On November 26, 2018 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics reported that it will present at the 30thAnnual Piper Jaffray Healthcare Conference (Press release, Sutro Biopharma, NOV 26, 2018, View Source [SID1234531607]).

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Details of the presentation are as follows:

30thAnnual Piper Jaffray Healthcare Conference

Date: Tuesday, November 27, 2018

Location: New York, NY

Presentation Time: 3:30 PM ET

A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

On November 26, 2018 Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) reported that it has received a European Commission decision granting a marketing authorisation to POTELIGEO (Generic name: mogamulizumab), a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy (Press release, Kyowa Hakko Kirin, NOV 26, 2018, View Source [SID1234531606]).
MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin’s lymphoma.

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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), adopted a Positive Opinion recommending approval of the marketing authorisation for POTELIGEO in September 2018.

The European Marketing Authorisation is valid in the 28 countries of the European Union and in Norway, Iceland and Liechtenstein. Kyowa Kirin plans to launch POTELIGEO in various markets in Europe from 2019. Kyowa Kirin International PLC, a Kyowa Hakko Kirin Group company, is responsible for commercialising POTELIGEO in Europe.

"With this approval, now there is a new option for the patients with mycosis fungoides (MF) or Sézary syndrome (SS) across Europe," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Kirin. "I’m delighted about the European Commission’s decision which is strategically important for us to realise our mid-term business plan and our goal as a global specialty pharmaceutical company."

Tom Stratford, CEO of Kyowa Kirin International, said: "Mycosis fungoides (MF) and Sézary syndrome (SS) are horrible conditions which patients literally wear on their skin. The granting of this marketing authorisation is encouraging news for those across Europe who live with these conditions every day and we look forward to making POTELIGEO available for patients and clinicians across Europe."

"POTELIGEO offers a new approach to tackling the underlying disease pathophysiology of mycosis fungoides (MF) and Sézary syndrome (SS). By targeting CCR4-expressing T cells in blood and skin we could have a new option to manage patient symptoms." Said Professor Martine Bagot, Head of the Department Dermatology in Hospital Saint Louis, Paris.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

On November 26, 2018 SmartTarget Ltd, a spinout of UCL (University College London) that has developed a CE-approved device for precision prostate biopsy and focal therapy, is reported the appointment of Bruce Lynn as its CEO (Press release, UCLB, NOV 26, 2018, View Source [SID1234531605]). Mark Kirby who has held the role of interim CEO, steps up to the role of Chairman of the board.

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Lynn is a 30 year veteran of the software industry having built a range of businesses including Kenan Systems UK, Microsoft UK digital technology, and Red Bee Piero. Most recently he has been working in the medical imaging sector with a number of organisations including Brandon Medical, Enteric HTC, Motilent, and Forclarity. Lynn commented "Real-time enhancement of imaging in surgery is poised at a major inflection point. Whereas ‘sci-fi’ technologies such as tele-robotics and augmented reality will no doubt play a part in the operating room of the future, the theatre is already seeing massive benefits in patient outcomes and cost of delivery by applying innovative modelling software to traditional clinical interventions. SmartTarget has successfully cracked one of the most demanding and requested technical challenges which is the mapping of high quality diagnostic imaging such as mp-MRI onto a lower quality imaging modality that is available to the clinician during the intervention, such as ultrasound, whilst accommodating dynamically and accurately for movement and deformation in the target organ even during the procedure." SmartTarget Director and UCLB Senior Business Manager Marina Santilli commented, "We are delighted to welcome Bruce to the SmartTarget team as we look to the company to capitalise on its best in class fusion software for prostate imaging for better informed biopsy and treatment targeting. The company’s strong academic pedigree and ongoing links with UCL’s medical imaging researchers is an asset that we hope to exploit further as Bruce brings his significant industry experience to develop a roadmap and vision that aims to bring all clinicians the benefit of advanced imaging into their operating room."

