurrent or metastatic breast cancer in postmenopausal women.

Lilly plans to publish further data from the MONARCH 1 trial later this year.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.1 In the U.S. this year, approximately 246,660 new cases of invasive breast cancer will be diagnosed and about 40,450 people will die from breast cancer.2 Of all early stage breast cancer cases diagnosed in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body. In addition, an estimated six to 10 percent of all new breast cancer cases are initially diagnosed as being stage IV, or metastatic.3 Metastatic breast cancer is considered incurable, but is generally treatable.

About Abemaciclib
Abemaciclib (LY2835219) is an investigational, oral cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting cyclin-dependent kinases, CDK 4 and CDK 6. In many cancers, uncontrolled cell growth arises from a loss of cell cycle regulation due to increased signaling from CDK 4 and CDK 6. Abemaciclib inhibits both CDK 4 and CDK 6, and was shown in cell-free enzymatic assays to be most active against Cyclin D 1 and CDK 4.

In 2015, the U.S. Food and Drug Administration granted abemaciclib Breakthrough Therapy Designation based on data from the breast cancer cohort expansion of the company’s Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. In addition to its current MONARCH clinical trials evaluating abemaciclib in breast cancer, a Phase 3 trial of abemaciclib in lung cancer is also underway.

On June 2, 2016 Argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, reported data published in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA) presenting efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors (Press release, arGEN-X, JUN 2, 2016, View Source [SID:1234512983]). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity. The abstract can be accessed here.

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In addition, data from preclinical studies demonstrate depletion of MET-positive myeloid-derived suppressor cells (MDSCs) by ARGX-111. These data provide an exciting new perspective for therapeutic intervention in MET cancer biology in targeting both the tumor cells and the tumor microenvironment.

About ARGX-111

ARGX-111 is a Met-targeting human monoclonal SIMPLE Antibody that modulates all known mechanisms of action of the receptor. ARGX-111 benefits from POTELLIGENT-enhanced Antibody Dependent Cellular Cytotoxicity (ADCC), which drives the immune system to destroy
c-MET positive cells of the primary tumor and the circulating tumor cells that are responsible for metastasis; and from NHance, which is thought to drive tissue penetration. This unique combination results in a potentially best-in-class drug candidate for c-Met therapies. ARGX-111 is tested in a Phase 1 safety expansion cohort in MET-amplified patients.

On June 2, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it has completed the sale of its European operations to Incyte Corporation and entered into the previously announced license agreement for Incyte to exclusively license Iclusig (ponatinib) in Europe and other select countries (Press release, Ariad, JUN 2, 2016, View Source;p=RssLanding&cat=news&id=2174467 [SID:1234512951]).

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ARIAD transferred all rights to its EU operations to Incyte, which has acquired all shares of ARIAD Pharmaceuticals (Luxembourg) S.a.r.l., the parent company of ARIAD’s European subsidiaries responsible for the commercialization of Iclusig in the licensed territory, for a payment to ARIAD at the closing of approximately $140 million (subject to customary post-closing adjustments). In addition, Incyte has now been granted an exclusive license to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

"With the closing of this transaction, we have completed a key outcome from our strategic review," stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. "This agreement puts ARIAD in a strong financial position. It will allow us to focus our resources on our promising R&D initiatives and our efforts to achieve the full commercial potential of Iclusig and brigatinib, if approved, in the highly valuable U.S. market, while also maintaining future strategic flexibility through the buy-back provision for the licensed Iclusig rights."

In connection with the closing of the Incyte transaction, the previously disclosed amendments to ARIAD’s royalty financing agreement with PDL BioPharma, Inc. (PDL), entered into on May 9, 2016, became effective. ARIAD and PDL agreed to amend the agreement to, among other things, include net sales of Iclusig made by Incyte in the calculation of net sales under the PDL agreement and to restructure ARIAD’s option to receive additional funding so that ARIAD may require PDL to fund up to an additional $40 million (instead of the original $100 million) in July 2017, rather than between January and July 2016.

Baker & McKenzie LLP represented ARIAD in the Incyte transaction, and Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. represented ARIAD in the PDL transaction.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Phase 2, Parellel-Arm Study of Receptor Tyrosine Kinase (RTK) Inhibitor MGCD265 in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor (MET)"

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