On May 15, 2018 Astellas reported that Bernhardt G. Zeiher, M.D., F.C.C.P., F.A.C.P., ("Bernie"), was promoted to Chief Medical Officer (CMO), effective April 1, 2018 (Press release, Astellas Pharma US, MAY 15, 2018, View Source [SID1234526669]). Zeiher will continue serving as president of Development, while now also overseeing all other functions of Astellas’ Medical and Development (M&D) organization, including Clinical and Research Quality Assurance, Medical Affairs, Pharmacovigilance, Planning & Administration, and Regulatory Affairs.

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Reporting directly to Astellas president and CEO, Kenji Yasukawa, Ph.D., Zeiher will join the company’s top executive leadership team. He will continue to lead the organization from Northbrook, Ill., Astellas’ headquarters for M&D and its Americas operations.

In his new role, Zeiher will focus on further integrating and enhancing Astellas’ delivery of its global innovative pipeline and driving support for the appropriate use of its products.

"I am honored to lead the Astellas M&D organization during this critical time," said Zeiher. "As we embark upon a new Corporate Strategic Plan, it is my goal to continue and further implement the corporate vision of turning innovative science into value for patients."

Zeiher started his career at Astellas in 2010 as vice president and Therapeutic Area leader for Inflammation, Immunology and Infectious Diseases. He was promoted to senior vice president and Therapeutic Area Head for Immunology, Infectious Diseases and Transplant in 2012. Zeiher was later named executive vice president and Therapeutic Area Head when his organization was expanded to include the company’s CNS and Pain programs. Most recently, Zeiher was promoted to president of Development in 2015. Prior to joining Astellas, Zeiher served as the vice president of the Inflammation/Immunology therapeutic area at Pfizer.

He earned his Doctor of Medicine at the Case Western Reserve University School of Medicine, and completed an internal medicine residency at University Hospitals of Cleveland as well as a fellowship in Pulmonary and Critical Care Medicine at University of Iowa Hospitals and Clinics. Zeiher is a Fellow in the American College of Physicians and the American College of Chest Physicians. He has worked in the pharmaceutical industry since 1998

On May 15, 2018 Savara Inc. (NASDAQ:SVRA), an orphan lung disease company, reported that the Company’s Chief Executive Officer, Rob Neville, will present at the Bank of America Merrill Lynch 2018 Healthcare Conference on Tuesday May 15th, 2018 at 1:55 p.m. Pacific Time at the Encore Hotel in Las Vegas (Press release, Savara, MAY 15, 2018, View Source [SID1234526660]).

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Interested parties can access a live audio webcast on the Savara website at www.savarapharma.com. An archived presentation will be available on the website for 30 days.

On May 15, 2018 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported that its President and Chief Executive Officer, John P. Butler, will present at the UBS Global Healthcare Conference on Tuesday, May 22, 2018, at 4:00 p.m. Eastern Time, at the Grand Hyatt New York in New York City (Press release, Akebia, MAY 15, 2018, View Source [SID1234526659]).

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A live webcast of the presentation will be available on the company’s website at www.akebia.com. To access the webcast, please log onto the Akebia website at least 15 minutes prior to the webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Akebia’s website following the conference.

On May 15, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2018 (Press release, Cel-Sci, MAY 15, 2018, View Source [SID1234526658]).The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study has been fully enrolled since September 2016. All 928 patients are being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database. All that remains to be done in this pivotal Phase 3 study is to continue to track patient survival until the 298 deaths have occurred and it can be determined if the primary endpoint has been met.
Closing arguments in the arbitration against the former clinical research organization (CRO) for the Phase 3 trial concluded on April 25, 2018. The parties are now awaiting a decision from the arbitrator.
The U.S. Patent and Trademark Office allowed a patent for CEL-SCI’s LEAPS technology for methods of inducing immune responses.
"We expect two significant and material outcomes in the near term. In the very near term we are awaiting a decision from the arbitrator in our case against our former CRO. The read out of the Phase 3 study is expected to take longer than the decision by the arbitrator, however, based on overall survival data available in the scientific literature for the study’s patient population and the fact that the last patient was enrolled in the study over 1.5 years ago, we believe that the end of the Phase 3 trial is approaching as well," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "Separately, we continue to advance our LEAPS technology through preclinical studies in preparation for human clinical studies. The current work with the Rheumatoid Arthritis vaccine is funded by a $1.5 million grant from the National Institutes of Health."

During the six months ended March 31, 2018, CEL-SCI’s cash increased by approximately $0.7 million. Significant components of this increase include net proceeds from the sale of CEL-SCI’s common stock of approximately $7.1 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $6.4 million.

CEL-SCI reported an operating loss of ($4,205,745) for the quarter ended March 31, 2018 versus an operating loss of ($7,906,557) for the quarter ended March 31, 2017. The operating loss was ($9,117,175) for the six months ended March 31, 2018 versus an operating loss of ($12,844,565) for the six months ended March 31, 2017.

The research and development expenses decreased by approximately $4.8 million compared to the six months ended March 31, 2017. The majority of CEL-SCI’s research and development expense relates to its on-going Phase 3 clinical trial. Clinical trial costs tend to be higher during the enrollment phase of the study and because the study is fully enrolled, the expenses incurred over the last six months have decreased. The general and administrative expenses increased by approximately $1.3 million compared to the six months ended March 31, 2017. This increase is primarily due to an increase of approximately $1.0 million in equity based compensation related to the Company’s shareholder approved 2014 Incentive Stock Bonus Plan, and a net increase of approximately $0.3 million in other general and administrative expenses primarily for accounting fees and public relations services.

On May 15, 2018 Agilvax, Inc., a biotechnology company that develops targeted cancer immunotherapies and vaccines, reported that it has completed a Series A1 financing, which complements the Series A round from 2014 (Press release, Agilvax, MAY 15, 2018, View Source [SID1234526657]). Both Series A and A1 were led by Hunt Holdings with a co-investment by Sun Mountain Capital. The funds will be used to expand the pre-IND studies for its lead program AX09 in triple negative breast cancer (TNBC). The Company is also evaluating the use of AX09 in combination with other cancer therapeutics, as well as strengthening its immunotherapy platform.

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Federica Pericle, Ph.D., MBA, Agilvax’s CEO, remarked, "This funding shows the belief our investors have in our progress and platform. With this additional funding, we will move AX09 closer to the clinic for TNBC, a truly unmet need in women’s health. We are also excited to continue to build our platform and pipeline."

TNBC is a histological subtype of breast cancer that is aggressive, with an overall poor prognosis due to a lack of effective treatment options. Chemotherapy remains the primary treatment for TNBC across the different settings: neoadjuvant, adjuvant, and metastatic.

AX09 is a virus-like particle (VLP) that displays a portion of the extracellular domain of the cystine-glutamate antiporter system protein xCT (SLC7A11), which has been found to be overexpressed in cancer stem cells. TNBC is enriched in cancer stem cells, which contributes to the aggressive nature of TNBC. Cancer stem cells have unique biological properties that represent a key cellular reservoir for relapse, metastatic progression and therapeutic resistance. Thus, the development of therapies that eliminate cancer stem cells is paramount to creating a durable response.