ViewRay Announces Conference Call for Preliminary First Quarter 2023 Financial Results to be held Pre-Market opening on April 13, 2023

On April 12, 2023 ViewRay, Inc. (NASDAQ: VRAY) reported it will hold a conference call to discuss results on Thursday, April 13, 2023, at 8:00 AM ET (Press release, ViewRay, APR 12, 2023, View Source [SID1234630014]). The dial-in number for domestic callers is (888) 886-7786. The confirmation number is 56031524. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

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After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website under "Events and Webinars".

PACIRA BIOSCIENCES TO PARTICIPATE IN FIRESIDE CHAT AT THE 22ND ANNUAL NEEDHAM VIRTUAL HEALTHCARE CONFERENCE

On April 12, 2023 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will participate in an analyst-led fireside chat at the 22nd Annual Needham Virtual Healthcare Conference at 10:15 AM ET on Wednesday, April 19, 2023 (Press release, Pacira Pharmaceuticals, APR 12, 2023, View Source [SID1234630013]). Live audio of the virtual event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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Fusion Pharmaceuticals Announces IND Clearance For FPI-2068, A Jointly Developed Novel Targeted Alpha Therapy

On April 12, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA) (Press release, Fusion Pharmaceuticals, APR 12, 2023, View Source,-a-Jointly-Developed-Novel-Targeted-Alpha-Therapy [SID1234630012]). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the companies’ multi-asset collaboration agreement.

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FPI-2068 is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

"The IND filing for FPI-2068 is an important milestone for Fusion as we advance this novel TAT, created by combining our radiopharmaceutical expertise, actinium supply and manufacturing infrastructure with AstraZeneca’s bispecific antibody which preferentially binds to cancer cells that express both EGFR and cMET," said Fusion Pharmaceuticals Chief Executive Officer John Valliant, Ph.D. "FPI-2068, which we believe will be the first TAT for two validated targets to enter the clinic, was designed to provide enhanced tumor specificity resulting from the co-expression of the two targets when compared to individual monoclonal antibodies against each of these targets. We are excited about the innovative work with AstraZeneca as we advance this and other programs under our broad collaboration agreement."

Fusion’s radiopharmaceuticals are a type of precision medicine whereby the cancer-targeted vector (e.g., the bispecific antibody) can be used to screen patients for expression of a tumor biomarker when combined with a corresponding imaging isotope (e.g., indium-111), and subsequently used for therapy when combined with the alpha-emitting radionuclide, actinium-225. Using imaging to identify patients who show uptake of the drug in tumors increases the likelihood of response to therapy. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening in order to better predict the cadence of patient enrollment.

FPI-2068 will be the first program to enter clinical development under the Company’s previously announced collaboration agreement with AstraZeneca, which includes joint discovery, development and the option to co-commercialize novel TATs leveraging Fusion’s proprietary Fast-Clear linker technology platform with antibodies from AstraZeneca’s oncology portfolio, as well as exploration of potential combination strategies involving existing assets in their respective portfolios. Fusion will be operationally responsible for the Phase 1 study, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development.

About FPI-2068

[225Ac]-FPI-2068 (FPI-2068) is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are validated cancer targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. FPI-2068 will be evaluated in a Phase 1 study.

Veracyte Announces Seven Abstracts for Its Decipher Urologic Cancer Tests To Be Presented at 2023 AUA Annual Meeting

On April 12, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that seven abstracts highlighting new data from studies of the company’s Decipher urologic cancer tests will be presented at the American Urological Association (AUA) Annual Meeting, taking place April 28-May 1, 2023, at McCormick Place in Chicago (Press release, Veracyte, APR 12, 2023, View Source [SID1234630011]). The abstracts include findings from two separate, large-scale studies that reinforce the real-world clinical utility of the company’s Decipher Prostate Genomic Classifier, which helps inform treatment decisions for men with prostate cancer.

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"The volume and quality of Decipher data being presented at AUA 2023 reinforce Veracyte’s ongoing commitment to evidence-based care and to advancing our understanding of urologic cancers. We are particularly excited about new data demonstrating the real-world impact of our Decipher Prostate test on patient care and outcomes," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.

