On March 16, 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 that two oral presentations and two poster presentations to be delivered at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, Louisiana (Press release, Kite Pharma, MAR 16, 2016, View Source [SID:1234509601]). The oral presentations will address KTE-C19, Kite’s lead chimeric antigen receptor (CAR) product candidate, and, separately, an engineered T cell receptor (TCR) product candidate targeting the cancer testis antigen MAGE-A3. The TCR product candidate is currently being studied as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute.

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Oral Presentations:

Title: Updated Phase 1 Results from ZUMA-1: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 (Anti-CD19 CAR T Cells) in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

Date: Tuesday, April 19, 2016 3:00-5:00PM Central Time
Session: Early Clinical Trials Evaluating Cell-based, Checkpoint Inhibitors, and Novel Immunotherapeutics
Abstract Number: CT135
Location: Room 343, Morial Convention Center
Presenter: Armin Ghobadi, M.D., Washington University, St. Louis, MO

Title: A Phase 1 Study of an HLA-DPB1*0401-restricted T Cell Receptor Targeting MAGE-A3 for Patients with Metastatic Cancer

Date: Sunday, April 17, 2016 2:15-4:00PM Central Time
Session: Immuno-Oncology Clinical Trials I
Abstract Number: CT003
Location: La Nouvelle Ballroom, Morial Convention Center
Presenter: Yong-Chen W. Lu, Ph.D., Surgery Branch, National Cancer Institute

Poster Presentations:

Title: Manufacturing and Characterization of KTE-C19 in a Multicenter Trial of Subjects with Refractory Aggressive Non-Hodgkin’s Lymphoma (NHL) (ZUMA-1)

Date: Monday, April 18, 2016 1:00-5:00PM Central Time
Session: Adoptive Cell Therapy
Abstract Number: 2308
Location: Poster Hall, Section 25, Poster Board 20
Presenter: Marc Better, Ph.D., Kite Pharma, Santa Monica, CA

Title: Comparative Evaluation of Peripheral Blood T cells and Resultant Engineered Anti-CD19 CAR T Cell Products from Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL) Patients

Date: Monday, April 18, 2016 1:00-5:00PM Central Time
Session: Adoptive Cell Therapy
Abstract Number: 2305
Location: Poster Hall, Section 25, Poster Board 17
Presenter: Timothy J. Langer, Kite Pharma, Santa Monica, CA

About KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR 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. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications.

On March 16, 2016 GSK and Miltenyi Biotec reported a strategic collaboration that will bring together GSK’s expertise in developing cell and gene therapy based treatments with Miltenyi Biotec’s global leadership in cell processing and related technologies in cell therapy (Press release, GlaxoSmithKline, MAR 16, 2016, View Source [SID:1234509747]). The collaboration seeks to optimise the manufacture and delivery of these personalised therapies using increased automation and leading edge processing technology.

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GSK is building a cell and gene therapy R&D platform to underpin development of novel therapies in oncology and rare diseases – two of its core research areas. This reflects the company’s belief in cell and gene therapy’s potential as an important treatment approach for tackling the underlying cause of serious disease.

Through the collaboration, Miltenyi Biotec will engage with GSK to integrate greater automation and high-tech processing technology into GSK’s current cell and gene therapy R&D manufacturing capabilities. The goal is to use this increased automation to further industrialise cell and gene therapy, overcoming the manufacturing and scale-up constraints associated with current, more manual cell and gene therapy processes. This could reduce the costs and geographical barriers associated with this treatment approach, speed development of therapies and support their potential beyond rare diseases and limited populations.

The collaboration will also bring together the technology and expertise of both companies to advance the discovery of new CAR (chimeric antigen-receptor) T-cell based therapeutics – cells that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. GSK and Miltenyi Biotec will collaborate on defined CAR-T oncology targets and on the development of advancements in technologies in this space that may be further applied by both companies. This collaboration supplements GSK’s existing CAR-T preclinical portfolio.

Patrick Vallance, President of Pharmaceuticals R&D at GSK, said: "Cell based gene therapies are living treatments, unique to individual patients and complex to manufacture. We see tremendous potential for the cell and gene therapy platform we are building within GSK, however the complexity of current manufacturing processes limits their use to local treatment of small patient populations. Working with Miltenyi Biotec, our vision is to transform current technology so that we can expand the possibilities for cell and gene therapy treatment to wider patient populations with broader geographical reach."

