On September 25, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported the European Commission (EC) has granted marketing authorization to UDENYCA (formerly CHS-1701), a pegfilgrastim (Neulasta) biosimilar (Press release, Coherus Biosciences, SEP 25, 2018, View Source [SID1234531697]). UDENYCA is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe.

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"Today’s EC approval decision is the first marketing authorization for Coherus, an important step forward in realizing our mission of increasing access to biologic treatments to patients globally," said Denny Lanfear, President and CEO of Coherus BioSciences. "This decision is the result of a concerted effort across analytical, process, manufacturing and clinical/regulatory, as well as intellectual property, the pillars of our product platform. I would like to congratulate my team and our partners for their dedication and extraordinary efforts in achieving this significant milestone."

"We look forward to the anticipated US approval later this year and to executing on a vigorous launch, supported by our strategic manufacturing partners in the United States, meeting the highest product quality and production reliability standards," said Vince Anicetti, Chief Operating Officer of Coherus BioSciences.

UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date of November 3, 2018.

About UDENYCA
UDENYCA (pegfilgrastim-cbqv), formerly CHS-1701, is a growth-colony-stimulating-factor designed to decrease the chance of infection as manifested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

UDENYCA is not yet available for commercial sale.

For more information about UDENYCA contact Coherus BioSciences Medical Information at (800) 4-UDENYCA (1-800-483-3692)

Neulasta is a registered trademark of Amgen Inc.

On September 25, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, will present a corporate overview at the Cantor Fitzgerald Global Healthcare Conference on Monday, October 1, 2018 at 9:30 a.m. Eastern time (Press release, Advaxis, SEP 25, 2018, View Source [SID1234529565]). The conference will be held October 1-3, 2018 at the InterContinental New York Barclay Hotel.

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Mr. Berlin’s presentation will be webcast live and available for replay in the Investors section of the Company’s website at www.ir.advaxis.com.

On September 25, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, will present at the following upcoming investor conferences (Press release, Aduro Biotech, SEP 25, 2018, View Source;p=RssLanding&cat=news&id=2368930 [SID1234529583]):

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Cantor Fitzgerald 2018 Global Healthcare Conference in New York, NY on Tuesday, October 2, 2018 at 3:25pm Eastern Time
Leerink Partners Roundtable Series: Rare Disease & Oncology in New York, NY on Wednesday, October 3, 2018 at 8:00am Eastern Time
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 September 25, 2018 Synlogic (Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer, and chief medical officer, will present a corporate update at the Leerink Partners Roundtable Series on Rare Diseases and Oncology at 11:30 am ET on Tuesday, October 2, 2018, in New York City (Press release, Synlogic, SEP 25, 2018, View Source [SID1234529599]).

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A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived webcast recording will be available on the Synlogic website for approximately 30 days after the event.

On September 25, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug Conjugate (PDC) product candidate, for the treatment of pediatric osteosarcoma, a rare pediatric cancer (Press release, Cellectar Biosciences, SEP 25, 2018, View Source [SID1234530174]). CLR 131 also received Rare Pediatric Disease Designation for osteosarcoma, as announced by the company on September 17, 2018.

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"Osteosarcoma is the most common type of primary bone cancer occurring most frequently in children. Currently, there are no commercially available drugs for pediatric sarcoma, including osteosarcoma," said John Friend, M.D., chief medical officer of Cellectar. "This orphan designation for osteosarcoma is the fourth such designation granted by the FDA to CLR 131 for the treatment of rare pediatric cancers in the last six months, and we look forward to evaluating CLR 131 in these deadly and underserved diseases."

The FDA grants ODD to therapies targeting conditions that affect fewer than 200,000 people in the U.S. The designation provides seven-year market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. In 2018 the FDA also granted CLR 131 orphan drug and rare pediatric disease designations for the treatments of neuroblastoma, rhabdomyosarcoma and Ewing’s sarcoma.

Cellectar plans to initiate a Phase 1 clinical study evaluating CLR 131 for the treatment of pediatric patients with osteosarcoma, Ewing’s sarcoma, rhabdomyosarcoma, neuroblastoma, high-grade glioma and lymphomas. The trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CLR 131 in pediatric patients with these cancer types. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03478462.

About Osteosarcoma

Osteosarcoma derives from bone forming mesenchymal, or connective tissue, cells and is the most commonly diagnosed primary bone malignancy among children and adolescents. The incidence is about 4.4 cases per 1 million per year in children younger than 24 years. While there is a 70% cure rate among patients with localized disease, 5-year overall survival rates are approximately 20% for among patients who develop metastatic disease. Additionally, among patients who experience disease progression or recurrence survival for is less than 30%.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in R/R MM and a range of B-cell malignancies and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2 as well as a fractionated dose of 15.625 mCi/m2 given twice over seven days in Cohort 5. All study doses and regimens have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.