Allergan to Present at the Bernstein Strategic Decisions Conference

On May 16, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the Bernstein 34th Annual Strategic Decisions Conference in New York, NY (Press release, Allergan, MAY 16, 2018, View Source(1) [SID1234526735]). The presentation will begin at 10:00 a.m. Eastern Time on Wednesday, May 30, 2018.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: https://cc.talkpoint.com/bern0…

An archived version will be available within approximately 3 hours of the live presentation, and can be accessed at the same location for 180 days

LIDDS signs license agreement for prostate cancer drug Liproca® Depot with major Chinese pharma company

On May 16, 2018 LIDDS AB (publ) reported that it has signed a license agreement for Liproca Depot with Jiangsu Ambition Medical, a Chinese pharmaceutical company specializing in global collaborations and in-licensing. Liproca Depot is LIDDS injectable cancer drug candidate for local treatment of prostate cancer (Press release, Lidds, MAY 16, 2018, View Source [SID1234555918]). LIDDS is receiving a signing fee exceeding USD 1 million followed by milestone payments and royalty. A phase III clinical trial will be conducted in China and will be fully financed by the licensee.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The strategic cooperation between Jiangsu Ambition Medical and LIDDS is expected to result in market approval for Liproca Depot in China as the first country in the world. Jiangsu Ambition Medical originates from Jiminkexin Group which ranks as one of the top 10 pharma companies in China. Jiangsu Ambition Medical has also expressed a strong interest for other drugs formulated in the NanoZolid technology platform.

LIDDS is very pleased to enter into the license agreement with Jiangsu Ambition Medical which has the highly regarded expertise to perform necessary clinical trials, and also an impressive sales organization to manage a future launch of Liproca Depot. The agreement is also a clear recognition of the international interest for the NanoZolid technology and Liproca Depot as treatment for prostate cancer, says Monica Wallter, CEO of LIDDS.

The prostate cancer market is substantial in China with around 500 000 patients being diagnosed annually. Oncology is a focus area at Jiangsu Ambition Medical and the company expects that the sales of Liproca Depot will reach yearly sales of 50 000 to70 000 treatments in 3 to 5 years after launch.

Jiangsu Ambition Medical views NanoZolid technology and specifically the Liproca Depot product as a very promising treatment for prostate cancer, a disease that is also very common in China. We are very happy to enter the agreement with LIDDS and will immediately start to prepare for conducting the Liproca Depot clinical trial in China. We hope to extend the partnership and get other products based on the NanoZolid technology into our pipeline, says Mr. Mark Dai, CEO of Jiangsu Ambition Medical.

Jiangsu Ambition Medical has its own regulatory and clinical departments and a highly recognized marketing and sales organization. Being deeply connected with the Chinese regulatory authorities and key clinical opinion leaders, their sales network covers 1,130 large scale public hospitals and an additional 4,592 hospitals in China. The sales team has launched four different drug products with an annual revenue of more than RMB 1.5 billion each and three drug products with revenues of RMB 1 billion respectively. LIDDS and Jiangsu Ambition Medical will work together to optimise the time to market for launching Liproca Depot in China.

Galera Therapeutics Announces Presentation of Data from Phase 2b Clinical Trial of GC4419 at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 16, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported that data from its Phase 2b clinical trial of GC4419 for severe oral mucositis in patients with head and neck cancer will be presented during an oral abstract session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 1-5, 2018 in Chicago (Press release, Galera Therapeutics, MAY 16, 2018, View Source [SID1234526703]). GC4419 is a highly selective and potent small molecule dismutase mimetic that rapidly converts superoxide to hydrogen peroxide and oxygen.

