On July 12, 2016 Amgen (NASDAQ:AMGN) reported that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee (Press release, Amgen, JUL 12, 2016, View Source;p=RssLanding&cat=news&id=2184704 [SID:1234513830]). ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

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During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.

"As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today, we’re looking forward to discussing the efficacy, safety and immunogenicity profile of ABP 501, Amgen’s first prospective biosimilar, with the FDA advisory committee. If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management."

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.

About ABP 501

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

On July 12, 2016 ONCODESIGN (ALONC – FR0011766229), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, reported the official launch of a clinical study focusing on the evaluation of its first radiotracer in humans, as part of the IMAkinib project conducted jointly with Cyclopharma and the study sponsor, the Cancer Centre Georges-François Leclerc (CGFL) in Dijon (Press release, Oncodesign, JUL 12, 2016, View Source [SID:1234513845]).

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The objective of this radiotracer (ODS2004436) is to measure increased EGFR1 kinase activity during the development of a tumour, to select the treatment best suited to individual patients and to detect the emergence of any resistance early on. The radiotracer will be visualised by PET (Positron Emission Tomography), a standard nuclear imaging technique used for clinical diagnosis.

Mutations activating EGFR kinase are responsible for non-small cell lung adenocarcinoma, which accounts for 10 to 15% of lung cancers and affects 6,000 patients each year in France alone.

The clinical study, authorised by the French National Agency for Medicines and Health Products ANSM, is now ready to begin at the CGFL Cancer Centre, which has been granted the CLIP designation2 to conduct early-stage clinical trials. The first patient with lung cancer will be recruited within the next few weeks in the medical oncology department of the CGFL Cancer Centre in Dijon (Dr. Isambert, Head of the early-stage unit).

The objective of this phase 0/1 is to demonstrate the sensitivity and specificity of the radiotracer in human lung tumours. The clinical study will include 3 successive stages, designed to verify the specific labelling of tumours expressing the mutated EGFR receptor, verify the absence of significant marking on non-mutated tumours, and finally confirm the findings in a larger number of patients.

"With the advent of targeted therapies and precision medicine, the development of new molecular imaging biomarkers has become essential to provide the best treatment for patients," comments Prof. Fumoleau, Director of the CGFL Centre. "As a founding member of the Pharmimage platform with Oncodesign, it was only natural that we should conduct this phase 0/1 clinical study on the first radiotracer generated by the IMAkinib programme."

"This radiotracer was generated using our Nanocyclix technology, a chemical platform of next generation kinase inhibitors. The specificity of our molecules is a key advantage for the development of therapeutic molecules as well as for associated biomarkers, in a context of precision medicine and personalised treatments," adds Jan Hoflack, PhD, CSO of Oncodesign. "Our approach, which combines research on new therapies and identification of high-precision imaging tracers as of the first stage of our discovery programmes, is unique."

"Reaching the clinical stage in the development of an internal program for the first time is crucial for Oncodesign and its teams. It marks the culmination of 20 years of work and commitment to Oncodesign’s mission, i.e. provide patients with new cancer treatments," concludes Philippe Genne, PhD, founder and CEO of Oncodesign. "The IMAkinib project launched in 2009 includes several radiotracer programmes, the most advanced being the development of the radiotracer targeting the activated EGFR receptor. Our role in this programme is that of a pioneer in pharmaco-imaging focusing on new molecular markers. As this approach may lead to more effective treatments of tumours expressing EGFR-activating mutations using specific kinase inhibitors, it is important to identify such mutations."

About IMAkinib

IMAkinib is an Oncodesign research programme, conducted jointly with Cyclopharma and Ariana Pharmaceuticals. This programme received a grant from Bpifrance of €10.3m as part of the Industrial Strategic Innovation Programme, with an overall funding of €25m. The objective of IMAkinib is to develop biomarkers used in nuclear medicine to provide diagnostic solutions in oncology and help select the treatment best suited to individual patients, then monitor its efficacy and any potential resistance. The radiotracers developed are small molecules generated by Oncodesign’s Nanocyclix technology, labelled with radioactive 18F-fluorine [18F]. The IMAkinib programme includes several independent projects, the most advanced entering its phase 0/1 clinical study in lung cancer. Oncodesign has also worked jointly with Guerbet, and the teams of Prof. Denis Guilloteau of University François Rabelais in Tours and Dr Louisa Barré of CEA-Cycéron in Caen, on the development of radiochemical synthesis and on the preclinical studies on the radiotracer targeting the EGFR receptor.

