On April 1, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will release its financial results for the first quarter of 2019 before the market opens on Wednesday, April 24, 2019, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, APR 1, 2019, View Source [SID1234534825]).

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During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, May 10, 2019.

On April 1, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported late-breaking preclinical data highlighting the Company’s unmatched ability to mass produce uniformly engineered chimeric antigen receptor (CAR) T cells for off-the-shelf cancer immunotherapy at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia (LB-073/18: Generation of Novel Single Cell-derived Engineered Master Pluripotent Cell Line as a Renewable Source for Off-the-shelf TCR-less CAR T Cells in support of First-of-kind Clinical Trial) (Press release, Fate Therapeutics, APR 1, 2019, View Source [SID1234534823]).

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The Company’s proprietary approach to CAR T-cell therapy utilizes a one-time genetic modification event followed by high-throughput selection of a single gene-edited induced pluripotent stem cell (iPSC). In contrast to repeatedly engineering large populations of patient- or donor-derived T cells which results in batch-to-batch and cell-to-cell variability, the Company has shown that a single gene-edited iPSC can be maintained as a clonal master engineered iPSC line which can be repeatedly used for production of uniformly engineered CAR T cells.

"The efficiency, accuracy, and uniformity of genetic modifications have the potential to impact the safety and efficacy of CAR T-cell therapy. We know that, when engineering a population of T cells, current gene-editing technologies create genomic heterogeneity and result in undesired byproducts, such as DNA mutagenesis and translocations. The selection of a single gene-edited cell for the derivation of a clonal master engineered iPSC line ensures that the effects of gene editing can be fully characterized and that only engineered T cells meeting rigorous quality standards are administered to patients," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics.

New preclinical data presented today at AACR (Free AACR Whitepaper) for FT819, the Company’s universal, off-the-shelf CAR19 T-cell product candidate being developed under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., demonstrate the production of clonal master engineered iPSC lines having complete elimination of T-cell receptor (TCR) expression and insertion of a novel 1XX CAR signaling domain into the T-cell receptor alpha (TRAC) locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic profile of CAR T cells.

Scientists from the Company and MSK are using clonal master engineered iPSC lines under the collaboration to overcome the complexity, heterogeneity, and substantial costs associated with engineering T cells from a patient or a donor. As proof-of-principle for the therapeutic advantages arising from selecting a single gene-edited cell for the production of CAR T-cell therapy, the scientists engineered a population of 545 cells using CRISPR-directed gene editing and found that only about 5% of cells contained both bi-allelic disruption of the TCR and insertion of the CAR into the TRAC locus. Upon further characterization for off-target genomic modifications and functional performance, only about 2% of the cell population were determined to meet the Company’s standards for genomic integrity and overall quality.

Previously published work by Dr. Sadelain in the journal Nature has shown that directing a CD19-specific CAR to the TRAC locus enhances T-cell potency, and that TRAC-targeted CAR T cells vastly outperform conventionally-generated CAR T cells in a mouse model of acute lymphoblastic leukemia (View Source). Additionally, Dr. Sadelain has shown in published work described in the journal Nature Medicine that the third-generation 1XX CAR signaling domain balances T-cell effector and memory programs, resulting in CAR T cells with potent activity and longer durability (View Source).

Fate Therapeutics has exclusively licensed from MSK foundational intellectual property covering the production and composition of iPSC-derived T cells for human therapeutic use. Additionally, in May 2018, the Company expanded its existing license agreement with MSK to include certain patents and patent applications relating to a novel 1XX CAR construct and off-the-shelf CAR T cells, including the use of CRISPR and other innovative technologies for their production. In addition, Fate Therapeutics owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. As a result, the Company’s platform is uniquely capable of addressing the limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

On April 1, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that new preclinical data for CG-806, its first-in-class, highly potent oral small molecule pan-FLT3/pan-BTK inhibitor, and APTO-253, its MYC inhibitor, are being presented in two separate posters at the 2019 AACR (Free AACR Whitepaper) Annual Meeting in Atlanta, GA (Press release, Aptose Biosciences, APR 1, 2019, View Source [SID1234534822]).

