On September 6, 2023 Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating promising treatments to market with its transformative AnovaOS technology platform, and the industry’s first collaborative ‘learning system’, reported a partnership with Dizal Pharmaceuticals (Dizal) to accelerate the development of DZD9008 for patients with EGFR Exon20ins mutant NSCLC (Press release, Dizal Pharma, SEP 6, 2023, View Source [SID1234634965]).

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Dizal is a commercial-stage biopharmaceutical company focused on the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Dizal are evaluating DZD9008 in a Phase III study in a first-line setting and a Phase II study in a recurrent setting.

EGFR Exon20ins occur in about 2% patients with NSCLC. No target therapy has gained full approval for the treatment. Chemotherapy is the most commonly used in the first-line setting, but the treatment’s efficacy is not optimal. Therefore, there is an unmet medical need to develop more effective therapy.

"Advances in precision medicine have clearly helped patients with EGFR mutations survive longer. Anova and Dizal are committed to building upon recent success with DZD9008 following NDA approval of Sunvozernitib for the treatment of adult patients with locally advanced or metastatic NSCLC patients with EGFR Exon20ins by the National Medical Products Administration (NMPA) of China. We are identifying the underserved group of NSCLC cases that have EGFR Exon20ins mutations and giving them an opportunity to participate in research designed to benefit them.

"It is not enough to identify patients with rare tumor mutations and hope they can access a promising clinical trial," said Martin Walsh, President at Anova. "AnovaOS provides a network that allows any patient to participate in research where they choose to receive care. Being able to deliver study opportunities in real time transforms the way research has been historically conducted."

Research sites and physicians interested in participating in this study should register their profile at www.anovaevidence.com. NSCLC patients with EGFR Exon20ins mutations can e-mail [email protected] to find out more about the study and consider participation. To find out more contact Victor Sirippi, Project Lead at [email protected]

On September 6, 2023 Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, reported it has closed a $55 million Series C financing round led by 83North (Press release, Ibex Medical Analytics, SEP 6, 2023, View Source [SID1234634964]). Additional participants in the round were Sienna Venture Capital and existing investors in the company, Octopus Ventures, aMoon, Planven Entrepreneur Ventures and Dell Technologies Capital. The financing brings total funding to over $100 million since Ibex’s inception in 2016.

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Ibex is transforming cancer diagnostics with AI-powered solutions that help pathologists improve the quality of diagnosis and support laboratories with enhanced efficiency and better turnaround times. Cancer incidence is rising around the world while its diagnosis becomes more complex and nuanced, causing heavy workloads for pathologists and laboratories. The increasing demand is compounded by a global shortage of pathologists who still rely heavily on manual work and solely on visual analysis of biopsies. Ibex’s Galen platform helps overcome these challenges with AI-powered workflows and decision support tools that pathologists use in their everyday practice.

"Ibex is leading the market in live customer deployments as we remain steadfast in our mission of providing every patient with a timely, accurate and personalized cancer diagnosis," said Joseph Mossel, Co-Founder and CEO of Ibex. "This latest financing round will enable us to take major steps toward reaching our goal. We will be using the funds to expand our footprint in the United States to meet the increasing demand for AI-powered diagnostic solutions, and to accelerate the growth of our product portfolio to create more tools for pathologists and labs as they digitally transform their practices. This financing round highlights our strong commercial momentum and our tenacity in pursuing the opportunities that lie ahead."

Ibex’s Galen platform is the most widely deployed AI technology in pathology and has been deployed in laboratories and pathology departments around the world. Ibex achieved several significant milestones recently, including live deployment of Galen at University of Pittsburgh Medical Center (UPMC), the completion of national roll out throughout Wales, and collaboration with AstraZeneca and Daiichi Sankyo for the development of an AI-powered biomarker scoring product for breast cancer. Galen provides health systems and diagnostic laboratories with an integrated solution for cancer diagnosis and biomarker scoring, capable of detecting more the 100 different cancer and non-cancer pathologies while offering enhanced interoperability with scanning systems, image management solutions and lab information systems. Ibex was recently showcased in a KLAS Research report which provided consistently favorable feedback from global customers.

"Our continued investment in Ibex is a testament to the company’s progress in recent years, bringing its unparalleled technology to laboratories, hospitals and digital pathology networks worldwide, catapulting the industry into an AI-powered era," added Gil Goren, Partner at 83North and Board Director of Ibex. "Ibex’s successful deployments demonstrate its responsiveness to market and customer needs, while its product portfolio continues to grow and meet new market demands. We are eager to see Ibex forge the way with new uses of AI in cancer diagnosis, supporting providers as they work to improve patient care and outcomes."

On September 6, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, reported that it will present updated, longer-term results from the ongoing investigator-initiated Phase 1 trial in China evaluating FasTCAR-enabled GC012F in transplant-eligible, high-risk patients with newly diagnosed multiple myeloma (NDMM) (Press release, Gracell Biotechnologies, SEP 6, 2023, View Source [SID1234634963]). The findings will be presented in a poster presentation at the 20th International Myeloma Society (IMS) Annual Meeting, taking place September 27-30, 2023, in Athens, Greece and virtually.

