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Veracyte Announces New Afirma Xpression Atlas Data on Medullary Thyroid Cancer to Be Presented at ENDO 2019

On March 18, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that new data derived from the Afirma Xpression Atlas, which help characterize the genomic underpinning of medullary thyroid cancer (MTC), will be presented at ENDO 2019, the Endocrine Society’s annual meeting (Press release, Veracyte, MAR 18, 2019, View Source [SID1234534419]). The findings on this rare–but aggressive–form of thyroid cancer will be presented in a guided poster presentation during the conference, which is taking place March 23-26 in New Orleans, La.

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"The Afirma Xpression Atlas is enabling us to shed new light on the scope and scale of gene alterations found in medullary thyroid cancer," said Giulia C. Kennedy, Ph.D., chief medical and scientific officer of Veracyte. "We believe that, in the emerging era of precision medicine, such information will be vital to advancing the diagnosis and treatment of this aggressive cancer and we look forward to sharing our findings at ENDO 2019."

The following guided poster will be presented during the meeting:

Title: The Genomic Landscape of Preoperative FNAs Positive for the Afirma GSC Medullary Thyroid Cancer Classifier

Presenter: S.G. Waguespack, M.D., University of Texas MD Anderson Cancer Center, Houston, Texas

Date: Monday, March 25, 1:00 – 3:00 PM CT

Location: ENDOExpo, Ernest N. Morial Convention Center

About Afirma

The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis. The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning and helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery. The Afirma Xpression Atlas provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma Xpression Atlas includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

corporate presentation of Vaccinex, Inc.

On March 18, 2019, Vaccinex, Inc. presented the corporate presentation (Presentation, Vaccinex, MAR 18, 2019, View Source [SID1234534418]).

Corcept Therapeutics Appoints Former Amgen Development Executive, Andreas Grauer, M.D., as Chief Medical Officer

On March 18, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported the appointment of Andreas Grauer, M.D., as Chief Medical Officer (Press release, Corcept Therapeutics, MAR 18, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-appoints-former-amgen-development-executive [SID1234534417]). Dr. Grauer most recently served as Vice President of Global Development at Amgen.

"We are delighted Andreas will be joining us," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "His extensive experience advancing novel compounds through every stage of development and regulatory approval will be invaluable as Corcept’s pipeline progresses."

"There is much to do," said Dr. Belanoff. "Relacorilant is in the midst of its Phase 3 trial as a treatment for patients with hypercortisolism and in Phase 2 as a treatment for patients with advanced ovarian cancer. More indications for relacorilant, including metastatic pancreatic cancer, are under consideration. We expect to select a dose this year of CORT125281 as a treatment for patients with castration-resistant prostate cancer. And CORT118335 will enter the clinic soon as a treatment for antipsychotic induced weight gain and, later this year, non-alcoholic steatohepatitis."

"I am excited to join Corcept at this key moment," said Dr. Grauer. "Cortisol modulation has the potential to improve the lives of many seriously ill patients. I look forward to bringing my experience and expertise to bear to develop truly novel, beneficial medications."

Prior to joining Corcept, Dr. Grauer spent more than ten years at Amgen in a variety of leadership roles, most recently as Vice President of Global Development, where he led or oversaw programs in therapeutic areas including bone, nephrology, and inflammation throughout all phases of development. Dr. Grauer also brings significant experience in regulatory filings across the world that culminated in multiple new drug application and biologic license application approvals. Before Amgen, he held senior executive positions at Procter & Gamble Pharmaceuticals. Dr. Grauer holds an M.D. from the University of Heidelberg Medical School, where he graduated magna cum laude. He is Board Certified in both internal medicine and endocrinology in Germany.

Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for HER2 (ERBB2) Mutant, Metastatic Cervical Cancer at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting

On March 18, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in Honolulu, Hawaii (Press release, Puma Biotechnology, MAR 18, 2019, View Source [SID1234534416]). "Neratinib in patients with HER2-mutant, metastatic cervical cancer: findings from the phase II SUMMIT ‘basket’ trial," was presented during the Scientific Plenary Session by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC). SGO selected this abstract as the recipient of the 2019 SGO Presidential Award. Slides from the presentation are available on the Puma Biotechnology website.

