Novartis Says Breakthrough Therapy LDK378 Shows Response; Nektar Announces Positive Preclinical Data for NKTR-214 Print E-mail
By Mary Davila   
Monday, 03 June 2013 19:52

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 3, 2013. Novartis (NYSE: NVS) announced data on its investigational compound LDK378 showing a marked clinical response in 78 patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during or after crizotinib therapy or had not been previously treated with crizotinib[1]. The trial will be featured as an oral presentation (abstract #8010; Monday, June 3) at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

The results from the study showed an overall response rate (including complete response [CR] and partial response [PR]) of 60% in patients with ALK+ NSCLC taking LDK378 (750 mg/day), which includes patients who had progressed during or after crizotinib therapy (overall response rate of 59%) and those who were crizotinib-naïve (overall response rate of 62%)[1]. In addition to the 78 patients treated at 750 mg/day, an additional 36 patients were treated with LDK378 at 400-750 mg/day. The study is continuing to enroll patients and evaluations are ongoing. This pivotal trial will serve as the basis for the first regulatory filing, anticipated in early 2014.

The most frequent adverse events (regardless of relationship to LDK378) were nausea (73%), diarrhea (72%), vomiting (58%) and fatigue (41%). The most frequent Grade 3/4 adverse events were alanine aminotransferase increased (19%), aspartate aminotransferase increased (10%) and diarrhea (8%).

"These results confirm that LDK378 has activity in patients with ALK+ NSCLC, including those who have progressed on crizotinib, as well as those who haven't taken crizotinib," said lead investigator Alice T. Shaw, MD, PhD, Massachusetts General Hospital Cancer Center, Boston. "LDK378 may become another standard targeted therapy for these ALK-positive patients."

In March, LDK378 received Breakthrough Therapy designation from the US Food and Drug Administration (FDA). The designation is intended to expedite the development and review of drugs that treat life-threatening conditions and show improvement over available therapies[2].

"LDK378 is representative of the Novartis targeted research approach to identify key disease pathways and those specific patients affected by the disease," said Hervé Hoppenot, President, Novartis Oncology. "Based on these data showing the potential of LDK378, we are developing a robust clinical program to move it forward as quickly as possible."

Currently, two Phase II clinical trials are actively recruiting patients worldwide. One study, highlighted as a Trials in Progress poster at ASCO, focuses on patients with ALK+ NSCLC who were previously treated with chemotherapy and crizotinib (presented on Saturday, June 1 from 8:00 - 11:45 AM; abstract #TPS8119). The second study examines LDK378 in patients who are crizotinib-naïve. In addition, Phase III clinical trials are planned to begin in the coming months, aiming to enroll more than 1,100 patients with ALK+ NSCLC at sites worldwide.

Non-small cell lung cancer is the most common type of lung cancer accounting for 85-90% of all cases[3]. Approximately 3-8% of patients with NSCLC have the ALK gene mutation[1]. There are limited treatment options for patients with ALK+ NSCLC, who tend to be non-smokers and younger than NSCLC patients without an ALK translocation[4].


Nektar Therapeutics (NASDAQ: NKTR)
announced positive preclinical data for NKTR-214, an investigational cancer immunotherapy which targets the IL-2 receptor complex and is being developed as a potential treatment for multiple cancers. The results were presented today at the 2013 ASCO Annual Meeting in Chicago. NKTR-214 targets the IL-2 receptor complex through selective receptor binding to the IL2R beta subtype. Activation of the IL2R beta subtype promotes tumor killing by the body's own immune system.

NKTR-214 is a novel immunocytokine therapy that is engineered using Nektar's polymer conjugate technology to selectively target the beneficial IL-2 receptor complex. NKTR-214 maintains high affinity for the IL-2 receptor subunit beta, which activates tumor-killing T-cells within the tumor microenvironment. At the same time, NKTR-214 exhibits up to 100-fold reduced affinity to the IL-2 receptor subunit alpha-beta, which is designed to minimize the immunosuppressive effects that normally limit the efficacy of standard aldesleukin. In the preclinical data presented at ASCO, NKTR-214 exhibits efficacy and tolerability that is superior to the clinically approved cytokine aldesleukin (Proleukin®). NKTR-214 was as efficacious as aldesleukin, even when NKTR-214 was dosed with 20-fold less total cytokine or dosed only once every fourteen days. NKTR-214 is currently undergoing further pre-clinical IND-enabling toxicological and efficacy studies.

NKTR-214 Preclinical Data Presentation -- Abstract Title: "An engineered immunotherapy (NKTR-214) with altered selectivity towards the IL-2 receptor: Efficacy and tolerability in a murine tumor model", Charych et al.  Abstract Number: 3060 Session Title/Track: Developmental Therapies - Immunotherapy Date: June 3, 2013, 8:00 a.m. — 11:45 a.m. Central Time Location: S Hall A2

Also Monday:

today announced results from a Phase I study of ABT-199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL), the most common leukemia in the United States, and relapsed/refractory non-Hodgkin's lymphoma (NHL).

