CRISPR Therapeutics to Participate in Upcoming Investor Conferences

On May 25, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the following virtual investor conferences in June (Press release, CRISPR Therapeutics, MAY 25, 2021, View Source [SID1234580537]):

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Jefferies Virtual Healthcare Conference
Date: Tuesday, June 1, 2021
Time: 1:00 p.m. ET

William Blair 41st Annual Growth Stock Conference
Date: Thursday, June 3, 2021
Time: 12:20 p.m. ET

Goldman Sachs 42nd Annual Global Healthcare Conference
Date: Tuesday, June 8, 2021
Time: 3:00 p.m. ET

A live webcast of these events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following each presentation.

Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes

On May 25, 2021 Novartis reported that the US Food and Drug Administration (FDA) has granted fast track designation for sabatolimab (MBG453) for the treatment of adult patients with myelodysplastic syndromes (MDS) defined with an IPSS-R risk category of high or very high risk in combination with hypomethylating agents. Fast track designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs1 (Press release, Novartis, MAY 25, 2021, View Source [SID1234580553]).

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MDS, a group of rare and often underdiagnosed blood cancers, is characterized by a dysfunctional immune system and leukemic stem cell proliferation2-4.
Despite treatment with HMAs – the last treatment innovation in higher-risk (HR) MDS over the past 15 years – patients face poor outcomes, including a limited duration of response, and have a median overall survival rate of less than a year5,6.
Sabatolimab is a first-in-class investigational immuno-myeloid therapy that binds to TIM-3, a novel target expressed on multiple immune cell types and leukemic cells and blasts, but not on the normal stem cells that induce blood formation; it is in development for HR-MDS and acute myeloid leukemia (AML)7,8.
The STIMULUS clinical trial program includes multiple studies evaluating sabatolimab as part of different combination therapies in patients with MDS and AML, including the Phase II STIMULUS-MDS1, Phase III STIMULUS-MDS2, Phase II STIMULUS-MDS3 and Phase II STIMULUS-AML1 studies9-12.

Biodesix to Present at the William Blair 41st Annual Growth Stock Conference

On May 25, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present at the William Blair 41st Annual Growth Stock Conference being held virtually June 1-3, 2021 (Press release, Biodesix, MAY 25, 2021, View Source [SID1234580569]).

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William Blair 41st Annual Growth Stock Conference
Date: Wednesday, June 2, 2021
Time: 2:00 PM CT

The presentation will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

Nordic Nanovector Announces Update from Archer-1 Phase 1b Trial of Betalutin® in combination with rituximab in 2L Follicular Lymphoma

On May 25, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that initial promising data from the Archer-1 Phase 1b trial investigating Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, MAY 25, 2021, View Source [SID1234580585]).

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The preliminary results show clinical activity with seven out of seven patients achieving a response, including 5 complete responses and 2 partial responses. All responses are currently ongoing, 5 of them 2 years after Betalutin administration.

Across this patient group, Betalutin with RTX showed a very good safety profile, comparable to that of single agent Betalutin, with no dose limiting toxicities observed.

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of CD37-targeted Betalutin in combination with CD20-targeted RTX in patients with relapsed/refractory FL who have received one or more prior therapies.

The starting doses of Betalutin and lilotomab were 10MBq/kg and 40mg, respectively, which was escalated to Betalutin 15MBq/kg and lilotomab 40mg in the second cohort. Following Betalutin dosing, patients received four weekly doses of RTX (375mg/m2) on days 7, 14, 21 and 28. Patients who did not progress (including CR, PR, SD) were scheduled to receive RTX maintenance for 2 years.

The primary objective of the study was to evaluate the safety and tolerability of Betalutin in combination with RTX, the secondary objective to evaluate the preliminary anti-tumour activity of combination treatment.

The rationale for Archer-1 was provided by earlier preclinical data showing Betalutin can up-regulate CD20 expression in different rituximab-sensitive NHL cell lines and act synergistically with rituximab in a rituximab-sensitive NHL animal model and, more recently, that Betalutin has the potential to counteract resistance to rituximab in non-Hodgkin’s lymphoma models.

