Bicycle Therapeutics and Cancer Research UK to Collaborate on Development of New Bicycle® Immuno-oncology Candidate, BT7401

On January 7, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research, in which Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase IIa clinical study (Press release, Bicycle Therapeutics, JAN 7, 2020, View Source [SID1234552799]).

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"The modular nature of the Bicycle platform enables a number of opportunities to generate new therapeutics that could address unmet need in oncology and other serious diseases," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle. "This new collaboration marks yet another initiative designed to help us bring a potentially important Bicycle-based therapy to patients more efficiently. We are excited to extend our relationship with Cancer Research UK by collaborating with them on BT7401. Cancer Research UK is a partner of choice, with a broad network of collaborators and extensive expertise in cancer treatment. Through our collaboration, we believe we will be able to characterize the biologic and therapeutic profile of BT7401, which we’re pleased to add to our growing portfolio of novel immuno-oncology assets."

Dr. Nigel Blackburn, Cancer Research UK’s director of drug development, said: "We’re delighted to be partnering again with Bicycle, building on our continuing relationship. Based on the preclinical data, we believe that BT7401 could offer improved anti-tumor activity with fewer side effects compared with antibody-based approaches, which so far have been limited by toxicity."

Dr. Blackburn continued: "Looking to the future, we believe BT7401 has the potential to open up new treatment options for the large numbers of patients who stop responding to checkpoint inhibitors, and we look forward to working with Bicycle in this new endeavor."

BT7401 is a chemically synthesized, multivalent small molecule agonist of CD137, comprised of Bicycles connected by stable linkers through a central hinge. Though prior programs using antibodies to agonize CD137 have demonstrated robust and durable anti-tumor effects, they have been limited by severe hepatotoxicity observed in clinical trials. Preliminary toxicology studies suggest BT7401 may circumvent this limitation. In addition, BT7401 has shown significant pharmacologic activity in preclinical models. These findings indicate that BT7401 may offer an improved therapeutic index compared to that of antibody-based approaches.

Under the terms of the Clinical Development Partnerships agreement, Cancer Research UK’s Centre for Drug Development will fund and sponsor development of BT7401 from current preclinical studies through the completion of a Phase IIa trial. Bicycle retains the right to advance the BT7401 program further, at which point an undisclosed payment split between cash and equity, success-based milestones and royalty payments would be made to Cancer Research UK.

PhoreMost and Boehringer Ingelheim enter multi-project drug discovery collaboration

On January 7, 2020 PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, reported it has entered into a multi-project drug discovery collaboration with Boehringer Ingelheim, one of the world-leading pharmaceutical companies developing innovative therapies for diseases with unsatisfactory treatments (Press release, PhoreMost, JAN 7, 2020, View Source [SID1234552798]). Under the terms of the agreement, PhoreMost will receive an upfront payment and research funding together with downstream success-based milestones. Further financial terms are not disclosed.

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PhoreMost will deploy its in-house expertise and next-generation phenotypic screening platform, SITESEEKER, towards disease relevant pathways nominated by Boehringer Ingelheim. Novel targets identified will be further validated and characterised by Boehringer Ingelheim as part of its internal Discovery Research pipeline. Boehringer Ingelheim’s Research programme is active in the fields of immunology and respiratory diseases, cardiometabolic diseases, oncology research and immuno-oncology, as well as diseases of the central nervous system.

The SITESEEKER platform is based on PhoreMost’s core proprietary protein interference, or ‘PROTEINi’, technology. Using SITESEEKER, PhoreMost probes the entire proteome in a live cell environment for novel druggable targets linked to any chosen disease, using the vast 3-D shape diversity of natural protein fragment (sub-domain) libraries. This enables the systematic unmasking of cryptic druggable sites, directly linking them to useful therapeutic functions.

Dr Chris Torrance, CEO of PhoreMost, said: "We are delighted that Boehringer Ingelheim has chosen to work with PhoreMost to enhance its drug discovery pipeline with attractive biological starting points. The collaboration is further recognition of the ability of PROTEINi and SITESEEKER to identify novel targets, and we look forward to working with the Boehringer Ingelheim team on these projects."

