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Oncolytics Biotech® Inc. Announces FDA Fast Track Designation for REOLYSIN® in Metastatic Breast Cancer

On May 8, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported that the United States Food and Drug Administration (FDA) has granted Fast Track designation for REOLYSIN, the Company’s proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer (Press release, Oncolytics Biotech, MAY 8, 2017, View Source [SID1234518954]).

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"Fast Track designation represents an important step for our clinical development plan, which is squarely focused on a registration pathway in metastatic breast cancer and advancing REOLYSIN to regulatory review as quickly as possible," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Our goal is to conduct an End-of-Phase 2 meeting with the FDA as soon as is practical and obtain scientific guidance. We are eager to leverage this designation and use the opportunity for more frequent dialogue with the FDA, as well as the potential for an expedited review process, to support the future development of REOLYSIN."

In April 2017, data from an open-label, randomized, phase 2 study assessing the therapeutic combination of intravenously-administered REOLYSIN given in combination with the chemotherapy agent paclitaxel versus paclitaxel alone, in patients with advanced or metastatic breast cancer (IND 213) was presented at the American Association of Cancer Research Annual Meeting. The combined treatment demonstrated a statistically significant increase in median overall survival. Based on Oncolytics’ evolving understanding of REOLYSIN’s mechanism of action, along with the positive overall survival data generated to date, the Company is pursuing metastatic breast cancer as its primary focus for late-stage clinical testing.

The FDA’s Fast Track process is designed to facilitate the development, and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Fast Track designation supports more frequent dialogue with the FDA on a company’s drug development plan, data requirements and clinical trial design. It also, in certain situations, enables the FDA to take action on a new drug or biologics license application more rapidly than under the standard review process.

Novartis receives FDA approval for first-of-its-kind Kisqali® Femara® Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer

On May 8, 2017 Novartis reported that the US Food and Drug Administration (FDA) has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women1 (Press release, Novartis, MAY 8, 2017, View Source [SID1234518952]). The Kisqali Femara Co-Pack is the first, and only currently available, combination pack with two prescription products in advanced breast cancer.

With this FDA approval, physicians in the United States now have the flexibility to prescribe Kisqali two different ways: via the new Co-Pack or as two separate prescriptions of Kisqali and any aromatase inhibitor.

"As we strive to keep the patient at the center of every decision that we make at Novartis, we are pleased that collaborating closely with the FDA has resulted in our being able to offer this unique combination pack of two prescription cancer medicines," said Bill Hinshaw, Executive Vice President and Head, US, Novartis Oncology. "Providing physicians a convenient one package prescribing option for their patients underscores our commitment to deliver innovative treatment solutions to the metastatic breast cancer community."

The innovative packaging of the Kisqali Femara Co-Pack allows patients the convenience of obtaining a full 28-day cycle of the two medicines in one package with one prescription and one co-pay. The Kisqali Femara Co-Pack is available at the same cost as Kisqali alone.

The Kisqali Femara Co-Pack is available in three dosage strengths: Kisqali 600 mg plus Femara 2.5 mg, Kisqali 400 mg plus Femara 2.5 mg, and Kisqali 200 mg plus Femara 2.5 mg. The Kisqali Femara Co-Pack will be available in the US later this month at both specialty and retail pharmacies, and does not change the indication for either medicine.

Kisqali was approved on March 13, 2017 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer2. Femara is an aromatase inhibitor approved for first-line treatment of postmenopausal women with HR+ or unknown advanced breast cancer3. Developed by Novartis, Femara has been a standard of care option for more than a decade in early and advanced breast cancer.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About Femara (letrozole)
Femara (letrozole) is a form of hormone therapy known as an aromatase inhibitor, which works by reducing the amount of estrogen produced in the bodies of postmenopausal women. Femara was first approved in 1997 for treatment of postmenopausal women with HR+ or unknown advanced breast cancer that progressed after antiestrogen therapy. In 2001, Femara was approved as first-line treatment of postmenopausal women with HR+ or unknown locally advanced or metastatic breast cancer.

Femara has been available for nearly 20 years and research by Novartis has continued during this time.

