On May 18, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported that data related to galeterone will be presented in two posters at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place from June 3-7, 2016, in Chicago (Press release, Tokai Pharmaceuticals, MAY 18, 2016, View Source;p=irol-newsArticle&ID=2169534 [SID:1234512555]). Galeterone, Tokai’s lead product candidate, is being developed for the treatment of men with metastatic castration-resistance prostate cancer.

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Title: Galeterone in treatment‐naïve patients with castration‐resistant prostate cancer with C‐terminal androgen receptor loss: Results from ARMOR2

Presenting author: Mary-Ellen Taplin, M.D., Associate Professor, Medicine, Harvard Medical School, and Chair, Executive Committee for Clinical Research, Dana-Farber Cancer Institute
Date/time: Saturday, June 4, 2016, 1 – 4:30 p.m. CDT
Location: Hall A
Abstract: 5064
Title: Randomized, open-label, multicenter, controlled study of galeterone vs enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC) expressing AR-V7 splice variant (ARMOR3-SV)

Presenting author: Emmanuel Antonarakis, M.D., Associate Professor of Oncology and Urology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Date/time: Saturday, June 4, 2016, 1 – 4:30 p.m. CDT
Location: Hall A
Abstract: TPS5085

A third abstract, "Galeterone targets proteasomal degradation of the androgen receptor in prostate tumor cells: A novel mechanism of action for treatment of AR-V7+ CRPC," was accepted for publication.

Additional information, including the presentation schedule and full abstracts, may be found at abstracts.asco.org. A copy of each presentation will be available on the "Publications & Presentations" page of Tokai’s website, www.tokaipharmaceuticals.com, after being presented at the meeting.

About Galeterone

Galeterone is an oral small molecule that utilizes the established pathways, including CYP17 enzyme and androgen receptor inhibition, of the current second-generation hormonal therapies abiraterone and enzalutamide. Galeterone also introduces a distinct third mechanism – androgen receptor degradation – that impairs the function of androgen receptors, decreasing their sensitivity to androgen activity and reducing tumor growth. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ARMOR3-SV, the company’s pivotal Phase 3 study of galeterone in treatment-naive mCRPC patients whose prostate tumors express the AR-V7 splice variant, is evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide. Tokai is also evaluating galeterone in mCRPC patients who have shown resistance following treatment with second-generation hormonal agents. Tokai has worldwide development and commercialization rights to galeterone.

On May 18, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) reported that it will present on its extensive oncology pipeline at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7, 2016 at McCormick Place, Chicago, Illinois (Press release, Merrimack, MAY 18, 2016, View Source [SID:1234512580]). Final results from a Phase 1 study evaluating the safety, pharmacology and initial efficacy of MM-151 will be presented in a Poster Discussion Session. Merrimack will also present on the results from its Phase 3 NAPOLI-1 study of ONIVYDE, as well as on multiple therapeutic candidates from its antibody engineering and antibody-directed nanotherapeutic (ADN) technology platforms in six poster sessions.

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Poster Discussion Session:

Final results of a first-in-human study evaluating the safety, pharmacology and initial efficacy of MM-151, an oligoclonal anti-EGFR antibody in patients with refractory solid tumors (Abstract 2518)
Session Title: Poster Discussion Session, Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Sunday, June 5, 2016, 11:30 AM – 12:45 PM CT
Location: Arie Crown Theater

Poster Sessions:

Updated overall survival (OS) analysis of NAPOLI-1: Phase 3 study of nanoliposmal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract 4126)
Session Title: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

Randomized Phase 2 study of paclitaxel (PTX), trastuzumab (T) with or without MM-111 in HER2 expressing gastroesophageal cancers (GEC) (Abstract 4043)
Session Title: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

A Phase 1b/2 study combining MM-151 + nal-IRI + 5-FU + leucovorin in RAS-wild type metastatic colorectal cancer (mCRC) (Abstract TPS3633)
Session Title: Gastrointestinal (Colorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

SHERLOC: A Phase 2 study of seribantumab (MM-121) in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive (HRG+), locally advanced or metastatic non-small cell lung cancer (NSCLC) (Abstract TPS9110)
Session Title: Lung Cancer – Non-Small Cell Metastatic
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1) (Abstract TPS631)
Session Title: Breast Cancer – HER2/ER
Sunday, June 5, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

