KaloBios 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, KaloBios, 2018, MAR 27, 2018, View Source [SID1234525020]).

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On March 27, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it has won the Life Science Innovation Award at the Business Weekly Awards ceremony (Press release, STORM Therapeutics, MAR 27, 2018, View Source [SID1234561045]). Held at Queen’s College, Cambridge, the Awards Dinner attracts entries from across the East of England and is the longest-running B2B competition in the UK. The Awards pride themselves on early identification of world-leading businesses.

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STORM Therapeutics was recognised by the judges for leading the field in a highly innovative area of drug discovery which has the potential to target novel disease mechanisms through the inhibition of RNA modifying enzymes.

Commenting on the award, Keith Blundy, CEO of STORM Therapeutics said: "We are very pleased to have been recognized for the Life Science Award, voted for by our peers in Cambridge. It is a credit to the team and our Investors, and a strong endorsement of STORM’s pioneering drug discovery programmes. As the first company tackling disease through harnessing the power of RNA epigenetics, we believe we are well positioned to build a world leading company."

On March 27, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that two abstracts1 related to the successful Phase III study with BEKINDA (RHB-102)2 24 mg for acute gastroenteritis and gastritis (the GUARD study) have been accepted for oral presentations at the Society for Academic Emergency Medicine (SAEM) 2018 Annual Meeting, May 16-17, 2018, at the JW Marriott Hotel in Indianapolis, IN (Press release, RedHill Biopharma, MAR 27, 2018, View Source [SID1234525013]).

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The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDA 24 mg successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis, and BEKINDA 24 mg was found to be safe and well tolerated in this indication3. If approved for marketing by the FDA, BEKINDA 24 mg could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis.

The first presentation, entitled ‘Treatment of Acute Gastroenteritis-Related Emesis with Bimodal Release Ondansetron (RHB-102)’, will be presented by Robert Silverman, MD, MS, Associate Professor of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell; Northwell Health, and Lead Investigator of the BEKINDA Phase III GUARD study, on Wednesday, May 16, 2018, at 3:00 PM EDT. The abstract concludes that the Phase III GUARD study is the first study of acute gastroenteritis-related emesis showing benefit from any ondansetron preparation in adolescents and adults and suggests that acute gastroenteritis can be treated with a long-acting, bimodal release tablet, potentially avoiding the need for intravenous access.

The second presentation, entitled ‘A 24 mg bimodal-release ondansetron pill (RHB-102) shows no evidence of QT interval prolongation’, will be presented by Joseph Miller, MD, MS, Associate Clinical Professor, Emergency Medicine, Henry Ford Hospital and Investigator of the BEKINDA Phase III GUARD study, on Thursday, May 17, 2018, from 9:00 AM EDT. The abstract concludes that in patients with normal baseline corrected QT interval (QTc), 24 mg bimodal extended-release ondansetron caused no QTc prolongation in comparison to placebo.

About BEKINDA (RHB-102):
BEKINDA is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents and targets several gastrointestinal indications. A first Phase III clinical study with BEKINDA 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) successfully met its primary endpoint. A Phase II study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) successfully met its primary endpoint.

On March 27, 2018 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique formulation of sodium thiosulfate) Breakthrough Therapy designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB) (Press release, Fennec Pharmaceuticals, APR 27, 2018, View Source [SID1234525799]).

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"The decision by the FDA to grant PEDMARK the first Breakthrough Therapy designation for the prevention of cisplatin ototoxicity reflects a recognition of the promising efficacy and safety data generated from SIOPEL 6 and COG ACCL0431 studies. We believe the recent receipt of Fast Track designation, and today, Breakthrough Therapy designation highlights the current lack of safe and effective treatments and overwhelming need to address this serious condition," said Rosty Raykov, President and Chief Executive Officer of Fennec. "This designation is another significant milestone for the advancement of PEDMARKTM, as we work closely with the Agency to expedite the NDA filing."

