1stOncology™: Cancer Intelligence Service – Page 17169 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Agios and Celgene Establish New Collaboration in Metabolic Immuno-Oncology and Amend Certain Rights from 2010 Agreement

On May 17, 2016 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) and Celgene Corporation (NASDAQ:CELG) reported an agreement creating a new global strategic collaboration focused on metabolic immuno-oncology, an emerging field of cancer research focused on altering the metabolic state of immune cells to enhance the body’s immune response to cancer (Press release, Celgene, MAY 17, 2016, View Source [SID:1234512504]). The goal of the collaboration is to discover, develop and commercialize novel therapies based on Agios’ innovative cellular metabolism research platform. Agios will receive an upfront cash payment of $200 million plus the potential for additional payments if certain development and regulatory milestones are achieved. Agios will host a conference call for investors today at 5 p.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"The immune system’s ability to attack tumors is highly regulated by cellular metabolism. This emerging discipline of metabolic immuno-oncology has great potential to provide novel insights and targets for cancer immunotherapy in solid and hematologic malignancies," said Rob Hershberg, M.D., Ph.D., chief scientific officer at Celgene. "This strategic agreement combines Agios’ scientific leadership in cellular metabolism with Celgene’s expertise and growing efforts in immuno-oncology and builds upon the extremely productive partnership and working relationship that exist between our two companies."

"Metabolic immuno-oncology is an exciting new area of research for Agios that holds tremendous promise for patients and builds on our strength in cellular metabolism," said David Schenkein, M.D., chief executive officer at Agios. "Following our successful cancer metabolism partnership, we look forward to continuing our work with Celgene in this new field. This strategic alliance will allow Agios to quickly expand our existing research platform into a third core area while leveraging Celgene’s capabilities and broad portfolio of immuno-oncology assets."

Also announced today, the companies modified certain rights from their 2010 collaboration (the "2010 Agreement"). First, Agios, which previously held U.S. rights for AG-120, gained global development and commercialization rights to the program from Celgene. As of August 15, 2016, neither party will have financial or other obligations to each other related to AG-120. There are no other changes to the existing IDH partnership between Agios and Celgene. Second, the companies agreed that rights to two cancer metabolism programs discovered under the 2010 Agreement, including a program focused on MTAP (methylthioadenosine phosphorylase) deleted cancers, will advance under the structure of the new research collaboration outlined below. Following the expiration of the discovery phase of the 2010 Agreement on April 14, 2016, all other cancer metabolism programs discovered at Agios will remain wholly owned by Agios.

New Metabolic Immuno-Oncology Collaboration

Metabolic immuno-oncology is a rapidly evolving scientific area focused on altering the metabolic state of immune cells, or the tumor microenvironment, to enhance the body’s immune response to cancer. There is increasing evidence that metabolism plays an important role in the regulation of immune cells and their response to tumors. The collaboration aims to discover novel metabolic pathways and their modulators that affect the metabolic state of immune cells, which may serve as potent anticancer therapies. In addition, Agios will focus on discovering molecular markers in order to identify patients who are most likely to respond to therapies.

Scope:

Agios will receive an upfront cash payment of $200 million for the initial four-year research term. Celgene has the option to extend the research term for up to two years for a pre-specified amount.
Exploratory research, drug discovery and early development will be led by Agios.
Generally, collaboration programs may be designated by Celgene when preclinical studies begin, and Celgene will then have an option on each program up through Phase 1 dose escalation for at least a $30 million fee.
Economic Terms on Optioned Programs:

For metabolic immuno-oncology programs, Celgene and Agios will enter into a global co-development and co-commercialization agreement with a worldwide 50/50 cost and profit share. Agios is eligible for up to $169 million in clinical and regulatory milestone payments for each program.
The two cancer metabolism programs from the 2010 Agreement, including a program focused on MTAP deleted cancers, are eligible for the same global co-development, co-commercialization and milestone structure described above.
Celgene will have a one-time opportunity to select a metabolic immuno-oncology program for which costs and profits will be shared 65 percent by Celgene and 35 percent by Agios. Agios may also receive up to $209 million in clinical and regulatory milestone payments for this program.
For any inflammation or autoimmune programs that may result from the collaboration, Celgene has the option to enter into an exclusive worldwide license agreement and lead worldwide development and commercialization. For any such licensed products, Agios may receive up to $386 million in clinical, regulatory and commercial milestone payments, as well as double-digit tiered royalties on any net sales.
Development and Commercial Rights:

Agios and Celgene will alternate leadership of all 50/50 programs in the U.S. territory, with Agios making the first program selection.
Celgene will lead ex-U.S. development and commercialization for all programs. Celgene will lead worldwide development and commercialization for the 65/35 program.
Global Rights for AG-120 Transferred to Agios

Agios now has full global development and commercial rights for AG-120, a first-in-class, oral, potent inhibitor of mutant isocitrate dehydrogenase 1 (IDH1). Agios is studying AG-120 in AML in multiple clinical trials, including as a single agent in the relapsed/refractory setting as well as in combination with standard chemotherapy regimens in the frontline setting. Additionally, Agios plans to initiate pivotal trials in AML and is exploring the use of AG-120 in several solid tumors, including cholangiocarcinoma and glioma.

"We are excited to consolidate the full worldwide rights for AG-120, providing us with another wholly owned investigational therapy discovered by Agios scientists to develop and commercialize along with our rare genetic disorders programs," said Dr. Schenkein. "We know that people with AML have limited treatment options today, and we are committed to bringing AG-120 through pivotal development as quickly as possible."

Camurus Interim Report January-March 2016

On May 17, 2016 Camurus reported its interim report for the period of January – March 2016 (Press release, Camurus, MAY 17, 2016, View Source [SID:1234512495]).

Business highlights first quarter 2016

Recruitment goals reached in two Phase 3 trials of CAM2038 for opioid dependence treatment.
Start of Phase 2 study of CAM2038 in patients with chronic pain.
Completion of Phase 2 study of CAM2029 in two patient groups with acromegaly or neuroendocrine tumors.
Completion of Phase 1 study of CAM4071 in healthy volunteers.
Clinical development supporting toxicology studies initiated for two new product candidates after completed formulation development and assessment
License agreement signed with Rhythm Inc. for long-acting FluidCrystal setmelanotide under development for rare genetic obesity disorders.
Significant events after the reporting period

Positive results from a Phase 2 study of the blockade of opioid effects by CAM2038 in patients with opioid dependence.
Financial summary first quarter 2016

Revenues MSEK 20.2 (58.6).
Operating result MSEK -24.9 (13.1).
Result after tax MSEK -19.4 (10.2).
Earnings per share SEK -0.52 (0.41).
Cash position MSEK 571.9 (116.4).
CEO comments
We have had strong start of the year with positive preclinical assessments of new promising drug candidates, initiation of the build-up of our commercial organization in Europe, and completed recruitment of more than 600 patients in two ongoing Phase 3 trials of our long-acting buprenorphine products for treatment of opioid dependence.

The development of CAM2038 is well-timed, as problems associated with opioid dependence continue to mount. In the US, opioid dependence has reached epidemic proportions. Its’ devastating consequences are getting high attention with daily news headlines and commentaries by leading politicians. The situation is serious and untenable from both humanitarian and socioeconomic perspectives. There is consensus about the need to reduce the stigma of opioid addiction and recognize this condition as a chronic disease that must be treated using evidence based approaches.

Our success in enrolling more than 600 patients in two Phase 3 trials in the US, Europe and Australia in just three months, speaks to the high unmet need in this underserved patient population. With this positive progress, we are looking forward to completing the ongoing trials and receiving Phase 3 efficacy results in Q4 2016. In this context, the recently announced positive results from our Phase 2 opioid challenge study and the continued successful collaboration with Braeburn Pharmaceuticals is noteworthy.

Besides opioid dependence, CAM2038 is also being developed for the treatment of chronic pain. During Q1, we initiated a Phase 2 study in patients with chronic pain, set to deliver results in Q4 2016. We are enthusiastic about the prospects of CAM2038 for treatment of chronic pain, with the potential for round-the-clock pain relief combined with minimal risks of misuse, abuse and diversion.

In our partnership with Novartis, we recently completed a Phase 2 trial of our long-acting octreotide product, CAM2029, in patients with acromegaly and neuroendocrine tumors. Results are expected late Q2 2016. The partnership with Novartis continues to develop well, with high activity in preparing the start of Phase 3 trials.

In the late stage pipeline, we have also recently completed a Phase 2 study of product candidate CAM2032 for treatment of prostate cancer. Top-line results from this trial are expected during the Q2 2016.

We are also progressing with promising new product developments and bridging toxicology studies with two promising candidates were recently initiated. Clinical development of a first prioritized product candidate is planned to start during Q4 2016.

Several collaborations projects are also ongoing with international pharmaceutical and biotech companies. As an example, a new license agreement was signed with the US biotech Rhythm Inc. in January for the development and commercialization of a once-weekly formulation of setmelanotide for treatment of genetic obesity disorders. Shortly after the agreement, Rhythm received a Breakthrough Therapy designation for setmelanotide by US FDA.

