On November 13, 2024 Servier reported that it will present data at the Annual Meeting for the American Society of Hematology (ASH) (Free ASH Whitepaper), December 7-10, 2024 in San Diego, California. Data presentations will focus on the company’s clinical and preclinical studies in IDH-mutated acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), providing new insights on existing programs and a better understanding of the challenges faced by people living with hematological malignancies (Press release, Servier, NOV 13, 2024, View Source [SID1234648308]).

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!

"Servier is driven to deliver innovative therapies for diseases where patient needs are not yet sufficiently met and where we believe we can have the greatest positive impact," said Becky Martin, PhD, Chief of Medical at Servier Pharmaceuticals. "We look forward to sharing data at this year’s ASH (Free ASH Whitepaper) annual meeting that build upon our expertise in developing medicines for patients living with hematological malignancies, including IDH-mutated AML and MDS."

On November 13, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that company management will participate in the following investor conferences (Press release, Tyra Biosciences, NOV 13, 2024, View Source [SID1234648307]):

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!

Jefferies London Healthcare Conference, November 19-21st, 2024:

Todd Harris, CEO of TYRA, will participate in a fireside chat on Tuesday, November 19th, at 2:00 pm GMT.
TYRA management will also participate in one-on-one investor meetings and B2B meetings.
36th Annual Piper Healthcare Conference, December 3-5th, 2024, New York:

Mr. Harris will participate in a fireside chat on Wednesday, December 4th, at 10:30 am ET.
TYRA management will also participate in one-on-one meetings with investors.
A live and archived webcast of the fireside chats will be available via the For Investors page on the TYRA website.

On November 13, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported positive data from the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients (Press release, Immutep, NOV 13, 2024, View Source [SID1234648306]).

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!

Prof. Dr. Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research (IKF) and project lead stated, "The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging. This promising data in INSIGHT-003 suggests a complementary effect from the addition of efti, a unique MHC Class II agonist, to the standard-of-care combination of pembrolizumab and chemotherapy which has revolutionised the treatment landscape in lung cancer. The IKF will also support and is looking forward to participating in the upcoming TACTI-004 study, which has PFS and OS as dual primary endpoints."

Key Results – Data cutoff – 15 October 2024 The survival data from the triple combination therapy in patients irrespective of PD-L1 expression with a minimum follow-up of 22 months (N=21) at data cut-off shows: INSIGHT-003 Results Median Overall Survival (OS) 32.9 months Median Progression-Free Survival (PFS) 12.7 months 24-month Overall Survival (OS) 81.0% These results compare favourably to the 22.0-month median OS, 9.0-month median PFS, and 24-month OS rate of 45.5% from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression. 1 Notably, ~19% of the 21 patients in INSIGHT-003 with mature survival data have high PD-L1 expression, who typically respond better to anti-PD-1 therapy, versus ~32% in the registrational trial of anti-PD-1 and doublet chemotherapy

Marc Voigt, CEO of Immutep, stated, "The overall survival and progression-free survival data from this mature cohort of patients in INSIGHT-003 with nearly a 2-year minimum follow-up exceeds our expectations. We are encouraged to see efti build upon the historical clinical outcomes from the most widely used immunotherapy-chemo combination today. Additionally, the early evaluations in the expansion cohort of 19 patients, who all have low or negative PD-L1 expression, are tracking well and we look forward to additional data updates from the INSIGHT-003 trial in 2025 and beyond. Our focus on potentially driving a new standard of care globally in first line treatment of NSCLC is boosted by these results and we are well advanced in our preparations to initiate the TACTI-004 Phase III trial."

Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate (ORR) according to RECIST 1.1 across all levels of PD-L1 expression compared to historical control2 :
• 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%)
• 58.8% ORR versus 49.2% ORR in patients with low PD-L1 expression (TPS 1-49%)
• 47.4% ORR versus 32.3% ORR in patients with negative PD-L1 expression (TPS <1%)

In this all-comer PD-L1 trial, the 55.0% ORR and 87.5% Disease Control Rate (DCR) are from the following breakdown of patients by PD-L1 expression: TPS >50% (N=4), TPS 1-49% (N=17), and TPS <1% (N=19). As compared to the general 1L NSCLC patient population of which each of these PD-L1 levels represents roughly one-third, INSIGHT-003 is biased towards low and negative PD-L1 (TPS <50%) patients who are typically less responsive to anti-PD-1 therapy.

