European Society for Medical Oncology

Ascendis Presents Updated and New TransCon™ IL-2 β⁄γ Monotherapy and Combination Therapy Data Confirming Clinical Activity Across Tumor Types at ESMO 2023

Retrieved on: 
Thursday, October 26, 2023
Patient, SCLC, Cmax, ESMO, Pembrolizumab, Colorectal cancer, European Society for Medical Oncology, Eosinophil, Carcinoma, Northern Transcon, Clinical, Oncology, Safety, European Society for Primary Immunodeficiencies, Interleukin, PR, Pharmaceutical industry, Extractive metallurgy

COPENHAGEN, Denmark, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) reported updated and new data from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in a poster presentation at ESMO 2023, the annual meeting of the European Society of Medical Oncology held in Madrid, Spain. The data included longer-term follow up of previously presented TransCon IL-2 β⁄γ monotherapy data from the IL-Believe Trial, and was the first presentation of dose escalation data informing recommended Phase 2 dose (RP2D) for TransCon IL-2 β⁄γ in combination with a checkpoint inhibitor.

Key Points: 
  • The data included longer-term follow up of previously presented TransCon IL-2 β⁄γ monotherapy data from the IL-Believe Trial, and was the first presentation of dose escalation data informing recommended Phase 2 dose (RP2D) for TransCon IL-2 β⁄γ in combination with a checkpoint inhibitor.
  • As of the August 15, 2023 data cutoff, 46 patients were enrolled into dose escalation: 25 to monotherapy and 21 to combination therapy.
  • RP2D for IL-Believe is 120 µg/kg of TransCon IL-2 β⁄γ administered intravenously every three weeks in both the monotherapy and combination therapy arms.
  • Additional details and highlights from the ESMO poster are available on the Investor & News section of the Ascendis Pharma website at https://investors.ascendispharma.com.

Medigene Reports Financial Results and Corporate Update for Q3 2023

Retrieved on: 
Thursday, October 26, 2023
Acceleration, IND, Patent, Innovation, ESMO, Logitech Driving Force GT, BioNTech, TCR, Platform, Congress, European Society for Medical Oncology, Intellectual property, KRAS, R, European Patent Office, Annual report, Kirsten, Partnership, CD28, EUR, Oncology, FSE, Senior, Therapy, European Patent Convention, IP, Patient, HLA, Frontiers, Rare-earth element, Pharmaceutical industry, Vaccine

Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results and provided a corporate update for the third quarter of 2023.

Key Points: 
  • Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results and provided a corporate update for the third quarter of 2023.
  • The Company’s Quarterly Statement Q3 2023 is available on Medigene’s website: https://medigene.com/investors-media/reports-presentations/
    “In the past quarter, we continued to successfully execute our corporate strategy and deliver on our commitments.
  • The Executive Management Board, therefore, maintains its guidance for the fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety.
  • Subsequent to the quarter, first pre-clinical data on MDG2011 was presented at the European Society for Medical Oncology (ESMO) Congress 2023 held in Madrid in October 2023.

Personalis Launches NeXT Personal® Dx for Early Access Clinical Use in Residual Disease and Recurrence Detection in Cancer

Retrieved on: 
Thursday, October 26, 2023
Biotechnology, Health, Oncology, EAP, Francis Crick Institute, University College London, ESMO, Medicare, Physician, Lung cancer, LDT, MD, Congress, Special access program, Access, UCL, Genomics, Recurrence, MRD, Breast cancer, Immunotherapy, PSNL, NeXT, Cancer, European Society for Medical Oncology, Patient, Neoplasm, DNA, Medical imaging, Chief Justice of Hungary

(Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced today the launch of the Early Access Program for NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer.

