OncoSec Presents Positive Melanoma Clinical Data at American Association for Cancer Research (AACR) Annual Meeting 2016

SAN DIEGOApril 19, 2016 -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today presented long-term, follow-up data of patients who were treated with its investigational therapy ImmunoPulse™ IL-12 and later went on to receive an anti-PD-1/PD-L1 therapy. These data suggest that ImmunoPulse™ IL-12 may prime and enhance response rates to PD-1/PD-L1 blockade. Alain Algazi, MD, skin cancer specialist in the Melanoma Center at the UCSF Helen Diller Family Comprehensive Cancer Center, presented the findings in an oral presentation entitled "Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma" (Abstract #CT134) at the American Association of Cancer Research (AACR) Annual Meeting in New Orleans, LA.

"We are encouraged by the data from this analysis, which show that intratumoral IL-12 DNA with electroporation can prime the immune system and help improve patient response to anti-PD-1," said Dr. Algazi. "These results are being validated prospectively in a Phase II clinical trial and they could make a clinically meaningful impact on patient outcomes and address a great unmet need in immuno-oncology."  

Read more: OncoSec Medical Incorporated ( ONCS )

Synergy Pharmaceuticals Announces Acceptance of New Drug Application for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation

2016-04-19 06:00 ET - News Release -- PDUFA target action date of January 29, 2017
 
NEW YORK -- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced the U.S. Food and Drug Administration (FDA) has determined that the company’s New Drug Application (NDA) for plecanatide, its first uroguanylin analog, for the treatment of chronic idiopathic constipation (CIC) is sufficiently complete to permit a substantive review. The FDA Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017.
 
"This is a transformative milestone for our company and reflects our relentless commitment to bringing meaningful treatment options to patients suffering from GI diseases,” said Gary S. Jacob, Chairman and Chief Executive Officer of Synergy Pharmaceuticals. “If approved, we believe plecanatide will become an important new treatment option that will benefit patients with CIC. I want to thank the Synergy employees and outside consultants working on the CIC NDA for their hard work and dedication which contributed to this important milestone.”
Read more: Synergy Pharmaceuticals Inc ( SGYP )

Heron Therapeutics Provides Update on FDA Review of SUSTOL ® NDA

2016-04-18 16:01 ET - News Release
 
REDWOOD CITY, Calif. -- Heron Therapeutics, Inc. (NASDAQ: HRTX), announced today that the U.S. Food and Drug Administration (FDA) has provided the Company with an update on its review of the New Drug Application (NDA) for SUSTOL® (granisetron) Injection, extended release. The FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.
 
SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary Biochronomer® drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.
Read more: Heron Therapeutics Inc ( HRTX )

Loxo Oncology TRK Inhibitor LOXO-101 Shows Durable Anti-Tumor Activity Across TRK Fusion Cancers in AACR Phase 1 Update

2016-04-17 17:15 ET - News Release – Five of Six Evaluable Patients with TRK Fusion Cancers Achieve Confirmed RECIST Partial Responses; All Six Demonstrate Significant Tumor Regressions –

– All TRK Fusion Patients Remain on Study, With Longest Follow-up Beyond One Year –
– Company to Host Investor Conference Call and Webcast on Monday, April 18, 2016 at 8:00 a.m. ET –

STAMFORD, Conn., April 17, 2016 -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced new results from its Phase 1 open-label, dose-escalation trial of LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK). A presentation at the 2016 American Association for Cancer Research (AACR) Annual Meeting in New Orleans on April 17, 2016 provided updated data from the Phase 1 trial, which was last reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2015.

Read more: Loxo Oncology Inc ( LOXO )

Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting

SAN DIEGO -- 2016-04-17 -- Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced that updated results of its Phase 1 clinical trials of entrectinib, the company's proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1or ALK, were presented in an oral plenary session at the 2016 Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana.

“We continue to be excited by entrectinib’s ability to help patients with advanced cancer,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “With respect to efficacy, in the 25 patients in the Phase 1 trials who would meet the eligibility criteria for our Phase 2 clinical trial, we saw tumor regression in 20 patients, or 80%. 

Read more: Ignyta Inc ( RXDX )