On December 1, 2020 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of oncolytic virus-based immunotherapies for cancer, reported that it has been granted a new patent from the European Patent Office (EPO) (Press release, Calidi Biotherapeutics, DEC 1, 2020, View Source [SID1234572049]). European Patent Number 3209382, "Combination Immunotherapy Approach for Treatment of Cancer," secures Calidi’s proprietary technology platform, Supernova 1 (SNV1), composed of the oncolytic agent, CAL1 vaccinia virus, loaded into allogeneic, adipose-derived mesenchymal stem cells (AD-MSC).

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"We’re very excited to be granted this European Patent to protect our innovative immunotherapy product and combination approach abroad," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "This new patent provides considerable opportunity for the expansion of Calidi’s years of research into the profound oncolytic potential of SNV1."

Pre-clinical data has shown Calidi’s SVN1 product to shield the viral payload of CAL1 vaccinia virus from the patient’s immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses.

"Our talented, seasoned team of doctors and scientists have exerted years of intensive research and groundbreaking work to produce Calidi’s SVN1 technology," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "This patent represents the culmination of their impressive expertise, dedication, and passion."

As of the EP Grant Date, November 25, 2020, the European Patent covers Calidi’s combination immunotherapy approach and SNV1 product in 37 contracting European countries. Earlier in the year, the patent was also granted in Canada, Russia, Singapore, Australia, and New Zealand.

On December 1, 2020 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported that two abstracts were selected for poster presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, BostonGene, DEC 1, 2020, View Source [SID1234572048]). The all-virtual event will be held from December 5 – 8, 2020.

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Details of the presentations are below:

Title: Integration and Iteration: Using Advanced, High-Content Imaging and Single-Cell Gene Expression Analysis to Uncover Unique Aspects of Follicular Lymphoma Biology
Session: 621: Lymphoma—Genetic/Epigenetic Biology: Poster I
Abstract Number: 1106
Date and Time: Saturday, December 5, 2020: 10:00 AM – 6:30 PM ET
Presenter: Andrea J. Radtke, PhD, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Follicular lymphoma is an indolent B-cell lymphoma with remarkable heterogeneity in disease progression and trajectory; therefore, determining the cell intrinsic and extrinsic factors underlying this clinical heterogeneity is necessary to impact patient clinical outcomes. Using a multi-omics approach, including whole exome sequencing (WES) and bulk RNA-seq integrated with single-cell analyses such as scRNA-seq and multiparameter imaging, notable patient-specific cellular interactions and expression patterns were identified that may drive cancer patient survival. This integrated approach provides insights into both tumor biology and disease trajectory, which can ultimately benefit therapeutic strategies in follicular lymphoma.

Research conducted with the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases (NIAID), both part of the National Institutes of Health (NIH).

Title: High Dimensional Tissue-based Spatial Analysis of the Tumor Microenvironment of Follicular Lymphoma Reveals Unique Immune Niches inside Malignant Follicles
Session: 622
Abstract Number: 1117
Date and Time: Saturday, December 5, 2020: 10:00 AM – 6:30 PM ET
Presenter: Jose C. Villasboas, MD, Mayo Clinic

Cells of the immune system play an important role in modulating the trajectory of lymphomas; therefore, understanding the composition and spatial distribution of immune cells within the tumor microenvironment (TME) is critical to improve clinical outcomes for patients. Analysis of a follicular lymphoma tumor section that used Co-Detection by Indexing (CODEX) multiplex immunofluorescence image processing identified unique cell subsets and specific spatial distribution of immune cells. These insights into the complex immune cell composition and architecture of the TME add to the prognostic value of the TME as a therapeutic target in follicular lymphoma.

Research conducted with Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Mayo Clinic, Memorial Sloan Kettering Cancer Center, Université Claude Bernard Lyon and the University of Iowa.

In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of "Blood".

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."