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Tocagen Provides Update on European Regulatory Path for Toca 511 & Toca FC

On October 2, 2018 Tocagen Inc. (Nasdaq: TOCA) reported it has received Protocol Assistance from the European Medicines Agency (EMA) under the Company’s PRIME (PRIority MEdicines) designation for Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) for the treatment of patients with recurrent high grade glioma (HGG) (Press release, Tocagen, OCT 2, 2018, View Source;p=RssLanding&cat=news&id=2369807 [SID1234529957]). In particular, the EMA indicated that the statistical analyses, seamless design, and the use of overall survival as the primary endpoint in the ongoing Phase 3 Toca 5 clinical trial are appropriate for a potential marketing authorization application for Toca 511 & Toca FC.

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"We are pleased the global Toca 5 trial has the potential to serve as the basis for a regulatory application in Europe, which we believe may expedite the advancement of Toca 511 & Toca FC as a treatment for patients with brain cancer. If the pivotal trial data are positive, our gene therapy would be the first medicine in over 20 years to show a treatment benefit in a randomized trial in patients with this disease," said Marty Duvall, chief executive officer of Tocagen. "Our interactions with the European regulators under the PRIME pathway are conducted in the spirit of collaboration and urgency to bring forward a new treatment for brain cancer as quickly as possible."

Toca 5 is an international, 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 HGG. The trial recently completed the planned enrollment of 380 patients. The primary endpoint of the trial is overall survival. Secondary endpoints of the Toca 5 trial include durable response rate, defined as complete or partial responses lasting at least 24 weeks, which is being assessed as a novel endpoint in the post-surgical setting of recurrent HGG. Tocagen plans to conduct a second interim analysis of Toca 5 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.

The Committee on Orphan Medicinal Products (COMP) of the EMA has designated both Toca 511 & Toca FC as orphan medicinal products indicated for the treatment of glioma. In addition, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Toca 511 & Toca FC in recurrent HGG.

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 197,000 worldwide, with approximately 38,000 in Europe. 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 comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 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, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered 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 resulting in anti-cancer immune activation and subsequent tumor killing.

Axumin® (fluciclovine (18F)) receives positive recommendation from Transparency Committee of the French HAS, for use in PET imaging of suspected recurrent prostate cancer

On October 2, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the Transparency Committee of the French Haute Autorité de Santé (HAS) has recommended that Axumin (fluciclovine (18F)) is included on the list of medicines approved in France for hospital use, in line with its European indication (Press release, Blue Earth Diagnostics, OCT 2, 2018, View Source [SID1234529924]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. The positive recommendation marks a further milestone in the roll-out of Axumin across Europe, following receipt of Marketing Authorisation from the European Commission in May 22, 2017.

Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe. The company now has six European manufacturing and distribution agreements for Axumin in place, covering seventeen countries. Axumin is already commercially available in Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "We’re delighted to announce another significant step towards our mission of making Axumin commercially available to clinicians and their patients across Europe. Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin across Europe."

Data from OncoSec’s OMS-100 Clinical Trial Accepted for Oral Presentation at the 2018 Melanoma Bridge Conference

On October 2, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Dr. Alain Algazi, Associate Professor of Medicine at UCSF, will present data from OncoSec’s OMS-100 study of TAVO (intratumoral tavokinogene telseplasmid) as a monotherapy treatment for metastatic melanoma in an oral presentation during the Melanoma Bridge Conference being held on November 29 – December 1 in Naples, Italy (Press release, OncoSec Medical, OCT 2, 2018, View Source [SID1234529888]).

Dr. Algazi’s recently accepted presentation, entitled Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients, will describe the OMS-100 Phase 2 multicenter, single-group study which evaluated the efficacy and safety observed after repeat dosing and different intervals between TAVO cycles. The primary endpoint was overall response rate (ORR) by modified "skin" Response Evaluation Criteria In Solid Tumors (mRECIST). Dr. Algazi, the primary investigator, is a leading expert in oncology research as well as a Clinical Strategic Advisor and a Clinical Advisory Board member for OncoSec.

The new data will demonstrate that local treatment with TAVO alone led to whole-body immune responses associated with regression of untreated lesions in half of the 50 patients treated on the study.

