On November 27, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing
multifunctional therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercialstage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the two companies have entered into a strategic collaboration for the clinical development and commercialization of Zymeworks’ investigational ZW25 and ZW49 HER2-targeted
bispecific antibodies (Press release, Zymeworks, NOV 27, 2018, View Source [SID1234531642]). In addition, Zymeworks granted BeiGene a license to Zymeworks’ proprietary Azymetric and EFECT platforms to develop and commercialize globally up to three other bispecific antibodies using the platforms.

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License and Collaboration for ZW25 and ZW49
Under the terms of the license and collaboration agreements for ZW25 and ZW49, Zymeworks has granted BeiGene exclusive rights to develop and commercialize Zymeworks’ clinical-stage bispecific antibody candidate ZW25 and its preclinical-stage bispecific antibody drug conjugate (ADC) ZW49 in Asia (excluding Japan), Australia, and New Zealand. BeiGene will be responsible for all clinical development and regulatory submissions in the licensed territories. The companies also plan to collaborate on global development of ZW25 and ZW49 in HER2-expressing solid tumors, including gastric and breast cancer, with BeiGene enrolling patients and contributing clinical trial data from the licensed territories. Zymeworks retains full rights to both ZW25 and ZW49 outside of the specified countries and will continue to lead global development of these drug candidates.

"Partnering with BeiGene was a key component of our development and commercialization strategy for ZW25 and ZW49," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "This collaboration allows Zymeworks to leverage BeiGene’s resources and expertise to accelerate the development of our most advanced product candidates and broaden our reach globally including in a key region of the world."

"Zymeworks’ promising candidates ZW25 and ZW49 complement our oncology pipeline and further advance our mission to develop treatments for patients who often have limited options," commented Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd. "Our deep clinical experience in China is an integral part of our business development efforts, as these trial data can be used to support global regulatory filings. We are excited by the clinical prospects of ZW25 and ZW49 in HER2-expressing cancers."

"At Zymeworks we are committed to developing new therapies to help address unmet medical need on a global basis," said Diana Hausman, MD, Zymeworks’ Chief Medical Officer. "We are looking forward to collaborating with BeiGene and benefiting from their extensive experience in oncology drug development in China and elsewhere. We expect that this collaboration will accelerate the development of ZW25 and ZW49 as potential new therapies for patients with HER2-expressing solid tumors, including gastric, breast and other cancers."

License to Zymeworks’ Azymetric and EFECT Platforms
In addition to the license and collaboration agreements for ZW25 and ZW49, Zymeworks and BeiGene entered into a separate research and license agreement for Zymeworks’ proprietary Azymetric and EFECT platforms, under which BeiGene will have global rights to research, develop and commercialize up to three bispecific antibody therapeutics directed to targets selected by BeiGene. BeiGene will be responsible for all research, development, and commercial
activities under this agreement.

Financial Consideration
Under the terms of the license and collaboration agreements for ZW49 and ZW25, Zymeworks will receive total upfront payments of US$40 million and is eligible to receive up to US$390 million in development and commercial milestone payments for both product candidates. In addition, Zymeworks will be eligible to receive tiered royalties on future sales of ZW25 and ZW49 in the licensed territory.

Under the terms of the research and license agreement for the Azymetric and EFECT platforms,
Zymeworks will receive an upfront payment of US$20 million and is eligible to receive up to an aggregate of US$702 million in development and commercial milestone payments for up to three bispecific product candidates developed under the agreement. In addition, Zymeworks will be eligible to receive tiered royalties on future global sales of bispecific products developed by BeiGene under the agreement.

Zymeworks’ Webcast and Conference Call
Zymeworks will host a webcast and conference call November 27th , at 8:30 a.m. ET (5:30 a.m. PT) to discuss the collaboration and license agreements. Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source A recorded replay will also be
available on the website shortly after the call concludes.

The live call and Q&A may be accessed by dialing 1-800-319-4610 for North American callers, or 1-604-638-5340 for international callers. Callers should dial in five to ten minutes prior to the scheduled start time and ask to join the "Zymeworks call."

About ZW25
ZW25 is being evaluated in a Phase 1 clinical trial in the United States and Canada. 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 ZW49
ZW49 is a novel bispecific ADC targeting two non-overlapping epitopes of HER2 resulting in enhanced internalization and delivery of its proprietary ZymeLink cytotoxic payload. ADCs incorporating ZymeLink have demonstrated a greater therapeutic window (range of doses that are both efficacious and tolerable) in preclinical testing than those incorporating the commonly used ADC payloads DM1 or MMAE. Zymeworks is developing ZW49 as a best-in-class HER2- targeting ADC for several indications characterized by HER2 expression, especially those patients whose tumors have progressed or are refractory to HER2-targeted agents, and those that express lower levels of HER2 and are ineligible for treatment with current HER2-targeted ZW49 was recently submitted to the FDA.

