On December 20, 2019 Heska Corporation (NASDAQ: HSKA – News; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty products, reported that Kevin Wilson, Heska’s President & Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 3 p.m. PT in San Francisco, CA (Press release, Heska, DEC 20, 2019, View Source [SID1234552561]).

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Management will be available for one-on-one meetings on January 15th and 16th. To schedule a meeting, please contact J.P. Morgan at 1×[email protected] or Heska Investor Relations at [email protected].

A live webcast of the company’s presentation can be accessed at View Source and a live webcast of the subsequent question and answer session can be accessed at View Source.

The webcast will be archived shortly after the event, and a replay will be available on the company’s website for 90 days following the conference. A copy of the presentation will be available on Heska’s website at View Source

On December 20, 2019, Arbutus Biopharma Corporation (the "Company") reported that it has entered into an amendment (the "Amendment") to the Open Market Sale AgreementSM, dated December 20, 2018 (the "Sale Agreement"), by and between the Company and Jefferies LLC, as sales agent (the "Agent"), in connection with the Company’s filing of a new shelf registration statement on Form S-3 (File No. 333-235674), filed with the Securities and Exchange Commission (the "SEC") on December 23, 2019 (the "New Shelf Registration Statement") (Filing, 8-K, Arbutus Biopharma, DEC 20, 2019, View Source [SID1234552579]). The Amendment revised the Sale Agreement to reflect that the Company may sell its common shares, without par value (the "Common Shares"), from time to time for an aggregate sales price of up to $50.0 million under the New Shelf Registration Statement. Under the original terms of the Sale Agreement, the Company, through the Agent, may issue and sell Common Shares pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-215290), previously filed with the SEC on December 23, 2016 and subsequently amended on January 12, 2017, and declared effective by the SEC on January 19, 2017 (the "Original Shelf Registration Statement"), and the Company’s prospectus supplement filed with the SEC on December 20, 2018 (the "2018 Prospectus"). Under the rules of the Securities Act of 1933, the Original Shelf Registration Statement is set to expire on January 19, 2020. The Company has remaining capacity under the Sale Agreement to sell up to approximately $36.2 million of its Common Shares under the Original Shelf Registration Statement until its expiration.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On December 20, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported will webcast its presentation at the 38th Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2020 (Press release, Regeneron, DEC 20, 2019, View Source [SID1234552562]). The presentation is scheduled for 10:30 a.m. Pacific Time (1:30 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A breakout session will immediately follow the formal presentation and can also be accessed from our website. An archived version of the presentation and the breakout session will be available for at least 30 days.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Following the announcement regarding the Intent to Restructure the Antibody Collaboration for Kevzara (sarilumab) and Praluent (alirocumab) with Sanofi, Regeneron will provide financial guidance for 2020 at a date subsequent to the J.P. Morgan Healthcare Conference.

On December 20, 2019 Case Western Reserve University cancer researcher reported that it has shown 90% accuracy in pinpointing brain tumors and will soon be tested in real-time with patients at Cleveland Clinic under a three-year, $600,000 V Foundation grant (Press release, Case Western Reserve University, DEC 20, 2019, View Source [SID1234553317]).

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Pallavi Tiwari

The grant was awarded to Pallavi Tiwari, an assistant professor of biomedical engineering at Case Western Reserve with dual appointments in the School of Medicine and Case School of Engineering, and Alireza Mohammadi, an assistant professor of neurosurgery at Cleveland Clinic.

The V Foundation, named for former college basketball coach Jim Valvano, funds innovative cancer research and has awarded more than $200 million since being founded in 1993, the year Valvano died from adenocarcinoma.

The need for neural precision
Tiwari said one particular aspect of the existing clinical workflow for managing treatment for brain tumor patients is imprecise: A post-operative MRI scan can’t effectively discern whether cancer has returned or if the lesion has been altered by what neurologists call a "benign treatment effect."

"So both radiation effects and tumor recurrence have similar clinical symptoms and appearances on routine MRI scans," said Tiwari, a lead faculty member in the Center for Computational Imaging and Personalized Diagnostics in Biomedical Engineering and a member of the Case Comprehensive Cancer Center at the School of Medicine.

"Additionally, a highly invasive brain biopsy is currently the only option for confirmation of disease presence—and each biopsy procedure costs $20,000 to $50,000 per patient," she said. "And more than 15% of patients who undergo a second biopsy will then get an incorrect diagnosis due to the difficulty in sampling of reliable locations of the tumor."

To address those issues, a team led by Tiwari has developed new image-based biomarkers drawn from routine MRI scans to differentiate between these two conditions with an accuracy of 92% on about 200 cases so far.

