On February 15, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that a comparative analysis of commercially available prognostic breast cancer tests in patients with early-stage breast cancer has been published in JAMA Oncology (Press release, Myriad Genetics, FEB 15, 2018, View Source [SID1234524010]). A key finding is that Myriad’s EndoPredict (EPClin) significantly outperformed Oncotype DX Recurrence Score at predicting the risk of disease recurrence in patients with early-stage breast cancer.

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In the article, Sestak et al. compared the prognostic value that four different commercial tests add to the Clinical Treatment Score (nodal status, tumor size, grate, age, endocrine treatment) for predicting distant recurrence (0-10 years) and late-distant recurrence (5-10 years) of breast cancer. The analysis included data from 774 postmenopausal women with ER+/HER2- breast cancer with node-negative disease or up to three positive lymph nodes, which is the most common form of breast cancer.

The results show that in all patients EndoPredict was the best overall test in predicting distant recurrence in years 0-10 (C-index 0.753; LRX2=69.3) and years 5-10 (C-index 0.761; LRX2=41.6). Importantly, EndoPredict identified the largest group of low-risk patients with 10 years distant recurrence below 10 percent in both node-negative and node-positive disease. EndoPredict also was a much better predictor for overall distant recurrence and for late-distant recurrence than Oncotype DX Recurrence Score. The JAMA Oncology publication can be accessed at View Source

"This study demonstrates that EndoPredict, which combines a multigene signature with clinical information, significantly improves the prediction of disease recurrence, specifically in women with node-positive breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "What this means is that EndoPredict can more accurately identify a larger percentage of patients who can safely forgo adjuvant chemotherapy and the associated toxicity."

These findings are consistent with a previous publication in the Journal of the National Cancer Institute, which also found that EndoPredict was superior to Oncotype DX Breast Recurrence Score in predicting the long-term recurrence of ER+, HER2- primary breast cancer.

Additionally, at the 2017 San Antonio Breast Cancer Symposium in December, the Company presented new predictive data that demonstrated women with a high EndoPredict score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low score responded better to neoadjuvant endocrine therapy.

"We are committed to saving and improving the lives of women with breast cancer, and making sure patients are benefitting from the latest advances in personalized medicine," said Lancaster. "Our expanding body of evidence strongly supports the use of EndoPredict to aid in clinical decisions regarding the use of chemotherapy and extended endocrine therapy."

EndoPredict is widely accessible and is covered by more than 90 percent of health insurance plans in the United States. It also is available in several major European markets. For more information, please visit: www.endopredict.com.

Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

Medical Policy Update
One of the largest private insurers in the United States has expanded its coverage policy on EndoPredict. The new policy supports the use of EndoPredict to aid in the controversial decision of whether or not to extend adjuvant hormonal therapy beyond five years of treatment.

"I applaud payers for recognizing the importance of biomarkers to help physicians and patients make important decisions about whether or not to use extended endocrine therapy out to 10 years," said Joyce A. O’Shaughnessy, M.D., Celebrating Women Chair in Breast Cancer Research, Baylor University Medical Center, and Chair of Breast Cancer Research at Texas Oncology. "This is another important step toward making personalized medicine a reality for all patients with breast cancer."

About Breast Cancer

One in eight American women will have breast cancer during her lifetime. Breast cancer is the second leading cause of cancer death among American women. The American Cancer Society estimates in its Cancer Facts & Figures 2018 report that more than 250,000 women will be told they have breast cancer in 2018. Currently, there are nearly 3.5 million American women living with the disease and every 13 minutes another American woman dies from breast cancer. That’s a little more than 40,000 this year.

About EndoPredict

EndoPredict is a second-generation, multigene prognostic test that aids personalized treatment planning for patients with early stage breast cancer. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive disease and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict accurately predicts the likelihood of both early (0-5 years) and late distant recurrence (5-10 years). Thus, EndoPredict can guide treatment decisions on both the need for chemotherapy, as well as extended endocrine therapy. For more information, please visit: www.endopredict.com.