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CG-806 Poster

The poster, CG-806, a pan-FLT3 / pan-BTK inhibitor, demonstrates superior potency against cells from IDH-1 mutant and other non-favorable risk groups of AML patients, explores the activity of CG-806 on primary patient samples with acute myeloid leukemia (AML), in studies that were conducted in collaboration with the Beat AML Initiative. CG-806 demonstrated significant potency across sub-groups of AML cells, including relapsed/refractory AML and those with genetic abnormalities related to poor prognoses in AML patients. CG-806 demonstrated superior potency when compared to other FLT3 inhibitors, including midostaurin, sorafenib, sunitinib, dovitinib, quizartinib, crenolanib and gilteritinib. While patient samples with FLT3-ITD mutations were expected to have greater sensitivity to CG-806, the sensitivity of patient cells with IDH1 R132 mutations was an unexpected finding. In 28-day GLP toxicity and toxicokinetic studies, CG-806 continued to demonstrate a favorable safety profile. The poster also highlights results of combination studies with CG-806 and venetoclax, which demonstrated enhanced killing of primary cancer cells from patients with AML and B-cell cancers.

"With our IND for CG-806 just recently allowed by the FDA, we are eager to begin Phase 1 human clinical trials," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "The Beat AML initiative has allowed us, with our research collaborators at Oregon Health & Science University (OHSU), to test the response of actual patient samples (ex vivo) to CG-806, alone and in combination, and enables us to assess its effectiveness based upon specific genetic profiles of patients. The wealth of CG-806 data continues to grow and strongly supports the clinical development of CG-806. It is our goal to improve the odds of achieving long-term disease remissions for patients."

APTO-253 Poster

The poster, Resistance to APTO-253 caused by internal deletion and alternate promoter usage of the MYC gene in Raji B cells, presents in vitro studies that further define the mechanism of action of APTO-253. A novel small molecule, APTO-253 inhibits expression of the MYC oncogene, leading to apoptosis in human-derived solid tumor and hematologic cancer cells without the myelosuppression seen with other chemotherapies. Researchers found that APTO-253 targets a G-quadruplex motif in the P1/P2 promoter region of the MYC gene and inhibits MYC gene expression to induce apoptosis, resulting in its ability to potently kill hematologic malignant cell lines and primary samples from AML and chronic lymphocytic leukemia (CLL) patients. In this study, researchers performed long-term in vitro studies to determine if and how cells might develop resistance to APTO-253. MYC driven Raji cells required three years in increasing concentrations of APTO-253 in order to adopt multiple modifications and develop high level resistance to APTO-253. These modifications include up-regulation of the ABCG2 transporter, acquisition of a more stable MYC protein lacking the conserved core sequence of MYC Box III generated by deletion of an internal region of the MYC gene exon 2, and utilization of alternate P3 promoter not inhibited by G4 binding and stabilization.

Both of the AACR (Free AACR Whitepaper) posters can be accessed here or at the publications and presentations section of Aptose’s website www.aptose.com.

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor and is in a Phase 1 clinical trial for hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

About APTO-253

APTO-253 is a clinical-stage, small molecule, targeted therapeutic agent that inhibits expression of the MYC oncogene, leading to cell cycle arrest and programmed cell death (apoptosis) in human-derived solid tumor and hematologic cancer cells. Indeed, the first AML patient treated with APTO-253 at the lowest dose level demonstrated significant reductions of MYC expression in peripheral blood mononuclear cells after one 28-day cycle of drug therapy. The MYC oncogene is overexpressed in hematologic cancers, including acute myeloid leukemia (AML). Aptose researchers have reported the ability of APTO-253 to induce cell death, or apoptosis, in multiple blood cancer cell lines including AML, as well as in vitro synergy with various classes of conventional approved and investigational therapies for AML or myelodysplastic syndromes (MDS). New findings reveal that APTO-253 might also serve certain solid tumor patients with BRCA1/2 mutations, but without causing toxicity to the normal bone marrow functions.

On April 1, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported positive interim data from the ongoing single-arm marginal zone lymphoma (MZL) cohort of its Phase 2b clinical trial known as UNITY-NHL (Press release, TG Therapeutics, APR 1, 2019, View Source [SID1234534821]). The MZL cohort of UNITY-NHL is designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. Umbralisib is an investigational, oral, once daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

The interim data were reported this morning by Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort, during this morning’s official 2019 Press Program at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Dr. Fowler will also present the data during an oral session this afternoon (details below).

