On June 24, 2019 City of Hope, a world-renowned independent research and treatment center for cancer, reported plans to invest more than $1B to develop and support a new comprehensive cancer campus at FivePoint Gateway in Orange County, accelerating highly specialized cancer care, phase I-III clinical trials, and precision medicine and early detection to the nation’s sixth most populous county (Press release, City of Hope, JUN 24, 2019, View Source [SID1234537253]). This unprecedented initiative in Orange County is part of City of Hope’s commitment to speeding pioneering treatments and scientific breakthroughs to the people who need them today.

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Last year, City of Hope and FivePoint announced their partnership to build a $200 million, 73,000-square-foot cancer center in FivePoint’s Great Park Neighborhoods by 2025. As planning progressed, FivePoint and City of Hope expanded their vision for the Great Park as a model community of the future with easily accessible world-class health and wellness as a core offering. In line with this vision, City of Hope significantly increased its investment with a focus on highly specialized cancer care, research and lifesaving treatments.

Now a space as big as the vision, the cancer campus on approximately 11 acres of land at FivePoint Gateway in Irvine will include an approximately 190,000-square-foot building that will be a center of innovative cancer research and treatments. This increased investment cuts City of Hope’s time to build the new campus by half, with the center expected to open its doors in 2021.

City of Hope officials cite several reasons for an expanded presence in the region. Nearly 20% of residents leave the area for advanced care, with many heading to City of Hope’s main campus in Duarte, California – an up to two-hour commute away. In addition, despite its reputation for healthy living, Orange County is not immune from the one-in-three national statistic for cancer incidence. In fact, the cancer incidence rate in the county is projected to increase by 18% over the next decade. Cancer risk increases with age and the county’s population is aging faster than the U.S. average.

City of Hope is answering the call to extend its personalized care, outstanding research and lifesaving treatments closer to home with the same sense of urgency as its scientists who find and deliver cures. The City of Hope cancer campus is planned to include:

Orange County’s only specialty hospital dedicated solely to treating and curing cancer.
An outpatient cancer center offering diagnostic imaging and screenings, precision medicine and early detection, medical oncology, chemotherapy, radiation therapy, surgical oncology and ambulatory surgery.
A clinical research center offering phase I-III clinical trials.
Personalized supportive care services that include palliative care physicians, psychiatrists, social workers and others who partner with patients and their families to address the many physical and emotional issues that can arise during and after treatment. City of Hope is the model for other institutions across the country.
Access to a wide range of solid tumor and blood cancer specialists dedicated to finding the best treatments for each patient.
This campus will be an extension of City of Hope in Duarte, providing access to highly specialized cancer experts and treatment for the most complex cases, such as bone marrow transplants, stem cell transplants and CAR T cell therapy.

City of Hope Orange County will include additional clinical locations that will provide medical oncology and infusion services, ensuring easy access to care throughout the region. As previously announced, City of Hope is planning to open its Newport Beach facility later this year, providing residents with a more convenient way to receive leading-edge medicine.

Science that is saving lives:

Each year, more than 100 million people benefit from discoveries made at City of Hope and patients from around the world are treated at its main campus in Duarte and at the 30 locations in its clinical network.
City of Hope is currently conducting more than 500 clinical trials and its internationally respected scientists and clinical experts collaborate across disciplines to turn science into practical benefit.
City of Hope’s research has saved lives around the world; four of the most widely used cancer drugs are based on technology pioneered by City of Hope, and the organization is a pioneer in bone marrow and stem cell transplants.
City of Hope is one of only 49 comprehensive cancer centers in the nation, as designated by the National Cancer Institute.
As one of the nation’s leading independent research clinical enterprises, City of Hope’s clinical network also includes three good manufacturing practice (GMP) facilities and, through an affiliation with Translational Genomics Research Institute (TGen), advances in genomics technologies for the application of precision medicine.
With City of Hope’s unique approach to care, physicians and scientists are connected through a powerful research environment that speeds the development of new drugs and interventions to the bedside, allowing patients to receive the latest treatments in cancer care.
Supporting quotes:

Robert Stone, president and CEO, City of Hope

"This is a time of great promise and innovation in cancer research and care, and we are bringing that excitement and expertise to Orange County. City of Hope is dramatically expanding to provide a cancer network of unparalleled scale for this community. It will be a nexus of service, science and care. It is made possible by our partnership with FivePoint Holdings and a strong community of philanthropic supporters in Orange County and beyond, who stand shoulder to shoulder with us in our determination to eradicate cancer."

