On March 28, 2019 -Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported positive topline results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201 (Press release, Seattle Genetics, MAR 28, 2019, View Source [SID1234534679]). The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate (ORR) per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study (EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The data will be presented at an upcoming medical meeting.

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Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a therapeutic target that is highly expressed in multiple solid tumors including urothelial cancers. Based on preliminary results from a phase 1 trial (EV-101), enfortumab vedotin was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following treatment with a PD-1 or PD-L1 inhibitor.

The companies plan to submit a Biologics License Application (BLA) to the FDA later this year based on the results from the EV-201 trial (cohort 1). A global, randomized phase 3 clinical trial (EV-301) is ongoing and intended to support global registration as well as to serve as the confirmatory randomized trial for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

"Despite recent approvals of multiple checkpoint inhibitors for previously treated locally advanced or metastatic urothelial cancer, there remains a high unmet need for effective treatments upon progression after initial chemotherapy and immunotherapy," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "These results for enfortumab vedotin indicate it may be able to help patients whose urothelial cancer progresses following treatment with standard chemotherapy and a PD-1 or PD-L1 inhibitor."

"After progression on platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, patients with locally advanced or metastatic urothelial cancer are left with no approved standard of care treatment options," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "These data are very encouraging, and we look forward to discussing the data with relevant health authorities."

Urothelial cancer is the most common type of bladder cancer (90 percent of cases).1 In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States.2 Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.3 Approximately 80 percent of people do not respond to PD-1 or PD-L1 inhibitors after a platinum-containing therapy has failed as an initial treatment for advanced disease.4 There are currently no approved therapies for metastatic urothelial cancer once it has progressed after chemotherapy and a PD-1 or PD-L1 inhibitor.5

In addition to the ongoing confirmatory phase 3 study intended to also support global registration, development of enfortumab vedotin is underway in earlier lines of treatment for locally advanced or metastatic urothelial cancer, including in newly diagnosed patients in combination with pembrolizumab and/or platinum chemotherapy.

About The EV-201 Trial

EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2). The EV-201 phase 2 trial continues to enroll patients in cohort 2. In cohort 1, 128 patients were enrolled at multiple centers internationally.6 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. More information about enfortumab vedotin clinical trials can be found at clinical trials.gov.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational 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 identified as an ADC target by Astellas, which is expressed on many solid tumors.

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 and become commercially available for the uses being investigated.

Seattle Genetics Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the announcement of enfortumab vedotin topline data. The event will be held today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, or by calling 866-288-0540 (domestic) or 786-460-7199 (international). The conference ID is 3807860. A replay of the live event will be available starting on March 28, 2019 on the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 3807860. The telephone replay will be available until 5:00 p.m. PT on April 1, 2019.

On March 27, 2019 Crown Bioscience, a global drug discovery and development services company, providing translational platforms to advance oncology, inflammation and autoimmune, cardiovascular and metabolic disease research reported that parent company, JSR Corporation, has entered into a strategic partnership with Hubrecht Organoid Technology (HUB) (Press release, JSR, MAR 27, 2019, View Source [SID1234553813]).

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The agreement provides CrownBio, a wholly owned subsidiary of JSR Corporation, with an exclusive license to provide preclinical oncology drug development and validation services using HUB Organoid Technology, including access to HUB’s highly characterized tumor organoid biobank. CrownBio and HUB will also launch a collaborative research & development program to accelerate further development of Organoid Technology, while CrownBio will establish a new operations center in Utrecht, Netherlands.

HUB’s adult stem cell-derived organoids, developed by Prof. Hans Clevers at the Hubrecht Institute in Utrecht, are generated using highly standardized, proprietary culture methods. The Organoids faithfully recapitulate tumors in patients and are extensively characterized by pathology, genomics, and sensitivity to known and experimental drugs.

"This agreement is a pivotal moment in our growth and the evolution of the company," said Dr. Jean-Pierre Wery, CEO of CrownBio. "This partnership positions CrownBio at the forefront of global preclinical research by creating an unparalleled translational platform to accelerate drug development and validation."