On February 15, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported that, pursuant to its continued collaboration with MD Anderson it has developed and licensed what it believes, based on preclinical testing, is a major breakthrough in its effort to develop a new cancer treatment that selectively kills highly resistant tumors (Press release, Moleculin, FEB 15, 2018, View Source [SID1234524009]).

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"We believe our unique approach to develop immuno-stimulating STAT3 inhibitors just took a major step forward," commented Walter Klemp, Chairman and CEO of Moleculin. "Our WP1066 portfolio has already resulted in multiple collaborations with some of the most prestigious cancer centers in the world and now this new discovery could dramatically improve our ability to treat a broader range of the most difficult cancers, and especially pancreatic cancer."

Dr. Don Picker, Moleculin’s Chief Science Officer, explained, "The scientific community recognizes the potential for small molecule immuno-stimulating STAT3 inhibitors to become a game-changer for treating cancer patients. We believe this discovery may not only dramatically improve our ability to develop and deliver such therapies, it may also help support a new mechanistic understanding of oncogenic transcriptional activity. Specifically, we now have preclinical evidence to suggest we are capable of controlling a process known as ‘ubiquitination’ to block the activated form of STAT3, an important oncogenic transcription factor. The study of the role of ubiquitination in cancer is cutting edge science and appears to hold great promise. And, given the desperate lack of treatment options for indications like pancreatic cancer, we believe clinical researchers across the country have been eagerly awaiting a breakthrough like this."

"In developing our current lead STAT3 inhibitor, WP1066, for brain tumors, we have focused on its oral bioavailability and brain uptake," continued Dr. Picker, "but at the same time we have continued our quest to expand this portfolio by the creating alternative inhibitors with increased bioavailability and altered tissue and organ distribution that are not affected by first-pass metabolism. The lead molecule resulting from this new discovery is called WP1732 and it not only appears to share the same key mechanistic properties with WP1066, it has markedly different organ distribution and its dramatically increased solubility makes it ideal for administration via standard IV injection. Importantly, preclinical testing has also shown that WP1732’s properties make it a promising candidate for treating pancreatic cancer, one of the most resistant and deadly forms of cancer."

"So much has happened in the past few months, it’s important to recap where we are," added Mr. Klemp. "Moleculin has three potential breakthrough disruptive technologies – (1) Annamycin, an anticancer agent that is active against multidrug resistant tumor cells and has been designed to be non-cardio toxic (unlike currently approved drugs in this class), (2) immuno-stimulating STAT3 inhibitors like WP1066 and, now, WP1732, and (3) WP1122, a metabolic inhibitor that has been shown in preclinical testing to effectively block the energy supply required by cancer cells to function and proliferate. Since our IPO in June 2016, we have accelerated to the point of having two drugs, Annamycin and WP1066, beginning clinical trials in the near term."

Mr. Klemp concluded, "We are now demonstrating the breadth of our drug pipeline and the benefits of collaborating with world-class cancer research centers. In the AML space, we expect patient dosing either in the United States or Poland to begin with Annamycin yet this quarter and we have begun to work with researchers at MD Anderson on using our immuno-stimulating STAT3 inhibitors to target AML as well. A second clinical trial targeting brain tumors with WP1066 should begin dosing within the first half of the year. In Poland, we are about to request a clinical trial authorization for WP1220 for the topical treatment of Cutaneous T-Cell Lymphoma (CTCL), which we expect will become our third clinical trial this year. WP1220 is our patented STAT3 inhibitor designed to be compatible with topical formulations and was selected based on its preclinical activity in CTCL cell lines and based on the need for better topical treatments for CTCL. Additionally, we just announced positive data for WP1122, our glycolysis inhibitor, in a pancreatic cancer mouse model. Along with the newly licensed discovery of WP1732, this sets the course for establishing the base for two more Investigational New Drug (IND) applications over the coming year and positions us as a leader in developing new approaches for pancreatic cancer. Our highly experienced leadership and expanding team is looking forward to sharing more progress on all of this activity as we move forward into 2018."