Synaffix announces expansion of license agreement with Shanghai Miracogen Inc. to a second ADC candidate

On January 7, 2020 Synaffix B.V., a biotechnology company focused on enabling antibody-drug conjugates (ADCs) with superior therapeutic index based on its proprietary ADC technologies, reported that Shanghai Miracogen Inc., a Chinese biotechnology company with a clinical-stage pipeline of ADCs, has expanded its existing collaboration by taking a license to develop and commercialize a second product candidate (Press release, Synaffix, JAN 7, 2020, View Source [SID1234552797]).

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Under the terms of the agreement, Miracogen has been granted non-exclusive rights to Synaffix’s proprietary GlycoConnect and HydraSpace ADC technologies for use in this second clinical candidate. Synaffix is eligible to receive upfront, milestone and royalty payments tied to this new program. Further financial details were not disclosed.

The original agreement was announced in April 2019, with Miracogen responsible for the research, development, manufacturing and commercialization of its ADC product, and Synaffix responsible for the manufacturing of components specifically related to its proprietary ADC technologies.

Peter van de Sande, CEO of Synaffix said:

"This expansion of our licensing agreement has resulted from the rapid and successful progression of Miracogen’s first ADC program with us and our strong working relationship. With six announced ADCs now under clinical or preclinical development based on Synaffix platform technologies, this expansion serves as further testament to the maturity of our proprietary ADC technologies.

"We look forward to continuing to work closely with Miracogen to develop innovative ADCs with enhanced therapeutic indexes for the treatment of cancer."

Mary Hu, CEO of Shanghai Miracogen added:

"Having worked with Synaffix over the past year and having seen highly positive results arising from the use of the GlycoConnect and HydraSpace technologies, we decided to expand the license agreement into a second ADC candidate. Using Synaffix’s platform, we hope to develop an additional ADC product candidate with an enhanced therapeutic index, and ultimately benefit cancer patients."

Notes to Editors

About GlycoConnect and HydraSpace

The clinical-stage GlycoConnect and HydraSpace technologies enable best-in-class ADCs with significantly enhanced efficacy and tolerability. GlycoConnect is the conjugation technology that exploits the native glycan for site-specific and stable payload attachment. HydraSpace is the compact and highly polar spacer technology. These technologies can be applied directly to any existing antibody without any protein sequence engineering and are compatible with all ADC payload classes.

The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect and HydraSpace to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

Y-mAbs Therapeutics To Present At 38th Annual J.P. Morgan Healthcare Conference

On January 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Claus Møller, MD, Ph.D., Chief Executive Officer of Y-mAbs Therapeutics will provide an overview and update on the company’s business at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Y-mAbs Therapeutics, JAN 7, 2020, View Source [SID1234552796]). The presentation will take place on Wednesday, January 15, 2020, at 4:30 PM Pacific Standard Time. The presentation can be accessed via a live webcast.

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Data from the Phase II Liver Cancer Study with Namodenoson will be presented at the ISCORT Conference by Dr. Stemmer

On January 7, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the principal investigator of the Company’s Phase II liver cancer study, Dr. Solomon Stemmer, will deliver a presentation titled "The Safety and Efficacy of Namodenoson in the Second-Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2 , Randomized, Double-Blind, Placebo-Controlled Trial" at the Israeli Society of Clinical Oncology and Radiotherapy (ISCORT) annual conference on January 8, 2020 11:00 am (Press release, Can-Fite BioPharma, JAN 7, 2020, View Source [SID1234552795]).

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Can-Fite’s completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with Child Pugh B7 (CPB7), the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint. The Company recently completed a successful End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA), in which the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval of Namodenoson in the treatment of HCC.

"The ISCORT is the most prestigious Israel oncology forum to discuss novel treatments in different malignancies and enable the creation of collaboration between leading investigators in the field. We are confident that Dr. Stemmer’s presentation will open the door for the participation of leading oncologists in the Company’s Phase III study", said Dr. Fishman, Can Fite CEO.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.