On July 11, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck’s Temodar (Press release, Mylan, JUL 11, 2016, View Source [SID:1234513811]). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

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Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, had U.S. sales of approximately $176.5 million for the 12 months ending May 31, 2016, according to IMS Health.

Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

On July 11, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), in collaboration with researchers from the Institute of Cancer Research in London, reported positive results for EndoPredict, a second-generation prognostic gene expression test for breast cancer (Press release, Myriad Genetics, JUL 11, 2016, View Source [SID:1234513812]). The study achieved its primary endpoint by demonstrating that EndoPredict (EPclin) was superior to the first-generation Oncotype DX Breast Recurrence Score (RS) in predicting the long-term recurrence of ER+, HER2- primary breast cancer. The study was published in the Journal of the National Cancer Institute (JNCI).

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"This important study demonstrated that EndoPredict more accurately predicted the recurrence of breast cancer up to 10 years after diagnosis in patients with ER+, HER2- breast cancer than the other test studied," said Jack Cuzick, Ph.D., FRS, director of the Wolfson Institute of Preventive Medicine in London, and an investigator of the study. "These findings will help physicians identify patients who do not need adjuvant chemotherapy following surgery, resulting in a more personalized treatment for their patients."

The analysis included 928 women from the TransATAC study and compared the prognostic power of EndoPredict versus the first-generation test. The primary endpoint of the study was distant relapse-free survival. This analysis showed that EndoPredict markedly outperformed Oncotype DX across the 10-year follow-up period with prognostic power more than four times higher (EPclin: LRX2= 139.3; RS: LRX2=29.1). Using pre-defined cutoffs, EndoPredict and Oncotype DX identified 58.8 percent and 61.7 percent of patients as low risk with hazard ratios for low- versus non-low-risk of 5.9 and 2.7, respectively. Importantly, the authors noted that "EPclin’s superior ability to classify patients as low risk was further demonstrated by the similar number of patients classified as low risk by RS coupled with a substantially lower 10-year recurrence rate (5.8% for EPclin vs 10.1% for RS)."

"EndoPredict significantly outperformed the first-generation prognostic test in this head-to-head study, especially for late distant recurrences and in node-positive patients" said Ralf Kronenwett, M.D., chief scientific and medical officer, Sividon. "Additionally, EndoPredict did not classify any patients as intermediate risk, while Oncotype DX classified 28 percent of as intermediate risk which can be confusing for clinicians trying to make treatment decisions."

The JNCI publication can be accessed at: View Source

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About EndoPredict
EndoPredict is a next-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety.

On July 11, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported that it has been granted a new European patent covering its investigational Phase 3 cancer immunotherapy drug Multikine* (Leucocyte Interleukin) (Press release, Cel-Sci, JUL 11, 2016, View Source [SID:1234513827]). The patent, EU Patent: EP 1 773 368 B1, titled "A Method Of Pre-Sensitizing Cancer Prior To Treatment With Radiation and/or Chemotherapy And A Novel Cytokine Mixture," is not limited to any one particular type of cancer and can include multiple types of cancer.

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This invention relates to a novel method for pre-sensitizing cancer cells prior to a therapeutic treatment such as chemotherapy or radiation therapy. This effect is created by CEL-SCI’s immunotherapy drug Multikine which, as part of its mode of action, induces cancerous cells to enter a proliferative cell cycle phase therapy, thereby potentially increasing their vulnerability to chemotherapy and radiation therapy.

Geert Kersten, Chief Executive Officer of CEL-SCI, said, "This European patent should protect one of the largest applications for Multikine, namely its use in combination with radiation and chemotherapy. Our ongoing Phase 3 clinical trial in head and neck cancer patients is administering Multikine therapy as part of a first-line treatment, before any other treatments and prior to surgery, followed by radiation or concurrent chemoradiotherapy."

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. The study is being conducted in 24 countries and has enrolled over 850 patients so far.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.