On May 26, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare reported that the company and partners within its Precision Oncology Alliance (POA) will collectively present 45 studies across more than 20 various solid tumor types at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7, 2022 (Booth #22081) (Press release, Caris Life Sciences, MAY 26, 2022, View Source [SID1234615142]).

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"The breadth of research being presented at ASCO (Free ASCO Whitepaper) illustrates the power of comprehensive molecular profiling and large-scale collaboration between more than 60 sites to address some of the biggest challenges in cancer care and precision oncology today," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The findings of these studies could help improve outcomes for patients with difficult-to-treat cancers and pioneer new approaches to care across diverse tumor types and patient populations."

"At Caris, our goal is to enable clinicians to make the best treatment choices, researchers to discover new targets, and the biopharmaceutical industry to develop the next breakthrough medicines," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. "These presentations show how our scientists and partners in the POA are using Caris’ unique AI-driven platform – which combines data from DNA (Whole Exome), RNA (Whole Transcriptome), and protein profiling with real-world clinical evidence from over 378,000 lifetime cases – to unravel the complexities of cancer. Ultimately, these discoveries could advance personalized cancer care and improve outcomes for many patients."

The Caris Precision Oncology Alliance includes 65 cancer centers and academic institutions in the United States and beyond. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and molecular testing in oncology. By leveraging the comprehensive genomic, transcriptomic and proteomic data available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and real-world clinical outcomes evidence for over 275,000 patients covering over 1 million data points per patient.

Three oral discussions focus on difficult to treat tumors and aggressive tumor types with low survival rates:

Comprehensive Genomic and Transcriptomic Characterization of Small Bowel Adenocarcinoma (Poster Number: 6)
June 4, 2022, 1:15-2:45 PM CDT

Biological and prognostic relevance of epigenetic regulatory genes in high-grade gliomas (HGGs) (Poster Number: 3570)
June 5, 2022, 11:30 AM-1:00 PM CDT

Surfaceome profiling revealed unique therapeutic vulnerabilities in transcriptional subtypes of small cell lung cancer (SCLC) (Poster Number: 142)
June 6, 2022, 11:30 AM-1:00 PM CDT
Other notable studies among the 45 accepted abstracts focus on key topics in oncology such as the tumor microenvironment, mechanisms of therapeutic resistance and rare biomarkers:

The tumor microenvironment and immune infiltration landscape of KRAS mutant pancreatic ductal adenocarcinomas (PDAC) compared to colorectal adenocarcinomas (CRC) (Poster Number: 127)
June 4, 2022, 8:00-11:00 AM CDT

Claudin 18 (CLDN18) gene expression and related molecular profile in gastric cancer (GC) (Poster Number: 36)
June 4, 2022, 8:00-11:00 AM CDT

The differential response to immune checkpoint inhibitors in colorectal and endometrial cancer patients according to different mismatch repair alterations (Poster Number: 418)
June 4, 2022, 8:00-11:00 AM CDT

Characterization of TIM3 and its ligands in colorectal cancer (Poster Number: 341)
June 4, 2022, 8:00-11:00 AM CDT

Exploring the nuances between BRCA1 and 2: a multiomic analysis (Poster Number: 456)
June 4, 2022, 1:15-4:15 PM CDT

S1314 Correlative analysis of ATM, RB1, ERCC2 and FANCC mutations and pathologic complete response (pT0) at cystectomy after neoadjuvant chemotherapy (NAC) in patients with muscle invasive bladder cancer (MIBC): implications for bladder preservation (Poster Number: 72)
June 4, 2022, 1:15-4:15 PM CDT

Reversion mutations in BRCA1 or BRCA2 genes: Resistant mechanism(s) in patients treated with platinum-based agents or poly (ADP-ribose) polymerase (PARP) inhibitors (Poster Number: 124)
June 5, 2022, 8:00-11:00 AM CDT

Characterization of MET exon 14 skipping alterations (METex14) in non–small cell lung cancer (NSCLC) using whole transcriptome sequencing (WTS) (Poster Number: 108)
June 6, 2022, 8:00-11:00 AM CDT
Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth 22081. The full abstracts will be available through the official ASCO (Free ASCO Whitepaper) website on May 26.

On May 26, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported the publication of data showing the potential best-in-class safety profile of its anti-CTLA-4 monoclonal antibody (mAb), ADG126. Interim results from the Phase 1 dose escalation portion of an ongoing Phase 1b/2 trial of ADG126 are published in an abstract on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting website in conjunction with the 2022 Annual Meeting taking place in Chicago from June 3-7, 2022 (Press release, Adagene, MAY 26, 2022, View Source [SID1234615159]).

