On April 25, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported the United States Patent and Trademark Office has granted a method of use patent for CLR 1501, CLR 1502 and an additional CLR 1401-boron-dipyrromethene analog for the detection of multiple cancer types (Press release, Cellectar Biosciences, APR 25, 2017, View Source [SID1234518684]). All of these compounds utilize Cellectar’s proprietary phospholipid drug conjugate (PDC) delivery platform.

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The recently issued patent, 9,616,140, outlines the method of use of these fluorophore compounds to detect a variety of solid tumors in patients, including melanomas, colorectal adenocarcinoma, uterine carcinoma, pancreatic carcinoma, ovarian adenocarcinoma, glioblastoma, clear cell carcinoma, and prostate adenocarcinoma. The current patent provides intellectual property protection through May 11, 2029.

"We continue to successfully execute our plan to expand the company’s intellectual property portfolio to protect and enhance the value of our PDC pipeline assets, both in diagnostic and therapeutic applications," said Jim Caruso, president and CEO of Cellectar. "While our focus continues to be the development of our therapeutic assets, specifically CLR 131, for the treatment of multiple myeloma and other hematologic malignancies, our platform assets offer significant additional opportunity in a variety of clinical applications."

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

On April 25, 2017 Circle Pharma , Inc. reported that it has completed an expansion of its Series A financing, with new investors WI Harper Group, Elements Partners, LLC, Whitesun Healthcare Ventures Limited and LifeForce Capital joining the round (Press release, Circle Pharma, APR 25, 2017, View Source [SID1234635668]). Mission Bay Capital led Circle’s Series A, with Pfizer Inc. (NYSE:PFE), ShangPharma Investment Group, Ltd. and a syndicated group of individual investors subscribing at the initial close. With this subsequent closing, a total of approximately $6.5M of shares of Circle’s Series A Preferred Stock has been issued in the Series A financing.

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"We are gratified to have this new group of high-caliber investors joining our first equity financing," said David J. Earp, J.D., Ph.D., Circle’s president and CEO. "The funds will support Circle’s platform development and our therapeutic pipeline, which is focused on intracellular protein-protein interactions that are key drivers in oncogenic pathways. This is an exciting time for Circle. We are adding new targets to our pipeline, including MCL1 and the substrate binding site of cyclinA / cdk2, both of which are important oncology targets that have proven challenging for small molecule drug development. Our chemistry process development work has recently successfully achieved key steps required for a more highly automated synthesis platform. Finally, with support from Pfizer, we are building a physical library of macrocycles which are predicted to have optimized permeability. This library will complement our rational design/virtual library screening approach. We will begin synthesis of the physical library shortly, enabling us to deliver it to Pfizer, and potentially other collaborators, for screening use later this year. We are especially delighted to welcome James Lu to our board in connection with this expanded Series A investment. He brings deep experience building high-growth, global companies both as an investor and in management roles."

Mr. Lu is a Managing Director of WI Harper, a cross border venture capital firm investing in leading healthcare and technology startups in the U.S. and China. Previously, Mr. Lu co-founded and was a General Partner of iD Ventures America (formerly Acer Technology Ventures), which managed several funds that were early investors in companies such as iRobot (NASDAQ:IRBT); Harmonix Music (acquired by MTV/Viacom (NYSE:VIA)); and Monolithic Power Systems (NASDAQ:MPWR). In prior roles, Mr. Lu was General Counsel of the Acer Group and earlier was a corporate and commercial attorney with the McCutchen law firm in San Francisco and a banker at JP Morgan in New York. Mr. Lu graduated with a BA from Yale College, an MBA from Harvard Business School and a JD from UC Berkeley School of Law.

Peter Liu, Founder and Chairman of WI Harper Group commented, "We are seeing excellent opportunities for investing in ground-breaking life science companies that are advancing new technologies and addressing unsolved problems. Circle Pharma is one such company; we are pleased to participate in their Series A financing and look forward to building a strong relationship with the management team and the other investors."

"Completion of Circle’s Series A financing strengthens Circle’s investor base and brings additional depth on the technical side, relations with strategic partners and, with WI Harper and Elements, connections to activities and initiatives outside of the U.S., and especially in key Asia markets," said Douglas Crawford, Ph.D., managing director of Mission Bay Capital.

About Macrocyclic Peptides
Macrocyclic peptides have the potential to allow drug developers to address the large proportion of known therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited by the need for a greater understanding of how to develop macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Circle is applying its ability to design potent macrocycles with intrinsic cell permeability and drug-like characteristics to unlock access to challenging, high value therapeutic targets that have been out of reach to other approaches.

On April 25, 2017 Immune Therapeutics, Inc. (OTCQB: IMUN), a clinical-stage biopharmaceutical company developing therapies for a range of conditions using LodonalTM its proprietary formulation of lower-dose naltrexone, reported it has submitted its New Drug Application (NDA) to the Pharmacy and Poison Board (PPB) in Kenya for Lodonal for the treatment of patients with HIV and cancer, both as a standalone treatment as well as an adjunct treatment, and as an immunomodulator (Press release, TNI BioTech, APR 25, 2017, View Source [SID1234518733]).

"This NDA submission initiates the process we believe will result in broad access to our therapy for those suffering from immune deficiency disease and cancer." said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. "We recognize the difficulty the immune-comprised community has had in obtaining affordable non-toxic therapies and look forward to working closely with the PPB as they review our application."

A full preclinical and clinical study program supports the filing including: four clinical efficacy trials involving more than 500 HIV/AIDS patients, and one clinical trial with 89 patients for cancer and over 1,200 patients with autoimmune disease. The clinical data showed that Lodonal could improve CD4 count, decrease viral load and reduce the number of opportunistic infections in patients suffering from comprised immune systems.

Omaera Pharmaceuticals, Ltd. and GB Pharma Holding supported this filing. "Without their support, the fast track of this process would not have been possible." noted Griffin. The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. "The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement." concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.

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"We look forward to a smooth regulatory process for Lodonal in Kenya. We have significant experience with Kenya’s PPB and have meetings planned with the Ministry of Health before the end of the month." notes Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings of Washington, DC.

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 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.