Year: 2015

Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Ovarian Cancer

On February 11, 2015 Oncolytics Biotech reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of ovarian cancer (Press release Oncolytics Biotech, FEB 11, 2015, View Source [SID:1234501535]).

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"This is an important regulatory milestone for Oncolytics and will provide us with a number of benefits as we advance the development and commercialization process for REOLYSIN," said Dr. Brad Thompson, President and CEO of Oncolytics. "Ovarian cancer is a devastating disease that represents a significant unmet need, particularly for those patients diagnosed in later stages."

Oncolytics has supported two sponsored clinical studies assessing REOLYSIN in the treatment of ovarian cancer. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of REOLYSIN that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

Advaxis Forms Clinical Trial Collaboration With Incyte to Evaluate Investigational Combination of Two Novel Cancer Immunotherapies for Early Stage Cervical Cancer

On February 11, 2015 Advaxis reported that it has entered into a clinical trial collaboration agreement with Incyte to evaluate the combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-HPV (ADXS11-001), with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360) (Press release Advaxis, FEB 11, 2015, View Source [SID:1234501537]). The Phase 2 multicenter, open-label, preoperative window-study will evaluate the safety and efficacy of ADXS-HPV as a monotherapy and in combination with epacadostat in approximately 20 patients with Stage I-IIa human papillomavirus (HPV)-associated cervical cancer.

Both ADXS-HPV and epacadostat are investigational cancer immunotherapies, a new class of treatments that use the body’s own immune system to help fight cancer.

“We are excited to collaborate with Incyte and to evaluate epacadostat in combination with our leading Lm-LLO immunotherapy candidate, ADXS-HPV,” said Daniel J. O’Connor, Chief Executive Officer of Advaxis. “In previous and ongoing studies, a single treatment cycle of ADXS-HPV, as a monotherapy, has demonstrated improvements in overall survival in women with recurrent cervical cancer. We believe the combination of immunotherapies may hold significant promise for the treatment of this difficult-to-treat disease.”

Under the terms of the agreement, Advaxis and Incyte will collaborate on a non-exclusive basis to evaluate the combination of ADXS-HPV with epacadostat for the treatment of cervical cancer. The companies will collaboratively conduct and fund the study, which is expected to begin later this year. Results from the study will be used to determine whether further clinical development of this combination is warranted. Further details of the agreement were not disclosed.

“We believe immune-targeted combination therapy represents a promising new approach in oncology,” said Rich Levy, MD, Chief Drug Development and Medical Officer at Incyte. “This clinical trial collaboration is a further illustration of our desire to investigate the therapeutic value of our IDO1 inhibitor in multiple tumor types as rapidly as possible.”

Takeda Announces That the First Interim Analysis of the Phase 3 Study of Oral Ixazomib in Patients with Relapsed or Refractory Multiple Myeloma Met the Primary Endpoint of Improvement in Progression-Free Survival

On February 10, 2015 Takeda Pharmaceutical Company reported that the randomized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase 3 trial evaluating the safety and efficacy of ixazomib, the first oral proteasome inhibitor, conducted in patients with relapsed or refractory multiple myeloma (MM) achieved its primary endpoint of improving progression-
free survival at the first pre-specified interim analysis (Press release Takeda, FEB 10, 2015, View Source [SID:1234501527]). In the trial, patients treated with investigational ixazomib plus lenalidomide and dexamethasone lived without their disease worsening for a significantly longer time compared to patients who received placebo plus lenalidomide/dexamethasone.

Efficacy and safety data were reviewed by an Independent Data Monitoring Committee (IDMC). Takeda intends to submit these data to health authorities globally for marketing authorizations.

“We are very pleased with the outcome of this interim analysis of the pivotal trial, and are excited about the potential that investigational ixazomib holds for patients with multiple myeloma,” said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Clinical Research,Takeda. “We thank the patients and investigators for their engagement and continued participation in this ongoing clinical evaluation of ixazomib.”

10-Q – Quarterly report [Sections 13 or 15(d)]

CellCeutix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , CellCeutix, FEB 9, 2015, View Source [SID1234501516]).

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Company to Partner with Phyton Biotech for Manufacture of the Key Ingredient in Mipsagargin

On February 9, 2015 GenSpera, Inc. (OTCQB: GNSZ) reported a strategic partnership with Phyton Biotech for the manufacture of thapsigargin, which is derived from the thapsia plant and is the key ingredient in the company’s investigational agent mipsagargin (Press release, GenSpera, FEB 9, 2015, View Source [SID:1234508845]). Phyton Biotech will offer its Plant Cell Fermentation (PCF) development expertise to convert the thapsia plant into a preserved, fermentable cell line with a goal of creating a sustainable source of high quality thapsigargin.

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"This partnership will revolutionize the way we obtain thapsigargin to develop our drugs, enabling us to boost supply and reduce the impurities that can arise when it is extracted from naturally grown plants," said Craig Dionne, Ph.D., chief executive officer at GenSpera. "By working with Phyton Biotech, we are leveraging state-of-the-art biotech that has the potential to improve the efficiency of our production process. It is through these kinds of partnerships that we can not only develop new drug candidates, but do so in a way that creates increased product value."

The announcement comes as GenSpera enters a stage of continued development of mipsagargin in hepatocellular carcinoma (HCC) and ongoing trials in glioblastoma (brain cancer) and prostate cancer. This week, GenSpera will present its long-term business growth plans at the BIO CEO & Investor conference being held in New York City. Last month, GenSpera presented positive Phase II study results for mipsagargin in treating HCC at the 2015 Gastrointestinal Cancers Symposium in San Francisco, Calif., demonstrating a proof of concept for its intellectual property.

"Working with an innovative partner like GenSpera, who is committed to developing new treatment options and doing so in a way that maximizes efficiency and quality, is exciting," said Mark Mitchell, president at Phyton Biotech. "Phyton has a proven track record for commercial supply of active pharmaceutical ingredients in the field of oncology using its PCF process. We share GenSpera’s vision of harnessing the power of the thapsia plant and expanding their capacity with the best biotech."