On February 19, 2018 St. Louis-based startup Unleash Immuno Oncolytics, which has developed viral-based biologics to attack cancerous tumors, reported that it has attracted a major investment from publicly-traded Japanese company Oncolys BioPharma (Press release, Unleash Immuno Oncolytics, FEB 19, 2018, View Source [SID1234540110]).

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Unleash is an immunotherapy company that develops genetically-engineered adenoviruses to harness the immune system to fight cancer. While malignant tumors can trick the body’s immune system from attacking them, the Unleash viruses trigger the body’s immune system into action. By introducing a virus designed specifically to attack cancer, the virus invades the cancer cells, then unleashes the body’s ability to recognize and fight those malignant cells, thus killing the virus and killing the cancer.

Oncolys, a publicly-traded company on the Tokyo Stock Exchange that also is developing oncolytic adenoviruses, has invested $3 million into Unleash to advance its lead patented programs UIO-512 and UIO-702 toward clinical trials. The programs have already shown promising proof-of-concept results in animal models and human explants.

An additional $330,000 investment from Oncolys also gives it an equity position within Unleash sister company Precision Virologics, which has developed biologically-targeted vaccines for Zika and Chikungunya. Less than a year ago, Oncolys invested $500,000 into those programs.

"We are honored to initiate this partnership with the Oncolys team, also leading developers of oncolytic viruses, who assessed tremendous potential in Unleash’s technology," Daniel Katzman, Unleash CEO, said. "Oncolys’ solid expertise in manufacturing and clinical development of oncolytic viruses is of great value for advancing our virus-based therapies through clinical trials."

Unleash Immuno Oncolytics was founded on the basis of licensing complementary viral-based technologies developed by research groups led by David T. Curiel, MD, PhD, Director of the Biologic Therapeutics Center at Washington University in St. Louis, and Osvaldo Podhajcer, PhD, member of the CONICET, National Council for Scientific and Technological Research of Argentina, and Head of the Laboratory of Molecular and Cellular Therapy at the Fundación Instituto Leloir in Buenos Aires, Argentina.

"This collaboration will allow us to expand our efforts in developing the next generation of oncolytic viruses for the treatment of cancer," Curiel said. "Labeled as promising for many years, now oncolytic viruses are in the forefront of cancer research. Unleash is positioned to become a leading player in this new field."

"I’m proud to see our research project advancing its way towards clinical trials and helping patients in need," Podhajcer said. "We are amazed by the level of interest it created among world-class organizations."

BioGenerator is the lead investor in Unleash and also supported the company with entrepreneur training through its Fundamentals program, non-dilutive grants, intellectual property strategy, independent third-party evaluation, and moving the company from Argentina to St. Louis’ Cortex Innovation Community.

"St. Louis’ innovation economy has to be globally-connected to grow and thrive, so being home to a company from Argentina with validated investors from Japan is another big step forward for our community," Donn Rubin, President & CEO of BioSTL, said. "With this new investment from Oncolys BioPharma, we’re seeing Unleash take a lead role in developing next-generation immunotherapy and solidifying St. Louis’ reputation as a world-class research hub."

On February 18, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that an abstract regarding the completed SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS), which was conducted through the National Institutes of Health (NIH)-sponsored NeuroNEXT network, has been selected for plenary presentation at the American Academy of Neurology (AAN) 70th Annual Meeting to be held April 21-27, 2018 in Los Angeles, California (Press release, MediciNova, FEB 18, 2018, View Source;p=RssLanding&cat=news&id=2333124 [SID1234524045]).

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The presentation entitled "A Phase II Trial of Ibudilast in Progressive Multiple Sclerosis" will be presented by Dr. Robert Fox, Staff Neurologist at the Cleveland Clinic and the principal investigator of this clinical trial.

Presentation details are as follows:

Date and Time: Tuesday, April 24, 2018, 9:15 am – 11:30 am

Session: Clinical Trials Plenary Session

Location: Los Angeles Convention Center, 1201 South Figueroa Street, Los Angeles, CA 90015

About the Progressive MS Trial

The Phase 2b Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) included 28 enrolling clinical sites across the U.S. and was designed to evaluate the safety, tolerability and activity of MN-166 (ibudilast) administered orally twice daily to subjects with primary progressive or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 255 qualifying subjects were randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of up to 100 mg/day (50 mg twice daily). The progressive MS subjects were either untreated with long-term disease modifying therapy (DMT) or continued on either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization was controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study were to 1) evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) evaluate the safety and tolerability of ibudilast (MN-166) versus placebo in subjects with PPMS or SPMS. Additional measures included disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain. Exploratory objectives included pharmacokinetic and biomarker analyses.