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that Allergan, Inc. (NYSE: AGN) has advanced an additional product candidate as a potential new treatment for glaucoma.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
today announced that final data for the Phase 1 portion of the ongoing Phase 1/2 trial with its lead oncology compound, zoptarelin doxorubicin (AEZS-108), demonstrated the compound's promising anti-tumor activity in heavily pre-treated men with castration- and taxane-resistant prostate cancer.

AmerisourceBergen Corporation (NYSE: ABC)
today announced that it has completed the divestiture of its Canadian pharmaceutical distribution business, AmerisourceBergen Canada Corporation (ABCC).

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT)
and its subsidiaries (the "Company") announced its results for the year ending December 31, 2012.

BioMed Realty Trust, Inc. (NYSE: BMR)
and Wexford Science & Technology, LLC announced today that they have completed their previously announced merger.

China Biologic Products, Inc. (Nasdaq: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company received a notice (the "Notice") this morning from a Hong Kong solicitors firm representing the plaintiffs (the "Plaintiffs") in the pending litigation of title dispute (the "Litigation") involving certain shares of the common stock of China Biologic Products, Inc. (the "Company") held by Ms. Siu Ling Chan ("Ms. Chan"), one of the individual shareholders of the Company.

Clovis Oncology (NASDAQ:CLVS)
today announced initial findings from an ongoing Phase I/II monotherapy study of rucaparib, the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of ovarian cancer.

GW Pharmaceuticals plc (Nasdaq: GWPH)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the second quarter and half year ended 31 March 2013.

ImmunoGen, Inc. (Nasdaq: IMGN)
, a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) ADC technology, today announced the presentation of the first clinical data with the Company’s IMGN853 product candidate.

Impax Laboratories, Inc. (NASDAQ: IPXL)
today announced that the Company will present at the Jefferies Global Healthcare Conference on Wednesday, June 5, at 2:30 p.m. Eastern Standard Time.

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced today that AstraZeneca has added a second development candidate, ISIS-ARRx, to its collaboration with Isis. Isis earned a $10 million milestone payment associated with this decision. ISIS-ARRx is an antisense drug designed to treat patients with prostate cancer by inhibiting the production of the androgen receptor (AR).

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)
today announced the presentation of updated efficacy and safety data from the Phase 3 long-term clinical trial of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

Lannett Company, Inc. (NYSE MKT: LCI)
, a manufacturer of generic pharmaceuticals, today announced the appointment of James M. Maher to its Board of Directors, effective July 1, 2013.

Maxygen, Inc. (Nasdaq: MAXY)
, a biopharmaceutical company, today announced that its Board of Directors has approved the liquidation and dissolution of the company, subject to shareholder approval, and plans to distribute all available cash to its shareholders after making reasonable provision for known and potential liabilities and other obligations of the company.

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced data showing that methylation of the Decoy Receptor 1 (DCR1) gene may help guide oncologists in selecting metastatic colorectal cancer (CRC) patients to receive irinotecanbased therapy.

MyMedicalRecords, Inc. ("MMR"), a wholly owned subsidiary of MMRGlobal, Inc. (OTCQB: MMRF), today announced that it has retained the legal firm of Rockwell Olivier to represent the Company in Australia.

Northwest Biotherapeutics (NASDAQ: NWBO)
(NW Bio), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that NW Bio was added to the MSCI Global MicroCap Index as of the close of the stock market on Friday, May 31, 2013.

Ohr Pharmaceutical, Inc. (OTCQB: OHRP)
, a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced a 1-for-3 reverse split of the Company's issued and outstanding common stock.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (, a developer of oral drug delivery systems, announced today that its abstract, titled "Decreased CRP levels in response to a six-week, once-daily oral insulin regimen" has been selected for a poster presentation at the 81st European Atherosclerosis Society (EAS) Congress being held on June 2-5 in Lyon, France.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, today announced positive results from the BELIEF trial, a pivotal, single-arm study of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) after failure of ≥1 prior systemic therapies.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced results from an interim survival analysis of the GALAXY-1 trial, a global, randomized, multi-center Phase 2b/3 study designed to evaluate the efficacy and safety of the Company’s lead drug candidate, the Hsp90 inhibitor ganetespib, as second-line treatment for patients with advanced non-small cell lung adenocarcinoma.

Teva Pharmaceutical Industries Ltd (NYSE:TEVA)
announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended that a Marketing Authorization may be issued in the European Union for Lonquex® (XM22 lipegfilgrastim) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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