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 Evelo Biosciences, Inc. (NASDAQ:EVLO) ("Evelo"), a clinical-stage biotechnology company developing monoclonal microbials to engage immune cells in the small intestine and drive changes in systemic biology, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada) (Press release, Evelo Biosciences, NOV 27, 2018, View Source [SID1234531985]). The collaboration will evaluate EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in multiple cancer indications. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

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The planned Phase 1/2 trial will evaluate the safety, tolerability, immune response markers and overall response rates (ORRs) achieved with EDP1503 in combination with KEYTRUDA (pembrolizumab) in three groups of patients: microsatellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment. Evelo expects to commence this clinical trial in the first half of 2019 and plans to enroll up to 120 patients in this non-comparative, single-arm, multicenter clinical study.

‘’We are very pleased to collaborate with Merck, one of the world leaders in immuno-oncology, in our clinical investigation of EDP1503 in combination with Keytruda. We have shown preclinically that oral delivery of EDP1503 activates multiple systemic immune pathways across clinically validated mechanisms of tumor immune stimulation which are complementary to and potentially synergistic with checkpoint inhibitors," said Humphrey Gardner, M.D., FCAP, chief of medical oncology at Evelo. "These immune-activation properties of EDP1503, including upregulation of MHC Class I expression, increased production of CXCL9 and CXCL10, and augmentation of NK cell infiltration point to the potential to offer a treatment approach in tumors that have, to date, proved unresponsive to checkpoint inhibitor monotherapy, such as microsatellite stable colorectal cancer."

EDP1503 is currently being evaluated in an investigator-sponsored Phase 2a clinical trial in combination with KEYTRUDA in patients with metastatic melanoma (CT.gov: NCT03595683). First patient dosing in this study is expected by the end of 2018.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About EDP1503

EDP1503 is Evelo’s first monoclonal microbial oncology product candidate and is being developed under the umbrella of its exclusive worldwide license with the University of Chicago. Under this license, Evelo has exclusive patent rights related to the administration of microbes to treat cancer, including in combination with checkpoint inhibitors. The patent rights describe many genera of microbes and will provide broad patent protection. A US patent covering the combination of Bifidobacteria and checkpoint inhibitors to treat cancer was granted in January 2018. Preclinical data suggests that EDP1503 is active through different and complementary immune mechanisms beyond those targeted by checkpoint inhibitors. In preclinical models, EDP1503 alone stimulated upregulation of the immune response to tumors, delayed tumor progression and, when combined with a checkpoint inhibitor, showed additive effects in delaying tumor progression.

On November 27, 2018 Celgene Corporation (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) reported the completion of enrollment for the KarMMa pivotal study of bb2121, the companies’ lead investigational anti-BCMA CAR T cell therapy candidate for patients with relapsed and refractory multiple myeloma (Press release, bluebird bio, NOV 27, 2018, View Source [SID1234531638]). bb2121 is being developed as part of a Co-Development, Co-Promote and Profit Share Agreement between Celgene and bluebird bio.

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"We continue to be excited about bb2121 as a potential first-in-class BCMA-targeted therapy for patients with multiple myeloma," said Alise Reicin, M.D., President, Global Clinical Development for Celgene. "We would like to thank everyone who enabled this achievement, especially the patients and caregivers, and we congratulate the physicians and others involved in the KarMMa study, including our dedicated partners at bluebird bio. We look forward to seeing the data from this study and are progressing our broader bb2121 development program as we advance closer toward delivering this important new option to appropriate patients in need."

"We are committed to developing new treatment options to improve the care of patients with multiple myeloma, and completing enrollment of the KarMMa study moves us closer to this goal," said David Davidson, M.D., chief medical officer, bluebird bio. "As we advance our clinical studies of bb2121 in earlier lines of therapy in collaboration with our partners at Celgene, we remain very grateful to the patients, families and healthcare providers who have made this program possible."

KarMMa is a pivotal, open-label, single-arm, multi-center phase 2 study evaluating the efficacy and safety of bb2121 in patients with relapsed and refractory multiple myeloma. In November 2017, bb2121 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration and PRIority Medicines (PRIME) eligibility by the European Medicines Agency. The BTD designation and PRIME eligibility were based on preliminary clinical data from the phase 1 CRB-401 study.

The FDA action date for the bb2121 NDA is anticipated in 2020. bb2121 is currently an investigational therapy; safety and efficacy have not yet been established. bb2121 has not been approved for use by any health authority.

On November 27, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that Dr. David Ralph, Director of Drug Development and IP Manager of Navidea, will be presenting at the RSNA 104th Scientific Assembly and Annual Meeting, which is taking place November 25-30, 2018 in Chicago, IL (Press release, Navidea Biopharmaceuticals, NOV 27, 2018, View Source [SID1234531659]).

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The oral presentation will highlight an abstract evaluated and selected through a competitive, blind peer-review process. The presentation will focus on recent imaging results obtained from Kaposi Sarcoma patients who have received 99mTc-tilmanocept by either a subcutaneous or an intravenous route of administration.

Oral Presentation Details
Presentation Title: Planar and SPECT/CT Imaging in Human Immunodeficiency Virus (HIV) Subjects Diagnosed with Kaposi Sarcoma (KS) using Intravenous 99mTc-tilmanocept
Abstract: SSK19-06
When: Wednesday, November 28 at 11:20am CT
Where: McCormick Place, Chicago, IL
Room: S504AB

RSNA 2018 annual meeting provides a hands on experience with cutting-edge tech, including artificial intelligence, 3D printing and virtual reality. Sessions cover the latest research and provides a platform to enhance skills and network. Over 70,000 people will attend this annual meeting.

More details on the annual meeting, including the full agenda can be found at View Source

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.