10-Q – Quarterly report [Sections 13 or 15(d)]

HedgePath Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, HedgePath Pharmaceuticals, 2018, JUL 23, 2018, View Source [SID1234527811]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

MediciNova has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, MediciNova, 2018, JUL 23, 2018, View Source [SID1234527810]).

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Epizyme Appoints Dr. Shefali Agarwal as Chief Medical Officer

On July 23, 2018 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company developing novel epigenetic therapies, reported the appointment of Dr. Shefali Agarwal as chief medical officer, effective July 23, 2018 (Press release, Epizyme, JUL 23, 2018, View Source [SID1234527842]). In this role, Dr. Agarwal will oversee all of the company’s activities related to the global strategic development of tazemetostat, a potent, selective, orally available EZH2 inhibitor, as well as additional pipeline candidates. A trained physician with expertise in medical oncology, Dr. Agarwal brings nearly two decades of clinical research and regulatory experience to Epizyme.

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"Dr. Agarwal’s distinguished career in both academia and the biotech industry make her an ideal candidate to lead our clinical organization and oversee the development of innovative therapies to potentially treat a range of solid tumor and hematological malignancies for which significant needs exist," said Robert Bazemore, president and chief executive officer of Epizyme. "Her proven leadership and understanding of the patient community, as well as the healthcare providers who care for them, will be instrumental as we continue to advance our lead product candidate, tazemetostat."

"I look forward to joining this dynamic management team, and leading the next phase of clinical development for tazemetostat, as well as for EZM8266, our novel agent that targets G9a for the treatment of sickle cell disease, as we prepare it to enter the clinic," said Dr. Agarwal. "I believe that Epizyme’s scientific vision and innovative approach will drive the continued success of the company, as we work together to deliver promising new options for underserved patients."

Over the span of her career, Dr. Agarwal has held leadership positions across medical research, clinical development, clinical operations, and medical affairs. She has led clinical and regulatory engagements for small molecules, biologics, liposomal and cell therapy products across the full spectrum of drug development, from pre-IND work to filing. Dr. Agarwal most recently served as chief medical officer at SQZ Biotech, where she built and led the clinical development organization, which included clinical research operations and the regulatory function. She brings significant oncology experience to Epizyme, having held leadership positions at Curis and Tesaro. At Curis, Dr. Agarwal oversaw the Phase 2 study for its dual HDAC/PI3K inhibitor in diffuse large B-cell lymphoma, and the Phase 1 study in solid tumors for its oral checkpoint inhibitor. At Tesaro, Dr. Agarwal led the NDA and EMA submissions for ZEJULA (niraparib) in ovarian cancer. She has also held positions of increasing responsibility at Covidien, AVEO Oncology and Pfizer.

In addition to receiving her MBBS medical degree from Karnataka University’s Mahadevappa Rampure Medical School in India, Dr. Agarwal earned a master’s of public health from Johns Hopkins University, where she led clinical research in the Department of Anesthesiology and Critical Care Medicine. She also holds a master’s of science in business from the University of Baltimore’s Merrick School of Business.

SELLAS To Present Data from Phase 2b Trial of NeuVax + Herceptin® at Upcoming European Society for Medical Oncology (ESMO) 2018 Meeting

On July 23, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that data on the adjuvant treatment of women with triple-negative breast cancer (TNBC) with the combination of trastuzumab (Herceptin) +/-nelipepimut-S (NeuVax) will be presented as a Proffered Paper in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany (Press release, Sellas Life Sciences, JUL 23, 2018, View Source;Herceptin-at-Upcoming-European-Society-for-Medical-Oncology-ESMO-2018-Meeting/default.aspx [SID1234527830]).

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The abstract, "Pre-specified interim analysis of a randomized phase 2b trial of trastuzumab + nelipepimut-S (NeuVax) vs trastuzumab for the prevention of recurrence demonstrates benefit in triple negative (HER2 low-expressing) breast cancer patients," describes research undertaken at Cancer Insight, LLC by a team of clinicians-scientists led by COL (ret) George E. Peoples, MD, FACS, the principal investigator for the study.

Data will be presented from a prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of Herceptin +/- NeuVax in HER 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences. As previously announced, a pre-specified interim analysis of safety and efficacy conducted by the study independent data safety monitoring board (DSMB), demonstrated a clinically meaningful and statistically significant difference between the TNBC cohort of patients and the control arm with a hazard ratio of 0.26, p-value = 0.023, in favor of the NeuVax + Herceptin combination compared to Herceptin alone. The analysis also showed an adverse event profile with no notable differences between treatment arms and no additional cardiotoxicity in the NeuVax + Herceptin arm. Based on these positive results, the DSMB recommended to expeditiously seek regulatory guidance from the U.S. Food and Drug Administration for further development of the combination of NeuVax + Herceptin in TNBC, a population with a large unmet medical need.

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

About ESMO (Free ESMO Whitepaper)

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) is Europe’s leading non-profit medical oncology organization. ESMO (Free ESMO Whitepaper) is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO (Free ESMO Whitepaper) organizes a large number of meetings to provide its members and the community with the resources they need and also plays a major role in public policy and European affairs. The ESMO (Free ESMO Whitepaper) 2018 Annual Meeting represents a multi-professional platform for oncology education and exchange, and for immense international visibility for scientific research, and will be held under the tagline "Securing access to optimal cancer care".

Diplomat to Release Second-Quarter 2018 Operating Results, Host Conference Call on Aug. 6

On July 23, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), repported that it will release its second-quarter 2018 operating results after market close Monday, Aug. 6, with a conference call to follow at 5 p.m. ET (Press release, Diplomat Speciality Pharmacy, JUL 23, 2018, View Source [SID1234527828]).

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Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering the participation code 1842529, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.