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MedImmune and Juno Therapeutics Announce Immuno-Oncology Clinical Trial Collaboration

On April 23, 2015 MedImmune and Juno reported that they have entered into a new collaboration to conduct combination clinical trials in immuno-oncology with one of Juno’s investigational CD19-directed chimeric antigen receptor (CAR) T cell candidates and MedImmune’s investigational programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitor, MEDI4736 (Press release, Juno, APR 23, 2015, View Source [SID:1234503138]). Under the initial development plan, both companies will explore the safety, tolerability and preliminary efficacy of the combination therapy as a potential treatment for patients with non-Hodgkin lymphoma (NHL).

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"We are pleased to enter into this clinical trial collaboration with Juno Therapeutics as our initial venture into the promising emerging field of CAR T cell therapies," said Dr. Ed Bradley, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune. "The combination of Juno’s CAR T cell candidate with MEDI4736 adds to our broad program of immuno-oncology combination trials, addressing multiple immune pathways and working with industry-leading partners to explore the significant potential of immunotherapies in transforming treatments for cancer."

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Under the terms of the non-exclusive collaboration, MedImmune and Juno will jointly co-fund the initial Phase Ib study, which is expected to begin later in 2015. The companies will also explore the combination of MEDI4736 with a next-generation, Juno-developed fully human CD19-directed CAR T cell candidate.

"We believe combination strategies such as this will help us better understand the full potential of our engineered T cell platform in both hematological and solid tumor settings," said Mark W. Frohlich, M.D., Executive Vice President, Research & Development at Juno Therapeutics. "We look forward to working with MedImmune, a leader in immuno-oncology and checkpoint inhibition, in understanding the potential clinical benefit of combining these two potent therapeutic classes."

Financial details were not disclosed.

About MEDI4736
MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics.
MEDI4736 was accelerated into Phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.
About Chimeric Antigen Receptor (CAR) Technology
Juno’s chimeric antigen receptor (CAR) technology genetically engineers T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. When the engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.

GTx and the University of Tennessee Research Foundation Enter Into Exclusive License Agreement to Develop UTRF’s SARD Drug Technology

On April 23, 2015 GTx reported that it has entered into an exclusive worldwide license agreement with the University of Tennessee Research Foundation (UTRF) to develop its proprietary selective androgen receptor degrader (SARD) technology which potentially can degrade and inhibit all forms of androgen receptor (AR), including those resistant to current therapies, in patients with progressive castration-resistant prostate cancer (CRPC) (Press release, GTx, APR 23, 2015, View Source [SID:1234503130]).

"While current therapies continue to have a clinically significant role in the treatment of castration-resistant prostate cancer, progressive disease and resistance to these agents will eventually develop in most patients," said Dr. Robert J. Wills, Executive Chairman of GTx. "The lack of activity of these agents in approximately one-third of patients makes the SARD technology we have licensed from UTRF very attractive due to the potential to develop compounds that not only degrade AR but also the splice variant mutations, thereby providing a potential novel therapy for the thousands of men who suffer from castration-resistant prostate cancer."

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The Company will host a conference call and webcast on Friday, May 8, at 9:00 a.m. Eastern Time, to provide a corporate update on the Company’s preclinical and clinical development initiatives, including a discussion of its near term plans for the licensed SARD technology, and its first quarter 2015 financial results. The call and webcast will follow the release of the financial results earlier that day.

First Quarter Conference Call and Webcast

To listen to the conference call, please dial 877-930-8288 from the United States or Canada or 253-336-8703 from other international locations. The access code for the call is 25497458. A playback of the call will be available for seven days after the conference call and may be accessed by dialing 855-859-2056 from the United States or Canada or 404-537-3406 from other international locations and referencing reservation number 25497458. Additionally, you may access the live and subsequently archived webcast of the conference call from the Investor Relations section of the Company’s website at View Source

About Castration-Resistant Prostate Cancer Therapy

Androgen deprivation therapy (ADT) is generally the initial treatment for men with metastatic prostate cancer. Despite initial response, nearly all men eventually develop progressive disease following ADT; this is referred to as castration-resistant prostate cancer (CRPC). The development of various agents for CRPC, such as androgen synthesis inhibitors and androgen receptor antagonists, has improved overall survival in these patients. However, progressive disease and resistance to these agents eventually develops in most cases. The mechanisms for resistance are not fully understood, but it is believed that CRPC growth is highly dependent on androgen receptor (AR) activity. Approximately one-third of CRPC patients develop resistance to currently available treatments, due in part to the emergence of mutations of the AR in late stage disease. These mutations contain a splice variant sequence where the main binding site, the ligand binding domain, necessary for the action of current therapies is lost. A therapeutic agent that would safely degrade or inhibit all forms of the AR, including those without the ligand binding domain, may be uniquely positioned to address these splice variant mutations in certain patients.

