Illumina Names Dr. Phil Febbo Chief Medical Officer

On March 12, 2018 -Illumina, Inc. (NASDAQ:ILMN) reported the appointment of Dr. Phil Febbo, a leading physician scientist, as Chief Medical Officer (CMO), starting March 26, 2018 (Press release, , DEC 12, 2018, View Source [SID1234524691]). In his new role, Dr. Febbo will be responsible for developing and executing on the Company’s medical strategy to drive genomic testing into healthcare practice.

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"We are very excited to welcome Dr. Febbo, who comes to us at a transformative time in the evolution of genomic medicine"

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"We are very excited to welcome Dr. Febbo, who comes to us at a transformative time in the evolution of genomic medicine," said Garret Hampton, Ph.D., Executive Vice President of Clinical Genomics at Illumina. "Phil brings a wealth of clinical and scientific experience to Illumina, from understanding the genomic basis of common human cancers, to the development of clinical tests based on next generation sequencing. We believe that his experience will ensure that Illumina is uniquely positioned to change medical practice with the use of genomics."

For the past 25 years, Dr. Febbo has worked at leading institutions throughout the United States, most recently serving as CMO of Genomic Health (NASDAQ:GHDX). Prior to joining Genomic Health, Dr. Febbo served as Professor of Medicine and Urology at the University of California, San Francisco (UCSF), where his laboratory focused on using genomics to understand the biology and clinical behavior of prostate cancer, and his clinical practice focused on genitourinary oncology. While at UCSF, Dr. Febbo was the co-leader of the Prostate Cancer Program at the Helen Diller Family Comprehensive Cancer Center and the Program Principal Investigator of the Translational Research Program for the Alliance for Clinical Trials in Oncology.

Dr. Febbo holds a Bachelor of Arts degree in Biology from Dartmouth College, received his M.D. degree at UCSF, and completed his internal medicine residency at the Brigham and Women’s Hospital. After his fellowship in medical oncology at the Dana-Farber Cancer Institute, he was an Attending Physician in the Genitourinary Oncology Center at Dana-Farber, Instructor at Harvard Medical School, and a post-doctoral fellow in Dr. Todd Golub’s laboratory at Dana-Farber, as well as the Whitehead Institute Center for Genomic Research of MIT (now the Broad Institute). In 2004, Dr. Febbo moved to Duke University Medical Center’s Institute of Genome Sciences and Policy. He has been a member of the American Society for Clinical Investigation since 2009.

Merrimack Pharmaceuticals Expands Phase II Lung Cancer Study

On March 12, 2018 Merrimack Pharmaceuticals Inc. saw a slight uptick in pre-market trading this morning after the company reported it is expanding enrollment in a Phase II lung cancer study (Press release, BioSpace, MAR 11, 2018, View Source [SID1234524670]).

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Cambridge, Mass.-based Merrimack said it has seen a "tremendous interest" in its open-label Phase II SHERLOC study assessing progression-free survival in patients who have received MM-121 in combination with docetaxel. The trial is comparing the combination treatment with docetaxel as a stand-alone therapy in patients with heregulin-positive non-small cell lung cancer who have progressed after a platinum-containing regimen.

In its announcement, Merrimack said it will expand trial enrollment from 80 patients to 100. The trial patients must have received a prior platinum-based therapy, as well as prior immunotherapy where available and clinically indicated, the company said.

The trial expansion followed a year in which Merrimack reset its focus on its 10 wholly-owned clinical and preclinical programs that target biomarker-defined cancers. Merrimack began its internally-developed focus in early January after the company sold some assets, including FDA-approved pancreatic cancer treatment Onivde to Ipsen for $575 million. That placed the company’s futures on its wholly-owned assets, including MM-121.

Investors have not been too happy with Merrimack since the Ipsen deal. Over the course of 2017, the company saw its share prices drop by 63 percent. Shares of Merrimack closed at $11.58 on March 9.

Merrimack’s MM-121 (seribantumab) is a fully human anti-HER3 (ErbB3) monoclonal antibody. The drug is designed to target phenotypically distinct heregulin positive cancer cells within solid tumors. Typically heregulin positive cancer cells have been able to "escape the effects" of targeted, cytotoxic and anti-endocrine therapies, Merrimack said. That ability provides the potential for the rapid progression of the disease. When MM-121 is used in combination with the chemotherapy drug docetaxel, the company believes the dual treatment will block the heregulin/HER3 signaling axis, which will make tumor cells more sensitive to the effects of the combination therapy.