Peter Braun, Nordic Nanovector CEO, commented: "We are encouraged by the results in this small Phase I study in second line FL patients. Both the overall safety of this combination and the preliminary signs of efficacy are promising. We look at this study as an additional building block in our overall strategy to develop Betalutin for difficult to treat hematological tumors. Our near-term focus remains very much on completing PARADIGME in 3L FL and delivering top line 3-month data by the end of 2021.

Quest Diagnostics and Paige Form Collaboration to Advance AI-generated Pathology Insights to Improve Cancer Diagnosis and Care

On May 25, 2021 Quest Diagnostics (NYSE:DGX) and Paige reported a collaboration designed to unlock the potential of artificial intelligence (AI) to improve and speed the diagnosis of cancer and other diseases that rely on pathologic assessment (Press release, Quest Diagnostics, MAY 25, 2021, View Source [SID1234580520]).

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The collaboration involves analysis using Paige’s proprietary machine learning expertise of pathology diagnostic data and digitized slides from Quest Diagnostics and its AmeriPath and Dermpath businesses to uncover markers of cancer and other diseases. Using these insights, the parties intend to develop new software products which, following regulatory approval, will be marketed to pathologists, oncologists and other providers to support disease diagnosis. Near term, the parties also intend to license the insights to biopharmaceutical and research organizations to aid biomarker discovery, drug research and development and companion diagnostics.

The collaboration will initially focus on solid tumor cancers, such as prostate, breast, colorectal and lung. The agreement involves shared revenue for achieving certain product and commercial milestones and, assuming regulatory approval, arrangements for Quest to use approved software products in its pathology operations as well as joint marketing and research. In addition, Quest’s pathologists will aid in defining pathology workflows for using the products to support diagnostic decision-making. Additional terms were not disclosed.

"As the leader in advanced diagnostics, we are excited to actively participate in the creation and use of new technologies that further the mission to make precision medicine clinically accessible, actionable and economical. We are energized about contributing our expertise to Paige’s computational pathology leadership to deliver insights from leading-edge technologies to improve the diagnosis of cancer and other diseases," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics.

The collaboration combines Quest’s leadership in advanced diagnostics, pathology subspecialty expertise and national scale with Paige’s leading AI-based software capabilities and proprietary data from millions of digitized pathology slides and associated therapy information. Quest and its specialty pathology businesses bring subspecialty expertise based largely from serving community cancer centers, which provide 80% of cancer care nationally, complementing insights from Paige’s academic center expertise.

"We are excited to collaborate with Quest to create new software products that can deliver faster, more accurate and more informed clinical insights to patients than what is possible today," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "Given Quest’s vast footprint in the diagnostic space this collaboration will enable us to ensure broad adoption of the clinical products and biomarkers we’re building."

Cancer diagnosis typically involves visual inspection of tumor tissue on a glass slide by a pathologist using a microscope. In contrast, AI-enabled computational pathology can identify known patterns in tissue that characterize disease as well as identify new markers, including those that are not necessarily detected by the naked eye. Because AI systems improve with exposure to new data, the data from Quest’s deep subspecialized expertise is poised to enhance Paige’s efforts to discern new insights that may improve cancer diagnosis and patient care.

Digital Pathology Use

The collaboration also aligns with Quest’s goal to expand its digital pathology network for its pathologists across the United States. The company employs widely used and cost-efficient digital technologies from different manufacturers to enable pathologists to capture and share digital images of slides with other experts to confer on findings, improving diagnosis. Paige’s software platform is interoperable across several digital systems and is designed to deploy AI-based diagnostic products into pathology workflows.

Digital pathology technologies enable pathologists to capture and share digital images of slides with experts in other locations – including in the United States and globally – to confer on findings and thereby improve diagnosis.

Quest Diagnostics is a world leader in advanced diagnostic services, including in oncology. With its AmeriPath and Dermpath specialty pathology businesses and 600 MDs and PhDs, Quest Diagnostics provides highly advanced pathology services for health systems and other providers in the United States and overseas.