1stOncology™: Cancer Intelligence Service – Page 16786 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

U.S. Food and Drug Administration Grants Fast Track Designation to Can-Fite’s CF102 in the Treatment of Liver Cancer

On September 17, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported the U.S. Food and Drug Administration (FDA) has granted the Company’s drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, SEPT 17, 2015, View Source [SID1234529378]). CF102 had already received the FDA’s Orphan Drug designation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar annual sales, as reported by Bayer, were €773 million in 2014.

About CF102

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, Rich Pharmaceuticals, SEP 17, 2015, View Source [SID:1234507492])

8-K – Current report

On September 17, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that Igor Bilinsky, Ph.D., has been appointed to the newly-created role of General Manager, Immuno-Oncology and Senior Vice President, Special Operations (Filing, 8-K, Ignyta, SEP 17, 2015, View Source [SID:1234507493]).

"As our team has continued to integrate the development programs we acquired from Teva in March of this year, we have become increasingly excited about the potential role of RXDX-106 in immuno-oncology, given its profile as a potent inhibitor of Tyro-3, Axl and MER, or TAM," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "As a result, we have decided to establish a division within Ignyta focused on pursuing immuno-oncology programs that will complement our pipeline as we seek to develop novel single agent and combination therapies for the benefit of cancer patients. Igor’s broad experience in strategic, operational, and entrepreneurial management in biopharmaceutical companies, including immunology experience relevant to this new role, will be valuable to us as we expand our capabilities in this important field."

Prior to joining Ignyta, Dr. Bilinsky was Senior Vice President, Corporate Development at Vical Incorporated, a position he held since 2010. Dr. Bilinsky was previously Vice President, Business Development and Special Operations at Halozyme Therapeutics from 2008 to 2010, after joining Halozyme in 2007 as Executive Director, Corporate Development and Special Operations. From 2005 to 2007, Dr. Bilinsky was Chief Executive Officer of Androclus Therapeutics, a privately held biotechnology company developing novel therapeutics for autoimmune and inflammatory diseases. He joined Androclus in 2004 as Chief Operating Officer. From 1999 to 2004, Dr. Bilinsky served in positions of increasing responsibility as a management consultant, project leader and ultimately as principal in the healthcare practice of the Boston Consulting Group, where he advised companies in the biotechnology, pharmaceutical and life science industries on business strategy, operational performance and mergers and acquisitions. Prior to joining the Boston Consulting Group, Dr. Bilinsky worked in research positions at Symyx Technologies and the Massachusetts Institute of Technology (MIT) Lincoln Laboratory. Dr. Bilinsky received his B.S. degree in physics from the Moscow Institute of Physics and Technology and his Ph.D. degree in physics from MIT.

On September 17, 2015, Dr. Bilinsky will receive an inducement stock option award under Ignyta’s 2015 Employment Inducement Equity Incentive Award Plan, which was adopted July 17, 2015 and provides for the granting of equity awards to new employees of Ignyta. The inducement award to Dr. Bilinsky consists of an option to purchase an aggregate of 200,000 shares of Ignyta common stock. In addition, on September 15, 2015, Ignyta issued inducement awards to four other, non-executive employees under the 2015 Employment Inducement Equity Incentive Award Plan, consisting of options to purchase an aggregate of 130,500 shares of Ignyta common stock. Each of the options has a ten-year term and an exercise price equal to the closing price per share of Ignyta’s common stock on the Nasdaq Capital Market on the date of grant. The options vest over a four-year period, with 25% of the options vesting on the first anniversary of the date of hire and the remainder vesting in equal monthly installments over the three years thereafter. The awards were approved by the compensation committee of Ignyta’s board of directors and were granted as an inducement material to the optionees entering into employment with Ignyta in accordance with Nasdaq Marketplace Rule 5635(c)(4).

Ignyta Announces Initiation of Phase 1/1b Clinical Trial of RXDX-107

On September 17, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported the initiation of the company’s Phase 1/1b clinical trial of RXDX-107, its next generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles (Press release, Ignyta, SEP 17, 2015, View Source [SID:1234507491]). This multicenter, open-label, dose-escalation clinical trial is designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of RXDX-107 in adult patients with locally advanced or metastatic solid tumors.

"We are excited to be able to begin dosing patients with this product candidate at leading cancer centers in this clinical trial," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "RXDX-107 represents our third product candidate in the clinic, furthering our goal of attacking cancer on multiple fronts for the benefit of cancer patients. The speed with which we have been able to file an IND and bring this molecule into clinical development six months after acquisition from Teva is a testament to the Ignyta team’s strong execution."

