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Resolution Bioscience (a part of Agilent) Investigated Acquired Resistance to KRAS G12C Inhibition

On June 28, 2021 Agilent Technologies Inc. (NYSE: A) reported the publication of a study carried out in partnership with Resolution Bioscience (a part of Agilent) and Dana-Farber Cancer Institute (Press release, Agilent, JUN 28, 2021, View Source [SID1234584420]). The paper was published in the New England Journal of Medicine (NEJM) on June 24 and is titled "Acquired Resistance to KRAS G12C Inhibition in Cancer." It demonstrates the clinical utility of liquid biopsy techniques to detect resistance to targeted therapies, including inhibitors of KRAS, one of the most commonly mutated oncogenes in cancer.

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KRAS G12C inhibitors, such as adagrasib, have shown promising efficacy in clinical trials, however, mechanisms of acquired resistance are not yet fully understood. Leveraging cell-free DNA (cfDNA) analysis, this study was conducted to investigate mutations that arise that may confer resistance to patients treated with KRAS inhibitors, including adagrasib and to better understand the process of acquired resistance and to identify new strategies to combat acquired resistance.

The results of the study showed KRAS G12C cancers have diverse genomic and histologic mechanisms, including point mutations, copy number changes, and fusions, that appear to impart resistance to KRAS G12C inhibitors. Developing therapeutic strategies to delay and overcome drug resistance will be an essential component in improving therapeutic outcomes in cancer patients.

"While results from these early clinical trials are encouraging, the cancer usually becomes resistant to these drugs," said Dana-Farber’s Mark Awad, MD, Ph.D., the co-first author of the paper with Shengwu Liu, Ph.D., also of Dana-Farber. "The mechanisms of resistance – the genomic and other changes that occur that allow the cancer to begin growing again – are largely unknown. This study sought to identify them."

"Given the high prevalence of KRAS driven cancers and resulting unmet medical need, elucidating the genetic underpinnings of acquired resistance to KRAS inhibitors at the time of progression is critical," Mark Li, CEO of Resolution Bioscience, said. "Importantly, in this study, more than three times as many patients were able to be genotyped by cfDNA compared to tissue alone at the time of progression. Furthermore, this study highlights the importance for cfDNA assays to accurately detect all major types of genetic aberrations, including gene fusions and copy number variations."

Agilent’s Resolution Bioscience team has partnered with Mirati Therapeutics Inc. (NASDAQ: MRTX) to use the Resolution ctDx FIRST assay as a companion diagnostic (CDx) in support of adagrasib for identifying patients with non-small cell lung cancer patients that harbor a KRAS G12C mutation. Liquid biopsy biomarker testing of patients in the adagrasib registrational clinical trial is being performed in Resolution’s clinical lab based in Kirkland, Washington.

Lengo Therapeutics Appoints Enoch K. Kariuki as Chief Executive Officer

On June 28, 2021 Lengo Therapeutics, a biopharmaceutical company developing novel precision medicines targeting driver mutations in oncology, reported the appointment of Enoch K. Kariuki, Pharm.D., as Chief Executive Officer (Press release, Lengo Therapeutics, JUN 28, 2021, View Source [SID1234584419]).

Dr. Kariuki is an accomplished industry leader with broad experience in healthcare strategy, life sciences finance, operations and business development. Prior to joining Lengo, Dr. Kariuki was Chief Financial Officer at VelosBio, a clinical-stage biopharmaceutical company developing novel, first-in-class cancer therapies targeting ROR1, which was acquired by Merck in 2020 for $2.75 billion.

Prior to VelosBio, Dr. Kariuki served as Senior Vice President, Corporate Development at Synthorx, Inc., where he led the company’s initial public offering, managed relationships with bankers, sell-side equity analysts and investors, and led the business development process that concluded with the successful sale of Synthorx to Sanofi for $2.5 billion.

Dr. Kariuki was previously Vice President at H.I.G. Capital, where he led investments into, and served on boards of, several life sciences companies. His roles prior to H.I.G. include Senior Associate at Leerink Partners and Associate Director at UBS Investment Bank. At Leerink and UBS, Dr. Kariuki advised healthcare companies on equity capital financings, mergers and acquisitions, leveraged buyouts, and recapitalizations.

"Enoch brings to Lengo extensive experience leading high-performing teams in the private and public sectors. His background in global finance and operations, as well as his track record of financing and building biotech companies, is exactly the type of leader Lengo needs as we advance into our next phase of growth," said Dave Johnson, Chairman at Lengo Therapeutics. "Enoch will be an invaluable asset to Lengo, and I look forward to working with him again to build a best-in-class pipeline targeting driver mutations in oncology."

"I am excited to join Lengo at such an exciting time. I look forward to working with Dave, our Board members and the senior management and scientific teams to help advance our pipeline of differentiated, best-in-class targeted oncology therapeutics," said Enoch Kariuki, Pharm.D., Chief Executive Officer at Lengo Therapeutics.