On February 15, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported Health Canada’s approval of ZYTIGA (abiraterone acetate) in combination with prednisone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who may have received up to three months of prior ADT (Press release, Johnson & Johnson, FEB 15, 2018, View Source [SID1234524007]).

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This latest approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, a multinational, multicenter, randomized, double-blind, placebo-controlled trial (N=1,199) that examined the use of ZYTIGA 1,000 mg once daily in combination with prednisone 5 mg once daily and ADT, compared to placebos plus ADT in patients with newly diagnosed mHSPC.3 The study showed ZYTIGA, in combination with prednisone and ADT reduced the risk of death by 38 per cent compared to placebo plus ADT (median OS not reached vs. 34.7 months, respectively; HR=0.62; 95% confidence interval [CI], 0.51 to 0.76; P < 0.001) in patients with mHSPC.4

"Previously men with newly diagnosed metastatic prostate cancer have had limited options for first-line treatments," Dr. Fred Saad, Chief of Urology, Centre Hospitalier de l’Université de Montréal, Université de Montreal and LATITUDE clinical investigator.** "This latest approval for ZYTIGA is an exciting milestone for men, their caregivers and treating clinicians as it provides a new first-line treatment option for high-risk metastatic hormone-sensitive prostate cancer that improves overall survival and quality of life."

About the LATITUDE Study
The LATITUDE study, published in the New England Journal of Medicine,5 enrolled 1,199 newly diagnosed patients with high-risk mHSPC and was conducted at 235 sites in 34 countries, including sites in 10 Canadian cities and with 33 Canadian patients.6,7 A total of 597 patients were randomized within three months of diagnosis to receive ADT plus ZYTIGA and prednisone, while 602 patients were randomized to receive ADT and placebo.8 Patients were high-risk mHSPC as defined as having at least two of the three following factors associated with poor prognosis: Gleason score ≥8, ≥3 bone lesions and/or presence of measurable visceral metastases.9

Overall, the safety profile of ZYTIGA in combination with prednisone and ADT was similar to prior studies in patients with metastatic castration-resistant prostate cancer (mCRPC).10 In the LATITUDE study, patients received a lower dose of prednisone at 5 mg/day with the usual dose of ZYTIGA at 1,000 mg/day plus ADT. The most common all grade adverse reactions (≥10%) observed with ZYTIGA compared to placebo were hypertension (36.7% versus 22.1%), hypokalemia (20.4% versus 3.7%) and hot flushes (15.4% versus 12.5%).

About Prostate Cancer in Canada
Prostate cancer is a disease where prostate cells lose control of growth and division, and are no longer able to function as healthy cells.11,12 It can be slow-growing and go undetected for years.13

Prostate cancer is the most common cancer among Canadian men, with approximately 21,300 men diagnosed each year.14 Roughly 10 to 20 per cent of those living with prostate cancer will present with metastatic disease,15 in which the tumour has spread beyond the prostate to other parts of the body. There is no cure for metastatic prostate cancer.16

Metastatic hormone-sensitive prostate cancer refers to prostate cancer that still responds to testosterone suppression therapy.17 Patients with newly diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.18

About ZYTIGA
ZYTIGA blocks CYP17-mediated androgen production at three sources: in the testes, adrenals and the prostate tumour tissue.19 Androgen production left unchecked fuels the growth of prostate cancer.20

Health Canada first approved ZYTIGA in 2011 to be used in combination with prednisone for the treatment of mCRPC in patients who have received prior chemotherapy containing docetaxel after failure of ADT. In 2013, it was approved for mCRPC in patients who are asymptomatic or mildly symptomatic after failure of ADT.21

On February 15, 2018 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing regenerative medicine therapeutics to treat neurological conditions associated with de-myelination and cellular immunotherapies to treat cancer, reported that it has strengthened its global IP portfolio over the past 12 months with the issuance of 46 new patents, including in the United States, Europe, Japan, Canada, China, Australia, Israel and South Korea (Press release, BioTime, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332687 [SID1234523999]). Of the 46 patents, 38 are owned or jointly owned by Asterias and eight patents are exclusively licensed to the Company.

