On April 28, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that the abstracts of TST001 and MSB0254 have been accepted by the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("2022 ASCO (Free ASCO Whitepaper) Annual Meeting") (Press release, Transcenta, APR 28, 2022, View Source [SID1234613184]). The abstracts are named "A Phase I Study of TST001, a High Affinity Humanized Anti-CLDN18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First Line Treatment of Advanced G/GEJ Cancer" and "A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MSB0254 in Chinese Solid Tumor Patients" respectively.

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The ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community. This year’s ASCO (Free ASCO Whitepaper) Annual Meeting will take place both online and in-person (McCormick Place; Chicago, IL) on June 3–7, 2022.

TST001 (Claudin18.2)
Abstract Number: 4062
Session Date and Time: June 4, 2022, 8:00 AM-11:00 AM CDT
Title: A Phase I Study of TST001, a High Affinity Humanized Anti-CLDN18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First Line Treatment of Advanced G/GEJ Cancer
First author: Professor Jifang Gong, Peking University Cancer Hospital and Research Institute
Presentation Format: Poster

MSB0254 (VEGFR2)
Abstract Number: 3023
Session Date and Time: June 5, 2022, 8:00 AM-11:00 AM CDT
Title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MSB0254 in Chinese Solid Tumor Patients
First author: Professor Tianshu Liu, Zhongshan Hospital, Fudan University
Presentation Format: Poster

About TST001

TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

About MSB0254

MSB0254 is a high affinity humanized anti-VEGFR-2 mAb, with an anti-tumor mechanism of action by inhibiting tumor angiogenesis. MSB0254 has been generated using Transcenta’s in-house antibody discovery platform. VEGFR-2 is overexpressed in neovascular tumor endothelial cells in many tumors in comparison to normal endothelial cells. Vascular permeability, survival and migration of the vascular endothelial cells are controlled by the VEGFR-2 pathway. VEGFR-2 inhibitors has been shown to be able to inhibit tumor-induced angiogenesis and effectively block tumor growth, and thus may have a potential therapeutic role in multiple tumor types.

On April 28, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that three abstracts highlighting new data on the genomic underpinnings of prostate and bladder cancers will be presented at the American Urological Association Annual Meeting, taking place May 13-16, 2022, in New Orleans (Press release, Veracyte, APR 28, 2022, View Source [SID1234613183]). The findings are derived from analyses of the Decipher GRID, a database that contains genomic profiling information from clinical samples used in the development and commercial application of the Decipher Prostate and Decipher Bladder tests.

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"The data being presented at AUA 2022 highlight the transcriptional complexity of prostate and bladder cancers, knowledge that we hope can be used to better personalize therapy," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Importantly, these analyses also reinforce the value of our Decipher GRID database, which contains over 100,000 transcriptomes of prostate and bladder cancers, for urologic oncology researchers all around the world."

On April 28, 2022 DermTech, Inc. (NASDAQ: DMTK) ("DermTech" or the "Company"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported the publication of "Noninvasive Genomic Characterization of Patients with Nonsclerotic and Superficially Sclerotic Chronic Cutaneous Graft-Versus-Host Disease Identified a Novel Gene Signature in Responders to Ruxolitinib Cream," in Transplantation and Cellular Therapy (Press release, DermTech International, APR 28, 2022, View Source [SID1234613182]).

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Graft versus host disease (GvHD) occurs when transplanted donor immune cells attack the recipient’s healthy cells and tissues. Dermatologic manifestations are an important aspect of GvHD, as they are often the earliest organ affected in GvHD and develop in more than half of GvHD patients. While oral ruxolitinib, a JAK1/2 inhibitor, has been approved by the U.S. Food & Drug Administration (FDA) for the treatment of acute and chronic GvHD (cGvHD), this is the first clinical trial evaluating the effectiveness of topical ruxolitinib in cutaneous GvHD patients.

Skin samples were non-invasively collected from cutaneous GvHD patients using the DermTech Smart StickerTM and subsequently analyzed by RNA sequencing to investigate the effect of topical ruxolitinib on gene expression in cGvHD. Specifically, the study evaluated the genomic differences between treatment with ruxolitinib cream and vehicle cream and the distinction between patients who responded to treatment and those who did not.

"Noninvasive characterization and prognostication of therapeutic response are needed for GvHD therapies," said Dr. Alina Markova, lead author and Assistant Attending of Dermatology at Memorial Sloan Kettering Cancer Center. "This is the first study to characterize the effect of topical JAK1/2 blockade with ruxolitinib cream on cutaneous cGVHD and differentiate the genomic signatures between responders and non-responders."

Bioinformatic analyses of Smart StickerTM collected skin samples successfully identified 210 differentially expressed genes (DEGs) between topical ruxolitinib and vehicle treatments with primary pathway differences in immune modulation and cell-signaling. Additionally, 383 DEGs were identified which differentiated patients who responded to treatment from those who did not.

"We are proud to partner with the Memorial Sloan Kettering Cancer Center to advance research on treatment for cutaneous GvHD patients and provide clinicians with objective genomic information to help identify patients that may benefit from treatment," said Michael Howell, PhD, chief scientific officer of DermTech. "This collaboration further demonstrates DermTech Stratum’s capabilities in offering translational medicine services to bring heightened precision and personalization to the diagnosis and treatment of dermatologic disease."

