On June 8, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite"), a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT) products for the treatment of cancer, reported three oral presentations relating to its clinical programs will be delivered at the upcoming 2016 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Copenhagen, Denmark, June 9-12, 2016 (Press release, Kite Pharma, JUN 8, 2016, View Source [SID:1234513140]).

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"We are excited to showcase the progress we have made with personalized T-cell immuno-oncology for people with refractory lymphoma and to share our understanding of the outcomes for this patient population who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data are important to advance our novel breakthrough personalized treatments and ultimately address critical unmet medical needs."

Updated data from Phase 1 of Kite’s ZUMA-1 study of KTE-C19 in patients with chemorefractory non-Hodgkin lymphoma (NHL) will be presented in an oral presentation. An additional oral presentation will feature data from the SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive and common form of NHL that is difficult to treat. Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.

Data from a Phase 1-2a study evaluating anti-CD19 CAR T-cell therapy after low-dose chemotherapy in people with advanced lymphoma will also be highlighted in an oral presentation. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute (NCI).

Kite also recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory DLBCL. PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

Oral presentations at the 2016 EHA (Free EHA Whitepaper) Annual Congress:

Results from SCHOLAR-1: Outcomes in patients with refractory aggressive diffuse large B-cell lymphoma (DLBCL)

Date: Saturday, June 11, 2016, 5:00 – 5:15 PM CEST
Location: Hall A1
Abstract Number: S481
Presenter: Christian Gisselbrecht, M.D., The Lymphoma Academic Research Organisation (LYSARC), Pierre-Bénite, France

Updated results from ZUMA-1: A phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)

Date: Sunday, June 12, 2016, 8:45 – 9:00 AM CEST
Location: Hall A1
Abstract Number: S791
Presenter: Tanya Siddiqi, M.D., City of Hope National Medical Center, Duarte, CA

Low-dose chemotherapy followed by anti-CD19 chimeric antigen receptor (CAR) T cells induces remissions in patients with advanced lymphoma

Date: Sunday, June 12, 2016, 9:00 – 9:15 AM CEST
Location: Hall A1
Abstract Number: S792
Presenter: Stephanie L. Goff, M.D., Surgery Branch, Center for Cancer Research, The National Cancer Institute, Bethesda, MD

About Kite’s ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies.

Study Phase Indication Status
ZUMA-1
NCT02348216 Phase 2 Pivotal
(N=112) Chemorefractory DLBCL, PMBCL, TFL Phase 2 enrolling
ZUMA-2
NCT02601313 Phase 2 Pivotal
(N=70) Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4
NCT02625480 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Pediatric ALL Phase 1/2 enrolling

DLBCL = diffuse large B-cell lymphoma
PMBCL = primary mediastinal B-cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia

On June 8, 2016 AstraZeneca reported it has entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anaesthetics portfolio outside the US (Press release, AstraZeneca, JUN 8, 2016, View Source [SID:1234513247]). The agreement covers seven established medicines – Diprivan (general anaesthesia), EMLA (topical anaesthetic) and five local anaesthetics (Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest).

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Under the terms of the agreement, AGI will acquire the commercialisation rights, outside the US, to AstraZeneca’s portfolio of anaesthetic medicines for an upfront consideration of $520 million. Additionally, AGI will pay AstraZeneca up to $250 million in a Product Sales-related payment, as well as double-digit percentage trademark royalties on Product Sales. AstraZeneca will manufacture and supply the products on a cost plus basis to AGI for an initial period of 10 years. Upon completion, Aspen will assume responsibility for all activities relating to the sale of the portfolio in all relevant markets.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "AstraZeneca has a rich heritage in anaesthetic medicines and this agreement will extend the reach of our established portfolio to a greater number of patients through AGI’s extensive commercial network. This agreement supports our strategic focus on the new medicines in three main therapy areas."

Stephen Saad, Group Chief Executive, Aspen, said: "This is a strategically-important investment for AGI and it is pleasing to have a company such as AstraZeneca recognise Aspen’s commercial competencies. This transaction is an excellent opportunity to build on the quality brands commercialised through AGI, working alongside an acknowledged pioneer and leader in the field of anaesthetics."

AstraZeneca’s portfolio of anaesthetics is available in over a hundred countries worldwide, including key markets such as China, Japan, Australia and Brazil. The portfolio continues to generate stable revenue, with global Product Sales in 2015 of $592 million. The US rights to the products were divested to Abraxis, now part of Fresenius Kabi, in 2006.

Financial considerations

The transaction is subject to customary closing conditions and is anticipated to complete in the third quarter of 2016. AstraZeneca will retain a significant ongoing interest in the anaesthetics portfolio through ongoing milestone and royalty payments and the manufacture and supply of the products to Aspen. The upfront and milestone payments, as well as royalty receipts, which are open-ended, will therefore be reported as Externalisation Revenue in the Company’s financial statements. The agreement will not impact the Company’s financial guidance for 2016.

