On September 19, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that it has completed the planned enrollment of 380 patients in the global Toca 5 pivotal Phase 3 trial approximately three months ahead of schedule (Press release, Tocagen, SEP 19, 2018, View Source;p=RssLanding&cat=news&id=2368044 [SID1234529590]). Toca 5 is a randomized, multi-center study evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma (HGG). The principal investigator is Timothy Cloughesy, M.D., director of the University of California, Los Angeles Neuro-Oncology Program.

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"Achieving our enrollment goal ahead of schedule is a testament to the enthusiasm and dedication of our investigators and study coordinators as well as the participating patients, families and patient advocates," said Asha Das, M.D., senior vice president and chief medical officer of Tocagen. "Achieving this enrollment goal takes us one step closer towards a potentially transformative new treatment option for patients with brain cancer."

"Completing enrollment in Toca 5 is the latest example of our recent progress as we continue to execute against our goals," said Marty Duvall, chief executive officer of Tocagen. "This important milestone also triggers the next milestone payment of $2 million from ApolloBio, our licensor of Toca 511 & Toca FC within the greater China region."

On August 23rd, Tocagen announced the Toca 5 study would continue without modification after an Independent Data Monitoring Committee completed the first interim analysis. Tocagen estimates the second interim analysis in the first half of 2019 and the final planned safety and efficacy analyses by the end of 2019. More information about Toca 5 can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165.

About High Grade Glioblastoma

Recurrent HGG is among the most common and aggressive primary brain cancers and often strikes in the prime of life. The two most common forms of HGGs are glioblastoma and anaplastic astrocytoma. The total number of new diagnoses of HGG expected in 2018 is about 188,000 worldwide. Unfortunately, HGG recurs in most patients after frontline treatment, and standard of care treatment typically offers a median survival of only seven to nine months.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

On September 19, 2018 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Michael C. Greiner, Executive Vice President and Chief Financial Officer, will present at the Cantor Global Healthcare Conference at 8:35 a.m. ET on Tuesday, October 2, 2018 in New York, NY (Press release, AngioDynamics, SEP 19, 2018, View Source [SID1234529494]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On September 19, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company focused on the development of drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported it has secured $150 million in a joint, oversubscribed Series C financing and royalty purchase agreement (Press release, Galera Therapeutics, SEP 19, 2018, View Source [SID1234529486]). The financing was led by new investor Clarus, with participation from additional new investors Adage Capital Management, HBM Healthcare Investments, Nan Fung Life Sciences, RA Capital, Rock Springs Capital and Tekla Capital Management LLC. Existing investors Correlation Ventures, Galera Angels, New Enterprise Associates, Novartis Venture Fund, Novo Ventures and Sofinnova Ventures also participated. In addition, Emmett T. Cunningham, Jr., M.D., Ph.D., MPH, Managing Director at Clarus, will join Galera’s Board of Directors.

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The financing includes a $70 million equity raise and an $80 million royalty financing payable from future sales. Per the terms of the royalty purchase agreement, Clarus will receive single-digit future commercial royalties from the sales of GC4419 and a related pipeline asset until the total royalty amount achieves an undisclosed multiple of the initial $80 million, upon which the royalty terminates.

Galera plans to use the proceeds of the combined equity and royalty financings to advance the clinical development of GC4419 into and through a pivotal Phase 3 clinical trial for the treatment of severe oral mucositis (SOM) in patients with head and neck cancer, its lead indication. SOM is one of the most debilitating side effects of radiotherapy, and there are currently no effective therapies to prevent or mitigate it. In a Phase 2b clinical trial, GC4419 demonstrated reductions in the incidence and duration of radiation-induced SOM in patients with locally advanced head and neck cancer.

"This significant raise further validates the dramatic and meaningful results of our randomized Phase 2b clinical trial and the potential of GC4419 to revolutionize radiotherapy. We are grateful for the robust support from existing and new investors as we prepare to advance GC4419 into a pivotal trial for SOM in head and neck cancer patients in the fourth quarter of this year," said Mel Sorensen, M.D., President and CEO of Galera. "The funds provide Galera with ample financial resources to complete the Phase 3 clinical trial, begin commercial planning activities and further explore the potential of GC4419 beyond SOM. We look forward to initiating a supportive care trial of GC4419 in radiation-induced esophagitis and a therapeutic trial in a second cancer indication, as well as continuing to evaluate the safety and anti-tumor effect of GC4419 in our ongoing Phase 1/2 pancreatic cancer clinical trial."

"Galera has generated robust, randomized Phase 2b data supporting the efficacy and safety profile of GC4419. These data, along with Breakthrough and Fast Track designations from the U.S. Food and Drug Administration (FDA), support the promise of GC4419 to transform how radiotherapy is used to treat patients with head and neck malignancies," said Dr. Cunningham. "With its highly differentiated scientific approach and its potential in a number of indications, GC4419 is well-positioned to address serious unmet medical needs. We’re pleased to support Galera as the company moves closer to potentially bringing GC4419 to head and neck cancer patients with SOM who need a new treatment option."

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 incidence and duration of radiation-induced severe oral mucositis. 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. GC4419 is currently being studied in combination with SBRT for its anti-tumor effect in a Phase 1/2 trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The 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.

On September 19, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported its participation in two upcoming investor conferences (Press release, TESARO, SEP 19, 2018, View Source [SID1234529487]). The two conferences are:

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The Cantor Global Healthcare Conference at the InterContinental New York Barclay Hotel on Wednesday, October 3, 2018.Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, are scheduled to present an overview of the Company’s business and development programs at 11:30 AM ET and will also host meetings with investors.

The Leerink Partners Roundtable Series: Rare Disease & Oncology at the Lotte New York Palace on Wednesday, October 3, 2018.Mary Lynne Hedley, Ph.D., President and COO of TESARO, and Timothy Pearson, Executive Vice President and CFO of TESARO, will participate in an analyst-led fireside chat at 1:30 PM ET and will also host meetings with investors.
Live webcasts of the presentations at the Cantor and Leerink Partners conferences will be available by visiting the Investors section of the TESARO website at www.tesarobio.com. Archived replays of these webcasts will be available on the Company’s website for 14 days following the conference.

1stOncology™, the leading oncology drug development surveillance and analysis platform from BioSeeker Group, now fully supports the latest release of the GLOBOCAN database (September 2018) which includes estimates of the incidence, mortality and prevalence from 36 types of cancer and for all cancers combined in 185 countries of the world. The estimates are presented for 2018, separately for each sex and for the 18 traditional age-groups.

The online tool allows the production of tables and visual descriptions of the current cancer burden by country or region, and permits projections regarding future cancer burden over the next 20 years.

Log-in here to access GLOBOCAN 2018 Epidemiology Data in 1stOncology™ or, if you are not a current user, request a free demo here to learn more.

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