On April 24, 2018 In conjunction with DURECT Corporation’s(Nasdaq: DRRX) reported that its first quarter 2018 financial results press release, you are invited to listen to a conference call that will be broadcast live over the internet on Wednesday, May 2, 2018 at 4:30 pm Eastern Time (1:30 pm Pacific Time) (Press release, DURECT, APR 24, 2018, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2344347 [SID1234525651]).

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A live audio webcast of the presentation will be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

On April 24, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on May 8, 2018, at 4:30 p.m. EDT to discuss its financial results for the fiscal 2018 second quarter ended March 31, 2018 (Press release, Arrowhead Pharmaceuticals, APR 24, 2018, View Source [SID1234525650]).

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 2895628.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 2895628.

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

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 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported results from the QUADRA study, which was designed to assess clinical benefit of ZEJULA treatment in heavily pre-treated patients with ovarian cancer (Press release, TESARO, APR 24, 2018, View Source [SID1234525646]). Results successfully achieved the pre-specified primary endpoint and demonstrated ZEJULA monotherapy activity in a biomarker selected patient population.

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Previous studies have shown PARP inhibitor activity in the late-line treatment of patients with BRCA mutations. QUADRA, a single arm study (n=461), was conducted to assess the activity of ZEJULA monotherapy in the fourth-line plus treatment of specific ovarian cancer patient populations. Of the 92% of QUADRA participants who were PARP inhibitor naïve, 15% had a BRCA mutation, over two-thirds were platinum resistant/refractory and 63% had received prior bevacizumab.

ZEJULA demonstrated activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive (n=45), with an objective response rate (ORR) of 29%, and duration of response (DOR) of 9.2 months. In patients who were fourth line or greater with BRCA mutations, including platinum-sensitive, resistant and refractory, (n=55), the ORR was 31% and the median DOR was 9.4 months.

At a starting dose of 300 milligrams of ZEJULA, the most commonly observed adverse events were consistent with prior clinical experience and included myelosuppression, which was generally managed via dose modifications. TESARO intends to discuss a biomarker focused regulatory submission with the U.S. Food and Drug Administration (FDA) for a potential supplemental New Drug Application (sNDA) in the second half of 2018.

"These results demonstrated that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations, which is the only treatment setting in which PARP inhibitors are approved today. In addition, the QUADRA data describe ZEJULA monotherapy activity in platinum-resistant/refractory patients, providing important context for our TOPACIO study of ZEJULA in combination with an anti-PD-1 inhibitor," said Mary Lynne Hedley, President and COO of TESARO. "With QUADRA data in hand, we continue to advance our mission to provide all patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA, and we are extremely grateful to the patients, caregivers, and investigators who took part in this study."

Beyond QUADRA, clinical trials of niraparib in ovarian cancer include:

First Line:

PRIMA: Monotherapy Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status expected to complete enrollment in Q2 2018; data anticipated in 2019
OVARIO: Combination Phase 2 trial assessing ZEJULA with bevacizumab for patients with newly diagnosed ovarian cancer
FIRST: Combination Phase 3 clinical trial of chemotherapy ± TSR-042, and ZEJULA in first-line ovarian cancer to be initiated in 1H 2018
Recurrent:

NOVA: Monotherapy Phase 3 trial for patients with platinum sensitive, recurrent ovarian cancer, regardless of biomarker status (complete; patients being followed for overall survival)
AVANOVA: Combination Phase 2 trial with bevacizumab for patients with recurrent ovarian cancer; anticipate data to be available in 2H 2018 to support data submission for a meeting held in 2019
Platinum-Resistant:

TOPACIO: Combination Phase 2 trial with anti-PD-1 for patients with platinum-resistant ovarian cancer or triple negative breast cancer (abstracts accepted for presentation at ASCO (Free ASCO Whitepaper))
Product Lifecycle:

A tablet formulation of ZEJULA is in development.
About the QUADRA Clinical Trial
QUADRA is an open-label, single arm trial designed to evaluate the safety and efficacy of ZEJULA in the treatment setting of ovarian cancer. Patients were enrolled and received a starting dose of 300 milligrams of niraparib once per day. The primary endpoint of this study was objective response rate (ORR) per RECIST in the fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive. Other endpoints include durability of response, disease control rate, progression free survival (PFS), overall survival (OS) and safety and tolerability.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.