On May 3, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended March 31, 2016 and provided an overview of key milestones for the company’s lead drug candidates (Filing, Q1, Lexicon Pharmaceuticals, 2016, MAY 3, 2016, View Source [SID:1234511829]).

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"We closed out the quarter with the filing of the NDA for telotristat etiprate, an important milestone for the company," said Lexicon President and Chief Executive Officer, Lonnel Coats. "We look forward to working closely with the FDA during the review process of this investigational treatment for the care of patients living with carcinoid syndrome."

Pipeline Progress

Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), the rate-limiting enzyme involved in serotonin production. Excess production of serotonin within metastatic neuroendocrine tumor cells can lead to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.

On March 30, 2016, Lexicon announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.

Sotagliflozin, which is being developed as a potential treatment for type 1 and type 2 diabetes, is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of which modulates glucose levels, and is the first investigational medicine to target both of these two proteins.

Lexicon recently entered into a collaboration with Sanofi, in which Lexicon will continue to be responsible for clinical development activities relating to type 1 diabetes and Sanofi will be responsible for clinical development activities relating to type 2 diabetes. Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, one of which has already completed enrollment and the second of which has completed patient screening, and expects top-line results from its two pivotal Phase 3 clinical trials to be available in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016.

Financial Highlights

Revenues: Lexicon’s revenues for the three months ended March 31, 2016 increased to $12.5 million from $1.8 million for the corresponding period in 2015, primarily due to revenues recognized from the collaboration and license agreement with Sanofi.

Research and Development Expenses: Research and development expenses for the three months ended March 31, 2016 increased 77 percent to $37.0 million from $20.9 million for the corresponding period in 2015, primarily due to increases in external clinical and nonclinical research and development costs.

Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon’s consolidated statements of operations. For the three months ended March 31, 2016 and 2015, the fair value of the Symphony Icon purchase liability increased by $1.0 million and $1.8 million, respectively.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2016 increased 47 percent to $8.4 million from $5.7 million for the corresponding period in 2015, primarily due to increased costs in preparation for commercialization of telotristat etiprate.

Consolidated Net Loss: Net loss for the three months ended March 31, 2016 was $34.9 million, or $0.34 per share, compared to a net loss of $28.1 million, or $0.27 per share, in the corresponding period in 2015. For the three months ended March 31, 2016 and 2015, net loss included non-cash, stock-based compensation expense of $1.8 million and $2.0 million, respectively.

Cash and Investments: As of March 31, 2016, Lexicon had $477.1 million in cash and investments, as compared to $521.4 million as of December 31, 2015.

Reverse Stock Split: In May 2015, Lexicon completed a one-for-seven reverse stock split. All references to common shares and per-share data for all periods presented in this release have been adjusted to give effect to this reverse stock split.

On May 03, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal third-quarter 2016, provided an update on recent business highlights, provided fiscal-fourth quarter financial guidance and updated its fiscal year 2016 financial guidance (Press release, Myriad Genetics, MAY 3, 2016, View Source [SID:1234511830]).

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"For the fourth consecutive quarter we have exceeded our financial projections and the highlight of this quarter was strong growth from new products including Prolaris and Vectra DA," said Mark C. Capone, president and chief executive officer of Myriad. "Importantly, we made significant progress in securing new product reimbursement coverage this quarter, and coupled with positive developments in our other development programs, we remain confident in our ability to deliver on our five-year strategic goals."

