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.

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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.

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"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.

On September 16, 2015 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, reported new preclinical data that showed cancer immunotherapy with intratumoral injections of IMO-2125 alone and in combination with ipilimumab demonstrated potent and systemic anti-tumor activity in preclinical cancer models (Press release, Idera Pharmaceuticals, SEP 16, 2015, View Source;p=RssLanding&cat=news&id=2088264 [SID:1234507478]). IMO-2125 is a synthetic oligonucleotide-based agonist of Toll-like receptor 9 discovered and developed by Idera. Ipilimumab is a checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Additionally, Idera presented preclinical data which demonstrated that IMO-2125 induces a systemic antitumor immune response with the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors. These data are being presented at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in New York City, beginning today.

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"The body of preclinical data that we have assembled further illustrates the potential of intratumoral IMO-2125 to play an important role in the emerging field of cancer immunotherapy," stated Sudhir Agrawal, D.Phil., President of Research at Idera Pharmaceuticals. "We are looking forward to advancing this approach into clinical development with our first study and exploring additional clinical studies with intratumoral IMO-2125 in other tumor types and with other checkpoint inhibitor combination regimens."

In the presentation, entitled "Intratumoral administration of IMO-2125, a novel TLR9 agonist, modulates the tumor microenvironment and exerts systemic antitumor activity alone and in combination with an anti-CTLA4 monoclonal antibody (mAb)," Idera scientists presented data suggesting that intratumoral IMO-2125 monotherapy led to dose-dependent decreases in treated and distant tumor volume, an increase in infiltrating CD8+ T cells and specific cytotoxic T cell responses against tumor antigens. Combination of intratumoral IMO-2125 and an anti-CTLA4 mAb showed improved inhibition of tumor growth, regression of systemic lung metastases and infiltration of TILs versus monotherapy with either agent. Collectively, these data demonstrate the potent antitumor activity of IMO-2125, a novel immunostimulatory TLR9 agonist, alone and in combination with a checkpoint inhibitor.

Idera expects to initiate the first clinical study of intratumoral IMO-2125 in combination with ipilimumab in patients with metastatic melanoma in the fourth quarter of this year as part of the previously announced clinical research alliance with MD Anderson Cancer Center.

In the presentation, entitled "Modulation of checkpoint expression in tumor microenvironment by intratumoral administration of a novel TLR9 agonist: Rationale for combination therapy," Idera scientists presented data suggesting that intratumoral IMO-2125 treatment led to antitumor activity in preclinical tumor models of lymphoma, colon carcinoma and melanoma. Specifically, intratumoral IMO-2125 treatment resulted in changes in the tumor microenvironment in both treated and distant tumors, as demonstrated by modulation of immune checkpoint gene expression. These data showed that intratumoral IMO-2125 has the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors.

These presentations are both currently available on Idera’s website at View Source

Additionally, Idera announced that pre-clinical data relating to the combination of intratumoral IMO-2125 and an anti-PD-1 mAb in a murine colon carcinoma model will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston from November 5-9th.

About Toll-like Receptors and Idera’s Immuno-Oncology Research Program

Toll-like receptors (TLRs) are believed to play a central role in the innate immune system, the body’s first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intratumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs); and potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.

Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company’s proprietary chemistry-based discovery platform. IMO-2125 has been shown to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data from these studies to be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in November in Boston.

On September 16, 2015 Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally-driven diseases, reported the appointment of Lisa Taylor as Senior Vice President, Commercial Development (Press release, Tokai Pharmaceuticals, SEP 16, 2015, View Source;p=RssLanding&cat=news&id=2088218 [SID:1234507479]). Ms. Taylor brings over two decades of experience in biopharmaceutical marketing, and was a member of the launch team for Xtandi (enzalutamide) at Medivation, Inc.

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At Tokai, Lisa will lead commercial preparedness for the launch of galeterone, a potential first-in-class Androgen Receptor Degrader. Tokai has commenced screening patients for the presence of the AR-V7 splice variant for enrollment in ARMOR3-SV, the company’s pivotal Phase 3 clinical trial of galeterone in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant. Top-line data from ARMOR3-SV are expected by the end of 2016.

"Lisa is an astute commercial strategist with deep expertise in prostate cancer, and we are thrilled to have her join Tokai’s management team," said Jodie Morrison, President and Chief Executive Officer of Tokai. "As we look ahead to results from our pivotal trial in late 2016 and prepare to commercialize galeterone, Lisa’s expertise and leadership will be critical to our successful delivery of this important therapeutic advance for men living with certain forms of advanced prostate cancer."

Most recently prior to joining Tokai, Ms. Taylor was the Principal and Founder of Packers Falls Group, Inc., a healthcare consulting firm that conducted commercial assessments and provided marketing and strategy consulting to biopharmaceutical companies. She previously served as Vice President, Commercial Development at Medivation, Inc., where she was the company’s first commercially-focused employee and subsequently served on the Xtandi (enzalutamide) launch team. Ms. Taylor began her career in strategy consulting at Booz, Allen and Hamilton and has held a number of strategic planning and marketing roles with in vitro diagnostic and medical device manufacturers. She is also an active patient advocate, serving on the Gynecologic Cancer Steering Committee’s Uterine Task Force at the National Cancer Institute and on the Developmental Therapeutics Committee of the Gynecologic Oncology Group.

"It is an honor to be joining Tokai at such an exciting time in the company’s growth," Ms. Taylor said. "We are developing a commercial strategy that builds from our differentiation as an Androgen Receptor Degrader with the potential to overcome the limitations seen with second-generation hormone therapies currently approved for CRPC. I look forward to applying my expertise in building a world-class commercial organization capable of effectively delivering galeterone to patients."

On September 17, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its consolidated financial results for the first half of 2015 (Press release, Innate Pharma, SEP 16, 2015, View Source [SID:1234507481]).

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Hervé Brailly, Chief Executive Officer of Innate Pharma, commented: "This first half of 2015 marked a major milestone in Innate Pharma’s corporate development with the signature of a landmark co-development and commercialization agreement in April with AstraZeneca to broaden and accelerate the development of IPH2201.

This agreement is a major step towards our corporate goal of further maturing the Company and developing capabilities in late stage development and potential commercial stage by keeping some co-development and co-promotion rights.

In the second half of 2015, additional Phase II clinical trials for IPH2201 will be opened and IPH4102 will start a multi-centric Phase I trial, becoming our third first-in-class, clinical-stage asset. With our increased financial flexibility, we are intensifying our efforts in R&D to enrich our pipeline of first-in-class proprietary antibodies.

As important new clinical data on lirilumab is generated, Innate Pharma is on track to leverage its unique positioning in the very promising area of immuno-oncology."