On December 1, 2020 Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that its partner, BeiGene, Ltd., has dosed the first patient in South Korea in a pivotal, single-arm clinical trial of zanidatamab (formerly ZW25) monotherapy in patients with advanced or metastatic HER2-amplified biliary tract cancer (BTC) (Press release, Zymeworks, DEC 1, 2020, View Source [SID1234572047]). Zymeworks will receive a US$10 million payment under its collaboration with BeiGene as a result of the achievement of this development milestone.

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"Patients with biliary tract cancer generally have a poor prognosis and few treatment options," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. "While BTC occurs in patients throughout the world, the incidence is particularly high in Asia. Our collaboration with BeiGene expands the potential of zanidatamab to help address this global unmet need."

Zymeworks and BeiGene are progressing the opening of multiple clinical trial sites in support of the global registration-enabling Phase 2b clinical trial of zanidatamab in patients with HER2-amplified BTC. In the Asia region, multiple sites are open for enrollment in South Korea, and in China all sites have been selected with enrollment anticipated to begin in the first quarter of 2021.

This global zanidatamab study may enable the submission of a Biologics License Application by Zymeworks in the United States as early as 2022. Multiple clinical sites are now open to enrollment in the U.S., Europe, and Asia, with additional sites planned, including in Canada and South America.

"We are pleased to have been able to initiate this important clinical trial and hope that it may help contribute to improving the lives of patients with advanced or metastatic BTC and HER2 amplification," said Lai Wang, Ph.D., Senior Vice President, Head of Global Research and APAC Clinical Development at BeiGene. "As our collaboration with Zymeworks continues, this trial may help lead to expedited global regulatory approvals, including in China and South Korea."

This pivotal Phase 2b clinical trial is a global, multicenter, open-label, single-arm study designed to evaluate the antitumor activity of zanidatamab monotherapy in patients with HER2-amplified, inoperable and advanced or metastatic BTC, including gallbladder cancer and cholangiocarcinoma (Phase 2:NCT04466891). Patients must have received at least one prior gemcitabine-containing systemic chemotherapy regimen for advanced disease and have experienced disease progression after (or developed intolerance to) their most recent prior therapy. The primary endpoint of the study is the confirmed objective response rate (ORR) by independent central review per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Ongoing clinical trials are evaluating zanidatamab in first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in combination with standard of care chemotherapy (Phase 2: NCT03929666) as well as in combination with the oral CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) and fulvestrant in advanced HER2-positive, HR-positive breast cancer (Phase 2: NCT04224272). Zymeworks, in collaboration with BeiGene, plans to develop zanidatamab as a potential first-line treatment for patients with HER2-positive GEA. BeiGene is also conducting a two-arm Phase 1b/2 trial evaluating zanidatamab in combination with chemotherapy as a first-line treatment for patients with metastatic HER2-positive breast cancer and in combination with chemotherapy and BeiGene’s PD-1-targeted antibody tislelizumab as a first-line treatment for patients with metastatic HER2-positive GEA (NCT04276493). In addition, an ongoing Phase 1 trial is evaluating the safety and antitumor activity of zanidatamab as a single agent and in combination with chemotherapy in HER2-expressing cancers that have progressed after prior standard of care treatments, including HER2-targeted agents (Phase 1: NCT02892123).

About Zanidatamab

Zanidatamab 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 antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

About Biliary Tract Cancer

Biliary tract cancer (BTC), including gallbladder cancer and cholangiocarcinoma (bile duct cancer), accounts for approximately 3% of all adult cancers and is associated with a poor prognosis. Globally, more than 210,000 people are diagnosed with BTC every year. Most patients (> 65%) with BTC are diagnosed with tumors that cannot be removed surgically, and even those patients who undergo potentially curative surgery have a high recurrence rate. Treatment options are limited for patients with advanced BTC who experience disease progression after front-line chemotherapy.

The human epidermal growth factor receptor 2 (HER2) is a well-described target for anti-cancer therapy. Tumor cells that produce a higher than normal level of HER2 tend to grow more quickly and spread to other parts of the body. About 5% to 19% of patients with BTC have tumors that express HER2, suggesting that these patients may potentially benefit from HER2-targeted therapy. Currently no HER2-targeted therapy has been approved for the treatment of BTC.

About the Zymeworks-BeiGene Collaboration

In November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New Zealand. The companies are collaborating on joint global development for selected indications, with the goal of developing zanidatamab and ZW49 worldwide across multiple HER2-expressing cancers and lines of therapy.

On December 1, 2020 Hologic, Inc. (Nasdaq: HOLX), an innovative medical technology company primarily focused on improving women’s health, reported U.S. Food and Drug Administration (FDA) clearance and commercial availability of the Company’s Genius AI Detection technology, a new deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images (Press release, Hologic, DEC 1, 2020, View Source [SID1234572046]).

