On November 6, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that it will present results from a study that further demonstrates the ability of the Company’s proprietary Discovery Engine, featuring the Company’s Immune Repertoire Capture (IRC) technology, to identify antibodies from treatment-responsive cancer patients that bind to non-autologous tumor tissue (Press release, Atreca, NOV 6, 2018, View Source [SID1234530932]). The study will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018, at the Walter E. Washington Convention Center in Washington, D.C.

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"Atreca has built a proprietary and unique discovery platform that enables us to discover, in a very efficient and industrialized manner from active immune responses, antibodies that can serve as the foundation of therapeutics," said Tito A. Serafini, Ph.D., Chief Strategy Officer and an Atreca founder. "The results to be presented at this conference provide another example of what this Discovery Engine enables in oncology; namely, our ability to identify tumor-targeting antibodies in treatment-responsive patients with the potential to be developed into therapeutics designed to treat large patient groups. Our most advanced program, ATRC-101, which we anticipate entering clinical trials in 2019, is a product of this approach."

In the study, (Abstract #O3; Title: Anti-tumor immune responses in metastatic breast cancer exceptional responder patients) to be presented both as an oral presentation and a poster by William Robinson, M.D., Ph.D., Professor of Medicine at Stanford University and an Atreca Founder, Atreca researchers collaborated with researchers led by Joyce O’Shaughnessy, M.D., at Baylor University Medical Center and Texas Oncology. Atreca researchers investigated the properties of antibodies identified in the active immune response of eleven metastatic breast cancer patients who had exceptional and durable responses to systemic therapy. Of the patient-derived antibodies assessed, over 40% displayed specific immunoreactivity to breast carcinoma tissue from unrelated patients, but not to adjacent tissue, indicating that they bind to public tumor antigens. Multiple antibody lineages, predominantly of the IgG2 subclass, showed evidence of convergent antibody evolution across patients, and a subset of responder antibodies drove killing of tumor cells in in vitro functional assays.

Abstract Title: Anti-tumor immune responses in metastatic breast cancer exceptional responder patients (Abstract #O3)

Oral Presentation

Concurrent Session 216: Role of B cells in Immunotherapy & Toxicity
Date & Time: Saturday, Nov. 10, 6:10 – 6:25 p.m. EST
Location: East Salon ABC
Atreca also has a second presentation. Details are below:

Abstract Title: The identification of potent anti-tumor antibodies applicable for ADC therapeutics from patients undergoing immunotherapy (Abstract #P1)

Poster Display (for both posters)

Date & Time: Friday, Nov. 9, from 8 a.m. – 8 p.m. EST and Saturday, Nov. 10, from 8 a.m. – 12 p.m. EST
Presentation Hours: Friday, Nov. 9, 12:45 – 2:15 p.m. EST and 6:30 – 8 p.m. EST
Location: Hall E

On November 6, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present company overviews at the following conferences (Press release, Alnylam, NOV 6, 2018, View Source [SID1234530770]):

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Stifel 2018 Healthcare Conference on Wednesday, November 14, 2018 at 10:15 am ET at the Lotte New York Palace Hotel in New York City
27th Annual Credit Suisse Healthcare Conference on Wednesday, November 14, 2018 at 3:25 pm MT (5:25 pm ET) at the Phoenician Hotel in Scottsdale, Arizona
A live audio webcast of each presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after each event.

On November 6, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported multiple presentations showcasing G100, its potent intratumoral TLR4 agonist, at the annual meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held in Washington D.C. this week (Press release, Immune Design, NOV 6, 2018, View Source [SID1234530792]). The presentations, which include both clinical and preclinical study data, further support the activity of G100 in follicular lymphoma patients and the potential combinability of G100 with other novel immune-modulatory agents.

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"These additional positive clinical data continue to support the ability of G100 to trigger a systemic therapeutic effect when injected into a single tumor in follicular lymphoma patients," said Carlos Paya, M.D., President and Chief Executive Officer of Immune Design. "In addition, we are pleased to observe that G100 can be synergistic with novel therapies such as anti-OX40 antibodies and adoptive T-cell therapies."

Key data to be presented:

The higher dose (20ug) of intratumorally-administered G100 is active, as determined by clinical outcomes and increased biomarker activity in patients with follicular lymphoma

Data from a new cohort of 18 follicular lymphoma patients treated with G100 at 20ug with low-dose radiation further confirms that G100 is active in the absence of an anti-PD-1 antibody and continues to have a favorable safety profile.
Comparison of data from these 18 patients treated with G100 at 20ug versus data from 16 patients previously treated with 10ug shows:
Positive trend toward more rapid overall clinical responses, including in abscopal (untreated) lesions.
Increased TILs and decreased lymphoma-associated CD20 cells in tumors following G100 treatment, which are biomarkers previously associated with improved clinical responses.
Higher ORR (60%) is observed in patients stratified by baseline tumor high TLR4 expression.
Consistently favorable safety profile.
Based on these positive data, Immune Design has selected the 20ug dose of G100 for further clinical development.

