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THOUSAND OAKS, Calif. and PRINCETON, N.J., Aug. 2, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Advaxis, Inc. (NASDAQ:ADXS) today announced a global agreement for the development and commercialization of Advaxis' ADXS-NEO, a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor. This collaboration brings together Amgen's development expertise in immuno-oncology with Advaxis' MINE™ (My Immunotherapy Neo-Epitopes) program, which is uniquely positioned to develop a customized approach to cancer treatment.

Under the terms of the agreement, Amgen receives exclusive worldwide rights to develop and commercialize ADXS-NEO. Amgen will make an upfront payment to Advaxis of $40 million and purchase $25 million of Advaxis common stock. Amgen will be fully responsible for funding clinical and commercial activities. Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept, retain manufacturing responsibilities, and receive development, regulatory and sales milestone payments of up to $475 million and potential high single digit to mid-double digit royalty payments based on worldwide sales.

"Amgen's collaboration with Advaxis leverages and enhances our development and commercialization expertise in novel immuno-oncology treatments," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to partnering with Advaxis to advance this highly targeted and patient-specific treatment option for patients."

"Amgen is a pioneer in the science of using living cells to develop biologic medicines, making them an incredibly strong partner to develop and commercialize Advaxis' MINE," said Daniel J. O'Connor, president and chief executive officer at Advaxis. "With Amgen's resources, worldwide reach and a culture that embraces science and innovation, we are positioned to accelerate the clinical development program for ADXS-NEO to improve the lives of those who suffer from cancer."

The Advaxis Lm Technology™ utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins within antigen presenting cells with the goal of generating strong, T-cell-mediated immunity. For ADXS-NEO, DNA from each patient's primary tumor and/or metastases as well as normal cells, is sequenced and compared to identify mutations in genes coding for potential neo-antigens in the cancer. Advaxis then engineers and manufactures patient-specific Lm-LLO (listeriolysin O) vectors capable of immunizing them against neoepitopes exclusive to their cancer. After the ADXS-NEO infusion, neoepitope peptides corresponding to each patient's cancer-associated mutations are delivered directly into their antigen presenting cells by Lm-LLO, where they can stimulate cellular immune responses against multiple neoepitopes simultaneously. Clinical trials for ADXS-NEO are expected to begin in 2017.

About MINE™ (My Immunotherapy Neo-Epitopes) / ADXS-NEO
MINE™ (My Immunotherapy Neo-Epitopes) and ADXS-NEO are designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in each individual patient's tumor. This strategy, using massive parallel sequencing, eliminates the need for predictive algorithms and enables the development of truly personalized immunotherapies that can be manufactured in a manner that is cost-effective and timely for patients.

MINE™ will evaluate the immunologic and anti-tumor activity of this patient tumor-specific, neoepitope-based immunotherapy. Advaxis and Amgen will use learnings from MINE to identify and target neoepitopes using Lm Technology™ and later develop patient specific immunotherapy constructs that incorporate the neoepitope sequences identified in the patient's tumor cells. Clinical studies using ADXS-NEO are in development.

Conference Call and Webcast
Advaxis will host a conference call today, Aug. 2, 2016, beginning at 9:30 a.m. ET. Please see below for details.

Conference call numbers:
Domestic/Canada: 888-466-4442
International: 719-325-2480
Conference ID: 2246109
Webcast: http://public.viavid.com/index.php?id=120644

Accessible via the Investor Relations section of Advaxis' website: http://ir.advaxis.com/

A replay of the conference call and webcast will be available beginning approximately one hour after the completion of the call. Access numbers for this replay are 1 (877) 870-5176 (U.S./Canada) and 1 (858) 384-5517 (international); conference ID: 2246109.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit Amgen and follow us on www.twitter.com/amgen.

About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer-fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology™ immunotherapy, axalimogene filolisbac (AXAL), targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation for each of these three clinical settings, as well as a Special Protocol Assessment for the Phase 3 AIM2CERV trial in patients with high risk, locally advanced cervical cancer. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency's Committee for Advanced Therapies. Advaxis has two additional immunotherapy products in human clinical development: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2-expressing solid tumors. Advaxis has received Fast Track Designation for ADXS-HER2 for the treatment of patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma and for AXAL for the treatment of high-risk locally advanced cervical cancer.



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Allegati

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Advaxis has had a bumpy road bringing its Listeria-based immunotherapy to the clinic, with some successes and failures in recent years.

Recently, its lead candidate axalimogene filolisbac received fast track designation, qualifying it for rolling review with the FDA.

Advaxis also initiated a partnership with Amgen to develop its neo-epitope platform, which will provide further funds needed to push a treatment to market.

The neo-epitope platform is perhaps the most precise treatment for cancer that I have encountered, which is potentially good or bad for its efficacy, as I discuss below.

Advaxis (NASDAQ:ADXS) has shown us a lot of promise over the years, with a lot of exciting research coming out for its programs in osteosarcoma, as I've written about previously. Its lead platform, modified Listeria monocytogenes designed to activate the immune system against tumors, has faced clinical holds due to adverse events, and its competitor Aduro Biotech experienced a setback in pancreatic cancer earlier this year, though I argued that this might not be the most damning news for the platform.

Now, 2016 is shaping up to be a big year for ADXS. This is on the heels of two huge pieces of news for the company that have already led to large gains in total valuation.

