On November 9, 2018 Cerus Corporation (Nasdaq:CERS) reported that William ‘Obi’ Greenman, Cerus’ president and chief executive officer, and Vivek Jayaraman, Cerus’ chief commercial officer, are scheduled to present a corporate update at the 2018 Canaccord Genuity Medical Technologies and Diagnostics Forum at 1:30 p.m. ET on Thursday, November 15, 2018 (Press release, Cerus, NOV 9, 2018, View Source;Diagnostics-Forum/default.aspx [SID1234531218]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available from the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the

On November 9, 2018 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported that it will provide a live webcast of its third quarter financial results and business update on Wednesday, November 14, 2018 at 5:30 PM Eastern Time (Press release, Cytori Therapeutics, NOV 9, 2018, View Source [SID1234531153]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The dial-in information is as follows:
Dial-In Number: +1.877.402.3914
Conference ID: 9699923

Prior to the webcast at approximately 4:30 PM Eastern Time on November 14, Cytori will issue its third quarter earnings release which will review Cytori’s third quarter and year-to-date performance. The webcast will be available both live and by replay two hours after the call in the "Webcasts" section of the company’s investor relations website.

On November 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported initial results from the Phase 1a dose escalation portion of a Phase 1a/b trial of etigilimab, the company’s anti-TIGIT antibody (Press release, OncoMed, NOV 9, 2018, View Source [SID1234531219]). TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is a next generation checkpoint receptor shown to block T-cell activation and the body’s natural anti-cancer immune response. OncoMed’s anti-TIGIT checkpoint inhibitor candidate is an IgG1 monoclonal antibody which binds to the human TIGIT receptor on T-cells with a goal of improving the activation and effectiveness of T-cell and NK cell tumor-killing activity. The data were presented today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting taking place in Washington, D.C.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The initial results from the Phase 1a dose escalation portion of the Phase 1a/b trial included data from 18 patients with a variety of late stage metastatic cancers including colorectal, endometrial, pancreatic, among others, who were treated with etigilimab at doses ranging from 0.3 to 20 mg/kg every other week. There were no dose-limiting toxicities through the 20 mg/kg every other week dose. In this "all comers" difficult-to-treat patient population, stable disease was observed in 7 (38.9%) patients with prolonged disease control seen in some patients with the longest durations of stable disease being 205 and 225 days. Of the remaining 11 patients in the study, ten patients had progressive disease, and one patient did not meet criteria to be evaluated for efficacy. The most frequent treatment-related adverse events were rash (27.8%), fatigue (16.7%), nausea (16.7%), pruritus (16.7%), and cough (11.1%). Immune-related adverse events, signaling immune activation included rash (27.8%), pruritus (16.7%), autoimmune hepatitis (5.6%) and stomatitis (5.6%). Grade 3 or higher treatment-related AEs included rash (16.7%), and abdominal pain, embolism, hypertension, and pulmonary embolism (11.1% each).

Biomarker analysis demonstrated a significant reduction of peripheral T regulatory cells (Tregs), most significant at doses ≥ 10 mg/kg, and signals of immune activation. These results are consistent with preclinical studies with a surrogate anti-TIGIT antibody and suggest select immune cell depletion and activation of T cell signaling in patients treated with the drug.

"These data indicate that etigilimab was well-tolerated by patients and showed modulation of specific subsets of peripheral T cells," said John Lewicki, Ph.D., President and Chief Executive Officer of OncoMed. "The decrease in peripheral Tregs and observations of stable disease in certain patients are consistent with the expected mechanisms of our IgG1 anti-TIGIT antibody."

The company is currently enrolling a single agent Phase 1a expansion cohort in select tumor types. Concurrently, the company is also enrolling the phase 1b portion of the trial where escalating doses of etigilimab are given in combination with nivolumab in the treatment of patients with solid tumors who have progressed after treatment with anti-PD1 or anti-PD-L1. The trial will define a dosing regimen that could provide the basis for expanded studies of etigilimab in combination with anti-PD1.

