Helocyte Announces Corporate and Clinical Milestones

On April 21, 2016 Helocyte, Inc. a majority-owned subsidiary of Fortress Biotech, Inc. (NASDAQ: FBIO) focused on the acquisition, development and commercialization of novel immunotherapies for the prevention and treatment of cancer and infectious disease (and in particular, cytomegalovirus or "CMV"), reported several corporate and clinical milestones (Press release, Fortress Biotech, APR 21, 2016, View Source;FID=1500083994 [SID:1234511213]).

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In June 2015, Helocyte’s Board of Directors appointed Frank Taffy as President and Chief Executive Officer (and in December 2015, as an additional member of the Board). Mr. Taffy has more than fifteen years of experience in life sciences corporate development and business operations. He identified the Helocyte programs and co-founded the company during his role as Entrepreneur in Residence at Fortress Biotech. Mr. Taffy previously held the positions of Head (Senior Director) of Business Affairs at Forest Laboratories (now Allergan) and Director of Corporate Development at Life Technologies (now Thermo Fisher Scientific), where he also held Board positions on behalf of the company. Mr. Taffy began his career as Counsel for Intellectual Property at Procter & Gamble. He holds a J.D. from Syracuse University College of Law and a B.A. in biochemistry from the University of North Texas.

In June 2015, a Phase 2 study of Helocyte’s PepVax opened for enrollment. The randomized, placebo-controlled, multicenter trial will evaluate the potential of PepVax to reduce the frequency of CMV events in 96 recipients of allogeneic hematopoietic stem cell transplant. The study is supported by funding from the National Cancer Institute. For additional information on the Phase 2 study of PepVax, please visit: View Source

In November 2015, a Phase 2 study of Helocyte’s universal Triplex opened for enrollment. The randomized, placebo-controlled, multicenter trial will evaluate the potential of Triplex to reduce the frequency of CMV events in 115 recipients of allogeneic hematopoietic stem cell transplant. The study is also supported by funding from the National Cancer Institute. For additional information on the Phase 2 study of Triplex, please visit: View Source

In November 2015, the results of a Phase 1 study of Triplex were selected for presentation at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). Triplex is the first CMV immunotherapy that uses a recombinant Modified Vaccinia Ankara (MVA) vector incorporating multiple CMV response antigens. The Phase 1 study demonstrated the safety and marked immunogenicity of Triplex. The complete text of the ASH (Free ASH Whitepaper) abstract can be accessed at: View Source

In December 2015, the results of a Phase 1b study of PepVax were published in The Lancet Haematology. PepVax was observed to be well-tolerated, immunogenic and highly effective in controlling CMV in patients. To our knowledge, PepVax is the first immunotherapy to demonstrate proof of concept for CMV control in the post-transplant setting. PepVax further demonstrated the unexpected clinical outcomes of reduced relapse and increased survival (from underlying cancer). The full text of the Lancet publication can be accessed at: http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)00246-X/abstract.

Celator® Pharmaceuticals to Present Phase 3 Data at 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2016 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that Phase 3 clinical trial data for VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7, 2016 (Press release, Celator Pharmaceuticals, APR 21, 2016, View Source [SID:1234511211]).

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A late-breaking abstract on the Phase 3 clinical trial was selected for an oral presentation:

Date & Track Time:
Saturday, June 4, 2016 – 3:00pm to 6:00pm CT

Track:
Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Presentation Title:
Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML.

Presenter:
Jeffrey E. Lancet, M.D., H. Lee Moffitt Cancer Center & Research Institute

Abstract #:
7000

Presentation Time:
3:00pm to 3:12pm CT

Location:
Arie Crown Theatre

Quantitative Computed Tomography Classification of Lung Nodules: Initial Comparison of 2- and 3-Dimensional Analysis.

The aim of this study was to compare the performance of 2- (2D) and 3-dimensional (3D) quantitative computed tomography (CT) methods for classifying lung nodules as lung cancer, metastases, or benign.
Using semiautomated software and computerized analysis, we analyzed more than 50 quantitative CT features of 96 solid nodules in 94 patients, in 2D from a single slice and in 3D from the entire nodule volume. Multivariable logistic regression was used to classify nodule types. Model performance was assessed by the area under the receiver operating characteristic curve (AUC) using leave-one-out cross-validation.
The AUC for distinguishing 53 primary lung cancers from 18 benign nodules and 25 metastases ranged from 0.79 to 0.83 and was not significantly different for 2D and 3D analyses (P = 0.29-0.78). Models distinguishing metastases from benign nodules were statistically significant only by 3D analysis (AUC = 0.84).
Three-dimensional CT methods did not improve discrimination of lung cancer, but may help distinguish benign nodules from metastases.