8-K – Current report

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]).

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.

Amgen’s Breakaway from Cancer® Public Service Announcement Delivers Message That Education, Resources And Hope Are Essential In The Fight Against Cancer

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.

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.

BioLineRx Reports First Quarter 2016 Financial Results

On May 17, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the first quarter ended March 31, 2016 (Press release, BioLineRx, MAY 17, 2016, View Source;p=RssLanding&cat=news&id=2168907 [SID:1234512464]).

Highlights and achievements during the first quarter of 2016, and to date:

Signing of immuno-oncology collaboration with Merck for BL-8040 Phase 2a study in pancreatic cancer
Successful top-line results from Phase 2a study for BL-8040 in r/r AML
Continued ramp-up of Phase 2b study for BL-8040 as consolidation treatment for AML patients following standard induction treatment
Initiation of Phase 2 study for BL-8040 in allogeneic stem-cell transplantation
Receipt of medical device classification for BL-7010 for celiac disease in Europe
BL-5010 for non-surgical removal of skin lesions receives CE mark and begins initial product launch in Europe
Expected upcoming significant milestones for the remainder of 2016:

Initiation of Phase 2a study for BL-8040 in combination with KEYTRUDA, in patients with metastatic pancreatic cancer, expected mid-year
Full set of data from Phase 2a study for BL-8040 in r/r AML to be provided at an upcoming US-based scientific conference
Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by end of 2016
Initiation of efficacy study in gluten sensitivity for BL-7010
Roll-out of BL-5010 product launch by Omega to additional countries and selection of 2nd OTC indication for development
Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "During the first quarter of 2016, we made significant progress in advancing BL-8040, our lead oncology platform. We announced successful results in our Phase 2a study for relapsed and refractory AML and we continue to push forward in our Phase 2b trial in an earlier treatment line for AML – as a consolidation treatment following standard induction treatment. We also announced our entering into the exciting field of immuno-oncology, through our collaboration with Merck on a Phase 2a study to investigate BL-8040 in combination with KEYTRUDA for the treatment of pancreatic cancer. In addition, we are progressing with our strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates. Novartis has flagged several pre-clinical projects, which we intend to bring into our pipeline over the next few months. With $45 million of cash on our balance sheet as of the end of the first quarter, we are well positioned to carry out our strategic and operational plans through the end of 2018, and look forward to achieving our expected milestones during the second half of 2016."

Financial Results for First Quarter Ended March 31, 2016

Research and development expenses for the three months ended March 31, 2016 were $2.5 million, a decrease of $0.7 million, or 20.9%, compared to $3.2 million for the three months ended March 31, 2015. The decrease resulted primarily from the conclusion of one of the clinical trials for BL-8040 in 2015, and the wind-down of a second clinical trial for BL-8040 during the 2016 period.

Sales and marketing expenses for the three months ended March 31, 2016 were $0.2 million, substantially similar to the comparable period in 2015.

General and administrative expenses for the three months ended March 31, 2016 were $1.0 million, an increase of $0.1 million, or 15.5%, compared to $0.9 million for the three months ended March 31, 2015. The small increase was the cumulative effect of an increase in several categories of expenses, none of which individually was material.

The Company’s operating loss for the three months ended March 31, 2016 amounted to $3.8 million, compared with an operating loss of $4.3 million for the corresponding 2015 period.

Non-operating income (expenses) for the three months ended March 31, 2016 and 2015 were not material, and primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

Financial income (expenses), net for the three months ended March 31, 2016 and 2015 were not material, and primarily relate to investment income earned on bank deposits, as well as banking fees.

The Company’s net loss for the three months ended March 31, 2016 amounted to $3.5 million, compared with a net loss of $4.3 million for the corresponding 2015 period.

The Company held $45.0 million in cash, cash equivalents and short-term bank deposits as of March 31, 2016

Net cash used in operating activities was $4.2 million for the three months ended March 31, 2016, compared with net cash used in operating activities of $3.5 million for the 2015 period. The $0.7 million increase in net cash used in operating activities was primarily the result of a decrease in trade payables and accruals.

Net cash provided by investing activities for the three months ended March 31, 2016 was $1.7 million, compared to net cash used in investing activities of $20.7 million for the corresponding 2015 period. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the three months ended March 31, 2016 was $1.6 million, compared to net cash provided by financing activities of $26.5 million for the corresponding 2015 period. The decrease in cash flows from financing activities reflects the underwritten public offering completed by the Company in March 2015.