On November 4, 2024 SimBioSys, a pioneering TechBio company at the forefront of digital precision medicine for cancer care, reported its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons across the US (Press release, SimBioSys, NOV 4, 2024, View Source [SID1234647677]). The updated TumorSight Viz now processes images with AI in a matter of minutes, integrates enhanced AI-driven tumor segmentation, enables seamless access to MRI images through direct connectivity to PACS systems, and has a first of its kind clinical decision support (CDS) feature that informs providers of evidence-based treatment options. The addition of the CDS application is designed to enhance treatment planning and optimize oncologists’ decisions for early-stage breast cancer patients’ surgery.

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With the recent FDA mandate which now requires breast density reporting for all women undergoing a mammogram, the demand for MRI as a supplementary screening tool is anticipated to rise. TumorSight Viz offers healthcare providers a powerful platform to visualize MRI data in 3D, supporting breast surgeons in tailoring treatment decisions to each patient’s unique tumor characteristics. The platform’s new CDS tool is designed to empower providers with advanced imaging insights and best practices for breast-conserving surgeries, aligning with updated NCCN guidelines promoting minimally invasive approaches when feasible and desired by patients.

"TumorSight Viz’s clinical decision support functionality provides a groundbreaking resource to assist breast surgeons and oncologists in considering the best possible approaches for each patient, fostering shared decision-making and precision care," said Dr. Freya Schnabel from NYU.

TumorSight Viz: Key Enhancements

Enhanced AI-Driven Segmentation: Utilizing AI, TumorSight Viz is designed to deliver accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.
Clinical Decision Support (CDS) Application: The new CDS application is designed to provide data-driven insights for informing breast surgeons’ planning and preparation for surgery
Direct MRI Access via PACS Systems: TumorSight Viz now supports integration with middleware software as well as direct to PACS systems, allowing automated access to MRI images for analysis within the TumorSight platform and seamless fit into the clinician workflow.
Recent NCCN guideline updates emphasize the importance of individualized, data-supported treatment planning to support breast reconstruction and oncoplastic surgery as safe and effective options for eligible patients. TumorSight Viz aligns with these recommendations by enabling volume and anatomical measurements that assist surgeons in utilizing volume displacement techniques with a goal to achieve optimal cosmetic and functional outcomes. With the new CDS capability, surgeons are now better equipped with output measurements from TumorSight Viz that are aligned with standard of care guidelines to help plan lumpectomies more precisely, supporting both effective tumor removal and preservation of breast appearance.

A Game-Changer in Breast Cancer Care

Breast cancer affects more than 300,000 patients in the U.S. annually, many of whom now stand to benefit from SimBioSys’s enhanced TumorSight platform. By combining advanced AI-driven visualizations with CDS tools, TumorSight Viz is designed to provide surgeons, together with their patients, greater confidence in their treatment decisions.

"This second FDA clearance represents a significant milestone in our mission to redefine precision medicine for cancer," said Barry Rosen, MD, Chief Medical Officer at SimBioSys. "TumorSight Viz’s latest capabilities elevate the standard of breast cancer care by allowing surgeons to make more informed choices, moving closer to an era of precision surgery that reduces variation and supports breast conservation when desired by the patient."

TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer.

About TumorSight Viz:
TumorSight Viz provides clinicians with 3D spatial visualizations of breast cancer using standard-of-care medical imaging (DCE MRI). Clear 3D "digital twin" renderings automatically display the tumor in the context of auto-segmented anatomical structures and provide key metrics used to inform the treatment planning process in conjunction with patient history and standard of care testing. TumorSight Viz received its original 510(k) FDA clearance in December 2023. Learn more about TumorSight Viz at View Source

On November 4, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that the U.S. Food and Drug Administration (FDA) has granted a Type C meeting with the Company in December 2024 to discuss the potential pathways to registration of Kazia’s blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM (Press release, Kazia Therapeutics, NOV 4, 2024, View Source [SID1234647676]).

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In July 2024, the Company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. Full data including secondary endpoints from the paxalisib arm of the GBM-AGILE study is expected to be presented at a scientific meeting later this year.

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Updated corporate presentation
Today, the Company also announced that it has updated its corporate presentation, which now incorporates preliminary data from the GBM AGILE Phase II/III clinical trial evaluating paxalisib versus the standard of care for the treatment of in patients with glioblastoma. The updated presentation can be found at View Source

Participation in Upcoming and Recent Medical and Investor Conferences

The company plans on attending the following medical conferences in the fourth quarter of 2024:

Society for Neuro-Oncology 29th Annual Meeting and Education Day, November 21-24, 2024, in Houston, TX
San Antonio Breast Cancer Symposium, December 10-13, 2024, in San Antonio, TX
These events provide Kazia with the opportunity to engage with key stakeholders and share the Company’s vision to make a difference in the lives of patients by developing innovative cancer treatments. Kazia looks forward to meeting with investors in person at these events and invites discussion regarding partnering and investment opportunities.

