On 2, April Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported the appointment of Carsten Thiel, Ph.D., as Chief Executive Officer. Timothy J. Miller, Ph.D., will remain President and assume the position of Chief Scientific Officer in charge of the company’s expanding clinical and preclinical research programs (Press release, Abeona Therapeutics, APR 2, 2018, View Source [SID1234525106]). Dr. Thiel most recently served as the Executive Vice President and Chief Commercial Officer of Alexion Pharmaceuticals, Inc. where he led global commercial operations bringing innovative and life-transformative therapies for rare diseases to patients.

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"The past year has been an extraordinary time in the history of Abeona, including significant progress in our clinical development programs and establishment of our new manufacturing facility in Cleveland," said Steven Rouhandeh, Executive Chairman of Abeona. "As CEO, Carsten Thiel brings a unique combination of extensive experience in research and global rare disease commercialization to Abeona. In his recent positions, he successfully created value by building cohesive talented teams, driving the commercial success of multiple products globally and fostering entrepreneurial culture; all key aspects that will be critical to our success in these areas in the years ahead. We are very grateful to Tim Miller for his vision and leadership that have brought us to this pivotal stage in our business growth."

Dr. Thiel brings 25 years of proven global biopharmaceutical industry experience, including rare and orphan diseases, to Abeona. Prior to leading his most recent position at Alexion, he served as its Senior Vice President, Europe/Middle East/Africa and Asia Pacific where he was responsible for driving Alexion’s global commercial operations in these regions, including maximizing the current rare disease portfolio as well as guiding the launch of anticipated new products and indications.

"I am thrilled to be joining Abeona during a period of major growth and momentum in the company’s range of promising development programs," said Dr. Thiel. "I look forward to bringing my experience in business development, biomedical research and commercialization to the outstanding Abeona team at a time when the company is ideally positioned to rapidly expand these areas."

Prior to joining Alexion, Dr. Thiel served as Vice President, Head of Europe at Amgen. In this role, he led regional operations and was responsible for multiple products in hematology/oncology, nephrology, and bone disorders, and prepared for new product launches in inflammation and cardiology. He also held various other senior leadership positions at Amgen, including General Manager, Germany, and General Manager, CEE, where he led all markets in Eastern Europe and established Amgen’s operations in Russia. He also served as Head of the Oncology franchise in Europe during the time of several blockbuster product launches. Prior to Amgen, Dr. Thiel held several sales and marketing leadership roles across Europe at Roche.

"As Abeona expands our innovative science and clinical research programs into new areas, I look forward to working more closely with our research and product development teams to fuel even greater success for developing novel gene and cell therapies," said Dr. Miller. "We welcome Carsten to our team at Abeona, and remain confident that our clinical advancements and strategic decisions have solidly positioned us to plan for many promising opportunities in global product commercialization and business strategy."

Dr. Thiel earned his doctorate in molecular biology & biochemistry at Max Planck Institute for Biophysical Chemistry in Goettingen, Germany.

On April 2, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that NERLYNX (neratinib) has been included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Central Nervous System Cancers for Breast Cancer patients with brain metastases (Press release, Puma Biotechnology, APR 2, 2018, View Source [SID1234525377]). The NCCN designated NERLYNX in combination with capecitabine as a category 2A treatment option and NERLYNX in combination with paclitaxel as a category 2B treatment option. Use, as designated for breast cancer patients with brain metastases, is outside the FDA approved indication for NERLYNX and considered investigational.

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"Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced breast cancer."

About Brain Metastases in Breast Cancer
Breast cancer is one of three types of cancers that are most likely to metastasize to the brain. Across all sub-types, approximately 10-15% of women with metastatic breast cancer develop brain metastases. This rate is as high as 30% for women with advanced HER2+ disease.

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.
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.

About HER2-Positive Breast Cancer
Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with a trastuzumab-based regimen experience recurrence.
IMPORTANT SAFETY INFORMATION
NERLYNX (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:
Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS:
Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:
Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.
To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

On April 2, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, will present at the H.C. Wainwright Annual Global Life Sciences Conference in Monte Carlo, Monaco on Monday, April 9, 2018, at 10:15 am Central European Summer Time (Press release, Aduro Biotech, APR 2, 2018, View Source;p=RssLanding&cat=news&id=2340610 [SID1234525107]).

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit Aduro’s website at www.aduro.com.

On April 2, 2018 XBiotech USA, Inc. (NASDAQ:XBIT) reported that it has obtained an exclusive, worldwide license from CT Atlantic AG (CTA), a Swiss biotechnology company. Under the terms of the license agreement, XBiotech will use its proprietary manufacturing technology to advance the development of the True HumanTM anti-NY-ESO-1 monoclonal antibody, 12D7 (Press release, XBiotech, APR 2, 2018, View Source;p=RssLanding&cat=news&id=2340533 [SID1234525378]). Accordingly, XBiotech will now begin to establish the production capability to enable 12D7 clinical development.

