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Solasia Announces Patient Registration Reached Target Number of Cases for Darinaparsin Phase 2 Pivotal Study for T-Cell Lymphoma

On September 17, 2019 Solasia Pharma K.K. (TSE:4597, Headquarters: Tokyo, President & CEO: Yoshihiro Arai, hereinafter "Solasia"), a specialty pharmaceutical company based in Asia, reported that patient registration reached the target number of cases for the darinaparsin Phase 2 study (Press release, Solasia, SEP 17, 2019, View Source [SID1234539585]).

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The Phase 2 study is being conducted as a multinational, multicentre, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma (hereinafter "PTCL") in Japan, South Korea, Taiwan and Hong Kong. Patients would receive maximum 6 cycles of darinaparsin, and the efficacy would be measured with tumor response as primary outcome measure.

This study is a pivotal (final) study for PTCL based on prior consultation with the authority. At present, Solasia expects to announce the study results in 2020.

Solasia holds an exclusive worldwide license to develop and commercialize darinaparsin. For Japan market, Solasia has already entered into an exclusive license agreement with Meiji Seika Pharma Co., Ltd., for the commercialization of darinaparsin, and for Latin America, with HB Human BioScience SAS. Going forward, Solasia will actively seek licensing partners outside of Asia.

Through the active development of darinaparsin, Solasia will continue to strive for providing new treatment option for PTCL patients. Furthermore, Solasia will continue to pursuit the possibility for developing other indications in cancer field following PTCL.

About darinaparsin
Darinaparsin is a novel mitochondrial-targeted agent (organoarsenic) being developed for the treatment of various hematologic and solid cancers. In a US Phase 2 study, darinaparsin demonstrated evidence of clinical activity in lymphoma, in particular PTCL. Furthermore, the Phase 1 study done in US, and the Pan-Asian Phase 1 study both demonstrated positive efficacy and safety. Darinaparsin has been granted orphan drug designation in US and EU. For more information, please see at View Source

KemPharm to Participate in the Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Diseases

On September 17, 2019 KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, reported that its president and chief executive officer, Travis C. Mickle, Ph.D., will host one-on-one meetings with investors at the Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Diseases being held September 23-24, 2019, at the Parker New York Hotel (Press release, KemPharm, SEP 17, 2019, View Source [SID1234539584]).

Details of the conference are as follows:

Event: Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Diseases
Dates: September 23-24, 2019
Format: One-on-One Meetings
Location: Parker New York Hotel, New York, NY
The Oppenheimer Fall Summit brings together the management teams from a select group of companies focused on specialty pharmaceuticals and orphan and rare diseases with investors to discuss therapeutic programs in development and recent corporate updates. During the one-on-one meetings, Dr. Mickle will discuss KemPharm’s recent strategic commercial partnering transaction, its corporate growth strategy and its focus on utilizing its proprietary LATTM (Ligand Activated Therapy) platform technology to discover and develop improved prodrug versions of FDA-approved drugs as well as prodrug versions of existing compounds that may have applications for new disease indications.

KemPharm’s prodrug product candidate pipeline is highlighted by its co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, which are based on a prodrug of d-methylphenidate. On September 4th, 2019, KemPharm announced a $493 million definitive collaboration and license agreement with an affiliate of Gurnet Point Capital (GPC) that provides the affiliate with exclusive worldwide rights to develop, manufacture and commercialize KP415 and KP484.

Seattle Genetics Announces Presentations of New Clinical Data from Multiple Studies of Novel Targeted Therapies at the European Society for Medical Oncology (ESMO) 2019 Congress

On September 17, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that new data from four of its investigational programs will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain, from September 27 – October 1, 2019 (Press release, Seattle Genetics, SEP 17, 2019, View Source [SID1234539583]).

"We look forward to the presentation featuring antibody-drug conjugate enfortumab vedotin in combination with the immune therapy pembrolizumab in patients with previously untreated advanced urothelial cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are also pleased to see initial results from an investigator-sponsored study called MOUNTAINEER examining the combination of our novel tyrosine kinase inhibitor tucatinib with trastuzumab for the treatment of HER2-amplified metastatic colorectal cancer. The development of these and other targeted medicines support our efforts toward becoming a multi-product oncology company."

Details of the oral presentation:

EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma
Abstract: 901O
Presenter: C Hoimes, Case Western Reserve University, Cleveland, OH, USA
Session: Oral Presentation Proffered Paper Session – Genitourinary tumours, non-prostate
Date and Time: Saturday, September 28, 8:30-10:00 a.m. CEST
Location: Barcelona Auditorium, Hall 2

Details of company-sponsored presentations are as follows:

Systemic therapy in 2nd-line metastatic triple negative breast cancer (mTNBC): a systematic literature review (SLR) and meta-analysis (MA) of efficacy
Abstract: 360P
First Author: PA Kaufman, University of Vermont Cancer Center, Burlington, VT, USA
Session: Poster Presentation
Date and Time: Sunday, September 29, 12:00-1:00 p.m. CEST
Location: Barcelona Auditorium, Hall 4

Quality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): data from EV-201 cohort 1
Abstract: 921P
First Author: B McGregor, Dana-Farber Cancer Institute, Boston, MA, USA
Session: Poster Presentation
Date and Time: Monday, September 30, 12:00-1:00 p.m. CEST
Location: Barcelona Auditorium, Hall 4