On November 26, 2018 CBT Pharmaceuticals (CBT) and Zhejiang Bossan Pharmaceutical Co., Ltd (Bossan) reported that they have entered into a clinical collaboration and license agreement to develop their respective assets in combination with each another (Press release, CBT Pharmaceuticals, NOV 26, 2018, View Source [SID1234531604]). The license agreement grants CBT exclusive, worldwide rights outside of Greater China to develop and commercialize ES-072, Bossan’s novel epidermal growth factor receptor (EGFR) inhibitor, in combination with CBT’s proprietary c-Met inhibitor (CBT-101) and anti-PD1 antibody (CBT-501).

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"CBT and Bossan share the desire to pool our respective development compounds on an exclusive, worldwide basis to develop safe and efficacious regimens that may lead to approval for the treatment of a variety of cancers," said Guo-Liang Yu, PhD, CBT Global Chief Executive Officer and Venture Partner, OrbiMed. "As demonstrated by our commitment to evaluate combination therapy with the recent announcement of our APOLLO program, we continue to investigate our assets in combination with other plausible agents with sound mechanistic and scientific rationale, potentially yielding promising results in the clinic."

"Bossan is committed to reinforcing the foundation of lifesaving breakthroughs with new ideas. CBT’s assets have shown promising preclinical and early stage clinical data, and we believe that the synergy of our combined assets may lead to improved outcomes for solid tumor cancer patients," added Bossan Chief Executive Officer, Dr. Hongguang Xia.

CBT and Bossan intend to jointly develop a collaboration product and conduct joint clinical trials of CBT’s c-Met inhibitor (CBT-101), and/or anti-PD1 antibody (CBT-501), in combination with Bossan’s EGFR inhibitor (ES-072). Under the terms of the agreement, CBT will be responsible for conducting clinical trials globally outside of Greater China. Both a Joint Steering Committee and Joint Clinical Development Subcommittee will be formed to oversee and coordinate research, development, manufacturing, regulatory and commercial activities.

About ES-072

ES-072 is a covalent, irreversible, mutant-selective EGFR inhibitor that has nanomolar inhibitory potency against EGFR (L858R, ex19del) and EGFR T790M. Pre-clinical data suggests that ES-072 is able to cross the blood brain barrier. ES-072 is currently in an ongoing Phase 1 clinical trial for non-small cell lung cancer (NSCLC) patients with mutant EGFR in China.

About CBT-101

CBT-101 is a novel, small molecule drug that targets the epithelial to mesenchymal transition (EMT) pathway that is dysregulated in several tumors. It is a specific inhibitor of the c-Met receptor. CBT-101 has demonstrated tumor inhibitory effect in a variety of human primary c-Met amplified gastric, hepatic, pancreatic and lung cancer xenograft animal models with c-Met fusions, mutations or amplifications. In China, CBT-101 is referred to as PLB1001 where it is being developed by CBT’s partner Beijing Pearl Biotechnology Co. Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: Combination NCT03655613; Single Agent NCT03175224, NCT02896231, and NCT02978261.

About CBT-501

CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. It has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti-PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile with very low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity. In China, CBT-501 is referred to as GB226 where it is being developed by CBT partner Genor BioPharma Co. Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: NCT03053466, NCT03374007, NCT03502629, NCT03623581, and NCT03639181

On November 23, 2018 Kancera AB (publ) reported that unique blockers of the Fractal System have been patented. From the patented blockers, Kancera intends to further develop a new drug candidate, which is estimated to take about 12 months (Press release, Kancera, NOV 23, 2018, View Source;releaseID=1593528 [SID1234531596]).

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• Kancera provided an operational update for the Fractalkine project as follows •Research results show that blockade of the Fractal system can be expected to protect both heart and kidney function in inflammation

• Clinical studies focusing on cardiovascular inflammation of myocardial infarction are expected to start in the first half of 2019

• Kancera’s research in cancer continues with a focus on lymphoma (biomarker study scheduled for completion in the fourth quarter of 2018) and ovarian cancer (EU-funded preclinical research), while the Vinnova-funded study of neuroblastoma has been reported and completed.