A Phase 1 biomarker-directed multi-arm study evaluating the co-administration of MM-151 with MM-121, MM-141, or trametinib in EGFR-driven cancers (Abstract TPS11619)
Session Title: Tumor Biology
Monday, June 6, 2016, 1:00 PM – 4:30 PM CT
Location: Hall A

On May 18, 2016 Eli Lilly reported that several studies will underscore the strength of Eli Lilly and Company’s (NYSE: LLY) diverse clinical cancer pipeline and portfolio during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, June 3 – 7, 2016 (Press release, Eli Lilly, MAY 18, 2016, View Source [SID:1234512520]). Presentations include new data on abemaciclib, a CDK 4 and 6 inhibitor, as well as: ramucirumab, a VEGF Receptor 2 antagonist; galunisertib, a TGFβ small-molecule kinase inhibitor; and emibetuzumab, a MET antibody.

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Other data to be presented at ASCO (Free ASCO Whitepaper) highlight Lilly’s ongoing immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in two trials that are evaluating ramucirumab and pemetrexed-plus-carboplatin, respectively, in combination with Merck’s pembrolizumab.

These presentations reflect Lilly’s multi-faceted strategy in developing cancer treatments – a balanced approach based on three scientific pillars of tumor cell growth and progression: cell signaling, tumor microenvironment and immuno-oncology. Lilly’s data at this year’s ASCO (Free ASCO Whitepaper) meeting highlight some of the recent progress it has made toward this strategy and touch on all three of these scientific pillars.

"The reality is that cancer is more than 200 diseases and the treatment of cancer needs to be aggressively approached from many angles," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "Our oncology R&D strategy is to produce a diverse portfolio of novel agents that attack tumor cell growth and progression in multiple ways to improve patient outcomes."

Dr. Gaynor continued, "We are encouraged by our data at ASCO (Free ASCO Whitepaper) and the progress of our pipeline toward achieving our overall goals. We’ve had notable clinical advancements with abemaciclib and olaratumab, both of which have been designated as breakthrough therapies by the FDA. These build on necitumumab and ramucirumab, which we are continuing to investigate in additional disease settings and combinations. Additionally, our immuno-oncology initiatives are increasingly producing results through collaborations and our own internal research efforts."

Select studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract #510: Oral Abstract Session: Friday, June 3, 2016; 4:42 – 4:54 pm CDT
MONARCH 1: Results from a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for advanced disease
Author/Speaker: Maura N. Dickler, M.D., Memorial Sloan Kettering Cancer Center
Location: Hall D1
Abstract #TPS9101: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A randomized phase 2 study of abemaciclib versus docetaxel in patients with stage IV squamous cell lung cancer (SqCLC) previously treated with platinum-based chemotherapy
Author/Speaker: Giorgio V. Scagliotti, M.D., Ph.D., University of Torino
Location: Hall A (Poster Board #423a)
Immuno-Oncology Collaborations with ramucirumab or pemetrexed

Abstract #3056: Developmental Therapeutics—Immunotherapy Poster Session: Sunday, June 5, 2016; 8:00 – 11:30 am CDT
A phase 1 study of ramucirumab (R) plus pembrolizumab (P) in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC): Phase 1a results
Author/Speaker: Roy S. Herbst, M.D., Ph.D., Yale University School of Medicine, Yale Cancer Center
Location: Hall A (Poster Board #378)
Abstract #9016: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C
Author/Speaker: Shirish M. Gadgeel, M.D., Karmanos Cancer Institute
Location: Hall A (Poster Board #339)
Poster Discussion Session: Saturday, June 4, 2016; 3:00 – 4:15 pm CDT Room E354b
Ramucirumab

Abstract #TPS4145: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A randomized, double-blind, placebo-controlled Phase III study of ramucirumab versus placebo as second-line treatment in patients with hepatocellular carcinoma and elevated baseline alpha-fetoprotein following first-line sorafenib (REACH-2)
Author/Speaker: Andrew X. Zhu, M.D., Ph.D., Massachusetts General Hospital Cancer Center
Location: Hall A (Poster Board #130a)
Abstract #9079: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
Exploratory subgroup analysis of patients (Pts) refractory to first-line (1L) chemotherapy from REVEL, a randomized phase III study of docetaxel (DOC) with ramucirumab (RAM) or placebo (PBO) for second-line (2L) treatment of stage IV non-small-cell lung cancer (NSCLC)
Author/Speaker: Martin Reck, M.D., Ph.D., Lungen Clinic Grosshansdorf, Airway Research Center North
Location: Hall A (Poster Board #402)
Galunisertib

