On October 26, 2016 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), reported that presentations related to the Company’s TIL technology will be made at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting & Associated Programs, being held on November 9-13, 2016 in National Harbor, MD (Press release, Lion Biotechnologies, OCT 26, 2016, View Source [SID1234516025]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentations at SITC (Free SITC Whitepaper) relate to:

Feasibility of growing TIL from non-melanoma solid tumors and development of TIL therapies for other solid tumors – Lion cultured TIL from non-melanoma solid tumors including bladder, cervical, head and neck, lung and triple negative breast cancer (TNBC) to investigate the feasibility of using adoptive cell therapy (ACT) as a therapy for patients in other cancer types (poster #42, Sethuraman, Saturday, November 12, 7:00 a.m. to 8:00 p.m. ET)

Evaluation of artificial antigen presenting cells (aAPC) as a potential substitute for allogeneic peripheral blood mononuclear cells (PBMC) – Preclinical evaluation of artificial antigen presenting cells as a substitute for PBMC (peripheral blood mononuclear cells) was conducted with a novel aAPC CD64+ MOLM-14 human leukemia cell line (poster #47, Veerapathran, Friday, November 11, 12:00 p.m. to 8:00 p.m ET)

Addressing the need to assess lytic potential of TILs – In order to test the potency of TILs that are infused into patients, a surrogate target cell line was developed that can be used to assess the lytic potential of TILs in a BRLA (poster #14, Gokuldass, Saturday, November 12, 7:00 a.m. to 8:00 p.m. ET)

Effect of cryopreservation on the measured phenotypic characteristics of TIL – Lion tested if cryopreservation affected the measured phenotypic characteristics of TIL which could enable Lion to further investigate the possibility of using cryopreserved TIL in a clinical setting (poster #11, Frank, Friday, November 11, 12:00 p.m. to 8:00 p.m ET)

Additional information, including a presentation schedule, titles and abstracts, can be found at View Source

On October 26, 2016 Varian Medical Systems (NYSE: VAR) and McKesson Specialty Health reported a strategic agreement for the deployment and servicing of Varian advanced radiotherapy equipment and software over a three-year period across The US Oncology Network and Vantage Oncology affiliated sites of care (Press release, Varian Medical Systems, OCT 26, 2016, View Source [SID1234516101]). This multiyear agreement delivers significant value to oncology providers in The US Oncology Network, which now operates the largest system of radiotherapy facilities in the U.S. following the acquisition of Vantage Oncology earlier this year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Over the next two years, seven Varian TrueBeam and five VitalBeam medical linear accelerators will be installed in The US Oncology Network and Vantage Oncology affiliated cancer centers across the U.S. In addition, McKesson and Varian will collaborate to establish interoperability between McKesson Specialty Health’s iKnowMedSM electronic health record (EHR) system and Varian’s ARIA oncology information system. The interoperability aims to deliver direct value to all physicians using these information systems in managing patient care.

"McKesson Specialty Health and The US Oncology Network offer robust, comprehensive practice management capabilities, value-based care expertise, and state-of-the-art technology solutions to its affiliated practices, providing support as they navigate today’s challenging healthcare landscape," said Kirk Kaminsky, president of The US Oncology Network and Practice Management for McKesson Specialty Health. "Combined, Vantage Oncology and The US Oncology Network support more than 1,300 affiliated physicians and approximately 400 affiliated sites of care. Bringing them together earlier this year and now executing this strategic agreement with Varian will help our affiliated practices simultaneously enhance clinical capabilities, workflow for physicians, and the quality of patient care while improving the cost-effectiveness of their operations. The specialized hardware, service offerings and roadmap for interoperability with iKnowMed gives clinicians greater efficiency and increased quality of patient care benefits."

"We are honored by the long-term commitment McKesson Specialty Health is making in Varian equipment and technology as part of this agreement," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "Our companies share a common goal to develop and deliver the highest level of care. Through this strategic agreement, we are increasing the ability of patients to access the most advanced treatments in their fight against cancer."

