On April 15, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported it has initiated its global multicenter Phase 2 clinical trial evaluating ZW25 in combination with standard of care chemotherapy for the first-line treatment of HER2-positive metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas (Press release, Zymeworks, APR 15, 2019, View Source [SID1234535130]).

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"Advancing ZW25 into a Phase 2 clinical trial represents another key milestone for Zymeworks," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "This reaffirms our commitment to execute our ambitious drug development strategy to address unmet need in patients with HER2-expressing cancers across multiple indications and lines of therapy. We anticipate that data from this trial will support initiation of a first-line registrational trial, which could position ZW25 as the new standard of care for HER2-positive metastatic gastric cancer."

In addition to the Phase 2 metastatic gastroesophageal cancer trial, ZW25 continues to be evaluated in multiple expansion cohorts in the ongoing Phase 1 trial as a single agent in gastrointestinal, gynecological, and other HER2-expressing cancers, and in combination with chemotherapy in breast and gastroesophageal cancers.

About the Trial

The Phase 2 trial is a two-part open-label study. The primary objectives of this trial are to confirm the safety, tolerability, and anti-tumor activity of ZW25 in combination with global standard of care regimens for gastroesophageal adenocarcinoma, including platinum and fluoropyrimidine-based regimens.

"While major advances have been made in the treatment of HER2-positive breast cancer, patients with HER2-positive gastroesophageal adenocarcinomas still have limited options," said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. "Based on the encouraging single agent anti-tumor activity we observed in patients with gastroesophageal adenocarcinomas in our Phase 1 study, we believe that ZW25 has the potential to address this need, and we are excited to be starting this first-line trial."

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Orphan Drug Designation to ZW25 for the treatment of both gastric and ovarian cancers.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug-resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

On April 15, 2019 INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported that the Board of Directors has appointed Andrew G. Long as Chief Executive Officer, effective immediately (Press release, Insys Therapeutics, APR 15, 2019, View Source [SID1234535129]). Mr. Long succeeds Saeed Motahari, who has mutually agreed with the INSYS Board of Directors to resign as President and CEO of the Company.

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In connection with INSYS’ leadership changes, Andrece Housley, INSYS’ Corporate Controller, has been appointed Chief Financial Officer, succeeding Mr. Long. Additionally, Dr. Venkat Goskonda has been promoted to Chief Scientific Officer, overseeing the Company’s R&D and manufacturing activities.

Steven Meyer, Chairman of the Board of Directors, remarked, "We believe that now is the right time to transition leadership and that Andy is an excellent choice to serve as the Company’s CEO. Andrece and Dr. Goskonda’s promotions are a reflection of their contributions to INSYS. On behalf of the Board, I thank Saeed for his commitment to INSYS and meaningful contributions to the enterprise. We appreciate Saeed’s dedication to INSYS’ employees and stakeholders and we wish him all the best in the future."

Mr. Long joined INSYS as Chief Financial Officer in August 2017 with more than three decades of experience in the life sciences, bio-pharma and industrial sectors. Prior to joining INSYS, he served as Senior Vice President of Global Finance at Patheon, where he worked on a number of initiatives leading up to Patheon’s IPO. Prior to working at Patheon, Mr. Long spent nine years as Vice President of Finance for multiple divisions at Thermo Fisher Scientific. He previously spent five years leading the global finance and supply chain functions for the BioScience Division of Cambrex Corporation. Previously, Mr. Long also spent almost a decade building his financial expertise in various roles at Abbott Laboratories.

On April 15, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported three oral presentations at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place April 29-May 2, 2019, in Washington, D.C (Press release, Intellia Therapeutics, APR 15, 2019, View Source [SID1234535128]).

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Intellia’s data includes important updates from the company’s programs and platform development activities:

"CRISPR/Cas9-Mediated Targeted Insertion of Human F9 Achieves Therapeutic Circulating Protein Levels in Mice and Non-Human Primates"

Intellia will present data showing that its targeted gene insertion platform achieved therapeutic levels of Factor IX protein in non-human primates (NHP). The company employs a proprietary hybrid delivery system, comprised of both lipid nanoparticles (LNPs) and adeno-associated virus (AAV), to insert the desired gene sequence. Factor 9 (F9) is a gene that encodes Factor IX (FIX), a blood-clotting protein that is missing or defective in hemophilia B patients.

The data showing therapeutic levels of FIX achieved in NHPs is from an ongoing research collaboration between Intellia and Regeneron Pharmaceuticals, Inc.

Presenter: Hon-Ren Huang, Ph.D., associate director, Vector Biology, Intellia
Abstract number: 11
Session: Advances in Genome Editing and Hemophilia Gene Therapies
Presentation date/time: Mon., April 29, 2019, 9-9:15 a.m. ET
Location: Heights Courtyard 2
"Exploiting Clonal Tracking of WT1-Specific T Cells to Generate a Library of Tumor-Specific T Cell Receptors (TCR) for TCR Gene Editing of Acute Leukemia"

This presentation will focus on Intellia’s ongoing research collaboration with IRCCS Ospedale San Raffaele in Italy to develop CRISPR-edited T cell therapies to address intractable cancers, such as acute myeloid leukemia (AML). Researchers generated and tested a library of TCRs with different epitope specificities and human leukocyte antigen (HLA) restrictions.