Phase 1/2 trial of tisotumab vedotin plus bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8)
Abstract: 1059TiP
First Author: I Vergote, Leuven Cancer Institute, Leuven, Belgium
Session: Poster Presentation
Date and Time: Sunday, September 29, 12:00-1:00 p.m. CEST
Location: Barcelona Auditorium, Hall 4

Details of select investigator-initiated trial presentation is as follows:

Trastuzumab and tucatinib for the treatment of HER2 amplified metastatic colorectal cancer (mCRC): Initial results from the MOUNTAINEER trial
Abstract: 527PD
First Author: JH Strickler, Duke University Medical Centre, Durham, NC, USA
Session: Poster Discussion Session – Gastrointestinal tumours, colorectal
Date and Time: Sunday, September 29, Poster Discussion: 3:00-3:15 p.m. CEST
Location: Cordoba Auditorium, Hall 7

For more information, including a complete list of abstract titles and presentation dates and times, visit the ESMO (Free ESMO Whitepaper) website at View Source

About Enfortumab Vedotin

Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas. A Biologics License Application is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/PD-L1 inhibitor and who have received a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. Enfortumab vedotin is being co-developed by Seattle Genetics and Astellas Pharma Inc.

The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval or become commercially available for the uses being investigated.

About Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the microtubule disrupting agent monomethyl auristatin E (MMAE). In cancer biology, Tissue Factor is a protein involved in tumor signaling and angiogenesis. The Tissue Factor antigen target is overexpressed in the vast majority of patients with cervical cancer and in many other solid tumors, including ovarian, lung, pancreatic, colorectal and head and neck. Based on its high expression on many solid tumors and its rapid internalization, Tissue Factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Seattle Genetics and Genmab.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 directed agents such as trastuzumab.1 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. 1 HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, ovarian and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tumors that overexpress HER2 are more aggressive and historically have been associated with poor overall survival compared with HER2-negative cancers. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

Oncolytics Biotech to Present at the Ladenburg Thalmann Healthcare Conference

On September 17, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will present at the Ladenburg Thalmann Healthcare Conference at 11:00 am Eastern Time on Tuesday, September 24, 2019 (Press release, Oncolytics Biotech, SEP 17, 2019, View Source [SID1234539582]). The conference is being held on September 24, 2019 at the Hotel Sofitel in New York City.

A live audio link to the webcast session will be available on the Company’s website at View Source It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

AC Immune Receives Milestone Payment in Connection with Initiation of a Phase 2 Trial of Tau PET Tracer PI-2620

On September 17, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, reported it has received a milestone payment from its partner Life Molecular Imaging in connection with the initiation of a Phase 2 study of the Tau positron-emission tomography (PET) tracer PI-2620 (Press release, AC Immune, SEP 17, 2019, View Source [SID1234539581]).

PI-2620 is a next generation Tau PET tracer developed using AC Immune’s proprietary Morphomer discovery platform in a research collaboration with Life Molecular Imaging. It binds to Tau deposits which, along with beta-amyloid plaques, represent a critical pathological hallmark of Alzheimer’s disease (AD). Tau deposits also play an important role in other neurodegenerative diseases.

The Phase 2 longitudinal study is being conducted in the UK and is expected to last approximately three years, with the overall goal being to evaluate PI-2620 as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain. The data generated are intended to be used for obtaining regulatory approval in the U.S. and Europe.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "The clinical advancement of PI-2620 is based on its excellent properties and imaging characteristics, and it further reinforces the proficiency of AC Immune’s Morphomer technology and our ability to establish highly productive partnerships with well-respected companies such as Life Molecular Imaging. Treating earlier and targeting Tau are both key elements of our Roadmap to Successful Therapies for Neurodegenerative Diseases.

"There is a growing body of clinical evidence that Tau pathology drives disease progression, and this new Phase 2 trial further broadens AC Immune’s world leading anti-Tau clinical pipeline, which also includes therapeutic antibodies (partnered with Roche/Genentech), small molecule inhibitors (partnered with Eli Lilly), and vaccines (partnered with Janssen). We are advancing these programs in parallel to generate robust clinical data, having most recently vaccinated the first patient in a Phase 1b/2a study of our clinically advanced anti-phospho-Tau vaccine candidate ACI-35.030."

The open label Phase 2 study will evaluate the safety and imaging characteristics of PI-2620 as a PET radioligand for imaging Tau deposition in the brains of patients with mild cognitive impairment (MCI) and mild to moderate AD in comparison with non-demented control (NDC) participants.

PI-2620 was discovered and developed in a research collaboration between AC Immune and Life Molecular Imaging. It has demonstrated robust brain uptake and fast wash-out in non-target regions, a broad imaging window between 30 and 90 minutes post-injection (p.i.) for AD, and excellent reproducibility between test and retest scans. The absence of significant off-target binding enables PI-2620 to detect and quantify early Tau deposition in the brain. PI-2620 also shows promise for non-AD Tauopathies like progressive supranuclear palsy (PSP). Life Molecular Imaging has the exclusive, worldwide license for research, development and commercialization of Tau PET tracers generated within the discovery program.