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Tocagen and NRG Oncology to Collaborate on a Phase 2/3 Trial of Toca 511 & Toca FC in Newly Diagnosed Glioblastoma

On November 29, 2018 Tocagen Inc. (Nasdaq: TOCA), a late clinical-stage, cancer-selective gene therapy company and NRG Oncology, a member of the National Cancer Institute’s (NCI) National Clinical Trial Network (NCTN), reported that the NCI Cancer Therapy and Evaluation Program (CTEP) Brain Malignancies Steering Committee has approved a concept to develop a clinical trial utilizing the investigational therapeutic regimen Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) for the treatment of patients with newly diagnosed glioblastoma (GBM) (Press release, Tocagen, NOV 29, 2018, View Source;p=RssLanding&cat=news&id=2378701 [SID1234531707]).

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NRG Oncology, as one of the four adult group members of the NCI NCTN, conducts practice-defining, multi-institutional Phase 2 and 3 trials funded primarily by the NCI. The proposed Phase 2/3 trial (NRG-BN006) is expected to begin enrollment in 2019 and will be conducted by NRG Oncology under its NCI-funded grant, with Tocagen supplying investigational drug and supplemental financial support. Additional information about the trial will be provided in 2019.

Standard of care (SOC) for newly diagnosed GBM, the most common and deadly form of primary malignant brain tumor, involves surgical removal of as much of the tumor as possible followed by radiation therapy and temozolomide with use of tumor treating fields in a select group of patients. The proposed NRG-BN006 trial is designed to assess the benefit of adding Toca 511 & Toca FC to chemotherapy and radiation compared to SOC alone.

"The Brain Tumor Committee at NRG Oncology elected to conduct and sponsor the Toca 511 & Toca FC clinical trial in patients with newly diagnosed GBM based on the merits of published clinical data, which show extended overall survival compared to historical controls, durable complete responses and a favorable safety profile in patients with recurrent high grade glioma along with preclinical data that support a novel immune-activating mechanism of action, synergy with radiation therapy and additive efficacy in combination with temozolomide," said Minesh P. Mehta, chair of the Brain Tumor Committee at NRG Oncology.

Added Manmeet Ahluwalia, Principal Investigator of the proposed study, "Glioblastoma remains a very high unmet need and there is excitement among the NRG Oncology membership to explore the potential of Toca 511 & Toca FC to enhance standard treatment to achieve greater tumor response and extend survival of patients with this aggressive type of cancer."

Tocagen is currently studying Toca 511 & Toca FC for the treatment of recurrent high grade glioma (HGG) in the ongoing Phase 3 trial (Toca 5) which has enrolled approximately 400 patients, equally randomized to receive either Toca 511 & Toca FC or standard of care. Across three ascending-dose Phase 1 trials, Tocagen has treated 127 patients with recurrent HGG with Toca 511 & Toca FC. In these trials, Tocagen observed potential benefits, including ongoing durable complete responses, extended overall survival and a favorable safety profile. The proposed NRG-BN006 trial will be the first clinical trial of the Toca 511 & Toca FC regimen in the newly diagnosed GBM setting.

GlycoMimetics to Host 2018 Investor/Analyst Meeting at 60th ASH Annual Meeting on December 3, 2018

On November 29, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host and webcast an investor/analyst meeting and update at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, on December 3 at 6 a.m. PT. Daniel J. DeAngelo, MD, PhD,Director of Clinical and Translational Research, Adult Leukemia Program, Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Associate Professor of Medicine, Harvard Medical School, who served as lead investigator of the GlycoMimetics’ recently completed Phase 1/2 clinical trial of uproleselan in acute myeloid leukemia patients, will recap and provide perspective on his December 2 oral presentation at the ASH (Free ASH Whitepaper) meeting, highlighting the trial’s findings (Press release, GlycoMimetics, NOV 29, 2018, View Source [SID1234531706]). GlycoMimetics management will review additional posters from the ASH (Free ASH Whitepaper) meeting.

The investor/analyst event will be webcast beginning at 6:15 a.m. PT. The dial-in number for the event is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9779654. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Investors/analysts are requested to pre-register for the private in-person event at [email protected]. The event will be held at Hard Rock Hotel San Diego in the Celebrate Room, 207 Fifth Avenue, San Diego. On-site inquiries will be handled by Shari Annes, (650) 888-0902, by text or phone.