Key Points: 
  • (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced today the launch of the Early Access Program for NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer.
  • “We’re excited to work with oncologists through this Early Access Program to detect cancer even earlier and increase confidence in clinical decisions.
  • The EAP will enable oncologists to access NeXT Personal Dx for clinical use, with a focus on lung cancer, breast cancer, and immunotherapy response monitoring.
  • Personalis also recently announced data from the groundbreaking TRACERx study investigating the use of NeXT Personal in early-stage lung cancer for MRD and recurrence detection.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

Retrieved on: 
Wednesday, October 25, 2023
Gene amplification, Corr, Stomach, NMPA, ESMO, Trae tha Truth, FGFR2, ATP, DOR, DCR, MOS, FGFR, Congress, Safety, National Medical Products Administration, Disease, Oncology, Hepatotoxicity, RECIST, European Society for Medical Oncology, GC, GEJ, Death, Pharmaceutical industry, Patient

1527P)

Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

Beam Therapeutics Presents Preclinical Data Highlighting Utility and Durability of BEAM-301 to Correct a Glycogen Storage Disease Type I Deficiency Disease-Causing Mutation at ESGCT

Retrieved on: 
Wednesday, October 25, 2023
Gene editing, Survival, FDA, Uric acid, DSM-IV codes, IND, Therapy, Glycogen storage disease, Biotechnology, The First Half of My Life, Congress, Liver, Kidney, Systemic administration, G6PC, Mouse, Hypoglycemia, Cell, Risk, Gene, Triglyceride, LNP, ESGCT, Glucose, European Society for Medical Oncology, Patient, Blood, Cholesterol, Coma, Pharmaceutical industry, Vaccine, Medical imaging, Silviculture, Beam

CAMBRIDGE, Mass., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported new preclinical data demonstrating the ability of its in vivo drug candidate, BEAM-301, to directly correct the R83C mutation, one of the primary disease-causing mutations of glycogen storage disease type Ia (GSDIa). The data were presented today in an oral presentation titled “A Single, Systemic Administration of BEAM-301 Mitigated Fasting Hypoglycemia One Year after Dosing in a Transgenic Mouse Model of Glycogen Storage Disease Type-Ia” at the 30th Annual European Society of Gene & Cell Therapy (ESGCT) Congress in Brussels.

Key Points: 
  • “GSDIa is a devastating disease that significantly impacts an individual’s quality of life and puts them at consistent risk of hypoglycemia, coma and potentially death.
  • BEAM-301 is a liver-targeting lipid-nanoparticle (LNP) formulation containing base editing reagents optimized to correct the R83C mutation.
  • These findings support the potential of BEAM-301 to directly correct the disease-causing R83C mutation with a single dose.
  • Beam plans to submit a U.S. IND application in the first half of 2024 for authorization to initiate clinical trials of BEAM-301.

Bolt Biotherapeutics Presents Updated Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at ESMO 2023 Congress

Retrieved on: 
Monday, October 23, 2023
CR, Memorial Sloan Kettering Cancer Center, PRS, Trastuzumab, Plasma, Cholangiocarcinoma, Aes, ESMO, ISAC, MPH, Nivolumab, Publication, HER2, Congress, LVEF, Salivary gland tumour, European Society for Medical Oncology, MSK, Phenotype, Pharmacodynamics, Bolt, Oncology, SDS, Cancer, Therapy, Patient, Breast, Toxicity, ASCO, TLR, Pharmaceutical industry, Vaccine

BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.

Key Points: 
  • BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.
  • The Phase 1 dose-escalation trial enrolled 131 patients with 16 different HER2-expressing solid tumor types across 18 dose levels in two arms, monotherapy and in combination with nivolumab.
  • The response rate at the RP2D was 29% in evaluable patients with HER2-positive tumors, both in monotherapy (2/7, 29%) and in combination with nivolumab (2/7, 29%).
  • Additionally, a copy of the presentation is available on the Publications page of the Bolt Therapeutics website.

Apollomics Announces Efficacy of Vebreltinib in NSCLC Patients with MetEx14 Skipping Mutation Achieving an Overall Response Rate (ORR) of 75%

Retrieved on: 
Monday, October 23, 2023
APLM, NSCLC, ESMO, Brain, DOR, DCR, Poster, Clinical trial, Cancer, Liver disease, ORR, Safety, European Society for Medical Oncology, Patient, MET, CI, Pharmaceutical industry

“The clinical results demonstrate the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations, particularly in Non-Small Cell Lung Cancer (NSCLC) with MetEx14 skipping mutation,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.

Key Points: 
  • “The clinical results demonstrate the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations, particularly in Non-Small Cell Lung Cancer (NSCLC) with MetEx14 skipping mutation,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.
  • Preliminary efficacy and safety data from the Phase 2 KUNPENG clinical trial (NCT04258033) is presented in poster 1378P.
  • and a notably rapid onset of response with a median time to response of 1 month (95% CI, 1, 2.8).
  • In the 35 treatment-naïve patients, ORR was 77.1% (95% CI, 59.9-89.6), with median DOR of 16.5 months (95% CI, 9.2-NE).