In October 2017 the U.S. Food and Drug Administration granted orphan drug designation to MM-121 in this setting. The orphan drug designation is granted to drugs that are being developed to treat a patient population of fewer than 200,000 people in the United States.

Sergio Santillana, Merrimack’s chief medical officer, said enrollment in the SHERLOC study has been faster than the company expected. Calling that an encouraging sign, Santillana said the interest reflects what the company believes is "the significant unmet medical need among this patient population."

"This expansion enables us to maximize this opportunity to gain meaningful insight, by strengthening the statistical design of the study, and emerge with a clear path forward," Santillana said in a statement.

Even with the additional patients added to the trial, Merrimack said it anticipates rolling out top-line data for the study in the second half of 2018.

In addition to heregulin-positive non-small cell lung cancer, Merrimack is also testing MM-121 in patients with heregulin-positive, hormone receptor-positive and HER2-negative post-menopausal metastatic breast cancer. In February the company dosed its first patient in a randomized Phase II trial. The mid-stage study, called SHERBOC, is testing the combination of MM-121 with chemotherapy treatment fulvestrant against placebo.

Advaxis to Host Business Update and First Quarter 2018 Financial Results Conference Call on March 12, 2018

On March 9, 2018 – Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of cancer immunotherapies, reported the upcoming release of financial results for the three months ended January 31, 2018, to take place on Monday, March 12, 2018 (Press release, Advaxis, MAR 9, 2018, View Source [SID1234524599]).

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Advaxis’ senior management will host a conference call to review its financial results and provide a business update. The conference call and live audio webcast will begin at 4:30 p.m. Eastern time on Monday, March 12, 2018.

Conference Call & Webcast Information
WHEN: Monday, March 12, 2018 at 4:30 p.m. Eastern time.
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 2588455
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning March 12, 2018 two hours after the close of the conference call. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 2588455. In addition, the audio webcast will be archived on the Company’s website for a period of time at ir.advaxis.com/events-presentations/events-calendar.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Exicure has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Exicure, 2018, MAR 9, 2018, View Source [SID1234524663]).

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AmpliPhi Biosciences Announces Presentation of Preclinical Data Demonstrating that AB-PA01 Reduces Biofilm in Pseudomonas aeruginosa In Vivo Model

On March 9, 2018 -AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported the presentation of in vivo preclinical data showing AB-PA01 reduces biofilm in a Pseudomonas aeruginosa preclinical model (Press release, AmpliPhi Biosciences, MAR 9, 2018, View Source [SID1234524600]). The data were presented at the Australian Society of Otolaryngology Head and Neck Surgery 68th Annual Scientific Meeting, being held March 9-11, 2018 in Perth, Western Australia.

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The presentation, titled "Efficacy and safety of a Pseudomonas aeruginosa bacteriophage cocktail in a sheep model of rhinosinusitis" will be delivered by Dr. Stephanie Fong on Saturday, March 10, 2018, at 1:40 p.m. local time in Crown Ballroom 1, Concurrent Session 10 – Rhinology, at the Crown Perth Convention Centre.

"The data presented demonstrate the potential of bacteriophage therapeutics by clearly showing AB-PA01’s effectiveness in reducing biofilm in vivo, a major obstacle in the treatment of Pseudomonas aeruginosa and its associated symptoms," said Peter-John Wormald, M.D., Professor of Otolaryngology Head & Neck Surgery at the University of Adelaide and Principal Investigator for AmpliPhi’s already completed Phase 1 study, "I believe bacteriophage therapeutics hold much promise and this study adds to the growing body of supportive evidence."

A sheep rhinosinusitis model was adapted to simulate Pseudomonas aeruginosa infection in sheep frontal sinuses. To assess efficacy, after a 7-day biofilm formation period, sheep received twice-daily flushes of AB-PA01 or saline for one week. Biofilm quantitation on the frontal sinus mucosa was performed using BacLight LIVE/DEAD stain. The study showed a statistically significant reduction in biofilm biomass with AB-PA01 compared to control (p<0.05). No safety concerns were noted