Financial Highlights

Below are tables summarizing the financial results and revenue by product class for our fiscal third-quarter 2016:

Revenue
Fiscal Third-Quarter
($ in millions) 2016 2015 % Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 156.3 $ 159.0 (2 %)

Vectra DA testing revenue 12.3 10.5 17 %

Prolaris testing revenue 5.2 0.5 940 %

Other testing revenue 3.6 3.0 20 %

Total molecular diagnostic testing revenue 177.4 173.0 3 %

Pharmaceutical and clinical service revenue 13.1 7.0 87 %

Total Revenue $ 190.5 $ 180.0 6 %


Income Statement
Fiscal Third-Quarter
($ in millions) 2016 2015 % Change
Total Revenue $ 190.5 $ 180.0 6 %

Gross Profit 150.3 143.7 5 %
Gross Margin 78.9 % 79.8 %

Operating Expenses 107.7 108.0 0 %

Operating Income 42.6 35.7 19 %
Operating Margin 22.4 % 19.8 %

Adjusted Operating Income 45.8 46.3 (1 %)
Adjusted Operating Margin 24.0 % 25.7 %

Net Income 32.6 21.4 52 %

Diluted EPS 0.44 0.29 52 %

Adjusted EPS $ 0.41 $ 0.40 3 %

Business Highlights

myRisk Hereditary Cancer
NCCN updated its professional guidelines for hereditary cancer to include additional surgical risk-reduction considerations for multiple genes on the myRisk Hereditary cancer panel including PALB2, BRIP1, RAD51C and RAD51D. Additionally, NCCN expanded criteria for hereditary pancreatic and prostate cancer increasing the number of patients in the United States eligible for testing in these indications to approximately 25,000.
At the Society for Gynecological Oncology (SGO) meeting in March, Myriad presented data in 381 endometrial cancer patients showing that myRisk Hereditary Cancer identified 60 percent more deleterious mutations than traditional single syndrome screening.
At the American College of Medical Genetics and Genomics annual meeting, Myriad presented data demonstrating that one of its proprietary myVision algorithmic variant classification tools, Pheno, could be utilized on a broader set of cancer risk genes with greater than 99.5 percent accuracy in classification of variants of unknown significance.

Vectra DA
Vectra DA volumes were up 18 percent year-over-year and 11 percent sequentially in the fiscal third-quarter with approximately 42,500 tests performed.
Expanded the successful practice integration pilot program to the national phase with our entire rheumatology sales team in the fiscal-third quarter.
Signed two private insurance contracts totaling 2 million additional covered lives for Vectra DA.

Prolaris/Urology
Prolaris sample volume was up 90 percent year-over-year and 21 percent sequentially with approximately 4,300 tests ordered.
Signed multiple additional private insurance contracts bringing our total covered private lives to 28 million.

myPath Melanoma
The second validation study on myPath Melanoma demonstrating a 90 percent diagnostic accuracy in differentiating melanoma from benign nevi has been submitted to a major dermatology journal and we anticipate acceptance in the fiscal fourth-quarter.
Additionally, the clinical utility study on myPath Melanoma has been submitted for publication and we also anticipate acceptance of this study in the fiscal fourth-quarter.

Companion Diagnostics
Presented data at the recent SGO meeting demonstrating that myChoice HRD predicted both progression free survival and overall survival in platinum treated ovarian cancer patients. The test also performed substantially better than any of the individual proprietary markers (LOH, TAI, LST) in isolation.
Announced a research collaboration with TESARO and Merck to evaluate myChoice HRD and Myriad’s other tumor tests to predict responders to an investigational combination therapy including Merck’s anti-PD-1 therapy KEYTRUDA and TESARO’s PARP inhibitor niraparib.
Announced a research collaboration with AbbVie in non-small cell lung cancer to utilize myChoice HRD and Myriad’s other new tumor companion diagnostics to help identify potential responders to veliparib.

International
International revenues were up 40 percent year-over-year in the third quarter and accounted for approximately five percent of total product revenue in the quarter.
The French government has established provisional funding for EndoPredict and other breast prognostic tests beginning in April. France represents a market opportunity of approximately 25,000 tests per year for EndoPredict.
Signed an agreement with Hospital Corporation of America in the United Kingdom covering testing for hereditary cancer, Tumor BRACAnalysis CDx, EndoPredict and Prolaris. HCA manages six hospitals seeing approximately 500,000 patients per year in the UK.