About the Cooperative Effort

The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS’s Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. (www.neuronext.org). The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS’s existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for NeuroNEXT is led by Dr. Merit Cudkowicz and is based at Massachusetts General Hospital and the data coordinating center is led by Dr. Chris Coffey at the University of Iowa. Principal Investigator Dr. Robert Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society provided patient advocate input, trial enrollment awareness, and additional funding. MediciNova holds the trial IND with the FDA’s Division of Neurology Products and provides scientific and analytical support, as well as drug and placebo supply.

About Progressive Multiple Sclerosis

According to the National MS Society, MS affects approximately 2.3 million people worldwide. Approximately 85% of MS patients are initially diagnosed with relapsing remitting MS (RRMS). Most RRMS patients will eventually transition into SPMS in which there are fewer or no relapses but gradual worsening of neurologic function. Approximately 15% of MS patients are diagnosed with PPMS at onset and exhibit gradually increasing disability in walking, vision, mental acuity, and other bodily functions without experiencing relapses or remissions. Current therapies for MS affect the inflammatory response, but provide limited benefit for the neurodegeneration seen in progressive MS. There is a significant unmet medical need for agents that may provide neuroprotection in progressive MS.

About MN-166 (ibudilast)

MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.

Salarius’ lead molecule, Seclidemstat, is scheduled to begin enrollment for a Phase 1 trial in Ewing sarcoma in 2018. Ewing sarcoma is a devastating pediatric illness and represents a major unmet clinical need. Currently, chemotherapy, radiation and tumor resection surgery are the only options for patients, and in many cases the tumors reoccur or is in too delicate of a location to risk surgery. There is a 90% five-year mortality rate for patients whose tumors recur after treatment or who are initially diagnosed with metastatic disease. Translocations in the EWS protein are the sole driver for over 85% of Ewing sarcoma, and EWS must complex with LSD1 to induce a cancer phenotype. Seclidemstat blocks this LSD1 interaction to reverse cancer pathology resulting in cures in animal models.

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On February 16, 2018 Immunomic Therapeutics (ITI), pioneering the study of investigational LAMP-based nucleic acid immunotherapy programs, reported that the company will participate at the 2018 BIO CEO & Investor Conference in two events (Press release, Immunomics, FEB 16, 2018, View Source [SID1234524030]):

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Monday, February 12, 2018, 7-9 p.m. EST, New York Marriott Marquis, Manhattan Ballroom

Scientific American Panel: "Hot Topics in Biotech: Cancer at a Crossroads"As new financing models become increasingly complex, immuno-oncology technologies present a promising, but complex landscape. Scientific American is hosting a salon conversation with leading industry experts like ITI focused on immuno-oncology.
Panel participants:
William Hearl, Ph.D., Founder & CEO, ITI
Jeremy Abbate, VP & Publisher, Scientific American
Andrew Marshall, Chief Editor, Nature Biotech
Barbara Ryan, Life Sciences Capital Markets & Strategy Advisor, Financial Communications, CNBC
Cliff Ransom, Executive Editor, Scientific American

Tuesday, February 13, 2018, 2:45 p.m. EST, Gilbert Room, New York Marriott Marquis

Corporate presentation: ITI’s Founder & CEO, William Hearl, Ph.D., will present an overview of the company and its LAMP-Vax technology.
About LAMP-Vax

ITI’s investigational LAMP-Vax platform is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put LAMP-Vax technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. LAMP is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of LAMP in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for LAMP-Vax therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On February 16, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that the company is scheduled to present at the 2018 RBC Capital Markets Healthcare Conference at 9:30 AM ET on Wednesday, February 21, 2018 in New York City (Press release, Pacira Pharmaceuticals, FEB 16, 2018, View Source;p=RssLanding&cat=news&id=2332988 [SID1234524038]).

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A live audio webcast of the Pacira presentation can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the presentation date.