On October 26, 2016 Genomic Health, Inc. (NASDAQ: GHDX) reported publication in Reviews in Urology of a comprehensive economic analysis of the use of the Oncotype DX Genomic Prostate ScoreTM (GPS) in low-risk prostate cancer patients (Press release, Genomic Health, OCT 26, 2016, View Source [SID1234516026]). Results showed that use of the GPS results in a net savings of $2,286 per patient – including the cost of the test – by decreasing unnecessary immediate invasive treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Not all low-risk prostate cancers are aggressive, but it is critical to know exactly which patient can forego immediate surgery safely," said study principal investigator David M. Albala, M.D., chief of urology, Crouse Hospital, Syracuse, New York. "Better treatment decisions can be made when patients have genomic information about their prostate tumors. Our study reconfirms that the GPS provides physicians and patients with additional risk assessment that resolves uncertainty in prognosis and informs individuals’ treatment decisions based on tumor biology."

Led by Associated Medical Professionals (AMP) of New York, the study demonstrated that incorporation of the GPS as part of the treatment decision algorithm for prostate cancer patients with NCCN very low and low-risk disease (64 percent of the study population) led to a 21 percent net increase in the use of active surveillance. The study specifically included prostate cancer patients covered by Excellus BlueCross BlueShield insurance in New York. Of these, treatment patterns and cost for 80 men tested with Oncotype DX were compared to 100 patients in the same practice without genomic testing.

Based on a real-world practice setting with a contemporary patient population and using current treatment cost averages, these published results demonstrated that the use of Oncotype DX represented a more than 50 percent return on investment over six months by reducing the cost of unnecessary immediate interventions. Additional savings can also be expected by removing the cost of management of associated side effects of treatment such as impotence and incontinence.

"The cost of caring for prostate cancer patients in the United States is estimated to be approximately $18 billion by 2020," said Phil Febbo, M.D., chief medical officer, Genomic Health. "The study provides additional important evidence to support broader adoption of Oncotype DX as we continue to fulfill Genomic Health’s vision to bring precision medicine to cancer patients, to empower physicians with actionable molecular information and to provide value and cost savings to our healthcare systems."

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The Oncotype DX prostate cancer test identifies which clinically low-risk patients are eligible for active surveillance, as well as those who may benefit from immediate treatment by predicting disease aggressiveness. With more than 600,000 patients tested in more than 90 countries, Oncotype DX testing has redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX prostate cancer test, visit www.OncotypeDX.com or www.MyProstateCancerTreatment.org.

On October 26, 2016 X-Rx, Inc, a biotechnology company focused on the creation of small molecule drug candidates, and Mercachem BV, a leading chemistry CRO with expertise in medicinal and process chemistry, reported progress with two discovery-stage oncology programs from the portfolio of X-Rx (Press release, X-Rx, OCT 26, 2016, View Source [SID1234527704]). The programs target Mcl1, an anti-apoptotic target that is over-expressed in many liquid and solid tumor types, and TAK1, a member of the mitogen-activated protein kinase family.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the service agreement with X-Rx, Mercachem is responsible for hit-to-lead and lead optimization campaigns targeting Mcl1 and TAK1. Mcl1-targeting agents could lead to inducing tumor cell death via apoptosis and via modulation of the tumor micro-environment, drive sensitivity to chemotherapy and other immunotherapy approaches. Blocking TAK1, a kinase that when over-expressed in many cell types can drive tumor onset and progression, fibrosis and autoimmune diseases, will have numerous clinical applications.

"In 2015, we successfully partnered two of our therapeutic programs with leading pharma organizations in major markets. We are committed to building on this initial success and bringing additional candidates towards a stage where significant value has been generated to partner them on favorable terms," said Dr. Lee Babiss, CEO of X-Rx. "With today’s news we are taking the next step in the discovery and development of our Mcl1 and TAK1 programs together with Mercachem."

