On May 19, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; hereinafter called "Sumitomo Dainippon Pharma") reported that clinical data of napabucasin (BBI608) and amcasertib (BBI503) will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 3 to June 7, 2016 (Press release, Dainippon Sumitomo Pharma, MAY 18, 2016, View Source [SID:1234512577]).

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Napabucasin: 6 presentations
1. ABSTRACT #3564, Poster #261: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-246: NCT02024607: Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) administered in combination with FOLFIRI +/- Bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC). The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

2. ABSTRACT #4128, Poster #120: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-118: NCT02231723: A Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) in combination with Gemcitabine and nab-Paclitaxel (nab-PTX) in patients (pts) with metastatic pancreatic cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

3. ABSTRACT #9093, Poster #416: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Non-Small Cell Lung Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

4. ABSTRACT #1094, Poster #199: Sunday, June 5 from 8:00 a.m. – 11:30 a.m.:BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Triple Negative Breast Cancer. 2 The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

5. ABSTRACT #5578, Poster #401: Monday, June 6 from 1:00 p.m. – 4:30 p.m.:BBI608-118: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Platinum Resistant Ovarian Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

6. ABSTRACT #TPS4144, Poster #129b: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.:BBI608-336: NCT02178956: The BRIGHTER trial: A phase III randomized double-blind study of BBI-608 + weekly paclitaxel versus placebo (PBO) + weekly paclitaxel in patients (pts) with pretreated advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

Amcasertib: 1 presentation
1. ABSTRACT #6018, Poster #340: Saturday, June 4 from 1:00 p.m. – 4:30 p.m. (Poster Session) Saturday, June 4 from 4:45 p.m. – 6:00 p.m. (Poster Discussion Session):BBI503-101: NCT01781455: Phase I Extension Clinical Study of BB503, a First-in-Class Cancer Stemness Kinase Inhibitor, in Adult Patients with Advanced Head and Neck Cancer.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

On May 18, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, MAY 18, 2016, View Source [SID:1234512600]).

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Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 to demonstrate a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b
A copy of the ASCO (Free ASCO Whitepaper) abstracts were made available today, May 18, 2016 at 5:00pm ET through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

On May 17, 2016 Amgen (NASDAQ:AMGN) reported a new public service announcement (PSA) featuring Breakaway from Cancer ambassador Patrick Dempsey in an effort to increase awareness of the importance of education and support services available for those impacted by cancer (Press release, Amgen, MAY 17, 2016, View Source;p=RssLanding&cat=news&id=2169080 [SID:1234512485]).

In 2016 alone, it is estimated that almost 1.7 million Americans will be diagnosed with cancer.[1] One person alone can’t beat cancer, it takes a team. The Breakaway from Cancer non-profit partner organizations – Prevent Cancer Foundation, Cancer Support Community, Patient Advocate Foundation and National Coalition for Cancer Survivorship – collectively offer a broad range of support services to people affected by cancer, complementing those provided by a patient’s team of healthcare professionals.

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The new Breakaway from Cancer public service announcement delivers its message through an impactful, straightforward video featuring four individuals with real-life cancer journeys. The PSA will first air during the 11th annual Amgen Tour of California, the nation’s largest and most prestigious professional cycling race.

Dempsey, who lost his mother to ovarian cancer, was motivated to join Breakaway from Cancer in 2007 by her courage and his family’s experience in rallying around her. In 2008, he founded the Patrick Dempsey Center for Cancer Hope & Healing in Maine and continues to work with Breakaway from Cancer to deliver the message that no one should fight cancer alone.

Cancer survivors join Dempsey in the PSA to share their messages of hope. Jackie Crowell, a cancer survivor and former professional cyclist, shares that resources help everyone affected by cancer – patients, caregivers and family members. Debra Parson, a caregiver to her brother during his cancer journey, explains that there is help navigating healthcare and insurance questions. Cancer survivor and long-time Breakaway from Cancer supporter Blaine Mauldin shares that finding a community is important.

Founded in 2005, Breakaway from Cancer aims to increase awareness of important resources available to those impacted by cancer – from prevention to survivorship.

"Amgen’s mission is to serve patients and we are proud to recognize individuals who make a positive difference in the fight against cancer," said Raymond C. Jordan, senior vice president of Corporate Affairs at Amgen. "Similar to the sport of cycling where it takes a team to achieve success, one person alone cannot beat cancer. Amgen is proud to be a part of the team to help empower patients with education, resources and hope through Breakaway from Cancer."

