On March 11, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that it has exclusively licensed worldwide rights to develop and commercialize a novel, oral, selective small molecule RET (rearranged during transfection) kinase inhibitor from the CRT Pioneer Fund LP, a £70 million specialist oncology investment fund managed by Sixth Element Capital, a UK based fund manager (Press release, Stemline Therapeutics, MAR 11, 2019, View Source [SID1234534227]). The RET inhibitor was rationally designed by scientists at Cancer Research UK Manchester Institute at the University of Manchester (United Kingdom). The preclinical compound has been designated SL-1001 and is expected to enter the clinic in 2020.

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RET kinase genetic alterations have been found in a diverse range of cancers and, we believe, is a clinically validated target in multiple indications. SL-1001 is an oral RET kinase inhibitor that has demonstrated potent, selective, preclinical anti-cancer activity, both in vitro and in vivo, in RET-driven tumor models.

"SL-1001 is an ideal strategic fit for us, given its targeted mechanism of action and potential for streamlined development," commented Stemline’s CEO, Ivan Bergstein. He continued, "Building upon our team’s proven track record of success, culminating with the recent ELZONRIS approval, we intend to advance SL-1001 swiftly through the clinical and regulatory process with an eye towards achieving our goal of helping more patients succeed in their fight against cancer."

Robert James, Managing Partner at Sixth Element Capital said, "We are delighted to have partnered SL-1001 with Stemline. We are confident that Stemline’s skills and resources will take the project forward rapidly and offer an alternative treatment option to patients with cancer driven by RET kinase".

On March 11, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that founder and Chief Executive Officer Dr. David Portman will present at the Boston Oncology Investor Conference (Press release, Sermonix Pharmaceuticals, MAR 11, 2019, View Source [SID1234534397]). Dr. Portman will discuss the Phase 2 study of its lead investigational drug, lasofoxifene, and the drug’s potential as a novel precision medicine treatment for metastatic breast cancer patients with an ESR1 mutation identified through a liquid biopsy.

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Dr. Portman will speak at 6 p.m. on Thursday, March 14. The conference, held at McDermott Will & Emery law firm, 28 State Street in Boston, is organized by the National Foundation for Cancer Research, OneMedMarket and the Altru Institute.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.

On March 11, 2019 Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced today that ImmuneOncia, a joint venture formed in September 2016, has completed the Phase 1 study of IMC-001 (also known as STI-3031), a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor (Press release, Sorrento Therapeutics, MAR 11, 2019, View Source [SID1234534199]).

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This Phase 1 dose-escalation study, approved by the South Korean Ministry of Food and Drug Safety (MFDS) in February of 2018, enrolled subjects with locally-advanced or metastatic solid tumors at Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC). The Recommended Phase 2 Dose (RP2D) was determined to be successful with no observations of dose-limiting toxicities. More results of this study will be disseminated at upcoming conferences.

"Based on the results of the Phase 1 trial of IMC-001, we are planning on conducting a Phase 2 trial to evaluate its efficacy in rare cancers in the second half of this year," stated Yun Jeong Song, CEO of ImmuneOncia. "Moreover, we greatly appreciate those who supported us and for their contributions as the company successfully completed a Phase 1 trial of IMC-001. In collaboration with various institutions, we will continue our research and development of IMC-001 as well as the additional checkpoint immune-oncology molecules in our pipeline."

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, suppressing the inhibitory signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody. The clinical-grade material of IMC-001 was manufactured by Sorrento in its San Diego-based GMP antibody production facility.

On March 11, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported two poster presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Advaxis, MAR 11, 2019, View Source [SID1234534226]).

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Poster Presentation 1
Title: Safety and immunogenicity of a personalized neoantigen-Listeria vaccine in cancer patients
Presenter: J. Randolph Hecht M.D., UCLA
Session: Phase I Clinical Trials: Part 1
Abstract Number: CT007
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Date and Time: Sunday, March 31, 2019 1:00 p.m. – 5:00 p.m. ET

Poster Presentation 2
Title: KEYNOTE-046: Effects of ADXS-PSA with or without pembrolizumab on survival and antigen spreading in metastatic, castration-resistant prostate cancer patients
Presenter: Mark N. Stein M.D., FACS, Columbia University, NYC
Session: Phase I Clinical Trials: Part 3
Abstract Number: CT098
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Date and Time: Monday, April 1, 2019 1:00 p.m. – 5:00 p.m. ET

All accepted abstracts will be published in the 2019 Proceedings of the AACR (Free AACR Whitepaper). Session information is available online via the Annual Meeting Itinerary Planner through the AACR (Free AACR Whitepaper) website at www.aacr.org.

On March 12, 2019 Varian (NYSE: VAR) reported its second quarter fiscal year 2019 earnings release date and upcoming investor event (Press release, Varian Medical Systems, MAR 11, 2019, View Source [SID1234534244]).

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Second Quarter Fiscal Year 2019 Earnings

The Company will report results for the second quarter of fiscal year 2019 after market close on Wednesday, April 24, 2019. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415, and enter conference ID 13688640. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, April 26, 2019.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Second Quarter Earnings Results.

Upcoming Investor Event

Chris Toth, president of Oncology Systems and J. Michael Bruff, senior vice president of investor relations and finance will participate in Jefferies’s Radiation Oncology & Energy-Based Therapeutics Summit in New York City scheduled for 8:00 a.m. Eastern Time on Wednesday, March 27, 2019.

Information about the company’s presentation will be available through a link on the company website at www.varian.com/investors.