Stefan Miltenyi, President and CEO at Miltenyi Biotec, said: "For more than 20 years we have been developing and providing cell therapy solutions to patients worldwide. Working together with the global experts at GSK, we will accelerate innovation to broaden patient access to future personalised cell and gene therapy."

About Cell and Gene therapies
Cell and gene therapies are potentially powerful disease modifying experimental treatments that focus on genetically engineering living cells to either repair the direct cause of a genetic defect or equip them with genes that enhance their functions.

To make cell and gene therapy treatments, selected populations of cells are extracted from the body and genetically-engineered to produce the desired therapeutic effect. This can mean replacing a faulty gene in a stem cell or changing immune cells so they can recognise tumours. The transformed cells are then re-introduced into a patient’s body where they exert their effect by replacing faulty genes or educating the immune system to recognise and kill cancer cells

On March 16, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery technology to develop a portfolio of targeted nucleic acid cancer drugs, reported operational and financial results for the year ended December 31, 2015 (Filing, Annual, Bio-Path Holdings, 2015, MAR 16, 2016, View Source [SID:1234509584]).

"2015 was a year of significant progress for Bio-Path," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "With two full remissions achieved in the safety segment of our Phase II trial of lead candidate BP1001 in advanced AML patients, the formation of an inaugural Scientific Advisory Board, and receiving orphan drug designation for BP1001 in AML, we are looking forward to a successful 2016."

2015 Operational Highlights:

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· Finalized the data package for the monotherapy portion of the Phase I clinical trial of Bio-Path’s lead product candidate, BP1001 (Liposomal Grb2 antisense), in blood cancers during the fourth quarter of 2015. BP1001 was well tolerated and showed signs of anti-leukemia activity and no drug-related toxicities. Among 21 evaluable patients, more than half experienced at least a 50 percent reduction in peripheral or bone marrow blasts from baseline. Additionally, several patients demonstrated transient improvement and/or stable disease. Notably, one patient with chronic myelogenous leukemia (CML) blast phase showed a significant reduction in blasts. Patient data from the Phase I clinical trial also demonstrated significant reductions in the target Grb2 protein and its downstream proteins, providing positive evidence that Bio-Path’s DNAbilizeTM neutral lipid delivery with proprietary antisense technology successfully delivers an antisense drug substance to a diseased cell to knock down the target protein.

· Received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BP1001 for the treatment of acute myeloid leukemia (AML) in the second quarter of 2015. Orphan drug status provides Bio-Path with seven years of exclusivity after receiving formal marketing approval, as well as additional development incentives.

· Performed preclinical testing of BP1001 in two additional indications—triple negative breast cancer (TNBC) and inflammatory breast cancer (IBC), two cancers characterized by formation of aggressive tumors and relatively high mortality rates. Bio-Path is rolling this initiative into a broader solid tumor testing program, including advanced ovarian cancer. The preclinical program may be expanded to include combination therapy evaluations.

· Added a second drug manufacturer, strengthening Bio-Path’s manufacturing process while increasing capability and capacity.

· Continued preclinical evaluation of a third DNAbilizeTM product. Bio-Path’s product candidate screening and development program has validated the next promising candidate, which will diversify the Company’s product pipeline. Potential indications include diffuse large B-cell lymphoma, non-small cell lung cancer, pancreatic cancer and disease candidates outside of oncology, such as autoimmune disorders.

· Formed a Scientific Advisory Board to support the advancement of Bio-Path’s clinical and preclinical therapeutic candidates. Jorge Cortes, M.D., renowned leukemia expert from The University of Texas MD Anderson Cancer Center, joined as Chairman. Amy P. Sing, M.D., a member of Bio-Path’s board of directors and Senior Director of Medical Affairs at Genomic Health, Inc., joined as a founding member.

· Presented Bio-Path’s proprietary technology and clinical trial results at an international meeting. Jorge Cortes, M.D. of The University of Texas MD Anderson Cancer Center and Chair of Bio-Path’s Scientific Advisory Board presented a poster at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 7, 2015 in Orlando, FL. Dr. Cortes discussed data from the Phase I and safety segment of the Phase II clinical trials of BP1001 in blood cancers. These data included the complete remission of two evaluable patients receiving BP1001 in combination with low-dose cytarabine (LDAC) chemotherapy.

· Presented to the medical and scientific community at the IBC’s 17th Annual TIDES: Oligonucleotide and Peptide Therapeutics Conference in San Diego. The presentation featured Bio-Path’s DNAbilizeTM technology for delivering liposome/antisense drugs and highlighted BP1001. The TIDES Summit is prominently known as the premier conference for the oligonucleotide and peptide discovery, development and manufacturing industries.