In these patients with low and negative PD-L1 expression (36 of 40 patients), the triple combination achieved a 52.8% ORR and 86.1% DCR. Of note, all 19 patients in the expansion cohort have TPS <50% and several with stable disease have potential to become responders.

Safety
Safety continues to be favourable for efti in combination with pembrolizumab and chemotherapy, with no new safety signals.

Next Steps
INSIGHT-003, a multi-centre study led by the Frankfurt Institute of Clinical Cancer Research IKF, is nearing completion of patient enrolment. Additional data updates from this trial are expected in 2025 and beyond.

About INSIGHT-003
INSIGHT-003 is an investigator-initiated, multi-centre study led by the Frankfurt Institute of Clinical Cancer Research (IKF). It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.

On November 13, 2024 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, reported data from the primary analysis of its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy (Press release, Adaptimmune, NOV 13, 2024, View Source [SID1234648304]). The primary analysis data are being presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting which takes place from November 13-16, 2024 in San Diego.

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!

Based on these positive data, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by the end of 2025. Lete-cel builds on the potential of Adaptimmune’s sarcoma franchise to change the way solid tumors are treated using cell therapies, more than doubling the addressable patient population eligible for Adaptimmune cell therapies to also include NY-ESO-1 positive synovial sarcoma and MRCLS solid tumors.

Sandra D’Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center: "Individuals with both synovial sarcoma and MRCLS are commonly diagnosed under 40, facing a devastating disease with limited treatments in the prime of their lives. I’ve been seeing these patients throughout my career and have frequently faced the frustrating reality of having incredibly limited treatment options to offer them. I’m encouraged by these data as they could lead to a potential therapeutic option and an improved prognosis for these patients."

Elliot Norry, MD, Adaptimmune’s Chief Medical Officer: "We are thrilled to see that 42% of patients with synovial sarcoma or MRCLS responded to treatment with lete-cel, following prior treatment with currently available therapies. Responses were durable across both indications, with an overall median duration of response greater than 18 months for people with synovial sarcoma and greater than one year for MRCLS. These data underscore lete-cel’s potential to transform the lives of people with these cancers who have a poor prognosis and few treatment options. We look forward to presenting our findings at CTOS and initiating a rolling Biologics License Application for lete-cel in 2025 for the treatment of both synovial sarcoma and MRCLS, building on the potential of our sarcoma franchise."

The primary analysis includes data from 64 people with synovial sarcoma or MRCLS who received lete-cel manufactured with the proposed commercial manufacturing process in the IGNYTE-ESO trial. In the analysis, 27/64 (42%) people with synovial sarcoma or MRCLS had RECISTv1.1 responses by independent review, with six complete responses and 21 partial responses. The response rate was 14/34 (41%) for people with synovial sarcoma and 13/30 (43%) for people with MRCLS.

The median duration of response (DoR) was 12.2 months (95% CI 6.8, 19.5). In synovial sarcoma, the median duration of response was 18.3 months (95% CI 3.3, -). In MRCLS, the median duration of response was 12.2 months (95%, CI 5.3, -). The median progression free survival (PFS) was 5.3 months (95% CI 4.0, 8.0).

Safety findings were consistent with the known profile of lete-cel from previous data. All patients experienced treatment-emergent adverse events: cytopenias, cytokine release syndrome (CRS) and rash were the most common adverse events. Overall, toxicities were manageable, and consistent with an acceptable benefit to risk profile.

CTOS presentation details:

Title: Planned Analysis of the Pivotal IGNYTE-ESO Trial of Lete-Cel in Patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (Paper 84)
Session 12: Immunology: Podium presentation
Presenter: Sandra D’Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center
Date/Time: Saturday, November 16, 10:30 AM – 12:00 PM PT / 1:30 – 3:00 PM ET
Adaptimmune virtual KOL event November 18th
Adaptimmune will host a virtual event to discuss and review the IGNYTE-ESO dataset and the impact of engineered cell therapies on the treatment landscape in sarcoma. The event will feature Sandra D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, an investigative clinician in both the SPEARHEAD and IGNYTE-ESO clinical trials, and author and presenter of the IGNYTE-ESO data update at CTOS. A live question and answer session will follow the formal presentation. The virtual event will take place on Monday, November 18, 2024 from 2:30 PM ET to 3:30 PM ET. To register, click here.

