On September 4, 2022 Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported the launch and roll-out of Galen 3.0, a transformative solution offering new detection capabilities and a broad set of features to support pathologists in the diagnosis of multiple tissue types across various digital pathology workflows (Press release, Ibex Medical Analytics, SEP 4, 2022, View Source [SID1234618976]). Galen 3.0 is CE-Marked, approved in additional countries and now generally available to Ibex customers.

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Creating a new modality for cancer diagnosis, Galen is the first and most widely deployed AI technology in pathology and used in routine clinical practice at laboratories, hospitals, and health systems worldwide. Galen supports pathologists across numerous diagnostic tasks during the review of breast, prostate, and gastric biopsies and helps improve the quality of cancer diagnosis, reduce turnaround time, boost productivity and improve user experience for pathologists. Galen demonstrated outstanding outcomes across clinical studies performed in multiple pathology labs and diagnostic workflows1,2,3,4,5.

Galen 3.0 incorporates the very latest evolution of Ibex’s AI algorithms for detecting cancer and other clinically relevant features in prostate, breast, and gastric biopsies. To ensure very high accuracy and generalizability, Ibex trained the Deep Learning networks on huge, enriched data sets from laboratories worldwide that were digitized by multiple scanning systems, including rare prostatic malignancies such as intraductal carcinoma, neuroendocrine tumor, colorectal adenocarcinoma, lymphoma, and urothelial carcinoma. Galen also calculates a Gleason score, tumor size and percentage for each cancer slide, potentially enabling pathologists to save review time and reduce subjectivity.

"With an estimated 1.9 million new cancer cases diagnosed in the United States alone this year, we are excited to bring Galen 3.0 to pathology labs worldwide, providing clinically validated, automated decision-support tools that help pathologists diagnose cancer more rapidly and more accurately to support the high demand," said Issar Yazbin, Vice President of Product Management at Ibex. "Keeping our customers’ needs central to our research and development, we are proud to deploy Galen 3.0, bringing enhanced detection capabilities, improved user experience, increased interoperability tools and ease of implementation into existing clinical workflows."

Galen 3.0 features an open API (Application Programming Interface) accelerating interoperability and seamless integration with image management solutions, lab information systems and digital pathology workflow solutions. The Ibex API is already used in multiple collaborations between Ibex and leading digital pathology partners where Ibex’s AI findings are seamlessly integrated to the partners’ solutions. Version 3.0 also includes new customizable reporting modules, enabling every customer site to tailor the slide and case reports according to their own needs.

Ibex Medical Analytics presents at the European Congress of Pathology which takes place in Basel, Switzerland, between September 3-7 (booth no. 1).

On September 4, 2022 Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting data in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) from the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 being held on September 9-12 (Press release, Leap Therapeutics, SEP 4, 2022, View Source [SID1234618975]). Safety and early efficacy data will be presented from the WAKING study, a multicenter Phase 2 non-randomized trial evaluating DKN-01 plus Tecentriq (atezolizumab), Roche’s anti-PD-L1 antibody, in patients with advanced oesophagogastric adenocarcinoma (OGA).

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"Data from the DisTinGuish study continue to demonstrate promising results with the combination of DKN-01 plus tislelizumab and standard chemotherapy as a first-line treatment in patients with advanced gastroesophageal adenocarcinomas," said Samuel Klempner, MD, Associate Professor at Harvard Medical School. "The mature median progression-free survival of 11.3 months compares favorably with recent benchmarks in this patient group. The outcomes in the aggressive DKK1-high and the less checkpoint-inhibitor sensitive PD-L1-low (CPS < 5) subgroups are notable and encouraging. As the last patient enrolled in early April 2021, the overall survival results are also on track to show an increase over current standards. Gastroesophageal cancer patients and physicians want new biomarker-directed therapies to improve the standard of care in first-line treatment, and we are enthusiastic about the upcoming randomized clinical trial involving this encouraging DKN-01 combination."

"Early results from the WAKING study show the promise of boosting anti-tumor activity by targeting the Wnt signaling pathway and DKK1-driven tumor microenvironment modulation with a DKN-01 plus atezolizumab combination therapy strategy in patients with advanced OGA," said Fiona Turkes, MD, Clinical Research Fellow at The Royal Marsden Hospital. "We look forward to continuing to enroll patients and studying the biological mechanisms of this unique chemotherapy-free combination therapy, especially in those patients whose tumors express high levels of DKK1."

