On January 4, 2018 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported that the U.S. Food and Drug Administration (FDA), following the customary 30 day review period, has accepted its submission without comment, providing clearance for the OVATION II Study, the Company’s planned Phase I/II clinical trial of GEN-1, its DNA-based immunotherapy for the localized treatment of ovarian cancer (Press release, Celsion, JAN 4, 2018, View Source [SID1234522887]). The Phase I/II trial was developed with extensive input from the Company’s Medical Advisory Board. The OVATION II Study builds on the highly promising clinical and translational research data from the Phase IB dose-escalating OVATION Study where enrolled patients received escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, in combination with neoadjuvant chemotherapy, followed by interval debulking surgery.

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This next Phase I/II study is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune response, followed by a continuation at the selected dose in Phase II in an open label, 1:1 randomized design up to 90 patients with Stage III/IV ovarian cancer at up to fifteen U.S. centers. The study is powered to show a 33% improvement in the primary endpoint, progression-free survival (PFS), when comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone.

Progression-free survival for patients treated per protocol in the Phase IB OVATION Study continues to be followed. Of the thirteen patients who received GEN-1 treatment in all four dose escalating cohorts, only four patients’ cancer has progressed to-date. This compares favorably to the historical median progression-free survival of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Summarized below are the latest PFS results for all patients treated per protocol in the Phase IB OVATION Study:

Cohort 1 (36 mg/m²) – All patients have progressed; Average PFS was 19.25 months; Longest progression-free patient in 1st cohort was 24.8 months.

Cohort 2 (47 mg/m²) – No patients have progressed after 21 months.

Cohort 3 (61 mg/m²) – One patient has progressed after 14 months; Two other patients in 3rd cohort are progression free over 17 months.

Cohort 4 (79 mg/m²) – No patients have progressed; Average PFS for these five patients in 4th cohort is 14 months.
"In previous clinical studies performed to date, GEN-1 has demonstrated excellent safety and impressive clinical activity supported with dose dependent, pro-immune improvement in the tumor micro environment. A onetime dose escalation may prove to be even more impressive," stated Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. "As we continue to follow patients, the latest PFS analysis from the OVATION Study is showing a median of at least 15.4 months in the as-treated group which compares favorably to a historical control of 12 months. Our highest dose cohort has not demonstrated any progressions at our current 14 month follow up. This same cohort also had a 100% R0 surgical resection rate. One of our patients in the OVATION Study even had a complete pathological response."

The Company expects to initiate enrollment of the Phase I portion of the OVATION II Study in the first half of 2018. The Company expects to have 25% of the study enrolled by the end of 2018. Due to the open label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study’s investigators.

"GEN-1 holds the potential for tremendous promise as a cancer treatment in the rapidly emerging area of immunotherapy. This new trial will evaluate GEN-1’s value as an adjuvant to current standard of care in newly diagnosed Stage III/IV ovarian cancer patients with a relatively healthy immune system. We look forward to initiating the study in the first half of 2018," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Designed in consultation with leading medical experts, this Phase I/II trial is expected to define an optimal dose, demonstrate GEN-1’s clinical benefit when compared with current standard of care, and provide insights on powering for a registration program as the candidate progresses through development."

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

On January 4, 2018 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that Jonathan Lim, M.D., its Chairman and Chief Executive Officer, will make a presentation at the 36th Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2018, at 9:00 a.m. Pacific time (Press release, Ignyta, JAN 4, 2018, View Source [SID1234522878]). The conference will be held at the Westin St. Francis Hotel in San Francisco.

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A webcast of the presentation will be available during the presentation in the Investors section of the company’s website at View Source, and will be archived and available at that site for 14 days.

On January 4, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, will present at the 36TH Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 11, 2018, at 9:00 am Pacific Time (Press release, Aduro Biotech, JAN 4, 2018, View Source;p=RssLanding&cat=news&id=2324984 [SID1234522902]).

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit Aduro’s website at www.aduro.com.