"We were grateful to Dr. Algazi and the Melanoma Bridge Conference for the opportunity to share this important TAVO monotherapy data demonstrating abscopal clinical responses with the clinicians, biotechnology executives, and industry opinion leaders in attendance," said Daniel J. O’Connor, OncoSec President and Chief Executive Officer. "Having Dr. Algazi present data from our OMS-100 study at the Melanoma Bridge Conference is an exciting opportunity for OncoSec as it serves to highlight our clinical work investigating TAVO as a monotherapy in the treatment of metastatic melanoma, as well as bring added visibility to our Phase 2b PISCES/KEYNOTE-695 clinical trial combining TAVO with pembrolizumab in metastatic melanoma for patients that have failed all available treatment options, including anti-PD-1 immunotherapy."

Details of the presentation are as follows:

Session Title: Mechanisms of resistance and drivers of response
Presentation Title: Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients will address
Date and Time: Friday, November 30, 2018; 4:50 PM – 5:05 PM CEST (10:50 AM – 11:05 AM ET)
Location: Naples, Italy

Cantor Fitzgerald Global Healthcare Conference Presentation

On October 2, 2018 Pieris Pharmaceuticals, Inc presented the Cantor Fitzgerald Global Healthcare Conference presentation (Presentation, Pieris Pharmaceuticals, OCT 2, 2018, View Source [SID1234529837]).

NYC-Based Quentis Therapeutics is Named a “Fierce 15” Biotech Company of 2018

On October 2, 2018 Quentis Therapeutics, Inc., a biotechnology company developing therapies that target endoplasmic reticulum (ER) stress pathways, reported that FierceBiotech has named the company to its "Fierce15" list for 2018, designating Quentis as one of the most promising private emerging biotechnology companies (Press release, Quentis Therapeutics, OCT 2, 2018, View Source [SID1234529833]). Quentis also announced the appointment of industry veteran, Mark Murcko, PhD, to its Board of Directors.

"Quentis is thrilled to be recognized by FierceBiotech at this stage in the company’s growth and development. The science and understanding of the role of ER stress in disease has advanced significantly, providing a path to develop new therapies with the potential to treat cancer and other diseases in a meaningful way. Our lead program has the potential to overcome suppression and restore normal immune-cell function in the tumor micro-environment leading to increased tumor killing and improved patient outcome," said Michael Aberman, MD, President and CEO of Quentis Therapeutics.

The endoplasmic reticulum (ER) is a structure within cells that is responsible for multiple functions, including serving as a sensor of cellular stress. Many diseases, including cancer, neurodegenerative, and autoimmune diseases, can cause persistent ER stress, triggering aberrant responses that disrupt normal cellular functions. The company’s lead program is a first-in-class IRE1α inhibitor designed to boost anti-tumor immunity in cancer. Quentis plans to advance a pipeline of programs designed to address ER stress in multiple diseases.

Sponsored by FierceBiotech, an internally recognized provider of life science news and analysis, Fierce15 is an annual award bestowed upon 15 privately held-life science companies that embody the word "fierce" – championing innovation and creativity in the face of intense competition. Now in its 16th year, recipients are selected from hundreds of private companies from around the world based on the strength of their technology and science, partnerships, investors and competitive market position.

New Appointment to Board of Directors

Quentis also announced that Dr. Murcko has joined its Board of Directors providing deep experience in drug discovery and development. Dr. Murcko is a Founder, Board member, and served as interim chief scientific officer of Relay Therapeutics. He is a senior lecturer in the Department of Biological Engineering at MIT and has served on scientific advisory boards and corporate boards of directors for a diverse range of organizations. Prior to co-founding Relay Therapeutics, Dr. Murcko was chief technology officer and chair of the Scientific Advisory Board of Vertex Pharmaceuticals. He previously worked at Merck Sharpe & Dohme, where he helped discover multiple drug candidates. Dr. Murcko has directly contributed to the development of seven marketed drugs over his career, is a co-inventor on more than 50 issued and pending patents, and has co-authored more than 85 scientific articles. He holds a PhD in organic chemistry from Yale University.

"I am excited to join the Board of Directors at this important time and look forward to collaborating with the talented Quentis team to realize the promise of ER stress in cancer and beyond," said Dr. Murcko