According to FDA, Breakthrough Therapy designation is given when preliminary clinical evidence has been provided to show that a treatment effect may represent substantial improvement over available therapies for the treatment of a serious condition. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program. Additional information is available under the FDA guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics:

View Source

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

On March 27, 2018 NexImmune, an emerging leader in the field of antigen-directed immunotherapy, reported that Scott Carmer has been appointed Chief Executive Officer (Press release, NexImmune, MAR 27, 2018, View Source [SID1234554957]). Mr. Carmer has served as NexImmune’s Chief Operating Officer since 2015. In addition, Kristi Jones has been promoted to Chief Operating Officer, and Alan Roemer has been appointed as Chairman of the Board of Directors.

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"I am pleased to congratulate Scott and Kristi, both respected and valued leaders within the organization, on their well-deserved promotions," said Alan Roemer, Chairman of NexImmune. "They have each played an integral role advancing the company’s immuno-oncology programs towards the clinic and closing our $24 million Series A Financing. I look forward to working with the leadership team and Board of Directors to bring NexImmune’s antigen-specific AIM adoptive cellular therapy to patients in need."

Scott P. Carmer
Scott Carmer joined NexImmune in February 2014 as the Company’s first Chief Business Officer and was promoted to Chief Operating Officer in July 2015. Prior to joining NexImmune, Mr. Carmer served as Executive Vice President, Commercial Operations at MedImmune from 2010 through 2013, where he was responsible for all sales, marketing, Medical Affairs, Managed Markets, Global Marketing & Alliances, and commercial analytics functions. He was previously Genentech’s Vice President, Immunology from 2006-2010, responsible for the US launches of Rituxan and ACTEMRA. Prior to Genentech, Mr. Carmer held several leadership roles of increasing responsibility at Amgen, most recently as Executive Director of global marketing, Immunology and Oncology and at GlaxoSmithKline, where he held key roles in global brand management, business development, commercial operations, managed care and field sales. Scott received his B.S. in Biology from the University of Kentucky.

Kristi Jones
Kristi Jones joined NexImmune in 2017 where she served as the Chief Business Officer. She served as NexImmune’s interim CBO in 2016. Prior to joining NexImmune, Ms. Jones was Vice President of Portfolio Strategy and Management at Astra Zeneca, where she played an instrumental role in building a scientifically innovative, diverse portfolio creating new value for the company. Prior to that she served at MedImmune, as Vice President of Global Strategic Marketing and payor planning where she focused driving value through differentiating products, establishing to market strategies and preparing MedImmune for multiple product launches. Previously, Ms. Jones held multiple leadership roles with increasing responsibility at Genentech, where she worked for 16 years, including Head of Immunology and Ophthalmology Pipeline Development – Global Portfolio and Product Strategy, Commercial Operations and Endocrine and Respiratory Franchise leadership. Kristi has held global and US roles in commercial, operations, strategy and business development. She received her B.S. in Biology from Texas Tech University Health Sciences Center and a pharmacy degree from The University of Texas at Austin.

Alan S. Roemer
Alan Roemer has served on NexImmune’s Board of Directors since 2017. Mr. Roemer is also a founding leadership team member of Roivant Sciences and has served as Senior Vice President, Corporate Development since July 2016. He previously served as Roivant’s Senior Vice President, Finance & Operations from the company’s inception through June 2016 and Chief Financial Officer of Axovant Sciences in 2015. From 2009 to 2014, Mr. Roemer was a Managing Director for the Trout Group, where he provided financing, strategic advisory and investor relations services for life sciences clients. He previously served as Chief Financial Officer & Treasurer of Zelos Therapeutics and was a Vice President at Pharmasset (acquired by Gilead) from 1999 to 2008. Prior to Pharmasset, Mr. Roemer was a healthcare consultant for Booz-Allen & Hamilton and Deloitte Consulting, and he held various operational roles at Bank of America. Mr. Roemer currently serves as a trustee of the Helene Fuld College of Nursing. He received his B.S. in Business Administration from Georgetown University and his M.B.A. and M.P.H. degrees from Emory University’s Goizueta Business School and Rollins School of Public Health.