On December 16, 2016 Redx Pharma Plc is pleased to announce that it has presented the pre-clinical profile of its reversible Bruton’s tyrosine kinase (BTK) inhibitor RXC005 at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California, United States, on 5 December 2016 (Press release, Redx Pharma, DEC 16, 2016, View Source [SID1234524745]).

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Redx’s development candidate RXC005 is a novel, potent and selective, reversible BTK inhibitor with efficacy and equivalent potency against wild-type and cysteine-481 (C481) mutated BTK. First generation BTK inhibitors, such as Ibrutinib and Acalabrutinib, specifically target C481 within BTK and mutations at this site interfere with covalent drug binding. Several mutations have been reported and linked to cases of resistance that have emerged in patients with chronic lymphocytic leukaemia (CLL) progression following treatment with Ibrutinib. Redx’s reversible BTK inhibitor RXC005 aims to overcome this resistance mechanism by targeting both wild type and C481-mutated BTK.

The Company is progressing studies to prepare the RXC005 program for first-in-human clinical trials. The aim is to commence these trials late 2017.

Dr Neil Murray, CEO of Redx, said: We’re delighted to have presented the compelling pre-clinical profile of our reversible BTK inhibitor RXC005 at the ASH (Free ASH Whitepaper) 2016 meeting in San Diego.

RXC005 has the potential to become a potent therapy for chronic lymphocytic leukaemia patients by tackling the growing resistance to Ibrutinib treatment. We aim to initiate first-in-human clinical studies for RXC005 late 2017.

Further Details:
American Society of Hematology web site: View Source
Poster title: RXC005 (REDX08608), a Novel, Potent and Selective, Reversible BTK Inhibitor with Efficacy and Equivalent Potency Against Wild-Type and Mutant C481S BTK
Download the presentation poster: RXC005 (REDX08608) BTK Inhibitor

On Dec 15, 2016 Progenra, Inc. announced a new immune-oncology drug whose mechanism differs from available cancer immunotherapies Opdivo and Keytruda (Press release, Progenra, DEC 15, 2016, View Source [SID1234517432]). The findings, published by Progenra with Dr. Wayne Hancock, University of Pennsylvania School of Medicine, support a new immune-oncology antitumor strategy by inhibiting USP7, an enzyme that prevents immune activity against cancer in addition to supporting the growth of cancer cells . According to a commentary on this publication, inhibiting USP7 works on T cells to diminish immunosuppression, permitting the patient’s own immune system to eliminate cancer ("the data by Wang and colleagues proposes a potential immunotherapy against tumors by targeting USP7, which … breaks the immune tolerance in the tumor microenvironment"… "these preclinical findings suggest that USP7 targeting … as well as directly induce tumor cell apoptosis, could have practical significance in clinical applications").

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"We are pleased that Progenra’s unique UbiPro Drug Discovery Platform is gaining traction outside the US and that a major pharmaceutical company such as Ono has agreed to collaborate with Progenra on the ubiquitin and ubiquitin-like protein pathways"

"We are pleased that Progenra’s USP7 inhibitors, tested in several laboratories worldwide, can eradicate cancers by both tumoricidal and immunological mechanisms," said Tauseef Butt, President of Progenra. "We are excited to move USP7 inhibitors into clinical trial as single agents or combined with marketed immunological agents such as Opdivo and Keytruda."

Dr. Hancock added," Immunotherapy must do more than affect a single target, since those approaches help only about 20% of patients. Pharmacologic inhibition of USP7 allows direct targeting through the immune system, in a graded manner that has antitumor efficacy used alone or combined with one or more biologic agents.".

Progenra (www.progenra.com) aims to develop high value medicines exploiting protein regulatory pathways. Its early product portfolio addresses unmet needs in cancer, inflammation, and neurodegeneration. Utilizing its drug discovery platform, Progenra identifies novel modulators of its protein regulatory targets for drug development; the company’s discovery platform is complemented by internal target validation, cell proof of concept, and medicinal chemistry.

Dr. Wayne Hancock is Professor of Pathology/Laboratory Medicine at The University of Pennsylvania School of Medicine and Chief, Division of Transplant Immunology at the Children’s Hospital of Philadelphia. His multidisciplinary team focuses on improving outcomes of organ transplantation and cancer immunotherapy by modulating immune cell production and function.

On December 15, 2016 Cancer Research UK, Cancer Research Technology (CRT), and Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported an agreement to trial a first-in-class drug for cancers of high unmet need (Press release, Cancer Research Technology, 15 15, 2016, View Source [SID1234523174]).

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Cancer Research UK’s Centre for Drug Development (CDD) will sponsor and fund a Phase Ia and Phase Ib clinical trial for a drug called BT1718, a Bicycle Drug Conjugate (BDC) being developed by Bicycle Therapeutics, in patients with advanced solid tumours. BT1718 targets Membrane Type 1 Matrix Metalloproteinase (MT1-MTP) which is highly expressed in many solid tumours, including triple negative breast cancer and non-small cell lung cancer.

Dr. Udai Banaji, Principal Investigator for the Phase I trial, said: "I’m very excited to be involved in the first clinical study of BT1718. Based on the impressive pre-clinical data, I look forward to evaluating the clinical utility of BT1718, the first of a new class of agents that specifically targets tumour cells using a bicyclic peptide linked to an anticancer agent."