Building on a global leadership in Patient-Derived Xenografts (PDX), CrownBio will offer comprehensive pharmacology and translational services based on HUB Organoid Technology, establishing a unique platform that incorporates in vitro screening of Patient-Derived Organoids (PDO) and PDX derived organoids (PDXO), matched to downstream in vivo models.

"We are delighted with the increased access to HUB Organoid Technology for researchers worldwide through CrownBio’s global reach and preclinical service expertise," said Dr. Robert Vries, Executive Director of HUB. "Our partnership with CrownBio equips the drug development community with powerful new translational tools to guide the creation of novel and improved treatments for cancer."

On March 27, 2019 XenTech SAS, a company specialized in the development and sale of preclinical research services to foster the development of oncology drugs, reported a strategic collaboration with Gustave Roussy, Europe’s leading cancer center (Press release, XENTECH, MAR 27, 2019, View Source [SID1234553821]). This co-operation, the first of its kind for XenTech, will focus on the development of a collection of tumor explant models from patients who developed acquired resistance to targeted therapies following initial response. These PDX models will be used in Gustave Roussy’s oncology R&D programs, as well as being added to XenTech’s existing PDX platform for translational oncology research projects for academic and industry customers.

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Patients with tumors that harbor specific driver molecular alterations benefit from targeted therapies, but responses are generally short-lived due to the emergence of adaptive/secondary resistance. Between 2015 and 2020 the MATCH-R trial led by Gustave Roussy (NCT02517892) will have enrolled 600 patients treated with targeted therapies. Biopsies will be used to generate PDX models, obtained from 300 patients who have developed resistance following initial response. The MATCH-R PDX platform will be regularly upgraded with new models, providing a unique resource in unravelling the mechanisms involved in acquired resistance to targeted therapies and testing novel therapeutic strategies to circumvent or delay the emergence of resistance.

"We are delighted to collaborate with Gustave Roussy on this unique and ambitious program," said Jean-Gabriel Judde, CSO and president of XenTech. "These new models will expand XenTech’s bank of PDX models with focus on the advanced drug-resistant setting. The MATCH-R PDX platform will enable a better understanding of acquired resistance to last-generation targeted therapies, providing clinically relevant models to perform preclinical POC studies, translating into increased patient survival. Full clinical and molecular annotation will enable model selection for testing innovative therapies, investigating new and existing pathways, and identifying biomarkers."

"Understanding the mechanisms of acquired resistance to novel targeting agents is crucial in providing optimal care to cancer patients," said Benjamin Besse, head of the department of medical oncology at Gustave Roussy and principal investigator of the MATCH-R clinical trial. "This strategic collaboration with XenTech, a renowned expert in PDX development and in vivo pharmacological studies, is a major asset for Gustave Roussy’s precision medicine program. There is no doubt that these clinically relevant models will speed-up the development of novel therapeutic agents leading to extended clinical benefit for metastatic cancer patients."

XenTech will participate in American Association Cancer Research Annual Meeting, Friday, March 29 – Wednesday, April 3, 2019, in Atlanta, GA.

On March 27, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "ImmunoPrecise") (TSX VENTURE: IPA) (OTC PINK: IPATF) reported its financial results for Q3 ended January 31, 2019 (Press release, ModiQuest Therapeutics, MAR 27, 2019, View Source [SID1234534957]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue. During the three months ended January 31, 2019, the Company increased revenues to $2,695,583 from $1,723,308 in 2018. This represents a 56% increase in revenue and stems from the acquisitions of U-Protein and ModiQuest, the Company’s ability to grow its core business and expand its market share in Europe, and an increase in projects for the B-cell lab.
Gross Margin. During the three months ended January 31, 2019, the Company increased its gross margin to $1,568,055 from $989,203 in 2018. In percentage terms, the Company’s gross margin increased to 58% from 57% in 2018. The higher gross margin in 2019 was mostly attributable to the fact that the Company focused on higher margin projects at its new B-cell lab and introduced additional efficiencies into its operations. The Company anticipates that gross margin on a percentage basis will continue to be over 50% for the balance of fiscal 2019.
Net Loss. The Company recorded a net loss of $1,187,056 during the three months ended January 31, 2019, which is consistent with the net loss of $1,211,591 for three months ended January 31, 2018. $577,720 of the costs incurred during the three months ended January 31, 2019 were one-time costs which are not expected to be incurred again. These one-time costs included costs incurred to improve operational efficiency across all the divisions, to integrate U-Protein and ModiQuest into IPA’s global network, and to continue to establish a global structure for reporting and oversight. In the current period the Company also made investments that would enable its future growth, such as new management hires, more training programs, and additional space
Adjusted EBITDA. For the three and nine months ended January 31, 2019, excluding the one-time costs of $577,720 and $1,251,613, respectively, EBITDA would have been $116,367 and ($301,477), respectively.