Share Repurchase
During the quarter, the Company repurchased approximately 1.2 million shares, or $45 million, of common stock under our share repurchase program and ended the quarter with approximately $47 million remaining on our current share repurchase authorization.

Fiscal Fourth-Quarter and Fiscal Full-Year 2016 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2016 and fiscal fourth-quarter 2016 financial guidance:

Revenue Adjusted Earnings Per Share GAAP Diluted Earnings Per Share
Fiscal Fourth-Quarter 2016 $186-$188 million $0.36-$0.38 $0.32-$0.34

Fiscal Year 2016 $753-$755 million $1.63-$1.65 $1.48-$1.50

The Company is providing fourth-quarter revenue guidance of $186 to $188 million and adjusted earnings per share of $0.36 to $0.38. As a result, the Company is narrowing the range for its fiscal full year revenue guidance to total revenue of $753 to $755 million and updating its adjusted earnings per share guidance to $1.63 to $1.65.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal third-quarter financial results and fiscal fourth-quarter and fiscal year 2016 financial guidance.

On May 3, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the first quarter ended March 31, 2016 (Press release, Nektar Therapeutics, MAY 3, 2016, View Source [SID:1234511831]).

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Cash and investments in marketable securities at March 31, 2016 were $288.3 million as compared to $308.9 million at December 31, 2015. This balance at March 31, 2016 does not include $28.0 million received from AstraZeneca in April of 2016 for the sublicense of MOVENTIG to ProStrakan in Europe.

"I am very pleased with the progress of both our proprietary pipeline and partner programs," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK has performed well in its first year with positive feedback from physicians and patients. ADYNOVATE, which was launched in the U.S. in December 2015 by Baxalta, recently received approval in Japan and has now been filed for approval in Europe. The NKTR-181 Phase 3 efficacy study in patients with chronic low back pain is on track to provide top-line results in early 2017. Finally, NKTR-214, our immuno-oncology candidate, is advancing in its first-in-human trial evaluating its safety and efficacy in cancer patients with solid tumors. We expect to report initial top-line data from the dose-escalation stage of the NKTR-214 study in the second half of 2016."

Revenue for the first quarter of 2016 was $58.9 million as compared to $108.8 million in the first quarter of 2015. Revenue for the first quarter of 2016 includes the recognition of $28.0 million received from AstraZeneca in April of 2016 for the sublicense of MOVENTIG to ProStrakan in Europe which occurred in the first quarter. Revenue in the first quarter of 2015 was higher primarily because of the one-time recognition of $90 million related to the U.S. commercial launch of MOVANTIK. Product sales and royalty revenue increased to $18.2 million in the first quarter of 2016 as compared to $8.1 million in the first quarter of 2015.

Revenue also included non-cash royalty revenue, related to our 2012 royalty monetization, of $6.5 million and $4.0 million for the three months ended March 31, 2016 and 2015, respectively. This non-cash royalty revenue is partially offset by non-cash interest expense also incurred in connection with the 2012 royalty monetization. Non-cash interest expense was $5.0 million in the first quarter 2016 as compared to $5.1 million in the first quarter 2015.

Total operating costs and expenses for the first quarter of 2016 were $68.4 million as compared to $65.8 million in the first quarter of 2015. Total operating costs and expenses increased primarily as a result of higher research and development (R&D) expense in the first quarter of 2016. R&D expense in the first quarter of 2016 was $49.3 million as compared to $47.0 million for the first quarter of 2015 and was higher in the first quarter of 2016 primarily due to expenses for the NKTR-181 Phase 3 studies and for initiation of the Phase 1/2 study of NKTR-214.

General and administrative expense was $10.2 million in the first quarter of 2016 as compared to $10.3 million in the first quarter of 2015.

In Q1 2016, net loss was $19.5 million, or $0.14 loss per share as compared to net income of $33.8 million, or $0.26 basic earnings per share in the first quarter of 2015. This decrease is primarily because of the one-time recognition of $90 million related to the U.S. commercial launch of MOVANTIK in the first quarter of 2015.