For additional information about DermTech Stratum, visit View Source

On April 28, 2022 Immunicom, Inc., a clinical-stage biotechnology company developing a breakthrough technology platform for immuno-oncology, reported that data from its ongoing clinical investigation, Protocol CP7-005 [NCT04004910], at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Conference in New Orleans (Press release, Immunicom, APR 28, 2022, View Source [SID1234613180]). The trial data, presented by Principal Investigator, Prof. Piotr Wysocki, detailed continued encouraging data for the Company’s LW-02 Cartridge Immunopheresis treatment used with chemotherapy.

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Expanding on Part A data where LW-02 Cartridge Immunopheresis was used as a monotherapy, results from Immunicom’s Part B & Extension—where Immunopheresis is combined with various chemotherapy regimens—continue to demonstrate effectiveness, safety, and tolerability. Median overall survival (OS) extended beyond six months in patients treated greater than four weeks. In addition, the incidence of brain metastases appears to be less than would otherwise be expected in this heavily pre-treated mTNBC population, and further analyses are underway to confirm this observation.

Immunicom’s Immunopheresis subtractive therapy selectively removes sTNF-Rs from plasma through therapeutic apheresis—a blood-filtering process like dialysis—using Immunicom’s unique LW-02 Cartridge (containing the Company’s proprietary, high-affinity, molecular ligand subtractive matrix). Removal of sTNF-R from plasma unleashes a patient’s natural TNF-α, an innate molecule in the body, to directly kill cancer tumor cells and upregulate the immune system to attack the tumor.

Commenting on the data, Dr. Wysocki stated, "We are seeing further confirmation that Immunopheresis is a potentially revolutionary treatment for cancer. In these difficult to treat late-stage cancer patients, the possibility of extending survival and preventing spread of the cancer to the brain, which is common in these patients, is especially promising and opens a new playing field in the battle against refractory cancers. Our longest surviving patient who had progressed three prior lines of treatment before being treated with Immunopheresis therapy had a robust response to treatment that lasted nine months. For this patient, disease progression occurred with reduced frequency of LW-02 Immunopheresis treatment, but a robust response was again observed on increasing the LW-02 treatment to three times per week, demonstrating the ability of LW-02 Immunopheresis therapy to produce a durable and sustained response now out to over 18 months."

Immunicom’s AACR (Free AACR Whitepaper) presentation underscores the burgeoning prospects for the Company’s Immunopheresis technology platform on multiple fronts in the fight against cancer and other immunologic disorders. The LW-02 Cartridge has received FDA Device Breakthrough Designation for treatment of solid malignancies and a CE Mark in Europe for use in chemo-refractory mTNBC. Three ongoing clinical trials continue to assess LW-02 Cartridge Immunopheresis as a monotherapy, and/or in combination with chemo- or immunotherapy, with other trials planned to initiate later in 2022.

Prof. Wysocki’s AACR (Free AACR Whitepaper) poster presentation is available on Immunicom’s website.

Subtractive Therapy – Immunopheresis and the LW-02 Cartridge

Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Cartridge to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), which are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-Rs receptor to trigger several cell death pathways. The selective removal of decoy sTNF-Rs by the LW-02 Cartridge unleashes the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drug and biologics that are infused into the patient. Immunopheresis is thus much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity.

On April 28, 2022 Crown Bioscience, a JSR Life Sciences company, and HUB Organoids (HUB) reported the publication of preclinical data in the journal, Nature Cancer, on a bispecific antibody which prevents the onset of metastasis and slows the growth of primary tumors in experimental models of cancer (Press release, Crown Bioscience, APR 28, 2022, View Source [SID1234613179]).

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The study was the result of work by an international consortium, SuppresSTEM which included Crown Bioscience (previously OcellO B.V.) and HUB. Crown Bioscience and HUB led the design of the experiments which were executed using the high content screening platform from Crown Bioscience using HUB Organoids. These studies enabled the discrimination of antibodies that were active against a broad range of mutational profiles and tumor subtypes, with hit validation and mechanism of action studies that enabled selection of optimally performing antibodies. Follow up in vivo studies in matched patient-derived xenograft (PDX) models were also performed by Crown Bioscience.

The work, spanning about five years, involved Crown Bioscience screening a library of hundreds of bispecific antibodies and rescreening of ‘hits’ in a panel of patient-derived colorectal cancer organoids and matching normal organoids, that were developed by HUB and characterized by HUB and other consortium members. Organoids are stem cell-derived mini-organs developed from any patient resection or biopsy tissue that can be grown in the laboratory, which can be applied like conventional cell lines in early drug discovery.

"This is the first study that has used organoids exclusively for cell-based compound screening and characterization, leading to a compound entering clinical trials. This is a truly remarkable achievement that demonstrates the validity and application of HUB Organoids in high throughput screening and oncology drug discovery", said Leo Price PhD, Senior Vice President In Vitro Oncology at Crown Bioscience.

"This groundbreaking work demonstrates the power and potential of HUB Organoid Technology", commented Rob Vries PhD, CEO at HUB. "Using organoids, we were able to accelerate the timeline from initial discovery to clinical trials to about five years."

Nature Cancer is a journal which covers the latest, most significant cancer-related advances across the life, physical, applied and social sciences, focusing on new approaches for the development and delivery of diagnostics and therapeutics, as well as clinical studies regarding cancer diagnosis, treatment and prevention.