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The 12D7 antibody targets NY-ESO-1, a cancer-related protein commonly found in many kinds of aggressive tumors. The therapeutic use of 12D7 offers the potential to target advanced tumors by activating cellular immunity or antibody directed immune responses against tumors. A 12D7 therapy may be combined with other therapies that unleash the immune system to produce anti-cancer responses.

John Simard, President & CEO of XBiotech, commented, "The 12D7 antibody was isolated from a human immune response against cancer and is therefore a logical fit with our pipeline of human-derived antibodies. 12D7 offers the potential to be used as a therapy with minimal side effects—and safely in combinations with other agents, including checkpoint inhibitors—to help direct a patient’s immune response against their cancer."

Simard further commented, "Although NY-ESO-1 has been the subject of an enormous amount of scientific investigation, pointing to its association with tumors and anti-tumor immunity, the 12D7 antibody has yet to be evaluated in clinical trials. 12D7 is a good example of how our unique manufacturing technology can be used to help advance promising candidates discovered elsewhere."

Prof. Alex Knuth, M.D., member of the Board of Directors at CTA, Medical Director and Chief Executive Officer of the National Center for Cancer Care and Research (NCCCR) and Chairman of Cancer Services at Hamad Medical Corporation, commented, "I am excited to bring this NY-ESO-1 specific True Human antibody to the clinic with the advanced technologies and expert guidance of XBiotech. NY-ESO-1 is the most immunogenic human cancer antigen known to date. The 12D7 antibody comes from a melanoma patient with a remarkably favourable disease course despite advanced metastasis. NY-ESO-1 immunity appears to predict a better response to immune checkpoint interventions and the 12D7 antibody has been shown to support conventional treatments like chemotherapy with better outcomes in animal models; and in combination with radiotherapy, 12D7 may also amplify immune responses against cancer cells."

About 12D7 Antibody
Work from the laboratories of Dr. Alexander Knuth and Dr. Steve Rosenberg previously showed that cellular immunity against NY-ESO-1 can be activated in cancer patients. The 12D7 antibody is expected to target the NY-ESO-1 antigen directly, as well as work to help direct the patient’s cellular immune response against NY-ESO-1 bearing tumors. 12D7 is the first True Human monoclonal antibody targeting NY-ESO-1.
NY‐ESO‐1 was discovered by researchers at the Ludwig Institute for Cancer Research and Weill Medical College of Cornell University in New York. Interestingly, NY‐ESO‐1 is encoded by the sex-linked X chromosome and is deregulated and expressed in a number of forms of cancer. NY‐ESO‐1 function is still not fully understood but may be involved in cell division in cancer. Consequently, expression of NY‐ESO‐1 is found in a wide range of metastatic tumors, including about 33% of all cancers of the bladder, esophagus, gut, liver, lung, ovaries, prostate and skin.
Natural antibody immunity against NY-ESO-1 is often seen in cancer patients but is absent in healthy individuals. The natural antibody 12D7 is thought to be capable of initiating cellular immune responses, a disease fighting mechanism that is now widely mobilized to fight cancer through the use of check point inhibitors.
The target of the 12D7 antibody, NY-ESO-1, is commonly found in high‐grade malignancies. The therapeutic use of 12D7 may therefore offer the potential to target these aggressive tumors in part by activating cellular immunity or antibody directed immune responses to the site of tumors. Anti-NY-ESO-1 antibody therapy may benefit from being combined with other therapies that reduce immune suppression. These combination therapies in particular offer hope that 12D7 could be a breakthrough approach to unleashing anti-cancer immunity against many forms of cancer
.
About True Human Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On April 2, 2018 -Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has accepted the abstract titled "ADXS-PSA plus pembrolizumab (pembro) in metastatic castration-resistant prostate cancer (mCRPC)" for a poster discussion at their annual meeting to be held June 1-5, 2018 in Chicago (Press release, Advaxis, APR 2, 2018, View Source [SID1234525108]). The discussion will be presented and lead by author and principle investigator of the study, Mark Stein, MD, medical oncologist at Columbia University Medical Center.

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Title: "ADXS-PSA plus pembrolizumab (pembro) in metastatic castration-resistant prostate cancer (mCRPC)"
Abstract Number:

5019
Session:

Genitourinary (Prostate) Cancer
Date:

June 2, 2018 4:45 PM-6:00 PM
Presenter:

Mark Stein, MD