The company also announced upcoming presentations at the following scientific congresses during the first half of 2016:

SMI 16th Annual Pain Therapeutics Conference, London, England:

Abstract Title: "NKTR-181, A Novel Mu-Opioid Analgesic Designed for Inherent Low Abuse Liability" presented by Stephen Doberstein, Ph.D.
Session: Opioid Dependence
Date: May 24, 2016
ASCO Annual Meeting, Chicago, IL:

Abstract 11545: "Immune Memory in Nonclinical Models after Treatment with NKTR-214, an Engineered Cytokine Biased Towards Expansion of CD8+ T Cells in Tumor", D. Charych, et al.
Poster Session: Tumor Biology
Date: June 6, 2016, 1:00 p.m. – 4:30 p.m. Central Time

On May 2, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported new results from 19 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 3rd – 7th June in Chicago, United States (Press release, Hoffmann-La Roche , MAY 2, 2016, View Source [SID:1234511800]). More than 200 abstracts have been accepted across eight cancer types, including four "late breakers" and nearly 30 oral presentations.

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"The confluence of new medicines, sophisticated diagnostics and advanced technologies has created an unprecedented opportunity to improve outcomes for patients today and in the future," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. "At this year’s ASCO (Free ASCO Whitepaper) meeting, we look forward to presenting results from studies that have the potential to define new treatment approaches for cancers that have not seen significant progress in decades."

New trial results for atezolizumab include data from a study in which people received the medicine as an initial treatment for metastatic bladder cancer (first-line). These data will be highlighted as part of ASCO (Free ASCO Whitepaper)’s official press program. New overall survival and diagnostic results will be presented in recurrent metastatic bladder and lung cancer, and results from early combination studies of atezolizumab with targeted medicines and the investigational cancer immunotherapy MOXR0916, an OX40 agonist, will also be featured.

Roche will be presenting data from the J-ALEX trial, an open-label, randomised phase III study that compared Alecensa and crizotinib in people with ALK-positive advanced or recurrent NSCLC who had not previously received an ALK inhibitor and who had a maximum of one prior treatment with a chemotherapy.

Results for Roche’s haematology medicines include data from a study of MabThera/Rituxan in children with high risk B-cell non-Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL). Results from Phase I/II studies of Venclexta (venetoclax) in acute myeloid leukemia (AML), as well as the first data from a phase 1b study of Venclexta in B-cell NHL in combination with either MabThera/Rituxan and CHOP chemotherapy or Gazyva/Gazyvaro and CHOP chemotherapy, will also be presented. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

An analyst briefing to discuss key data presented on the Roche Group’s oncology products and pipeline at ASCO (Free ASCO Whitepaper) 2016 will take place on Sunday 5 June from 6:30 -8:00 pm CDT at the Marriott Downtown Chicago Magnificent Mile. This event, independently organized by Roche, is open to analysts and investors who have registered for the event. To register for the event, please follow the link (Password: Analyst2016)

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) 2016 Annual Meeting news and updates by using the hashtag #ASCO16.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2016

Medicine Abstract title Abstract number
Atezolizumab (investigational use) Atezolizumab (atezo) as first-line (1L) therapy in cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (mUC): Primary analysis of IMvigor210 cohort 1. Abstract LBA4500 (oral)
Sunday, 5 June
08:00-11:00 CDT

Updated efficacy and > 1-y follow up from IMvigor210: Atezolizumab (atezo) in platinum (plat) treated locally advanced/metastatic urothelial carcinoma (mUC). Abstract 4515 (oral)
Sunday, 5 June
08:00-11:00 CDT

Updated survival and biomarker analyses of a randomized phase II study of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR). Abstract 9028 (poster)
Saturday, 4th June
08:00-11:30 CDT

Correlation of peripheral and intratumoral T-cell receptor (TCR) clonality with clinical outcomes in patients with metastatic urothelial cancer (mUC) treated with atezolizumab. Abstract 3005 (oral)
Saturday, 4 June
13:15-16:15 CDT