Presenter: Eliana Ruggiero, Ph.D., Experimental Hematology Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS Ospedale San Raffaele, Italy
Abstract number: 123
Session: Cancer Adoptive Immunotherapy
Presentation date/time: Mon., April 29, 2019, 5-5:15 p.m. ET
Location: Georgetown
"CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria"

Intellia will provide information demonstrating successful knockout of two targets of interest, lactate dehydrogenase A (LDHA) and hydroxyacid oxidase 1 (HAO1), to address primary hyperoxaluria type 1 (PH1) in a PH1 mouse model. The data shows the continued progression of the company’s modular platform capability using CRISPR to knock out liver gene targets. The data being presented includes results from an ongoing collaboration with researchers at the University of Alabama at Birmingham.

Presenter: Anette Hübner, Ph.D., associate director, Liver Biology, Intellia
Abstract number: 1000
Session: Use of New Technologies for Hepatic Therapy
Presentation date/time: Thur., May 2, 2019, 12-12:15 p.m. ET
Location: Heights Courtyard 3
"Delivering on the Therapeutic Promise of CRISPR/Cas9"

Intellia also will participate in the ASGCT (Free ASGCT Whitepaper) Gene Editing Workshop, which will provide an overview of current gene editing technologies and approaches, as well as emerging uses and applications.

Presenter: Sean Burns, M.D., senior director, Hematology and New Therapeutic Areas
Session: Corporate Review II
Session date/time: Sun., April 28, 2019, 5-6 p.m. ET
Location: Lincoln

On April 15, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that it has expanded its existing BENDEKA (bendamustine hydrochloride) licensing agreement with Teva Pharmaceuticals International GmbH ("Teva") (Press release, Eagle Pharmaceuticals, APR 15, 2019, View Source [SID1234535127]). Under the terms of the revised licensing agreement, beginning on October 1, 2019, Eagle’s royalty payment will increase from 25% to 30% of BENDEKA net U.S. sales, provided that BENDEKA’s orphan drug exclusivity has not been rescinded, withdrawn or waived by such date. The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter.

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The revised agreement, effective April 13, 2019, also extends the U.S. BENDEKA royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. The extended term recognizes the strength of the bendamustine patents with expiries through 2033, and the value of the product beyond the original ten-year period. As part of the agreement restructuring, Eagle will continue to manufacture BENDEKA for the U.S. market for so long as it is sold in the United States and has agreed to assume a portion of the BENDEKA-related patent litigation expenses.

"We are very pleased to deepen our relationship with Teva by extending and expanding our licensing agreement for BENDEKA. This agreement recognizes the long-term value of the product, which is supported by orphan drug exclusivity through December 7, 2022 and an extensive patent portfolio through 2033. Teva has been a strong commercial partner, and we look forward to exploring additional areas of cooperation," stated Scott Tarriff, Chief Executive Officer of Eagle.

BENDEKA was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

On April 12, 2019 Wayshine Biopharm reported that it has received IND approval from FDA about its innovative experimental medicine WSD0922, a First-in-Class CNS penetrable EGFR/EGFRvIII inhibitor for the treatment of Glioblastoma, Anaplastic Astrocytoma and cancers with CNS metastasis patients (Press release, Wayshine Biopharm, APR 12, 2019, View Source [SID1234537799]). The WSD0922 program is under the sponsorship of Wayshine and the clinical trial, entitled "A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU" will be performed at Minnesota, Arizona and Florida, the three campuses of Mayo Clinic. Glioblastoma is the most aggressive malignant primary brain tumor in adults and is nearly always fatal. Treatment options for GBM are scarce and recurrence is inevitable. After recurrence, no standard treatment has been established. WSD0922 could be a potential game-changing program in treating GBM and other brain cancers.

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"We are very pleased that the FDA has approved the application of IND, which is a significant development milestone in advancing our Portfolio," said Wei Zhong, Ph.D., CEO and Founder of Wayshine Biopharm. "WSD0922 is the first and only BBB penetrable EGFR/EGFRvIII inhibitor under development. The discovery of WSD0922 truly reflects our innovation and commitments and the clinical potential has been recognized and endorsed by the FDA, for this substantial unmet medical need. "

"If only one target can be picked for brain cancer, it’s EGFR/EGFRvIII." Comments from KOLs in Neuro-Oncology field.

"We make difference! WSD0922 is discovered and developed by Chinese scientists and the IND approval in US is a very important progress in its development. With the help from FDA and Mayo Clinic, we can definitely move this program forward quickly to benefit patients who are suffering Glioblastoma and the data generated from the study in cancer patients will significantly contribute to the brain cancer field." commented by Jinqiang Zhang, Ph.D., VP and co-founder at Wayshine.