Enterome Presents Positive Data from Phase 1/2 SPENCER Trial of EO2401 in Adrenal Tumors at ESMO 2023 Congress

Retrieved on: 
Monday, October 23, 2023
ESMO, MSS, Nivolumab, Congress, European Society for Medical Oncology, Inflammation, Adrenocortical carcinoma, Adrenal tumor, CD8, Service provider, Neoplasm, CT, Oncology, MPP, Patient, Peptide, Associate, Memory, Institut Gustave Roussy, ACC, Medical imaging, Pharmaceutical industry

PARIS, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced updated, encouraging results from Phase 1/2 SPENCER trial of EO2401 in combination with nivolumab in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP), two forms of adrenal tumors. EO2401 is composed of three non-self, microbiome-derived HLA-A2 restricted peptides, designed to activate memory CD8 T cells targeting tumor-associated antigens (TAAs) upregulated in adrenal tumors.

Key Points: 
  • EO2401 is composed of three non-self, microbiome-derived HLA-A2 restricted peptides, designed to activate memory CD8 T cells targeting tumor-associated antigens (TAAs) upregulated in adrenal tumors.
  • The data was featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023.
  • “We are excited to share positive, updated results from the SPENCER trial at this year’s ESMO Congress,” said Pierre Belichard, Chief Executive Officer of Enterome.
  • “EO2401 in combination with nivolumab continues to demonstrate a meaningful anti-tumor activity in patients with adrenal tumors.

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising 52% PSA50 (≥50% Reduction) and a Highly Differentiated Safety and PK Profile in Patients with mCRPC, who Progressed on Multiple FDA-Approved Treatments

Retrieved on: 
Monday, October 23, 2023
Patient, FDA, Șaeș, Lymphocytopenia, Taxane, PSA, ESMO, Trae Elston, Infrared spectroscopy correlation table, Congress, HIV disease progression rates, Prostate cancer, Poster, ADC, Clinical trial, PK, Oncology, Immunotherapy, Serum, RECIST, UCLA, Safety, European Society for Medical Oncology, PSMA, Neoplasm, SAN, Pharmaceutical industry, Vaccine, Nursing, Generic drug, Airline

SAN DIEGO, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that in biomarker unselected patients ARX517 monotherapy demonstrated a strong antibody-drug conjugate (ADC) safety profile at all doses tested with promising early efficacy signals that included PSA50 declines, ctDNA reductions, and RECIST v1.1 tumor response. The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 (NCT04662580).   Posters were made available as part of the 2023 European Society for Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023, and are summarized below.

Key Points: 
  • The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 ( NCT04662580 ).
  • APEX-01 is a Phase 1 / 2, first-in-human, open label dose escalation and dose expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC).
  • APEX-01 opened for enrollment in July 2021 and is the only on-going clinical trial in the United States targeting PSMA with an ADC.
  • The two primary objectives of APEX-01 are to analyze the safety and tolerability of ARX517 and establish a recommended Phase 2 dose.

Sensei Biotherapeutics Presents Trial-in-Progress Poster for Phase 1/2 Clinical Study of SNS-101 at ESMO 2023

Retrieved on: 
Monday, October 23, 2023
VISTA, Arm, Northwest Biotherapeutics, ESMO, Therapy, Pharmacokinetics, Safety, European Society for Medical Oncology, Cancer, Patient, Pharmaceutical industry

The multi-center Phase 1/2 clinical trial is a first-in-human, open-label, dose escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® in patients with advanced solid tumors.

Key Points: 
  • The multi-center Phase 1/2 clinical trial is a first-in-human, open-label, dose escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® in patients with advanced solid tumors.
  • To date, four patient cohorts have been enrolled in the monotherapy arm.
  • Sensei expects to report initial pharmacokinetic and safety monotherapy data in the fourth quarter of 2023, and topline monotherapy data in 2024.
  • The full poster is available for viewing on Sensei’s website in the “Events & Presentations” section of the Company’s Investor Relations website at www.senseibio.com.