Transgene to Present Additional Immunology Data from the TIME trial with TG4010 in patients with advanced lung cancer at SITC 2017

On October 30, 2017 Transgene (Paris:TNG), a biotech company that designs and develops viral-based immunotherapies, reported that it will be presenting a poster on additional immunology data generated from the randomized, placebo-controlled Phase 2b trial (TIME) that evaluated the combination regimen of TG4010 and chemotherapy in patients with advanced lung cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting 2017, in National Harbor, Maryland, November 8-12 (Press release, Transgene, OCT 30, 2017, View Source [SID1234521307]).

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Poster title: Immune mechanisms of the response to TG4010, a viral-based vaccine, in patients with advanced non-small cell lung carcinoma

• Poster ID: P137

• Date, time, location: Saturday, November 11, 2017, 12:30 – 2:00 pm and 6:30 – 8:00 pm

The abstract will be published on November 7, 2017, on the SITC (Free SITC Whitepaper) website.

All publications on TG4010 can be accessed via www.transgene.fr, Pipeline>Publications.

About TG4010
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2) in a modified Vaccinia virus (MVA).
The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC (Quoix et al. Lancet Oncol. 2015). TG4010 is currently being investigated in combination with nivolumab (ICI) for the 2nd-line treatment of advanced NSCLC (NCT02823990). A trial in 1st-line treatment of NSCLC is expected to begin at the end of 2017, evaluating the combination regimen of TG4010 + nivolumab + chemotherapy in patients whose tumors express low or undetectable levels of PD-L1.

FibroGen to Report Third Quarter Financial Results on Wednesday, November 8, 2017

On October 30, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported that it will report financial results for the third quarter of 2017 on Wednesday, November 8, 2017, after market close, and will host a conference call to discuss financial results and provide a business update at 5:00 p.m. ET (2:00 p.m. PT) (Press release, FibroGen, OCT 30, 2017, View Source [SID1234521316]).

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Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 45903141#.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 45903141

8-K – Current report

On October 30, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, reported data demonstrating that the company’s phospholipid ether delivery vehicle conjugated to a non-reactive iodine (I-127), or CLR 127, decreased tumor volumes and markedly delayed tumor regrowth in preclinical in vitro and in vivo animal studies of both pediatric and adult cancers. Investigators observed that CLR 127 was taken up and retained in the tumor cells at 6-10 fold higher level than normal tissue and sensitized the tumor cells to external radiation (Filing, 8-K, Cellectar Biosciences, OCT 30, 2017, View Source [SID1234521312]).

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University of Wisconsin investigator, Dr. Mario Otto presented these data during a poster presentation held at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) held by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute and European Organisation for Research and Treatment of Cancer. The poster, titled “The Phospholipid Ether Analog CLR 127 Delays Radiation-Induced dsDNA Damage Repair in Pediatric and Adult Solid Tumors,” was presented on Saturday, October 28th at 12:30 PM ET at the Pennsylvania Convention Center in Philadelphia.

Dr. Otto and his fellow investigators treated adult and pediatric cancer cells and in vivo xenograft-bearing mice with CLR 127 followed by external radiation. The group reported that the effect of the radiation was meaningfully increased versus external radiation alone and persisted at higher levels for up to 24 hours post-administration of the external radiation. Additionally, treatment with CLR 127 appears to inhibit DNA repair function that typically occurs in the tumor cells following radiation treatment.

“The data presented by Dr. Otto and his team provide external confirmation of Cellectar’s PDC tumor targeting capabilities and retention in the tumor cells that may improve clinical outcomes,” said Jim Caruso, president and CEO of Cellectar Biosciences. “This study reports important additional data regarding the potential benefits of combining our PDC platform with external beam radiation for the treatment of both adults and pediatric cancers.”

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 designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate the discovery and development of improved targeted novel therapeutic compounds. 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.

Endocyte Announces Third Quarter 2017 Earnings Conference Call

On October 30, 2017 Endocyte, Inc., (NASDAQ:ECYT) reported that the company will host a conference call on Monday, Nov. 6th, at 4:30 p.m. EST to discuss its third quarter financial results and provide an operational update (Press release, Endocyte, OCT 30, 2017, View Source [SID1234521315]).

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Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company’s website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).

The webcast will be recorded and available on the Company’s website for 90 days following the call.

New clinical collaboration with SCRI in immune-oncology

On October 30, 2017 Boehringer Ingelheim and Sarah Cannon Research Institute reported an expansion of their strategic partnership to bring innovative treatments to cancer patients by developing novel immuno-oncology therapies (Press release, Boehringer Ingelheim, OCT 30, 2017, View Source [SID1234521329]). The new effort combines Boehringer Ingelheim’s oncology research and Sarah Cannon’s expertise in clinical trial design and recruitment to evaluate BI 891065, a novel and potent SMAC mimetic, alone and as a potential combination partner with PD-1-directed cancer therapy.

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SMAC mimetics are a new class of targeted, small molecules that trigger tumor cell death and immune system activation that may enhance the activity of immunotherapies in the treatment of cancer. Through this collaboration, Boehringer Ingelheim’s BI 891065 will be studied in a Phase I clinical trial [NCT03166631] (link is external) alone and in combination with BI 754091 (anti-PD-1) in patients with advanced metastatic solid tumors. The first patient has been enrolled in the Phase I study, which aims to include approximately 100 patients. Previously, the partners had announced a joint clinical development program to study Boehringer Ingelheim’s BI 754091 (anti-PD-1) and BI 754111 (anti-LAG 3) monoclonal antibodies for the combination treatment of multiple cancers with high unmet medical needs. More immune-oncology combination studies are planned moving forward.

Mehdi Shahidi, M.D.
“Ground-breaking advances in immuno-oncology are expected to transform cancer treatment paradigms. We are significantly expanding our efforts in this area including a broad research program focusing on the development of rational combinations of novel immuno-oncology approaches,” said Mehdi Shahidi, M.D., Global Medical Head Oncology, Boehringer Ingelheim. “As part of these ongoing efforts to transform the lives of cancer patients, we are extremely proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development,” added Shahidi.

Preclinical data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the Keystone Symposia Conference on Molecular and Cellular Biology earlier this year, suggest that BI 891065 is a promising combination partner for checkpoint inhibitors and, when used together, may provide a new approach to cancer therapy.

“We look forward to continuing our research to find more effective therapies for patients across tumor types through novel immune therapies and combinations of therapies,” said Howard A. “Skip” Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. “This expanded collaboration furthers our mission to provide access to the latest treatments in the community for our patients.”

Through Sarah Cannon Development Innovations, a full-service, oncology-focused contract research organization (CRO), Sarah Cannon is providing comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. Expansion of the collaboration with Sarah Cannon, will enable rapid patient enrollment and expand access to Boehringer Ingelheim’s investigational oncology treatments through Sarah Cannon’s extensive network across the U.S. and UK.

About Sarah Cannon Research Institute
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.

Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. For more information, visit sarahcannon.com (link is external).

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for non-small-cell lung cancer (NSCLC) that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.