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"We look forward to presenting the latest findings from our clinical study evaluating GC012F for patients with newly diagnosed multiple myeloma at this year’s IMS Annual Meeting," said Dr. Wendy Li, Gracell’s Chief Medical Officer. "There remain significant opportunities to improve outcome for front-line high-risk multiple myeloma patients. With a demonstrably impressive safety profile, differentiated BCMA/CD19 dual-targeting design and FasTCAR next-day manufacturing, we believe GC012F is a compelling, innovative candidate to address the unmet needs for this patient population."

Poster presentation details are as follows:

Abstract title: Phase I open-label single-arm study of dual targeting BCMA and CD19 FasTCAR-T cells (GC012F) as first-line therapy for transplant-eligible newly diagnosed high-risk multiple myeloma
Abstract number: P-136
Abstract category: Treatment of Newly Diagnosed Myeloma – Transplant Eligible
Presentation time: 1:30-2:30PM EEST, Wednesday, September 27, 2023
Additional information about the poster and the IMS Annual Meeting is available on the IMS website.

About GC012F

GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases, and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in the United States and a Phase 1/2 clinical trial in China is to be commenced imminently. Gracell has also launched an investigator-initiated trial (IIT) evaluating GC012F for the treatment of refractory systemic lupus erythematosus (rSLE).

On September 6, 2023 Verismo Therapeutics, a clinical-stage CAR-T company developing novel KIR-CAR platform technology invented at and licensed from the University of Pennsylvania ("Penn"), reported that a first patient has been dosed in their STAR-101 clinical trial to study the SynKIR-110 product in individuals with advanced ovarian cancer, mesothelioma, and cholangiocarcinoma (Press release, Verismo Therapeutics, SEP 6, 2023, View Source [SID1234634962]). The Phase 1 clinical trial, designed to evaluate the safety, feasibility, and potential activity of SynKIR-110, represents a crucial step forward in improving treatment options in patients with mesothelin-expressing solid tumors.

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STAR-101 (NCT05568680) is a first-in-human trial that aims to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of the SynKIR-110 product, which is comprised of autologous T cells transduced with a mesothelin-targeted KIR-CAR. By targeting mesothelin-expressing ovarian cancer, mesothelioma, and cholangiocarcinoma, SynKIR-110 holds potential for creating a new treatment option for these challenging malignancies.

"This represents a significant milestone for our company and demonstrates the commitment of our team to address the critical need for additional treatment options for patients with mesothelin-expressing solid tumors," said Dr. Bryan Kim, Co-Founder and CEO of Verismo Therapeutics. "We’re proud to work with the distinguished team at Penn to take our SynKIR-110 treatment out of the lab and to the patients with unmet medical needs."

The STAR-101 clinical trial will encompass an intervention period, during which subjects will receive non-myeloablative lymphodepleting chemotherapy followed by a single infusion of SynKIR-110, as well as a 12-month follow-up period. For more information on the STAR-101 clinical trial, please visit ClinicalTrials.gov – NCT05568680.

"We are excited to initiate this Phase 1 clinical trial of SynKIR-110, which, based on preclinical testing in relevant animal models, holds promise as a potential new therapeutic for patients with advanced ovarian cancer, cholangiocarcinoma, and mesothelioma," said Dr. Janos L. Tanyi, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and a principal investigator for the trial, "By leveraging the power of autologous T cells transduced with Mesothelin KIR-CAR, we hope to enhance treatment options and ultimately improve outcomes for patients facing these challenging malignancies."

About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acts as a novel costimulatory molecule for T cells using additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell functional persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.

On September 6, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported presentations featuring the Company’s theranostic programs at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Vienna from 9 – 13 September 2023 (Press release, Telix Pharmaceuticals, SEP 6, 2023, View Source [SID1234634961]).

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Further data from Telix’s completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be presented in on oral session on Sunday 10 September.

In addition, the congress program features the following Telix initiatives:

Sponsored symposium on personalised diagnostics in urological cancers: the promise of nuclear medicine;
Phase III ProstACT GLOBAL study of TLX591 investigational prostate cancer therapy;
Artificial intelligence (AI) Segmentation and primary characterisation of prostate cancer lesions using models trained on 68Ga–PSMA–11 image datasets;
Nobody Left Behind (NOBLE) Registry of Telix’s single photon emission computed tomography (SPECT)-based prostate cancer imaging agent TLX599-CDx;[1] and,
A preclinical evaluation of carbonic anhydrase IX- (CAIX)-targeted lutetium-177 radionuclide therapy in combination with immune checkpoint inhibition.
Dr Colin Hayward, Telix Chief Medical Officer, said, "We are pleased to be so well represented at this year’s EANM Annual Congress, with a sponsored symposium and abstracts accepted across Telix’s late-stage prostate and kidney cancer imaging and therapy programs. In addition, our innovations in AI and quantum computing for prostate cancer segmentation and characterisation will be featured in an oral presentation.