Cervical cancer development reaching its climax

Just last month, the company announced that its most clinically advanced therapy, axalimogene filolisbac (AXAL), received the FDA's fast track designation.

The news comes as quite welcome, though a little unsurprising since AXAL previously received orphan designation, and ADXS worked with the FDA to develop a special protocol assessment (SPA), which essentially establishes the clinical trial design the FDA will want to see in order to allow for approval of a new drug.

The pivotal trial for AXAL is called AIM2CERV, recruiting patients from 20 different countries. These patients have locally advanced cervical cancer, and they will receive chemotherapy and radiation before being randomized to placebo or AXAL in order to determine if disease-free survival is improved with this therapy.
 
news:

AXAL meets stage 1 primary objective, demonstrates increased systemic HPV-reactive T-cell responses


Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that its Phase 2 “window of opportunity” clinical study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with late-stage HPV-associated oropharyngeal cancer (HPVOPC) met its stage 1 primary objective and is advancing into the second stage of the clinical study.
This is an investigator-initiated prospective clinical study of patients with stage I-IV HPVOPC who are to undergo ablative trans-oral robotic surgery (TORS) as a preoperative treatment. The clinical study leverages the five- to six-week period between diagnosis and TORS, making it possible to analyze and compare the tumor microenvironment as well as peripheral blood samples collected before and after AXAL treatments.

The clinical study is designed to show that AXAL is highly immunogenic and worth further investigation if the overall rate of vaccine-induced T-cell responses is 75 percent or more. By looking at both IFN-γ and TNFα expressing T cells in the peripheral blood, it was found that systemic HPV-reactive T-cell responses were increased in enough patients treated with AXAL to meet the stage 1 immune response target. This evidence of systemic response is consistent with a recent abstract presented at the American Association for Cancer Research (AACR) describing increased cytotoxic T-cell infiltration into the tumor microenvironment in HPVOPC patients treated with AXAL.

“The assessment of the TNFα and IFN-γ response based on data from eight of the anticipated nine patients to be enrolled in stage 1 confirmed that the clinical study has already met the target for the overall rate of vaccine-induced T-cell response, paving the way for us to progress to stage 2,” said the study’s lead investigator Andrew G. Sikora, MD, PhD, of the Bobby R. Alford Department of Otolaryngology-Head and Neck Surgery at Baylor College of Medicine. “Together with our prior published data showing increased intratumoral T-cell infiltration in a significant number of AXAL treated patients, these data provide the confidence needed to move forward with the definitive evaluation of its immunogenicity.”

Stage 2 of the clinical study will enroll up to 13 patients with late-stage HPVOPC. This stage of the clinical study will be conducted at the Icahn School of Medicine at Mount Sinai and a second investigative site anticipated to be the Baylor College of Medicine. The study received a three-year $1.1 million grant from the U.S. Food and Drug Administration’s Office of Orphan Products Development, which funds research for the development of products for rare diseases.

HPV-Associated Head and Neck Cancers

More than 90 percent of head and neck squamous cell oropharyngeal cancers originate from the mucosal linings of the oral cavity, pharynx or larynx. Currently, 60 to 80 percent of these cancers are caused by HPV. Head and neck cancers are treated by surgical removal of the cancer and lymph nodes, often followed by radiation and chemotherapy based on the extent of the disease. While patients may achieve good long-term survival, standard treatments can change their physical appearance and are associated with significant short and long-term toxicities which may interfere with salivary gland function, taste, smell, and the ability to swallow.

The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the World Health Organization, approximately 15 to 20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the U.S.

About Axalimogene Filolisbac

AXAL is Advaxis' 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. AXAL has Orphan Drug Designation in the U.S. for the treatment of these three indications. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, AXAL 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.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology™ immunotherapy, AXAL, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation for each of these three clinical settings, as well as a Special Protocol Assessment for the Phase 3 AIM2CERV trial in patients with high risk, locally advanced cervical cancer. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency's Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.
 
$11.24
Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, will unveil its new state-of-the-art manufacturing facility in Princeton, N.J., with remarks from Governor Chris Christie, BioNJ President and CEO Debbie Hart and Advaxis CEO Daniel O’Connor. The facility enables Advaxis to manufacture clinical-grade immuno-oncology product candidates for hundreds of patients enrolled in several trials for multiple cancer types, as well as the capability to manufacture commercial-grade products in the future, including personalized cancer treatments that are being developed as part of its MINE™ (My Immunotherapy Neo-Epitopes) program.

WHERE: Advaxis, Inc.
305 College Road
East Princeton, NJ 08540
Register here

WHEN: Friday, September 9, 2016 – 11 a.m. EDT

WHY:


Developing immunotherapies that capitalize on the body’s ability to recognize and attack bacterial infections, using the core Lm Technology™ is Advaxis’ number one priority in helping patients. This facility allows Advaxis to manufacture these immunotherapies efficiently and cost-effectively in-house, while nearly doubling the company’s corporate footprint to 48,511 sq. ft. As an epicenter of innovation, the team is proud to continue growing our New Jersey headquarters.

WHO: Advaxis welcomes New Jersey Gov. Christopher J. Christie and other distinguished guests to attend the unveiling, as they celebrate this important corporate milestone.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, AXAL, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted AXAL orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency's Committee for Advanced Therapies. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.

For additional information on Advaxis, visit Home - Advaxis and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.
 
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