· Continued enhancement of Bio-Path’s public profile within the investment community and biopharmaceutical industry. Chief Executive Officer Peter Nielsen delivered company presentations at the 17th Annual Rodman & Renshaw Global Investment Conference in September 2015, the 14th Annual BIO Investor Forum in October 2015, Biotech Showcase 2015 Conference in San Francisco, CA in January 2016 and the 18th Annual BIO CEO & Investor Conference in New York City in February 2016.

· Established an "at-the-market" ("ATM") program during the second quarter of 2015, through which it may offer and sell up to $25 million of common stock from time to time, at Bio-Path’s discretion, through an investment banker, acting as sales agent. Sales of Bio-Path common stock under the ATM program may be made directly on or through the Nasdaq Capital Market, among other methods. As of December 31, 2015, the Company has not offered or sold any shares of common stock under the ATM program.

Recent / First Quarter 2016 Operational Highlights:

· Completed the safety segment of the Phase II clinical trial of BP1001, in combination with low-dose cytarabine (LDAC) chemotherapy, in patients with advanced AML. Of the six evaluable patients, two had a complete response and two had a partial response, with one patient continuing treatment. Bio-Path saw no adverse events attributable to BP1001 treatment.

· Entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate Bio-Path’s clinical pipeline for its ability to modulate pancreatic cancer.

Expected Upcoming Milestones:

· BP1001 in Acute Myeloid Leukemia (AML): Bio-Path is finalizing steps to commence a multi-site Phase II clinical trial assessing the efficacy of BP1001 in combination with low-dose cytarabine (LDAC) chemotherapy, which is expected to commence in the second quarter of 2016.

· BP1001 in Chronic Myelogenous Leukemia (CML): Bio-Path commenced development of a protocol for a Phase II clinical trial evaluating BP1001 in combination with frontline chemotherapy in CML patients in blast crisis, an area of unmet medical need. This clinical trial is expected to start in the second quarter of 2016.

· BP1002 (Liposomal Bcl2; L-Bcl2): Bio-Path is finalizing a preclinical package of toxicity, tissue distribution, pharmacokinetics and efficacy studies for its second product candidate, BP1002. An Investigational New Drug (IND) application will be filed with the FDA upon finalizing drug batch required for the Chemistry, Manufacturing and Controls section of the IND. Bio-Path expects that the favorable toxicity profile of BP1001 will allow for a Phase I clinical trial of BP1002 to begin at a higher dose, thus reducing the number of patients required to complete the safety phase of the trial.

2015 Financial Highlights:

· Bio-Path reported a net loss of $5.5 million for the year ended December 31, 2015, compared to a net loss of $4.5 million for the year ended December 31, 2014. The increase was primarily due to increased clinical trial expenses, manufacturing development, preclinical study costs and personnel costs associated with the addition of research and development support staff in the second half of 2014. The Company reported a net loss of $0.06 per share for the year ended December 31, 2015, compared to a net loss of $0.05 per share for the year ended December 31, 2014.

· Research and development expenses for the year ended December 31, 2015 increased to $3.0 million, compared to $1.8 million for the year ended December 31, 2014.

· General and administrative expenses for the year ended December 31, 2015 decreased to $2.5 million, compared to $2.7 million for the year ended December 31, 2014.

· As of December 31, 2015, the Company had a cash balance of $8.9 million, compared to $13.9 million at December 31, 2014. Net cash used in operating activities for the year ended December 31, 2015 was $5.0 million, compared to $3.8 million for the comparable period in 2014.

About Bio-Path’s Delivery Technology

Bio-Path’s drug delivery technology, called DNAbilize, involves microscopic-sized liposome particles that distribute nucleic acid drugs systemically and safely throughout the human body, via simple intravenous infusion. The delivery technology is applied to proprietary, single stranded (antisense) nucleic acid compounds with the potential to revolutionize the treatment of cancer and other diseases where druggable targets of disease are well characterized. The Company is currently focused on developing liposomal antisense drug candidates. Bio-Path also anticipates developing liposome tumor targeting technology, representing next-generation enhancements to the Company’s core liposome delivery technology.

