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Molecular Partners’ collaboration partner Allergan exercises the third option for a DARPin® product candidate in ophthalmology

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.

BioCryst Pharmaceuticals and Idera Pharmaceuticals to Present at Two Upcoming Healthcare Investor Conferences

On February 19, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), reported they will be presenting at two upcoming healthcare-focused investor conferences (Press release, Idera Pharmaceuticals, FEB 19, 2018, View Source [SID1234524650]).

BioCryst Pharmaceuticals, Inc.
BioCryst Pharmaceuticals, Inc.

The companies will be presenting at the RBC Capital Markets 2018 Global Healthcare Conference on Wednesday, February 21, 2018 at 3:05 P.M. E.T. The conference is being held at the Lotte New York Palace Hotel.

The companies will also be presenting at the 2018 Barclays Global Healthcare Conference on Tuesday, March 13, 2018 at 9:00 A.M. E.T. The conference is being held at the Lowes Miami Beach Hotel.

As a reminder, on January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to combine into a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. At the upcoming conferences, the companies will discuss the strategic initiatives of both companies, and how the combination of the two companies is expected to capitalize on the collective expertise and combined assets to create a comprehensive, sustainable rare disease-focused biotechnology leader.

Live audio webcast of these presentations will be accessible in the Investors and Media section of Idera’s website at View Source and in the Investors section of BioCryst’s website at http://www.biocryst.com. Archived versions will also be available on the respective Company’s websites after the events for 90 days

US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer

On February 19, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the US Food and Drug Administration (FDA) has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT) (Press release, AstraZeneca, FEB 19, 2018, View Source [SID1234524035]).

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: "The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting."

Scott J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial, said: "Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients."

The approval of Imfinzi is based on the positive PFS data from the Phase III PACIFIC trial

in which Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs. placebo in all patients, regardless of PD-L1 status. The PACIFIC trial is ongoing to evaluate overall survival (OS) in unresectable Stage III NSCLC. Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine (NEJM).

Imfinzi
1 Blinded Independent Central Review (BICR)

2 Among the ITT population, 7% in the IMFINZI arm and 10% in the placebo arm had non-measurable disease as assessed by BICR according to RECIST v1.1

3 Stratified by sex, age, and smoking history

4 Pike estimator

5 Compared with allocated α of 0.0104 (Lan DeMets spending function approximating O’Brien Fleming boundary) for interim analysis

Overall, the incidence and severity of adverse events were comparable for patients receiving Imfinzi and the patients receiving placebo. In patients receiving Imfinzi, the most common adverse reactions (greater than or equal to 20% of patients) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnoea (25%), and rash (23%). Discontinuation after concurrent CRT due to adverse reactions, regardless of causality, occurred in 15% of patients receiving Imfinzi vs. 10% of patients receiving placebo.

On 28 September 2017, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology were updated to include Imfinzi for the treatment of patients with unresectable Stage III NSCLC with no disease progression after two or more cycles of concurrent CRT.

NOTES TO EDITORS
About Stage III NSCLC

Stage III (locally advanced) NSCLC is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has spread (metastasised) to distant organs.

Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in France, Germany, Italy, Japan, Spain, the UK and the US in 2016. The majority of Stage III NSCLC patients are diagnosed with unresectable tumours. Until now, the current standard of care has been chemotherapy and radiation therapy, followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi has already received accelerated approval in the US for the treatment of patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

As part of a broad development programme, Imfinzi is also being investigated for the adjuvant treatment of patients with NSCLC in the Canadian Cancer Trials Group BR31 trial (ADJUVANT). In the MYSTIC, NEPTUNE and PEARL Phase III trials, Imfinzi is being studied for 1st-line treatment as monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new medicine, for the treatment of metastatic NSCLC. The POSEIDON trial is investigating Imfinzi with and without tremelimumab in combination with chemotherapy in a similar patient population.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have three approved medicines and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca’s Approach to Immuno-Oncology

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes durvalumab (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a growth platform for AstraZeneca, focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

Alder BioPharmaceuticals® to Host Conference Call to Discuss Fourth Quarter and Year-End 2017 Financial and Operating Results

On February 19, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its fourth quarter and year-end 2017 financial and operating results after the close of U.S. financial markets on Monday, February 26, 2018 (Press release, Alder Biopharmaceuticals, FEB 19, 2018, http://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-fourth [SID1234524109]). Alder management will host a conference call and live audio webcast to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 6943609. The webcast and any accompanying slides can be accessed from the Events & Presentations page in the investors section of Alder’s website at www.alderbio.com and will be available for replay following

BioCryst Pharmaceuticals and Idera Pharmaceuticals to Present at Two Upcoming Healthcare Investor Conferences

On February 19, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), reported they will be presenting at two upcoming healthcare-focused investor conferences (Press release, BioCryst Pharmaceuticalsa, FEB 19, 2018, View Source [SID1234524108]).

The companies will also be presenting at the 2018 Barclays Global Healthcare Conference on Tuesday, March 13, 2018 at 9:00 A.M. E.T. The conference is being held at the Lowes Miami Beach Hotel.