Over the last several months, the Company has also participated and presented at a number of medical and investor conferences, including:

H C Wainwright 26th Annual Global Investment Conference from Sep. 9-11, 2024
15th Biennial AACR (Free AACR Whitepaper) Ovarian Cancer Research Symposium, Sep. 20 – 21, 2024
Oppenheimer Oncology Summit, in collaboration with MD Anderson Cancer Center, Sep. 26, 2024
American Society for Radiation Oncology Annual Meeting, Sep. 29 – Oct. 1, 2024
Deerfield CEO Conference, Oct. 8-9, 2024
Maxim Group’s 2024 Healthcare Virtual Summit, Fireside Chat, Oct. 15, 2024

On November 4, 2024 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported that it will present Phase 1 results for the clinical study of OR502, a novel, humanized anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody that rescues innate and adaptive immune responses from LILRB2 mediated immune suppression (Press release, OncoResponse, NOV 4, 2024, View Source [SID1234647675]). The Phase 1 study results will be presented as a late-breaker poster presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024), taking place in Houston, Texas, November 8-10, 2024.

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Details are as follows:

Title (Late-Breaking Abstract): Phase 1 results of OR502, an antibody against leukocyte immunoglobulin-like receptor B2 (LILRB2), in subjects with advanced cancers

Abstract Number: 1464
Details: Saturday, November 9, George R. Brown Convention Center

Title: Adaptive design elements in a Ph 1-2 study of OR502, a novel antibody against leukocyte immunoglobulin-like receptor B2 (LILRB2), in response to evolving Ph 1 data and changing regulatory environment

Abstract Number: 680
Details: Saturday, November 9, George R. Brown Convention Center

OncoResponse poster presentations from SITC (Free SITC Whitepaper) are available on the Publications page of the Company website following their respective sessions.

On November 4, 2024 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, and Nobelpharma Co., Ltd. reported that they have entered into an exclusive license and distribution agreement for the development and commercialization in Japan of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and, upon agreement by the parties, potentially relapsed osteosarcoma (Press release, Y-mAbs Therapeutics, NOV 4, 2024, View Source [SID1234647672]).

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Under the terms of the agreement, Nobelpharma will employ its regulatory, marketing, sales and access expertise to carry out development work and to submit DANYELZA for approval by Japanese regulatory authorities, and to market, sell, and distribute DANYELZA in Japan, if approved. Pursuant to the agreement, Y-mAbs will receive an upfront payment of $2.0 million from Nobelpharma in connection with entering into the agreement and is entitled to receive up to $31.0 million in product and commercial milestone payments in addition to royalties in the low double digits on commercial sales on DANYELZA, if successfully approved and commercialized in Japan.

"Our exclusive license and distribution agreement with Nobelpharma in Japan is an important step in our continued global expansion efforts of DANYELZA," said Michael Rossi, President and Chief Executive Officer of Y-mAbs. "If approved in the region, we believe DANYELZA can deliver a meaningful impact to patients in Japan fighting relapsed/refractory high-risk neuroblastoma and improve long-term quality of life for these children."

"We believe that Nobelpharma is the right partner for Y-mAbs in Japan, and we are excited to work with Nobelpharma towards the potential approval and commercial launch of DANYELZA in the region," said Thomas Gad, Founder and Chief Business Officer of Y-mAbs. "DANYELZA, if approved in Japan for relapsed/refractory high-risk neuroblastoma, will provide a new out-patient anti-GD2 therapeutic option for physicians in the treatment of children facing this advanced form of pediatric cancer. We remain steadfast in our commitment to provide access to DANYELZA and improve the lives of children and families around the globe facing advanced cancers."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

DANYELZA is currently not approved for the treatment of osteosarcoma in any jurisdiction.

On November 4, 2024, Syndax Pharmaceuticals, Inc. ("Syndax") reported to have entered into a Purchase and Sale Agreement (the "Purchase and Sale Agreement") with Royalty Pharma Development Funding, LLC ("Royalty Pharma"), pursuant to which Royalty Pharma purchased rights to certain revenue streams from net sales of products comprising or containing axatilimab (including Niktimvo) (collectively, the "Product") by Syndax, its affiliates and its licensees in the United States and its respective territories, districts, commonwealths and possessions (including Guam and Puerto Rico) (the "Territory") in exchange for $350 million (Press release, Syndax, NOV 4, 2024, View Source [SID1234647671]).

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Pursuant to the Purchase and Sale Agreement, Royalty Pharma purchased the right to receive a percentage of net sales equal to a royalty rate of 13.8% on quarterly net sales of the Product in the Territory; provided that the royalty rate is subject to certain adjustments based on future aggregate net sales of the Product in the Territory (the "Revenue Participation Right"). Aggregate payments made to Royalty Pharma in respect of the Revenue Participation Right will be capped at $822.5 million (the "Royalty Cap").

The Purchase and Sale Agreement contains customary representations, warranties and indemnities of Syndax and Royalty Pharma and customary covenants relating to the royalty payments, including the grant of a back-up security interest in the purchased royalties and certain assets related to the Product and restrictions on the incurrence of additional indebtedness and on the existence of liens on Syndax’s assets related to the Product.

Upon a change of control, Syndax will have the right, but not the obligation, to repurchase the Revenue Participation Right at a repurchase price set forth in the Purchase and Sale Agreement. In addition, the Purchase and Sale Agreement provides that if certain events of default occur, including certain bankruptcy events or certain termination events with respect to Syndax’s license agreement with UCB Biopharma Srl, Royalty Pharma may require Syndax to repurchase Royalty Pharma’s interests in the Revenue Participation Right at a repurchase price equal to the Royalty Cap.

The foregoing description of the terms of the Purchase and Sale Agreement does not purport to be complete and is qualified in its entirety by the full text of the agreement. Syndax intends to file a copy of the Purchase and Sale Agreement with its Annual Report on Form 10-K for the year ending December 31, 2024.