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The new technology represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam.*1 The new technology highlights areas with subtle potential cancers that can be difficult to detect for further examination by the radiologist, and is designed to provide higher sensitivity and a false-positive rate much lower than Hologic’s previous generation CAD products.

"As the latest breakthrough in breast cancer screening, Genius AI Detection reinforces Hologic’s commitment to improving cancer detection, optimizing workflow and enhancing the patient experience across every step of the breast health care continuum," said Jennifer Meade, Hologic’s Division President, Breast and Skeletal Health Solutions. "Not only did studies show that Genius AI Detection aids in image interpretation by highlighting suspicious, and often subtle, areas of interest, it also provides the radiologist the opportunity to prioritize the most concerning patient cases. This is a real game changer as it has the potential to shorten the cycle between screening and diagnostic follow-up, and ultimately improve patient outcomes."

The new software delivers key metrics at the time of image acquisition to help radiologists categorize and prioritize cases by complexity and expected read time in order to optimize workflow and expedite patient care. It is the only deep learning product on the market that runs on the acquisition workstation of the mammography system without the need for a separate server, providing a simple, convenient and secure environment.

The Genius AI Detection software is the only 3D CAD solution that supports Hologic’s latest innovations in tomosynthesis imaging, Clarity HD and 3DQuorum imaging technology, in addition to standard-resolution tomosynthesis. To learn more, visit View Source

The Genius 3D Mammography exam is acquired on the Hologic 3D Mammography system and consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set. The Genius exam is only available on the Hologic 3D Mammography system.

On December 1, 2020 CANbridge Pharmaceuticals Inc., a company developing and commercializing innovative drugs to treat rare diseases and targeted cancers, reported that it has completed a US$43 million Series E financing, led by 3W Fund Management (Press release, CANbridge Life Sciences, DEC 1, 2020, View Source [SID1234572045]). New investors include Casdin Capital, Summer Capital, SPDBI and Yaly Capital, with additional participation by existing investors, including Hudson Bay Capital Management, RA Capital Management, Hangzhou Tigermed Consulting Co. Ltd and LYFE Capital. The raise, which was expanded due to high demand, is a follow-on of the US$98 million Series D financing, completed in February. The proceeds will be used to expand the CANbridge rare disease pipeline through internal development and external partnerships, accelerate the clinical development of pre-clinical stage assets, prepare the commercial launch of CAN101 (Hunterase) and supplement working capital.

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CANbridge recently received marketing approval in China for its first rare disease candidate, Hunterase, for the treatment of Hunter syndrome (mucopolysaccharidosis II or MPS II). In addition, it has a deep rare disease pipeline, which includes an ongoing strategic partnership for rare disease treatment development with WuXi Biologics and two collaborative agreements with the Horae Gene Therapy Center at the UMass Medical School for rare disease gene therapy research. In addition, CANbridge recently received marketing approval for its second commercial product, NERLYNX (neratinib), in Taiwan, for early stage HER2-positive breast cancer.

"We are grateful and humbled by the tremendous investor enthusiasm in CANbridge," said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. "Since closing our $98 million Series D financing in February, CANbridge has strengthened its operating capabilities and achieved a number of milestones, including three marketing approvals, as the China rare disease market continues to generate momentum in the positive direction."

"As a leading pharmaceutical company in the rare disease sector, we believe CANbridge is well-positioned for commercialization of innovative drugs, and applaud its successful execution in drug development," said Cathy Chen, Managing Director of 3W Fund. "We are impressed by Management’s extensive experience and past track record and are truly excited to share in the next chapter of CANbridge’s success."

On December 1, 2020 Proscia, a leading provider of digital and computational pathology solutions, reported that it has secured $23 million in Series B funding led by Scale Venture Partners, with participation from Hitachi Ventures, the strategic corporate venture capital arm of Hitachi, Ltd., bringing its funding total to $35 million (Press release, Proscia, DEC 1, 2020, View Source [SID1234572044]). The company will use the investment to accelerate its global growth and strengthen its position of leadership in transforming cancer research and diagnosis at a time when demand for modernizing pathology is higher than ever.

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The practice of pathology sits at the core of biomedical research and cancer diagnosis. Until recently, this practice has remained largely unchanged in its 150-year history, depending solely on the human eye recognizing patterns in tissue under the microscope. With its Concentriq software platform, Proscia is accelerating the transformation to digital pathology, which centers around high-resolution images of tissue biopsies, as the new standard of care. Concentriq combines enterprise scalability with powerful AI applications to help laboratories, health systems, and life sciences companies unlock new insights, accelerate breakthroughs, and improve patient outcomes.

"Digitization has swept through almost every domain of healthcare, and we are now seeing its revolutionary impact on pathology," said Alexander Niehenke, Partner at Scale Venture Partners. "Proscia is a high-growth company with a unique platform-plus-AI approach that is enabling it to capitalize on a multi-billion-dollar market opportunity. We’re excited to be a part of Proscia’s success as it expands its leadership position in pathology’s shift from analog to digital."