Athenex Announces Licensing Agreement with PharmaEssentia for Rights to Oradoxel (Oral Docetaxel) in Certain Asian Territories

On November 29, 2018 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into an agreement with PharmaEssentia Corporation (Taipei Exchange:6446) to license the rights to develop and commercialize Athenex’s Oradoxel in Taiwan, Singapore and Vietnam (Press release, Athenex, NOV 29, 2018, View Source;p=RssLanding&cat=news&id=2378678 [SID1234531705]). The existing licensing agreement for Oraxol (oral paclitaxel) and Oratecan (oral irinotecan) with PharmaEssentia is being expanded to account for additional considerations, including milestone payments, for Oradoxel (oral docetaxel). In December 2013, Athenex and PharmaEssentia entered into a license agreement, pursuant to which PharmaEssentia was granted a license to develop and commercialize Oraxol and Oratecan in Taiwan and Singapore. The agreement was amended in December 2016 to also include Vietnam in the territories covered by the license.

Under the terms of the expanded agreement, which includes Oradoxel, Athenex will receive a cash payment as well as the potential to receive additional milestone payments for certain development and regulatory milestones of Oradoxel in the territories. PharmaEssentia will be responsible for all activities and expenses relating to clinical development, regulatory approval, and commercialization of Oradoxel in the territories.

Docetaxel is an anti-cancer chemotherapeutic agent that is used widely in the treatment of breast, prostate, gastric, head and neck, and lung cancers. Oradoxel is an oral formulation of Docetaxel combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Oradoxel is currently in Phase I clinical studies in the U.S. and New Zealand, and is ready to advance to Phase II with studies expected to begin in the first half of 2019.

Dr. Kochung Lin, Chief Executive Officer of PharmaEssentia, commented, "We are excited with the encouraging results so far from clinical trials of Athenex’s Orascovery drug candidates, particularly Oraxol. The potential of oral chemotherapy drugs to improve efficacy and safety, and improve patients’ quality of life, cannot be overstated. Athenex has generated promising Phase I data with both Oratecan and Oradoxel, and we are pleased to participate in the development of these exciting products in Taiwan, Singapore and Vietnam to help realize the full potential of this platform. We have been impressed by the Athenex team in their execution and are delighted to continue and expand our excellent partnership with the addition of Oradoxel."

Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, stated, "This agreement builds on our longstanding relationship with PharmaEssentia. PharmaEssentia has demonstrated strong commitment to cancer drug research and development, and we are confident they have the capabilities for successfully delivering Oradoxel to patients in the licensed territories."

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

MacroGenics and Zai Lab Announce Exclusive Collaboration and License Agreement to Develop and Commercialize Margetuximab, MGD013 and TRIDENT™ Molecule in Greater China

On November 29, 2018 MacroGenics (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, and Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported that the companies have entered into an exclusive collaboration and license agreement involving three immuno-oncology (I-O) programs from MacroGenics’ pipeline of product candidates (Press release, Zai Laboratory, NOV 29, 2018, View Source;p=RssLanding&cat=news&id=2378649 [SID1234531704]):

Margetuximab, an immune-optimized anti-HER2 monoclonal antibody currently being evaluated in Phase 3 metastatic breast cancer with anticipated topline results in the first quarter of 2019.
MGD013, a first-in-class bispecific DART molecule designed to provide coordinate blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies.
An undisclosed multi-specific TRIDENT molecule in preclinical development.
Zai Lab obtains regional development and commercialization rights for these programs in mainland China, Hong Kong, Macau and Taiwan. Zai Lab will lead clinical development in its territory by leveraging its regulatory and clinical development expertise and broad regional network of investigators. As part of the collaborative clinical development effort, Zai Lab and MacroGenics intend to initiate a global study using combination regimens containing margetuximab in order to maximize potential clinical benefit in gastric cancer, the fifth most common cancer in the world and the second most common in China.

"We believe Zai Lab is an ideal partner to enable us to expand MacroGenics’ global efforts to address patient populations with high unmet medical needs such as gastric cancer," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region."

Dr. Samantha Du, Chief Executive Officer of Zai Lab said, "MacroGenics is a leader in the immuno-oncology field and we are thrilled to enter into this comprehensive strategic collaboration for a broad set of innovative assets. We believe we can build off the promising, previously reported results from MacroGenics’ clinical studies of margetuximab in HER2-positive breast and gastric cancer, which are highly synergistic operationally with our other existing pipeline programs. We also look forward to working with MacroGenics in advancing MGD013, an exciting first-in-class I-O program that will help distinguish our pipeline and create combination opportunities with our other oncology assets. We believe this collaboration significantly increases the value of our oncology portfolio and is another step in establishing Zai as a leader in the field of innovative cancer treatments."

Under the terms of the agreement, MacroGenics will receive an upfront cash payment of $25 million and will be eligible to receive up to $140 million in potential development and regulatory-based milestone payments. In addition, Zai Lab would pay MacroGenics double-digit royalties on annual net sales of the assets, which may be subject to adjustment in specified circumstances.