Astellas Pharma and Potenza Therapeutics Partner to Build a Portfolio of Immuno – oncology Therapeutics

On April 22, 2015 — Astellas Pharma Inc. (Tokyo: 4503) and Potenza Therapeutics, Inc. , a biotechnology company developing a portfolio of immuno-oncology programs, reported an exclusive research and development collaboration (Press release, Potenza Therapeutics, APR 22, 2015, View Source [SID1234518755]).

The goal of the collaboration is to advance a portfolio consisting of programs with novel mechanisms of action targeting immune checkpoint pathways, co – stimulatory signals and regulatory T cells. The agreement includes an option that allows for the future acquisition of Potenza by Astellas on pre-determined terms at the end of the collaboration period.
"We are at the beginning of a new era in cancer therapy. First generation immuno-oncology therapeutics have demonstrated meaningful clinical benefit to patients with certain cancer s . The new targets and pathways that Potenza is working on offer promise for continued expansion of immunotherapy treatment options ," said Daniel Hicklin, PhD, co – founder of Potenza and the company’s Chief Executive Officer.
"We are excited to partner with Astellas to progress our programs in support of their strategy to become a global leader in oncology and next – generation therapeutics ." Under the terms of the collaboration agreement, Potenza will lead drug discovery activities and deliver development candi dates to Astellas. Astellas will be responsible for clinical development activities and commercialization. Specific financial terms will not be disclosed, but include an equity investment, option fee, research funding, and potential future acquisition and milestone payments. "
Despite the recent clinical success of checkpoint – blocking monoclonal antibodies targeting PD – 1 , PD – L1 and CTLA – 4, there still remain s significant unmet medical need in non – responder patients and unresponsive tumor types. Astellas is focusing on this unmet medical need with novel mechanisms of action and modalities, "said Kenji Yasukawa, Ph.D., Senior Vice President and Chief Strategy Officer, at Astellas. "I am pleased that we are collaborating with Potenza, whose team of scientific founders, management and venture capitalists all have a proven track record in the field of cancer immunotherapy. This collaboration is one piece of Astellas’ cancer immunotherapy strategy, and we will continue to make aggressive investment s in this field."
Potenza’s founders and scientific advisory board include world – renowned pioneers in cancer immunotherapy including Drew Pardoll, MD, PhD, Abeloff Professor of Oncolog y, Director, Cancer Immunology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ; Jedd Wolchok, MD, PhD , Chief, Melanoma and Immunotherapeutics Service , Memorial Sloan – Kettering ; Ana Anderson, PhD , Assistant Professor , Center for Neurologic Disease , Brigham and Women’s Hospital , Harvard Medical School ; Charles Drake, MD, PhD, Professor of Oncology, Co – Director Prostate Cancer Multi – Disciplinary Clinic; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ; Vijay Kuchroo, PhD, DVM , Professor, Dept. of Neurology , Director, Evergrande Center for Immunologic Diseases, Harv ard Medical School ; Dario Vignali, PhD , Vice Chair & Professor of Immunology; Co – Leader of the Cancer Immunology Program , University of Pittsburgh .
Previously, Potenza closed a Series A equity financing of $38 million in December 2014 which was led by founding investor MPM Capital, with InterWest Partners and Astellas Venture Management LLC participating.

ARIAD Announces Issuance of Key U.S. Patent on Brigatinib

On April 22, 2015 ARIAD Pharmaceuticals reported the issuance of its first U.S. patent on brigatinib, ARIAD’s investigational ALK inhibitor (Press release, Ariad, APR 22, 2015, View Source [SID:1234503114]). The United States Patent and Trademark Office granted U.S. Patent No. 9,012,462 under the title, "Phosphorous Derivatives as Kinase Inhibitors." The patent provides composition-of-matter protection through at least December 30, 2030 for ARIAD’s investigational ALK inhibitor, brigatinib. Additional patent applications covering brigatinib are pending in the U.S. and in other countries.

"This has been an important week for brigatinib, beginning with ARIAD’s presentation of preclinical and clinical data on brigatinib and the unveiling of its novel design features at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The issuance of the initial brigatinib patent highlights the innovative design of the brigatinib molecule," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We continue to enroll patients in our Phase 2 ALTA trial and look forward to sharing the first data from that clinical trial later this year."