About BP1001 (Liposomal Grb2 antisense)

BP1001 (Liposomal Grb2 antisense) is a neutral-charge, liposome-incorporated antisense drug substance designed to inhibit Grb2 protein expression. The protein Grb2 is essential to cancer cell signaling because it is utilized by oncogenic tyrosine kinases to induce cancer progression. Suppressing the function or expression of Grb2 should interrupt its vital signaling function and have a therapeutic application in cancer.

On March 16, 2016 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will feature new preclinical data on FPA144 in a poster presentation during the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 16-20 in New Orleans (Press release, Five Prime Therapeutics, MAR 16, 2016, View Source [SID:1234509614]).

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Abstract #1407 titled, "FPA144, a Therapeutic Monoclonal Antibody Targeting the FGFR2b Receptor, Promotes Antibody Dependent Cell-Mediated Cytotoxicity and Stimulates Sensitivity to PD-1 the 4T1 Breast Tumor Model in Mice," is now accessible on the meeting website. The poster presentation will take place from Monday, April 18, 2016, from 8:00 AM – 12:00 PM in Section 22. The poster will be made available on the publications page of the Five Prime website following the presentation.

FPA144 is an FGFR2b-specific humanized monoclonal antibody designed to treat patients with cancers that overexpress the FGFR2b receptor. FPA144 is a targeted immunotherapy that has been engineered to recruit NK cells into the tumor microenvironment and kill cancer cells by antibody-dependent cell-mediated cytotoxicity (ADCC). At the 2014 AACR (Free AACR Whitepaper) Annual Meeting, Five Prime presented data showing that FPA144 can produce complete and durable tumor growth inhibition in FGFR2b-overexpressing and FGFR2 gene-amplified gastric cancer xenografts in immune-compromised mice. The ongoing Phase 1 monotherapy trial is enrolling patients with gastric cancer, a disease in which FGFR2b protein overexpression and FGFR2 gene amplification have been associated with poor prognosis.

In recent months, Five Prime evaluated the anti-tumor effects and immune cell recruitment of FPA144 in the 4T1 model of breast cancer in immune-competent mice. Although the tumor cells in this model express FGFR2b, the FGFR2 gene is not amplified. Therapeutic treatment with FPA144 alone in the orthotopic 4T1 model resulted in a reduction in tumor burden (33%, P<0.001) and within 24 hours, the recruitment of NK cells to the site of tumor implantation, while a modified antibody lacking Fc effector function neither inhibited tumor growth nor led to the recruitment of NK cells. Together these data indicate that enhanced ADCC activity of FPA144 may have the potential to play an important mechanistic role in anti-tumor efficacy in cancers that have modest expression of FGFR2b.

In addition, four days after treatment with FPA144, there was an influx of T cells into the tumor as well as increased expression of PD-L1, providing a strong rationale that FPA144 may combine effectively with PD-1 blockade. Although PD-1 blockade by the RPM1-14 antibody did not inhibit tumor growth as a single agent in the 4T1 model, treatment with RPM1-14 in combination with FPA144, inhibited tumor growth by 49% (P<0.001), demonstrating an additive benefit of combination therapy. These results suggest that FPA144 alters the immune cell composition of the tumor microenvironment in a way that primes the tumor for additional anti-tumor activity when combined with PD-1 blockade.

About FPA144

FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy for tumors that over-express FGFR2b, as determined by a proprietary immunohistochemistry (IHC) diagnostic assay. FPA144 is designed to block tumor growth through two distinct mechanisms. First, it binds specifically to FGFR2b and prevents the binding of certain fibroblast growth factors that promote tumor growth. Second, it has been engineered to drive immune-based killing of tumor cells by antibody-dependent cell-mediated cytotoxicity (ADCC) and the recruitment of natural killer (NK) cells. FGFR2 gene amplification (as identified by FISH) is found in a number of tumors, including in approximately 5% of gastric cancer patients, and is associated with poor prognosis.

On March 16, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and its collaborators reported new data in a variety of tumor types at the 2016 United States and Canadian Academy of Pathology (USCAP) Annual Meeting taking place March 12-18 in Seattle (Press release, Foundation Medicine, MAR 16, 2016, View Source [SID:1234509585]). The data further strengthens the growing body of evidence across various cancers in support of integrating comprehensive genomic profiling with FoundationOne into the clinical pathology assessments of cancer patients to help inform targeted therapy utilization and improve patient care. The data presented underscore an urgent need for innovative solutions capable of accurately informing therapeutic options based on unique genomic alterations found within each patient’s tumor. Oncology case reports and series have indicated positive responses to targeted therapies for certain rare tumor types, and additional evidence supporting clinical utility is evolving to support payor coverage.