About TIGIT
TIGIT and its ligands, PVR and PVR-L2 comprise a novel immune checkpoint which blocks T-cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (etigilimab) is intended to activate the immune system through multiple mechanisms and to enable anti-tumor activity. At the 2018 AACR (Free AACR Whitepaper) Annual Meeting, OncoMed presented preclinical data (Abstract 5627) which demonstrated that anti-TIGIT treatment reduced the abundance of Tregs within tumors in animal models. Mechanistic studies demonstrated an important contribution of effector function for anti-tumor efficacy. Using a surrogate anti-TIGIT antibody, potent single-agent dose-dependent anti-tumor efficacy was demonstrated on large established CT26 WT tumors and in other models. Anti-TIGIT efficacy was shown to require effector function for tumor growth inhibition and biomarker analysis demonstrated reduction of Treg frequency and activation of T-cells and NK cells as part of the mechanism of action of anti-TIGIT. Additionally in a human tissue study, TIGIT expression on Tregs was found to be considerably higher than on CD8+ T-cells in multiplexed IHC panels across a panel of multiple solid tumors types. This program is part of OncoMed’s collaboration with Celgene.

On November 9, 2018 OPKO Health, Inc. (NASDAQ: OPK) reports financial results and business highlights for the three months ended September 30, 2018 (Press release, Opko Health, NOV 9, 2018, View Source [SID1234531170]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial Highlights

•
Net loss for the three months ended September 30, 2018 decreased by 23% to $27.7 million or $0.05 a share compared to net loss of $35.9 million or $0.06 per share for the comparable 2017 period. Total revenues improved to $249.8 million during the three months ended September 30, 2018 compared to $246.0 million for the comparable period of 2017.
•
Revenues from products during the three months ended September 30, 2018 include $5.8 million from RAYALDEE and revenues from services were $202.8 million for the 2018 period compared with $200.9 million for the corresponding 2017 period.
•
During the three months ended September 30, 2018, costs of revenue and selling, general and administrative expenses decreased by approximately 8%, or $19.5 million, compared to the 2017 period. Research and Development expenses were $30.2 million compared to $32.5 million for the corresponding 2017 period.
•
On November 8, 2018, OPKO secured approximately $150 million of additional capital, consisting of a private placement of common stock resulting in proceeds of $92.5 million, and an unsecured credit line of $60 million.

Business Highlights

•
RAYALDEE total prescriptions reported by IMS for Q3 2018 increased 222% compared with Q3 2017 and 18% compared with Q2 2018: As of November 1, 2018, approximatley 79% of patients have access to RAYALDEE under their insurance plans.
•
Initiated the Phase 2 clinical trial to study the safety and efficacy of RAYALDEE as a new treatment for secondary hyperparathyroidism (SHPT) in adults with vitamin D insufficiency and stage 5 chronic kidney disease (CKD) requiring hemodialysis. The trial will be conducted at multiple dialysis centers in the U.S. in two sequential cohorts. The first cohort of approximately 44 patients will be treated for 26 weeks in a randomized, open-label fashion with