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Presentation details are as follows:

Title: Results of a randomized, placebo (PBO) controlled, double-blind P2b trial of GC4419 (avasopasem manganese) to reduce duration, incidence and severity and delay onset of severe radiation-related oral mucositis (SOM) in patients (pts) with locally advanced squamous cell cancer of the oral cavity (OC) or oropharynx (OP)

Abstract Number: 6006

Oral Abstract Session: Head and Neck Cancer

Date / Time / Location: June 3, 2018 / 10-10:12 a.m. CDT / McCormick Place E451

Presenter: Carryn M. Anderson, MD, Radiation Oncologist, University of Iowa Hospitals and Clinics

The abstract has also been selected for inclusion in the 2018 Best of ASCO (Free ASCO Whitepaper) program, which aims to increase global access to cutting-edge science by condensing highlights from ASCO (Free ASCO Whitepaper)’s Annual Meeting into a two-day program to be held this summer.

For information about the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit View Source

About GC4419

GC4419 is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. GC4419 works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

GC4419 has been studied in patients with head and neck cancer, GC4419’s lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis (SOM). Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.

TESARO Announces Presentations of Abstracts at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 16, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five ZEJULA (niraparib) abstracts, including two oral presentations, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1 to June 5, 2018, in Chicago, Illinois (Press release, TESARO, MAY 16, 2018, View Source [SID1234526719]). In addition, TESARO will webcast an investor and analyst briefing on Monday, June 4 at 6:15PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting.

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"TESARO has a targeted clinical development program to assess ZEJULA monotherapy activity in the front-line ovarian cancer setting and in combination with bevacizumab or anti-PD-1 in ovarian, breast and lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, we look forward to oral presentations of results from the TOPACIO trial of niraparib plus anti-PD-1 in patients with triple-negative breast cancer or recurrent ovarian cancer, and a poster presentation of data from the QUADRA trial, which evaluated niraparib as a treatment for patients with advanced ovarian cancer."

Please plan to visit TESARO at Booth #10123 to learn more about ZEJULA, TSR-042 (anti-PD-1 antibody), TSR-022 (anti-TIM-3 antibody), and TSR-033 (anti-LAG-3 antibody).

Presentation Details:

Sunday, June 3, 2018, 9:45AM to 11:15AM
TOPACIO/Keynote-162 (NCT02657889): A phase 1/2 study of niraparib + pembrolizumab in patients (pts) with advanced triple-negative breast cancer or recurrent ovarian cancer (ROC): results from ROC cohort.
Oral Presentation; Abstract #106, 10:21AM, Location: Hall D1

Monday, June 4, 2018, 1:15PM to 4:45PM
Cost-effectiveness of niraparib versus routine surveillance, olaparib, and rucaparib for the maintenance treatment of adult patients with ovarian cancer in the United States.
Poster Presentation; Abstract #5559, Poster Board #286, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
OVARIO: The phase 2, single-arm, open-label study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer following response on frontline platinum- based chemotherapy.
Poster Presentation; Abstract #TPS5606, Poster Board #330a, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer (ROC) who have received >3 prior chemotherapy regimens.
Poster Presentation: Abstract #5514, Poster Board #241 Location: Hall A
Poster Discussion: Monday, June 4, 4:45PM – 6:00PM; Location: S100bc

Monday, June 4, 2018, 3:00PM to 4:30PM
TOPACIO/Keynote-162: Niraparib + pembrolizumab in patients (pts) with metastatic triple- negative breast cancer (TNBC), a phase 2 trial.
Oral Presentation; Abstract #1011, 3:36PM, Location: Hall D2

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Monday, June 4th at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting. A reception will begin at 6:00 PM CT, preceding the presentation. During this briefing, TESARO management will provide a business overview and pipeline update and will answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.

FogPharma Secures $66 Million Series B Financing

On May 16, 2018 FogPharma reported the closing of a $66 million Series B financing (Press release, FogPharma, MAY 16, 2018, View Source [SID1234552458]). The round was led by 6 Dimensions Capital, with participation by additional new investors, including GV (formerly Google Ventures), Blue Pool Capital, Horizons Ventures, Nan Fung Group, and Leerink Partners. All existing investors participated in the round including Deerfield Management, Boyu Capital, WuXi AppTec Corporate Ventures, and a prominent international group of non-institutional investors.