"We are pleased that X-Rx has chosen Mercachem as their collaboration partner as they further explore the therapeutic potential of their two promising oncology targets using our competence and expertise with kinases and PPI targets," commented Dr. Gerhard Müller, SVP Medicinal Chemistry of Mercachem.

On October 26, 2016 Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, reported its third quarter 2016 financial results and provided an update on recent events and development timelines for its therapeutic programs (Press release, Sangamo BioSciences, OCT 26, 2016, View Source [SID1234516044]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sangamo BioSciences, Inc. (PRNewsFoto/Sangamo BioSciences, Inc.)
"The third quarter of 2016 has been a pivotal time for Sangamo, as we worked to focus our efforts and execute on our prioritized therapeutic programs in hemophilia B, hemophilia A, MPS I and MPS II," said Sandy Macrae, M.B., Ch.B., Ph.D., Sangamo’s president and chief executive officer. "I am pleased to announce that the Phase 1/2 clinical trial for SB-FIX, our in vivo genome editing program for hemophilia B, is open. We are also on track to file an IND application for our AAV cDNA Factor 8 gene therapy program for hemophilia A by the end of this year. In addition, we submitted the additional data package for our MPS I and MPS II programs to the FDA in September, and I am pleased to report that the FDA has cleared these programs for clinical development. Preparations are now underway to initiate Phase 1/2 clinical trials for these indications in early 2017."

Dr. Macrae continued, "We also made a number of organizational changes, including several key hires in our clinical and technical operations teams and instituted new procedures in order to position the company for clinical success. I am very encouraged by the commitment of our entire team and the progress we have made in the third quarter to drive these activities forward. I remain confident that we can demonstrate the value and therapeutic potential of our genome editing and gene therapy platforms and with reliable steps, make sensible progress and realize our vision of transforming Sangamo into a patient-focused therapeutics company."

Recent Highlights

Initiation of FIXtendz (SB-FIX-1501) Phase 1/2 clinical trial designed to assess safety, tolerability and potential efficacy of SB-FIX in adults with hemophilia B. In October, Sangamo opened the first clinical study of an in vivo genome editing therapeutic, its Phase 1/2 clinical trial (FIXtendz, SB-FIX-1501). SB-FIX-1501 is an open-label, dose-escalation study in male subjects over eighteen years of age, with severe hemophilia B, who do not have inhibitors or hypersensitivity to recombinant Factor IX protein (rFIX). The study will enroll up to nine subjects in three dosing cohorts of two subjects per cohort, with additional subjects to be enrolled at the optimal therapeutic dose, and will evaluate the safety and potential efficacy of a single administration of SB-FIX.

U.S. Food and Drug Administration (FDA) grants orphan drug designation to SB-FIX, the first in vivo genome editing therapeutic in development. In September, Sangamo announced that the FDA granted Orphan Drug Designation (ODD) to SB-FIX, the company’s zinc finger nuclease (ZFN)-mediated in vivo genome editing therapeutic candidate for hemophilia B. Orphan drug designation is granted to investigational drugs and biologics that are intended to treat rare diseases that affect fewer than 200,000 people in the U.S. This designation helps facilitate drug development by providing several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trial costs, exemption from certain FDA application fees and seven years of market exclusivity upon regulatory product approval.

FDA clearance to initiate Phase 1/2 clinical trials for SB-318 (MPS I) and SB-913 (MPS II) therapeutic programs. Sangamo submitted the additional in vitro studies requested by the FDA in September and recently received clearance to initiate Phase 1/2 clinical trials for the Mucopolysaccharidosis Type I (MPS I, Hurler syndrome) and Mucopolysaccharidosis Type II (MPS II, Hunter syndrome) programs based on its ZFN-mediated in vivo genome editing therapeutic platform. The company expects to initiate the clinical studies in early 2017.