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Key data in the abstract, titled "Phase 1 study of ADG126, a novel masked anti-CTLA-4 SAFEbody, that combines tumor-localized activation with strong Treg depletion and soft ligand blocking in patients with advanced solid tumors," include the following:

In this dose escalation of 16 patients with advanced metastatic solid tumors, approximately one third received three or more lines of prior therapies, and approximately one third had progressed from immuno-oncology (IO) therapy. ADG126 was administered to this heavily pretreated patient population intravenously as monotherapy once every three weeks at doses up to 10 mg/kg.
No dose-limiting toxicities or treatment-related SAEs were observed and only Grade 1 treatment related adverse events (TRAEs) were reported with repeat dosing across all dose levels; fatigue (19%) and pruritis (13%) were most common.
Plasma pharmacokinetics (PK) were approximately linear and the activated ADG126 accumulated steadily during repeat dosing across different dose levels. As the first clinical data validating the SAFEbody precision masking technology, the approximately 1.7-fold increase in half-life of total ADG126 is reflective of prolonged exposures of activated ADG126 in the tumor microenvironment (TME).
In an early indication of antitumor activity, two heavily pretreated patients with cold tumors (one ovarian and one uveal melanoma) showed durable reductions in target lesions (over 20%) and increased CD8+ T cells post-dosing. After the seventh cycle of ADG126 treatment at 1 mg/kg the ovarian cancer patient also showed a 77% reduction in CA-125 levels, an established biomarker of clinical benefit for ovarian patients. This activity is likely due to the accumulation of activated ADG126 in the TME upon repeat dosing at 1 mg/kg. The uveal melanoma patient was resistant/refractory to prior IO-IO combination therapy, having progressed on the combination of nivolumab and ipilimumab.
At the data cut-off of February 15, 2022, stable disease was seen in 5/16 patients, including the ovarian cancer and uveal melanoma patients. Dose escalation in this trial continues at 20 mg/kg and dose expansion has started at 10 mg/kg.
Commenting on the findings, Dr. Gary Richardson, OAM, MBBS, FRACP, Group Director at Cabrini Health Research, Neil Beauglehall Endowed Chair, Medical Oncology Research, and Professor of Medicine at Monash University, Australia, said, "With the emerging clinical data evaluating this novel immunotherapy candidate ADG126, a masked anti-CTLA-4 SAFEbody, we have the opportunity to detangle safety from efficacy, and deeply understand the benefits of Treg depletion while we optimize anti-CTLA-4 therapy as a cornerstone of future therapy. Another exciting and surprising aspect of these interim findings is that we see early signals of efficacy in certain ‘cold’ tumors with SAFEbody ADG126, which further builds on prior clinical evidence with its parental antibody ADG116, targeting a unique epitope of CTLA-4 to enable not only a safer but potentially better therapy than the options we have available today."

ADG126 SAFEbody applies precision-masking technology to the parental anti-CTLA-4 antibody, ADG116, for conditional activation in the TME to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies. Binding to the same unique epitope as ADG116, the masked ADG126 is designed to provide enhanced safety and efficacy profiles due to the combination of the potent Treg depletion in the TME and soft ligand blocking.

"Following these monotherapy dose escalation results, we look forward to releasing further data in coming months to confirm if the strong safety profile of ADG126 is preserved in combination with anti-PD-1 therapy, consistent with our preclinical observations," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene.

May 26, 2022 NovalGen Ltd ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies, reported first clinical data from the ongoing Phase 1/2 study of NVG-111, a novel ROR1 targeting bispecific antibody T cell engager, in patients with relapsed and refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting McCormick Place, Chicago, IL, June 3 to 7, 2022 (Press release, NovalGen, MAY 26, 2022, View Source [SID1234615177]). The Company will also be presenting additional clinical data at the conference.

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As of the January 31, 2022 data cut-off date, 6 patients had been enrolled to the study; three into each of the accelerated dose titration (ADT) cohorts and the remaining into a 30 µg/day flat dosing cohort. Early signs of efficacy and evidence of response was observed in all patients from Cohort 2 onwards. Amongst these, 2 patients had undetectable MRD in the blood with one being MRD negative in the bone marrow and the remaining patients achieved partial responses. NVG-111 was well tolerated with the most common adverse event being transient, Grade 1 lethargy, headaches, nausea, vomiting and thrombocytopenia. Dose escalation is ongoing, including exploration of step-up dosing.

"The safety and selectivity of NVG-111 observed in the pre-clinical studies have translated into the preliminary data in this on-going Phase I/II study," said Professor Amit Nathwani, Founder and CEO of NovalGen. "We are encouraged by these early clinical data, demonstrating a predictable and manageable safety profile, alongside promising efficacy and it underscores NovalGen’s commitment to bring transformational therapies to patients".

Dr Parag Jasani, Consultant Haematologist with NHS practice at Royal Free London NHS Trust and University College London Hospitals and Chief Investigator on the study added, "NVG-111 represents an important, novel treatment opportunity for patients with CLL and MCL as well as many other hematological malignancies. The data in this heavily treated patient population are encouraging and warrants further investigation, with the potential to broaden its use into other malignancies."

