Sarah Cannon Development Innovations Collaborates with Pivotal on Immuno-Oncology Trials

On April 25, 2018 Sarah Cannon Development Innovations reported a new strategic collaboration with Pivotal to expand access to novel immunotherapies in early phase clinical trials in Europe (Press release, Sarah Cannon Research Institute, APR 25, 2018, View Source [SID1234525708]). In late 2016, Sarah Cannon and Boehringer Ingelheim announced a strategic collaboration for a joint clinical development program in the U.S. for immune checkpoint inhibitors for the treatment of multiple difficult-to-treat cancers. Through Sarah Cannon´s collaboration with Pivotal, a European Contract Research Organization (CRO), patients in Europe will have greater access to innovative cancer therapies.

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"The combined expertise in drug development and clinical research excellence of Pivotal and Sarah Cannon will enable us to accelerate research and provide access to novel investigational agents," said Lourdes Huarte, PharmD, MBA, VP Regulatory and Clinical Operations, Pivotal. "We look forward to collaborating with these experts to impact the lives of people facing cancer throughout Europe."

Through Sarah Cannon Development Innovations, a full-service, oncology-focused CRO, Sarah Cannon provides comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. With Pivotal’s expertise as a European CRO, the organization will facilitate rapid patient enrollment into clinical trials across selected sites in Europe.

"The collaboration with Pivotal to expand clinical research access in Europe further advances Sarah Cannon’s mission to bring the latest therapies to patients close to home," said Dawn Sauro, President of Sarah Cannon Development Innovations. "Working together with Boehringer Ingelheim over the last two years has further accelerated drug development in immunotherapies that will continue to impact patients around the world."

The expansion of Boehringer Ingelheim and Sarah Cannon’s joint clinical development program with the incorporation of Pivotal’s deep knowledge of the European populations in the clinical trials field will address a critical need for many cancer patients. Immunotherapy is showing very promising results for patients with unmet medical needs such as melanoma and metastatic non-small-cell lung cancer among others. Immunotherapy has shown impressive response rates compared to standard chemotherapy, improving progression-free survival in this population with some patients experiencing long-lasting responses. This therapeutic approach is becoming available for more cancer populations, but despite these advances, there are still many cancer patients with unmet needs. The current trial program by Boehringer Ingelheim supported by Sarah Cannon as CRO, and to which Sarah Cannon expands the reach by collaborating with Pivotal, is focused on the clinical development of BI 754091 (anti- PD-1) and BI 754111 (anti-LAG- 3) monoclonal antibodies, immune checkpoint inhibitors that mobilize the patient’s immune system to defeat cancer.

"As part of our dedication to transforming the lives of cancer patients, we are pleased to see that Sarah Cannon expands its reach by collaborating with Pivotal to help speed development of novel immunotherapies," said Mehdi Shahidi, Global Medical Head Oncology, Boehringer Ingelheim. "The power of partnerships, such as the one Sarah Cannon and Pivotal are embarking on, brings together the best minds and capabilities to accelerate this dynamic area of research. This is in line with our goal to transform the lives of patients and help win the fight against cancer."

About Pivotal

Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognized the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the "doers" but also as the "co-thinkers" for their clients, through its strategic scientific advice. To date, we are the trusted advisor and counselor for many companies to deliver maximum value in their drug development programmes. We are a leading privately-held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.

Pivotal clients’ portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, and we have long-standing relations with over 188 clients. Pivotal has extensive experience across major therapeutic areas and phases I to IV. Our highly customized teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, rare diseases and early phases hub that enables us to tackle our customers most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our client’s preferred outsourcing solution partner.

For more information, please visit www.pivotal.es.

PATENT TRIAL AND APPEAL BOARD DENIES HOLOGIC CHALLENGE

TO ENZO BIOCHEM PATENT INVOLVED IN DELAWARE INFRINGEMENT CASE

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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Third Rock Ventures Launches Cedilla Therapeutics with $56 Million Investment to Target Protein Stability Using Small Molecule Therapeutics

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

Exicure Announces Chief Executive Officer, Dr. David Giljohann, Named to Endpoints News’ “Under-40s” Biopharma Executives List

On April 24, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported that the Company’s Chief Executive Officer, David Giljohann, Ph.D., has been recognized by Endpoints News as an outstanding up-and-coming biopharma professional under the age of 40 (Press release, Exicure, APR 24, 2018, View Source;p=RssLanding&cat=news&id=2344263 [SID1234525632]).

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Dr. Giljohann was Exicure’s founding scientist in 2011. He has served as Chief Executive Officer since November 2013 and on the Company’s Board of Directors since March 2014. He completed his Ph.D. in the laboratory of Dr. Chad A. Mirkin where he developed oligonucleotide-modified nanoparticles, including Exicure’s Spherical Nucleic Acid (SNA) constructs.

"It is an incredible honor to be recognized in Endpoints News’ under-40s biopharma professionals list," states Dr. Giljohann, 37. "I would like to see a dramatic change in how quickly we can design and develop drugs for patients in need, and this is a driving force for our team at Exicure. With three drugs now in the clinic, we hope that the advancement of our SNA technology can provide great promise for a broad range of chronic conditions and orphan diseases."

Dr. Giljohann has been recognized for his work with a Materials Research Society Gold Award, Baxter Innovation Award, Rappaport Award for Research Excellence, NSEC Outstanding Research Award, and as a finalist in the National Inventors Hall of Fame Collegiate Inventors Competition. Dr. Giljohann has contributed to over 25 manuscripts and over 100 patents and applications. He received his Ph.D. in 2009 from Northwestern University.

Arrowhead Pharmaceuticals to Webcast Fiscal 2018 Second Quarter Results

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.