Corporate:

On August 20, 2018, the Company announced that Mr. Guy Champagne resigned from his position as a Director of the Company, and joined the Company’s Advisory Board.

On November 21, 2018, the Company announced that Paul Andreola was appointed as a Director of the Company at its annual general meeting ("AGM") held in Vancouver, BC on November 20, 2018. Mr. Andreola has over 20 years of business development and financial markets experience including senior management, marketing, and communications roles for early stage companies. Previously in his career, Mr. Andreola was a licensed investment advisor for over 10 years and has facilitated multiple early stage private and public companies in the resource and technology sectors. Mr. Andreola is currently the CEO and Director of NameSilo Technologies Corp. (CSE: URL) and Ironwood Capital Corp. (TSXV: IRN.P).

On March 27, 2019 Elicio reported that it launched with $30 million in funding and an immunotherapy strategy aimed at getting cancer vaccines into the lymph nodes, a location that orchestrates immune responses but has been hard to target directly (Press release, Elicio Therapeutics, MAR 27, 2019, View Source [SID1234534871]).

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Elicio Therapeutics (Cambridge, Mass.) has exclusively licensed the Amphiphile platform from Darrell Irvine at the Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. Irvine’s group figured out in 2014 how to ferry cancer vaccines into lymph nodes by tethering the vaccines to albumin to "hitchhike" on the carrier’s normal transportation route (see "Hitchhiker’s Guide to the Lymph Node").

Irvine’s group noticed that albumin effectively carried dyes and other compounds into the lymph nodes. In preclinical studies, the team showed that by conjugating vaccines to an albumin-binding lipid tail, tumor-targeting antigens and adjuvants elicited strong immune responses and slowed or reduced tumor growth in mice.

Elicio’s lead candidates from the Amphiphile platform will target pancreatic, colorectal and head and neck cancers. CEO Robert Connelly told BioCentury that Elicio is developing cancer vaccines with a range of different types of shared antigens, including viral antigens.

Connelly said the antigens Elicio is using "have only been delivered systemically, not directly to the lymph nodes," which results in weak immune responses and occasional systemic toxicity. "This is why cancer vaccines have been disappointing to date," he added.

Elicio plans to begin a Phase I/II trial in early 2020 of VED-002, a vaccine targeting KRAS mutations, to treat pancreatic cancer. Its second candidate, VED-001, is a vaccine targeting HPV E6 and E7 transforming proteins. It is set to enter the clinic in 2020 as a single agent and in combination with a checkpoint inhibitor for HPV-positive head and neck cancers.

Connelly declined to disclose the company’s investors.

Connelly was previously a venture partner at Flagship Pioneering and has served as CEO of multiple companies, including pulmonary disease company Pulmatrix Inc. (NASDAQ:PULM) from 2007 to 2012 and metabolic dysregulation company Axcella Health Inc. (Cambridge, Mass.) from 2013 to 2018.
Irvine is a professor of materials science and engineering and of biological engineering at MIT.

Targets: E6 transforming protein (Human papillomavirus-16) – HpV16gp1; E7 transforming protein (Human papillomavirus-16) – HpV16gp2; KRAS – K-Ras