Appointment of new head of technical operations. In August, Sangamo appointed Mohammad El-Kalay, Ph.D., as Vice President, Technical Operations. Dr. El-Kalay brings over 25 years of operational management experience in the life sciences field, including expertise in process development and cGMP manufacturing operations at clinical scale with hematopoietic stem cells, T-cells and various other cell types. Dr. El-Kalay is responsible for process development and manufacturing of all biotherapeutics for Sangamo.

Third Quarter 2016 Results
For the third quarter ended September 30, 2016, Sangamo reported a consolidated net loss of $19.0 million, or $0.27 per share, compared to a net loss of $9.2 million, or $0.13 per share, for the same period in 2015. As of September 30, 2016, the Company had cash, cash equivalents, marketable securities and interest receivable of $155.4 million.

Revenues for the third quarter of 2016 were $2.8 million, compared to $8.6 million for the same period in 2015. Third quarter 2016 revenues were generated from the Company’s collaboration agreements with Biogen and Shire International GmbH (Shire), enabling technology agreements and research grants. The revenues recognized for the third quarter of 2016 consisted of $2.7 million from collaboration agreements and $0.1 million from research grants, compared to $8.4 million and $0.2 million, respectively, for the same period in 2015. The decrease in collaboration agreement revenues was a result of an amendment to the Company’s collaboration and license agreement with Shire in the third quarter of 2015, which returned the rights to the hemophilia programs to Sangamo, as well as a decrease in revenues from the Biogen agreement as the initial research phase of these programs has matured and activities during this quarter were largely internal.

In the third quarter of 2016, Sangamo recognized $1.2 million of revenues related to research services performed under the collaboration agreement with Biogen, and $0.2 million of revenues related to research services performed under the collaboration agreement with Shire. In addition, Sangamo received upfront payments of $13.0 million and $20.0 million pursuant to the agreements entered into with Shire in 2012 and Biogen in 2014, respectively. The Shire payment is being recognized as revenue on a straight-line basis over the initial six-year research term. Beginning in January 2016, the Biogen payment is being recognized over approximately 42 months which reflects the revised service period related to Sangamo’s deliverables under the Biogen agreement. The Company recognized $0.5 million of the Shire upfront payment and $0.6 million of the Biogen upfront payment as revenue for the third quarter of 2016.

Research and development expenses were $17.0 million for the third quarter of 2016, compared to $16.7 million for the same period in 2015. General and administrative expenses were $5.0 million for the third quarter of 2016, compared to $4.6 million for the same period in 2015.

Total operating expenses for the third quarter of 2016 were $22.0 million, compared to $21.3 million for the same period in 2015.

Nine Months Results
For the nine months ended September 30, 2016, the consolidated net loss was $62.0 million, or $0.88 per share, compared to a consolidated net loss of $26.7 million, or $0.38 per share, for the nine months ended September 30, 2015. Revenues were $10.5 million for the nine months ended September 30, 2016, compared to $30.4 million for the same period in 2015. The decrease in revenues was primarily related to the amendment of our collaboration and license agreement with Shire, as well as a decrease in revenues related to our agreements with Sigma and Biogen. Total operating expenses were $73.2 million for the nine months ended September 30, 2016, compared to $61.6 million for the same period in 2015 and reflect increased expenses related to salaries and benefits, including stock-based compensation expense, as well as professional fees, consulting services and other corporate costs.

Financial Guidance for 2016
The Company reiterates guidance as follows:

Cash and Investments: Sangamo expects that its cash, cash equivalents and marketable securities will be at least $140 million at the end of 2016, inclusive of research funding from existing collaborators but exclusive of funds arising from any additional new collaborations or partnerships, equity financings or other new sources.

Revenues: Sangamo expects that revenues will be in the range of $12 million to $17 million in 2016, inclusive of research funding from existing collaborations.

Operating Expenses: Sangamo expects that operating expenses will be in the range of $85 million to $95 million for 2016.