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.

New Oncology Clinical Collaboration between Nektar and Takeda to Evaluate Combination of NKTR-214, a CD122-biased Agonist, and TAK-659, a Dual SYK and FLT-3 Inhibitor, in Liquid and Solid Tumors

On April 24, 2018 Nektar Therapeutics (NASDAQ:NKTR) reported that it has entered into a new clinical collaboration with Takeda Pharmaceutical Company Limited to evaluate Nektar’s investigational medicine, NKTR-214, with Takeda’s investigational medicine, TAK-659, as a potential combination treatment regimen in multiple cancer settings (Press release, Nektar Therapeutics, 24 24, 2018, View Source [SID1234525633]). NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. TAK-659 is a dual inhibitor of both spleen tyrosine kinase (SYK), a kinase involved in cell proliferation and FLT-3, a cytokine receptor in the receptor tyrosine kinase class III.

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"We look forward to collaborating with Takeda to explore a range of combination therapy approaches with NKTR-214 and TAK-659 in liquid and solid tumor settings," said Jonathan Zalevsky, PhD, Chief Scientific Officer and Senior Vice President of Research, Nektar. "Importantly, this clinical collaboration will allow us to understand how we can increase the clinical benefit of immunotherapies for patients when we leverage multiple I-O modalities and target the immune cycle in complementary and novel ways."

Under the terms of the collaboration, Nektar and Takeda will each maintain global commercial rights to their respective investigational medicines. Nektar and Takeda will split the costs related to the clinical trial and each company will contribute their respective compounds to the clinical collaboration. The first trial is expected to start in the second half of 2018 and will evaluate the combination of an every three-week schedule of NKTR-214 with oral daily doses of TAK-659 in patients with Non-Hodgkin Lymphoma.

"Based upon highly compelling preclinical data, we are looking forward to combining Nektar’s unique CD122-biased agonist with TAK-659, which is a dual inhibitor of both SYK and FLT-3," said Phil Rowlands, PhD, Head, Oncology Therapeutic Area Unit, Takeda. "NKTR-214 is unique in that it can stimulate tumor-killing T-cells in the tumor micro-environment itself. By combining with TAK-659, we hope to target different stages of the cancer immunity cycle in a combination regimen. This collaboration is aimed at achieving our goal of allowing more patients with different types of cancer to benefit from immunotherapies."

NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. NKTR-214 is being evaluated in multiple clinical trials in cancer patients. It has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

TAK-659 is an orally-available investigational reversible dual SYK/FLT-3 inhibitor. SYK is a non-receptor cytoplasmic kinase that binds to phosphorylated immuno-receptor tyrosine-based activating motifs and mediates cellular proliferation and survival. Mutations in FLT-3 genes can result in the constitutive activation of the FLT-3 receptor and result in acute myeloid leukemia and acute lymphoblastic leukemia. TAK-659 demonstrates both direct- and immune-mediated tumor cell kill mechanisms. It is currently being explored in clinical studies as a single agent and in combination in solid and hematological malignancies