On June 27, 2024 EditCo Bio, Inc., a leader in genome engineering innovation, reported the expansion of its T-cell editing portfolio with the launch of Knockout CD8+ T-cell Pools (Press release, EditCo Bio, JUN 27, 2024, View Source [SID1234644588]). This new addition builds upon the success of their Knockout CD4+ T-cell Pools, offering researchers an advanced tool for primary T-cell editing that brings unprecedented precision and scalability to cancer and immunotherapy research.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Leveraging EditCo Bio’s cutting-edge automated platform, the new Knockout CD8+ T-cell Pools allow researchers to bypass challenging optimization steps and access highly functional edited T-cells ready for immediate use. This innovation accelerates the transition from research discovery to clinical application and delivers several key benefits:

Accelerated results: EditCo Bio’s unique 7-day protocol and proprietary guide RNA technology achieve knockout efficiencies approaching 100% in primary human CD8+ T-cells. Additionally, EditCo has several prescreened and optimized donor cells available to kick off projects immediately.
Dependable performance: Edited CD8+ T-cell pools demonstrate exceptional editing efficiency (~100%) and viability (>85%). with editing efficiency unchanged for at least 4 weeks in culture.
Enhanced functionality: Edited CD8+ T-cell pools showed antigen-specific CD107a mobilization, a hallmark of cytotoxic activity.
Customizable solutions: EditCo Bio can efficiently onboard customer-supplied donor cells, ensuring high knockout efficiencies, viability, and turn-around times tailored to specific project needs.
"For researchers working on the front lines of immunotherapy, having access to high-quality CD8+ T-cells can significantly accelerate the pace of discovery and therapeutic development," said Travis Maures, CSO of EditCo Bio. "Our new Knockout CD8+ T-cell Pools provide the precision, efficiency, and scalability needed to push the boundaries of what’s possible in cellular research."

The addition of Knockout CD8+ T-cell Pools further strengthens EditCo Bio’s comprehensive Engineered Cell portfolio, solidifying its position as a leader in cell engineering solutions. The company plans to continue to expand its range of edited primary cell products to include other primary cell subsets, which will be available later this year.

For more information regarding EditCo Bio’s Knockout T-cell Pools, visit www.EditCo.bio/contact.

On June 27, 2024 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported FDA clearance of its IND application for GTB-3650, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to start in second half of 2024 (Press release, GT Biopharma, JUN 27, 2024, View Source [SID1234644569]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"FDA clearance for GTB-3650 is a tremendous accomplishment and we look forward to submitting our next IND in the first quarter of 2025 for GTB-5550, which will target multiple solid tumors", said Michael Breen, Executive Chairman and Interim Chief Executive Officer of GT Biopharma. "As we ramp up our clinical activities, we plan to start the Phase 1 trial with GTB-3650 in the coming months followed by multiple data readouts in 2025. We also expect to start a basket trial with GTB-5550 for multiple solid tumors in 2025 and remain very enthusiastic in our pursuit of additional opportunities for various autoimmune indications where our TriKE’s may have therapeutic utility."

The Phase 1 dose escalation study will evaluate GTB-3650 in up to six cohorts of adult patients with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

"GTB-3650 is designed to target NK cells within the immune system to potentially overcome many of the limitations of current AML chemotherapies," said Michael Breen. "Our trial design should give us an early read on safety and potential therapeutic activity and also provide valuable learnings that we can translate into our clinical development plans for follow-on TriKE molecules, including GTB-5550."

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce two main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of two heavy chains and two light chains. They also produce another type of antibody that is made up of only two heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

On June 27, 2024 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported the results of the study "HER2DX ERBB2 mRNA assay Following Trastuzumab-Based Chemotherapy in HER2-Positive Advanced Gastric Cancer" presented at ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2024 in Munich, showing that HER2DX genomic test demonstrates significant potential in refining patient selection for trastuzumab-based chemotherapy in HER2-positive advanced gastric cancer (Press release, REVEAL GENOMICS, JUN 27, 2024, View Source [SID1234644589]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HER2+ advanced gastric cancer treatment shows variable response to trastuzumab plus chemotherapy, indicating the need for precise biomarkers. The HER2DX is a promising tool for enhancing patient selection by quantifying ERBB2 mRNA expression levels, and classifying tumor samples into different groups: low, medium, and high.