On June 7, 2016 Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, reported that it has presented new prospective data for its MammaPrint 70-gene breast cancer recurrence assay at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Agendia, JUN 7, 2016, View Source [SID:1234513121]).

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Results from the Prospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) show that MammaPrint can provide clear guidance on whether a patient should receive chemotherapy, compared to the indeterminate results from 21-gene assay (OncotypeDx). MammaPrint provides a definitive, binary High or Low Risk result for a patient’s cancer recurring and thus whether the patient needs more aggressive, or less aggressive therapy.

Between 38-67% of women tested in different studies using the 21-gene assay were classified as having an intermediate/indeterminate Recurrence Score (between 18 and 30).1 PROMIS evaluated 840 estrogen receptor (ER)-positive, lymph node (LN) positive or LN negative women across 58 US institutions who had previously received an intermediate/indeterminate risk score from the 21-gene assay. Patient samples were re‑tested using MammaPrint to refine the risk classification and provide additional treatment guidance.

Of the 840 intermediate risk patients, MammaPrint reclassified 55% (466) of these patients as High Risk and 45% (374) as Low Risk of the individual’s cancer recurring. No correlation between definitive MammaPrint results or the indeterminate 21-gene assay Recurrence Score could be identified, reinforcing the discordance between these assays and inability to use the results interchangeably. MammaPrint was shown to provide additional prognostic information independent from clinicopathological factors to support the treatment decision.

Based on the outcome of the MammaPrint test, 34% (282/840) of physicians changed their treatment decisions, preventing both under and over treatment: 37% (171/466) of the high risk patients had chemotherapy added to their treatment recommendation and 29% (108/374) of the low risk patients had chemotherapy removed from their treatment recommendation. Of the MammaPrint Low Risk patients who were previously indicated to receive chemotherapy based on the 21-gene assay results, 76% of patients (108/142) decided to forego chemotherapy, preventing unnecessary overtreatment in this group.

Medical oncologist Dr. Michaela Tsai from the Virginia Piper Cancer Center, Minneapolis, MN and primary author of the PROMIS poster commented, "Of 466 intermediate patients reclassified as High Risk by MammaPrint, 342 have an Recurrence Score ≤25 and were not recommended for chemotherapy by St. Gallen Guidelines (Goldhirsch, Winer et al. 2013), risking up to a 73% chance of under-treatment." She also noted, "79% of physicians reported that they had greater confidence in their treatment recommendations with MammaPrint."

Dr. William Audeh, Chief Medical Officer of Agendia said: "The clinical performance of MammaPrint and its ability to accurately inform and guide treatment decisions has been definitively proven by the recent presentation of the MINDACT trial at the 2016 AACR (Free AACR Whitepaper) meeting. This unique phase III prospective, randomized, controlled study provides the highest level of clinical evidence to MammaPrint above any other genomic assay for making adjuvant therapy decisions in early-stage breast cancer."

MINDACT included 6,693 patients and is a phase III, prospective, randomized controlled, clinical trial comparing the use of MammaPrint 70-gene assay with clinicopathological criteria (current standard of care) for selecting early-stage breast cancer patients who should be treated with adjuvant chemotherapy.

"The PROMIS trial showed the positive impact a binary test could have in the clinical setting by providing a clear risk assessment of the patient to physicians" said Mark Straley, Chief Executive Officer at Agendia. "MammaPrint is the only FDA-cleared assay for early-stage breast cancer patients of all ages, further validating the quality and clinical utility of the test."

1 Lo, Mumby et al. 2011, Sulayman, Spellman et al. 2012, Stemmer, Klang et al. 2013, Sparano, Grey et al. 2015

On June 7, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), reported that it is unveiling new data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting further confirming the utility, speed and efficiency of its ICE COLD-PCR (ICP) technology for liquid biopsy detection of tumor mutations (Press release, Transgenomic, JUN 7, 2016, View Source [SID:1234513122]). The company is distributing a new educational handout at the meeting highlighting expanded concordance data showing that ICP plasma-based liquid biopsies detect all of the mutations identified using conventional tissue samples and also detect additional tumor alterations missed by conventional methods. Another educational handout presents data showing how use of ICP with Thermo Fisher’s Veriti thermal cycler expedites the testing of liquid biopsy samples, producing accurate results rapidly and efficiently.

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TBIO President and CEO Paul Kinnon commented, "As the highest profile cancer meeting of the year, ASCO (Free ASCO Whitepaper) is an excellent venue for presenting our expanded concordance study data further confirming the accuracy and superior performance of ICE COLD-PCR liquid biopsies for tumor detection and monitoring. We also are unveiling new study data highlighting the speed and efficiency of our ICP enrichment technology when used with a leading thermal cycler. We believe ICP’s accuracy, versatility and ease of use have the potential to enable wide adoption of routine genomic testing in cancer research and patient care, and the new data we are discussing at ASCO (Free ASCO Whitepaper) further supports the technology’s near-term clinical and commercial potential."

