On June 28, 2016 STORM Therapeutics, a spin-out company from the University of Cambridge’s Gurdon Institute focused on the identification and development of small molecule drugs that target RNA-modifying enzymes, reported that it has received £12 million in Series ‘A’ funding from Cambridge Innovation Capital, Merck Ventures, Pfizer Venture Investments and Touchstone Innovations (Press release, STORM Therapeutics, JUN 28, 2016, View Source [SID1234561051]). STORM Therapeutics is based upon the ground-breaking work of its co-founders, Professor Tony Kouzarides and Professor Eric Miska, in the field of RNA epigenetics.

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RNA (ribonucleic acid) is the only direct product of the human genome and acts as the template for the synthesis of all proteins, the molecular machines of the cell. RNA is also known to be a key player in cellular decision-making. There are several large families of RNA-modifying enzymes which catalyse a diverse range of epigenetic modifications of RNA, changing RNA activity and thereby key processes within the cell. There is a growing understanding of the importance of RNA modification in the development of cancer, opening up novel therapeutic targets in cancer treatment.

Professors Kouzarides and Miska and their research groups have identified certain of these RNA-modifying enzymes against which STORM Therapeutics intends to develop potential therapeutics using intellectual property licensed from the University of Cambridge and Cancer Research UK. The company will use the proceeds of the funding to identify small molecule modulators of these novel targets in RNA modification pathways and develop them into new classes of anti-cancer treatments.

Professors Tony Kouzarides and Eric Miska commented: "The work that our research groups are undertaking on non-coding RNA and the enzymes that modify this RNA is giving us incredibly interesting insights into how gene expression can be modified at a cellular level. The funding and support that STORM Therapeutics has received from its investors will allow the development of these insights into a new class of therapeutics ready to be taken into clinical trials."

On June 28, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid drugs, reported that it has entered into a sponsored research agreement with Thomas Jefferson University to investigate DNAbilize antisense DNA technology for the development of a brain cancer immunotherapy that works by activating the patient’s own immune system to fight their cancer (Press release, Bio-Path Holdings, JUN 28, 2016, View Source [SID:1234513645]).

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D. Craig Hooper, Ph.D., Department of Cancer Biology, Sidney Kimmel Cancer Center at Thomas Jefferson University and the Principal Investigator of the study, previously evaluated Bio-Path’s DNAbilize liposomal delivery and antisense technology in preclinical studies that demonstrated efficacy, suggesting the potential for a systemic antisense immunotherapy for brain cancers. The objective of the collaboration is to demonstrate that DNAbilize delivered systemically would have an effect in redirecting the immune system to fight a patient’s own cancer.

"Brain cancers, such as glioblastoma, are very aggressive and with median survival of about 15 months, novel treatments are urgently needed," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "We are excited to continue our work with Dr. Hooper to further demonstrate the potential of DNAbilize to safely and systemically deliver a brain cancer immunotherapy. We are entering the immunotherapy market with a unique approach to triggering the immune system to fight a patient’s cancer. This collaboration offers a significant development opportunity for Bio-Path that has the potential to create a second technology platform of immunotherapy products."

On June 28, 2016 FUJIFILM Corporation (President: Kenji Sukeno) reported the progress in a Phase I clinical trial of radioimmunotherapeutic anti-cancer agent FF-21101 in the United States in patients with advanced solid cancers (Press release, Fujifilm, JUN 28, 2016, View Source [SID:1234513609]). In imaging, tumor uptake of antibody FF-21101 was demonstrated in administered patients. Taking these results, it is expected to treat diseases with emission from the radiolabeled antibody. Fujifilm will proceed with the clinical trial and evaluate FF-21101 as an anti-cancer agent.

FF-21101 is an anti-cancer agent consisting of a radioisotope labeled antibody (armed antibody*1), and uses radiation emitted by the radioisotope to directly attack cancer cells. This is why it is expected to have a higher level of efficacy, regardless of the state of patient’s immune system. In addition, its accumulation in cancer tissue can be confirmed by imaging with an administration of antibodies labeled with a radioisotope. To date, tumor uptake of antibody was demonstrated in 3 of 4 patients who have undergone imaging with an administration of radiolabeled FF-21101.
These results were presented on June 27th at the World Innovative Networking in Personalized Cancer Medicine Symposium 2016 (Paris, France) by principal investigator, Vivek Subbiah MD, of The University of Texas MD Anderson Cancer Center*2 (MD Anderson Cancer Center, hereafter), Houston, TX, USA.