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"We are encouraged by the latest data presented amongst the global leaders and top minds in the pathology field at USCAP," said Jeffrey S. Ross M.D., medical director of Foundation Medicine, chair of pathology at the Albany Medical Center and lead author of two of the studies. "The pathology community is essential to advancing the next generation of novel therapies and personalized treatment for cancer patients worldwide. We are honored to provide an evidence-based platform to help the oncology community identify clinically relevant genomic alterations that hold the potential to influence patient treatment options, both for therapies that are FDA approved and therapies that are being investigated in clinical trials."

Three of the posters presented at the event focused on cancers with diverse, clinically relevant alterations, many of which are undetectable with standard screening, and represent indications with unmet clinical need, including refractory and metastatic breast cancer, triple negative breast cancer (TNBC) and adult and pediatric brain tumors. Results from all three data sets point to the importance of comprehensive genomic profiling to potentially influence and personalize treatment and guide the selection of approved targeted therapies or access to novel therapies that are being investigated in clinical trials.

Key Data Highlights:

The poster presentation titled, "Pangenomic Analysis of BRAF Genomic Alterations Across All Types of Brain Tumors Reveals Expanded Opportunities for Targeted Therapies," by Zachary R. Chalmers, lead researcher, senior research associate with Foundation Medicine, and presented by Dr. Ross demonstrates the need for additional basket-type clinical trials aimed to identify BRAF genomic alterations in various types of non-melanoma cancers to further understand targeted therapy choice and efficacy. Comprehensive genomic profiling using FoundationOne was performed to search for all classes of BRAF alterations in a large series of intracranial neoplasms including adult and pediatric brain tumors, and key findings include:

142 (4.8 percent) brain tumors featured BRAF alterations including base substitutions (70 percent), fusions (25 percent) and rare amplifications and other alterations types (5 percent). Genomic alterations in BRAF are widely distributed in brain tumors with base substitutions primarily seen in high-grade gliomas and BRAF fusions in low grade gliomas

The presentation demonstrated that BRAF base substitutions and fusions can be successfully targeted with anti-BRAF and anti-MEK targeted therapies

Preliminary findings outlined in the poster presentation titled, "Genomic Alterations of MCL1 is a Predictive Biomarker of Triple Negative Status and Therapy Response in Breast Cancer," led and presented by Dr. Ross, draw attention to the vital need for comprehensive analysis of breast cancer genes and the inherent limitations of hotspot testing in uncovering potential therapy options. Two hundred patients with breast cancer underwent comprehensive genomic profiling using FoundationOne, and key findings include:

MCL1 amplification is a frequent feature in advanced stage and high grade breast cancer, and MCL1 amplified breast cancer is very seldom ERBB2 co-amplified

Of the MCL1 amplified breast cancer cases, 88 percent were high grade and 98 percent were stage IV at the time of sequencing

Of the 200 MCL1 amplified breast cancer patients, 12 (6 percent) were ERBB2 (HER2) amplified

Clinical observation across several case studies suggest that treatment with targeted therapies including sorafenib and vorinostat in heavily pre-treated MCL1 amplified breast cancer may be correlated with clinical benefit

These preliminary findings suggest that MCL1 amplified TNBC may benefit from combination targeted therapy, and warrant further investigation in a prospective clinical trial

Consistent with the other two data sets, the findings in the poster presentation titled, "The Detection of IHC-/FISH- ERBB2 Non-Amplification Mutations in 5,606 Cases of Refractory and Metastatic Breast Cancer: an Emerging Opportunity for anti-HER2 Targeted Therapies," led by Siddhartha Dalvi, MBBS, lead researcher, Albany Medical College, and presented by Dr. Ross, demonstrate the potential for missing critical information with routine hotspot sequencing tests and thus the need for comprehensive profiling with FoundationOne. Comprehensive genomic profiling was performed on 5,606 metastatic breast cancer patients, and key findings include:

ERBB2mut are responsible for nearly 20 percent of ERBB2 alterations in metastatic breast cancer, though such mutations are not detectable by routine IHC and FISH slide-based HER2 tests

698 (12.5 percent) featured ERBB2 alterations, 596 (10.6 percent) featured ERBB2 amplifications (ERBB2amp) and 137 (2.4 percent) featured ERBB2mut

Evidence that ERBB2mut driven mBC are responsive to anti-HER2 targeted therapies is steadily accumulating