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Included in the issued patents are those covering differentiation of pluripotent stem cells to hematopoietic progenitors and differentiation of pluripotent stem cells to immature and mature dendritic cells, providing key patent protection to the Company’s allogeneic (non-patient specific) cancer immunotherapy AST-VAC2 program. Other issued patents cover various aspects of culture and expansion of undifferentiated stem cells, providing support for both AST-VAC2 and the Company’s AST-OPC1 product candidate which is currently being evaluated in the Company’s Phase 1/2a clinical program for severe spinal cord injury. Additional issued patents cover differentiation of pluripotent stem cells to various other lineages, including neural cells such as dopaminergic neurons, cardiomyocytes, and hepatocytes.

"We are excited about these new patents as they provide additional protection for certain aspects of the AST-VAC2 manufacturing process and support scalable processes of culturing pluripotent stem cells," said Michael Mulroy, President and Chief Executive Officer of Asterias. "In addition to being important for our own programs, these patents and our entire patent portfolio could enhance shareholder value by providing future licensing and partnering opportunities with third parties."

On February 15, 2018 Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the enrollment of patients is on target for the Company to be able to conduct a second interim analysis in the Oraxol KX-ORAX-001 Phase III clinical trial in the third quarter of 2018 (Press release, Athenex, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332730 [SID1234523998]).

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Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor). The Oraxol KX-ORAX-001 Phase III clinical trial is an international randomized controlled clinical trial comparing Oraxol monotherapy against intravenous (IV) paclitaxel monotherapy in patients with metastatic breast cancer, with target sample size of 360 patients. The study is designed to show superiority of clinical efficacy of Oraxol over IV paclitaxel based on independently confirmed response rates.

In accordance with the protocol the Company conducted a first interim analysis when 90 patients completed 18 weeks of treatment in October 2017. Based on that analysis, the independent Drug Safety Monitoring Board (DSMB) unanimously recommended continuation of the study. The DSMB was impressed by the conduct of the study in achieving a good overall response rate. The DSMB noticed that neuropathy was rare with Oraxol treatment. Neuropathy is a dose limiting toxicity of IV paclitaxel. The DSMB encouraged the rapid patient recruitment toward the scheduled second interim analysis at 180 patients.

Athenex has already enrolled more than 180 patients and therefore expects the second interim analysis in the third quarter of 2018.

Dr. Rudolf Kwan, Chief Medical Officer, commented, "In January 2018, we had positive feedback from the FDA that if this study meets the primary endpoint with an acceptable benefit/risk profile, it could be adequate as a single comparative trial to support registration of Oraxol for a metastatic breast cancer indication in the United States. We are looking forward to seeing results from the second interim analysis of this clinical trial."

Dr. Johnson Lau, Athenex’s Chief Executive Officer and Chairman of the Board, stated, "We are very proud of the excellent planning and execution of our clinical team. To be able to deliver both the enrollment for the Oraxol Phase III study on target time and the enrollment of two Phase III studies for KX-01 Ointment for the treatment of actinic keratosis ahead of schedule reflect the hard work, quality and the commitment of our clinical operation team. We are delighted that we are going to again deliver an interim analysis of the topline Oraxol Phase III study results on schedule as planned. Athenex is also conducting clinical studies on Oraxol in other geographic areas as well as for the expansion of clinical indications. We are also proud that Oraxol has recently obtained the Promising Innovative Medicine (PIM) designation by the United Kingdom Health Authority MHRA and also the allowance of two IND (HM30181A and oral paclitaxel capsules) by the Chinese FDA."