Key Findings DisTinGuish
DKN-01 and tislelizumab plus CAPOX was well tolerated in first-line treatment for advanced GEA patients, with a safety profile consistent with previous reports
Overall median progression-free-survival (PFS) of 11.3 months exceeds benchmark results in unselected patients and in all four important biomarker-directed subgroups
11.3 months PFS in DKK1-high and 12.0 months in DKK1-low
10.7 months PFS in PD-L1-low (CPS < 5) and 11.6 months in PD-L1-high (CPS > 5)
Median overall survival (OS) is not mature with only 44% of patients deceased as of the data cut (June 30, 2022), with a median duration on study of 15.7 months and last patient enrolled in early April 2021
High and durable overall response rate (ORR) in unselected and aggressive subgroups (DKK1-high and PD-L1-low) (mITT): 68% (1 CR, 14 PR) overall
DKK1-high: 90% ORR (9 PR)
DKK1-low: 56% ORR (1 CR; 4 PR)
PD-L1-low expression: 79% (11 PR)
100% (6/6) ORR in DKK1-high, PD-L1-low patients
PD-L1-high expression: 67% (1 CR; 3 PR)
75% (3/4) ORR in DKK1-high, PD-L1-high patients
Key Findings WAKING
DKN-01 up to 600mg every 2 weeks in combination with atezolizumab was considered safe
3 patients with the longest time on treatment received the 600mg dose level
At time of data cut off (August 16, 2022), 18 patients were enrolled in the study
12 patients were treated in initial phase
10 patients were response evaluable at the time of data cut-off
1 patient had a PR and DKK1 expression of 81% tumor percentage score (TPS)
Disease control rate: 50% (1 PR, 4 SD, 5 PD)
Elevated baseline DKK1 expression (TPS > 20%) may be associated with clinical response
4 DKK1-high patients: Best ORR 25% (1 PR, 1 SD, 1 PD, 1 NE)
Translational analyses and assessment of PD-L1 status are ongoing
Safety
No dose-limiting toxicity (DLT) was observed, and no formal maximum tolerated dose (MTD) was reached
No treatment-related deaths occurred, and no dose reductions were required
Leap Poster Details:
Title: DKN-01 and Tislelizumab + Chemotherapy as First-line (1L) Investigational Therapy in Advanced Gastroesophageal Adenocarcinoma (GEA): DisTinGuish Trial
First Author: Samuel J. Klempner, Harvard Medical School
Session Category: Poster Session
Session title: Oesophagogastric cancer
Date and time: Monday, September 12, 2022, at 12:00 CET
Poster Number: 1213

Title: Safety and efficacy of Wnt inhibition with a DKK1 inhibitor, DKN-01, in combination with atezolizumab in patients with advanced oesophagogastric adenocarcinoma (OGA): Phase IIa results of the WAKING trial
First Author: Fiona Turkes, The Royal Marsden NHS Foundation Trust
Session Category: Poster Session
Session title: Oesophagogastric cancer
Date and time: Monday, September 12, 2022, at 12:00 CET
Poster Number: 1253

About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study has completed enrollment patients with second-line DKK1-high G/GEJ cancer. Part C of the study will be a randomized controlled trial of DKN-01 in combination with tislelizumab and chemotherapy compared to tislelizumab and chemotherapy. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene.

About the WAKING Study
The WAKING study (NCT04166721) is a Phase IIa/b nonrandomized, open-label, multicenter study to be conducted concurrently in 2 Parts. Approximately 52 patients aged 18 years or older with inoperable, histologically confirmed locally advanced or metastatic G/GEJ adenocarcinoma with measurable disease (RECIST v1.1) requiring therapy will be enrolled in the study. Both parts are designed to evaluate safety, tolerability, and efficacy of the combination therapy of DKN-01 and atezolizumab in immunotherapy naïve, PD-L1 unselected G/GEJ adenocarcinoma patients. Treatment continues in repeating 14-day cycles until patient meets criteria for discontinuation or is no longer deriving clinical benefit. The WAKING study is being led by the Royal Marsden Hospital in the United Kingdom with financial support from Roche.

On September 4, 2022 CatalYm reported that the mature results from its Phase 1, first-in-human trial "GDFATHER-1" (GDF-15 antibody-mediated human effector cell relocation) will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (Press release, Catalym, SEP 4, 2022, View Source [SID1234618974]). The trial evaluated CatalYm’s lead GDF-15 neutralizing antibody visugromab (previously known as CTL-002), in combination with immune checkpoint inhibitor nivolumab in last-line, anti-PD-1/PD-L1 relapsed/refractory patients. Growth and differentiation factor 15 (GDF-15) is recognized as a negative regulator of antitumoral T cell activity preventing T cell recruitment to the tumor microenvironment as well as potently suppressing an adaptive immune response by additional mechanisms recently identified. The ESMO (Free ESMO Whitepaper) congress will be held in Paris, France, from September 9 to 13, 2022.