Abstract #4070: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A phase 2 study of galunisertib, a novel transforming growth factor-beta (TGF-β) receptor I kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC) and low serum alpha fetoprotein (AFP)
Author/Speaker: Sandrine J. Faivre, M.D., Ph.D., Service d’Oncologie Médicale
Location: Hall A (Poster Board #62)
Abstract #4019: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A phase II, double-blind study of galunisertib+gemcitabine (GG) vs gemcitabine+placebo (GP) in patients (pts) with unresectable pancreatic cancer (PC)
Author/Speaker: Davide Melisi, M.D., University of Verona
Location: Hall A (Poster Board #11)
Poster Discussion Session: Saturday, June 4, 2016; 3:00 – 4:15 pm CDT at Hall D1
Emibetuzumab

Abstract #9070: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT
A randomized, open-label, phase 2 study of emibetuzumab plus erlotinib (LY+E) and emibetuzumab monotherapy (LY) in patients with acquired resistance to erlotinib and MET diagnostic positive (MET Dx+) metastatic NSCLC
Author/Speaker: D. Ross Camidge, M.D., Ph.D., University of Colorado
Location: Hall A (Poster Board #393)

On May 18, 2016 Fresh Medical Laboratories, Inc., doing business as ProLungdx, reported the initial results of its ongoing European Lung Cancer Registry (Press release, Fresh Medical Laboratories, MAY 18, 2016, View Source [SID:1234512556]). When the Electro Pulmonary Nodule (EPN) Scan was administered to patients with lung nodules suspicious for cancer, the scan demonstrated results consistent with earlier research performed at Johns Hopkins and published in the Journal of Thoracic Oncology. The non-invasive test correctly identified 23 out of 27, or 85% of patients where malignancy was confirmed by tissue biopsy. More results are expected soon, as the EPN Scan has been administered to more than 170 patients in Europe and over 100 of these are enrolled in the registry. Other research is underway at eight cancer centers in the US and four in Asia.

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"The key to improved survival is understanding the risk associated with a suspicious pulmonary nodule. It’s heartening to see such positive results coming from leading European interventional pulmonologists. They are pioneers focused on immediate evaluation of indeterminate lung nodules. Compared with the standard of care, we believe that the EPN Scan can increase the time available for treatment and may ultimately save lives," said Steven Eror, President and CEO of ProLungdx.

The EPN Scan uses its novel mass averaging bioconductance technology to evaluate patients who discover lung nodules incidentally or by lung cancer screening. As the low-dose computed tomography (LDCT) screen becomes widespread, risk stratification tools, such as ProLungdx’s EPN Scan, will be essential to aiding physicians to evaluate the risk of cancer while treatment options are still available.

On May 17, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the U.S. Patent and Trademark Office has issued U.S. patent number 9,340,830, entitled, "Optimization of Multigene Analysis of Tumor Samples (Press release, Foundation Medicine, MAY 17, 2016, View Source [SID:1234512446])." The patent, which is assigned to Foundation Medicine, includes fundamental claims describing methods of analyzing a cancer patient’s tissue or blood specimen to detect multiple classes of genomic alterations. The patent carries a term extending to 2032. The company is also pursuing patent applications covering aspects of its genomic analysis platform with the European Patent Office and in other jurisdictions outside the United States.

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"Foundation Medicine has been at the leading edge of innovation in genomic analysis of cancer since our inception six years ago," said Michael Pellini, M.D, chief executive officer for Foundation Medicine. "We believe this patent both acknowledges our pioneering efforts in research and development, and, importantly, it demonstrates our expertise in translating innovation into clinically validated, best-in-class assays that benefit cancer patients around the world. We are gratified that our contributions to the clinical and scientific communities are enabling new genomic analysis products in the fight against cancer."

Dr. Pellini continued, "We believe patients and their physicians should have access to the full complement of test offerings that, when used appropriately, can meaningfully guide and inform treatment plans. We plan to evaluate strategies to maximize the value of this patent and our other intellectual property. That said, in leveraging this asset, we do not intend to block the use of methods covered by the patent in patient testing that may be offered by others. We are pleased with the issuance of this patent to strengthen Foundation Medicine’s intellectual property position and reinforce our overall leadership in transforming cancer care."