The infusion of capital will enable Proscia to continue to meet growing demand for digital pathology across research and diagnostics. The company will use the funds to accelerate commercial expansion, ramping up its global sales, marketing, and support teams. Proscia will also further drive pathology’s data-driven future by expanding its data assets and AI application portfolio, building off of the initial success of its DermAI application. The investment will additionally advance Proscia’s regulatory strategy to secure FDA clearance, drawing on the foundation that the company has established with its CE Mark and MDSAP certification.

Since closing its Series A round in 2018, Proscia has amassed a customer base of laboratory titans and digital pathology pioneers as well as 10 of the top 20 pharmaceutical companies. This includes Johns Hopkins School of Medicine and the Joint Pathology Center (JPC), the premiere pathology reference center for the U.S. government. JPC selected Concentriq to drive a complete modernization of its pathology practice and digitize the world’s largest human tissue repository of over 55 million slides, unleashing a transformative wave of biomedical research. Proscia also recently established a Computational Pathology Center of Excellence with University Medical Center (UMC) Utrecht, one of the first organizations in the world to implement digital pathology. As part of this collaboration, UMC Utrecht will deploy Proscia’s AI applications into its high-throughput workflows leveraging Concentriq.

"We are excited for this next milestone in our journey," said David West, CEO of Proscia. "Over the past few years, we have battle tested Concentriq at leading organizations and demonstrated the unprecedented potential of AI. In welcoming Scale Venture Partners and Hitachi Ventures to the Proscia team, we are better positioned than ever before to drive a transformation that will impact millions of cancer patients and their families."

Proscia’s commercial traction comes amid a surge in digital pathology adoption. Laboratories have increasingly shifted to digital to overcome the manual and subjective nature of the traditional standard of care and keep pace with the rising cancer burden. In the U.S. alone, pathologists have faced a 42% rise in diagnostic workload over the last decade, a challenge that will continue to intensify as the total number of cancer cases is projected to increase by 55% by 2030. Recently, laboratories have been implementing digital pathology to maintain operations during the COVID-19 pandemic, as digitization is the only means by which they can continue to serve patients.

"Digital pathology is quickly becoming the expected standard of diagnosis," said Steve Holloway, Company Director & Principal Analyst at Signify Research. "The global pandemic has exacerbated longstanding pressures, accelerating adoption. This market has now crossed an inflection point, with a critical mass of digital laboratories creating the momentum for more widespread implementation of digital pathology and augmentation by artificial intelligence."

On December 1, 2020 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the completion of its Series A financing totaling $62 million (Press release, Tallac Therapeutics, DEC 1, 2020, View Source [SID1234572043]). Tallac is backed by a syndicate of leading global life science venture firms including venBio Partners, Morningside Venture, Lightstone Ventures, Matrix Partners China, and MRL Ventures Fund. The Company plans to use the Series A funding to advance the discovery and development of immunotherapy candidates for multiple solid tumor maligniancies. Its pipeline of next generation immunotherapies are derived from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform.

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Immunotherapies such as checkpoint inhibitors and adoptive CAR-T therapies have become foundational treatment options in oncology, yet the majority of patients only receive a temporary benefit or no benefit as they either develop resistance to treatment or are non-responsive to treatment. Novel immunotherapies known as Toll-like receptor (TLR) agonists are a class of immunotherapy that generates both an innate and adaptive immune response which may produce more robust and durable anti-cancer immunity to help overcome resistance.

"We believe targeting innate immunity represents a transformative approach to creating the next-generation of breakthrough therapeutics in cancer immunotherapy," said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics. "Our team has generated robust preclinical data on the Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform that we recently presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. With the support of our existing and new investors, I am excited to lead the Tallac team on its mission to advance first-in-class therapies for the benefit of patients in desperate need of new treatment options."

"Tallac has developed a scientifically innovative technology platform to create potent, systemically delivered therapeutics with the potential to provide powerful innate and adaptive anti-tumor immunity across multiple tumor types," said Corey Goodman, board chair, co-founder of Tallac Therapeutics and Managing Partner at venBio. "We are pleased to see the progress made by the team during the seed stage and look forward to supporting Tallac as they advance their pipeline towards the clinic."

Tallac Therapeutics was founded in 2018 by Drs. Goodman and Wan (previously CSO of ALX Oncology) with two other co-founders, Dr. Jaume Pons (currently CEO of ALX Oncology) and Dr. Curt Bradshaw (most recently CSO at Arrowhead Pharmaceuticals), to develop technology for targeted immune activation using an antibody-immune activator conjugate. The research team at Tallac has significant biologics discovery and development expertise. Most recently, under Dr. Wan’s leadership at ALX Oncology, the team designed and advanced ALX148, a best-in-class myeloid checkpoint inhibitor, for multiple tumor indications.