Fujifilm has organized the technologies of its Group companies to develop FF-21101. The bio-venture, Perseus Proteomics, has contributed to antibody drug discovery, while the biopharmaceutical contract manufacturer, FUJIFILM Diosynth Biotechnologies, has taken charge of antibody production. The radiopharmaceutical company, FUJIFILM RI Pharma, utilized its technology for developing the diagnostic and therapeutic radiopharmaceuticals.

Fujifilm initiated the Phase I clinical trial of radiolabeled FF-21101 in patients with advanced solid cancers at MD Anderson Cancer Center in the United States, one of the world’s most distinguished facilities for cancer research and treatment, in January 2016. In this trial, FF-21101(111In), antibodies labeled with Indium-111*3, were administered prior to therapy and its biodistribution to normal and cancerous tissues were visualized and quantified by imaging procedures. In addition, for safety estimation in advance, radiation absorbed doses of Yttrium-90*4 in organs were calculated from these data, after which, patients were moved on to the therapeutic dosing of FF-21101(90Y), antibodies labeled with Yttrium-90.

Although the trial is still underway, preliminary observations include:
Imaging revealed tumor uptake in 3 of 4 patients administered FF-21101(111In).
FF-21101 was well tolerated in all patients who went on to receive the therapeutic dose of FF-21101(90Y).

Fujifilm will continue the study to further evaluate tolerability and efficacy in multiple advanced solid tumors at MD Anderson Cancer Center, and will move on to the phase IIa study.

Fujifilm is working on the R&D of innovative pharmaceutical products and creation of their production processes by combining the technologies and know-how accumulated in the photographic film business including analysis technology, nanotechnology, and production technology, with the technological expertise of its core pharmaceutical affiliates such as Toyama Chemical. Defining "oncology", a field with numerous unmet medical needs as its focal area, the company will actively promote R&D to expand business deployment and supply innovative pharmaceutical products so as to contribute to resolving challenges social issues.

*1： Armed antibody: Antibody conjugated with toxin or radioisotope via a chemical linker. It is expected to have a potent anti-tumor effect.
*2：One of the world’s largest cancer centers based in Houston. Texas (USA), specializing in cancer treatment, research, education and prevention. It was established in 1941 with a mission to eliminate cancer. Under the core values of "Caring", "Integrity" and "Discovery", the Center has developed numerous new cancer treatments and is as an international leader in oncology.
*3：A radioisotope which emits gamma rays appropriate for imaging. Its physical half-life is, approximately 67 hours.
*4：A radioisotope which emits beta particle radiation with a range of 5 mm in human body, appropriate for treatment. Its physical half-life is, approximately 64 hours.
　　
About anti-cancer agent FF-21101:
FF-21101 uses antibodies that target P-cadherin*5, which is overexpressed on the surface of solid cancer cells, including lung, pancreatic and colon cancers, and is implicated in tumor growth and cancer metastasis. For the clinical application of FF-21101, tumor uptake will be confirmed in patients administered antibodies radiolabeled with emitter, such as Indium-111 or other radioisotopes. Antibodies labeled with Yttrium-90 namely FF-21101(90Y), will be subsequently administered and directly attacks cancer cells by radiation emitted from the 90Y radioisotope. FF-21101 is expected to be more effective than therapy using the P-cadherin targeted antibody without the 90Y. In animal testing, it has already demonstrated a high efficacy in shrinking human tumors implanted in mice.

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On June 28, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported recent advancements in electroporation (gene electro-transfer) for immunotherapy in two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Engineering and Physical Sciences in Oncology in Boston (Press release, OncoSec Medical, JUN 28, 2016, View Source [SID:1234513598])1. New data related to OncoSec’s Tissue-based Real-time Adaptive Controlled Electroporation (TRACE) technology and helical integrated applicator (Helix) showed that these technologies have the potential to reduce procedural frequency as well as enhance usability by physicians. Together, these novel technologies may improve a patient’s experience to gene electro-transfer and improve therapeutic outcomes, which will help broaden the adoption of gene-electro transfer technologies in immunotherapy.

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The TRACE and Helix technologies are central to OncoSec’s next-generation device development and represent a significant advancement in electroporation technology. Existing electroporation systems apply fixed pulses, independent of tissue conditions, that are typically optimized by heuristics. The new TRACE technology brings together OncoSec’s research and engineering efforts to adapt the pulses to tissue conditions in real time and detect when optimal conditions have been achieved to complete electroporation treatment. The new Helix applicator integrates engineering advancements to function synergistically with the TRACE technology. The TRACE and Helix technologies have the potential to improve delivery of new therapeutic agents and access a variety of new tumor types and locations.

