On March 28, 2018 bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) reported that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States (Press release, bluebird bio, MAR 28, 2018, http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-and-celgene-corporation-enter-agreement-co-develop [SID1234525035]).

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"Entering into this co-development and co-promotion partnership with Celgene is a significant step forward in building a fully integrated oncology franchise for bluebird and together, we are committed to rapidly advancing development of bb2121 for patients," said Joanne Smith-Farrell, Ph.D., oncology franchise leader and senior vice president, corporate development and strategy, bluebird bio. "The collaboration builds upon our extensive research and development capabilities in oncology and is a testament to the strong partnership that exists between our two companies."

The companies originally entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology, which included bb2121.

"We are extremely pleased to advance our collaboration with bluebird on bb2121 and we believe this therapy has the potential to significantly impact the treatment approach and outcomes for patients with multiple myeloma," said Nadim Ahmed, President, Hematology and Oncology for Celgene.

About the bluebird bio-Celgene Collaboration

bluebird bio and Celgene are collaborating to develop CAR T cell therapies targeting BCMA. The collaboration’s lead oncology program, bb2121, is currently being studied for the treatment of relapsed and refractory multiple myeloma. For bb2121, bluebird and Celgene have joint responsibility for development, manufacturing and commercialization in the United States. Celgene will assume sole responsibility for drug product manufacturing and commercialization outside the United States.

bluebird bio and Celgene are also working together on a second clinical-stage anti-BCMA CAR T program, bb21217.

On March 27, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that Charles D. Kaplan, Director of Immuno-Oncology Research at Five Prime, has been invited to give an oral presentation at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14 – 18, 2018, in Chicago (Press release, Five Prime Therapeutics, MAR 27, 2018, View Source [SID1234525010]).

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Presentation Title: FPA150: A recombinant, afucosylated, fully human IgG1 monoclonal antibody for the treatment of malignancies that express high levels of B7-H4
Presenter Name: Charles D. Kaplan
Session Type: Drug Development Track – Special Session
Session Title: New Drugs on the Horizon 1
Session Start Time: April 15, 20181:00 PM
Location: Room S103 – McCormick Place South (Level 1)

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast, bladder and gynecologic cancers, and has been documented to correlate with poor prognosis. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering potent antibody-dependent cell-mediated cytotoxicity against tumor cells expressing B7-H4. Five Prime anticipates initiating Phase 1 development of FPA150 during the first half of 2018.

On March 27, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has entered an agreement with The University Hospitals Cleveland Medical Center, which includes the Seidman Cancer Center and the Cleveland Clinic, to participate in its U.S. Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) and that patient enrollment has begun (Press release, Moleculin, MAR 27, 2018, View Source [SID1234525011]).

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"This is an important milestone in establishing the efficacy of Annamycin in the treatment of AML in a U.S. trial," commented Walter Klemp, Chairman and CEO of Moleculin. "Coupled with the impending Annamycin clinical trial in Poland, we believe we are at an important inflection point to demonstrate the safety and effectiveness of our leading drug candidate. We have worked hard to get to this point, and we are gratified with the opportunities to move Annamycin forward."

On March 27, 2018 i2020 Accelerator reported that Stelvio Therapeutics has joined its early drug discovery ecosystem (Press release, Stelvio Therapeutics, MAR 27, 2018, View Source [SID1234555715]). i2020 aims to accelerate research programs with differentiated biology and established development paradigms towards advanced leads and clinical candidates. The i2020 Accelerator deploys a world-wide network of well-established R&D resources, financial and BD&L capabilities to help Stelvio Therapeutics advance its proprietary epigenetic platform for glioblastoma therapies.

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i2020 received a startup funding commitment of $30 million from the specialty life science investor, Torrey Pines Investment. "With the risk of taking on projects at early development stages being very significant, i2020 has to be reasonably selective with the programs it supports," comments Nikolay Savchuk, Managing Director at Torrey Pines. "Stelvio Therapeutics’ AI-driven epigenetic signature-based platform, which identifies compounds that trigger differentiation of cancer stem cells into benign cell types, matches i2020’s target profile well. It is a first-in-class project with strong clinical hypothesis, a well-defined product profile and clear development milestones."

"i2020 aligns well with our overall goals, since it provides a robust network of relevant R&D, business strategy and scientific resources, together with an agile business model and flexible partnering options," comments Attila Hajdu, CEO at Stelvio Therapeutics. "This exciting partnership is a tremendous step towards our shared mission of delivering innovative medicines of value to the patients that need them. With our combined technology and resources, the traditional approaches of chemo and radiotherapy would be toppled and we could see a cure for glioblastoma within our lifetime."

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.