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Immune Design Announces Presentations at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that data from three immuno-oncology studies will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place June 3 to June 7, 2016 in Chicago (Press release, Immune Design, APR 21, 2016, View Source [SID:1234511207]).

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The ASCO (Free ASCO Whitepaper) presentation details are as follows:

Pilot trial of intratumoral (IT) G100, a toll-like receptor-4 (TLR4) agonist, in patients with Merkel cell carcinoma (MCC): Final clinical results and immunologic effects on the tumor microenvironment (TME).

Abstract # 3021

Session Type: Poster Discussion Session
Session Title: Developmental Therapeutics—Immunotherapy

Date: Sunday, June 05
Time: 8 a.m. — 11:30 a.m. (poster session) / 4:45 p.m. — 6 p.m. (poster discussion)
Location: Hall A (poster session) / Hall B1 (poster discussion)
Poster Board: #343

Presenter: Shailender Bhatia, M.D., University of Washington, Fred Hutchinson Cancer Research Center

Using G100 (glucopyranosyl lipid A) to transform the sarcoma tumor immune microenvironment

Abstract #: 11017

Session Type: Poster Discussion Session
Session Title: Sarcoma

Date: Monday, June 6, 2016
Time: 8 a.m. — 11:30 a.m. (poster session) / 3 p.m. — 4:15 p.m. (poster discussion)
Location: Hall A (poster session) / S406 (poster discussion)
Poster Board: 143

Presenter: Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center

Single-agent LV305 induces anti-tumor immune and clinical responses in patients with advanced or metastatic sarcoma and other cancers expressing NY-ESO-1

Abstract # 3093

Session Type: Poster
Session Title: Developmental Therapeutics—Immunotherapy

Date: Sunday, June 5
Time: 8 a.m. — 11:30 a.m.
Location: Hall A
Poster Board: 415

Presenter: Neeta Somaiah, M.D. Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center

Additional data than those included in the abstracts may be included in the presentations.

OncoCyte’s Bladder Cancer Abstract to be Featured in a Poster Discussion Session at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported that its bladder cancer abstract has been selected for presentation in a poster session, including a live panel discussion on the results, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in Chicago, Illinois June 3rd through the 7th (Press release, BioTime, APR 21, 2016, View Source;p=RssLanding&cat=news&id=2159019 [SID:1234511206]).

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The Company has been developing a urine-based diagnostic that could be more effectively used for screening for bladder cancer in patients presenting with hematuria, confirming indeterminate cytology findings, and diagnosing recurrence of bladder cancer in patients in remission. OncoCyte presented interim clinical study data for the non-invasive detection of bladder cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April of 2015 demonstrating a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer. At AACR (Free AACR Whitepaper) OncoCyte reported a ROC AUC of .91, sensitivity of 90% and specificity of 83%. The study to be presented at ASCO (Free ASCO Whitepaper) continued the development of the diagnostic first reported in the 2015 study.

"ASCO is one of the largest medical meetings of the year and OncoCyte is excited to be presenting clinical data for our diagnostics for the second year in a row," commented William Annett, Chief Executive Officer. "Our bladder test has the potential to screen approximately four million patients along the cancer spectrum annually and reflects our robust clinical pipeline of diagnostics assays. We are looking forward to sharing our results with the medical community as well as our shareholders."

The data will be presented by Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research.

Presentation Title: "Derivation of gene expression classifiers for the non-invasive detection of bladder cancer in the hematuria and recurrence surveillance populations."
Session Title: Tumor Biology
Poster Session: 1 PM – 4:30 PM June 6, 2016
Poster Discussion Session: 4:45 PM – 6 PM, June 6, 2016

About Bladder Cancer

Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. Bladder cancer in the U.S. was estimated to cost $125B in 2010, growing to $155B in 2014. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease.