1stOncology™: Cancer Intelligence Service – Page 16205 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center

On July 14, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by delivering high quality biological products through its contract development and manufacturing organization (CDMO) services and by advancing its novel R&D pipeline, reported that the company has entered into an exclusive licensing agreement with University of Texas (UT) Southwestern Medical Center for a novel exosome technology that has potential application as a simple blood test to detect or monitor cancer (Press release, Peregrine Pharmaceuticals, JUL 14, 2016, View Source [SID:1234513872]). The company intends to develop a novel cancer test utilizing internal expertise and then pursue revenue-generating partnering opportunities at an early stage of development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Tumor exosomes represent small pieces of tumor cells that are released into the blood as tumors grow. Tumor derived exosomes have phosphatidylserine (PS) on their surface as a detectable marker. It is believed that even small tumors begin to release PS-positive exosomes and thus the ability to detect these exosomes in the blood may be an indicator of the presence of a tumor.

The licensing agreement is the result of the long-standing sponsored research agreement between Peregrine and UT Southwestern focused on PS, a highly immunosuppressive signaling molecule. The new technology licensed by Peregrine relates to assays that are able to detect small amounts of PS-exosomes in a patient blood sample as a way to potentially detect cancer at a very early stage of development. Preliminary studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes detected in the blood of cancer patients and disease burden.

"We are excited to enter into this licensing agreement with our long-term collaborators at UT Southwestern. This technology offers a promising product development opportunity and aligns directly with the company’s expertise with our proprietary PS-targeting platform and our longstanding CDMO capabilities around the development, qualification, and validation of in vitro analytical assays. As such, there are significant opportunities to use this technology as both a complementary tool in bavituximab’s ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts," said Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research. "It is important to note that this development program will require minimal capital investment and has the potential to create significant value over the next 18 months, including potential partnering opportunities. As a result, we feel that today’s licensing deal provides yet another important driver in our ongoing efforts to achieve profitability."

Together, the Peregrine and Avid Bioservices teams have the existing infrastructure, staff and expertise to develop, optimize and validate a functional assay capable of detecting PS-positive exosomes from a blood sample. Given the company’s extensive experience in developing assays of this type, Peregrine does not anticipate the need to add personnel or any specialized equipment for this project. The company intends to establish clinical proof-of-concept for the test and expects to initiate partnering discussions for the program in 2017.

"One of the most exciting aspects of this technology is the potential synergy that it offers with our ongoing bavituximab clinical development program. Through our ongoing work with bavituximab, we have gained significant understanding of PS-mediated immunosuppression in cancer," said Joseph Shan, MPH, vice president, clinical and regulatory affairs of Peregrine. "The availability of a PS-specific biomarker which can be implemented in our planned future bavituximab clinical trials aligns nicely with our refocused bavituximab development strategy aimed at generating the most meaningful data possible from small, early stage clinical trials to support partnering efforts."

Juno Therapeutics Adds Adenosine Receptor Antagonist Through Acquisition of RedoxTherapies

On July 14, 2016 Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported that it has acquired RedoxTherapies, Inc., a privately held company based in Boston, Massachusetts (Press release, Juno, JUL 14, 2016, View Source [SID:1234513886]). The acquisition provides Juno with an exclusive license to vipadenant, a small molecule adenosine A2a (A2a) receptor antagonist that has the potential to disrupt important immunosuppressive pathways in the tumor microenvironment in certain cancers. Juno intends to explore this molecule in combination with its engineered T cell platform and may over time explore it in other areas as well.

The adenosine pathway is increasingly recognized as one of the most important drivers in decreasing the immune response in cancer through upregulation of checkpoints, metabolic downregulation of T cells, and overall immune suppression. Inhibiting this pathway, particularly through the blockade of A2a receptor signaling, has been shown in pre-clinical models to enhance the efficacy of adoptive T cell therapy, checkpoint inhibitors, and vaccines across a number of blood and solid organ cancers.

Vipadenant, an orally bioavailable synthetic small molecule, potently and selectively blocks adenosine receptor mediated immunosuppression. In Phase I and II clinical trials in approximately 250 Parkinson’s disease patients and healthy volunteers, vipadenant was found to reach serum levels that predict saturation of the A2a receptor and blockade of signaling through this pathway and to be well tolerated in these subjects. In addition to vipadenant, with the transaction Juno has acquired proprietary know-how and intellectual property pertaining to the development of A2aR antagonists in combination with immuno-modulatory agents, such as the company’s engineered T cells. RedoxTherapies founder and adenosine biology pioneer Michail Sitkovsky, Ph.D. will become a scientific consultant to Juno.

"Multiple approaches to overcoming the tumor microenvironment will be key in optimizing the clinical benefit of engineered T cells, and T cells more broadly, in the treatment of cancer. Inhibiting the adenosine pathway is one of the most intriguing pathways in this important area of science, and we look forward to testing the hypothesis around this pathway clinically," said Hy Levitsky, M.D., Juno’s Chief Scientific Officer. "We look forward to integrating this asset into our ongoing research and clinical efforts and exploring it in combination with product candidates from our portfolio."

"As a leader in understanding the potential for adenosine receptor antagonists to destroy the immunosuppressive tumor-protecting barrier created by the tumor-generated extracellular adenosine, Redox compiled critical intellectual property to interrogate this biology. Reversing the inhibition caused by hypoxia and adenosine has the potential to unlock T cells in even the most difficult to treat tumors. The ability to combine our assets with Juno’s pipeline in the field of TCR and CAR T cell therapies is an ideal match, and we share a vision to optimize the activity of engineered T cells," said Michail Sitkovsky, Ph.D., Founder of RedoxTherapies.
The upfront consideration for the RedoxTherapies acquisition was $10 million in cash. Redox is also eligible to receive payments upon the achievement of undisclosed clinical, regulatory, and commercial milestones.

Boehringer Ingelheim and Lilly Announce Clinical Trial Collaboration in Metastatic Breast Cancer

On July 13, 2016 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) reported a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of BI 836845, Boehringer Ingelheim’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralising antibody, in combination with abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in patients diagnosed with HR+/HER2- mBC (Press release, Boehringer Ingelheim, JUL 13, 2016, View Source [SID:1234513868]). Based on the Phase 1b trial results, the collaboration has the potential to expand to Phase 2 trials in patients with HR+/HER2- mBC and other solid tumours. Enrolment is scheduled to begin in late 2016 and Boehringer Ingelheim will be the sponsor of the study programme.

"We are pleased to join with Boehringer Ingelheim to study the potential of their molecule in combination with Lilly’s abemaciclib, for which we have an active Phase 3 development programme underway," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "For patients living with metastatic breast cancer, the limited treatment options available make this an important area of focus for our efforts to advance the most innovative treatments."

Dr. Mehdi Shahidi
Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, " Boehringer Ingelheim is excited about initiating this collaboration with Lilly to investigate a novel combination of two compounds that have individually shown promising results in metastatic breast cancer and have a complementary mode of action. We hope that this study will lay foundations for making much needed new therapies available to patients with metastatic breast cancer."

Boehringer Ingelheim’s BI 836845 is an IGF ligand-neutralising antibody that binds to both IGF-1 and IGF-2 preventing activation of the respective receptor resulting in decreased growth-promoting signalling, which may decrease tumour growth. In a Phase Ib/II trial BI 836845 has shown promising preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ mBC.1 Lilly’s abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signalling from CDK 4 and 6.

The rationale for the collaboration is based upon the hypothesis that these two agents, in combination, could offer a more complete pathway interference and could potentially prolong cell cycle arrest. For HR+/HER2- mBC patients, this could translate to a reversal of resistance to hormone therapy.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. this year, approximately 246,600 new cases of invasive breast cancer will be diagnosed and about 40,450 women will die from breast cancer.3 Of all early stage breast cancer cases diagnosed in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.4 Approximately 75% of breast cancers are hormone receptor-positive and are typically managed with endocrine therapies, including aromatase inhibitors and selective oestrogen receptor modulators.5 Metastatic breast cancer is considered incurable, but is generally treatable.

About BI 836845
BI 836845 is an investigational compound in Phase II clinical development. It is a humanised antibody that binds to insulin-like growth factor (IGF) signalling pathways, which may play a role in the development or spread of cancer by providing a growth mechanism for tumours. BI 836845 specifically binds to IGF-1 and IGF-2. It is being studied in combination with other agents for use in patients with advanced solid tumours.

Provectus Biopharmaceuticals Announces PV-10 Data Discussed at 6th European Post-Chicago Melanoma/Skin Cancer Meeting

On July 13, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that data on PV-10 as a treatment for melanoma was presented June 30, 2016 at the 6th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany (Press release, Provectus Pharmaceuticals, JUL 13, 2016, View Source [SID:1234513864]).

Sanjiv Agarwala, MD, Professor of Medicine at Temple University, Chief, Oncology & Hematology at St. Luke’s Cancer Center in Bethlehem, Pennsylvania and Global Lead Investigator for the phase 3 study of PV-10 in locally advanced cutaneous melanoma (protocol PV-10-MM-31), participated in a symposium, "Current Clinical Trials I." His presentation covered the status of clinical trials of leading oncolytic agents for the treatment of soft tissue and skin metastases, including the ongoing phase 3 study of PV-10 and the phase 1b study of PV-10 in combination with pembrolizumab (Keytruda).

During his presentation, Dr. Agarwala noted that "systemic therapy is not always possible or appropriate" for patients with locally advanced disease, and that "local-regional control of soft tissue/skin metastases is clinically important." Touching on six different types of oncolytic therapy, he highlighted key efficacy and safety data for PV-10 when used for direct ablation of dermal and soft tissue metastases, and noted that PV-10 is the only one currently being studied as both monotherapy and in the combination setting (with pembrolizumab). With regard to combination therapy, he noted that newer intralesional therapies like PV-10 are the "backbone for future combinations" since they are capable of producing a systemic anti-tumor immune response complementary to that of immune checkpoint inhibitors.

To view his presentation, please visit
http://www.pvct.com/presentation/EuropeanPostChicago-2016.

For more information about the meeting visit: View Source

Amgen And Daiichi Sankyo Announce Agreement To Commercialize Biosimilars In Japan

On July 13, 2016 Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo; TSE: 4568) reported the execution of an exclusive agreement to commercialize nine biosimilars in Japan (Press release, Amgen, JUL 13, 2016, View Source [SID:1234513874]). The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.

Under the terms of the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan, while Amgen will have a limited right to co-promote the products.

"Amgen is excited to collaborate with Daiichi Sankyo as we seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide," said Scott Foraker, vice president and general manager of Biosimilars at Amgen.

Amgen will retain all additional distribution and commercialization rights for the biosimilar programs outside of Japan. Specific financial terms of the agreement were not disclosed.