On April 30, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical program testing the safety, immunogenicity, and clinical efficacy of GEN-009, the company’s lead personalized neoantigen cancer vaccine candidate (Press release, Genocea Biosciences, APR 30, 2018, View Source [SID1234525835]).

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"We are excited to have advanced GEN-009 one step closer to the clinic," said Chip Clark, president and chief executive officer of Genocea. "Our GEN-009 program is designed to use our proprietary ATLAS platform to include only empirically confirmed neoantigens and to exclude what we’ve identified as inhibitory neoantigens in each patient’s vaccine. Our scientific data continue to demonstrate that widely used in silico-based neoantigen prediction methods fail to identify most empirically confirmed neoantigens and, critically, misclassify as good the inhibitory neoantigens that vastly outnumber stimulatory neoantigens. We therefore believe that ATLAS distinguishes GEN-009 from other neoantigen vaccine approaches and should enable better immune responses and, ultimately, therapeutic benefit for patients."

Genocea plans to commence the GEN-009 Phase 1/2a clinical program later this year, first studying the safety and immunogenicity of GEN-009 as monotherapy in cancer patients with no evidence of disease, but at high risk of relapse. This part of the program is expected to enroll at least six patients previously treated for melanoma, non-small cell lung cancer, head or neck cancer, or urothelial carcinoma. Genocea expects to announce the first top-line data from this study in the first half of 2019. Following proof of immunogenicity, Genocea expects to study GEN-009 in combination with checkpoint inhibitors in patients with advanced or metastatic solid tumors and as monotherapy in patients who have failed checkpoint inhibitory therapy.

On April 30, 2018 Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the 43rd Annual Deutsche Bank Health Care Conference as follows (Press release, Eagle Pharmaceuticals, APR 30, 2018, View Source [SID1234525851]):

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Date: Wednesday, May 9, 2018

Time: 8:40 a.m. EDT

Location: The InterContinental Boston Hotel

The presentation will be webcast live at the aforementioned time, and archived for 90 days thereafter, via the company’s website at www.eagleus.com, under the Investors Section and is also available at View Source

On April 30, 2018 United Therapeutics Corporation (NASDAQ: UTHR) and SteadyMed Ltd. (NASDAQ: STDY) reported the signing of a definitive merger agreement under which United Therapeutics will acquire SteadyMed for $4.46 per share in cash at closing and an additional $2.63 per share in cash upon the achievement of a milestone related to the commercialization of Trevyent (Press release, United Therapeutics, APR 30, 2018, View Source [SID1234526054]). The transaction, including the $75 million in contingent consideration, is valued at $216 million.

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SteadyMed is a specialty pharmaceutical company focused on the development and commercialization of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs. SteadyMed’s product portfolio includes Trevyent, a development-stage drug-device combination product that combines SteadyMed’s two day, single use, disposable PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue, for the subcutaneous treatment of pulmonary arterial hypertension (PAH). United Therapeutics is a leading biotechnology company focused on the development and commercialization of therapies for the treatment of PAH and other orphan diseases.

"We are optimistic about acquiring SteadyMed and adding Trevyent to our pipeline of products to treat PAH," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We are especially impressed with SteadyMed’s management team and global supply chain. Trevyent fits in well with our mission, and we look forward to bringing the product to the maximum number of patients as soon as possible."

"United Therapeutics has always been at the forefront of developing therapies to treat PAH, and we are delighted at the prospect of our companies coming together, as one, to continue that mission," said Jonathan M.N. Rigby, President and Chief Executive Officer of SteadyMed. "We believe that this proposed acquisition will help us realize our commitment to bring Trevyent to market to improve the lives of patients with PAH."

The Board of Directors of SteadyMed has unanimously approved the merger agreement and unanimously recommends that SteadyMed shareholders adopt the merger agreement. SteadyMed shareholders owning approximately 43.3 percent of the ordinary shares of SteadyMed have entered into an agreement to vote their shares in favor of the transaction.