Synergistic anti-tumor effects of G100 with anti-OX40 antibodies

Combination of intratumoral G100 and systemic anti-OX40 monoclonal antibody is synergistic in aggressive lymphoma and melanoma preclinical models.
Improved anti-tumor activity in comparison to either agent alone.
Increased biomarker levels that correlate with effectiveness, such as TILs and the ratio of CD8/CD4 tumor-specific T cells.

G100 enhances the efficacy of adoptive T-cell therapy

Combination of intratumoral injection of G100 and adoptive T-cell therapy was found to be synergistic in pre-clinical tumor models.
Tumor eradication observed in 70% of mice treated compared to no tumor regression with either approach alone.
Median survival was significantly improved with the combination regimen.
About G100

G100 is Immune Design’s lead product candidate and contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist called Glucopyranosyl Lipid A (GLA). G100 activates innate and adaptive immunity in the tumor microenvironment to generate an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. G100 is currently in development to treat patients with relapsed follicular lymphoma (FL), a sub-type of Non-Hodgkin lymphoma. Immune Design intends to start a study in earlier-stage lymphoma patients in combination with rituximab, a standard treatment for lymphomas, and is evaluating studies in other B-cell malignancies beyond FL, as well as potential solid tumor indications

On November 6, 2018 DXC Technology (NYSE: DXC) reported results for the second quarter of fiscal year 2019, representing the period from July 1 through September 30, 2018 (Press release, DynPort Vaccine Company, NOV 6, 2018, View Source [SID1234530872]).

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"In the second quarter, DXC Technology delivered year-over-year and sequential growth in earnings per share and margins," said Mike Lawrie, chairman, president and CEO. "We continue to see strong demand for our digital solutions, and we are helping clients leverage efficiency gains in their existing IT environment to reinvest in digital transformations. We also continue to strengthen our industry-leading partner network, and we are making strategic investments in the business, including our recent acquisitions of argodesign, Molina Medicaid Solutions, TESM, and BusinessNow."

Financial Highlights – Second Quarter Fiscal 2019

Diluted earnings per share from continuing operations was $0.92 in the second quarter, including $(0.41) per share of restructuring costs, $(0.34) per share of transaction, separation and integration-related costs, and $(0.35) per share of amortization of acquired intangible assets. This compares with $0.67 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $2.02. This compares with $1.67 in the year ago period.
Revenue in the second quarter was $5,013 million. Revenue decreased 8.1% compared with $5,453 million in the prior year, reflecting a stronger dollar, completion of several large transformation projects, and slower ramp-up on a few large Digital contracts.
Income from continuing operations before income taxes was $332 million in the second quarter, including $(157) million of restructuring costs, $(128) million of transaction, separation and integration-related costs, and $(132) million of amortization of acquired intangibles. This compares with $284 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $749 million compared with $683 million in the year ago period.
Income from continuing operations was $259 million in the second quarter, including $(116) million of restructuring costs, $(98) million of transaction, separation and integration-related costs, and $(100) million of amortization of acquired intangibles. This compares with $205 million in the year ago period.
Non-GAAP income from continuing operations was $573 million compared with $492 million in the year ago period.
Adjusted EBIT was $799 million in the second quarter compared with $740 million in the prior year. Adjusted EBIT margin was 15.9% compared with 13.6% in the year ago quarter.
Net cash provided by operating activities was $412 million in the second quarter, compared with $991 million in the year ago period.
Adjusted free cash flow was $604 million in the second quarter.
Global Business Services (GBS)

GBS revenue was $2,111 million in the quarter compared to $2,311 million for the prior year. GBS revenue decreased 8.7% year-over-year, primarily driven by a decline in the traditional application maintenance and management business. This was partially offset by growth in the Enterprise and Cloud Applications business. GBS profit margin in the quarter was 18.9%, up from 16.0% in the prior year, reflecting ongoing cost actions including the in-sourcing of contract labor and shift to near-shore and low-cost locations. New business awards for GBS were $2.2 billion in the second quarter.

Global Infrastructure Services (GIS)

GIS revenue was $2,902 million in the quarter compared to $3,142 million for the prior year. GIS revenues decreased 7.6% year-over-year, reflecting the timing of client migrations from traditional to cloud environments. GIS profit margin in the quarter was 16.3%, up from 14.3% in the prior year, reflecting the impact of actions taken to drive greater operating efficiencies. These include broader deployment of our Bionix automation program and the ongoing rationalization of hardware, software, and maintenance spend. New business awards for GIS were $2.5 billion in the second quarter.

Returning Capital to Shareholders

During the second quarter, DXC Technology returned $181 million to shareholders, consisting of $54 million in common stock dividends and $127 million in share repurchases.

