On June 3, 2016 Bayer and Orion Corporation reported the expansion of the global clinical development program for the investigational androgen receptor (AR) antagonist BAY-1841788 (ODM-201) in the area of prostate cancer (Press release, Bayer, JUN 3, 2016, View Source;sessionID=1464982658 [SID:1234512984]). A new Phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy. BAY-1841788 (ODM-201) is an investigational oral AR-antagonist that has a unique chemical structure designed to block the growth of cancer cells through binding to the AR with high affinity and inhibiting the receptor function. The compound is currently in Phase III development ARAMIS study for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). The new trial ARASENS is expected to start the enrolment of patients towards the end of 2016.

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"Although the treatment options for patients with advanced prostate cancer who are castration-resistant have evolved considerably in recent years, there were only few advances in the earlier, hormone-sensitive stage of metastatic disease. Novel treatment approaches are urgently needed for patients to delay the progress of the cancer and improve survival," said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. "Bayer’s commitment to prostate cancer research runs deep, and the initiation of ARASENS is the latest in a long line of studies designed to evaluate treatment options for patients with advanced disease."

Bayer and Orion have recently expanded the 2014 agreement to include the joint development of BAY-1841788 (ODM-201) for mHSPC. Under that agreement, Bayer will commercialize the product globally; Orion has the option to co-promote BAY-1841788 in Europe, and is responsible for the manufacturing of the product.

"We believe that the profile of ODM-201 makes it an excellent treatment candidate for patients with metastatic hormone-sensitive prostate cancer. This is another example of how Orion’s oncology research is aiming to contribute to the benefit of patients. We are also happy to see Bayer’s continuous commitment to ODM-201", said Dr. Reijo Salonen, Senior Vice President of R&D at Orion.

About ARASENS
ARASENS (A Randomized, double-blind, placebo-controlled Phase III study of ODM 201 versus placebo in addition to standard Androgen deprivation therapy and docetaxel in patients with metastatic castration SENSitive prostate cancer) is planned to be initiated towards the end of 2016. Approximately 1,300 patients will be randomized (1:1 ratio) to receive either BAY-1841788 or placebo in combination with an ADT of investigator’s choice (LHRH agonist/antagonists or orchiectomy), started ≤12 weeks before randomization. Six cycles of docetaxel will be administered after randomization. The primary endpoint of the study is overall survival, and secondary endpoints include time to castration-resistant prostate cancer (time to CRPC), time to initiation of subsequent antineoplastic therapy, symptomatic skeletal event free survival (SSE-FS), time to first symptomatic skeletal event (time to SSE), time to initiation of opioid use, time to pain progression, time to worsening of physical symptoms of disease and safety.

ARASENS adds to the ongoing clinical development program for BAY-1841788, which includes ARAMIS (NCT02200614), a randomized, Phase III, multicenter, double-blind, placebo-controlled trial evaluating patients with non-metastatic CRPC who are at high risk for developing metastatic disease. ARAMIS is currently enrolling patients.
 
About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer (PC) is the second most common form of cancer worldwide and the fifth leading cause of cancer-related death in men. More than 1.1 million men worldwide were diagnosed with the disease in 2012.

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately five percent of men will already suffer from prostate cancer with distant metastases when first diagnosed. Men with newly diagnosed metastatic hormone-sensitive prostate cancer (HSPC) will start their treatment with hormone therapy, such as ADT or a combination of the chemotherapy docetaxel and ADT. Despite this first line treatment, most men with metastatic HSPC will eventually progress to castration-resistant prostate cancer (CRPC), which can impact survival and quality of life.

About BAY-1841788 (ODM-201)
BAY-1841788 (ODM-201) is an investigational oral androgen receptor (AR) antagonist that has a unique chemical structure designed to block the growth of cancer cells through binding to the AR with high affinity and inhibiting the receptor function. In preclinical studies, BAY-1841788 and its main circulating metabolite are active also in known AR mutants (ex W742L, F877L), and have been found to have negligible blood-brain barrier penetration.

BAY-1841788 (ODM-201) is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

On June 3, 2016 CellAct Pharma, a developer of innovative treatments for cancer, reported that population pharmacokinetic (PK) data from a phase 2 study of CAP7.1 supports efficacy findings in biliary tract cancer patients. CAP7.1 is a newly designed prodrug of the well-established anticancer agent etoposide, converted by carboxylesterases into etoposide in selected tissues (Press release, CellAct Pharma, JUN 3, 2016, View Source [SID:1234512981]). Analysis of the population PK indicated higher blood concentrations of etoposide resulted in the majority of patients maintaining an increase in tumor size below 20%. Data were published in conjunction with the 52nd Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Abstract e15602).

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"Population pharmacokinetics is an important consideration in the drug development process as it helps to explain the variable effects of certain inter patient characteristics, such as age, body weight and co-medication, can have on a drug’s efficacy and safety. The data presented at ASCO (Free ASCO Whitepaper) will help in determining a standard dosing regimen for CAP7.1," explained Nalân Utku, MD, PhD, MDRA, Chief Executive Officer of CellAct Pharma. "These population PK data provide additional support to the results from our Phase 2 with CAP7.1, where encouragingly, planned interim analysis showed that more than half of therapy refractory, advanced stage biliary tract cancer patients met the primary objective of disease control, as presented at the ASCO (Free ASCO Whitepaper) GI Meeting in San Francisco."