On January 4, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI) reported that it will receive a $50 million milestone payment from Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a company of the Vifor Pharma Group and Fresenius Medical Care (Press release, ChemoCentryx, JAN 4, 2018, View Source [SID1234522888]). The milestone was triggered by the European Medicines Agency (EMA)’s validation of the Company’s Conditional Marketing Authorization (CMA) application for avacopan in the treatment of patients with anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (ANCA-associated vasculitis), announced earlier today. In addition to the $50 million milestone from VFMCRP, the Company also entered into a $50 million growth capital financing agreement with Hercules Capital, Inc. (NYSE:HTGC), bringing total new capital commitments of up to $100 million to ChemoCentryx. Such additional capital is expected to provide funding to advance avacopan through topline data from the Phase III ADVOCATE trial as well as potential registration filings in the U.S. and EU.

"The validation of our CMA application by the EMA is a pivotal milestone in our Kidney Health Alliance with Vifor. It is also a major advance in heightening the awareness of the plight of ANCA vasculitis patients," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "The status quo is simply not good enough for ANCA patients and new therapies are desperately needed. The decision of the EMA to validate our conditional marketing application will enable a thorough examination of how we at CCXI and our partners at Vifor may create just such a valuable new paradigm for ANCA treatment."

ChemoCentryx, which is responsible for the discovery and development of avacopan, owns and retains the commercial rights to the drug in the United States and China, and VFMCRP has licensed the rights to commercialize the drug in all other countries. Under the terms of the Kidney Health Alliance with Vifor Pharma, which comprises both avacopan and CCX140, ChemoCentryx has received a total of $155 million in upfront cash and cash commitments in addition to the $50 million milestone announced today. ChemoCentryx is eligible to receive additional payments upon the achievement of certain development, regulatory and sales-based milestones, as well as tiered double-digit royalties on potential net sales of avacopan and CCX140 in the Vifor licensed territories.

The $50 million credit facility from Hercules Capital comprises three tranches. The first tranche of $15 million, of which $5.0 million was funded upon closing of the agreement, is available through June 2018. The remaining $35 million is available in two additional tranches, subject to certain conditions. The term loan has a 24-month interest-only period from initial funding, which is extendable to 30 months upon the achievement of certain milestones and matures in 48 months. Further information with respect to the growth capital financing agreement with Hercules is contained on a Form 8-K to be filed by ChemoCentryx with the Securities and Exchange Commission.

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On January 3, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, reported that Allergan has exercised two options to develop and commercialize DARPin product candidates from its 2012 discovery alliance agreement with Molecular Partners (Press release, Molecular Partners, JAN 3, 2018, View Source [SID1234522825]). Upon receipt of approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, Molecular Partners will grant Allergan an exclusive license to the selected DARPin molecules for use in ophthalmology.

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Molecular Partners and Allergan entered into a broad discovery alliance in ophthalmology in 2012 aiming to develop novel multi-DARPin molecules for diseases with high unmet medical need. This alliance broadened the initial collaboration on abicipar, which is now in phase 3 development in wet AMD.

All amounts payable under these two option exercises are included in the aggregate milestone payments and the tiered royalty payments previously disclosed in our July 21, 2015 press release. Molecular Partners is entitled to certain success based development, regulatory and sales milestone payments aggregating up to USD 640 million, as well as tiered royalty payments (up to low double digit percentage range) on any future product sales. Allergan will be responsible for all future development costs.

"The DARPin platform is a key part of our strategy to develop highly differentiated drugs in ophthalmology," said David Nicholson, Chief R&D Officer, Allergan. "Our partnership with Molecular Partners continues to deliver such differentiated drug candidates and by exercising these options we will obtain exclusive rights to develop and commercialize these molecules and expand our efforts to address important diseases in ophthalmology. "

"We are excited to support our long-standing partner Allergan in advancing multi-DARPin product candidates. This is an important showcase of the value of the DARPin platform to deliver potential patient benefit in ophthalmology in addition to the work Molecular Partners is doing in oncology. I would like to thank the teams on both sides of the collaboration for their efforts and the achievement of this important milestone," commented Patrick Amstutz, CEO of Molecular Partners.

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 mayor 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 just 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.