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.

About the EFECT Platform
The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity
of the antibody-mediated immune response, which includes both the up- and down-regulation of
effector functions. This platform, which is compatible with traditional monoclonal as well as
Azymetric bispecific antibodies, further enables the customization of therapeutic responses for
different diseases.

On November 27, 2018 Celgene Corporation (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) reported the completion of enrollment for the KarMMa pivotal study of bb2121, the companies’ lead investigational anti-BCMA CAR T cell therapy candidate for patients with relapsed and refractory multiple myeloma (Press release, bluebird bio, NOV 27, 2018, View Source [SID1234531638]). bb2121 is being developed as part of a Co-Development, Co-Promote and Profit Share Agreement between Celgene and bluebird bio.

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"We continue to be excited about bb2121 as a potential first-in-class BCMA-targeted therapy for patients with multiple myeloma," said Alise Reicin, M.D., President, Global Clinical Development for Celgene. "We would like to thank everyone who enabled this achievement, especially the patients and caregivers, and we congratulate the physicians and others involved in the KarMMa study, including our dedicated partners at bluebird bio. We look forward to seeing the data from this study and are progressing our broader bb2121 development program as we advance closer toward delivering this important new option to appropriate patients in need."

"We are committed to developing new treatment options to improve the care of patients with multiple myeloma, and completing enrollment of the KarMMa study moves us closer to this goal," said David Davidson, M.D., chief medical officer, bluebird bio. "As we advance our clinical studies of bb2121 in earlier lines of therapy in collaboration with our partners at Celgene, we remain very grateful to the patients, families and healthcare providers who have made this program possible."

KarMMa is a pivotal, open-label, single-arm, multi-center phase 2 study evaluating the efficacy and safety of bb2121 in patients with relapsed and refractory multiple myeloma. In November 2017, bb2121 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration and PRIority Medicines (PRIME) eligibility by the European Medicines Agency. The BTD designation and PRIME eligibility were based on preliminary clinical data from the phase 1 CRB-401 study.

The FDA action date for the bb2121 NDA is anticipated in 2020. bb2121 is currently an investigational therapy; safety and efficacy have not yet been established. bb2121 has not been approved for use by any health authority.

On November 27, 2018 Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cellular immunotherapies to treat cancer and cell-based therapeutics to treat neurological conditions associated with demyelination, reported enrollment and dosing of the fourth subject in the first-in-human Phase 1 clinical trial of VAC2 in the United Kingdom (Press release, Asterias Biotherapeutics, NOV 27, 2018, View Source [SID1234531636]). This is the first patient enrolled and dosed at Queen Elizabeth Hospital, Birmingham, UK. This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK, will examine the safety and tolerability of VAC2 in non-small cell lung cancer (NSCLC) as the study’s primary endpoints. Secondary and tertiary endpoints of the study include evaluations of the immunogenicity of VAC2 in NSCLC.

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"We are excited to be participating in this clinical trial using Asterias’ groundbreaking dendritic cell technology, VAC2 for NSCLC," commented Gary Middleton, Professor of Medical Oncology at The University of Birmingham and Principal Investigator at Queen Elizabeth Hospital, the trial center. "The patient received their sixth and final injection of VAC2 this week and there have been no reported complications."

"We remain excited about the potential of VAC2 for NSCLC and we are thankful for Cancer Research UK’s sponsorship of the clinical trial and look forward to more patients being enrolled at Queen Elizabeth Hospital, as well as at the third trial site that CRUK is planning on opening," commented Michael Mulroy, President and Chief Executive Officer of Asterias. "The enrollment timeline for this trial remains on track and we are continuing to evaluate further development of VAC2 as a monotherapy or in combination with other therapies in various cancer indications that may benefit from this therapy."

About VAC2

VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase invokes enhanced stimulation of immune responses to the protein. Similar to an earlier, Asterias-sponsored, hematological cancer program using an autologous approach, the VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. VAC2’s mode of action is complementary to and potentially synergistic with other immune therapies such as checkpoint inhibitors or other immune pathway inhibitors.