At the ASCO (Free ASCO Whitepaper) meeting, Transgenomic is distributing an educational report, "CRC Concordance Update – Stage IV CRC Sample Analysis with ICE COLD-PCRTM," which describes the results of an expanded concordance study assessing the ability of its multiplexed ICE COLD-PCR technology to detect a key tumor mutation in matched plasma samples compared to detection in the same patients using tissue and plasma samples analyzed using conventional Sanger sequencing methods. The expanded study included 32 patients with late stage colorectal cancer. Use of ICP-enriched testing resulted in an overall 96.9% concordance rate, with a 94.7% concordance rate for the mutation positive samples. In addition, actionable mutations were detected in two patient samples analyzed using ICP-enriched methods that were missed using conventional PCR with Sanger sequencing. Notably, the missed mutations were detected by ICP in both the plasma and tissue samples from these patients.

The researchers conclude that the high concordance rates achieved in the study and the ability of the ICP-enriched approach to detect relevant mutations missed by conventional methods support the clinical validity and utility of ICP-based liquid and tissue biopsies for mutation detection and monitoring in cancer patients.

Anil Vachani, MD, MS, Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center and an investigator working with TBIO, commented, "The ability to accurately and efficiently detect tumor mutations from non-invasive blood-based patient samples is essential for realizing the potential of precision medicine approaches to transform cancer treatment. I welcome studies that increase our confidence in the validity of new technologies such as ICE COLD-PCR to help enable use of targeted and other precision treatment approaches."

A second TBIO educational handout, "Simple and Effective Clinical Testing Protocol Using ICE COLD-PCRTM across Targeted Cancer Gene Panels using the Veriti Thermal Cycler and Sanger Sequencing," details a new study that demonstrates how combining multiplexed ICE COLD-PCR with the Thermo Fisher Veriti thermal cycler expedites mutation detection and monitoring using liquid biopsy samples. It shows that with the Veriti thermal cycler, ICE COLD-PCR amplifications can be grouped based on temperature and primer annealing parameters to enable multiple amplicon enrichments in a single thermal cycler run. By combining the flexibility of the Veriti thermal cycler, the superior enrichment power of ICP and the rapid turnaround time of Sanger sequencing, liquid biopsy test results were generated in about four days, compared to total turnaround times of about four weeks for conventional tissue biopsies. Rapid results are an important advantage in cancer clinical testing and patient monitoring, where critical patient treatment decisions increasingly rely on up-to-date genomic data.

The study researchers note too that these results provide an opportunity for molecular diagnostic laboratories to reevaluate the use of Sanger sequencing for confirmation of mutation detection results from next-generation sequencing (NGS) platforms, and point out that by using this protocol, Sanger platforms can also be re-considered for front line mutation detection, with the potential to produce accurate results more rapidly and cost effectively than NGS platforms.

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

On June 7, 2016 Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, and Siemens’ PETNET Solutions, Inc., a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc., reported the commercial availability of Axumin (fluciclovine F 18) injection in the United States (Press release, Blue Earth Diagnostics, JUN 7, 2016, View Source [SID:1234513123]). Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment. Axumin was approved by the U.S. Food and Drug Administration (FDA) on May 27, 2016, and is the first FDA-approved F-18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.

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"Blue Earth Diagnostics is extremely pleased to be working with Siemens’ PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management."
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Axumin will be commercially available this month through Blue Earth Diagnostics’ manufacturer and exclusive distributor in the United States, Siemens’ PETNET Solutions. Initial commercial production of Axumin will be underway at certain Siemens’ PETNET Solutions radiopharmacies, with increasingly broader availability planned in the coming months.

"We are tremendously pleased with FDA’s recent approval of Axumin for suspected biochemically recurrent prostate cancer, and hope that this will make a real difference to patients and their physicians," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd. "Blue Earth Diagnostics is extremely pleased to be working with Siemens’ PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management."

"This is a significant milestone for the PET industry, as this is the first proprietary F-18 labeled agent for an oncology indication approved by the FDA. And, being F-18 labeled enables efficient distribution and wide patient access," said Barry Scott, head of Siemens’ PETNET Solutions. "Through our broad network of radiopharmacies we are able to increase access to PET tracers, like Axumin, helping healthcare providers to address society’s most challenging diseases. We are proud to work with Blue Earth Diagnostics as the U.S. commercial supplier making Axumin available to imaging centers and their patients."

Blue Earth Diagnostics and Siemens’ PETNET Solutions welcome visitors to the upcoming SNMMI meeting to visit their exhibit booths. Blue Earth Diagnostics is at Booth 337; Siemens’ PETNET Solutions is at Booth 431.

About AxuminTM (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following initial therapy. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F18 for PET imaging. Axumin was approved by the U.S. Food and Drug Administration on May 27, 2016 following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Prostate Cancer/Recurrent Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients. In some patients recurrent disease is detectable only by a rise in prostate specific antigen (PSA) levels, yet the location of the recurrence cannot consistently be located by conventional imaging, severely limiting treatment guidance for these patients.