• Kancera announced that the company is reorganizing to focus on Fractalkine projects.

• Kancera announced that results of cooperation with Karolinska Institutet were published in the journal Nature Communications under the title "Targeting PFKFB3 radiosensitizes cancer cells and suppresses homologous recombination".

SIGNIFICANT EVENTS AFTER THE END OF THE THIRD QUARTER

• Kancera has reported that the company has registered a patent application (EP18205819.8) for a third series of novel substances that selectively inhibit the enzyme HDAC6 for the treatment of inflammation and cancer

.• In the framework of EU research program Horizon 2020, Kancera has been awarded a research grant of a total of approximately 250,000 Euro for funding a doctoral student in order to explore the role of the Fractalkine system in the development of pain in arthritis.

• Kancera has announced that terms have been developed for shareholders’ investment decisions in the company by Global Corporate Finance Inc. (GCF), New York. The investment, which covers a maximum of SEK 60 million over 30 months, is intended to take place in tranches (rounds) of which Kancera determines the timing.

• Kancera hereby provides a status update for the Fractalkine project:

New effect study in animal model of myocardial infarction showed that lower doses than expected give a significant cardiovascular effectssww
Preliminary results from the GLP toxicology study showed that the calculated effective dose of KAND567 was safe (final results from this study are expected in January).
Phase 0 study in lymphoma patients will be completed in December and the analyzes are expected to be completed in January 2019
STATEMENT FROM THE CEO

In the Fractalkine project, we have strengthened our patent protection against competition and conducted a series of studies aimed at both preparing for Phase IIa cardiovascular patients and evaluating the possibility of an effect on blood cancer (lymphoma).

The protection has been further strengthened after our patenting of a new series of Fractalkine blockers that allow for the development of several independent products within the project.

Prior to the cardiac study in humans, the choice of intravenous dosing with KAND567 has been evaluated for efficacy and safety. The effect has been evaluated in a disease model of myocardial infarction and safety in a toxicological GLP study. The efficacy study showed that lower doses than expected provide a significant heart-protecting effect. Preliminary results from the toxicology study provide evidence pointing towards the safety of the calculated effective dose of KAND567 (final results from this study are expected in January). The next step in the preparation is the start of manufacturing KAND567 for intravenous treatment in clinical trials, which will occur within a few weeks. This means that the application for authorization for implementation of Fas Ib is planned to be submitted to the Medical Products Agency during the first quarter and completed during the second quarter of 2019 and that the corresponding Phase IIa application is scheduled for submission during the second quarter.

In May, we started a biomarker study (Phase 0) in lymphoma patients together with partners at Karolinska Hospital and the Institute. The aim of the study is to investigate whether there are groups of lymphoma patients in which the Fractalkine system is activated and possibly pervasive in the disease. Recruitment of patients has proceeded at a high rate in parallel with immunological analysis of blood samples. This means that sample collection can be completed in December and be analyzed in January. The results will determine whether continued evaluation of the role of the Fractalkine system in cancer continues toward lymphoma or focuses on the EU-funded solid tumor research project.

Interest in how Fractalkine affects various diseases in humans increases with continuous research progress, in the field of dementia and nerve pain amongst others. This has resulted in an invitation to participate in a further EU-funded research project with European research groups and pharmaceutical companies with the above focus. Kancera has participated in the application for this now approved EU project, starting in the spring of 2019.

The fact that Kancera is developing in the right direction we believe also forms the basis for the interest from the family-owned company GC Finance to invest in the company. The intention is to use capital injection from GC F (to be decided by an extraordinary general meeting) to expand to evaluate additional indications for the portfolio of Fractalkine blockers, expand clinical studies and for operations.