About Non-Small Cell Lung Cancer and the VAC2 Trial

Lung cancer (both small cell and non-small cell) is the leading cause of cancer-related death, accounting for about one-quarter of all cancer deaths and more than colorectal, breast, and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers, according to the American Cancer Society. The three main types of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The American Cancer Society’s estimates for lung cancer in the United States for 2017 are: about 222,500 new cases of lung cancer, and about 155,870 deaths from lung cancer. Despite the large number of people afflicted by non-small cell lung cancer, patients remain vastly underserved due to a scarcity of effective treatments. According to statistics published by Cancer Research UK, the five year survival rate for lung cancer patients in England and Wales is less than 10%.

As currently designed, the first VAC2 clinical trial will enroll up to 24 subjects into one of two cohorts, depending on the stage of their non-small cell lung cancer. The first cohort will evaluate VAC2 in up to 12 subjects with advanced non-small cell lung cancer. Subjects in this cohort, who carry the major histocompatibility gene, HLA-A2, will receive six weekly injections of VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival. These survival results will be compared directly to a control group who meet all of the other inclusion/exclusion criteria but do not possess the HLA-A2 gene. Assuming safety is demonstrated in the first cohort, enrolment will advance to a second cohort. In the second cohort, early stage subjects who have had successful resection of their tumor with no evidence of metastasis will be enrolled. Up to 12 subjects in this second cohort who carry the major histocompatibility allele HLA-A2 will receive six, weekly injections of VAC2 and will be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse. These survival results will again be compared directly to a control group who meet all of the inclusion/exclusion criteria of cohort 2 but are not HLA-A2+. Subjects will be followed for one year for immune response to telomerase and for 2 years for the survival endpoints. The supply of VAC2 to be used in this trial is being manufactured by Cancer Research UK’s Biotherapeutics Development Unit. Asterias and Cancer Research UK are exploring the combination of VAC2 with an immune pathway inhibitor.

On November 27, 2018 Sandoz, a Novartis division and the pioneer and global leader in biosimilars, reported that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo (pegfilgrastim) (Press release, Novartis, NOV 27, 2018, View Source [SID1234531635]).

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Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes.[1] These indications match those of the reference medicine.**[1],[3]

"Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity,"[4] said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer."

This approval was based on comprehensive analytical, preclinical and clinical data. In these studies, Ziextenzo matched the reference medicine in terms of safety, efficacy and quality.[5]-[8] Pegfilgrastim, the active substance in Ziextenzo, is a long-acting form of filgrastim, which stimulates the production of white blood cells.[1]

"Pegfilgrastim biosimilars, such as Ziextenzo, mark a true advancement for people with cancer. These medicines help deliver optimized long-acting dosing and patient convenience while creating savings for our hard-pressed health systems," said Dr. Paul Cornes, oncologist and member of the Continuing Medical Education program of the European Association of Hospital Pharmacists and Core Lecturer for the European School of Oncology, United Kingdom.

Sandoz remains committed to making access happen for patients and leads in biosimilars with eight approved biosimilars worldwide, including five in the last 18 months. We look forward to making available a robust portfolio of biosimilar medicines that enables early and expanded access for patients as well as generates healthcare savings worldwide.

About Ziextenzo (pegfilgrastim)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person’s own body. Filgrastim may be used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.[1]

On November 27, 2018 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company, today reported that data from three abstracts—including an oral presentation—were accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2018) (Press release, TapImmune, NOV 27, 2018, View Source [SID1234531632]). The studies describe results achieved using multi-tumor antigen specific T cells that were developed at the Baylor College of Medicine in the laboratories of Dr. Ann Leen and Dr. Juan Vera, and exclusively licensed to Marker.

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Among the highlights, results from an ongoing Phase 1 study in patients with multiple myeloma will be reviewed in an oral presentation by Premal Lulla, M.B.B.S., Assistant Professor of Medicine at the Center for Cell and Gene Therapy, Hematology-Oncology, at the Baylor College of Medicine.

ASH 2018 will take place in San Diego, CA from December 1-4.

Oral Presentation Details:

Title: Safety and Efficacy of Multiantigen-Targeted T Cells for Multiple Myeloma (Abstract # 1014)

Date: Monday, December 3, 2018

Time: 7:30 p.m. PST (San Diego Convention Center, Ballroom 20D)

Poster Presentation Details:

Title: Targeting Lymphomas Using Non-Engineered, Multi-Antigen Specific T Cells (Abstract #1685)

Date: Saturday, December 1, 2018

Presentation Time: 6:15 p.m. – 8:15 p.m. PST (San Diego Convention Center, Hall GH)

Title: Adoptive T-Cell Therapy for Acute Lymphoblastic Leukemia Targeting Multiple Tumor Associated Antigens (Abstract #2693)

Date: Sunday, December 2, 2018

Presentation Time: 6:00 p.m. – 8:00 p.m. PST (San Diego Convention Center, Hall GH)