On November 27, 2018 C4X Discovery Holdings plc (AIM: C4XD), a pioneering drug discovery company, reported that it has entered into a discovery partnership with LifeArc, one of the UK’s leading medical research charities (Press release, LifeArc, NOV 27, 2018, View Source [SID1234531656]). C4XD and LifeArc will join forces to progress medicinal chemistry efforts on a novel, commercially attractive programme with applicability across oncology and inflammation indications. The undisclosed target originated from LifeArc’s extensive partnerships in early-stage academic research.

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The partnership will combine leading drug discovery expertise from both organisations, including application of C4XD’s unique and proprietary ligand-focussed conformational analysis platform, Conformetrix, to LifeArc’s extensive background and experience in the programme. The aim is to develop oral, potent and selective small molecule drug candidates against the undisclosed target suitable for pre-clinical out-licensing to a clinical development partner and, ultimately, to deliver a novel treatment in an area of high unmet clinical need.

This discovery partnership adds a high value programme to C4XD’s portfolio. Furthermore, it demonstrates continued progress against its stated strategy of utilising its cutting-edge drug discovery engine, and establishing productive partnerships, to develop novel small molecules against targets with high partnering interest. Terms of the agreement are undisclosed.

Dr Clive Dix, CEO of C4X Discovery, said: "LifeArc is a highly-respected medical charity with access to world-leading academic research for conditions where there is a clear need for new treatments coupled with deep experience in drug discovery. This partnership not only demonstrates the potential of our Conformetrix platform, it also highlights our strategic approach of accelerating towards a diversified portfolio of pre-clinical assets for out-licensing. We are delighted to be working with the LifeArc team and look forward to a successful outcome and continuing to build on our strategic relationship."

Dr Justin Bryans, LifeArc’s Executive Director, Drug Discovery, added: "LifeArc is delighted to partner with C4XD. Our new partner’s expertise in the rapid design and analysis of novel small molecule therapeutics complements LifeArc’s drug discovery expertise. C4XD’s focus on diseases with high unmet medical need is entirely in line with our objective of ensuring that innovative life sciences technologies progress along their development pathway towards the patients who so desperately need them."

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.

On November 27, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming ICI Europe Summit 2018 in Berlin, Germany on Wednesday, November 28, 2018 at 9.30 AM, CET (Press release, Personalis, NOV 27, 2018, View Source [SID1234531655]).

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The presentation, entitled "Enabling Multidimensional Biomarker Discovery: Interrogating the Tumor, its Microenvironment, and Neoantigens with ACE ImmunoID," will discuss how the Personalis Platform overcomes the limitations associated with conventional NGS approaches that are used in translational research and the clinical development of new oncology therapeutics. The presentation will also introduce Personalis’ new ImmunoID NeXT Platform.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Erin Newburn, PhD, Associate Director, Field Applications Scientist

On November 27, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that it will host an analyst and investor luncheon event and webcast on Monday, December 3, 2018 at 12:00 p.m. – 1:30 p.m. PST in San Diego, California (Press release, Bellicum Pharmaceuticals, NOV 27, 2018, View Source [SID1234531652]).

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The event will follow the Company’s key data presentations at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including interim analyses of the overall results from the BP-004 trial in children with acute leukemias and nonmalignant blood diseases, as well as the comparator C-004 trial, a multicenter, observational study of similar pediatric patients receiving a matched unrelated donor (MUD) transplant. Featured speakers include Dr. Alice Bertaina, Associate Professor of Pediatrics (Stem Cell Transplantation), Lucile Packard Children’s Hospital at the Stanford School of Medicine, as well as Bellicum senior management.

A webcast replay of the event will be available on the News & Events section of the Bellicum website. An archived version of the webcast will be available for replay for at least two weeks following the event.

On November 27, 2018 Engitix Ltd, a company pioneering the development of both tissue-specific and disease-specific human extracellular matrix (ECM) for accelerating and improving the drug discovery process, reported it has closed a £5 million Series A financing, led by a private investor (Press release, Engitix, NOV 27, 2018, View Source [SID1234531649]).

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Engitix has validated its proprietary tissue-specific and disease-specific human ECM platform in determining drug efficacy in liver fibrosis through successful collaborations with a number of biotech and big pharma companies. With this new investment, the Company is now evolving its business model to in-house drug discovery, to develop a pipeline of candidate drugs targeting liver fibrosis and liver and pancreatic cancers.

Engitix was spun-out of the Institute for Liver and Digestive Health (ILDH), Division of Medicine, University College London (UCL) in 2016 by Dr Giuseppe Mazza, an inventor of decellularization protocols for human liver and other tissues, and Professor Massimo Pinzani, Director of ILDH and a world-renowned expert in the field of liver fibrosis. The Company acquired an exclusive license in 2017 from UCLB, UCL’s commercialisation company, to enabling ECM patents and other intellectual property.

The Company’s mission is to increase the efficacy and to the reduce cost of later stage drug failure by establishing more advanced platforms for drug target identification and validation in which healthy and diseased cells can be tested with potential therapeutic agents within their natural physiological and pathological microenvironment.

A key current limitation in developing more effective treatments in fibrosis and various solid cancers has been the failure to include human ECM in experimental models, with the majority of compounds failing in late stage clinical trials because of lack of efficacy.

The Company plans to double the size of its R&D team, recruiting at least an additional 10 scientists in London in the fields of drug discovery, bioinformatics and immune oncology, as well as establishing a presence in Boston, Massachusetts, USA.

Giuseppe Mazza, PhD, Co-Founder and Chief Executive Officer, said: "The traditional drug discovery process in fibrosis and solid tumours relies on artificial in vitro substrates and animal models. So far, these models have been shown to have limitations in providing efficient therapies for patients affected by these devastating diseases. The Engitix platform technology has already shown we can revolutionise our current understanding of human diseases while discovering more realistic targets for future drug development."

Steve Arlington, PhD, a Fellow of the Royal Society of Medicine, former Lead Global Partner, Life Sciences and Pharmaceuticals at PWC and recently appointed Chairman, said: "Engitix is developing a unique platform with many research applications, which allows the study of human pathophysiology leading to the discovery of novel targets and therapeutics that will benefit patients through the acceleration of drug discovery in liver disease and cancer."

On November 27, 2018 Generex Biotechnology Corporation (OTCMKTS:GNBT) reported that it has signed a clinical trial agreement (CTA) with the NSABP Foundation, Inc. (NSABP), to manage a Phase II clinical trial of Pembrolizumab (Keytruda) in combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer (Press release, Generex, NOV 27, 2018, View Source [SID1234531648]).

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The clinical trial, sponsored by Generex and conducted in conjunction with Merck, is currently being reviewed by the FDA, and clinical operations including site qualification, drug shipment and packaging, and IRB review and approval are underway, with plans to enroll patients in the first quarter of 2019.

Eric von Hofe, President of Generex’s wholly-owned subsidiary Antigen Express, commented, "We are very pleased to be working with the NSABP Foundation on this important trial combining AE37 and Keytruda in triple-negative breast cancer patients. The extensive expertise of the NSABP Foundation and their network of sites and investigators will be a great asset in this development effort."

Generex EVP of R&D Richard Purcell commented, "This contract with our research partners at the NSABP Foundation provides cost and timeline certainty to our AE37 development program in combination with Keytruda. We look forward to our continued collaboration with Merck and the NSABP Foundation research team."

Previously, the Company reported that it filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer.

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat cancer in women with certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

AE37 does not directly target HER2, but instead acts as a vaccine to activate the immune system to recognize the HER2 protein that is expressed on cancer cells as foreign.

AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response