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]). Schedule your 30 min Free 1stOncology Demo! 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.
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"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.
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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. Schedule your 30 min Free 1stOncology Demo! "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."
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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.
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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.
Blend Therapeutics Presents Preclinical Data for Lead Candidate BTP-114 that Demonstrated Superiority to Cisplatin in Tumor Growth Inhibition
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 BTP-114, a novel personalized cisplatin prodrug, with demonstration of improved and sustained tumor growth inhibition in preclinical models as compared to the conventional platinum cytotoxic cancer drug, cisplatin (Press release, Tarveda Therapeutics, APR 21, 2015, View Source [SID:1234508888]). Results from preclinical studies were presented in a poster entitled "BTP-114: An albumin binding cisplatin prodrug with improved and sustained tumor growth inhibition" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Philadelphia, Penn.
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BTP-114 is Blend’s lead product candidate for which the company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in Q2 2015. Once administered, BTP-114 rapidly conjugates to serum albumin in blood with a high degree of specificity, and is preferentially taken up by cancer cells with certain molecular profiles, resulting in enhanced DNA damage and cell death.
"We are excited by the novel mechanism of action of BTP-114 that leverages our growing understanding of disregulated cancer metabolism and the molecular underpinning of cancers, enabling the development of the first personalized platinum marking a major advance in the field of platinum anti-cancer agents," said Richard Wooster, PhD, President of Research and Development of Blend. "Designed to overcome limitations of conventional platinum therapies which are the largest class of oncology drugs today, BTP-114 has the potential to increase the proportion of patients who respond and their duration of response to platinum-based therapies."
The data presentation at AACR (Free AACR Whitepaper) describes BTP-114’s novel mechanism as a platinum prodrug of cisplatin that covalently attaches to serum albumin in the blood giving a 15-fold increase in exposure and a predicted human plasma half-life of 10 days. The therapeutic dose of platinum was increased by up to 2-fold, resulting in a 15-fold increase in platinum accumulation in multiple xenograft models. BTP-114 was shown to improve efficacy in models of lung and ovarian cancer compared to cisplatin, while reducing key dose limiting toxicities of cisplatin.
BTP-114 was developed by researchers at Blend Therapeutics and builds on the breakthroughs in platinum chemistry pioneered by the company’s scientific co-founder, Professor Stephen J. Lippard of Massachusetts Institute of Technology (MIT).
About Blend Therapeutics
Blend Therapeutics, Inc., is a biopharmaceutical company discovering and developing two distinct classes of targeted anti-cancer medicines to advance the treatment of patients with solid tumor cancers. Blend’s pipeline includes its lead drug candidate, BTP-114, a novel, personalized cisplatin prodrug derived from the company’s R&D heritage in platinum drugs, as well as BTP-277 and other novel drug conjugates from the company’s proprietary Pentarin platform. Blend’s first Pentarin drug candidate, BTP-277, represents the proprietary components of Blend’s miniaturized biologic drug conjugate (mBDC) technology – a novel targeting ligand conjugated to a potent cell-killing agent with a chemical linker – incorporated into nanoparticles to enable the penetration of the conjugates deep in to the tumor tissue where they selectively bind to tumor cells. Blend’s strategy includes developing its own proprietary Pentarins as well as applying the Pentarin platform to enhance the therapeutic capabilities of the targeting protein scaffolds or payloads of pharmaceutical collaborators.
The company was founded by three leaders in the fields of chemistry and nanomedicine from the Brigham and Women’s Hospital (BWH)–Harvard Medical School (HMS), and Massachusetts Institute of Technology (MIT): Dr. Omid Farokhzad of BWH–HMS, and Dr. Robert Langer and Dr. Stephen J. Lippard of MIT. Blend has attracted top-tier investors including Eminent Venture Capital, Flagship Ventures, NanoDimension, and New Enterprise Associates.
Generex Announces Presentation of Data Correlating Immune Response with Reduction of Relapse in AE37 Phase II Breast Cancer Trial at AACR 2015
On April 21, 2015 Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) reported presentation of data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine correlating local immune response to a reduction in relapse (Press release, Generex, APR 21, 2015, View Source [SID:1234506588]). AE37 is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex. The presentation was made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held in Philadelphia, PA from April 18 to 22.
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The abstract entitled ‘Correlation of robust local reactions prompting GM-CSF dose reduction to clinical response in a Phase II trial of the AE37+GM-CSF HER2 peptide vaccine’ by Julia Greene, et al was presented at the Clinical Trials in Progress session of the AACR (Free AACR Whitepaper) on April 20. The goal of the study was to establish the importance of the local reaction to immunization with AE37. The controlled, randomized and single-blinded trial is comparing the ability of AE37 plus the adjuvant GM-CSF versus the GM-CSF adjuvant alone to reduce recurrence of breast cancer in early stage patients. The study found that those patients receiving AE37 who had the largest responses (requiring reductions in the amount of GM-CSF) had a relapse rate of 5.9% versus a rate of 14.2% in those who did not require dose reduction. This indicates that a robust stimulation of the immune system by AE37, as evidenced by the need for dose reduction, results in positive anti-cancer activity.
The AE37 vaccine is designed to activate critical components of the immune system to combat cancer cells. Prior analyses have shown a trend toward reduction of relapse in patients receiving the vaccine, particularly those who are not eligible for the cancer drug Herceptin as well as those with triple negative breast cancer. The current study correlates the extent of immune response with reduction in relapse. A priority in all forms of cancer immunotherapy today is in establishing means of identifying which patients are more likely to respond to treatment.
The current results add to prior studies both from the ongoing Phase II trial as well as a completed Phase I study of AE37 in patients with prostate cancer showing robust yet specific immunological responses together with almost negligible toxicity. The distinguishing feature of AE37 is its ability to specifically activate CD4+ T helper cells, which govern both the quality and magnitude of an immune response to a novel target. The correlation of a robust immune response with reduced relapse confirms the importance of this type of immunological activity in combating cancer.
Encouraging results from both the breast and prostate cancer trials of AE37 warrant further clinical development of AE37, both as mono- and/or combination therapy. The current study provides important biomarker information relevant to identifying those patients who may be expected to benefit most from AE37. Similarly, the information may help guide possible combination studies; i.e., using agents that may enable all patients to respond robustly to AE37 (e.g., checkpoint inhibitors).