Following are details of the Decipher abstracts accepted for presentation at the AUA 2023 meeting:

Date/Time:

April 28, 2023, 10:00-10:10 a.m. CT

Title:

Molecular Correlates with PSMA Expression in Prostate Cancer (#PD04-04)

Format:

Podium Session

Presenter:

Adam Weiner, M.D., UCLA Health

Location:

McCormick Place, S401C

Date/Time:

April 28, 2023, 1:00-3:00 p.m. CT

Title:

Association Between the Decipher Genomic Classifier and Prostate Cancer Outcome in a Large-Scale Real-World Dataset (#MP17-02)

Format:

Moderated Poster Session

Presenter:

Michael Leapman, M.D., Yale University School of Medicine
Location:

McCormick Place, S504

Date/Time:

April 28, 2023, 1:00-3:00 p.m. CT

Title:

Development of a Longitudinal Prostate Cancer Transcriptomic and Real-World Clinical Data Linkage (#MP17-09)

Format:

Moderated Poster Session

Presenter:

Michael Leapman, M.D., Yale University School of Medicine

Location:

McCormick Place, S504

Date/Time:

April 28, 2023, 1:00-3:00 p.m. CT

Title:

Differential Transcriptomic Indicators of Potential Therapeutic Response to Targeted Therapy for AJCC IIC+ Localized Prostate Cancer With Decipher >0.95 (#MP17-01)

Format:

Moderated Poster Session

Presenter:

Eric Li, M.D., Einstein Healthcare Network

Location:

McCormick Place, S504

Date/Time:

April 29, 2023, 3:30-5:30 p.m. CT
Title:

Use of Decipher Prostate Biopsy Test in Men With Favorable Risk Disease Undergoing Conservative Management in the SEER Registry (#MP44-17)

Format:

Moderated Poster Session

Presenter:

Alec Zhu, MD, Weill Cornell Medical College

Location:

McCormick Place, S403

Date/Time:

April 30, 2023, 3:40-3:50 p.m. CT

Title:

A Composite Biomarker Approach to Spare Neoadjuvant Chemotherapy in Muscle-Invasive Bladder Cancer Patients (#PD36-02)

Format:

Podium Session

Presenter:

Joep de Jong

Location:

McCormick Place, S501A

Date/Time:

April 30, 2023, 5:20-5:30 p.m. CT

Title:

Biology and performance of pre- and post-pembrolizumab (Pembro) Vesical Imaging-Reporting and Data System (VI-RADS) to predict the pathological response in muscle-invasive urothelial bladder cancer (MIBC): Full data analysis from a clinical trials pipeline (#LBA03-12)

Format:

Podium Session

Presenter:

Andrea Necchi, M.D., Vita-Salute San Raffaele University

Location:

McCormick Place, S404A

Vaccinex New ActivMab® application published in Nature Communications for Directed Evolution of GPCRs in Mammalian Cells

On April 12, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D reported a new publication in the March 30, 2023 issue of Nature Communications describing a novel way that the ActivMab platform can be used for functional studies and drug discovery of the "hard to drug" class of membrane-associated G protein-coupled receptors (GPCRs) and ion channels (Press release, Vaccinex, APR 12, 2023, View Source [SID1234630010]).

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The Nature Communications article, titled "A Vaccinia-based system for directed evolution of GPCRs in mammalian cells" provides an overview of how Vaccinex and its collaborators at the University of Zurich created an elegant system to make highly diverse libraries of functional GPCR variants and to enrich for variants with improved expression levels and stability while maintaining functional aspects of GPCR signaling. GPCRs are a very important class of drug targets because of their critical role in physiological processes. However, low expression levels and dependence on the mammalian membrane environment for conformational stability and function make them difficult targets for drug selection. The authors demonstrate that the ActivMAb technology overcomes these limitations by engineering directed protein evolution libraries in a mammalian signaling environment allowing GPCR expression that is amenable to structural studies. This novel application could be utilized to decipher the functional properties of GPCR for drug discovery or to incorporate GPCR membrane receptors into novel drug screening assays.

"Vaccinex is very pleased that this pioneering work by our scientists in collaboration with the group of Dr. Andreas Plückthun of the University of Zurich has been published in Nature Communications," said Ernest Smith, Ph.D., Sr. Vice President Research and Chief Scientific Officer. "GPCRs are a very important class of drug targets because of their critical role in physiological processes. The complex biophysical properties of these important targets embedded in the cell membrane can make them "difficult to drug". We believe that our novel directed evolution system will allow us to generate improved variants of any GPCR in a mammalian signaling system, better enabling us and our partners to study the functional properties of these complex receptors and develop new and valuable drugs against these important targets. We believe this new technology application will further enhance our ActivMab offering, and we look forward to sharing it with our partners."

About ActivMAb
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique capabilities for multi-pass membrane targets such as G-protein-coupled receptors (GPCRs). The ActivMAb technology has five main applications: complex membrane antigen presentation, antibody or antigen discovery, directed evolution and protein optimization. The first clinical candidate selected through use of this technology (SRF114, a fully human monoclonal antibody targeting CCR8 for the potential treatment of solid tumors), recently entered development in a Phase 1/2 study sponsored by our licensee, Surface Oncology. Vaccinex has entered into multiple antibody discovery collaborations with leading biopharmaceutical companies.