On July 25, 2018 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1 study evaluating investigational agent TP-0184, an activin A receptor type 1 (ACVR1) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, JUL 25, 2018, View Source [SID1234527870]). The Phase 1, open-label, dose-escalation study will evaluate the safety, pharmacokinetics, and pharmacodynamics of TP-0184 administered orally daily for the first 21 days of a 28-day cycle across a range of doses.

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"The initiation of this study of TP-0184 represents an important milestone for Tolero Pharmaceuticals, as it marks the second investigational agent from our development program to enter the clinical research stage this year,"said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "We look forward to understanding more about the profile of TP-0184 and its role in inhibiting ACVR1, which is mutated in approximately 1-4 percent of solid tumors and 32 percent of diffuse intrinsic pontine gliomas (DIPGs), an aggressive form of pediatric brain cancer."

The primary objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of TP-0184 orally administered daily for 21 days, over a range of doses in patients with advanced solid tumors. Secondary objectives in the study are to evaluate the pharmacokinetics and pharmacodynamics of TP-0184, observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment, and establish the recommended Phase 2 dose for future studies with TP-0184. The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03429218).

About TP-0184
TP-0184 is small molecule inhibitor of ACVR1, an activin A receptor type 1 (ACVR1) inhibitor, which is involved in the transforming growth factor beta (TGFβ) signaling pathway. ACVR1, also known as activin receptor-like kinase 2 (ALK2), is mutated in multiple types of cancers, including diffuse intrinsic pontine glioma (DIPG), a malignancy with high morbidity and mortality affecting the pediatric population.1,2,3 ACVR1 mutations are present in approximately 1-4 percent of solid tumors and, more commonly, in 32 percent of diffuse intrinsic pontine gliomas (DIPGs), a brain cancer with high morbidity and mortality afflicting the pediatric population.4,5 There is currently no approved therapy for the treatment of DIPG. ACVR1 is also involved in regulation of iron hemostasis, through stabilization of hepcidin and reduction of bioavailable iron, which is associated with anemia of chronic inflammation.4 TP-0184 is currently being evaluated in a Phase 1 clinical trial in advanced solid tumors (NCT03429218).

On July 25, 2018 Innovent Biologics, a world-class China-based biopharmaceutical company that develops and intends to commercialize high quality innovative antibody-based therapeutics, reported that it has received Investigational New Drug (IND) approval from the China Food and Drug Administration (CFDA) to initiate clinical trials in China with IBI101, an anti-OX40 agonistic antibody, and with IBI307, an anti-RANKL antibody (Press release, Innovent Biologics, JUL 25, 2018, View Source [SID1234527869]).

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Innovent’s IBI101, is the first OX40-targeted molecule to receive IND approval in China. OX40 is one of the most important targets in the field of immune-oncology. Innovent will be among one of a few companies pursuing the development of OX40 agonists in early stage clinical trials globally. IBI307 is an anti-RANKL antibody under development for the treatment of osteoporosis and lytic bone lesions associated with cancer metastasis. Currently there is no anti-RANKL inhibitors approved for marketing in China.

"The IND approvals for IBI101 and IBI307 by CFDA once again demonstrate Innovent’s capability and commitment to lead the rapid development of China’s biopharmaceutical market. As part of our 17 drug candidates under development, we will prepare to bring these two targeted therapeutic agents into clinical trials quickly," said Michael Yu, Founder, Chief Executive Officer and Chairman. "Innovent will continue to discover and develop new biopharmaceutical drugs to expand our portfolio of products to treat patients. With today’s rapid improvements in cancer treatment modalities, we will utilize our well-established platform to discover, develop, manufacture and commercialize innovative high-quality biopharmaceutical drugs."

About IBI101

IBI-101 is a fully human monoclonal antibody drug candidate that was developed to treat cancers and hepatitis B. IBI101 binds to and stimulates OX40, which should increase the survival and activation of tumor specific T cells. OX40 agonists can be combined with a variety of therapeutic products, such as our PD-1 mAb, sintilimab, and other products in our pipeline, resulting in improved outcomes for patients. Innovent intends to pursue simultaneous development of this asset in China as well as outside of China. There are currently no OX40 agonists approved globally.

