On April 24, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments (Press release, AstraZeneca, APR 24, 2018, View Source [SID1234525609]). This randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, versus standard-of-care chemotherapy (SoC) in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).

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In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to SoC. Activity and safety of monotherapy arms of sub-study B were consistent with prior published data.

Sub-study A was not powered for statistical significance; however, Imfinzi monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy.

Full data from the ARCTIC trial will be presented at a forthcoming medical meeting.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in this heavily pre-treated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting."

AstraZeneca recently received approval from the US FDA for Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

NOTES TO EDITORS
About ARCTIC

The ARCTIC trial was a randomised, open-label, multi-centre, global Phase III trial containing two sub-studies: sub-study A (1:1 randomisation of patients with PDL1-high tumours to Imfinzi (durvalumab) vs. SoC) and sub-study B (2:3:1:2 randomisation of patients with PDL1-low/negative tumours to Imfinzi monotherapy, Imfinzi plus tremelimumab or tremelimumab vs SoC). Tumour PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay with PD-L1 high defined as ≥25% of tumour cells with membrane staining.

About Imfinzi

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In February 2018, Imfinzi received US FDA approval for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi also received accelerated approval in the US for the treatment of patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new medicine, as a first-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

About tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicines that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in an extensive clinical-trial programme in combination with Imfinzi in NSCLC, locally-advanced or metastatic urothelial carcinoma, head and neck cancer, liver cancer and blood cancers.

On April 24, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reported that its first quarter 2018 financial results will be released after market close on Thursday, May 10, 2018 (Press release, Coherus Biosciences, APR 24, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2344193 [SID1234525630]). Starting at 4:30 p.m. EDT, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing first quarter 2018 financial results, we will post them on the Coherus BioSciences website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, May 10, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 2767588
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On April 24, 2018 Autolus Limited, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the execution of a license agreement under which Autolus has acquired global rights from UCL Business plc (UCLB), the technology-transfer company of University College London (UCL), to develop and commercialize a novel CD19 chimeric antigen receptor (CAR) T cell therapy with novel targeting properties for the treatment of B cell malignancies (Press release, UCLB, APR 24, 2018, View Source [SID1234525647]).

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The product candidate, which we have designated as AUTO1, is an investigational therapy in which a patient’s T cells are genetically modified to express a novel CD19-specific CAR designed to reduce side effects related to cytokine release syndrome (CRS). CD19 is a protein expressed by B-cell lymphomas and leukaemias. CD19 CAR T cells have proven effective in treating leukaemia and lymphoma, with efficacy dependent on engraftment and expansion of CAR T cells. However, rapid activation and expansion of CAR T cells can result in CRS, which in some cases can be life-threatening, particularly for elderly patients and patients with higher tumour burden that have poor tolerance for toxicity. Furthermore, excessive activation of CAR T cells can lead to cell exhaustion and limit their persistence.

AUTO1 is currently the subject of two Phase 1 studies, one in paediatric acute lymphoblastic leukaemia (ALL) and the other in adult ALL*. AUTO1 has been designed to recognise CD19 with a fast-off binding kinetic, which allows CAR T cells to efficiently recognize cancer cells, inject cytotoxic proteins to initiate the natural self-destruction process present in all human cells and then rapidly dissociate from them in order to engage the next cancer cell – a process also known as serial killing. We believe that avoiding prolonged residence on targeted cells may minimize excessive activation of CAR- T cells and reduce toxicity and CAR T cell exhaustion. In a UCL Phase 1 clinical study (CARPALL) in paediatric ALL patients evaluating the properties of AUTO1, investigators observed levels of efficacy similar to those in other reported studies, without observing grade 3 or 4 CRS and without the need to administer immunosuppressive drugs. Data from the CARPALL study were presented at the 2017 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)**.

Dr Martin Pule, Chief Scientific Officer of Autolus Limited and Senior Lecturer in Haematology at UCL, commented:"Current CARs in the clinic are designed with high affinity binders that can engage the CD19 target for an extended period of time. This can lead to excessive T cell activation and cytokine release, as well as exhaustion of the T cell.We developed a CD19 CAR that is designed to bind to its target with a fast on-rate but then releases quickly, which is more similar to naturally occurring T cell activity. The initial clinical data supports the premise that this kinetic profile reduces toxicity and increases CAR T cell engraftment."

Dr Christian Itin, Chief Executive Officer of Autolus Limited, added:"This licensing arrangement represents an exciting opportunity for Autolus as we continue to expand our broad pipeline of clinical-stage T cell programs, with clinical trials currently ongoing for five programmes in six indications. With AUTO1, we are collaborating with UCLB in an ongoing trial in adult ALL patients and also expect to leverage the improved safety profile of the CD19 binder in future generations of our programmed T cell therapies for the treatment of patients with B cell malignancies."