Zai Lab to Host Webcast and Conference Call

Zai Lab will host a webcast and conference call to discuss the collaboration and license agreement on Thursday, November 29th, at 8:30 a.m. ET.

Zai Lab Investor Conference Call Details
Date: Thursday, November 29, 2018
Time: 8:30 a.m. ET
Dial-In Details: 1-866-394-4355 (US); 1-314-888-4344 (International); 4006828609 (China)
Conference ID: 5874458

A live webcast and replay will be available on the Investor section of Zai Lab’s website at View Source A slide presentation will accompany the webcast and will also be available on Zai Lab’s website.

About MacroGenics’ Margetuximab Program

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, oncoprotein. HER2 is expressed by tumor cells in breast, gastric, and other solid tumor cancers, making it a key marker for biologic therapy. MacroGenics has completed enrollment of its pivotal Phase 3 SOPHIA study, which is evaluating the treatment of relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics anticipates disclosure of topline PFS results from this trial in the first quarter of 2019. In addition to being studied in metastatic breast cancer, margetuximab is also being studied in combination with an anti-PD-1 agent in a Phase 2 clinical trial in gastric cancer, for which data was recently presented at the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

About MacroGenics’ MGD013 Program

MGD013 is a first-in-class bispecific DART molecule designed to provide coordinate blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MacroGenics recently established the dose and schedule for MGD013 administration and has initiated dose expansion in up to nine tumor types.

Alpine Immune Sciences Announces ALPN-101 Data to be Included in Oral Presentation at 60th American Society of Hematology Annual Meeting and Exposition

On November 29, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported pre-clinical data from its lead autoimmune/inflammatory program, ALPN-101, will be included in an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Sunday, December 2, 2018 at 9:30am PT in San Diego, CA (Press release, Alpine Immune Sciences, NOV 29, 2018, View Source [SID1234531700]).

The presentation highlights the novel role ICOS ligand (ICOS-L) plays in acute GvHD, extending what is currently understood about the CD28/B7 protein family in disease pathogenesis. In particular, there is a strong correlation with ICOS-L positive plasmacytoid dendritic cells and the gastrointestinal manifestations of GvHD that may act as a biomarker for identification of patients. There are no current therapies in development blocking both the CD28 and ICOS pathways. The oral presentation will include data evaluating ALPN-101, a highly potent and effective first in class dual blocker of both the ICOS and CD28 pathways, in GvHD and discuss its potential role and mechanism. It will be delivered by Dr. Djamilatou Adom from the Indiana University School of Medicine laboratory of Dr. Sophie Paczesny.

"I’m excited about the potential of ALPN-101 in GvHD given its dual CD28/ICOS mechanism of action," said Dr. Paczesny, Professor of Immunology and Pediatrics at Indiana University School of Medicine and lead of the Biomarkers Stem Cell Transplantation Program, and one of Alpine’s research collaborators. "Targeting the ICOS/ICOSL and CD28/B7 pathways may represent a new avenue to treat or prevent GvHD, and early biomarker development could identify patients at risk and support ALPN-101 as an early intervention in this patient population."

Oral Presentation

Title: ICOSL+ Plasmacytoid Dendritic Cells As Biomarker and Inducer of Graft-Versus-Host Disease
Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Biomarkers and the Microbiome
Date and Time: Sunday, December 2, 2018 at 9:30-9:45 a.m. PT
Location: Grand Hall A of the Manchester Grand Hyatt San Diego.
As previously announced, the company will also have two poster presentations at the ASH (Free ASH Whitepaper) Annual Meeting. Both posters will be available in Hall GH of the San Diego Convention Center on Saturday, December 1, 2018 from 6:15 p.m. PT – 8:15 p.m. PT:

Poster Presentations

Abstract Title: Therapeutic Candidate ALPN-101, a Dual ICOS/CD28 Antagonist, Potently Suppresses Human/NSG Mouse Xenograft Graft Vs. Host Disease (GvHD) in a Dose Ranging Study and Reduces Disease Activity in a Mouse Model of Hemophagocytic Lymphohistiocytosis (HLH)
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I
Publication Number: 2037
Abstract Title: "Switch" Transmembrane Immunomodulatory Proteins (TIPs) Consisting of High-Affinity PD-1 Extracellular Domains (PD-1 vIgDs) and Costimulatory Intracellular Domains Potently Enhance the Activity of TCR-Engineered T Cells
Session Name: 703. Adoptive Immunotherapy: Poster I
Publication Number: 2052