Kisqali (ribociclib) and Femara (letrozole) Important Safety Information
Kisqali (ribociclib) is a prescription medicine used in combination with an aromatase inhibitor as the first hormonal-based therapy to treat women who have gone through menopause with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) is a prescription medicine used as the first hormonal based therapy to treat women who have gone through menopause with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. The Kisqali Femara Co-Pack contains 2 different types of medicines: Kisqali and Femara. It is not known if Kisqali or the Kisqali Femara Co-Pack is safe and effective in children. Kisqali or the Kisqali Femara Co-Pack can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. Kisqali or the Kisqali Femara Co-Pack can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking Kisqali or the Kisqali Femara Co-Pack and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking Kisqali or the Kisqali Femara Co-Pack, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali or the Kisqali Femara Co-Pack can harm an unborn baby. Females who are able to become pregnant and who take Kisqali or the Kisqali Femara Co-Pack should use effective birth control during treatment and for at least 3 weeks after the last dose. Do not breastfeed during treatment with Kisqali or the Kisqali Femara Co-Pack and for at least 3 weeks after the last dose. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking Kisqali or the Kisqali Femara Co-Pack. The most common side effects (incidence ≥20%) of Kisqali + letrozole are white blood cell count decreases, nausea, tiredness, diarrhea, hair thinning or hair loss, vomiting, constipation, headache, and back pain. The most common grade 3/4 side effects in the Kisqali + letrozole arm (incidence >2%) were low neutrophils, low leukocytes, abnormal liver function tests, low lymphocytes, and vomiting. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

Please see full Prescribing Information for the Kisqali Femara Co-Pack, available at View Source

About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific advancements for breast cancer patients and improving clinical practice in collaboration with the global community. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.

Mateon Provides Corporate Update and Reports First Quarter 2017 Financial Results

On May 8, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the three months ended March 31, 2017 (Press release, Mateon Therapeutics, MAY 8, 2017, View Source [SID1234518924]).

Recent Corporate Highlights

•Announced results of the first interim analysis from the phase 2/3 FOCUS Study of CA4P in platinum-resistant ovarian cancer.

Two of nine (22%) patients treated with CA4P had partial responses compared to one of eleven (9%) in the control arm. The magnitude of the responses was larger for patients treated with CA4P, with reductions of approximately 76% and 64% in lesion size compared to a reduction of 46% for the patient receiving control.
No significant safety issues were identified in the interim analysis.
•Expect results from the second interim analysis (n=40) of the FOCUS Study in August 2017.

•Presented data from phase 2 monotherapy study in neuroendocrine tumors (NETs) and announced initiation of an investigator-sponsored phase 1 clinical trial in NETs using CA4P in combination with everolimus (AFINITOR).

•Announced data from the third cohort of phase 1b study of OXi4503 in patients with relapsed/refractory acute myeloid leukemia (AML), showing that one patient (25%) in the cohort had a complete remission and two other patients demonstrated evidence of AML blast reduction following one cycle.

"I am excited about the progress we are making in both our CA4P and OXi4503 clinical development programs, including initial indications of efficacy for each of these investigational drugs," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "Our pipeline is advancing well, and we remain confident in the significant prospects for these promising product candidates. Additional clinical data read-outs are planned for each of these investigational drugs over the balance of 2017, and we look forward to receiving and announcing these results."

Financial Results for the First Quarter of 2017

For the three months ended March 31, 2017, Mateon reported a net loss of $4.0 million, compared to a net loss of $3.3 million for the three months ended March 31, 2016. Research and development expenses increased to $2.8 million for the three months ended March 31, 2017 compared to $2.0 million for the three months ended March 31, 2016, primarily due to costs associated with the ongoing clinical trials. General and administrative expenses decreased to $1.1 million for the three months ended March 31, 2017 compared to $1.4 million for the three months ended March 31, 2016.

At March 31, 2017, Mateon had cash and short-term investments of $8.3 million.

Rasna Therapeutics, Inc. Advances Development of a Novel Treatment for NPM1-mutated Acute Myeloid Leukemia

On May 8, 2017 Rasna Therapeutics, Inc. (OTCQX: RASP), a clinical stage biotechnology company focused on the development of disease-modifying drugs for hematological malignancies, reported an update from further studies towards the development of formulated RASP-101, a novel modality for treatment of NPM1-mutated acute myeloid leukemia (AML) (Press release, Rasna Therapeutics, MAY 8, 2017, View Source [SID1234518920]).

NPM1-mutated AML is a specific genetic variation of leukemia that accounts for approximately one third cases of AML in adults. A phase II clinical trial which was initiated in 2014 and completed in two and a half years, involved patients with refractory or relapsed NPM1-mutated AML treated with cycles of dactinomycin at a dose of 15µg per kilogram per day for 5 consecutive days (EudraCT number 2014-000693-18). As earlier published, intravenous treatment of refractory or relapsed AML patients with dactinomycin (12.5µg or 15µg per day) for 5 consecutive days had produced hematological complete response in specific patients (Falini et al., N Eng J Med. 373: 12, 2015).

"We are pleased to report an update to these initial promising findings, which are now corroborated by the follow up of a phase II clinical study which achieved complete response in 40% of patients. Although further studies are warranted to understand the mechanism of action of dactinomycin in NPM1-mutated AML, we are delighted to move forward with development of a formulated RASP-101 for treatment of AML patients," said Dr. Brunangelo Falini, a member of the scientific advisory board of Rasna Therapeutics, Inc.

