On November 26, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has initiated a Phase I/II clinical study to assess the safety, tolerability and activity of Oraxol in combination with an anti-PD1 antibody (pembrolizumab) in patients with advanced solid malignancies, in collaboration with Mayo Clinic (Press release, Athenex, NOV 26, 2018, View Source;p=RssLanding&cat=news&id=2378119 [SID1234531608]).

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Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Pembrolizumab is a checkpoint inhibitor approved by the United States Food and Drug Administration (FDA).

The study (KX-ORAX-011) is a Phase I/II study being conducted in patients with urothelial, gastric/gastroesophageal or non-small cell lung cancer that have previously failed treatment with a checkpoint inhibitor. The primary outcome measures are tumor response rate and determination of maximum tolerated dose, while the secondary outcome measures include progression free survival, overall survival, duration of response and pharmacokinetics.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "Oraxol has an excellent pharmacokinetic profile. Early studies showed that Oraxol, given without concomitant steroids, has the potential to offer a better efficacy and safety profile when compared with traditional intravenous paclitaxel. We are excited to test the hypothesis that a combination of Oraxol with checkpoint inhibitors will achieve a good efficacy and safety profile in patients who have already failed prior checkpoint inhibitor treatment."

Dr. Johnson Lau, Chief Executive Officer of Athenex, stated, "The recent approval by the FDA of an anti-PD1 drug in combination with carboplatin and paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer serves as recognition of the synergy of immunotherapy in combination with chemotherapeutic drugs. We believe that Oraxol may be an excellent choice in combination with cancer immunotherapy and success in this study could be a major milestone, reinforcing the Company’s commitment to delivering safe and effective innovative therapies to cancer patients."

For more information about the study, please visit View Source;rank=7.

Oraxol is currently also being tested in combination with ramucirumab (an anti-VEGF-R2 monoclonal antibody) in a Phase I/II study in patients with gastric cancer. Athenex reported earlier in the year the encouraging results in the first cohort of patients.

The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi

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