The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The cervical cancer cohort was comprised of 11 patients with advanced and/or metastatic disease treated with neratinib monotherapy. Patients received a median of 2 (range 1–4) prior regimens in the recurrent or metastatic setting before entering this trial. Six patients (54.5%) had been previously treated with bevacizumab prior to entering the study; 7 patients (63.6%) had received prior surgery; and 9 patients (81.8%) received prior radiation therapy. The objective response rate was 27.3% (95% CI: 6.0%–61.0%). The clinical benefit rate was 54.5% (95% CI: 23.4%–83.3%) and included 3 patients with confirmed partial responses and 3 patients with stable disease that lasted greater than 16 weeks. The median progression free survival was 7.0 months (95% CI: 0.7–20.1 months).

The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-amplified metastatic breast cancer. The most frequently observed adverse event was diarrhea, any grade (n=9, 81.8%) including 1 (9%) grade 3 diarrhea event. The duration of grade 3 diarrhea was 1 day. None of the diarrhea events resulted in dose reduction, dose discontinuation or hospitalization.

"Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for metastatic cervical cancers. Treatment with neratinib led to durable responses and disease control in metastatic patients with HER2-mutant cervical cancer," said Dr. D’Souza, who practices oncology at the USC Norris Comprehensive Cancer Center.

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population."

vTv Therapeutics Announces $15 Million of Class A Common Stock Financings

On March 18, 2019 vTv Therapeutics Inc. (Nasdaq:VTVT) (the "Company") reported that it has entered into a definitive agreement with certain institutional investors for the purchase and sale in a registered direct offering (the "Registered Direct Offering") of 3,636,364 shares of the Company’s Class A common stock (the "Common Stock") at a price of $1.65 per share for aggregate gross proceeds of approximately $6.0 million (Press release, vTv Therapeutics, MAR 18, 2019, View Source;p=RssLanding&cat=news&id=2391591 [SID1234534415]). The offering is expected to close on or about March 20, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent.

The Company also entered into a letter agreement (the "Letter Agreement") with MacAndrews & Forbes Group LLC ("M&F Group"), the Company’s largest shareholder, pursuant to which M&F Group has committed to purchase, at the Company’s option and exercisable on demand during a one-year period after the date of the Letter Agreement, up to 5,454,545 unregistered shares of Common Stock at a fixed price of $1.65 per share for aggregate proceeds of approximately $9.0 million assuming the Company elects to sell the entire amount. M&F Group may also exercise a right to purchase those shares on the same terms three times during the same one-year period.

"This financing allows us to initiate two important trials to study therapeutics for underserved populations, one for Type 1 diabetics who rely primarily on insulin and a second for diabetics with Alzheimer’s," said Steve Holcombe, the chief executive officer of vTv Therapeutics. "We expect readouts from these trials in the first quarter of next year and fourth quarter of next year, respectively."

The Company intends to use the net proceeds from the Registered Direct Offering and the Letter Agreement to fund start-up activities for current and future clinical trials, in addition to ongoing business operations. The clinical trials include:

A phase 2 and phase 3 clinical trial under a single protocol designed to investigate the safety and efficacy of azeliragon in patients with mild Alzheimer’s disease and type 2 diabetes as evidenced by elevated HbA1c.
The part 2 confirmatory phase of the ongoing Simplici-T1 Study, a 12-week study to evaluate TTP399 as an add-on to insulin therapy for type 1 diabetics. This trial is being conducted in partnership with JDRF.
The Common Stock in the Registered Direct Offering is being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (Registration No. 333-223269) that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on March 19, 2018. The Registered Direct Offering of shares of Common Stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A prospectus supplement and the accompanying prospectus relating to the Registered Direct Offering will be filed with the SEC. Copies of the prospectus supplement and the accompanying prospectus relating to the Registered Direct Offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.