Summary of Data Presented:

The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported today included safety and tolerability data on all 69 treated patients (safety population) and efficacy data on 42 patients who were enrolled at least 9 cycles (28 day cycles) prior to the data cut-off date (interim efficacy population). The primary endpoint is overall response rate (ORR) as assessed by IRC using criteria adopted from the International Working Group criteria for malignant lymphoma.

Efficacy

Analysis of the interim efficacy population (n=42) with a median follow-up of 12.5 months showed the following:

Interim Efficacy Population (n=42)
Overall Response Rate by IRC (CR + PR), %
52%
Complete Response by IRC (CR), (%)
19%
Partial Response by IRC (PR), (%)
33%
Median duration of response, months
NR (95% CI: 8.4 – NE)

CI = confidence interval; NR = not reached; NE = not estimable; SD = stable disease

Additional Efficacy Highlights:

● 88% clinical benefit rate by IRC (defined as patients obtaining Complete Response + Partial Response + Stable Disease)

● All patients achieving a Complete Response by IRC remain on study (range: 10.1+ to 15.7+ months)

● 86% of patients had a reduction in tumor burden

● Median time to initial response was 2.7 months

● Kaplan-Meier (KM) estimate of progression-free survival (PFS) at 12 months was 66%, with the median PFS not reached

Safety

Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea, and fatigue, with the majority of events Grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively.

A subgroup analysis of patients treated for greater than 6 cycles (n=41) was also conducted to evaluate long-term incidence of key toxicities of interest occurring after 6 cycles of treatment. Median duration of treatment of this subgroup was 10.1 months (range: 5.6 – 19.1 months). In this subgroup, grade 3 or higher adverse events of interest were rare, limited to 2 patients with diarrhea and 1 patient with pneumonitis, with no events of ALT/AST elevation, pneumonia, or colitis.

Key Safety Findings (n=69):

● No events of colitis were reported and only 1 event of Grade 3 pneumonitis was reported

● Grade 3 infections were limited, occurring in 3 patients (bronchitis, pneumonia, and influenza)

● Discontinuations due to umbralisib-related AEs were limited (14%) with no discontinuations after 6 months due to a treatment-related AE

● No deaths occurred on study

Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center and the Study Chair of the UNITY-NHL MZL cohort, stated, "MZL remains an incurable disease with few treatment options for patients who relapse after first-line chemoimmunotherapy. The exciting results presented today suggest that this oral targeted therapeutic has significant activity against relapsed/refractory marginal zone lymphoma and offers hope for patients." Dr. Fowler continued, "The adverse event and clinical activity data are highly encouraging at this point and we are excited to continue following patients for a longer time. With the results reported thus far, umbralisib has the potential to make a real difference for patients with relapsed/refractory marginal zone lymphoma."

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are very excited about these interim data and believe the results today demonstrate the activity and differentiated safety and tolerability profile of umbralisib at our Phase 3 dose of 800 mg once per day." Mr. Weiss continued, "As announced previously, the efficacy for the entire population has already reached our target range of 40-50% ORR and we look forward to presenting the final data from the entire MZL cohort later this year when all patients have had the opportunity to be followed for at least 9 cycles. In addition, we look forward to discussing the results with the FDA with a goal of filing for accelerated approval by year end."

CONFERENCE CALL INFORMATION

The Company will host a conference call today, Monday April 1, 2019, at 12:00pm (noon) ET. Michael S. Weiss, Chief Executive Officer of TG Therapeutics, will host the call and Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston and Study Chair of the MZL cohort, will review the UNITY-NHL interim MZL data.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics AACR (Free AACR Whitepaper) Update Call.

A live webcast and accompanying slides will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com for a period of 30 days after the call.

2019 AACR (Free AACR Whitepaper) ORAL PRESENTATION DETAILS

● Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study
o Session Date and Time: Monday April 1, 2019 3:00 PM – 5:00 PM ET
o Presentation Time: 4:20 PM ET
o Session Title: The Next Generation of Clinical Trials in Molecularly-driven Therapy
o Session Location: Marcus Auditorium- Bldg A-GWCC
o Presenter: Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
o Abstract Number: 7821

The full text of the abstract is now available and can be accessed via the AACR (Free AACR Whitepaper) meeting website at www.aacr.org. The slides to be presented in this afternoon’s oral presentation are available on the Company’s corporate website at www.tgtherapeutics.com/publications.cfm.

ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort

The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted when all treated patients have had at least 9 cycles (cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

ABOUT BREAKTHROUGH THERAPY DESIGNATION

The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 regimen.

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.

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On April 1, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that new preclinical data from the Company’s innovative portfolio of next generation immunotherapies has been presented in a conference session by Pr. Eric Vivier, Chief Scientific Officer, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held from March 29–April 3, in Atlanta (Press release, Innate Pharma, APR 1, 2019, View Source [SID1234534820]).

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Eric Vivier, Chief Scientific Officer of Innate Pharma, said:"Innate Pharma has always been driven by scientific leadership and we are very proud to present new preclinical data from our broad and innovative portfolio of next generation cancer immunotherapies. For the first time, we also shared data from our multi-specific NK-cell engager technology that highlight a new generation of molecules for fighting cancers."

While chairing the conference session"Innate Immunity and Complement in Solid Tumors", the following findings were presented by Eric Vivier in a lecture titled "Targeting innate immunity in next generation cancer immunotherapies" yesterday at AACR (Free AACR Whitepaper):

IPH5201 (anti-CD39) and IPH5301 (anti-CD73), targeting the adenosine pathway:

CD39 and CD73 are membrane-bound extracellular enzymes which play a major role in promoting immunosuppression through the pathway degrading adenosine triphosphate (ATP) into immunosuppressive adenosine (Ado). The blockade of CD39 and CD73 has the potential to promote anti-tumor immune responses across a wide range of tumors.

New data demonstrate that a combination of Innate Pharma’s anti-CD39 monoclonal antibody, IPH5201, and ATP-inducing oxaliplatin had a synergistic effect that improved the control of tumor growth in a preclinical mouse model.

Previous findings showed that IPH5201 enhances the stimulatory effect of ATP on antigen presenting cells and abrogates the suppressive effect of ATP-derived Ado on the proliferation of T cells from healthy donors and cancer patients. In October 2018, Innate Pharma and AstraZeneca entered into a development collaboration and option for further co-development and co-commercialization for IPH5201.

New data from a crystal structure of the CD73/IPH5301 complex support a model for the differentiated mode of action of IPH5301 and enhanced efficacy compared to competitors. Analysis by electron microscopy revealed that the IPH5301 monoclonal antibody interacts mainly with CD73 dimer in an intra-dimer mode, constraining the CD73 enzyme in an inactive state in which AMP could not be hydrolyzed, in contrast to other antibodies in development that interact in an inter-dimer mode. Findings presented at the 2018 American Association of Cancer Research (AACR) (Free AACR Whitepaper) conference demonstrated that IPH5301 is more potent in vitrothan benchmark anti-CD73 antibodies currently under clinical development, on both membrane-bound and soluble CD73, in enzymatic activity as well as T cell proliferation assays.

Innate expects INDs to be filed for IPH5201 in the second half of 2019 and for IPH5301 in the first half of 2020.

First-in-class trifunctional NKCEs create a new generation of molecules for fighting cancer:

Innate Pharma’s proprietary multifunctional NKCE technology targets two activating receptors, NKp46 and CD16, on NK cells and a tumor antigen on cancer cells.

New pre-clinical data outlined in the presentation demonstrate that these first-in-class trifunctional NKCEs are more potent in vitroand in vivo than clinical therapeutic monoclonal antibodies targeting the same tumor antigen, such as rituximab, obinituzumab or cetuximab, with nooff-target effects. The data also demonstrate that co-engagement of NKp46 synergizes with CD16 to potentiate both tumor cell lysis and NK cell activation.

NKCEs stimulate NK cells instead of T cells and have been designed to improve the benefit-risk profile for the treatment of solid tumors.

Innate Pharma has a research collaboration and licensing agreement with Sanofi for the generation and evaluation of up to two multifunctional NK cell engagers, using both Innate Pharma’s and Sanofi’s technology and tumor targets. Under the terms of the license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma is eligible for up to €400m in development and commercial milestone payments as well as royalties on net sales.