SignalRx Announces In Silico Design And Discovery Of The First-In-Class HDAC6-BRD4-PI3K Epigenetic Kinase Inhibitor SRX3225

On January 4, 2018 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics to inhibit key orthogonal and synergistic oncotargets for the treatment of cancer, reported the in silico design and discovery of SRX3225, its first-in-class small-molecule potent inhibitor of three key cancer targets HDAC6, BRD4, and PI3K (Press release, SignalRx, JAN 4, 2018, http://www.ireachcontent.com/news-releases/signalrx-announces-in-silico-design-and-discovery-of-the-first-in-class-hdac6-brd4-pi3k-epigenetic-kinase-inhibitor-srx3225-668070373.html [SID1234527319]).

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SignalRx’s proprietary CRIMP technology platform led to the in silico design and identification of SRX3225 within its triple inhibitor program. SRX3225 is a novel picomolar potent HDAC6 inhibitor with high selectivity over HDAC1, HDAC2 and HDAC3 isoforms (31-35 times selective) and more so against isozymes HDAC4 through HDAC11 (up to 20,000 times selective). In addition, SRX3225 potently inhibits the epigenetic target BRD4-BD1 with >5X selectivity over BRD4-BD2, and it also potently inhibits PI3K alpha and delta isoforms. Importantly, because the design of SRX3225 is achieved in silico using cancer targets’ structural data, it is possible to independently dial in and out each of the three inhibitory components in a small molecule generating dual and single inhibitory chemotypes from SRX3225.

"This is a huge immuno-oncology breakthrough because it creates a synergistic synthetic lethality effect as a result of PI3K and BRD4 and HDAC inhibition delivered with a single molecule. While dual PI3K/BRD4, dual HDAC/PI3K, and dual BRD4/HDAC inhibitors are under investigation, SRX3225 is the only triple HDAC/PI3K/BRD4 inhibitor that we know of" said SignalRx’s scientific advisor and founder Donald L. Durden, MD, PhD. "This new approach of inhibiting three targets simultaneously yields a more complete block of multiple key cancer signaling providing increased lethality coupled with less toxicity than a combination of three single agents. This novel 3-in-1 anticancer drug paves the way for more sophisticated and cost-effective combinations in cancer patients that should block development of resistance resulting in longer duration of benefits in more patients."

"We achieved this milestone by leveraging the experience in multi-targeted inhibitors and discoveries we have made in our advanced BRD4/PI3K program coupled with the knowledge we have acquired on these targets as exemplified in our recent PNAS publication (View Source)" said Dr. Joseph Garlich, Chief Scientific Officer at SignalRx. "Rational combinations of targeted agents in clinical development often face a common detrimental limitation: unwanted additive off-target toxicities from the individual agents used. This leaves no option but to reduce the effective dosages of the agents resulting in less than optimal therapeutic administrations and inefficient treatments. Our approach combines 3 drug mechanisms into one resulting in 1 single agent with a single ADME/safety profile which also simplifies and expedites its development."

SignalRx is interested in partnering discussions to quickly take these novel small molecules through clinical trials together with companion diagnostics for streamlined development and approval.

CureVac and Arcturus Therapeutics Announce Broad Strategic Collaboration to Advance Next Generation of Lipid-Mediated mRNA Therapeutics

On January 4, 2018 CureVac AG, a leading clinical-stage biopharmaceutical company focused on the development of pioneering mRNA therapeutics, and Arcturus Therapeutics Ltd. (NASDAQ:ARCT), an RNA medicines company, reported they have entered into a broad strategic collaboration to jointly discover, develop and commercialize novel messenger RNA (mRNA) therapeutics (Press release, CureVac, JAN 4, 2018, View Source [SID1234522914]).

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Under the agreement, the companies will collaborate to develop up to four molecular therapy products for rare diseases using Curevac’s optimized natural mRNA sequence (RNAoptimizer) and Arcturus’s lipid-mediated nucleic acid delivery system (LUNAR). The agreement focuses on developing mRNA therapeutics for enzyme replacement and antibody generation. Development costs will be shared between the companies, with plans to co-commercialize products in the future under a profit sharing arrangement. The first mRNA therapy to be jointly developed and potentially commercialized by the companies will target ornithine transcarbamylase (OTC) deficiency, a genetic disease characterized by the accumulation of ammonia in the blood. The collaboration also grants CureVac access to the full suite of Arcturus’s lipid-mediated delivery intellectual property to enable the development of additional mRNA product candidates.

"This collaboration for up to four products establishes a sound relationship with Arcturus, which we believe is one of the leaders in developing lipid-mediated delivery systems for mRNA molecules," said Ingmar Hoerr, Ph.D., co-founder and CEO of CureVac. "Just as important, we are excited to have secured access to Arcturus’s leading intellectual property rights for future product development in molecular therapies. This partnership combines both companies’ technology platforms with the expertise necessary to develop the next generation of therapeutics based on the considerable potential of mRNA."

"We are thrilled to combine Arcturus’s platform technologies and expertise with CureVac’s recognized capabilities in mRNA construct optimization and GMP manufacturing to co-develop messenger RNA medicines for patients in need," said Joseph Payne, President and CEO of Arcturus. "We believe our collaboration with CureVac has the potential to help reduce costs, mitigate manufacturing risks, and accelerate our timelines for ushering quality mRNA medicines into the clinic."