Dr. Kariuki completed a Post-Doctoral Fellowship in R&D Strategy and Analytics at Bristol Myers Squibb and was a Pharmacist at CVS Caremark. He holds an MBA from the Tuck School of Business at Dartmouth College and a PharmD from Texas Southern University. He serves on the boards of Zentalis Pharmaceuticals (NASDAQ:ZNTL) and Imago Biosciences.

KRBP Presenting at 2021 Next-Gen Immuno Oncology Congress Showcasing Its Proprietary AI Targets for Off-the-Shelf Allogenic CAR-T for Solid Tumors

On June 28, 2021 Kiromic reported as a pioneer of immuno oncology with a presentation at the 4th Annual Next-Gen Immuno Oncology Congress in June 2021 (Press release, Kiromic, JUN 28, 2021, View Source [SID1234584418]).

At the conference, we will:

— Present our artificial intelligence (AI) predicted and selected targets, and

— Discuss how our AI targets will offer better safety and efficacy compared to immuno oncology peers with classic targets.

Our AI targets are predicted and selected based on the following characteristics:

High expression in cancer cells

Heat map of T-cell, B-cell epitopes

Low expression in normal cells

High affinity to TCR

Quantity surface antigen expression signature

We intend to use our AI target, Mesothelin isoform 2, in the upcoming first-in-human dosing for solid tumors in 3Q-2021. At the first-in-human dosing, Kiromic will also introduce a CAR-T with chPD1, our PD1 activator, which will we believe offer immuno oncology with new tools to address Tumor Micro Environment (TME).

Our topics for the session on June 29th are:

— Mesothelin isoform 2 is a novel target for allogenic CAR γδT cell therapy in solid tumors

— Diamond Artificial Intelligence /CancerSplice : ADVANCING CAR through A.I. for Target
Link to 4th Annual Next-Gen Immuno Oncology Congress (Virtual) June-28, 2021

Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, commented:

"We are honored to be invited to present at the 4th Annual Next-Gen Immuno Oncology Congress.

The challenges for immuno oncology and the employment of classic targets result from low specificity, which results in higher side effects and low affinity, which results in low efficacy.

We believe our AI selected iso-mesothelin will address both of these issues.

Our selection and prediction algorithm is robust and extensive, poring over billions of data points, to arrive at these targets in hours which otherwise would have required many man-years if done manually.

We believe that the first-in-human dosing will demonstrate the safety and efficacy of our product and will also demonstrate that AI targeting is superior compared with classic targeting with immuno chemistry."

Chief Medical Officer of Kiromic, Dr. Scott Dahlbeck, commented:

"As an oncologist treating these patients and reading the data, I know first-hand about the needs in immuno oncology to address the problems of specificity and affinity in targeting.

It’s very exciting for me to be part of our innovative team that is introducing AI algorithms into the search for better targets.

We are looking forward to the first in-human dosing with these AI targets in 3Q-2021."

Chief Strategy and Innovation of Kiromic, Gianluca Rotino, stated:

"The time has come for the world to see the power of AI algorithms unleashed on targets research and immuno oncology to finally get CAR-T which offers better safety and efficacy compared with classic small molecules."

MaaT Pharma Announces DSMB Approval to Proceed to Cohort 4 out of 5 in Phase 1b CIMON Trial Testing Capsule Formulation of Microbiome Ecosystem Therapy

On June 28, 2021 MaaT Pharma, a clinical-stage biotechnology company focused on developing Microbiome Ecosystem Therapies in oncology, reported that the Data Safety and Monitoring Board (DSMB) recommended to proceed to the fourth cohort of the dose-finding Phase 1b CIMON clinical trial, without modifications (Press release, MaaT Pharma, JUN 28, 2021, View Source [SID1234584417]). The DSMB is an independent committee monitoring the progress of the company’s clinical trial and is reviewing safety, tolerability and data quality while the trial is ongoing.

"We are very pleased that the third of five cohorts in this important study with MaaT033 has successfully been completed without any safety signals reported. This is a very meaningful step towards determining the target dose of this oral capsule product candidate, and we expect to initiate a pivotal Phase 3 study next year," commented John Weinberg, MD, Chief Medical Officer at MaaT Pharma.

The CIMON trial (NCT04150393) is enrolling a total of 27 patients at 6 sites across France. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy.

The CIMON Phase 1b trial is expected to be completed at the end of 2021.

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory "Butycore" species, which characterize MaaT Pharma’s Microbiome Ecosystem Therapies.

Cardiff Oncology Added to the Russell 2000® and other FTSE Russell Indexes

On June 28, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic and castrate-resistant prostate cancer, reported that it has been added as a member of the small-cap Russell 2000 Index, the all-cap Russell 3000 Index, and the Russell Microcap Index, effective upon the U.S. market open today, June 28, 2021, as part of the 2021 Russell indexes reconstitution (Press release, Cardiff Oncology, JUN 28, 2021, View Source [SID1234584416]).

The 2021 annual reconstitution of the Russell indexes captured the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell 3000, Russell 2000 and Russell Microcap Indexes and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.