On November 28, 2022 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, reported the preliminary safety and efficacy data from the Phase I study of GFH009 monotherapy for treatment of relapsed/refractory hematological malignancies will be shared at the 2002 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in New Orleans, Louisiana, on December 12, 2022 (Press release, GenFleet Therapeutics, NOV 28, 2022, View Source [SID1234624524]).

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Through a phase I, multicenter, dose-escalation trial (NCT04588922), GFH009 (a highly selective CDK9 inhibitor) monotherapy is well tolerated with preliminary clinical activity in patients with relapsed/ refractory lymphomas. No dose limiting toxicities were observed to date. 4 lymphoma patients with different histology achieved stable disease. One patient with peripheral T cell lymphoma (PTCL) at 9 mg dose level had tumor shrinkage with tumor burden decreased by 62% after 8 weeks of treatment. The study is currently ongoing.

"We are delighted to collaborate with GenFleet in the study of GFH009 as China’s first highly selective CDK9 inhibitor moving into clinical trial. We are pleased to report the initial promising phase I data and preliminary clinical activity of GFH009 monotherapy. We hope to explore more indications in following studies and observe encouraging results from potential combination therapies in the future." said Professor Jianxiang Wang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences.

"GFH009 is GenFleet’s first clinical-stage program treating hematologic malignancies and the company’s first global multi-center clinical program granted with FDA’s IND approval. GenFleet entered into its first overseas out-licensing deal with SELLAS Life Sciences (NASDAQ: SLS) to co-develop GFH009 this year. We are planning for more monotherapy and combination studies and looking forward to presenting data from such studies in future academic conferences."said Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet.

First in Human (FIH) Study of GFH009, a Highly Selective Cyclin-Dependent Kinase9 (CDK9) Inhibitor, in Patients with Relapsed/Refractory (r/r) Hematologic Malignancies
ID#: 4263
Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials

This is a phase I, multicenter, dose-escalation trial of GFH009 enrolling patients with relapsed/refractory acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and lymphoma. In the first part of the trial, GFH009 was administered intravenously twice per week. The primary objective was to evaluate the safety of GFH009 and dose limiting toxicities (DLTs).

As of 15 July 2022, 30 patients enrolled and no DLTs were observed to date. Four lymphoma patients (3 in 4.5 mg and 1 in 9 mg) achieved stable disease (SD) including one peripheral T cell lymphoma (PTCL), one diffuse large B-cell lymphoma, one Hodgkin lymphoma and one mucosa-associated lymphoid tissue (MALT) lymphoma. The patient with PTCL at 9 mg dose level had tumor shrinkage with tumor burden decreased by 62% after 8 weeks’ treatment. One MALT lymphoma patient achieved a durable SD of 41 weeks and is still on treatment. PK exposure increased in a dose-proportional manner as increasing dose from 2.5 mg to 22.5 mg. The mean half-life ranged from 14.9 h to 17.7 h.

GenFleet and SELLAS are also presenting the pre-clinical research results of GFH009 introducing its mechanism of action at 2022 ASH (Free ASH Whitepaper) Annual Meeting on December 11th（In Vitro and In Vivo Studies Support GFH009, a Selective CDK9 Inhibitor, As a Potential Treatment for Hematologic Cancers，ID#:3477）. Treatment with GFH009 demonstrated anti-proliferative activity in hematologic malignancy cell lines.

Preclinical research indicates that GFH009 is a potent and highly selective CDK9 inhibitor with the ability to reduce expression of downstream oncogenes required for rapid cellular division and protein expression through specific, short-lived inhibition of CDK9. This depletion via GFH009 inhibition of CDK9 likely deprives oncogene-addicted cancer cells of crucial survival signals, leading to senescence and death.

About GFH009 & CDK9

As the first highly selective CDK9 inhibitor entering clinical stage in China, GFH009 is a potent and highly selective small-molecule inhibitor of CDK9 with more than 100 times selectivity over other CDK subtypes. Preclinical data have also suggested the potential anti-tumor effects of GFH009 in combination with BCL-2 inhibitors.

As a potent and highly selective small molecule CDK9 inhibitor, GFH009 exhibits strong apoptosis-inducing and anti-proliferative activities in multiple human cell lines and animal models of diseases. It effectively inhibits the growth of tumor in various xenograft models and significantly improves survival of tumor bearing animals.

As a family of serine & threonine kinases, cyclin-dependent kinase (CDK) family plays an important role in cell cycle regulation and transcription. CDK9 is one of the most potential targets for cancer therapeutics in the CDK family. Compared with non-selective CDK inhibitors, highly selective CDK9 inhibitors are advantageous in avoiding off-target toxicity against other CDK subtypes and reducing the risk of dose-limiting toxicity. Currently, no highly selective CDK9 inhibitors have been authorized with New Drug Application (NDA) approvals on the global market.