As part of the Breakaway from Cancer initiative, cancer survivors will participate in a variety of activities during the Amgen Tour of California, May 15-22, 2016, including start activities each stage of the race. At the conclusion of each race day, a local cancer survivor will present Amgen’s Breakaway from Cancer Most Courageous Rider jersey to the professional rider who best exemplifies the character of those engaged in the fight against cancer—courage, sacrifice, inspiration, determination, and perseverance.

All Breakaway from Cancer programs benefit the initiative’s four nonprofit partners – Prevent Cancer Foundation, Cancer Support Community, Patient Advocate Foundation and National Coalition for Cancer Survivorship. Representatives of these four organizations will travel with the Amgen Tour of California, hosting a Breakaway from Cancer information booth at the Lifestyle Festival held at each stage along the race route.

More information about Breakaway from Cancer, including valuable resources offered by Amgen’s partners, is available at www.breakawayfromcancer.com.

About Breakaway from Cancer
Amgen is leading the race to dramatically improve patients’ lives through its national initiative, Breakaway from Cancer. Founded in 2005 by Amgen, Breakaway from Cancer aims to increase awareness of important resources available to people affected by cancer – from prevention through survivorship. Breakaway from Cancer is a collaboration between Amgen and four nonprofit partner organizations: Prevent Cancer Foundation, Cancer Support Community, Patient Advocate Foundation, and National Coalition for Cancer Survivorship. These organizations offer a broad range of support services complementing those provided by a patient’s team of healthcare professionals. For more information, please visit www.breakawayfromcancer.com or follow us on www.twitter.com/breakawaycancer.

On May 17, 2016 Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) reported an expanded analysis of its Phase 2 study of seribantumab (MM-121) in combination with exemestane in HER2-negative, hormone receptor positive metastatic breast cancer (Press release, Merrimack, MAY 17, 2016, View Source [SID:1234512509]). Top line results from this study were announced in 2014. The final analysis, as well as a poster on Merrimack’s investigational companion diagnostic for seribantumab, were presented this week at the AACR (Free AACR Whitepaper) Precision Medicine Series: Targeting the Vulnerabilities of Cancer, in Miami, Florida.

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"This data package underscores the most significant finding from all of our seribantumab Phase 2 studies – the identification of a heregulin-positive cancer cell phenotype that infiltrates approximately 30-50% of tumors and that may directly impact response to current standard-of-care therapies. This hypothesis is supported by a strong consistent data set that spans three solid tumor types where we saw improved progression free survival when seribantumab was added to each of the standard-of-care regimens," said Akos Czibere, MD, Ph.D., Senior Medical Director and Team Lead for the seribantumab program. "We are currently pursuing a registration study for seribantumab in patients with non-small cell lung cancer whose disease has progressed following immunotherapy."

"These additional analyses from our Phase 2 breast cancer study reinforce the significant opportunity for seribantumab to be the first therapy to treat heregulin-positive disease," said Robert Mulroy, President and CEO of Merrimack. "We are focused on executing our strategy in NSCLC as our near term path to registration for seribantumab and its heregulin diagnostic."

A randomized trial of exemestane +/- seribantumab (MM-121) in postmenopausal women with locally advanced or metastatic ER/PR+ HER2- breast cancer: Final analysis and extended subgroup analysis

Final analysis and extended subgroup analysis of a Phase 2 study of seribantumab in combination with exemestane in metastatic HER2-negative, ER/PR+ breast cancer was presented. The study was randomized, double-blinded and placebo-controlled to evaluate whether the combination of seribantumab and exemestane was more effective in prolonging progression free survival (PFS) than exemestane in ER/PR+ metastatic breast cancer (n=118) who had previously failed anti-estrogen therapy. Of the patients with tissue available for heregulin testing, 45% (n=34/76) were heregulin-positive. Patients in the heregulin-positive group who received seribantumab had a 74% decrease in risk of progression, (HR 0.26; 95% CI [0.11 — 0.63], p=0.003) compared with patients who did not receive seribantumab. The study did not meet its primary endpoint of PFS though the overall study population trended in favor of the MM-121 arm (HR 0.772; 95% CI [0.496 — 1.201]). Notably, across all treated patients, overall survival data trended in favor of the seribantumab arm with a 59% decrease in risk of death (HR 0.436; 95% CI [0.197 — 0.966]) versus patients on the standard-of-care arm. Click here to view the full data set from the poster.

