Cue Biopharma to Present at the JMP Securities Hematology and Oncology Summit

On November 22, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, reported that it will take part in a fireside chat at the JMP Securities Hematology and Oncology Summit being held virtually from December 5-6, 2023 (Press release, Cue Biopharma, NOV 22, 2023, View Source [SID1234637938]).

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During the fireside chat, Cue Biopharma will discuss recent data highlights from its lead clinical programs, CUE-101 and CUE-102, representative of the IL-2-based CUE-100 series of selective T cell engagers, as well as market opportunities, competitive positioning and anticipated milestones for 2024.

Presentation Details
JMP Securities Hematology and Oncology Summit
Date and Time: Tuesday, December 5, 11:30 a.m. EST
Webcast Link: View Source
Presenter: Daniel Passeri, M.Sc., J.D., chief executive officer, Cue Biopharma

A live and archived webcast of the fireside chat will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

Veracyte Announces Seven Posters Highlighting Clinical Value of Decipher Prostate Genomic Testing To be Presented at SUO 2023

On November 22, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that seven posters will be presented at the 24th Annual Meeting of the Society of Urologic Oncology (SUO 2023), where they will demonstrate the clinical performance of Veracyte’s Decipher Prostate Genomic Classifier in identifying patients whose prostate cancer is likely to progress and require treatment (Press release, Veracyte, NOV 22, 2023, View Source [SID1234637936]). Collectively, the posters will report data from more than 60,000 patients. The meeting will take place in Washington, DC, from November 28 to December 1.

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The American Cancer Society estimates that there will be nearly 290,000 new cases of prostate cancer in the U.S. this year. An ongoing challenge in the management of prostate cancer is distinguishing between patients whose tumors require careful monitoring, known as active surveillance, and those who require intervention. Routinely used clinical factors, such as Gleason score and prostate-specific antigen (PSA) level, are not sufficient to determine which prostate cancers are likely to progress and which are not.

"These presentations by users of the Decipher Prostate Genomic Classifier will add to the growing body of clinical evidence supporting the use of the test to help physicians guide care for their patients with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "This breadth of real-world data truly distinguishes our genomic classifier from other molecular tests available today and serves as a strong foundation for using Decipher results to provide a more complete understanding of each patient’s cancer for more personalized care."

The following posters will be presented at the SUO 2023 meeting on Friday, December 1:

Title: Assessing molecular heterogeneity of prostate cancer biopsy sampling: Insights from the MAST trial
Presenter: Tarek Ajami, M.D., University of Miami
Poster: #214
Time: 10 a.m. to 11 a.m. ET

Title: Decipher Genomic Classifier on initial prostate biopsy is associated with Gleason score upgrading on final radical prostatectomy pathology
Presenter: John Sheng, M.D., Washington University School of Medicine in St. Louis
Poster: #226
Time: 12:45 p.m. to 1:45 p.m. ET

Title: Decipher Genomic Classifier score on initial biopsy is associated with progression from active surveillance to treatment in prostate cancer
Presenter: John Sheng, M.D., Washington University School of Medicine in St. Louis
Poster: #237
Time: 1:45 p.m. to 2:45 p.m. ET

Title: Does genomic risk score at biopsy correlate with focality of disease at radical prostatectomy: Implications for focal therapy candidates
Presenter: Jenna Winebaum, M.D., University of California, San Francisco
Poster: #189
Time: 9 a.m. to 10 a.m. ET

Title: Grade and volume progression and its association with the Decipher Genomic Classifier using patients enrolled in a prospective active surveillance protocol
Presenter: Archan Khandekar, M.D., University of Miami
Poster: #219
Time: 12:45 p.m. to 1:45 p.m. ET

Title: Molecular correlates with PSMA expression in primary prostate cancer
Presenter: Adam B. Weiner, M.D., University of California, Los Angeles
Poster: #201
Time: 10 a.m. to 11 a.m. ET

Title: Understanding population-wide genomic risk distribution and integrating clinical-genomic risk for prognostication in patients with clinically localized prostate cancer
Presenter: Udit Singhal, M.D., University of Michigan
Poster: #200
Time: 9 a.m. to 10 a.m. ET

Oncovita raise 8M€ to support the development of its MVdeltaC immunotherapeutic vaccine in oncology