On November 28, 2022 Presage Biosciences, a biotechnology company whose mission is understanding the complexity of drug response in the tumor microenvironment, reported completion of a first-of-its-kind Phase 0 clinical study utilizing its CIVO (Comparative In Vivo Oncology) multiplexed microdosing technology (Press release, Presage Biosciences, NOV 28, 2022, View Source [SID1234624523]). Presage evaluated an investigational immuno-oncology agent, subasumstat, alone and in combination with other immuno-oncology agents. The spatial biology and mechanistic insights generated from this fully-enrolled Phase 0 study not only provided additional target validation in patient tumors, but also delivered unique drug combination and pharmacodynamic biomarker data with the potential to inform further clinical development of the investigational therapy.

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"This pioneering collaboration has delivered important translational data early in the clinical development process to help elucidate the modulation of the tumor microenvironment by an investigational agent through detailed visualization and molecular profiling in patients with head and neck cancer," said Christopher Arendt, Head of Oncology Cell Therapy and Therapeutic Area Unit at Takeda.

"Execution of this first-of-its-kind trial (NCT04065555) required innovation on multiple fronts: Development of novel technology, training and coordination of clinical trial sites; establishment of a novel regulatory path with the U.S. Food and Drug Administration, and exploration of a new dimension in spatial biology – pairing drug-exposure with molecular profiling technology," said Rich Klinghoffer, PhD, Presage CEO. "These achievements enabled us to successfully execute on a truly cutting-edge study and I am proud of the Presage Team’s accomplishment."

The Presage platform was developed to interrogate the highly complex tumor microenvironment that is unique to each individual patient, and to better understand the potential therapeutic response to treatment with investigational cancer agents. Accurate ex vivo modeling of tumors has proven difficult, and represents a fundamental challenge to early drug development. Under the conventional drug development paradigm, evidence of biological activity of a drug is typically not known until later stages of clinical development, and only after investment of significant time, resources, and cost. With a mission to address this fundamental issue, Presage Biosciences operates as a translational oncology research organization that is uniquely capable of providing spatial biology insights to help advance novel treatments for cancer patients.

"Patients have unmet needs and require more options to reduce cancer burden, improve survival, and enhance their quality of life and Presage will continue to interrogate the tumor microenvironment and work towards furthering the precision and efficiency of cancer drug development," said Klinghoffer.

Preliminary findings from the PBI-TAK-01 study were highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting and additional spatial biology data was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 Annual Meeting. Presage has ongoing collaborations with Takeda and Merck for Phase 0 trials with CIVO.

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of deep spatial biology insights. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.

On November 28, 2022 SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, reported CE (Conformité Européenne) Mark approval for SeekInCure Cancer Recurrence Monitoring Kit and is now ready to launch this test in European Union and other countries that recognize CE-IVD Mark (Press release, SeekIn, NOV 28, 2022, View Source [SID1234624522]).

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Cancer recurrence after the curative resection of the primary tumor arises from minimal residual disease (MRD) not detected in current practice via imaging, laboratory tests, or clinical assessment. Therefore, a sensitive and specific clinical tool that helps identify patients with MRD who are more likely to relapse or allows avoidance of unnecessary and potentially toxic therapy for lower-risk patients with no evidence of MRD is a major unmet need.

SeekInCure is applied to monitoring cancer recurrence and risk evaluation for post-operation cancer patients by monitoring the alterations of cancer genome in cell-free DNA (cfDNA) continually, combined with protein tumor markers, equipping big data and artificial intelligence. In addition, this approach does not require tumor analysis.

"This test only requires an 8ml blood draw within a month after radical surgery to assess whether MRD exists, meanwhile, peripheral blood can also be collected regularly after surgery to monitor cancer recurrence. We have conducted a prospective study to evaluate the effectiveness of SeekInCure to detect MRD in patients with hepatocellular carcinoma (HCC), and this study has confirmed the excellent performance of SeekInCure in the detection of MRD and the prognostic value of MRD in HCC patients. In addition, the blood-only features make it to be a cost-effective approach and faster turnaround time to allow clinicians to make a quick treatment decision," Mao Mao, M.D., Ph.D., SeekIn’s founder and CEO, said in a statement. "CE-IVD Mark is a recognition of the performance of SeekInCure, and is also a milestone for SeekIn, representing our test may be more widely accessible to cancer patients around the world. We believe that SeekInCure can be a powerful tool for MRD detection and recurrence monitoring for the patients after radical surgery."

About SeekInCure
SeekInCure is a blood-based cost-effective and tumor-naïve approach for molecular residual disease (MRD) assessment and recurrence monitoring for all cancer patients with radical surgery. Combining genomic/epigenetic signals (copy-number aberrations (CNA) and fragment size (FS)) and protein tumor markers quantification, the approach dynamically monitors the change of molecular tumor burden (MTB) in blood after surgery to identify patients with MRD who may benefit most from adjuvant therapies and to monitor for recurrence of the disease.