Annette M. Walker, president, City of Hope Orange County

"We’ve spent the last year listening intently to the people in Orange County and identifying how we can contribute to meeting both the present and future community needs. It became evident that we needed to bring our highly specialized treatments as soon as possible. We’re delivering on our promise and opening our doors faster to alleviate the unnecessary hardships on patients and their families. Residents soon will be able to access City of Hope’s latest and most advanced therapies closer to home."

Michael Caligiuri, M.D., president, City of Hope National Medical Center, and the Deana and Steve Campbell Physician-in-Chief Distinguished Chair in Honor of Alexandra Levine, M.D.

"City of Hope researchers are working every day to speed novel cancer drugs and immune cell therapies from our laboratories into the clinic for our patients. With more than 500 clinical trials and world-class experts across cancer types, City of Hope is changing the landscape of cancer care. Our expansion into Orange County provides greater access to our highly specialized medical expertise and to the next generation of promising cures and treatments."

Emile Haddad, Chairman and CEO, FivePoint Holdings LLC

"At FivePoint, we believe in creating places that offer equal access to the most important aspects of our lives. Building a sustainable society that moves humanity forward goes beyond building structures for housing, schools and recreation. It includes creating spaces where the body, mind and soul get strengthened together. Because it takes a village to build a community, FivePoint is constantly searching for partners that innovate and shape the future of how people will live. As FivePoint considered the importance of wellness, it was clear that City of Hope is the ideal partner to bring world-class cancer treatment and research to Irvine and Orange County."

For updates on the initiative, or to become a volunteer or philanthropic partner of City of Hope Orange County, go to CityofHope.org/OC.

On June 24, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the closing of its initial public offering of 9,109,725 shares of common stock at a public offering price of $17.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,188,225 additional shares of common stock (Press release, Personalis, JUN 24, 2019, View Source [SID1234537252]). All of the shares of common stock were offered by Personalis. Personalis estimates net proceeds from the offering to be approximately $140.8 million, after deducting underwriting discounts and commissions and estimated offering expenses. The company’s stock began trading on The Nasdaq Global Market on June 20, 2019 under the trading symbol "PSNL."

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Morgan Stanley, BofA Merrill Lynch and Cowen acted as joint book-running managers of the offering. Oppenheimer & Co. Inc. acted as co-manager of the offering.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission and was declared effective on June 19, 2019. A copy of the final prospectus relating to this offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; BofA Securities, Inc., Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 631‐274‐2806.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 24, 2019 Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), reported that the United States Food and Drug Administration (FDA) has approved a new pre-filled syringe for Somatuline Depot (lanreotide) (Press release, Ipsen, JUN 24, 2019, View Source [SID1234537251]).1 The syringe includes updated features, such as larger flanges, designed to help make it easier for healthcare providers to administer the injection.1 The indications remain the same as those for the previous pre-filled syringe and include the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy; and the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Please see Important Safety Information below and accompanying full Prescribing Information.

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"The conditions of GEP-NETs and acromegaly can be associated with a number of uncomfortable and unpleasant symptoms, and innovation aimed at improving the injection process is a step forward," said Daphne Adelman, Clinical Nurse Specialist, Northwestern University, Chicago, and one of the authors of the study.

Ipsen conducted five separate but complementary studies in partnership with patients, their caregivers, nurses and other healthcare professionals to better understand the current use of the existing Somatuline Depot pre-filled syringe and to evaluate ways to improve the features of the device.1 The result of this collaboration is a redesigned delivery system intended to make it easy to grip the syringe and administer the injection. The new syringe features a needle shield removal system, more stable plunger and thermoform tray that has recessed areas designed to help prevent accidental plunger depression.1 The built-in safety system, which may help to prevent needle stick injury by locking in place following the administration, has not been changed.1

"We consistently look for opportunities to respond to the needs of the communities we serve, and this approval would not have been possible without the direct involvement of nurses and the patients with GEP-NETs and acromegaly whom they treat," said Bradley Bailey, SVP, and Franchise Head Oncology/Endocrinology Business Unit at Ipsen. "We listened and collaborated to enhance the existing pre-filled syringe, making it sturdier for healthcare providers when administering treatment, with the intention of improving the injection process. We look forward to bringing this innovation to healthcare providers for their patients soon."