"We believe that our approach is a breakthrough and a first-in-class treatment for AML patients. We are determined to rapidly develop formulation of RASP-101 to enable multi-center clinical studies in NPM1-mutated AML. Patient stratification, based on specific AML gene mutations, is part of Rasna’s strategy to improve clinical outcome for this unmet clinical need," commented Alessandro Padova, Chairman of Rasna.

Kite Reports First Quarter Financial Results

On May 8, 2017 Kite Pharma, Inc. (NASDAQ:KITE), a cell therapy company, reported first quarter 2017 financial results and provided a corporate update for the period ended March 31, 2017 (Press release, Kite Pharma, MAY 8, 2017, View Source [SID1234518912]).

"Kite is intensely focused on bringing axicabtagene ciloleucel to market in 2017. Our preparation for the potential commercialization of the first CAR-T therapy in aggressive non-Hodgkin lymphoma began two years ago. With the team and infrastructure we now have in place, we are confident in our readiness to deliver upon potential approval in the U.S. and expect to file for approval in Europe in the third quarter of this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We are also keeping an eye toward future growth with additional indications across the KTE-C19 program and development of earlier stage product candidates, including KITE-585, which we believe has the potential to become the next significant opportunity for Kite."

First Quarter 2017 Financial Results

Revenues were $9.8 million for the first quarter of 2017.
Research and development expenses were $65.9 million for the first quarter of 2017, which includes $12.7 million of non-cash stock-based compensation expense.
General and administrative expenses were $35.8 million for the first quarter of 2017, which includes $11.4 million of non-cash stock-based compensation expense.
Net loss was $90.4 million, or $1.74 per share, for the first quarter of 2017.
Non-GAAP net loss for the first quarter of 2017 was $66.3 million, or $1.28 per share, excluding non-cash stock-based compensation expense of $24.1 million.
As of March 31, 2017, Kite had $804.0 million in cash, cash equivalents, and marketable securities. A public offering of common stock generated approximately $409.7 million in gross proceeds to Kite. In addition, Kite received a $50 million upfront payment related to its strategic collaboration with Daiichi Sankyo.
2017 Financial Guidance

Kite continues to expect the full year 2017 net cash burn to be between $325 million and $340 million. This guidance assumes GAAP operating expenses to be between $490 million and $515 million, which includes approximately $135 million in non-cash stock based compensation expense. Kite expects 2017 total operating expenses to consist of approximately 60 percent Research and Development and approximately 40 percent General and Administrative.
First Quarter 2017 and Recent Highlights

Axicabtagene Ciloleucel/KTE-C19 Progress

Presented positive topline results from the primary analysis of the ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive non-Hodgkin lymphoma (NHL) at the 2017 American Association of Cancer Research annual meeting. Data included the 99 percent success rate in the manufacturing of clinical product patient dose from a single apheresis for the multi-center ZUMA-1 clinical trial.
Completed the submission of a Biologics License Application (BLA) to the FDA for axicabtagene ciloleucel in patients with aggressive NHL.
Initiated ZUMA-5 study of axicabtagene ciloleucel in patients with follicular NHL.
Initiated ZUMA-9 study to provide patients access to axicabtagene ciloleucel during the regulatory review period.
Strategic Collaborations

Entered a strategic collaboration with Daiichi Sankyo to develop and commercialize axicabtagene ciloleucel in Japan.
Established a joint venture with Fosun Pharma to develop and commercialize T-cell therapies, including axicabtagene ciloleucel, in China.
Pipeline Expansion

Cleared an investigational new drug (IND) application for KITE-718, a T cell receptor (TCR) cell therapy candidate that targets MAGE-A3/A6 antigens expressed on solid tumors.
Commercial Preparation

Started recruitment and training of cell therapy account managers to support customer service and logistical coordination.
Additional 2017 Clinical Milestones

KTE-C19 and axicabtagene ciloleucel

Submit marketing authorization application (MAA) to the European Medicines Authority (EMA) for axicabtagene ciloleucel in aggressive NHL in the third quarter of 2017.
Availability of preliminary 12-month follow-up data from ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive NHL.
Availability of preliminary follow-up Phase 1 data from ZUMA-3 and ZUMA-4 studies of pediatric and adult acute lymphoblastic leukemia, respectively.
Advance ZUMA-3 and ZUMA-4 studies into Phase 2.
Availability of preliminary data from ZUMA-6 combination study of axicabtagene ciloleucel and atezolizumab PD-L1 checkpoint inhibitor in aggressive NHL.
Cell Therapy Pipeline

Initiate Phase 1 study of KITE-718 in patients with solid tumors in the second quarter of 2017.
File IND for KITE-585, a CAR T cell therapy candidate that targets BCMA for the treatment of multiple myeloma, in the third quarter of 2017.