On November 22, 2023 Oncovita, a biotech company specializing in the development of therapeutic and prophylactic vaccines, reported that it has won the « Innovations in biotherapies and bioproduction » call for projects under the « Biotherapies and bioproduction of innovative therapies » acceleration strategy of France 2030’s health component, the Innovation Santé 2030 plan (Press release, Oncovita, NOV 22, 2023, View Source [SID1234637935]). This financing, operated by Bpifrance, will provide Oncovita with €4.5 million. At the same time, the company is announcing a €3.5 M round of financing from private investors and business angels. These funds, totaling €8 million, will support the development of its immunotherapeutic cancer vaccine MVdeltaC.

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The €8 million will enable Oncovita to finance its ambitious development strategy, starting with the production of a first clinical batch of MVdeltaC, followed by the initiation of a phase 1/2a clinical trial in solid tumors during 2025. The company also plans to develop an innovative industrial production process to be used for MVdeltaC’s various clinical trials. It could also be applied to the production of other therapeutic and prophylactic vaccines developed by Oncovita.

« We would like to thank France 2030, Bpifrance and our investors for their confidence. The funds raised will enable us to accelerate the preclinical and clinical development of MVdeltaC. Our development program is ambitious. It includes the evaluation of MVdeltaC in a first basket trial in 5 solid tumor types, as well as a translational component to identify relevant markers of tumor sensitivity to MVdeltaC. Our program also includes, at this stage, the development of an innovative industrial production process for MVdeltaC. Our aim is to master complex production processes to ensure the security and success of the project. This is a key factor in creating value in the vaccine sector. This is why we are in advanced discussions with one of the leaders in pharmaceutical subcontracting (CDMO) to sign a collaboration agreement », explains Jean-François Le Bigot, PhD, CEO of Oncovita.

The MVdeltaC vaccine candidate (MVP-06-01) is based on MeasovirR technology using measles vaccine virus, the world’s most widely used and safest vaccine. This technology has already been successfully used to develop 6 prophylactic vaccines tested in human clinical trials, notably for immunogenicity.

MVdeltaC’s immuno-oncolytic efficacy has already been widely demonstrated in multiple in-vitro and in-vivo tumor models, and its unique mechanism of action has been documented and published in the international scientific literature. Preclinical pharmacological and regulatory safety trials on MVdeltaC are currently being finalized.

The promising results of MVdeltaC were presented at the International Society for Vaccines (ISV) Congress held from October 22 to 24, 2023 in Lausanne, Switzerland.

Northwest Biotherapeutics Provides Update On Final Preparations for Marketing Authorization Application

On November 22, 2023 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported an update about the final preparations for the Marketing Authorization Application (MAA) that will be submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA) in the U.K. for commercial approval of the Company’s DCVax-L treatment for glioblastoma (Press release, Northwest Biotherapeutics, NOV 22, 2023, View Source [SID1234637934]).

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The Company previously reported that one key section of the MAA package remained to be completed and to then be delivered to an independent publisher for quality control checking of citations, numbers, cross-references, formatting and the like, in preparation for the submission.

The Company provided an update that most of the work has been completed on the key section of the MAA that remained to be done at the time of the prior update, as well as on required supporting documents, the majority of which have been delivered to the publisher/QC team. That team is now under way on this final stage of their work.

As described in the Company’s prior update, it is anticipated that the publisher/QC team will need several weeks to complete their work on both the last portion of the MAA package and the integrated whole. Their work is independent of the Company.

Be Biopharma to Present at the 35th Annual Piper Sandler Healthcare Conference

On November 22, 2023 Be Biopharma, Inc. ("Be Bio"), a company pioneering the discovery and development of Engineered B Cell Medicines (BeCMs), reported that Chief Executive Officer Joanne Smith-Farrell, Ph.D., will present at the 35th Annual Piper Sandler Healthcare Conference being held at the Lotte New York Palace in New York, NY on Thursday, November 30, 2023 (Press release, Be Biopharma, NOV 22, 2023, View Source [SID1234637932]).

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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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35th Annual Piper Sandler Healthcare Conference

Presentation Date: Thursday, November 30, 2023

Presentation Time: 10:10 am ET