About Brigatinib

Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) that is resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 for the treatment of patients with ALK+ NSCLC that is resistant to crizotinib on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review.

Blend Therapeutics Presents Preclinical Data for Lead Pentarin™ Program, BTP-277, Demonstrating Specific and Potent Tumor Cell Targeting for Small-Cell Lung Cancer

On April 21, 2015 Blend Therapeutics, Inc., a biopharmaceutical company discovering and developing two distinct classes of targeted anti-cancer medicines to advance the treatment of patients with solid tumor cancers, presented preclinical data today on its lead Pentarin program, BTP-277, showing specific and potent targeting of tumor cells expressing the somatostatin receptor, which is known to be over expressed in small cell lung cancer (SCLC) and neuroendocrine cancer tumor cells (Press release, Tarveda Therapeutics, APR 21, 2015, View Source [SID:1234508889]). BTP-277 is the first in a series of proprietary drug candidates from Blend’s Pentarin platform, which creates miniaturized biologic drug conjugates (mBDCs) incorporated in polymeric nanoparticles that offer the potential for highly effective penetration and distribution of targeted anti-cancer treatment deep into the tumor tissue. The results were presented in a poster entitled "Pentarins: Improved tumor targeting through nanoparticle encapsulation of miniaturized biologic drug conjugates" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Philadelphia, Penn.

BTP-277’s biologic targeting ligand is designed to specifically and selectively target cancers that over-express the somatostatin receptor. The targeting ligand is conjugated to a potent cytotoxic payload through an optimized chemical linker to create miniaturized biologic drug conjugates (mBDCs), which are incorporated in nanoparticles to create the Pentarin, BTP-277. Synergistic anticancer activity occurs based on the unique approach of the Pentarin: the nanoparticle enables high therapeutic concentration of mBDCs in the tumor; the small size of mBDCs allows for effective penetration deep into the tumor tissue; and ligand’s targeting ability allows for specific binding to tumor cells and selective intracellular payload delivery.

"Pentarins are novel biologic drug conjugates specifically designed for solid tumors, with a unique structure, miniaturization and nanoparticle combination designed to enable the selective targeting of cancer cells and impressive penetration deep into tumor tissue. Our approach represents a significant advance in the field since the first development of antibody drug conjugates 35 years ago and other medicines designed for the treatment of solid tumor cancers," said Richard Wooster, PhD, President of Research and Development of Blend. "Our most advanced Pentarin, BTP-277, has shown the ability to specifically and potently target small cell lung cancer tumor cells, providing highly encouraging results for the superior potential of a Pentarin. We expect BTP-277 to have a similar effect in additional somatostatin receptor over-expressing tumors. We are on track to complete the studies necessary to advance our first Pentarin into clinical trials in early 2016 to prove its potential to meet the unmet needs of cancer patients."

The data presentation at AACR (Free AACR Whitepaper) describes that the Pentarin from the BTP-277 program resulted in complete tumor regressions in small cell lung cancer tumors with no tumors reappearing by the end of the study at 103 days. In contrast, the miniaturized biologic drug conjugate (mBDC) alone – without the additional Pentarin components – resulted initially in shrinkage of tumors which then regrew. The mBDC in the BTP-277 Pentarin showed high affinity for the somatostatin receptor and was rapidly internalized into somatostatin over-expressing tumor cells where the potent cytotoxic payload exerted its cell killing effects. BTP-277 resulted in a 10-fold increase in total plasma levels and detectable levels in plasma 24 hours after dosing. In contrast, the mBDC alone was undetectable in plasma two hours after dosing.

About Pentarins
Pentarins represent a novel approach for the application of biologic drug conjugates to the treatment of cancer. Pentarins are comprised of a miniaturized biologic drug conjugate (mBDC) in a polymeric nanoparticle. Blend applies its proprietary suite of technologies to create novel mBDCs comprised of a proprietary targeting ligand conjugated to a potent cell-killing agent through a chemical linker. The mBDCs are incorporated in polymeric nanoparticles to protect them from their rapid clearance and allow for their accumulation in the tumor. Pentarins are designed to overcome the biological barriers that limit therapeutic effectiveness against solid tumors. Together, the components of Blend’s proprietary Pentarins have distinct yet synergistic anticancer capabilities: the nanoparticle enables high therapeutic concentration at the tumor site, the small size of mBDCs allows for effective penetration and distribution deep into the tumor tissue, the ligand’s targeting ability allows for specific binding to tumor cells, and the cell-killing payload is released inside the cancer cells.