Molecular Partners’ collaboration partner Allergan exercises options for two DARPin® product candidates

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.

LabCorp is Scheduled to Present at the 36th Annual J.P. Morgan Healthcare Conference

On January 3, 2018 LabCorp (NYSE: LH) reported that it will participate at the 36th Annual J.P. Morgan Healthcare Conference (Press release, LabCorp, JAN 3, 2018, View Source;p=RssLanding&cat=news&id=2324630 [SID1234522842]). LabCorp’s presentation is scheduled for Tuesday, January 9, 2018 at 9:30 am (PT).

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A live audio webcast of the presentation will be available via the Company website at www.labcorp.com and archived for replay.

Karyopharm Therapeutics to Present at the 36th Annual J.P. Morgan Healthcare Conference

On January 3, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2018 at 7:30 a.m. PT at the Westin St. Francis in San Francisco (Press release, Karyopharm, JAN 3, 2018, View Source [SID1234522830]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

NanOlogy to Present Update on Cancer Treatment Clinical Program at Biotech Showcase in San Francisco

On January 2, 2018 NanOlogy, a clinical stage pharmaceutical development company, reported that Gere diZerega, MD, VP of Medical Affairs, will present at Biotech Showcase, January 8, 2018, at 3:45 pm in Franciscan room D on the Ballroom Level of the Hilton San Francisco Union Square Hotel (Press release, NanOlogy, JAN 2, 2018, View Source [SID1234522843]).

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Dr. diZerega will present an update on the status of the NanOlogy clinical development programs. The company is developing a submicron particle technology platform for local delivery of chemotherapeutic agents in the treatment of cancer and related illnesses via intratumoral, intracystic, intraperitoneal, and topical administration.

Clinical Programs
NanOlogy has four Phase 2 clinical trials underway for NanoPac, a sterile suspension of submicron particle paclitaxel, in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. NanOlogy also is conducting a Phase 2 trial of SOR007, submicron particle paclitaxel suspended in a topical anhydrous base, for cutaneous metastases, while NanOlogy affiliate, DFB Soria, has a Phase 2 trial of SOR007 nearing completion for actinic keratosis.

Preclinical
In addition, NanoPac for nebulized inhalation has shown tumor reduction in a preclinical lung cancer study after pharmacokinetic studies demonstrated more than 14 day retention of drug in lung tissue. In 2018, clinical trials are planned for NanoDoce, a sterile suspension of the submicron particle docetaxel, pending IND approval.

Patent Portfolio
The NanOlogy submicron particle technology platform is protected by an extensive intellectual property (IP) portfolio covering production processes, uses, formulations, and specifications, as well as composition under US patent 9,814,685 entitled Taxane Particles and Their Use granted on November 14, 2017 covering particle size, density, surface area, drug dissolution, and other aspects. "NanOlogy investigational drugs are being developed under FDA’s streamlined 505(b) 2 pathway" said Michael Baltezor, PhD, head of product development. "Coupled with a composition patent on our particles, we now enjoy NME [new molecular entity] – like IP advantages without the corresponding risk and time associated with NME development."

NanOlogy expects results from its clinical trials in 2018 and during this time will be identifying a pharmaceutical or strategic investment partner to progress its drug candidates to NDA submission, market approval, and commercial distribution.

Five Prime Therapeutics Submits Investigational New Drug Application for Novel B7-H4 Antibody FPA150

On January 3, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported the December 2017 submission of an Investigational New Drug (IND) application for FPA150, a first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, JAN 3, 2018, View Source [SID1234522850]). Five Prime discovered FPA150 using the company’s protein therapeutics platform and anticipates initiating a Phase 1 trial of FPA150 during the first half of 2018.

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FPA150 is a high affinity, afucosylated monoclonal antibody designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Non-clinical data of FPA150 featured in an oral poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress described potent ADCC and T cell checkpoint blockade activity in vitro and significant dose-dependent anti-tumor efficacy in vivo.

"We are excited to expand our clinical pipeline with the addition of FPA150, which offers a differentiated approach to existing immunotherapies," said Bryan Irving, Ph.D., Senior Vice President of Research at Five Prime. "B7-H4 represents a T cell checkpoint ligand that is not currently targeted by other immuno-oncology agents and is also expressed in several solid tumor types not typically associated with elevated PD-L1 expression."

Five Prime designed the planned Phase 1 trial with a standard 3+3 dose escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and urothelial carcinomas. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150
FPA150 is a novel, high affinity, afucosylated monoclonal antibody discovered by Five Prime with its protein therapeutics platform. FPA150 is designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Five Prime anticipates initiating Phase 1 development of FPA150 during the first half of 2018.