On April 25, 2017 Servier and CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) jointly reported that they agreed to expand their existing license and development collaboration agreement for PIXUVRI (pixantrone) (Press release, CTI BioPharma, APR 24, 2017, View Source;p=RssLanding&cat=news&id=2264222 [SID1234518679]). Under this expanded agreement, Servier will have rights to PIXUVRI in all markets except the US, where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million with the potential for CTI BioPharma to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.

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PIXUVRI has been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).i As a specific post-authorization requirement, PIXUVRI is currently being investigated in a Phase III clinical trial, PIX306. If positive, the results from this trial will confirm the treatment’s current indication and could support broader indications.

In 2014, CTI granted Servier rights to commercialize the drug globally except in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, UK and the US. With this expanded agreement, which provides Servier’s rights to all markets except the US, the companies will continue to work closely together to build the efficacy and safety evidence for PIXUVRI and to ensure that as many eligible patients as possible are benefitting from it.

"Over the past three years, we have worked hand in hand with our partner, CTI BioPharma, to bring new treatment options to patients in Europe," said U. Marion Schrenk, MD, Head of Therapeutic Area Oncology of Servier. "We are looking forward to leveraging our expertise in these additional markets to ensure more eligible patients have access to PIXUVRI. Oncology is an important focus for us, and we are fully committed to working with our partners, researchers and scientists to provide patients with novel therapeutic options in areas with high unmet needs."

"Servier is an important strategic partner for us and has helped bring PIXUVRI to many patients," said Adam R. Craig, President and CEO of CTI BioPharma. "We look forward to our expanded partnership as we aim to complete the PIX306 trial in the near-term."

About PIXUVRI (pixantrone)
PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells in B-cell NHL cannot divide and eventually die.ii

PIXUVRI is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.

The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.servier.com.

About NHL
NHL is an uncommon type of cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.iii The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.iv

Around 93,500 new cases of NHL were diagnosed in Europe in 2012, making it the eleventh most common cancer on the continent.v

NHL comprises more than 60 subtypes, with each requiring a different diagnostic evaluation and treatment approaches. Lymphoma patient groups around the world, led by the umbrella group Lymphoma Coalition, have been recently calling for accurate subtype reporting to allow patients to clearly understand their subtype and have better communication with their doctors. Given the complexities of the condition, access to information is essential to empower patients.

On April 24, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) reported that it will publish its first three months’ 2017 results on May 3, 2017 at 7:00 am CEST (Press release, MorphoSys, APR 24, 2017, View Source [SID1234556343]).

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At 3:00 pm CEST (2:00 pm BST, 9:00 am EDT), the Management Board of MorphoSys AG will host a public conference call and webcast to present MorphoSys’s first quarter interim statement 2017 and provide further details on the Company’s latest developments.

Dial-in numbers (listen only):

Germany: +49 89 2444 32975

United Kingdom: +44 20 3003 2666

USA: +1 202 204 1514

We request that you please dial in up to 10 minutes before the call to ensure a prompt start and a secure line.

The presentation slides and webcast link will be available at the Company’s website at www.morphosys.com/conference-calls
A slide-synchronized audio replay of the conference will also be available at the corporate website following the live event.

The Annual General Meeting of MorphoSys AG will take place on May 17, 2017 in Munich. A live webcast of the event and all related information are available on www.morphosys.com/agm.

On April 20, 2017 Polaris Group reported that its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) in combination with pemetrexed and cisplatin (ADIPemCis) demonstrated a good safety profile and a strong efficacy signal in argininosuccinate synthetase (ASS1) deficient malignant pleural mesothelioma (MPM) and non-small cell lung carcinoma (NSCLC), as reported in the Journal of Clinical Oncology (Press release, Polaris Pharmaceuticals, APR 20, 2017, View Source [SID1234526286]). In the first nine patients (5 MPM, 4 NSCLC) enrolled in the dose escalation cohorts of this biomarker-directed phase 1 study, partial response was seen in 7 patients (4 MPM, 3 NSCLC). The study was led by Dr. Peter Szlosarek of Barts Cancer Center, Queen Mary University of London, and involved multiple sites in the United Kingdom.

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The main goal of this phase 1 study is to determine the recommended phase 2 dose, safety and tolerability of ADIPemCis in patients with ASS1-deficient MPM and NSCLC. The nine enrolled patients were treated with fixed-dose pemetrexed and cisplatin (PemCis), the standard first-line chemotherapy for MPM and NSCLC, in combination with increasing doses of ADI‑PEG 20. The treatment appeared to be safe and well tolerated. Notably, three out of four MPM patients with a partial response had non-epithelioid tumor histology, which carries an unfavorable prognosis and historically responded poorly to chemotherapy.