Patricia Villagrasa, REVEAL GENOMICS’ CEO, says, "This study marks the first time that HER2DX has been applied outside of breast cancer, illustrating its precision and potential across different oncological applications. Our findings underscore the test’s capability to improve patient selection, fundamentally transforming the treatment approach for those battling advanced gastric cancer. This represents a significant milestone in our ongoing commitment to advance personalized medicine."

Dr. Tamara Saurí, medical oncologist, coordinator of upper- gastrointestinal cancers, and principal investigator of the study at Hospital Clinic of Barcelona, stresses: "Advanced HER2+ gastric cancer treatment shows variable response to trastuzumab plus chemotherapy, indicating the need for precise biomarkers. HER2DX not only addresses a crucial unmet need but also explains why HER2-positive gastric cancers often have poorer responses compared to HER2-positive breast cancers. By revealing tumor diversity and expression patterns, the test might guide the development of more effective, personalized treatment strategies. This insight is crucial as we explore novel anti-HER2 therapies alone or in combination, aiming to improve patient outcomes."

HER2DX: beyond breast cancer
The study utilized the HER2DX genomic test with a focus on the ERBB2 score to evaluate its association with survival outcomes. The HER2DX genomic test was evaluated in 60 patients with HER2+ advanced gastric cancer treated at two hospitals in Spain (Hospital Clinic of Barcelona and Hospital General Granollers).

The study highlighted the test’s effectiveness, showing a hazard ratio of 0.38 for PFS, indicating a 62% reduction in the risk of progression for patients with high ERBB2 mRNA levels compared to those with low levels. Additionally, the hazard ratio for OS was 0.53, reflecting a 47% reduction in the risk of death for patients in the high ERBB2 mRNA group compared to the low group.

Comparative Analysis with Breast Cancer
The study also included a comparative analysis of ERBB2 expression between gastric and breast cancers, revealing generally lower levels of ERBB2 in gastric cancer, including within the HER2 +3 immunohistochemical category. This comparison further highlights the nuanced role of ERBB2 across different cancers and the need for better methods to quantify this target.

About HER2DX️
HER2DX️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS️ since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️ predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About GASTRIC CANCER
According to the article "The current and future incidence and mortality of gastric cancer in 185 countries, 2020−40: A population-based modeling study" published online by eClinicalMedicine in 2022: "In total, approximately 1.1 million new cases and 770,000 deaths of gastric cancer were estimated in 2020. Incidence rates were on average 2-fold higher in males than females (15.8 and 7.0 per 100,000, respectively) with variation across countries. The annual burden of gastric cancer is predicted to increase to approximately 1.8 million new cases and 1.3 million deaths by 2040."

On June 27, 2024 Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it has called all $225 million aggregate principal amount of its outstanding 1.75% Convertible Senior Notes Due 2025 (the "Notes") (CUSIP No. 457669AA7) for redemption on August 9, 2024 (the "Redemption Date"). Insmed is redeeming the Notes as permitted under Section 11.03 of the indenture governing the Notes (the "Indenture") (Press release, Insmed, JUN 27, 2024, View Source [SID1234644570]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Redemption Process

The redemption price will be payable on the Redemption Date in cash and equal to 100% of the principal amount of the Notes outstanding on the Redemption Date, plus accrued and unpaid interest on such Notes to, but excluding, the Redemption Date (the "Redemption Price"). For each $1,000 principal amount of Notes, the Redemption Price will be equal to approximately $1,001.17. Unless Insmed defaults in making the payment of the Redemption Price, interest on the Notes will cease to accrue on and after the Redemption Date.

For all Notes surrendered in book-entry form, payment of the Redemption Price will be made through the facilities of the Depository Trust Company ("DTC"), and all redeemed Notes in book-entry form will be surrendered for payment of the Redemption Price in accordance with the applicable rules and procedures of DTC. The paying agent is Computershare Trust Company, N.A. and the address of the paying agent for delivery of any Notes in certificated form is Corporate Trust Operations, 1505 Energy Park Drive, St. Paul, MN 55108.

Right to Convert the Notes

Holders of the Notes may surrender their Notes (or any portion thereof having a principal amount that is an integral multiple of $1,000) for conversion at any time prior to 5:00 p.m. (New York City time) on August 8, 2024 or, if the Company fails to pay the Redemption Price on the Redemption Date, such later date on which the Redemption Price is paid. To convert any Note, the holder must comply with the applicable rules and procedures of DTC. The Company has elected to settle any conversions of Notes in shares of common stock in accordance with the Indenture. As of June 27, 2024, the conversion rate of the Notes is 25.5384 shares of common stock of the Company per $1,000 principal amount of Notes, which is equivalent to a conversion price of approximately $39.16 per share of common stock. Based on this conversion rate, an aggregate of up to 5,746,140 shares of common stock will be issued if all of the Notes are converted.

This press release shall not constitute a notice of redemption or convertibility of the Notes. This press release is neither an offer to sell nor a solicitation of an offer to buy the Notes or any other securities and shall not constitute an offer to sell or a solicitation of an offer to buy, or a sale of, the Notes or any other securities in any jurisdiction in which such offer, solicitation or sale is unlawful. No representation is made as to the correctness or accuracy of the CUSIP number either as printed on the Notes or as contained in this press release.

On June 27, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, reported a new gastroesophageal cancer trial, DECIPHER, that will utilize the company’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to guide patient selection and assess the rate of MRD clearance in patients being treated for gastroesophageal cancer (Press release, Natera, JUN 27, 2024, View Source [SID1234644590]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DECIPHER (Developing ctDNA Guided Adjuvant Therapy for Gastroesophageal Cancer) is a single-arm, open-label phase II trial, and the first trial to evaluate the efficacy of a HER2-directed antibody-drug conjugate in gastroesophageal adenocarcinoma (EGC) patients in the adjuvant setting. The study plans to enroll 25 patients from more than 10 sites across the United Kingdom. Patients who are Signatera-positive following neoadjuvant chemotherapy and surgery will forgo standard-of-care adjuvant chemotherapy and receive the investigational therapy for a maximum of eight cycles. Signatera will be used to measure MRD-positivity following surgery and serially thereafter, with MRD clearance serving as the primary endpoint.

"With an adaptive approach aimed at eliminating MRD, DECIPHER is designed to offer patients a second chance at a cure when they have not responded to standard of care therapies," said Dr. Elizabeth Smyth, M.D., consultant in medical oncology at Oxford University Hospitals NHS Foundation Trust l and chief investigator of the trial. "Signatera’s personalized, tumor-informed approach, which has demonstrated high sensitivity across several different cancer types including EGC, will be a key component of this study."

This launch of DECIPHER follows data from the PLAGAST study presented last month at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data showed that EGC patients who were Signatera-positive following neoadjuvant FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) chemotherapy and surgical resection were at an extremely high risk of disease progression by 12 months, despite standard of care adjuvant treatment, and had a 24-month overall survival rate of zero.1

Gastroesophageal cancer is a common global cancer that has sustained a nearly 2.5-fold increase in incidence over the last two decades.1 Patients with early-stage disease are typically treated with neoadjuvant chemotherapy, followed by surgery and adjuvant chemotherapy. Despite this aggressive and multimodal approach, treatment is curative in less than 50 percent of patients.2

"We are pleased to work with leading investigators in the UK on the first interventional trial for Signatera in gastroesophageal cancer," said Adham Jurdi, M.D., senior medical director of oncology at Natera. "With DECIPHER, we aim to demonstrate how the pairing of Signatera with innovative therapies can potentially enable new personalized treatment options and ultimately improve outcomes for EGC patients."

DECIPHER will be featured today, June 27, 2024, in a poster at the European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) Congress 2024 in Munich, Germany. The poster is entitled, "A single arm phase II trial of trastuzumab deruxtecan in patients with gastro-oesophageal adenocarcinoma cancer who are ctDNA and HER2 positive: DECIPHER".

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.