On October 29, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc. (Janssen) (Press release, TESARO, OCT 29, 2018, View Source [SID1234530297]). The milestones are related to Janssen’s ongoing GALAHAD trial, which is assessing niraparib monotherapy for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. Data from the trial are anticipated to support global regulatory filings in 2019.

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In addition, data from the Phase 1b BEDIVERE trial were recently presented at the European Society of Clinical Oncology (ESMO) (Free ESMO Whitepaper) and demonstrated the safety and tolerability of combining niraparib with abiraterone acetate + prednisone (AA-P) in men with mCRPC. Data from the BEDIVERE trial will be used to inform the dosing regimen in a future Phase 3 trial that will assess the clinical benefit of niraparib in combination with AA-P in mCRPC patients.

TESARO entered into a global prostate collaboration and license agreement with Janssen in 2016, through which Janssen received rights to develop and commercialize niraparib for patients with prostate cancer worldwide, except Japan. Under the terms of the agreement, TESARO is eligible to receive development, regulatory and commercial milestones, in addition to royalty payments.

About the Janssen GALAHAD Clinical Trial
GALAHAD is an ongoing Phase 2, open-label, single arm trial designed to evaluate the safety and efficacy of niraparib monotherapy (300mg daily) in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies progressing on/after taxane-based chemotherapy and androgen receptor targeted therapy. Patients are enrolled in the study based on their DNA-repair deficiency status.

About the Janssen BEDIVERE Clinical Trial
BEDIVERE is an ongoing Phase 1b, open-label, dose-selection study with dose expansion designed to evaluate the safety of niraparib in combination with AA-P in men with metastatic castration-resistant prostate cancer (mCRPC) who may or may not have had DNA-repair anomalies.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

On October 29, 2018 Apexian Pharmaceuticals reported that researchers will continue to explore the impact of Apexian’s target molecule, APX3330, on cancer cachexia with additional grant funding from the National Institutes of Health (NIH) National Cancer Institute(NCI) (Press release, Apexian Pharmaceuticals, OCT 29, 2018, View Source [SID1234530421]). Cancer cachexia is weight loss with chronic inflammation and defective metabolism, which causes roughly one third of all cancer deaths. It is particularly prevalent in pancreatic ductal adenocarcinoma (PDAC), which has a dismal five-year survival rate.

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Dr. Mark R. Kelley, Apexian Chief Scientific Officer and the Betty and Earl Herr Professor of Pediatric Oncology Research at the Indiana University Simon Cancer Center; Dr. Melissa Fishel, Research Associate Professor, Wells Center for Pediatric Research; and Dr. Teresa Zimmers, Associate Professor of Surgery at the Indiana University School of Medicine, have been working to define mechanisms of cachexia stemming from treatment in PDAC, as well as for identifying mechanism-driven, targeted anti-cachexia therapies.

"The goal of this research is to determine the anti-cachexia potential of Ref-1 inhibition, HIF-1a inhibition, or the combination in mouse models of PDAC," said Dr. Kelley. "APX3330 has proven effective at inhibiting Ref-1, and has been safe and well tolerated when taken by patients with advanced cancers in our Phase 1 clinical study."

Previous studies support Ref-1 as a target in PDAC, on-target effects of APX3330, and the use of APX3330 as a clinical agent in cancer. This study will focus on demonstrating improvement in fat/muscle mass and PDAC cachexia symptoms using APX3330. Positive results from this study would lead to immediate clinical trials using APX3330 to prevent or reverse PDAC cachexia.

"Dr. Kelley’s research on APX3330 as a Ref-1 inhibitor continues to offer promise as a treatment for cancer and cancer-related issues like cachexia and cancer chemotherapy-induced neuropathy," said Steve Carchedi, CEO of Apexian Pharmaceuticals. "As we complete our Phase I trial, we continue to aggressively pursue additional therapeutic uses for APX3330 and build on our pipeline of novel, first in class molecules."