"Once again, we will be supporting the EANM Sanjiv Sam Gambhir Young Investigator Award, an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals. We look forward to seeing you at booth number 241 to discuss Telix’s industry leading theranostic pipeline and opportunities for collaboration."

EANM presentation details are as follows:

Sponsored Symposium: Personalised diagnostics in urological cancers: the promise of nuclear medicine
Chairperson: Professor Stefano Fanti, Director of Nuclear Medicine Division and of PET Unit – Policlinico S.Orsola, Bologna, Italy
Introduction: How PSMA PET dusted off the Management of Prostate Cancer.
Professor Stefano Fanti.
Prostate Cancer Imaging: is there only one PSMA-PET?
Dr. Macarena Rodríguez Fraile, Nuclear Medicine Clínica Universidad de Navarra, Pamplona, Spain
Next Generation Imaging in Urology: What’s new in Bladder and Kidney Cancers.
Prof. dr. Karolien Goffin, Nuclear Medicine, University Hospital Leuven – KU Leuven, Leuven, Belgium.
The Use of Artificial Intelligence in Prostate Cancer Management.
Dr. László Papp, Center for Medical Physics and Biomedical Engineering (CMPBME), Medical University of Vienna, Vienna, Austria.
Date & Time: Sunday, 10 September, 2023, 1:15 – 2:45 PM (CEST).
Session: Theranostics Track – Oncology & Theranostics Committee / EARL – Featured Session: Old but Novel Techniques
Title: 89Zr-DFO-girentuximab PET/CT imaging for clear cell renal cell carcinoma – ZIRCON study results of diagnostic performance, including in very small lesions (oral presentation)
Date and Time: 10-Sep-23, 4:20 – 4:30 PM
Presenter: Clement Bailly, Nantes University Hospital, Nantes, FRANCE
Presentation ID: OP-194

Session: Cutting Edge Science Track – TROP Session: Segmentation and Denoising
Title: Using a 3-D UNet artificial intelligence model to segment PSMA-avid lesions in 68Ga–PSMA–11 PET/CT images (top-rated oral presentation)
Date and Time: 10-Sep-23, 4:55 – 5:05 PM
Presenter: Simon Wail, Telix Pharmaceuticals, North Melbourne, AUSTRALIA
Presentation ID: OP-222

Session: M2M Track – TROP Session: TME and Therapy: Direct Targeting and Secondary Effects
Title: Evaluation of Therapeutic and Immunological Action of CAIX-Targeted Lutetium-177 Radionuclide Therapy Combined with Immune Checkpoint Inhibition (top-rated oral presentation)
Date and Time: 11-Sep-23, 10:15 – 10:25 AM
Presenter: Simone Kleinendorst, Department of Medical Imaging, Radboud University Medical Center, Nijmegen, NETHERLANDS
Presentation ID: OP-358

Session: Clinical Oncology Track – TROP Session: Prostate Cancer Biochemical Recurrence
Title: The imaging characteristics of theranostic 99mTc/188Re-PSMA-GCK01 is equivalent to dedicated diagnostic 99mTc-HYNIC-iPSMA in prostate cancer (top-rated oral presentation)
Date and Time: 11-Sep-23, 6:05 – 6:15 PM
Presenter: Eduards Mamlins, Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, GERMANY
Presentation ID: OP-512

Session: e-Poster Presentations Session 10 – Oncology & Theranostics Committee: Haematological and Abdominal Malignancies / localised Treatments
Title: NOBLE (Nobody Left Behind) Registry: Initial Experience of [99mTc]-HYNIC-iPSMA Imaging in the Detection of Prostate Cancer (oral e-poster presentation)
Date and Time: 12-Sep-23, 10:53 – 10:57 AM
Presenter: Fuad Novruzov, Department of Nuclear Medicine Azerbaijan National Centre of Oncology, Baku AZERBAIJAN
Presentation ID: EPS-206

Session: Cutting Edge Science Track – TROP Session: AI Methods and Applications
Title: Primary prostate characterization in PSMA-11 PET on real quantum computers (top-rated oral presentation)
Date and Time: 12-Sep-23, 3:00 – 03:10 PM
Presenter: Laszlo Papp, Medical University of Vienna, Vienna, AUSTRIA
Presentation ID: OP-706

Session: Clinical Oncology Track – TROP Session: Prostate Cancer Treatment
Title: ProstACT GLOBAL: A Phase 3 Study of 177Lu-DOTA-rosopatamab (TLX591) With and Without the Best Standard of Care for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment with a Novel Androgen Axis Drug (top-rated oral presentation)
Date and Time: 12-Sep-23, 3:30 – 3:40 PM
Presenter: Neel Patel, Telix Pharmaceuticals, North Melbourne, AUSTRALIA
Presentation ID: OP-718

Session: D: Technical Studies -> D5 Radiopharmacy/ Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control
Title: The Optimization of the Current ININ Method of Lu-177-DOTA-HYNIC-iPSMA (e-poster)
Presenter: Yehia Omar, Misr Radiology Center, Cairo, EGYPT
Presentation ID: EP-0880