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.

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.

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.

Siamab Therapeutics to Present New Data on its ST1 Antibody Therapeutic Program Targeting Tumor-Associated STn and MDSCs at Biotech Showcase™ 2018

On January 3, 2018 Siamab Therapeutics, Inc., a biopharmaceutical company developing novel cancer therapeutics, reported that Jeff Behrens, president and chief executive officer, will present at the 10th annual Biotech Showcase conference in San Francisco on Tuesday, January 9, 2018 at 1:45 p.m. PT (Press release, Siamab Therapeutics, JAN 3, 2018, View Source [SID1234522845]). The conference will be held January 8-10, 2018, at the Hilton San Francisco Union Square.

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"We look forward to presenting an overview of our glycan-targeting platform to treat solid tumors"

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Mr. Behrens will provide an overview of the company, its proprietary technology platform and its development pipeline, including the ST1 program. ST1, Siamab’s lead monoclonal antibody (mAb) therapeutic, is in late stage preclinical development formatted as an antibody drug conjugate (ADC) for the treatment of solid tumors expressing Sialyl-Tn (STn). Mr. Behrens will also present new data on targeting STn+ myeloid-derived suppressor cells (MDSCs), major regulators of the tumor anti-immune response that act by suppressing T cells. Siamab has for the first time identified and utilized the presence of STn on MDSCs to target and deplete MDSCs in vivo, providing a potential new therapeutic approach for the treatment of solid tumors.

"We look forward to presenting an overview of our glycan-targeting platform to treat solid tumors," said Mr. Behrens. "We will be focusing on promising new data from the ST1 program that points to STn+ MDSCs as an exciting and untapped immune-oncology target. ST1 has demonstrated excellent efficacy and safety in multiple IND-enabling tumor models as a direct anti-cancer therapy, and it may also have the potential to deplete MDSCs, which are known to be potent suppressors of tumor immunity."

Siamab’s proprietary technology platform enables the development of highly specific mAb therapeutics, including ADCs, bi-specific antibodies and CAR-T cell therapies, targeting cancer cell surface glycans called tumor-associated carbohydrate antigens (TACAs). TACAs are an emerging set of tumor antigens that are implicated in immune suppression, chemoresistance and a cancer stem cell (CSC) phenotype. The elevated presence of STn—a key TACA observed in a number of solid tumors, including ovarian, prostate, pancreatic, gastric, and colon—is associated with metastatic disease, poor prognosis, and reduced overall survival. Elevation of STn expression is linked to chemotherapy resistance and enables tumors to evade the host immune system. In addition, STn is expressed on multiple biomarkers including the CSC biomarkers CD44 and MUC1, which reside on both CSCs and mature malignant cells in some cancer types.

Siamab scientists have demonstrated the safety and efficacy of their anti-STn antibody therapeutic in multiple preclinical studies. The company’s lead ST1 ADC was shown to inhibit tumor progression in cell line-derived and patient-derived xenograft (PDX) mouse models of ovarian and pancreatic cancer, with complete regression observed in some treatment arms. In addition, preclinical evaluation has demonstrated the compound’s safety across species, including in non-human primates.

Siamab is also utilizing STn-selective antibodies to develop both tissue- and serum-based biomarker assays with the potential to become companion diagnostics for both the stratification of patients as well as tools for assessing the pharmacodynamics action of the anti-STn therapeutic in the clinic.

MOLECULAR PARTNERS TO PRESENT AT THE 36th ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

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 it will present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, 10 January, 2018 at 8:30 AM Pacific Standard Time (11:30 AM Eastern Time; 5:30 PM CET) (Press release, Molecular Partners, JAN 3, 2018, View Source [SID1234522863]).
The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

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The presentation will be webcast live and can be accessed on the day via this link. A copy of the presentation handout as well as a replay of the webcast will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.