The transaction is subject to customary closing conditions, including approval by SteadyMed’s shareholders and the expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to be completed in the third quarter of this year.

United Therapeutics received legal advice from Gibson, Dunn & Crutcher and Herzog, Fox & Neeman; SteadyMed received legal advice from Cooley LLP and Yigal Arnon & Co.; and Wedbush PacGrow acted as an advisor to the SteadyMed Board of Director

Zai Laboratory has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Zai Laboratory, 2018, APR 30, 2018, View Source [SID1234527579]).

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On April 30, 2018 Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments, reported Tarek Sahmoud, M.D., Ph.D., as its chief medical officer, initially a part-time role reporting to the company’s chief executive officer (Press release, Humanigen, APR 30, 2018, View Source [SID1234525836]).

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Dr. Sahmoud brings more than 25 years of experience in oncology drug development and medical and regulatory affairs to Humanigen. During his career, Dr. Sahmoud has led global oncology drug development programs in solid tumor and hematologic malignancies through regulatory approval and has advised on CAR-T programs. Dr. Sahmoud currently consults with leading CAR-T companies on their clinical and regulatory plans. He recently served as chief medical officer for H3 Biomedicine, a precision medicine company, and prior to that, he was vice president, oncology clinical development and medical affairs (USA), and global associate therapeutic area head (global) at Boehringer Ingelheim. He has served at Celgene as corporate vice president and global head of clinical development in solid tumors and immunoncology. Previously, Dr. Sahmoud was at Novartis as vice president and senior global clinical program head, oncology global drug development. He also held roles at Bristol-Myers Squibb as executive director, global medical affairs, oncology and at AstraZeneca as senior global medical director and US physician for breast cancer. In addition, he served at EORTC where he was responsible for all clinical trials coordination for several of the disease groups. Dr. Sahmoud received his medical degree from Cairo University Medical School, Egypt, and he holds a Ph.D. in public health, epidemiology and biostatistics from the University of Bordeaux II, France.

"Tarek is a strong addition to the Humanigen team, as he brings world-class abilities in oncology drug development and global regulatory strategy, coupled with domain expertise in the rapidly evolving CAR-T and immunoncology fields," said Cameron Durrant, M.D., chairman and chief executive officer of Humanigen. "Tarek will be instrumental in helping to guide the impending start of our clinical work to show lenzilumab’s potential to optimize CAR-T therapy to make it safer, better and more routine – and position our platform portfolio for maximum value for our stakeholders."

"I am excited to work with Humanigen and its clear opportunity and scientific rationale in granulocyte-macrophage colony-stimulating factor’s (GM-CSF) role in CAR-T-induced toxicities, including the unmet need of neurotoxicity, and optimizing CAR-T therapy overall," said Dr. Sahmoud. "I look forward to guiding the strategy and execution of Humanigen’s development programs to fulfill the ultimate goal of helping patients with significant unmet needs in oncology."

About Lenzilumab

Lenzilumab is a first-in-class, novel Humaneered recombinant monoclonal antibody designed to target and neutralize circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), the myeloid inflammation factor involved in the recruitment of myeloid cells to a tumor and a central actor in leukocyte differentiation, autoimmunity and inflammation. There is also extensive evidence linking GM-CSF expression to serious and potentially life-threatening side effects in chimeric antigen receptor T-cell (CAR-T) therapy, such as neurotoxicity and Cytokine Release Syndrome (CRS). Humanigen is working with leading CAR-T experts to develop lenzilumab as a potential prophylactic treatment to minimize neurotoxicity associated with CAR-T cancer therapy. In addition, lenzilumab is currently being evaluated as a potential treatment for rare leukemias in a phase 1 trial (NCT02546284) in patients with chronic myelomonocytic leukemia (CMML) with additional potential in juvenile myelomonocytic leukemia (JMML), a rare pediatric cancer. In previous clinical trials, lenzilumab has shown to be safe and well-tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers. It is a potent inhibitor of GM-CSF in vivo.