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Oral presentation details:

Presentation Title: Final results of the first-in-human clinical trial of the GDF-15 neutralizing antibody CTL-002 in combination with nivolumab in subjects with solid tumors relapsed/refractory to prior anti-PD-1/PD-L1 treatment.
Presenter: Dr. Ignacio Melero Bermejo, MD | Universidad de Navarra
Session: Investigational immunotherapy
Session Date and Time: Saturday September 10, 2022, from 2:45 PM – 4:15 PM CEST
Location: In-Person & Live Stream | Paris Expo Porte de Versailles, 7.3.O – Orléans Auditorium
Presentation Number: 729MO

About the GDFATHER-1 Trial
The GDFATHER-1 trial (GDF-15 antibody-mediated human effector cell relocation) is the first-in-human study of visugromab (CTL-002). This dose escalation study recruited 25 patients that received escalating doses of visugromab (CTL-002) in a "3+3" manner with the lead candidate given as a monotherapy for two weeks, then followed by combination with an anti-PD-1 checkpoint inhibitor.

About Visugromab (CTL-002)
Visugromab, formerly known as CTL-002, is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. Visugromab counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.

On September 4, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, taking place in Paris, France from September 9-13, 2022 (Press release, Wugen, SEP 4, 2022, View Source [SID1234618973]).

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The results highlight key features of WU-NK-101’s unique cytokine-induced memory-like (CIML) phenotype and support its clinical development for solid tumors. The data reinforced key phenotypic characteristics of WU-NK-101, including its potent anti-tumor cytotoxicity and enhanced metabolic fitness that supports resilience within the immunosuppressive solid tumor microenvironment (TME). Additionally, when used in combination with monoclonal antibodies (mAbs), in preclinical models, WU-NK-101 demonstrated further enhanced anti-tumor activity, with robust tumor penetration and persistence.

The details of Wugen’s presentation at ESMO (Free ESMO Whitepaper) are as follows:

Title: WU-NK-101: An Enhanced NK Cell Therapy Optimized for Function in the Tumor Microenvironment (TME)
Abstract Number: 11P
Date and time: Sunday, September 11, 2022, from 12:00 – 13:00 CEST (6:00 – 7:00 a.m. EDT)
Location: Paris Expo Porte De Versailles, Poster Area, Hall 4
Additional meeting information can be found at View Source

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary Moneta platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On September 4, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the release of an abstract by ESMO (Free ESMO Whitepaper) with preliminary results from the company’s Phase 1 study of zanidatamab zovodotin (ZW49), an investigational novel bispecific HER2 targeted antibody-drug conjugate (Press release, Zymeworks, SEP 4, 2022, View Source [SID1234618972]).

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Results from the study entitled "Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers" will be presented by Komal Jhaveri, MD, FACP, Medical Oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation on Monday, September 12 at 5:25 pm CEST during the ESMO (Free ESMO Whitepaper) meeting being held September 9-13, 2022, at the Paris Expo Porte de Versailles in Paris, France.

"Treatment of HER2-expressing solid cancers remains an area with significant unmet need, and these preliminary Phase 1 clinical results for zanidatamab zovodotin (ZW49) show that it offers a manageable safety profile and encouraging single-agent anti-tumor activity in patients with advanced disease that has progressed after treatment with standard of care therapies," said Dr. Jhaveri. "We look forward to continuing enrollment in the trial and to reporting on additional data as it becomes available in the months ahead."

In an ongoing Phase 1 study of 76 patients with HER2+ cancers including gastric (28%) and breast (22%) cancers, preliminary results show that the majority of treatment related adverse events (TRAEs) were Grade 1 or 2 and included keratitis (42%), alopecia (25%) and diarrhea (21%). Among seven patients who experienced TRAEs of grade 3 or higher, two were grade 4 events including infusion-related reaction and decreased neutrophil count. There were three patient discontinuations associated with TRAEs and no reported treatment-related patient deaths or cases of interstitial lung disease. Results also showed encouraging single-agent anti-tumor activity in heavily pretreated patients with HER2+ cancers, including a confirmed objective response rate of 28% and a disease control rate of 72% in 29 patients treated at a dose of 2.5 mg/kg on an every three week (Q3W) schedule.

"We are excited to share our preliminary results from the ongoing Phase 1 study at ESMO (Free ESMO Whitepaper)," said Kenneth Galbraith, Chair and CEO of Zymeworks. "We look forward to Dr. Jhaveri’s presentation of updated study results on September 12th in Paris and discussing the future development of zanidatamab zovodin, on our conference call and webcast following the ESMO (Free ESMO Whitepaper) presentation."

Conference Call and Webcast

Zymeworks will host a conference call and webcast on Monday, September 12th at 4:30 pm Eastern Standard Time (EST) to discuss the clinical data presented at ESMO (Free ESMO Whitepaper) and provide an overview on future clinical development plans for zanidatamab zovodotin. The event will feature a presentation by Komal Jhaveri, MD, FACP, Clinical Oncology, Memorial Sloan Kettering in NYC, and Neil Josephson, M.D., Zymeworks’ Chief Medical Officer. An open question & answer session with all presenters will conclude the event.

Interested parties can access the live webcast via Zymeworks’ website at View Source A recorded replay will be accessible after the event on the Zymeworks website.

Disclosure: Dr. Jhaveri has a consulting relationship with Zymeworks.