About IBI307

IBI307 is a fully human monoclonal antibody drug candidate that we are developing for the treatment of osteoporosis and lytic bone lesions associated with cancer metastasis. It binds to RANKL (RANK ligand), a molecule that controls the activation and survival of osteoclasts, the cells that remodel bone. By blocking the activity of RANKL, bone resorption is inhibited resulting in stronger and denser bones. There are currently no RANKL inhibitors approved for marketing in China.

On July 25, 2018 Varian (NYSE: VAR) reported its third quarter fiscal year 2018 results (Press release, Varian Medical Systems, JUL 25, 2018, View Source [SID1234527868]). All comparisons in this announcement are year-over-year unless noted otherwise.

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GAAP Net Earnings, GAAP Net Earnings per Diluted Share, Non-GAAP Net Earnings and Non-GAAP Net Earnings per Diluted Share refer only to continuing operations.

Non-GAAP Net Earnings and Non-GAAP Net Earnings per Diluted Share are defined as GAAP Net Earnings and GAAP Net Earnings per Diluted Share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, restructuring and impairment charges, significant litigation charges or benefits, legal costs and significant effects of tax legislation.

"In the third quarter, the team continued to deliver robust results, and we strengthened our leadership in radiation therapy with strong orders and revenue performance," said Dow Wilson, Chief Executive Officer of Varian. "Investment will continue to be a key driver of our long-term growth and value creation, and we made strategic investments in the quarter in R&D, Sales, and Marketing to support the company’s future innovation and growth strategies."

The company ended the quarter with $536 million in cash and cash equivalents and $18 million of debt. Net cash provided by operating activities was $102 million. During the quarter, the company invested $39 million to repurchase 325,000 shares of common stock.

Oncology Systems Segment
In the fiscal third quarter, Oncology revenues totaled $667 million, up 18 percent in dollars and 16 percent in constant currency. Gross orders were $763 million, up 11 percent in dollars and 9 percent in constant currency. Gross orders in the Americas increased 9 percent in dollars and in constant currency, driven by North America at 9 percent. In EMEA, gross orders rose 27 percent in dollars and 21 percent in constant currency; in APAC, gross orders decreased 7 percent in dollars and 9 percent in constant currency. Operating earnings for the segment increased 20 percent.

Particle Therapy Segment
In the fiscal third quarter, Particle Therapy revenues totaled $42 million, down 39 percent. The company did not book any new ProBeam orders in the quarter.

Acquisition-Related Expenses and Impairment Charges in Q3
Varian’s GAAP net earnings include acquisition-related expenses totaling $13 million for the quarter, primarily driven by acquisition costs and the loss related to hedging the Australian dollar purchase price of Sirtex, partially offset by the breakup fee received from Sirtex in connection with the termination of the acquisition. Additionally, GAAP net earnings include an impairment charge of $11 million related to the expected refinancing of the Maryland Proton Treatment Center in Baltimore. Together, these costs, and their associated tax effects, reduced Varian’s net earnings in the third quarter of fiscal 2018 by $0.20 per diluted share on a GAAP basis, and were excluded from non-GAAP results.

FY18 Annual Guidance Updated
Considering the financial and operational performance year-to-date and the impact of currency and tariffs, fiscal year 2018 guidance is updated to the following:

Revenue growth range of 9 percent to 11 percent
Non-GAAP Operating earnings as a percentage of revenues range of 17.5 percent to 18.0 percent
Non-GAAP effective tax rate of 20 percent
Weighted average diluted shares of 93 million
Non-GAAP Net Earnings per diluted share range of $4.43 to $4.48
Cash flows from operations range of $475 million to $550 million
Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its third quarter fiscal year 2018 conference call at 2:00 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13680748. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, July 27, 2018.

On July 25, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that it will report its second quarter financial results before the open of the U.S. markets on Thursday, August 2, 2018 (Press release, Pacira Pharmaceuticals, JUL 25, 2018, View Source;p=RssLanding&cat=news&id=2359881 [SID1234527867]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

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To participate in the conference call, dial 1-877-845-0779 and provide the passcode 5387259. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 5387259. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

On July 25, 2018 Ophthotech Corporation (Nasdaq: OPHT) reported that it will report its second quarter 2018 financial and operating results on Wednesday, August 1, 2018 (Press release, Ophthotech, JUL 25, 2018, View Source [SID1234527866]). Following the announcement, Ophthotech’s management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update.

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To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2597 (International), passcode 3698278. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3698278.