The new pre-filled syringe is for deep subcutaneous injection and is intended for administration by a healthcare professional. Healthcare providers can expect to receive the new syringe during Q3 2019. The device is approved for use in the U.S., EU and additional ex-U.S. markets.

ABOUT NETs

A neuroendocrine tumor (NET) begins in the hormone-producing cells of the body’s neuroendocrine system, which is made of cells that are a combination of hormone-producing endocrine cells and nerve cells.2 NETs are a group of uncommon tumors occurring in both men and women aged 50 to 60 years old although they can affect anyone of any age.2

The three main areas where NETs are found in the body are the gastrointestinal tract, the pancreas and the lungs.2

Gastrointestinal NETs (GEP-NETs) are found in the gastrointestinal tract or digestive system and are the most common type of NETs.2
Pancreatic NETs (pNETs) are formed in the islet cells of the pancreas and include several uncommon types of NETs.2
Lung NETs are less common than other types, accounting for about one quarter of NETs.2
The symptoms of NETs are often not distinct and difficult to identify, and average time from initial onset of symptoms to proper diagnosis can take more than 5 years.3 Although NETs affect only a small percentage of the general population at any one time, the number of people being newly diagnosed with NETs overall is believed to be rising.2 This is mainly due to increased awareness of the condition and diagnostic testing.2 NETs are now the fastest growing class of cancers worldwide, accounting for around 2% of all cancers at any time.2

ABOUT ACROMEGALY

Acromegaly is an uncommon hormonal or endocrine disorder with slowly developing, but eventually distinct clinical symptoms.4 In the U.S., approximately 3,500 new cases of acromegaly are diagnosed each year.5

It is usually caused by having too much growth hormone in the body which, over time, results in some characteristic symptoms and signs, such as heavy or prominent facial features with a prominent jaw line and enlarged hands and feet.4

ABOUT SOMATULINE DEPOT

SOMATULINE DEPOT (lanreotide) is a somatostatin analog indicated for:

the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option; the goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal;
the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and
the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
IMPORTANT SAFETY INFORMATION

Contraindications

SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
Warnings and Precautions

Cholelithiasis and Gallbladder Sludge
SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation.
Periodic monitoring may be needed.
If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately
Hypoglycemia or Hyperglycemia
Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
Cardiovascular Abnormalities
SOMATULINE DEPOT may decrease heart rate.
In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension.
In patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia.
In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
Thyroid Function Abnormalities
Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients.
Thyroid function tests are recommended where clinically appropriate.
Monitoring/Laboratory Tests: In acromegaly, serum GH and IGF-1 levels are useful markers of the disease and effectiveness of treatment.
Adverse Reactions

Acromegaly: Adverse reactions in >5% of patients who received SOMATULINE DEPOT were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reactions (9%), constipation (8%), flatulence (7%), vomiting (7%), arthralgia (7%), headache (7%), and loose stools (6%).
GEP-NETs: Adverse reactions >10% of patients who received SOMATULINE DEPOT were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).
Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions occurring in ≥5% of patients who received SOMATULINE DEPOT and at least 5% greater than placebo were headache (12%), dizziness (7%), and muscle spasm (5%).
Drug Interactions: SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).

Special Populations

Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
Moderate to Severe Renal and Hepatic Impairment: See full prescribing information for dosage adjustment in patients with acromegaly.
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for the full Prescribing Information and Patient Information.

On June 24, 2019 Gilead Sciences, Inc. (NASDAQ: GILD) and Carna Biosciences Inc. (JASDAQ: 4572) reported that the companies have entered into a research and development collaboration to develop and commercialize small molecule compounds in immuno-oncology and to access Carna’s proprietary lipid kinase drug discovery platform (Press release, Gilead Sciences, JUN 24, 2019, View Source [SID1234537246]).

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This press release features multimedia. View the full release here: View Source

Under the terms of the license agreement, Gilead will license from Carna worldwide rights to develop and commercialize inhibitors against an undisclosed immuno-oncology target. In connection with this agreement, Carna will receive an upfront payment of $20 million and is eligible to receive up to an additional $450 million in potential milestone payments upon achievement of certain development and commercial milestones. Carna will also receive royalties on future net sales.