The NIH grant of $227,554 pushes Kelley’s grant budget for research on Ref-1 inhibitors to nearly $700,000 just in 2018.

On October 29, 2018 Thermo Fisher Scientific, the world leader in serving science, and Symphogen, a clinical-stage antibody oncology-focused company, reported that have entered into a two-year collaborative partnership to deliver validated, platform workflows for simplified characterization and quality monitoring of complex therapeutic proteins (Press release, Thermo Fisher Scientific, OCT 29, 2018, View Source [SID1234530443]).

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Building on a decade-long relationship, the new collaboration will develop protein analysis workflows to accelerate drug development for biopharmaceutical innovators, biosimilar manufacturers, contract research organizations, and contract development and manufacturing organizations.

Symphogen will use the Thermo Scientific Q Exactive Plus Orbitrap liquid chromatography-tandem mass spectrometry (LC-MS/MS) system with BioPharma Option to create, test and validate platform workflows for intact and native mass analysis of therapeutic monoclonal antibody (mAb) mixtures. Additional focus will be placed on the development of automated multi-attribute method (MAM) workflows for monitoring critical quality attributes of proteins using high-resolution accurate-mass mass spectrometry in a quality control environment.

"The growing demand for more targeted and personalized treatment modalities results in the development of increasingly complex drug products, requiring research and development of advanced workflows to monitor their structure, manufacturing variation and quality," said John Rontree, senior director pharma & biopharma, chromatography and mass spectrometry, Thermo Fisher Scientific. "The collaboration with Symphogen, in addition to our commitment to the opening of Global Customer Solution Centers, will enable us to jointly leverage our established mass spectrometry technology, along with the expertise of our customers, to develop and implement novel, easy-to-use analytical strategies for complex mAb mixtures needed by drug manufacturers to drive the development of new therapies for cancer patients."

"Through this collaboration, we can leverage the knowledge and world-class technology provided by Thermo Fisher to effectively address our needs," said Dan Bach Kristensen, Ph.D., principal scientist, Symphogen. "The exceptional spectral resolution enabled by the Q Exactive BioPharma mass spectrometry platform means we now have a highly powerful tool for simple, reliable characterization and quality monitoring of complex biopharmaceutical products."

The Q Exactive Plus Orbitrap LC-MS/MS system is the latest addition to the Thermo Fisher portfolio of products used by Symphogen, which includes Thermo Scientific ultra high-performance liquid chromatography (UHPLC) systems and Thermo Scientific Chromeleon Chromatography Data Systems (CDS).

For more information about Thermo Fisher’s chromatography and mass spectrometry workflows for biopharmaceutical characterization, please visit www.thermofisher.com/contactmebiopharma.

On October 29, 2018 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported a poster presentation demonstrating the ability of AVID200, an isoform selective TGF-β inhibitor, to enhance the anti-tumor activity of T-cells (Press release, Forbius, OCT 29, 2018, View Source [SID1234531669]). Notably, AVID200 significantly enhanced the activity of anti-PD-L1 immune checkpoint inhibition in vivo. This presentation highlights the collaborative work done with the laboratory of Dr. James Koropatnick, Director of the Strategic Training Program in Cancer Research and Technology Transfer at the London Health Sciences Centre. This research is sponsored by the previously announced peer-reviewed BioCanRx grant with a total project value of CAD$1,655,297, and BioCanRx contributing CAD$675,000.

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About AVID200
Forbius developed AVID200 to be a highly potent and isoform-selective TGF-β inhibitor. AVID200 neutralizes TGF-β1 and-β3 with pM potency. These isoforms are known to be drivers of fibrosis and tumor immune resistance. In contrast, TGF-β2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-β2 is therefore undesirable. The ability of AVID200 to selectively target TGF-β1 and -β3 positions it to be an effective and well-tolerated therapeutic in fibrotic diseases and immuneoncology.

On October 29, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Thursday, November 1, 2018 at 5:00 p.m. ET to report its third quarter 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, OCT 29, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-third-4 [SID1234530298]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 6998539. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event