SignalRx to Present at the 12th Annual Drug Discovery Chemistry 2017 Meeting on its First-In-Class Triple PI3K/CDK4-6/BRD4 Inhibitor SRX3177 for Treating Cancer

On April 25, 2017 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics to inhibit key orthogonal and synergistic oncotargets for the treatment of cancer, reported the presentation of its novel triple PI3K/CDK4-6/BRD4 inhibitor program and first-in-class triple inhibitor SRX3177 (Press release, SignalRx, APR 25, 2017, http://www.ireachcontent.com/news-releases/signalrx-to-present-at-the-12th-annual-drug-discovery-chemistry-2017-meeting-on-its-first-in-class-triple-pi3kcdk4-6brd4-inhibitor-srx3177-for-treating-cancer-620334743.html [SID1234527323]). The presentation by Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, will be at 5pm on Tuesday April 25th, 2017, in the Fragment-Based Drug Discovery session at the Drug Discovery Chemistry 2017 meeting in San Diego, CA.

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Using SignalRx’s proprietary CRIMP technology platform, the company developed SRX3177 to simultaneously inhibit three key cancer-driving oncotargets: PI3K, CDK4-6 and BRD4. Cancer biology has demonstrated that PI3K inhibition abrogates resistance to CDK4/6 inhibition, and the combined CDK4/6 and PI3K inhibition leads to synthetic lethality in a number of cancer types (e.g., breast cancer, mantle cell lymphoma). BRD4 is a key epigenetic target that drives many cancers and the transcription of cyclin D1 and MYC, the latter in turn drives the immuno-oncology targets CD47 and PD-L1. The simultaneous inhibition of PI3K/CDK4-6/BRD4 with a single molecule presents the opportunity to deliver synthetic lethality to cancers dependent on these onco-pathways where kinase resistance is also developed.

The presentation will cover the discovery and in silico design of the small-molecule triple inhibitor SRX3177. Key highlights to be presented include:

Potent target profile (IC50: CDK4/6 = 2-3 nM; PI3Kα/δ @ 80 nM, BRD4-BD1 = 33 nM, BRD4-BD2 = 89 nM).
In silico design.
Cell cycle arrest and apoptosis induction.
Biomarkers (p-AKT, p-Rb, BRD4-chromatin release).
82-Fold more potent than FDA-approved palbociclib against mantle cell lymphoma, neuroblastoma, and hepatocellular carcinoma cells.
5-Fold more potent in cancer cells than combination of palbociclib (CDK4/6 inhibitor) + BKM120 (PI3K inhibitor) + JQ1 (BRD4 inhibitor).
Much safer with 40-fold less toxicity to normal epithelial cells vs palbociclib + BKM120 + JQ1.
SignalRx is also seeking partnering opportunities to accelerate the development of its programs and advance novel anticancer therapeutics into first-in-man clinical trials based on the promising profile and mode of action of its inhibitors. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to streamline their development alone and in combination therapies.

TESSA THERAPEUTICS AND VYRIAD FORM PARTNERSHIP TO CREATE NEXT GENERATION OF CANCER IMMUNOTHERAPY TREATMENTS

On April 25, 2017 Tessa Therapeutics, an immunotherapy company dedicated to revolutionizing the treatment of cancer, and Vyriad, an oncolytic virotherapy company using engineered viruses to destroy tumors and boost the antitumor immune response, reported a collaboration that will enable Tessa and Vyriad to investigate T cell and oncolytic virus combination therapies (Press release, Vyriad, APR 25, 2017, View Source [SID1234527874]). The combination of these two therapies is highly synergistic and has the potential to target a wide range of solid tumors with increased efficacy.

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Tessa and Vyriad have signed a collaboration agreement to combinae Tessa’s HPV-specific T cells with Vyriad’s vesicular stomatitis virus (VSV) for the treatment of HPV-associated cancers such as cervical as well as head and neck cancers. Tessa is currently employing its HPV-specific T Cell technology in an FDA Phase I trial targeting these cancers, and aims to commence Phase II trials in 2017/2018. Vyriad is currently testing its oncolytic VSV technology in FDA Phase I trials. Additionally, Vyriad plans to clinically test a virus that has been engineered to drive proliferation of HPV-specific T cells in early 2018.

Whilst oncolytic viruses are known for their ability to specifically infect and destroy tumors, Vyriad’s oncolytic viruses have been engineered to express antigens to improve the immune response against the tumor. This increased antigen expression is expected to significantly enhance the efficacy of Tessa’s VSTs by improving their ability to recognize, target, and destroy cancer cells, thus making the combination of both treatments highly synergistic. Furthermore, oncolytic viruses can be engineered to express viral tumor antigens in nonvirus associated cancers, hence widening the potential range of cancers that can be targeted by Tessa’s VST-based treatments.

Andrew Khoo, co-founder and CEO of Tessa Therapeutics, commented on the partnership "We are constantly looking for ways to expand the efficacy and potential applications of our cancer treatments to benefit as many patients as possible. The combination of VSTs with oncolytic viruses is a novel approach that is entirely aligned with our philosophy of redirecting the body’s highly effective anti-viral immune response to target and destroy solid tumors."

Dr Stephen Russell, co-Founder, President and CEO of Vyriad, said "Through this partnership, Tessa and Vyriad can build on each company’s expertise to develop treatments that are more potent with broader applications. The use of engineered viruses, together with VSTs, is highly synergistic and has the potential to benefit a greater range of patients in areas of significant unmet medical need."

Servier and CTI BioPharma Expand License and Collaboration Agreement to Develop and Commercialize PIXUVRI®

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.

MorphoSys to Host Q1 2017 Conference Call on May 3, 2017

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.

Xenetic Biosciences’ PolyXen™ Platform Technology Accepted for Poster Presentation at the 13th Annual Protein Engineering Summit (PEGS) Boston

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.