either RAYALDEE or placebo to identify the appropriate dosing to be studied in the second cohort. Data readout for this first cohort is expected in 2019. The second cohort of more than 200 patients will be treated for 26 weeks in a randomized, double-blind fashion with one of three different doses of RAYALDEE or placebo. The primary efficacy endpoint will be correction of vitamin D insufficiency and control of SHPT. Patients will then be treated with RAYALDEE for another 26 weeks in an open-label extension.
•
4Kscore utilization in Q3 2018 was approximately 18,700 tests compared to 18,900 during Q3 2017. Utilization of the 4Kscore remains strong while we continue to work with our Medicare administrator, Novitas, on their proposed local coverage determination. During this process, Novitas has continued to provide coverage of the 4Kscore to Medicare beneficiaries.
•
Completed the enrollment of a Global Phase 3 study of somatrogon (hGH-CTP) in Growth Hormone Deficient Children: The somatrogon Phase 3 trial is a randomized, open-label study comparing once-weekly somatrogon to once daily Genotropin. This study has enrolled 228 treatment naïve children with growth hormone deficiency (GHD) in 21 countries. The primary endpoint of the trial is height velocity at 52 weeks. Secondary endpoints are safety and pharmacodynamics.
•
Enrollment in Japanese Phase 3 registration trial of somatrogon in growth hormone deficient children expected to complete by year end: The global and Japanese pediatric studies utilize the multiple dose pen device that will be launched commercially upon approval.
•
Completed the enrollment of a Phase 2b clinical trial for our once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity: In a previous Phase 2 trial in 420 overweight patients with type 2 diabetes, the drug was shown to be safe and effective. The current trial is to study a new dosing schedule to achieve even greater weight loss and topline results are anticipated during 1Q 2019.
•
Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment of approximately 110-120 patients in this dose ranging study of our orally administered SARM is expected to be completed by the end of this year.
•
Premarket Approval (PMA) application for Claros point-of-care PSA test under review by FDA; decision anticipated during 1H 2019: OPKO has completed a PMA submission to FDA for Sangia, our point of care PSA test utilizing the Claros 1 immunoassay analyzer. This is the first test on our proprietary diagnostic platform that can provide rapid, quantitative blood test results in the physician’s office with only a finger stick drop of whole blood. Several biomarkers and biological meaningful chemistry tests such as testosterone and Vitamin D utilizing the Claros platform are advancing toward a 510(k) submission to the FDA.

Conference Call & Webcast Information

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:15 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

WHEN: Friday, November 9, 2018 at 4:15 p.m. Eastern time
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
PASSCODE: 3487296
WEBCAST: www.investor.opko.com/events

For those unable to participate in the live conference call or webcast, a replay will be available beginning November 9, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 3487296. The replay can be accessed for a period of time on OPKO’s website at www.investor.opko.com/events.

On November 9, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported the launch of its universal cancer immunogenomics platform, ImmunoID NeXT (Press release, Personalis, NOV 9, 2018, View Source [SID1234531186]). This is the first platform to enable comprehensive analysis of both a tumor and its microenvironment from a single sample.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Personalis CEO, John West, said, "While the success of checkpoint blockade has been hugely promising, it’s increasingly apparent that predicting response to immunotherapies and developing new ones requires a more comprehensive approach to tumor immunogenomics. With ImmunoID NeXT, it’s now possible to characterize the complex interactions between the tumor cells and immune cells of the microenvironment using a single platform. This means researchers no longer have to make the difficult choice of which biomarkers to analyze due to sample limitations, particularly when dealing with FFPE specimens."

The unique design of the ImmunoID NeXT Platform facilitates the delivery of therapeutic and diagnostic biomarker information across ~20,000 genes from DNA and RNA, including:

Neoantigen identification and characterization
Human leukocyte antigens (HLA) typing
Tumor infiltrating adaptive immune cells
T-cell receptor (TCR) repertoire (α, β, γ, and δ chains)
B-cell receptor (BCR) repertoire (heavy and light chains)
Tumor infiltrating innate immune cells
Immune response and tumor escape mechanisms
Neoantigen load and tumor mutational burden (TMB)
Microsatellite instability (MSI) status
Oncoviral detection
Germline genomic variation
Personalis is offering pharmaceutical customers the opportunity to participate in an Early Access Program beginning in January, 2019. The company also anticipates the release of a clinical diagnostic test based on this platform in 2019.

Personalis will be presenting new data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C., November 8-11, 2018. Personalis representatives will also be available to discuss the ImmunoID NeXT Platform at the company’s exhibit (Booth #617).