"Based on the encouraging efficacy signal from these preliminary results, we have initiated a randomized, double blind, phase 2/3 trial comparing ADIPemCis with PemCis in patients with non-epithelioid MPM," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "With ADIPemCis, we hope to bring an effective treatment to this subset of MPM patients, who have a dire need for medical intervention."

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

On April 20, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that an abstract highlighting the Company’s proprietary drug development platform technology, PolyXen, which is designed to improve the half-life and other pharmacological properties of biologic drugs, has been accepted for a scientific poster presentation at the 13th Annual PEGS Boston conference to be held May 1-5th, 2017 in Boston, MA (Press release, Xenetic Biosciences, APR 20, 2017, View Source [SID1234537801]).

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The poster presentation details are as follows:

Title: "Polysialylation – A Platform Technology for Enhancing Therapeutic Proteins and Its Clinical Application"
Authors: He Meng, Curtis Lockshin, Sanjay Jain, Dmitry Genkin, Umesh Shaligram, Joseph Martinez, David B Hill, Camille Ehre, Henry Hoppe IV
Date: May 1-2, 2017
Location: Poster Session A

The poster will be accessible following the conference on the Publications page of the Company’s website, www.xeneticbio.com.

On April 19, 2017 CytRx Corporation (NASDAQ: CYTR) reported the U.S. Food and Drug Administration (FDA) has reached an agreement with CytRx on preparations for a New Drug Application (NDA) submission for aldoxorubicin in soft tissue sarcomas (STS) (Press release, CytRx, APR 19, 2017, View Source;p=RssLanding&cat=news&id=2262830 [SID1234518613]). STS remains a high unmet medical need.

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"We are very pleased to have achieved clarity from the FDA regarding CytRx’s soft tissue sarcoma program," said Daniel Levitt, MD, PhD, Chief Operating Officer and Chief Medical Officer. "The FDA agreed that CytRx could use the application pathway for its filing that has been successfully used previously by the oncology drugs Abraxane, Doxil and Onivyde. Our interaction with the FDA was part of a continued collaborative and productive relationship with the Agency. We look forward to providing the study reports and analysis that can lead to the approval of aldoxorubicin for the treatment of patients with soft tissue sarcomas."

The Company’s goal is to submit a rolling NDA under section 505(b)(2) to the FDA for soft tissue sarcomas in the last quarter of 2017. CytRx also plans to discuss with the European Medicines Agency (EMA) a path to filing a Marketing Authorization Application (MAA). The commercial launch of aldoxorubicin is still projected for 2018 in the United States. Aldoxorubicin has received Orphan Drug Designation by the FDA for the treatment of STS. Orphan designation provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.

The proposed product label would include the treatment of soft tissue sarcomas. New data could allow future use of aldoxorubicin in neoadjuvant (pre-surgery) settings, as well as a replacement for doxorubicin in combinations. CytRx is also working on a market expansion strategy which could include other indications for aldoxorubicin including combinations with other chemotherapeutics and immunotherapies.

CytRx is under confidentiality agreements with a number of companies for a commercial partnership for the marketing of aldoxorubicin. The Company believes those active discussions may be further advanced by this latest news.

About a 505(b)(2) New Drug Application

A new drug application (NDA) under the Food and Drug Administration’s (FDA) section 505(b)(2) is for a new drug containing similar active ingredients as a previously approved drug. According to the publication Regulatory Focus, a drug reviewed under 505(b)(2) represents a modified version of a previously approved product that requires additional clinical and nonclinical studies, other than bioavailability/bioequivalence studies, to demonstrate safety and efficacy. Such an application differs from a typical NDA in that the sponsor can rely on, at least in part, the FDA’s findings of safety and/or effectiveness for a previously approved reference drug.

About the Phase 2b and Phase 3 Clinical Trials

The Phase 2b trial involved 123 patients at 31 sites. Patients with advanced soft tissue sarcomas were randomized 2:1 to receive either 350 mg/m2 of aldoxorubicin (83 patients) or 75 mg/m2 of doxorubicin (40 patients) every 3 weeks for up to 6 cycles. The trial was designed to compare aldoxorubicin directly with doxorubicin.

The randomized, controlled Phase 3 trial enrolled a total of 433 patients at 79 clinical sites. Patients with metastatic, locally advanced or unresectable soft tissue sarcomas who had either not responded to, or who had progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapy were randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient), or gemcitabine plus docetaxel.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue. It can arise anywhere in the body at any age. STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer. According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the U.S. and approximately 5,000 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

Aldoxorubicin is a rationally engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream. Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of the drug well in excess of 5,000 mg/m2. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS.