On May 28, 2019 Bio-Techne reported the publication of a recent validation study demonstrating that the proprietary exosome-based liquid biopsy tests from Bio-Techne’s Exosome Diagnostics brand may be used to assess the mutational status of the Epidermal Growth Factor Receptor (EGFR) gene in patients with non-small cell lung cancer (NSCLC) (Press release, Bio-Techne, MAY 28, 2019, View Source [SID1234536927]). The data from this study will be available to discuss at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 31 to June 4 in Chicago, IL.

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NSCLC is the most common type of lung cancer. Approximately 10-40% of patients with NSCLC have mutations within the EGFR gene. Several treatment options for NSCLC use drugs targeting cells with EGFR mutations; however, over half of these patients develop resistance during treatment due to the emergence of a resistance mutation in the gene. It is critical that tumor mutations be monitored during therapy of NSCLC patients, given the aggressive nature of this lung cancer, and to ensure that patients receive the most effective treatment option.

The study published in Oncotarget describes Bio-Techne’s proprietary technique to co-isolate exosomal RNA/DNA and cell-free tumor DNA in a single step, followed by a qPCR-based assay to detect 29 different types of mutations in EGFR, including EGFR T790M.

Highlights of the data include:

The extended EGFR panel achieved a sensitivity of 92% (L858R) and 95% (T790M) both at 100% specificity, and 86% sensitivity for exon 19 indels at 94% specificity in patients with M1b extra-thoracic disease.
Including the challenging patients with intrathoracic (M0/M1a) disease resulted in a sensitivity of 90% (L858R), 83% (T790M) and 73% for exon 19 indels.
"This a game-changer for liquid biopsies," stated Steven Silverman, VP and General Manager of Bio-Techne’s Exosome Diagnostics brand. "The results from this validation study shows not only that our proprietary technique increases the performance of liquid biopsy mutation assays, but it can also be used to measure changes on the RNA transcriptome. In addition, we can enrich for exosomes derived from specific tissues using surface markers, making it possible to profile the RNA transcriptome from those tissue-specific cells in the biofluids."

On May 28, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products, reported that its lead investigational drug, lasofoxifene, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) (Press release, Sermonix Pharmaceuticals, MAY 28, 2019, View Source [SID1234536622]). Sermonix is currently engaged in a Phase 2 clinical study of lasofoxifene in estrogen receptor-positive (ER+) metastatic breast cancer.

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Fast Track designation allows companies to "get important new drugs to the patient earlier," according to the FDA. It is designed to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The Fast Track designation will allow Sermonix more frequent interactions with the FDA during Phase 2 and for the potential to obtain breakthrough designation and priority review of a New Drug Application.

"Lasofoxifene’s Fast Track designation highlights the significant unmet medical needs of women who have estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation," said Sermonix Chief Executive Officer Dr. David Portman. "Fast Track will allow us to more quickly complete our development program and, if successful, make lasofoxifene available to patients sooner."

Sermonix’s open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study will assess the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation. ESR1 mutations are commonly found in women with ER+ metastatic breast cancer progressing after prior endocrine treatment and confer poorer prognosis. A liquid biopsy test will be utilized to identify women for inclusion in the ELAINE study.

"We are very encouraged to receive Fast Track designation, a recognition of lasofoxifene’s potential promise as a precision medicine for women with ER+ metastatic breast cancer," said Sermonix Chairman Dr. Anthony Wild.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On May 28, 2019 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported its Rights Offering has closed (Press release, Galectin Therapeutics, MAY 28, 2019, View Source [SID1234536626]).

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The Rights Offering resulted in the issuance of approximately 10.4 million shares of the Company’s common stock at a price of $4.28 per share, for total gross proceeds of $44.5 million to the Company. Investors in the Rights Offering also received warrants for the purchase of approximately 2.6 million shares of the Company’s common stock with an exercise price of $7.00 per share, which expire seven years after issuance. After giving effect to the rights offering, the Company has approximately 56 million shares of common stock issued and outstanding.

Richard E. Uihlein, Chairman of the Board of Directors, subscribed for $20,033,000 in the Rights Offering. Mr. Uihlein stated, "We are pleased with the results of the Rights Offering and are gratified that so many of our stockholders responded by making further investments in our Company. From the outset, we wanted to turn first to our stockholder base and give them the opportunity to continue supporting our company, its development program, and its clinical trials; we are proud that so many did so, with investments large and small. This capital raise positions us to proceed with plans to initiate a Phase 3 clinical trial this fall in patients with NASH cirrhosis."

Separately, Mr. Uihlein also exercised 500,000 common stock warrants at an exercise price of $5.00 per share for proceeds of $2,500,000.

A registration statement relating to the shares of common stock in the Rights Offering was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on April 12, 2019. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on May 23, 2019, have expired.

On May 28, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported the appointment of Pascal Touchon as President, Chief Executive Officer and member of the Board of Directors (Press release, Atara Biotherapeutics, MAY 28, 2019, View Source [SID1234536625]).

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Dr. Touchon has over 30 years of global biopharmaceutical leadership experience, most recently at Novartis Oncology serving as Global Head, Cell & Gene and member of the Oncology Executive Committee. Notably in this role he was accountable for the Oncology Cell & Gene unit financial performance and responsible for all activities including the global launch of KYMRIAH (tisagenlecleucel), securing regulatory approval and reimbursement in major markets, expanding global CAR T manufacturing and technical operations, overseeing multiple new clinical studies and building a strong leadership team.

Previously at Novartis, Pascal Touchon served as Global Head, Strategy, Business Development, Oncology where he was responsible for various activities including early commercial strategy, portfolio management, business development and external collaborations as well as member of the Oncology Executive Committee. Prior to joining Novartis Oncology, Dr. Touchon held leadership roles in research, marketing, general management and business development at various companies including Servier, Sanofi, Glaxo and Glaxo-Wellcome.

"We are delighted that Pascal Touchon will be Atara’s next Chief Executive Officer," said Carol G. Gallagher, Pharm.D., Atara’s Lead Independent Director. "His proven oncology leadership as well as CAR T development and global commercialization experience make him an ideal choice to lead Atara. We are confident that Pascal’s capability to unite cell and gene immunotherapy teams will help to guide strategy and execution in the years ahead and enable Atara to further realize its mission to transform the lives of patients with serious diseases."

In connection with Dr. Touchon’s appointment, Isaac Ciechanover stepped down from his role as President, Chief Executive Officer and member of the Board of Directors, effective today. Dr. Ciechanover will serve as a special advisor to a subcommittee of the Board who will lead the Company until Dr. Touchon begins his tenure as President, Chief Executive Officer and member of the Board of Directors on June 24, 2019.

"When I announced my decision to step down in January, I had agreed to stay on until my successor was chosen," said Isaac Ciechanover M.D. "I am thrilled with the appointment of Pascal, who I know will lead the company in its next stages of growth."

"Isaac has been the inspiration and architect of Atara since its founding nearly seven years ago," added Dr. Gallagher. "We thank him for his leadership and vision building a world-class T-cell and CAR T immunotherapy company. We wish him the very best in his next endeavor."

In addition, Dr. Dietmar Berger, Atara’s Global Head of Research and Development, has resigned from the Company effective as of May 31, 2019 to pursue other opportunities.

On May 26, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the Jefferies 2019 Global Healthcare Conference as follows (Press release, Eagle Pharmaceuticals, MAY 28, 2019, View Source [SID1234536624]):

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Date: Tuesday, June 4, 2019
Time: 9:30 a.m. Eastern Daylight Time
Location: Grand Hyatt, New York, NY
Webcast:

View Source

The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.eagleus.com, under the Investors + News Section.