Poster Presentation Details:

Abstract Title: First-in-Human Phase I Study of a ROR1 targeting bispecific T cell engager (NVG-111) shows evidence of efficacy in patients with relapsed refractory CLL and MCL (ClinicalTrials.gov identifier: NCT04763083).

Lead Author: Dr Parag Jasani

Session Date/Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT

Abstract Number: 7535

In addition to releasing preliminary clinical data, NovalGen is also publishing 4 other abstracts encompassing NVG-111 pharmacokinetic, manufacturing and our next generation pipeline assets including ROR1 Extended Half Life and inducible armoured CAR-T.

Abstract Title: A sensitive and robust bioanalytical assay for pharmacokinetic analysis of ROR1xCD3 bispecific T cell engager (NVG-111) in a first-in-human study.

Abstract Title: The use of a transient transfected expression system to deliver high quality bispecific T cell engager drug product, NVG-111, to the clinic for a fraction of the cost and time associated with the development and use of a producer cell line.

Abstract Title: Activity and biophysical properties related to clinical evaluation of a first-in-class EHL ROR1xCD3 T Cell Engager.

Abstract Title: A Next Generation Inducible Armored CAR to Overcome the Immunosuppressive Tumour Microenvironment and Enhance the Cytotoxicity of CAR-T and TILs.

On May 26, 2022 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported the University of Iowa Holden Comprehensive Cancer Center’s presentation of preliminary data from an investigator-sponsored phase 1/2 trial evaluating vidutolimod, a first-in-class, immunostimulatory, noninfectious virus-like particle (VLP) containing a CpG-A Toll-like receptor 9 (TLR9) agonist (Press release, Checkmate Pharmaceuticals, MAY 26, 2022, View Source [SID1234615194]). The early phase trial is investigating intratumoral vidutolimod therapy in combination with intravenous pembrolizumab in patients with relapsed lymphoma. The objective of this study is to determine the dose of vidutolimod that, in combination with pembrolizumab, has optimal clinical efficacy and acceptable toxicity in patients with relapsed lymphoma who have failed at least one line of therapy. In addition to the funding provided by Checkmate, the ongoing study is supported by NCI grant P50 CA97274 to the University of Iowa/Mayo Clinic (UI/MC) Lymphoma SPORE (specialized program of research excellence).

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Preliminary results from an early-phase trial of in situ immunization of lymphoma with a virus-like particle containing a TLR9 agonist combined with anti–PD-1 therapy (Abstract #: 2639: NCT03983668)

During the 2022 ASCO (Free ASCO Whitepaper) Developmental Therapeutics—Immunotherapy Poster Session on Sunday, June 5 at 9:00am ET, Umar Farooq, M.D., Clinical Associate Professor of Internal Medicine at University of Iowa Hospitals & Clinics, principal investigator, and study sponsor, will present preliminary safety, response and translational laboratory data from 7 enrolled patients with relapsed lymphoma.
Key highlights from the presentation include:

Preliminary results suggest that in situ immunization with vidutolimod plus systemic pembrolizumab had clinical activity in a variety of lymphomas in 5 of 7 patients studied
No significant adverse effects (AEs) were reported after the 4-hour observation period other than mild headache or fatigue lasting only through day 1
Consistent with preclinical data, generation of anti-Qβ antibodies after the initial subcutaneous (SC) vidutolimod dose correlated with response to study treatment; further evaluation in additional patients is needed to confirm these initial observations
Additional evaluation of complex interactions between cells in the tumor microenvironment in response to vidutolimod will be needed to understand these findings
Study enrollment is ongoing and given the common use of B cell depleting therapies for the treatment of certain lymphomas, the study was modified to require generation of anti-Qβ antibodies after the initial SC dose of vidutolimod before patients receive IT therapy.

"Our understanding of the immune and therapeutic responses to intratumoral vidutolimod with checkpoint inhibitors continues to grow stronger based on these data," said Art Krieg, M.D., Founder and Chief Scientific Officer of Checkmate. "These initial observations provide valuable insights into the mechanism of action of vidutolimod and reinforce earlier preclinical data from the Iowa team that suggest the activity of vidutolimod requires the generation of anti-Qβ antibodies. We look forward to the continued investigation of vidutolimod in combination with immune checkpoint inhibitors to improve available treatment options for people with lymphoma and other difficult to treat cancers."

On May 26, 2022 Chiome Bioscience Inc. reported joint research agreement with Kidswell Bio Corporation (Press release, Chiome Bioscience, MAY 26, 2022, View Source [SID1234625711]). The collaborative research makes us join their ongoing research project to develop therapeutic antibody for cancer.

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Our mission is to shine the light on unmet medical needs through our research project of drug discovery and development. This collaborative research will expect to merge our research functions and experiences with novel antibody drug discovery project. We will continue to discuss the extended collaboration scheme with Kidswell Bio in case our joint research make the progress pushing the project up to the therapeutic drug development stage.