On June 8, 2016 Cantargia AB reported that the United States Patent and Trademark Office ("USPTO") has issued a Notice of Allowance on Cantargia AB’s ("Cantargia") patent application regarding IL1RAP as a target molecule for antibody therapy of acute lymphatic leukemia (ALL) (Press release, Cantargia, JUN 8, 2016, View Source [SID:1234513153]).

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The patent application with application number 13/390,459 which has now obtained Notice of Allowance by the USPTO concerns the company´s method to use IL1RAP as a target molecule for the treatment of hematological cancers. As a first step the USPTO plans to issue a patent on IL1RAP as a target molecule for antibody based therapy of ALL. As a subsequent step Cantargia is preparing a divisional application to obtain granted claims on areas outside ALL. This means that the examination will continue around the other parts of the original application, ie other hematological forms of cancer.

The issuance of a Notice of Allowance indicates that the USPTO intends to approve the company’s patent application. Certain administrative steps remain before the patent is formally granted.

"Our patent portfolio is progressing and the information from USPTO gives further validation of IL1RAP as a unique target molecule" says Göran Forsberg, CEO of Cantargia AB. "It is a welcome notice, as USA is the biggest market for cancer therapies."

On June 08, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported dose administration for the first patient in the first stage of its Phase 2 clinical trial of their FAWCETT study, testing the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic anal cancer (Press release, Advaxis, JUN 8, 2016, View Source [SID:1234513150]).

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The multi-center, open-label, two-stage study is designed to evaluate the efficacy and safety of AXAL as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Stage 1 of the trial will enroll 31 patients with anal cancer whose disease recurred after receiving treatment. Patients will receive AXAL 1×109 colony forming unit (CFU) doses every three weeks for up to two years.

In collaboration with Brown University Oncology Research Group, AXAL has been evaluated in high-risk, locally advanced anal cancer with concurrent standard chemotherapy and radiation treatment. Preliminary data show treatment with AXAL indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.

"The FAWCETT study is an important step in the development program for AXAL," said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. "People living with anal cancer desperately need new treatment options, which is why Advaxis is pursuing two areas of evaluation, including monotherapy with AXAL and a second study with an immune checkpoint inhibitor in combination with AXAL."

The FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy) study was named in honor of Farrah Fawcett, who passed away due to HPV-associated anal cancer. In 2015, the Farrah Fawcett Foundation honored Advaxis with its inaugural "Medical Visionary Angel Award" based on the Company’s clinical research and efforts to treat this disease, initiating a partnership among the organizations.

About Anal Cancer

Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one’s lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.

About Axalimogene Filolisbac

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. 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. AXAL has Orphan Drug Designations in the U.S. for the treatment of invasive cervical cancer, head and neck cancer and anal cancer.

About the Farrah Fawcett Foundation

The mission of the Farrah Fawcett Foundation is to provide funding for cutting edge cancer research, to support prevention and awareness, and to help those struggling with cancer today. Farrah Fawcett was diagnosed with anal cancer in 2006 and established the Foundation before her death in 2009. For more information, visit www.thefarrahfawcettfoundation.org and follow them on Facebook.

On June 08, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) reported an exclusive global option and license agreement focused on the development of CG026806 (CG’806), a first-in-class, highly potent, non-covalent small molecule inhibitor of the Bruton’s tyrosine kinase (BTK), FMS-like tyrosine kinase 3 (FLT3) and the Aurora kinases (AURK) (Press release, Aptose Biosciences, JUN 8, 2016, View Source [SID:1234513135]). Further to enacting the agreement, Aptose expects to undertake Investigational New Drug (IND) enabling studies immediately, and, if it exercises its option under the agreement, to initiate a Phase 1 clinical trial by mid 2017.

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The potential option exercise would occur prior to submission of an IND application in the U.S. Upon exercise of the option, Aptose will own global rights to develop and commercialize the program outside of Korea and China – the Licensed Territory. Total deal value is up to $303 million USD, inclusive of development, regulatory and commercial-based milestones. CrystalGenomics will also receive a single-digit royalty on sales in the Licensed Territory.

CG‘806 has the potential to serve as a transformational agent for multiple forms of cancer, particularly those resistant to current BTK inhibitors or those that possess the FLT3-ITD alteration. BTK plays a critical role in B-cell hematologic malignancies, such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), and certain autoimmune diseases. FLT3, including the Internal Tandem Duplication (ITD), a mutation of the FLT3 gene, occurs in approximately 30-35% of patients with acute myeloid leukemia (AML). Aurora kinases participate in the epigenetic phosphorylation of histones and are key drivers in a series of hematologic malignancies and solid tumors.

"CG’806 offers a unique capacity through a non-covalent, reversible mechanism to inhibit wild type and mutant forms of the validated BTK, FLT3 and AURK targets, but with the discretion to offer a robust safety profile," commented Avanish Vellanki, Senior Vice President and Chief Business Officer of Aptose. "Indeed, we are impressed by the ability of once-daily oral dosing of CG’806 to demonstrate tumor eradication in the absence of toxicity in murine xenograft models of human hematologic malignancies," added William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose.

"We are excited to work with the Aptose team, which is uniquely qualified to accelerate development of our BTK/FLT3/AURK inhibitors, including our lead compound CG’806," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "With a demonstrated commitment to high scientific and development standards, Aptose and its clinical advisors recognize the potential of this class of anticancer compounds and will make clinical development a priority."

"The in vivo potency of CG’806 shows unprecedented potential," said Michael Andreeff, M.D., Ph.D., Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center (MDACC), and a member of the Aptose Scientific Advisory Board. "The combination of this candidate’s potency with a stellar in vivo safety profile gives us enthusiasm for CG’806 as a therapeutic option for patients with AML, CLL and other malignancies."

On June 8, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations (Press release, Hoffmann-La Roche , JUN 8, 2016, View Source [SID:1234513126]).

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The pivotal phase II JO25567 study showed a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone.1 Avastin and Tarceva each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.2,3

"The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer," said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing important progress for a group of patients who typically face a poor prognosis."

Each year, an estimated 23,000 Europeans are diagnosed with non-squamous NSCLC with EGFR-activating mutations, the equivalent of more than 60 diagnoses every day.4-8 NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.4,7-9 Of all cancers, lung cancer has the greatest global economic and societal impact, making improvements in outcomes for patients with lung cancer a key global healthcare challenge.10

About the JO25567 study
JO25567 is a randomised phase II study conducted by Chugai that assessed the safety and efficacy of first-line Avastin in combination with Tarceva compared to Tarceva alone in Japanese patients with advanced non-squamous NSCLC with EGFR-activating mutations. Study data from 154 patients showed:
Patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS)(primary endpoint) compared to those who received Tarceva alone, representing a statistically significant 46 percent reduction in the relative risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015).1

No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.1

About Roche in lung cancer
Lung cancer is a major area of focus and investment and Roche is committed to developing new approaches, medicines and tests that can help people with this deadly disease. Roche is aiming to provide effective treatment options for every person diagnosed with lung cancer. Roche currently has three approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About NSCLC with EGFR-activating mutations
Lung cancer is the leading cause of cancer-related death in Europe and across the world.4,9 In Europe, it kills more people than breast and prostate cancers combined.4 Each year, over a quarter of a million people die as a result of the disease, equating to more than 700 deaths every day in Europe.4 NSCLC is the most common type of lung cancer and accounts for 85 percent of all lung cancer diagnoses.7,8

Epidermal growth factor receptor (EGFR) is a protein that sits across the cell membrane and forms part of normal cell signalling. NSCLC with EGFR-activating mutations occurs when there is a mutation in a specific area of DNA in the EGFR gene (commonly exon 19 and exon 21), which leads to a change in the structure and function of the EGFR proteins and results in EGFR signalling being constantly active. This can cause accelerated cell growth and division, angiogenesis and the development of metastases. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year.4-8

About Avastin
With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and platinum-resistant, recurrent ovarian cancer. In addition, Avastin is approved in over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

About Tarceva
Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to inhibit EGFR, a protein involved in the growth and development of cancers.

Tarceva is developed and commercialised by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.