Identification of heregulin expression as a driver of a difficult-to-treat cancer phenotype and development of a prospective companion diagnostic for the heregulin-ErbB3 targeting drug seribantumab

A poster highlighting the potential importance of a diagnostic in treating heregulin-positive patients across three different solid tumors (breast, lung and ovarian cancers) was also presented. In three Phase 2 studies, Merrimack’s novel heregulin assay was able to identify patients with heregulin-positive tumors where the addition of seribantumab to standard-of-care therapies may provide benefit. Heregulin was detected at significant levels across multiple solid tumor types, with a prevalence of between 30-60% of patients, potentially defining a critical patient phenotype that has a high-unmet need. Tumor biopsies were measured by RNA-ISH. A fully validated RNA-ISH assay is currently being used to identify heregulin-positive patients in a Phase 2 randomized trial of seribantumab in patients with NSCLC. Merrimack recently announced a strategic partnership with Leica Biosystems to develop Merrimack’s novel heregulin assay for seribantumab into a kit for commercial use. Click here to view the full data set from the poster.

About Seribantumab

Seribantumab is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner.

While Merrimack is encouraged by the clinical results in breast and ovarian cancers, Merrimack has chosen to initially pursue seribantumab in a potentially registration-enabling Phase 2 study in non-small cell lung cancer (NSCLC). The NSCLC study is an open-label, biomarker-selected randomized study of MM-121 in combination with docetaxel or pemetrexed compared to docetaxel or pemetrexed alone in patients with heregulin-positive, locally advanced or metastatic NSCLC.

On May 17, 2016 Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its third quarter ended March 31, 2016 (Filing, Q1, Palatin Technologies, 2016, MAY 17, 2016, View Source [SID:1234512487]).

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Quarter Ended March 31, 2016 and Recent Highlights
·
Bremelanotide development for Female Sexual Dysfunction (FSD):

‒ Palatin’s two Phase 3 clinical trials for the treatment of FSD initiated in December 2014 and January 2015 are progressing as planned and meeting target objectives.

‒ Patient enrollment was completed in the fourth quarter of calendar year 2015.

‒ Last patient out is expected in the third quarter of calendar year 2016.

‒ Top-line results are expected to be released in the third quarter of calendar year 2016.

‒ The clinical trials randomized approximately 1,100 women (~550 each trial) to evaluate efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder as an on-demand, as-needed treatment. For more information visit reconnectstudy.com.

‒ A Notice of Allowance was issued by the U.S. Patent and Trademark Office on a patent for methods of treating female sexual dysfunction using the dose and formulation in Phase 3 trials.

Third Quarter Fiscal 2016 Financial Results
Palatin reported a net loss of $(12.7) million, or $(0.08) per basic and diluted share, for the quarter ended March 31, 2016, compared to a net loss of $(9.2) million, or $(0.07) per basic and diluted share, for the same period in 2015.

The difference between the three months ended March 31, 2016 and 2015 was primarily attributable to the increase in expenses relating to the Phase 3 clinical trial program with bremelanotide for FSD in the quarter ended March 31, 2016.

Revenue
There were no revenues recorded in the quarters ended March 31, 2016 and 2015.

Operating Expenses
Total operating expenses for the quarter ended March 31, 2016 were $12.1 million compared to $8.7 million for the comparable quarter of 2015. The increase in operating expenses for the quarter ended March 31, 2016 was the result of an increase in expenses primarily relating to the Phase 3 clinical trial program with bremelanotide for FSD.

Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarter ended March 31, 2016 consisting primarily of interest expense related to the venture debt and $(0.4) million for the quarter ended March 31, 2015 primarily consisting of interest expense related to the venture debt and secondarily a foreign exchange transaction loss.

Cash Position
Palatin’s cash, cash equivalents and investments were $23.1 million as of March 31, 2016, compared to cash and cash equivalents $27.3 million at June 30, 2015. Current liabilities were $13.1 million as of March 31, 2016, compared to $7.4 million as of June 30, 2015.

Palatin believes that existing capital resources will be adequate to fund our planned operations through the quarter ending September 30, 2016.