‘GPS maps’ reveal recurring cancer
Actual images of brain tissue scans showing ‘hot’ areas where cancer is present
An image from the research underpinning the ‘brain GPS’ work done by Tiwari and her team.
They’re calling it a "GPS map" or "heat map" for the brain, as it is expected to reliably show by use of colors which part of a tumor has a recurrence of cancer, or whether it has been instead altered by the radiation.

"We’ll use the routinely acquired MRI scans, feed them into our computational algorithm and create a GPS map that the surgeon can use—one that will have a ‘heat map’ of hot-spots for cancer to guide him or her in finding the correct biopsy site within the lesion," Tiwari said.

Mohammadi said the next step in the project is critical in saving patients and money.

"The first part of this study was done retrospectively, meaning that looking at cases in which they already knew the outcome, but the accuracy was very impressive," Mohammadi said, referring to studies on the mapping Tiwari led in 2016 and early 2019. "Now we are trying to validate this in clinical trials, and if we have that same high accuracy, we won’t need to do that second, expensive biopsy."

Actual brain scan images showing color-coded areas where neurosurgeons would look to find a tumor
Brain scan images used to detect which areas of the lesion should be biopsied.
Clinical trials are expected in the final year of the grant, in late 2021 or early 2022, Tiwari said. In the meantime, researchers will be working to perfect the computational algorithms across multi-institutional data.

Stan Gerson, director of the Case Comprehensive Cancer Center and professor of medicine and environmental health sciences at the School of Medicine, said the new grant will allow to researchers to "focus on patient benefit."

"It enables us to link incredible insight from imaging computational technology with a critical medical need, linking our biomedical engineers to our diagnostic physicians," he said. "I like to say that we are ‘turning clinicians into prognosticators.’ "

Tiwari said the clinical trials are one step closer toward realizing those bringing real benefits.

"We develop these cool technologies and we get excited about 90% accuracy, but it doesn’t mean anything until you can prove it in clinical trials—because that’s when patients can begin to get the benefits," she said. "That’s why this is so exciting for me."

On December 20, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration ("NMPA") has granted Priority Review status to the New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors ("NET") (Press release, Hutchison China MediTech, DEC 20, 2019, View Source [SID1234552546]).

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"Surufatinib is our second drug to be granted priority review by the NMPA," says Christian Hogg, Chief Executive Officer of Chi-Med. "We are working closely with the NMPA as they review our NDA for the treatment of non-pancreatic NET. Surufatinib being granted priority review is a positive step forward in potentially bringing this innovative drug to patients, who currently have very limited treatment options."

In November 2019, the NDA for surufatinib for the treatment of non-pancreatic NET was accepted for review by the NMPA, and the U.S. Food and Drug Administration granted Orphan Drug designation to surufatinib for the treatment of pancreatic NET.

About Surufatinib

Surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies. Surufatinib is in several late-stage and proof-of-concept clinical trials in China and proof-of-concept clinical trials in the U.S.

According to Frost & Sullivan, the market for anti-angiogenesis VEGF/VEGFR inhibitors in China has grown from US$500 million in 2015 to over US$1.5 billion in 2019 and is expected to reach US$5 billion by 2026.

Chi-Med currently retains all rights to surufatinib worldwide.

Non-Pancreatic neuroendocrine tumors in China: In 2015, we initiated the SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. In June 2019, a 198 patient interim analysis was conducted, leading the independent data monitoring committee to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early. In November 2019, the NDA was accepted for review by the NMPA.

Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic neuroendocrine tumors in China. The primary endpoint is PFS. We expect an interim analysis in the first half of 2020 and enrollment to complete in 2020 (clinicaltrials.gov identifier: NCT02589821).

Neuroendocrine tumors in the U.S. and Europe: We are planning a U.S. registration study in neuroendocrine tumors patients based on the encouraging data from the Phase II and Phase III studies of surufatinib in neuroendocrine tumors in China (clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937).

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt, approved in China by Innovent Biologics, Inc.

About Neuroendocrine Tumors (NET)

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. Approved targeted therapies include Sutent and Afinitor for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of neuroendocrine tumors in the U.S. in 2018. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with neuroendocrine tumors in the U.S. in 2018 of which over 90%, or approximately 132,000, were non-pancreatic neuroendocrine tumor patients.

In China, there were approximately 67,600 newly diagnosed neuroendocrine tumor patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country1. It is estimated that approximately 80% of the patients living with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumor patients.

1 According to Frost & Sullivan, in 2018, there were 19,000 newly diagnosed cases of NETs in the U.S and an estimated 141,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.