"The new TRACE and Helix technologies are a testament to the expertise of OncoSec’s engineering and research teams," said Punit Dhillon, President and CEO. "Electroporation is a powerful gene delivery tool, and we believe that these novel technologies are a breakthrough in the field of electroporation therapy. As we look beyond the proof-of-concept stage for our intratumoral immunotherapy programs, these advancements are a major step forward in being able to consistently deliver more advanced therapeutic agents with the potential to target multiple facets of tumor immune subversion."

TRACE Technology
The poster presentation entitled "Feedback Optimized Gene Electro-Transfer for Immunotherapy" highlights the efficacy of modulating pulse durations in real-time for the intratumoral delivery of plasmid DNA in mouse tumor models. OncoSec’s generator incorporating TRACE technology was used to perform electroporation with electrochemical impedance spectroscopy feedback operating in a closed-loop configuration to optimize each pulse duration in real-time.

Preclinical studies demonstrated electroporation integrating TRACE technology is capable of achieving maximum expression of reporter genes with minimal energy delivered. Based on these findings, it is hypothesized that this technology will minimize collateral cell death and reduce treatment variability observed in patients. These findings represent a significant advancement in gene electro-transfer, because retaining the viability of transfected cells is critical for treatment success.

Helix Technology
The poster presentation entitled "A Novel Applicator for Endoscopic Gene Electro-Transfer" discusses the role of DNA dispersion during intratumoral gene delivery and its impact on gene electro-transfer efficiency. OncoSec researchers developed a single-helical injection needle that anchors the target tissue and delivers plasmid DNA. This achieves delivery of the plasmid to an area three times larger than that of a standard injection needle. Helix combines the helical needle with electroporation electrodes on a single applicator, which may enhance gene delivery by increasing surface area for tissue-DNA-electroporation interaction.

The Helix technology showed enhanced efficacy of IL-12 plasmid electroporation in an aggressive B16.F10 mouse melanoma model, significantly reducing tumor growth rate and increasing survival after a single treatment. The anchoring associated with the helical needle and the close proximity of the electrodes ensures co-localization of the electric field with the injected plasmid DNA as well as repeatable treatment of malleable tumors. In addition, the compact design of the electrodes and helical needle could make the applicator compatible with standard medical devices, including trocars, endoscopes, and other catheter based devices, thus enabling the application of intratumoral gene immunotherapy to a broad range of deep tissue cancers.

The poster presentations are available in the Publications section of OncoSec’s website.

On June 28, 2016 Novartis reported that it has entered into a collaboration and licensing agreement with Xencor for the development of bispecific antibodies for treating cancer (Press release, Novartis, JUN 28, 2016, View Source [SID:1234513584]). The agreement is the latest in a series of acquisitions and strategic collaborations between Novartis and biotech companies that have helped bolster its deep and diverse immuno-oncology pipeline.

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Traditional monoclonal antibodies target and bind to a single antigen. Bispecific antibodies are engineered to recognize and target two different antigens, which makes them potentially more effective in targeting complex diseases. A T-cell engaging bispecific antibody is able to bind an antigen on a tumor cell with one arm and engage T-cells capable of their destruction with the other.

Novartis receives the right to develop four additional bispecific antibodies and to use other Xencor proprietary antibody engineering technology for up to ten additional biotherapeutic programs across the Novartis R&D portfolio. In addition, The companies will collaborate to co-develop Xencor’s two bispecific T-cell engaging antibodies targeting CD3xCD123 and CD3xCD20 for the treatment of acute myeloid leukemia and B-cell malignancies.

"This collaboration is part of our strategy to join forces with technology innovators who can help us rapidly advance new medicines to the clinic, " said Jay Bradner, President of the Novartis Institutes for BioMedical Research. "We look forward to working with the Xencor team to advance these programs in immuno-oncology and to using their antibody engineering platform to develop biotherapeutics for additional diseases."

The addition of Xencor’s T-cell engaging bispecific antibody programs expands Novartis’ immuno-oncology portfolio that includes novel checkpoint inhibitors, chimeric antigen receptor T-cell (CART) technology, myeloid cell targeting agents, the T-cell stimulating factor IL-15, STING agonists that enhance immune recognition of cancers, and adenosine receptor antagonists and TGF-beta blocking antibodies that overcome immunosuppression in the tumor microenvironment. Currently seven of these programs are in the clinic and five more are expected to enter the clinic individually and as combinations by the end of 2016.

Under the terms of the agreement, Xencor is receiving a $150 million upfront payment from Novartis and the two companies will equally share the cost to jointly develop two Xencor antibodies targeting the CD3 domain. Xencor retains full US commercial rights to these programs, and Novartis has ex-US commercial rights. In addition to these antibodies, Novartis receives worldwide rights to develop and commercialize four additional bispecific programs, with Xencor eligible to "opt in" to one of these programs in the U.S..