Earnings Conference Call and Webcast

DXC Technology senior management will host a conference call and webcast to discuss these results today at 5 p.m. EDT. The dial-in number for domestic callers is 877-260-1479. Callers who reside outside of the United States should dial +1-334-323-0522. The passcode for all participants is 4189723. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until November 13, 2018. The replay dial-in number is 888-203-1112 for domestic callers and +1-719-457-0820 for callers who reside outside of the United States. The replay passcode is also 4189723. A replay of this webcast will also be available on DXC Technology’s Investor Relations website.

Non-GAAP Measures

In an effort to provide investors with supplemental financial information, in addition to the preliminary and unaudited financial information presented on a GAAP basis, we have also disclosed in this press release preliminary non-GAAP information including: constant currency, earnings before interest and taxes ("EBIT"), adjusted EBIT, adjusted EBIT margin, adjusted free cash flow, and non-GAAP results including non-GAAP income from continuing operations before taxes, non-GAAP income from continuing operations and non-GAAP EPS from continuing operations.

On November 6, 2018 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported that clinical and immunological data from the Phase 1 clinical trial of SNS-301 will be highlighted in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, to be held November 9-11, 2018 in Washington, D.C (Press release, Sensei Biotherapeutics, NOV 6, 2018, View Source [SID1234530933]). Data showed rapid and significant antigen-specific B-cell and T-cell responses induced by SNS-301, a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a novel tumor-specific embryonic antigen.

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"These data clinically confirm the immunogenicity and mechanism of action of SNS-301, as we see strong, ASPH-targeted activation of the immune system in patients who received the immunotherapy. Taken together, the data indicate that SNS-301 is capable of overcoming central immune tolerance. We plan to target ASPH with both cancer vaccines and cell therapies to benefit different patient populations," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Based on these encouraging results, we look forward to initiating a Phase 2 trial for SNS-301 in various hematological malignancies and solid tumors in early 2019."

Twelve patients with biochemically recurrent prostate cancer who were screened for ASPH using Sensei’s proprietary companion diagnostic were treated with SNS-301 in the Phase 1, multi-center, proof-of-concept study. SNS-301 was administered every 21 days via intradermal injection using a fixed dose-escalation schema through which patients received between 8 and 23 doses at three different dose ranges, and the recommended Phase 2 dose was determined based on the immunogenicity data and changes seen in prostate specific antigen (PSA) doubling times at the three evaluated doses. Highlights of the immunogenicity data from the SNS-301 Phase 1 study presented at SITC (Free SITC Whitepaper) include:

Natural Killer (NK) cell levels in patients treated with SNS-301 were higher than NK cell levels in healthy donors, indicating activation of the innate immune system.
All patients evaluable for immune profiling experienced dose-dependent, ASPH-specific immune responses including B-cell, T-cell and antibody responses.
Increases in activated interferon gamma (IFN-γ) releasing T cells were demonstrated, and both ASPH-specific CD4+ helper T cells and CD8+ cytotoxic T cells showed dose-dependent activation over the first six cycles of SNS-301 dosing with peak responses often occurring after only three or four doses.
An average of eight to ten-fold increase in the percentage of ASPH-specific CD8+ T cells was observed post-treatment, compared to baseline measurements.
Anti-ASPH antibody titers increased in a dose-dependent manner over the first four to six cycles (80-120 days) after administration of SNS-301. This increase in antibody response correlated with concomitant increases in the percentages of ASPH-specific B cells, as measured by flow cytometry.
An average five to seven-fold increase in the percentage of ASPH-specific B-cell responses was observed post-treatment, compared to baseline measurements.
Eight out of the twelve patients (67%) achieved improvements in PSA doubling time and/or absolute PSA level, leading to decreased PSA velocity and suggesting a disease stabilizing effect of SNS301.
Based on evaluation of the three different dose ranges (2 x 1010, 1 x 1011, 3 x 1011 particles), immune responses occurred more rapidly at the two higher doses, as compared to the lower dose. Immunologic efficacy generally correlated with biochemical responses in these patients.
In the Phase 1 study, SNS301 was well tolerated with a favorable safety profile at all three dose levels with no dose-limiting toxicities or grade 4 or 5 adverse events.

About SNS-301
SNS-301 is a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during embryonic development. Following embryonic development, the protein is no longer expressed in healthy adults. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH alters signaling that occurs through the Notch pathway and its expression levels in various tumors are inversely correlated with disease prognosis. SNS-301 is a bio-engineered, inactivated bacteriophage virus expressing a fusion protein of native bacteriophage gpD (gene product D) and a selected domain of ASPH. SNS-301 is designed to overcome immune tolerance and induce robust and durable ASPH-specific humoral and cellular responses. SNS-301 is paired with a companion diagnostic to ensure appropriate patient selection and is delivered easily through an intradermal injection to aid in generating robust immune response.