On November 28, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing as an alternative to surgical tumor removal, reported it will report its business and financial results as of and for the nine months ended September 30, 2022 on Monday, December 5, 2022 with a press release issued at 7:30 a.m. EST (Press release, IceCure Medical, NOV 28, 2022, https://www.prnewswire.com/news-releases/icecure-medical-to-report-financial-results-for-the-9-month-period-ended-september-30-2022-and-conduct-conference-call-on-december-5-2022-301687653.html [SID1234624521]). IceCure’s management team, joined by Dr. Hania Bednarski, oncoplastic breast surgeon and cryoablation specialist at Serenity Surgery & Wellness and author of "Freeze Breast Cancer: your guide to an alternative breast cancer treatment", will host a conference call that morning at 8:00 a.m. EST.

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Dr. Bednarski uses the ProSense System to perform cryoablation procedures at her clinic, Serenity Surgery & Wellness, and she has conducted a webinar to train other surgeons on how to perform breast tumor cryoablation using IceCure’s ProSense. Dr. Bednarski is a board certified general surgeon with a fellowship in aesthetic breast oncology, and she is known as an oncoplastic breast surgeon. Dr. Bednarski’s goal is to reduce surgery’s footprint. She is a comprehensive breast surgeon, performing all types of procedures, from minimally invasive breast biopsies, oncologic procedures, reconstruction of the breast, as well as cosmetic breast procedures.

On November 28, 2022 Lunit (KRX:328130.KQ), a global provider of AI-powered cancer solutions, reported that it unveiled real-world data (RWD) validating the clinical efficacy of AI in actual medical settings for the first time in the field of breast cancer research at this year’s RSNA meeting (Press release, Lunit, NOV 28, 2022, View Source [SID1234624520]). The company will be presenting a total of 12 abstracts—8 oral presentations and 4 poster presentations—at the 108th RSNA Annual Meeting to be held from Nov. 27 – Dec. 1.

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The highlight of Lunit’s program is an oral presentation on a large-scale population-based prospective study of Lunit’s AI solution for mammography as a potential replacement for radiologists. While past retrospective studies have shown promising performance by AI in mammography screening, this clinical trial conducted in a prospective screening setting truly reflects the real-world impact of AI in a breast screening workflow.

A Swedish team of researchers, led by radiologist Dr. Fredrik Strand at the Karolinska Institutet, conducted a prospective interventional study using Lunit INSIGHT MMG; the CE- and FDA-cleared AI solution for mammography analysis is currently in clinical use across numerous medical institutions around the world. Study results were collected over approximately 14 months (April 1, 2021 – June 9, 2022) analyzing 55,579 patient cases of breast cancer screening in actual clinical settings.

Interpreting mammograms is an inherently difficult task. Once suspicious lesions are found through mammograms, women are recalled to the clinic for further tests and biopsies. While recalls are aimed to increase the detection of cancer, only fewer than 1 in 10 women called back are diagnosed with breast cancer. These false-positive mammograms can cause patient anxiety and physical discomfort, as well as cost significant time and money due to extra tests, potentially doing more harm than good. To tackle this problem, most European countries have adopted a system of double reading in which two radiologists decide whether the patient should be recalled or not.

In keeping with this practice, the study included three independent readers: Radiologist 1, Radiologist 2, and Lunit INSIGHT MMG. This study design allows for results to be reviewed according to different reader combinations: two radiologists, Lunit AI + one radiologist, and each reader separately.

Comparison of the Cancer Detection Rate (CDR) Between Lunit INSIGHT MMG and Radiologists

Results from the study showed that Lunit INSIGHT MMG, when combined with a single radiologist, can detect more cancers compared to two radiologists. Furthermore, using AI alone showed non-inferior cancer detection rate (CDR) performance compared to the traditional double reading setting: the CDR per 1,000 exams of two radiologists, one radiologist + AI, and AI alone was 4.1, 4.3, and 4.1, respectively.

Comparison of the Recall Rate (RR) Between Lunit INSIGHT MMG and Radiologists

Lunit INSIGHT MMG also showed a lower recall rate (RR) in combination with one radiologist as well as alone, compared to the traditional double reading setting. The RR per 1,000 exams of two radiologists, one radiologist + AI, and AI alone was 29.3, 28.0, and 15.5, respectively. This result indicates that AI use for breast screening analysis, in combination with a radiologist as well as alone, leads to better performance for RR.

"While double readings have been established as the common practice across Europe and Australia, many countries are experiencing great difficulties due to the shortage of radiologists," explained Dr. Strand, breast radiologist and associate professor at Karolinska Institutet. "This prospective study lays the groundwork for the widespread adoption of AI in breast cancer screening by filling the role of one radiologist, which in turn can reduce medical costs and lead to healthcare reimbursement."

"AI will eventually become the standard of care for breast cancer screening. While developing a high-performing product has always been critical, this study is key in that Lunit is the first to prove the effectiveness of AI through a large-scale prospective clinical trial in actual medical settings," remarked Lunit CEO Brandon Suh. "With our recent contract to supply our AI for the BreastScreen NSW State program in Australia, Lunit’s AI is continuing to prove its positive impact in the medical field."