About the IGNYTE-ESO trial
IGNYTE-ESO is a pivotal, Phase 2, open-label trial for people with previously treated, advanced synovial sarcoma or MRCLS to evaluate the efficacy, safety, and tolerability of lete-cel. Lete-cel’s engineered TCR T-cells target NY-ESO-1+ tumors. NY-ESO-1 is a solid tumor antigen highly expressed in synovial sarcoma and MRCLS.

About lete-cel
Lete-cel is an investigational, engineered TCR T-cell therapy targeting the solid tumor antigen NY-ESO-1. Lete-cel is being investigated for the treatment of synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) in the pivotal IGNYTE-ESO (NCT03967223) trial in patients who received prior anthracycline treatment.

About synovial sarcoma
There are approximately 50 types of soft tissue sarcomas which are categorized by tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5% to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue cases in the U.S. each year).2,3 One third of patients with synovial sarcoma will be diagnosed under the age of 30.3 The five-year survival rate for people with metastatic disease is just 20% and most people undergoing standard of care treatment for advanced disease experience recurrence and go through multiple lines of therapy, often exhausting all options.4

About Myxoid/round cell liposarcoma (MRCLS)
MRCLS is one of several types of liposarcoma, a rare cancer that grows in the cells that store fat in the body. MRCLS usually grows in the arms and legs. Each year in the United States, about 2,000 people are diagnosed with liposarcoma. MRCLS is one of the most common types of liposarcoma and makes up about 30% of all liposarcoma cases. It is more common in people aged 20 to 40 years old.5 One-third of MRCLS cases will become metastatic with tumors spreading to unusual bone and soft tissue locations.

On November 13, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported data on the newest addition to its End-to-End (E2E) Platform, an Interferon-Gamma (IFN-γ) Biosensor technology that allows real-time monitoring and quantification of IFN-γ release from cytokine-secreting cells at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Conference taking place in Houston, TX, USA from November 6-10, 2024 (Press release, MediGene, NOV 13, 2024, View Source [SID1234648303]).

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!

The poster "The IFN-γ Biosensor – A universal tool for IFN-γ detection in cellular co-culture assays" is available on Medigene’s website: View Source

"Release of IFN-γ is one of the most common parameters used to measure T cell or NK cell functionality. Current methods for detection of IFN-γ secretion have several drawbacks, including extensive hands-on-time and needs for expensive, temperature-sensitive reagents," said Dolores Schendel, CSO of Medigene AG. "The IFN-γ Biosensor is an innovative tool within our E2E Platform that provides a simple, low-cost, cell-based alternative for quantification of secreted IFN-γ. This biosensor addresses limitations of current methods by reducing time, costs and complexity. The biosensor cells can be added directly as third-party bystander cells to co-cultures of T or NK cells, thereby dramatically reducing assay steps while enabling a dynamic assessment of IFN-γ secretion over time, going beyond standard end-point assays." The presented poster displayed a direct comparison between the conventional standard method Enzyme-linked Immunosorbent Assay (ELISA) and the Company´s proprietary innovative IFN-γ Biosensor to determine IFN-γ release directly in cell co-cultures or in cell supernatants. The biosensor cells were generated to produce a green fluorescent protein (GFP) when exposed to IFN-γ and allow for quantitative analysis of the GFP fluorescent reporter signal

The IFN-γ biosensor demonstrated comparable sensitivity to ELISA, effectively detecting low levels of IFN-γ using standard measurement tools like flow cytometry and fluorescence readings. Detection was highly specific for IFN-γ, with minimal response observed only when exposed to exceedingly high levels of IFN-α or IFN-β, two other interferon types. Further in vitro assays showed that the biosensor produced dose-dependent results comparable to ELISA, that were stable and sensitive to IFN-γ stimulation over extended co-culture periods. The addition of this process optimization technology to the Medigene End-to-End Platform significantly reduces costs and complexity while increasing speed and reproducibility when applied in high-throughput screening assays of T or NK cell functionality. The time from assay completion to analysis of results was significantly reduced, providing faster data processing and is more efficient and streamlined when implemented in robotic workflows.

Overall, with its broad detection range, dynamic measurements over time, and high specificity, the IFN-γ Biosensor technology to provide a sensitive and efficient alternative that extends beyond a traditional ELISA for measuring T cell and NK cell functionality. Simple readouts using either flow cytometry and fluorescence readers-supports its easy integration in high-throughput workflows, cutting costs and handling times.