Study Details

Data for the population PK model was analyzed from a total of 434 observations taken from 39 patients from Phase 1 and 2 studies. Using PK modeling software, etoposide AUC0-24h, cmax and cmin for each biliary cancer patient were simulated and compared with the individual changes in total target lesion (TTL) size. A higher AUC0-24h was found to be associated with a lower increase in TTL size (R2=0.172). Out of all patients for which PK information was available, 50% maintained a TTL size increase below 20%. This compared to 80% of patients with an 24hAUC > 120 h ug/mL who maintained a TTL size increase below 20%. Similarly, a higher cmax (R2=0.177) or cmin (R2=0.11) were associated with a larger effect on TTL size.

On June 3, 2016 Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7 (Press release, Mylan, JUN 3, 2016, View Source [SID:1234512980]). The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab.

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"As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan’s biosimilar program," Mylan President Rajiv Malik said. "There is an urgent, unmet need for more affordable versions of biologic products and through our collaboration with Biocon we are well-positioned to be at the forefront to help deliver these complex products to patients around the world. We’re pleased that ASCO (Free ASCO Whitepaper) has recognized the importance of biosimilars in advancing cancer care and the significant role they will play in providing patients greater access to affordable treatment."

Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, added: "The positive outcomes of the global Phase 3 clinical study with our proposed biosimilar trastuzumab for HER2-positive breast cancer patients are a significant milestone in our joint biosimilars development program with Mylan. The trial will enable regulatory filings of our product in the developed markets. Biocon remains committed to develop affordable biologics and these study results will help us in enhancing access for cancer patients, caregivers and healthcare systems across the globe."

Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20% to 30% of primary breast cancers are HER2-positive.

Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients. It is also indicated for adjuvant treatment of HER2 overexpressing breast cancer and metastatic gastric cancer. It is a targeted therapy that interferes with the HER2 protein and impedes cancer cell growth.

"The HERITAGE study successfully met the predefined endpoints of response equivalency. We are proud of this international collaboration which puts us one step closer to approval of this proposed biosimilar. The response rates at 24 weeks were 69.6% with MYL-1401O combined with taxane chemotherapy versus 64% with branded trastuzumab combined with the same chemotherapy agent. The ratio of overall response and difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products. Safety was comparable between treatment groups. The rates of serious adverse events were 38% with MYL-1401O and 36% with branded trastuzumab, and there was no difference in cardiac safety," commented lead study author Dr. Hope S. Rugo, professor of Medicine at the University of California, San Francisco.

Details of the sessions as on the ASCO (Free ASCO Whitepaper) website are as follows:
"Abstract 583: A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar Myl-1401O (A) vs EU-Herceptin (B) and US-Herceptin ©"
June 5, 8-11 a.m. CDT (Poster Session)
Poster #71
Presenter: Cornelius F. Waller, MD, University of Freiburg Medical Center
Location: Hall A
Link to abstract on the ASCO (Free ASCO Whitepaper) website: View Source

"Abstract LBA503: HERITAGE: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin"
June 6, 2:15-2:27 p.m. CDT (Oral Abstract Session)
Presenter: Hope S. Rugo, MD, University of California, San Francisco
Location: Hall D1
Link to abstract on the ASCO (Free ASCO Whitepaper) website: View Source
The abstract for the HERITAGE study has also been selected for the Best of ASCO (Free ASCO Whitepaper) program this summer which will include several meetings across the globe.
Full session details and abstracts for the 2016 Annual Meeting can be found on the ASCO (Free ASCO Whitepaper) website at am.asco.org.

About the HERITAGE Study
HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the proposed trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either MYL-1401O or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include progression free survival, overall survival, and safety. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for MYL-1401O versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).

About Biosimilars
A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine and has demonstrated no clinically meaningful differences in safety, purity, and potency compared to that of the reference biologic. A biosimilar product and its reference biologic product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions. Biosimilars may offer a less-costly alternative to existing biological medicinal products that have lost their exclusivity rights.

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 03, 2016 NewLink Genetics Corporation (NASDAQ:NLNK) reported that it will present two posters highlighting the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5 in Chicago (Press release, NewLink Genetics, JUN 3, 2016, View Source [SID:1234512977]).

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The company’s two abstracts at ASCO (Free ASCO Whitepaper) will highlight:

Abstract 3075: Updates on Phase 1b/2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus checkpoint inhibitors for the treatment of unresectable stage 3 or 4 melanoma;
Time: 8:00 AM to 11:30 AM
Date: Sunday, June 5, 2016
Poster Discussion Session: Developmental Therapeutics—Immunotherapy
Abstract 3020: Interim analysis on Phase 2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus gemcitabine/nab-paclitaxel for the treatment of metastatic pancreas cancer.
Time: 8:00 AM to 11:30 AM
Date: Sunday, June 5, 2016
Poster Discussion Session: Developmental Therapeutics—Immunotherapy
About NewLink Genetics’ Indoleamine 2,3-Dioxygenase (IDO) Pathway Inhibitors

The indoleamine 2,3-dioxygenase (IDO) pathway regulates immune response by suppressing T cell function and enabling local tumor immune escape. NewLink Genetics is researching two IDO pathway inhibitors, GDC-0919 (in partnership with Genentech) and indoximod, both small-molecule product candidates that have the potential to disrupt mechanisms by which tumors evade the immune system. NewLink Genetics’ indoximod and GDC-0919 each have a distinct mechanism of action within the IDO pathway and are in Phase 1 or 2 clinical trials for a range of cancers, including breast cancer, melanoma, and other solid tumors.

About NewLink Genetics Corporation