On February 19, 2018 Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that Allergan has exercised the third option to develop and commercialize DARPin product candidates from its 2012 discovery alliance agreement with Molecular Partners (Press release, Molecular Partners, FEB 19, 2018, View Source [SID1234524046]). Upon the exercise of this option, Molecular Partners granted Allergan an exclusive license to the selected multi-DARPin product candidates for use in ophthalmology.

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Building on abicipar with phase 3 wet AMD topline data expected in H2 2018, these novel multi-DARPin product candidates further expand Molecular Partners’ and Allergan’s DARPin pipeline in ophthalmic diseases with high unmet medical need.

All amounts payable under the option exercises are included in the aggregate milestone payments and the tiered royalty payments previously disclosed in the company’s July 21, 2015 press release. For the exercise of the third option, Molecular Partners is entitled to certain success based development, regulatory and sales milestone payments aggregating up to USD 320 million, as well as tiered royalty payments (up to low double-digit percentage range) on any future product sales.

About abicipar
Abicipar is a long-acting mono-DARPin drug candidate that inhibits vascular endothelial growth factor A (VEGF-A) and is currently under investigation for the treatment of two major causes of blindness worldwide: neovascular, or wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Abicipar has the potential to require less frequent injections into the eye than the current anti-VEGF standards of care, while providing equal or better improvements in vision, both seen as major patient benefits in these indications. Molecular Partners granted an exclusive license to Allergan for Abicipar in May 2011.

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.

Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and has entered into Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

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 Oncolys BioPharma ("Oncolys") reported that the board of the company resolved to enter
into an investment and share transfer agreement with Unleash Immuno Oncolytics, Inc. (Saint Louis, Missouri,
USA. CEO: Daniel Kazman hereinafter "Unleash"), a biotech venture specialized in development of novel
oncolytic adenovirus (Press release, Oncolys BioPharma, FEB 16, 2018, View Source [SID1234532349]).

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1. Purpose of Investment

Unleash was established in 2015 by Dr. David Curiel, a top scientific leader with broad experience in oncolytic
virus, with the purpose to develop new adenovirus based cancer therapy. Its lead product, UIO-512, is an oncolytic
virus designed to target both malignant cells and tumor-associated stroma cells and currently under development
for refractory solid tumors. Unleash also has a novel pipeline, UIO-702, that is genetically modified virus with
camelid antibody incorporated to fiber so that it evades human immune responses. UIO-702 is a systemically
delivered oncolytic virus for neoplastic metastatic disease.
In addition to the purchase of convertible bonds issued by Unleash, Oncolys is to enter into a share transfer
agreement with Unleash to receive common shares of Precision Virologics Inc. (Saint Louis, Missouri, USA.
Chairman/CEO: Daniel Kazman hereinafter "Precision Virologics"), a Washington University biotech venture,
currently held by Unleash. Oncolys has been a shareholder of Precision Virologics since March 2017.
Oncolys strongly believes that a capital tie-up with Unleash and Precision Virologics, with their world-leading
gene-modification technology, can further reinforce its existing pipeline of cancer virotherapy led by its own
oncolytic adenovirus Telomelysin (OBP-301), and help to expand drug candidates portfolio in both cancer and
serious infectious diseases with no cure at present.
2. Details of the agreement
（1）Oncolys will be entitled to have a board seat within the board of directors of Unleash.
（2）Oncolys agrees to purchase $3,000,000 convertible bonds issued by Unleash with the expected voting rights
ratio of approximately 27%, when fully converted. Oncolys also agrees to purchase 294,118 ordinary shares of
Precision Virologics held by Unleash for $330,000, which will increase Oncolys’ voting rights ratio of
NB: this is a summary translation of the press release
original drafted in Japanese for the disclosure in
compliance with the TSE regulations. In case of any
discrepancy, the Japanese original shall prevail.
Precision from 14.3% to 23%, approximately.

（3）Number of shares purchased by Unleash and its ratio against shares outstanding: None
3. Overview of the companies

(1) Name Unleash Immuno Oncolytics, Inc.
(2) Address 4320 Forest Park Avenue, Saint Louis, MO 63108 USA
(3) Representative Daniel Katzman, CEO
(4) Type of Business Research and development of cancer immunotherapy based on
genetically modified adenovirus
(5) Establishment 26 August 2015
(6) Total Paid-In Capital Not applicable
(7) Major Shareholders Name/Ownership Attribution
Daniel Katzman Founder & CEO
Dr. David Curiel Founder & CSO
Washington University School of Medicine
Axia Ventures, LLC Venture Capital
Dr. Osvaldo Podhajcer Lead Scientific Advisor
Marina Scuseria Founder
(8) Relationship with Oncolys
Capital No
Personal No
Transactional No
Related Parties No
(9) Operating Performance and Financials in the previous 3 years （USD）
Fiscal Year Dec. 2015 Dec. 2016 Dec. 2017
Net Asset
N/A*
-133,548.19 -179,604.45
Total Asset 94,006.37 56,552.69
Sales － 61,500.00
Operating Profit -115,067.15 -32,055.31
Net Profit -130,597.84 -33,447.59
*No earnings report is available as Unleash was established in August 2015

(1) Name Precision Virologics Inc.
(2) Address 4320 Forest Park Ave
Saint Louis, Missouri 63108 USA
(3) Representative Daniel Katzman, CEO
(4) Type of Business Research and development of biologically targeted adenovirus based vaccines for
emerging infectious diseases
(5) Establishment 18 February 2012 as Precision Virologics, LLC.
Converted to Precision Virologics, Inc. in August 2016.
(6) Total Paid-In Capital Not applicable
(7) Major Shareholders Name/Ownership Attribution
Dr. David Curiel Founder & CSO
Washington University School of Medicine
Daniel Katzman CEO
Oncolys BioPharma Listed company
Unleash Immuno Oncolytics Private company
(8)Relationship with Oncolys Capital Ordinary shares: 14%
Personal Board member: 1
Transactional First refusal right in Asian countries with relation to all projects
developed by Precision Virologics
Related Parties No
(9) Operating Performance and Financials in the previous 3 years
Fiscal Year Dec. 2015 Dec. 2016 Dec. 2017
Net Asset
No earnings report filed for these years as the
company was converted from Precision Virologics,
LLC. to Precision Virologics Inc. in August 2016.
409,512.75
Total Asset 409,512.75
Sales –
Net Profit -90,497.27
4. Schedule
(1) Board Resolution 16 February 2018
(2) Execution of Agreement February 2018（provisional）
(3) Execution of Investment February 2018（provisional）
5. Future Outlook
As neither Unleash nor Precision Virologics falls under the category of equity method affiliates for Oncolys, the
announcement above will not significantly affect Oncolys’ earnings for the fiscal year ending 31 December 2018.

On February 16, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported Dr. Johnson Lau, Chief Executive Officer, will present at the 2018 RBC Capital Markets Healthcare Conference in New York City on Wednesday, February 21, 2017 at 11:00 am EST (Press release, Athenex, FEB 16, 2018, View Source;p=RssLanding&cat=news&id=2333004 [SID1234524025]).

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The presentation will be webcasted, and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until May 22, 2018.