"We are delighted to partner with Gilead on our immuno-oncology pipeline targeting the lipid signaling pathway, as we believe modulators of lipid signaling have the potential to become the next generation of cancer immunotherapies," said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences.

Under the collaboration, Gilead will also have exclusive access to Carna’s proprietary lipid kinase drug discovery platform.

"We are excited to work with Gilead, a biopharmaceutical company known for its science-driven innovation and productivity," said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences. "We are proud that our drug discovery support team can also help the development of potentially innovative cancer immunotherapies at Gilead by utilizing Carna’s proprietary kinase drug discovery technology platform."

"Gilead is committed to building a pipeline in immuno-oncology with a focus on opportunities with the potential to be first-in-class or to be meaningfully differentiated from other therapeutic options," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. "Our Carna collaboration also reflects this strategy and we look forward to working with the Carna team to advance novel immunotherapies into clinical testing for the potential benefit of patients."

On June 24, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported that its Supervisory Board has appointed Jean-Paul Kress, M.D., as its new Chief Executive Officer (CEO) (Press release, MorphoSys, JUN 24, 2019, View Source [SID1234537240]). The appointment will take effect on September 1, 2019.

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Dr. Kress brings over 20 years of experience in the pharmaceutical and biotechnology industry, with a strong track record of commercial and operational leadership in various senior management roles in North America and Europe. His focus has been on operations, corporate development and especially the commercialization of innovative products addressing unmet medical needs across diverse disease indications. Prior to joining MorphoSys, Dr. Kress served as Chief Executive Officer at Syntimmune, a clinical-stage biotechnology company developing differentiated drug candidates in a wide range of autoimmune diseases, which was acquired by Alexion in November, 2018. Previously, he acted as Head of North America at Sanofi Genzyme, where he was instrumental in launching dupilumab, the first biologic agent approved in atopic dermatitis.

In his new position, Dr. Kress will succeed Dr. Simon Moroney, who will step down as CEO on September 1, 2019. Dr. Moroney will support Dr. Kress during a transition period.

"I am delighted to welcome Jean-Paul Kress as the new CEO of MorphoSys." said Dr. Marc Cluzel, Chairman of the Supervisory Board of MorphoSys. "He is a seasoned and highly experienced pharma executive with a strong commercial and operational track record. MorphoSys is at an inflection point of its business evolution, bringing its first product to the market and establishing a commercial presence in the U.S. Jean-Paul’s industry expertise will perfectly complement the experienced MorphoSys Management Board to ensure successful execution on the key business priorities while continuing to grow shareholder value."

"On behalf of the entire Supervisory Board, I want to express our sincere gratitude to Simon Moroney for fulfilling the role as CEO over the past 27 years. His tireless efforts for MorphoSys have contributed substantially to making it the biopharmaceutical success story that it is today." Marc Cluzel continued.

"I am excited and privileged to be the next CEO of MorphoSys, and I appreciate the confidence that the Supervisory Board has placed in me," commented Jean-Paul Kress. "This is a dynamic and outstanding time for MorphoSys, and I look forward to working with my new colleagues to deliver innovative medicines to patients all over the globe and contribute to MorphoSys becoming a fully integrated biopharmaceutical company."

Dr. Moroney said, "I am immensely proud of everything we have achieved over the past 27 years since MorphoSys was founded. MorphoSys is stronger than it has ever been and now is an excellent time to make the transition to a new CEO. With Jean-Paul’s medical, commercial and leadership expertise I have every confidence that MorphoSys will make great strides in the execution of its strategy."

About Jean-Paul Kress
Dr. Jean-Paul Kress has a proven track record of senior leadership positions in the biopharma and biotechnology industry. Prior to joining MorphoSys, Dr. Kress served as Chief Executive Officer at Syntimmune, a clinical-stage biotechnology company developing differentiated drug candidates in a wide range of autoimmune diseases. Before, he acted as Executive Vice President and Head of Global Therapeutic Operations at Biogen and Senior Vice President, Head of North America at Sanofi Genzyme, where he was instrumental in launching several therapeutic products, including dupilumab, the first biologic agent approved in atopic dermatitis. He gained further experience in positions at Sanofi Pasteur MSD, Gilead, Eli Lilly and Abbvie. Dr. Kress received an M.D. degree from Faculté Necker-Enfants Malades in Paris, and graduate and post-graduate degrees in pharmacology and immunology from École Normale Supérieure in Paris.