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]).

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"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.

On September 17, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported that it will present an update on the lead candidate from its IL-2 superkine platform, MDNA19, at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) to be held from September 25-28, 2019 in Paris, France (Press release, Medicenna Therapeutics, SEP 17, 2019, View Source [SID1234539600]). The conference is co-sponsored by the Cancer Research Institute (CRI), the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), the European Academy of Tumor Immunology (EATI), and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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The presentation will provide additional preclinical data on MDNA19 (formally known as MDNA109-LA1), a best-in-class long-acting IL-2 developed from Medicenna’s Superkine platform that has shown unique ability to selectively stimulate cancer killing immune cells without the limitations seen with other long-acting IL-2 programs.

The details of the poster presentation are as follows:

Title:

Long-acting MDNA109: Emerging IL-2 Superkines displaying potent anti-tumoral responses.

Presenter:

Dr. Minh To, Ph.D.

Poster #:

B042

Date/Time:

Friday, September 27th, 2019 from 1:00-3:00pm and 6:30-8:00pm

Location:

Espace Grande Arche, Tunnel de Nanterre-La Défense, 92044 Paris La Défense, France

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]).

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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.

On September 17, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX) reported an oral and poster presentation of updated clinical data from its ongoing Phase 2 clinical trial of DKN-01, its anti-Dickkopf-1 (DKK1) antibody, as both a monotherapy and in combination with paclitaxel chemotherapy in patients with advanced gynecological malignancies will be presented at the 2019 International Gynecologic Cancer Society Annual Global Meeting taking place September 19-21, 2019 in Rio de Janeiro, Brazil (Press release, Leap Therapeutics, SEP 17, 2019, View Source [SID1234539601]). The poster will be presented on Friday, September 20 at 6:15 p.m. (BRT).

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"We are very enthusiastic about the single agent and combination activity of DKN-01 observed in this heavily pre-treated patient population. DKN-01 targets DKK1, which is a modulator of Wnt signaling. In this study, patients with Wnt activating mutations and high levels of DKK1 have had clinical benefit and prolonged progression-free survival (PFS)," commented Rebecca C. Arend, M.D., Department of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine, who presented the data on behalf of the study group. "A monotherapy complete response and the correlation of patient outcomes with prevalent tumor biomarkers are impressive signals of activity in these patients, who have poor prognosis and few treatment options."

Key Findings from the P204 Study include:

DKN-01 single agent complete response: Following the data cut-off date, one patient with Wnt signaling alterations has had her monotherapy partial response deepen into a complete response. She has remained on DKN-01 monotherapy for 14 months after enrolling in July 2018 and having a partial response after cycle 8. This represents the first complete response for a patient on DKN-01 monotherapy.
Patients with Wnt activating mutations have longer PFS: Across the study, patients with Wnt activating mutations have demonstrated a longer PFS (n=21, 175 days) as compared to patients without Wnt activating mutations (n=67, 63 days). The benefit observed in patients with Wnt activating mutations was statistically maintained regardless of treatment type (monotherapy or combination therapy) and cancer type (endometrial or ovarian cancer).
Patients with DKK1-high tumors have longer PFS:DKK1 expression as measured by in situ hybridization RNAscope assay is currently available for 54 of the patients on the study, and 13 patients (24.1%) were identified as DKK1-high tumoral expression. Similar to the results from Leap’s study in patients with esophagogastric cancer, patients whose tumors are DKK1-high have prolonged PFS (n=13, 168 days) as compared to patients with tumors that are DKK1-low (n=41, 63 days). The benefit observed in patients with DKK1-high tumors was statistically maintained regardless of monotherapy or combination therapy treatment and cancer type (endometrial or ovarian cancer).
Few survival events in Wnt activating mutation or DKK1-high populations: Median overall survival (OS) has not yet been reached for the patients with Wnt activating mutations as compared to 321 days OS for patients without Wnt activating mutations. Only 3 of 21 patients with Wnt activating mutations (14.3%) have had events as compared to 18 of 67 patients (26.9%) without Wnt activating mutations. Median OS has also not been reached for the DKK1-high patients as compared to 365 days for the patients who are DKK1-low. Only 2 of 13 DKK1-high patients (15.4%) have had events as compared to 12 of 41 (29.3%) DKK1-low patients. Patient follow-up remains ongoing.
About the P204 Study
The P204 study is a Phase 2 basket study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory endometrioid endometrial cancer (EEC), endometrioid ovarian cancer (EOC) or carcinosarcoma. Ninety-two patients have been enrolled in the first four groups that were designed to evaluate the efficacy, safety, and pharmacodynamics of DKN-01 monotherapy and combination therapy in both EEC and EOC. The study has been expanded to include DKN-01 monotherapy and paclitaxel combination cohorts in patients with carcinosarcoma. Approximately fifty percent (50%) of patients in each cohort were required to have Wnt pathway alterations, which included Wnt activating mutations and Wnt signaling mutations. Additional patient follow-up is expected in the first half of 2020.

About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells.

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