Sangamo Therapeutics To Present At The 36th Annual J.P. Morgan Healthcare Conference

On January 4, 2018 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported that Dr. Sandy Macrae, CEO of Sangamo, will present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10th at 4:00 p.m. PT. Dr. Macrae’s presentation will be followed by a separate Q&A session starting at 4:30 p.m. PT (Press release, Sangamo Therapeutics, JAN 4, 2018, View Source [SID1234522912]). The conference is being held in San Francisco, CA from January 8-11, 2018.

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The presentation and Q&A session will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentation will be archived on the Sangamo website for two weeks after the event.

AVANTGEN AND TANABE RESEARCH LABORATORIES EXPAND COLLABORATION FOR THERAPEUTIC ANTIBODY DISCOVERY

On January 4, 2018 AvantGen reported the successful completion of a first cancer therapeutic antibody discovery program for Tanabe Research Laboratories USA, Inc. (TRL) and the initiation of a second program (Press release, AvantGen, JAN 4, 2018, View Source [SID1234522916]).

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Under the terms of the collaboration, AvantGen is responsible for generating novel antibodies to specified cancer targets using its proprietary human antibody yeast display technology platform. TRL has worldwide rights to develop and commercialize antibodies discovered by AvantGen. AvantGen receives upfront payments and is eligible to receive milestone payments and royalties associated with the development and sale of any products derived from the collaboration.

"AvantGen’s antibody discovery and optimization services have been extensively validated against hundreds of targets primarily through numerous NIH SBIR I and II funded projects. Since the recent introduction of our new, state-of-the-art human antibody discovery and optimization platform, this second project with TRL represents the fifteenth de novo antibody discovery project we have initiated specifically for corporate partners," said Xiaomin Fan, Ph.D., founder and president of AvantGen. "The platform utilizes advantageous technologies, including a robust yeast display system, large natural human antibody database and fully human antibody libraries, for the generation of antibodies to meet challenging design goals for therapeutic, diagnostic and research tool purposes."

"The therapeutic antibody discovery program conducted by AvantGen was highly collaborative and was accomplished faster than expected, without the need to further optimize the antibodies in order to meet TRL’s design goals," said Roland Newman, Ph.D., chief scientific officer for TRL. "We look forward to working together on the second program and others in the future."

Genelux Announces Gynecologic Oncology Associates/Women’s Cancer Research Foundation as New Site for the Ongoing Phase 2 VIRO-15 Study

On January 4, 2018 Genelux Corporation, a privately-held biopharmaceutical company focused on the development of its proprietary oncolytic immunotherapy platform, is reported that Gynecologic Oncology Associates/Women’s Cancer Research Foundation (GOA/WCRF) in Newport Beach, California has been added as a clinical site for its Phase 2 VIRO-15 Study: Oncolytic Vaccinia Immunotherapy in Recurrent Ovarian Cancer (Press release, Genelux, JAN 4, 2018, View Source [SID1234532452]).

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GOA/WCRF, a renowned gynecologic oncology care & research center, is now actively enrolling patients. The Principal Investigator at the site is Alberto A. Mendivil, MD, FACOG, FACS, with the following sub-investigators:

Lisa N. Abaid, MD, MPH
Tiffany L. Beck, MD, MPH
John V. Brown, MD
Kristina M. Mori, MD

Adding GOA/WCRF will accelerate the clinical development timeline of GL-ONC1 and completion of this important Phase 2 study.

Thomas Zindrick, Genelux CEO, said, "We are pleased to welcome one of the largest and most well-respected gynecological practices in the country to the VIRO-15 Study. We look forward to working with GOA/WCRF, especially given the investigators’ expertise in the conduct of ovarian cancer clinical research."

GOA/WCRF joins Florida Hospital Cancer Institute as participating sites in the study. These geographically diverse sites will drive enrollment and bring a convenient trial location to western United States.

John P. Micha, MD, President/Founder/Board Member of WCRF and founder of GOA, commented, "GL-ONC1 immunotherapy is one of the most exciting and promising gynecologic oncology treatment modalities to come along in recent years for late stage ovarian cancer. Our patients and staff have renewed hope that we will be able to improve clinical outcomes in the not too distant future."

About the Study

The open label, Phase 2 study (NCT02759588) is currently recruiting participants with recurrent ovarian, fallopian tube, or primary peritoneal cancer. It is expected to enroll up to a total of 40 patients in two cohorts. Patients will receive GL-ONC1 as a monotherapy treatment regimen, consisting of intraperitoneal bolus infusions on 2 consecutive days. The study’s primary endpoint is progression-free survival, and secondary endpoints include incidence of adverse events, anti-tumor response, objective response, disease control rate, and overall survival.

About GL-ONC1

GL-ONC1, Genelux’ lead product candidate, is an attenuated therapeutic vaccinia virus, a non-pathogenic virus, modified by Genelux to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in over 100 subjects treated in Genelux studies have shown GL-ONC1 is well tolerated with documented antitumor activities and clinical benefits.

About Gynecologic Oncology Associates (GOA) & Women’s Cancer Research Foundation (WCRF)

Founded in 1985, GOA is the largest gynecologic oncology practice on the West Coast. WCRF is a nonprofit organization. The physicians from the WCRF have been pioneers in clinical research to improve cure rates for women with ovarian, uterine, endometrial, cervical and other gynecological cancers. WCRF designs, conducts and publishes research on leading-edge medical advances. WCRF has developed collaborative research relationships with many prominent pharmaceutical and biotech companies. GOA/WCRF physicians have received many honors in recognition of their excellence in cancer care, including Best Physicians in Orange County, America’s Best Oncologists, ACOG/Ortho National Research Award and many other honors for teaching and clinical care