About RXDX-107

RXDX-107 is a new chemical entity comprising an alkyl ester of bendamustine encapsulated in HSA to form nanoparticles. RXDX-107 is designed to have increased half-life and improved tissue biodistribution by leveraging the affinity characteristics of albumin for tumor cells, while retaining the unique cytotoxic properties of bendamustine. These improvements may provide meaningful benefit to patients with solid tumors. In preclinical pharmacology studies, RXDX-107 has demonstrated anti-tumor activity in multiple in vitro and in vivo studies, including cell line-based and patient-derived xenograft models of solid tumors.

8-K – Current report

On September 17, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and the Gynecologic Oncology Group (GOG, now part of NRG Oncology), reported clinical data from Stage 1 of an ongoing two-stage Phase 2 study (GOG-0265) of Advaxis’s lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy (Filing, 8-K, Advaxis, SEP 17, 2015, View Source [SID:1234507490]). The Stage 1 data showed that treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients.

Evaluation of safety data showed that Grade 1 or 2 adverse events occurred in 19 out of 26 patients (73 percent), with fatigue, chills and fever being the most common. Four patients (15 percent) experienced a Grade 3 adverse event (hypotension and cytokine release syndrome) and one patient (4 percent) experienced a Grade 4 adverse event (lung infection and sepsis). The results were presented at the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif. by Tom Herzog, M.D., Clinical Director at the University of Cincinnati Cancer Institute.

"Patients with PRmCC who have failed at least one line of therapy face a life threatening condition with an estimated survival of 4 to 7 months and no available treatment options," said Dr. Herzog. "The Stage 1 results for axalimogene filolisbac, which show 12-month survival, are a meaningful step forward in meeting the needs of women who require second-line treatment for PRmCC."

The GOG has conducted over 17 studies of a diverse set of investigational agents and regimens, but never has the 12-month overall survival rate exceeded 30 percent in people with PRmCC. Stage 2 of the GOG-0265 study is currently enrolling and the protocol has been amended by GOG to allow for continuous cycles of treatment until disease recurrence (the Stage 1 protocol provided for 3 doses of axalimogene filolisbac over 3 months).

"The axalimogene filolisbac data presented at AGOS by the GOG and Dr. Herzog represent some of the most encouraging Phase 2 data to date in metastatic cervical cancer and supports the results previously observed in Advaxis’s own Phase 2 study," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "Advaxis is grateful to NRG Oncology and the GOG for having the foresight several years ago to design, sponsor and conduct this study."

Advaxis has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3 study evaluating the safety and efficacy of axalimogene filolisbac in high-risk, locally advanced cervical cancer (HRLACC). The SPA review process remains ongoing. The planned Phase 3 trial will be conducted in collaboration with the GOG Foundation, Inc. and is intended to begin enrollment by the end of 2015, depending on the length of the FDA’s SPA review process.

A completed randomized Phase 2 trial of axalimogene filolisbac with or without cisplatin chemotherapy in Indian patients with PRmCC (0-2 prior lines of therapy) also demonstrated promising activity (12-month overall survival rate of 32 percent) and acceptable tolerability with chills and flu-like symptoms the most common treatment-related adverse events. Results from this trial were featured in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2014.

Business Update & Webcast

Advaxis will hold a business update conference call today, September 17, at 4:30 p.m. ET / 1:30 p.m. PT to provide Advaxis investors and stakeholders with a review of the Stage 1 clinical data from the GOG-0265 study presented at AGOS 2015. Dr. Herzog will be the featured presenter on the call.

A live broadcast of the conference call will be available by direct dial at 1-888-364-3109 in the U.S. or 1-719-325-2455 outside of the U.S.; Conference Passcode 2197270, or by live webcast available online at this URL: View Source

The call will be recorded and available for playback through October 1 by dialing 1-877-870-5176 in the U.S. and 1-858-384-5517 outside of the U.S.; Replay Passcode 2197270. In addition, the webcast will be available for replay at the URL above.

About the GOG-0265 Study

GOG-0265 is an open-label, single-arm, two-stage Phase 2 study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac in approximately 67 patients with PRmCC who have received at least one prior line of systemic therapy. The primary efficacy endpoint is 12-month overall survival rate, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The trial is being conducted in the United States by GOG, now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Further information about the study can be found on ClinicalTrials.gov, using Identifier NCT01266460.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.