The trial will be co-managed by Cancer Research UK and Bicycle Therapeutics. Under the terms of the agreement, Bicycle retains the right to further advance the BT1718 programme, and can license the results of the trial for an undisclosed amount split between cash and equity, success based milestones and royalty payments to Cancer Research UK.

Dr Kevin Lee, chief executive officer of Bicycle Therapeutics, said: "Through this important collaboration we aim to advance BT1718 through Phase I trials, generating a robust dataset to drive the programme forward. We’re excited to have developed this innovative relationship with Cancer Research UK that allows us access to their extensive network of collaborators and world class expertise to fully explore the potential of this new and transformative class of treatment for cancer patients."

Dr Nigel Blackburn, Cancer Research UK’s, director of drug development, said: "Finding new ways to target difficult-to-treat cancers is a crucially important area of research and a priority for Cancer Research UK. Through this collaboration, we hope we can speed up the development of therapies for patients who urgently need new treatment options."

On December 15, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported the successful closing of the acquisition of 100% shares in Cyprotex PLC ("Cyprotex", AIM: CRX-GB), a specialist pre-clinical contract research organisation in ADME-Tox and DMPK headquartered in the UK (Press release, Evotec, DEC 15, 2016, View Source [SID1234517081]). The proposed acquisition was announced in detail on 26 October 2016.

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Following a scheme of arrangement regulated by the UK takeover code, all shares of Cyprotex have been acquired by and transferred to Evotec AG effective 14 December 2016 and the shares will this morning be cancelled from AIM. Evotec is paying £ 55.7 m (EUR 66.3 m; at an assumed £/EUR exchange rate of 1.19) in cash for the acquisition of all 26.1 million issued and to be issued Cyprotex shares and the funding of company debt mainly in the context of loan notes. The offer of 1.60 £ per Cyprotex share reflects a 9.4% premium to the VWAP of the past 30 trading days at AIM prior to the offer on 26 October 2016. MCF Corporate Finance, led by Ian Henderson, acted as Evotec’s exclusive financial adviser throughout the acquisition process.

Cyprotex, headquartered in the UK, was founded in 1999 and is publicly traded on AIM (CRX). The company currently has 136 employees working from sites at Macclesfield and Alderley Park, both of which are located near Manchester in the UK, and at Watertown, MA, and Kalamazoo, MI, in the USA. Cyprotex will continue to operate and serve its loyal client base in all currently existing segments under its brand name "Cyprotex" whilst employees and capabilities will be integrated into Evotec’s global drug discovery group, thereby leveraging both companies’ extensive partner networks and identifying further commercial synergies.

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: "We are pleased the acquisition has closed and we can now approach the exciting phase of welcoming Cyprotex’ employees and clients to our global drug discovery services platform. The addition of the market’s most industrialised ADME-Tox platform and proven expertise in in vitro ADME screening, mechanistic and high-content toxicology screening and predictive modelling to our offering substantially improves our ability to provide our alliance partners with access to the most comprehensive drug discovery platform. Cyprotex’ proven technology platform and its expert and dedicated employees perfectly augment Evotec’s business strategy and offering."

Dr Werner Lanthaler, Chief Executive Officer of Evotec, added: "The highest quality and completeness of our drug discovery platform is key to improve the efficiency in the process for our partners. With Cyprotex we make here an important next step. We warmly welcome the Cyprotex employees to the Evotec Group and look forward to working with them."

Evotec confirms its liquidity guidance for 2016. The Company expects liquidity to be at a similar level to the prior year, excluding any potential cash outflow for M&A or similar transactions. Based on current estimates, it is expected that the Cyprotex business will add approx. EUR 18-20 m in revenues in 2017 and will be accretive to Evotec’s 2017 EBITDA.

On December 15, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has submitted its pre-Investigational New Drug (pre-IND) meeting package to the U.S. Food and Drug Administration (FDA) for PharmaCyte’s therapy in inoperable locally advanced pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, DEC 15, 2016, View Source [SID1234517091]). PharmaCyte’s pre-IND submission follows its recent announcement that the FDA has granted PharmaCyte a pre-IND meeting for its pancreatic cancer therapy.

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The package provides the FDA with a full history of PharmaCyte’s therapy, including information on the previous preclinical studies and the clinical trials that were performed using the Cell-in-a-Box live-cell encapsulation technology combined with low doses of the chemotherapy drug ifosfamide. That combination makes up PharmaCyte’s pancreatic cancer therapy. The package also provides detailed information on the manufacturing process used to produce the Cell-in-a-Box capsules and a synopsis of the structure of the clinical trial that PharmaCyte plans to conduct in the U.S. and Europe in patients with inoperable LAPC.

The FDA’s response to the pre-IND submission will be provided after the pre-IND meeting. The regulatory agency’s response will serve as a roadmap in guiding PharmaCyte as it prepares the full IND application that must be deemed acceptable to the FDA before the clinical trial can begin.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "The submission of the pre-IND package is yet another major step that PharmaCyte has completed in its efforts to develop its pancreatic cancer therapy. We are looking forward to the pre-IND meeting and the FDA’s guidance as we prepare for our clinical trial in patients with inoperable LAPC where there is an unmet medical need we plan to address."