A phase Ib dose escalation study of the OX40 agonist MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors. Abstract 101 (oral)
Saturday, 4 June
08:00-09:30 CDT

Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC). Abstract 3502 (oral)
Sunday, 5 June
08:00-11:00 CDT

Phase Ib trial of atezolizumab in combination with nab-paclitaxel in patients with metastatic triple negative breast cancer (mTNBC) Abstract 1009 (poster discussion)
Sunday, 5 June
16:45-18:00 CDT

Alecensa (alectinib) (investigational use) Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC): primary results from the J-ALEX study Abstract 9008 (oral)
Monday, 6 June
9:45-12:45 CDT

Avastin (bevacizumab) Overall survival of patients with HER2-negative metastatic breast cancer treated with a first-line paclitaxel with or without bevacizumab in real-life setting: Results of a multicenter national observational study Abstract 1013 (poster discussion)
Sunday, 5 June
16:45-18:00 CDT

ipatasertib (investigational use) Randomized phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study) Abstract 5017 (poster discussion)
Saturday, 4 June
13:00 – 16:30 CDT

MabThera / Rituxan (rituximab) (investigational use) Results of the randomized Intergroup trial Inter-B-NHL Ritux 2010 for children and adolescents with high risk B-cell non Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL): Evaluation of rituximab (R) efficacy in addition to standard LMB chemotherapy (CT) regimen Abstract 10507 (oral)
Friday, 3 June
15:00-18:00 CDT

Venclexta (venetoclax) (investigational use) Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ≥65 years ineligible for standard induction therapy Abstract 7009 (poster discussion)
Monday, 6 June
11:30-12:45 CDT

Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged ≥65 years with acute myelogenous leukemia Abstract 7007 (oral)
Saturday, 4 June
15:00-18:00 CDT

Phase 1b study of venetoclax plus R- or G-CHOP in patients with B-cell non-Hodgkin lymphoma Abstract 7566 (poster)
Monday, 6 June
8:00-11:30 CDT

About personalised cancer immunotherapy
The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab, PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent versus those who may benefit more from combination approaches; the purpose is to inform treatment strategies which will give the greatest number of patients a chance for transformative benefit. The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.
Personalised Cancer Immunotherapy is an essential component of how Roche delivers on the broader commitment to personalised healthcare.

On May 2, 2016 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that data on its engineered allogeneic CAR T-cell programs will be featured in three poster presentations at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 19th Annual Meeting (Filing, 6-K, Cellectis, MAY 2, 2016, View Source [SID:1234511835]).

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The meeting will be held from May 4 to May 7, 2016 in Washington, DC, USA.

Allogeneic CAR T-Cells Targeting CD123 Effectively Eliminate Myeloid Leukemia Cells

Presentation by Julianne Smith, Ph.D., Vice President CART Development at Cellectis
Poster Session: Cancer-Immunotherapy, Cancer Vaccines II
Session Time: Thursday, May 5, 2016, 5:45 PM
Room: Exhibit Hall C & B South
Final abstract number: 397

An Engineered CAR T-Cell Platform for Allogeneic Combination Immunotherapy

Presentation by Philippe Duchateau, Ph.D., Chief Scientific Officer of Cellectis
Poster Session: Cancer-Targeted Gene and Cell Therapy II
Session Time: Friday, May 6, 2016, 6:00 PM – 8:00 PM
Room: Exhibit Hall C & B South
Final abstract number: 676

Integration of Dual Signal Input Strategies in Novel Chimeric Antigen Receptors to Control the CAR T-Cell Functions

Presentation by Alexandre Juillerat, Ph.D., Senior Scientist at Cellectis
Poster Session: Cancer-Immunotherapy, Cancer Vaccines III
Session Time: Friday May 6, 2016 6:00 PM – 8:00 PM
Room: Exhibit Hall C & B South
Final abstract number: 651

Posters will be posted on Cellectis’ website on May 7, 2016.