Syros to Present on Design of Ongoing Phase 1 Clinical Trial of SY-1365 at Upcoming ASCO Annual Meeting

On May 16, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that the Company will present on the design of its Phase 1 clinical trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Syros Pharmaceuticals, MAY 16, 2018, View Source [SID1234526718]).

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The Phase 1 trial is currently enrolling advanced solid tumor patients in the dose-escalation portion of the trial, with planned expansion cohorts to further evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Syros expects to open the expansion phase of the trial in mid-2018 and to report data from the dose-escalation portion of the trial in the fourth quarter of 2018.

Details on the presentations are as follows:

Date & Time: Monday, June 4, 8:00 a.m. – 11:30 a.m. CDT
Presentation Title: Trial Design of a First-in-Human Phase 1 Evaluation of SY-1365, a First-in-
Class Selective CDK7 Inhibitor, with Initial Expansions in Ovarian and Breast Cancers
Session Title: Developmental Therapeutics—Clinical Pharmacology and Experimental
Therapeutics
Presenter: Geoffrey Shapiro, M.D., Ph.D., Dana-Farber Cancer Institute
Abstract Number: TPS2600
Location: McCormick Place, Hall A

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An archived version will be available within approximately 3 hours of the live presentation, and can be accessed at the same location for 180 days

NanOlogy to Unveil Positive Preclinical Data for Inhaled NanoPac® in Treatment of Lung Cancer at 2018 ASCO Annual Meeting

On May 16, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported it will present data from preclinical studies of inhaled NanoPac (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC) (Press release, NanOlogy, MAY 16, 2018, View Source [SID1234526907]).

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The data will be presented in an abstract entitled "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model" during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 3rd, from 8:00 AM to 11:30 AM in Hall A of McCormick Place in Chicago.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in rat lung tissue following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression.

Gere diZerega, MD, VP of Medical Affairs, said, "In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials."

Lung cancer is by far the leading cause of cancer death according to the American Cancer Society with more than 154,000 deaths expected this year. More people die of lung cancer every year than breast, prostate, and colon cancers combined.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

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.

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.