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FogPharma was founded by renowned scientist-entrepreneur Dr. Gregory Verdine, whose Harvard lab invented cell-penetrating miniproteins and who coined the term "drugging the undruggable" to describe his life’s mission. FogPharma’s research and development strategy is unique in that it pairs a broadly-enabling new drug class, designed to access the cell interior, with a massively parallelized engine to discover – rapidly and on-demand – drugs that engage the most intractable of disease targets. FogPharma’s drug discovery engine has been configured to deliver multiple new medicines in rapid succession, with clinical entry for the first product, a first-in-class beta-catenin antagonist, by the end of 2019, followed by a steady stream of first-in-class clinical product candidates addressing other intractable targets.

While FogPharma’s approach has many therapeutic applications, the company’s early focus is on drugging the major, intractable drivers of cancer and on pharmacological management of the immune response.

"One of the most important challenges of our time is making actionable the enormous, inactionable trove of biological data on human disease targets. FogPharma is addressing this challenge by bringing forward a new class of medicines that combine the cell-penetrating ability of small molecules with the broad, target power of biologics, and by learning how to discover these medicines better, faster and smarter," said Verdine, chief executive officer and chief scientific officer, FogPharma.

Added Verdine, "We are thrilled to have such an incredible group of investors who share our vision of fundamentally advancing the treatment of cancer and other serious diseases with few if any current treatment options. We are excited at the opportunity provided by this financing to propel our programs and drug discovery engine forward."

Proceeds from the Series B raise will enable the company to advance its first-in-class beta-catenin inhibitor (iCat) program into Phase 2 development for cancer indications involving Wnt pathway activation. The financing will also be used to advance clinical development of its first-in-class Cbl-b inhibitor program and a third as-yet-undisclosed program through IND-enabling studies, and FogPharma’s drug discovery platform for three additional, distinct and differentiated forms of cell-penetrating miniproteins.

In association with the Series B financing, FogPharma has appointed to its board of directors: Dr. Leon Chen, chief executive officer, 6 Dimensions Capital; Dr. Krishna Yeshwant, general partner, GV; and Dr. Rick Klausner, founder and director, Juno Therapeutics, GRAIL and Mindstrong.

"There is substantial and persistent interest in tackling targets like beta-catenin and Cbl-b, which are clearly important biologically and medically, but untouchable by conventional therapeutics. I was captivated by the FogPharma team’s unprecedented ability to go after these and other intractable targets," said Klausner, formerly director of the National Cancer Institute and executive director of the Bill and Melinda Gates Foundation.

"The opportunity in the near term to bring cell-penetrating miniproteins to the 20-25 percent of cancer patients whose disease is driven by the Wnt pathway is tremendous, and the opportunity beyond that to be the first to drug Cbl-b for immuno-oncology indications, is extraordinary. On behalf of 6 Dimensions Capital, I am thrilled to have led this exceptional investor syndicate and foster FogPharma’s mission," said Chen, chief executive officer, 6 Dimensons Capital, and member of the FogPharma board of directors.

Through seed and Series A financing, FogPharma previously secured $11 million bringing the company’s total funding to-date to $77 million.

In addition to FogPharma, Verdine founded and leads LifeMine Therapeutics, which has buit a first-of-its-kind, genomically-enabled drug discovery platform that can rapidly develop new drugs from fungi. Both LifeMine Therapeutics and FogPharma are headquartered in Cambridge, Mass. and were established operationally in 2016. Verdine is highly regarded for having moved seamlessly between successful roles as life scientist, entrepreneur, investor, and chief executive throughout his career. He is Erving Professor at Harvard University and Harvard Medical School and has founded multiple NASDAQ-listed biotech companies including Wave Life Sciences, Enanta, Eleven Bio, Variagenics, Tokai, Aileron, and a private company, Gloucester Pharmaceuticals, acquired by Celgene in 2010.