Cengiz Tarhan, Managing Director of UCLB, said:"The development of this product candidate represents the culmination of several years of research led by Martin Pule and his collaborators, drawing on funding from multiple government and charitable sources. UCLB is delighted to be able to partner with Autolus to support the continued development of this promising approach."

* Paediatric ALL "CARPALL Study": View Source and adult ALL "ALLCAR19 Study": View Source;
**Abstract: View Source;

Media Contact:

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Julia Wilson
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On April 24, 2018 Enzo Biochem, Inc. (NYSE: ENZ) and its subsidiary Enzo Life Sciences, Inc. reported that the Patent Trial and Appeal Board has denied a petition filed by Hologic, Inc. (Nasdaq: HOLX) for inter partes review, a procedure for challenging the validity of patent claims, against U.S. Patent 6,221,581. Enzo Life Sciences, Inc. is asserting U.S. Patent 6,221,581 in patent infringement litigation against Hologic, Inc., Grifols Diagnostic Solutions, Inc., and Grifols S.A. in the U.S. District Court for the District of Delaware (Press release, Enzo Biochem, APR 24, 2018, View Source [SID1234525631]).

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On April 24, 2018 Cedilla Therapeutics, a new biotechnology company broadening the reach of small molecule therapeutics by discovering and exploiting unique insights into protein stability, reported that its launched $56.2 million in Series A funding from Third Rock Ventures (Press release, cedilla therapeutics, 24 24, 2018, View Source [SID1234525649]).

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Cedilla is leveraging a growing understanding of the principles that dictate protein stability and applying those principles to target proteins that drive cancer and other diseases. Cedilla’s integrated product engine includes target-centric and unbiased approaches and is designed to produce small molecule therapeutics that degrade protein targets. Although degradation by small molecules has been observed serendipitously, degradation as a mechanism of action has not been pursued systematically in small molecule drug discovery.

Led by a veteran team with extensive drug discovery experience, Cedilla harnesses existing protein stability mechanisms that are upstream of ubiquitination and do not rely upon engineered recruitment of the cell’s degradation machinery.

"We are launching Cedilla at a time of rapidly growing insight into the mechanisms underlying protein stability," said Alexandra Glucksmann, Ph.D., Cedilla’s president and chief executive officer. "We have designed a systematic approach to discover the rules that govern protein stability, which we will apply to find new points of therapeutic intervention. Our integrated product engine allows us to prosecute any protein of interest and to deliver precisely targeted therapeutics to patients in need."

Cedilla’s small molecule drug discovery focuses on the transitions between stable and susceptible protein states to develop targeted therapies. Cedilla is building an integrated and multi-faceted product engine to enhance endogenous degradation pathways. Approaches include:

Direct ligand-induced degradation triggered by the binding of small molecules to target proteins
Identification and disruption of stabilizing protein-protein interactions
Discovery of upstream regulators that modulate the stability of target proteins
Implementation of large-scale proteomics to map protein susceptibility
"We are initially focused on oncology targets. We also believe our small molecule approach is broadly applicable, for example to access targets in the central nervous system," said Brian Jones, Ph.D., Cedilla’s chief scientific officer.

The Cedilla management team includes recognized leaders in discovery chemistry, translational oncology research, molecular and cellular biology and company building. CEO Alexandra Glucksmann was a founding scientist at Millennium Pharmaceuticals and Cerulean Pharma and founding employee and chief operating officer at gene editing company Editas Medicine, Inc. Brian Jones, Cedilla’s chief scientific officer, has led the molecular discovery behind more than 20 investigational new drug (IND) applications across several therapeutic areas, and most recently served as head of discovery chemistry at Novartis Institutes for BioMedical Research in Cambridge. Other company leaders include Andres Tellez, Ph.D., senior director of business and strategy; and Dale Porter, Ph.D., vice president and head of biology.

Cedilla’s scientific founders are distinguished academics recognized for expertise in regulation of protein stability, cancer biology, proteomics and protein structure and dynamics. They include:

Alan D’Andrea, M.D., a professor at Harvard Medical School and director of the Center for DNA Damage and Repair at Dana-Faber Cancer Institute
Steve Gygi, Ph.D., a professor of cell biology at Harvard Medical School
Matthew Jacobson, Ph.D., a professor at the University of California, San Francisco School of Pharmacy
William Kaelin, Jr., M.D., a professor at the Dana-Farber Cancer Institute and Harvard Medical School and investigator of the Howard Hughes Medical Institute
Jack Taunton, Ph.D., a professor at the University of California, San Francisco School of Medicine