ESMO

ImmunOs Therapeutics Presents Details of Novel Bispecific Anti-Tumor Molecules at ESMO Immuno-Oncology Congress 2023

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Monday, December 11, 2023

Schlieren (Zurich Area), Switzerland, and Gaithersburg, MD, USA – December 11, 2023 – ImmunOs Therapeutics AG , a biopharmaceutical company pioneering HLA-based therapeutics to create transformational medicines for cancer and inflammation, announced details of its novel multi-functional anti-cancer modality at ESMO Immuno-Oncology Congress 2023 in Geneva (Switzerland) on December 7, 2023.

Key Points: 
  • Schlieren (Zurich Area), Switzerland, and Gaithersburg, MD, USA – December 11, 2023 – ImmunOs Therapeutics AG , a biopharmaceutical company pioneering HLA-based therapeutics to create transformational medicines for cancer and inflammation, announced details of its novel multi-functional anti-cancer modality at ESMO Immuno-Oncology Congress 2023 in Geneva (Switzerland) on December 7, 2023.
  • “We already have encouraging in vitro data demonstrating potent anti-tumor efficacy and primary cell data demonstrating an enhanced safety profile compared to competing CD47 targeting molecules,” said Osiris Marroquin Belaunzaran, PhD, CSO and co-founder of ImmunOs Therapeutics.
  • “We believe that HLA molecules can serve as a versatile backbone to develop novel therapies capable of stimulating the immune system of cancer patients to eliminate tumor cells.
  • Moreover, we are also utilizing specific HLA molecules to develop novel therapies to treat inflammatory diseases.”

TILT Biotherapeutics Announces Positive Clinical Data in Checkpoint Resistant Metastatic Melanoma Phase I Trial at ESMO Immuno-Oncology 2023

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Friday, December 8, 2023

This is the first-time clinical data with an oncolytic virus in combination with tumor infiltrating lymphocyte therapy has been presented.

Key Points: 
  • This is the first-time clinical data with an oncolytic virus in combination with tumor infiltrating lymphocyte therapy has been presented.
  • TILT’s approach uses oncolytic viruses to selectively replicate in and lyse cancer cells, while simultaneously stimulating immune responses towards the tumor.
  • The data announcement at ESMO-IO relates to 16 patients with checkpoint inhibitor (CPI) resistant progressive metastatic melanoma, who were treated with multiple intravenous and intratumoral injections of TILT-123 and a one- or two- time treatment with TILs.
  • The company has several trials currently underway, reflecting its commitment to pushing the boundaries of cancer treatment (NCT04217473, NCT05271318, NCT05222932).

Xilio Therapeutics Announces Initiation of Enrollment for Phase 1 Combination Trial of XTX101, a Tumor-Activated, Fc-Enhanced Anti-CTLA-4, and Updated Phase 1 Monotherapy Data

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Thursday, December 7, 2023

WALTHAM, Mass., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced the initiation of enrollment for its Phase 1 clinical trial of XTX101, an investigational tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab and reported updated monotherapy data from its ongoing Phase 1 clinical trial evaluating XTX101 in late-line patients with advanced and immuno-oncology (IO) refractory solid tumors. The data were presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress on December 7, 2023.

Key Points: 
  • The data were presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress on December 7, 2023.
  • XTX101 monotherapy was generally well-tolerated with treatment-related adverse events (TRAE) primarily Grade 1 or 2, and no patients discontinued treatment due to a TRAE.
  • In addition, as previously reported, no Grade 4 or 5 TRAEs were reported by investigators across all dosing levels and dosing intervals.
  • Xilio recently completed enrolling patients at the RP2D of 150 mg Q6W in monotherapy dose expansion and initiated enrollment in Phase 1 combination dose escalation to evaluate the safety, tolerability and efficacy of XTX101 in combination with atezolizumab.

Regeneron to Share Progress of Novel Combination Therapies in Oncology at ESMO IO

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Thursday, December 7, 2023

TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of new and updated data on multiple combination therapies from its oncology pipeline at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023 from December 6 to 8 in Geneva, Switzerland. Highlights include first Phase 1 dose-escalation data for the investigational costimulatory bispecific antibody REGN5668 (MUC16xCD28) in combination with PD-1 inhibitor Libtayo® (cemiplimab) showing encouraging initial activity in patients with recurrent ovarian cancer. Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).

Key Points: 
  • Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).
  • “Our ESMO IO presentations highlight the continued progress of Regeneron’s oncology pipeline, which was strategically curated to have the potential to offer novel and differentiated combinations targeting several types of difficult-to-treat cancers.
  • Dose escalation is ongoing and has included administration of REGN5668 doses beyond 300 mg in combination with Libtayo.
  • Regeneron presentations at ESMO IO:

Cidara Therapeutics Presents New Promising Preclincal Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress

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Thursday, December 7, 2023

SAN DIEGO, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the presentation of new preclinical data on its novel, multi-specific CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress. Cidara also presented new preclinical data on CBO421, its first-in-class CD73-targeting DFC. The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.

Key Points: 
  • Cidara also presented new preclinical data on CBO421, its first-in-class CD73-targeting DFC.
  • The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.
  • “We are thrilled to be presenting promising preclinical data on our novel multi-specific DFC in colorectal cancer for the first time at ESMO-IO this year,” said Jeffrey Stein, Ph.D., president and chief executive officer at Cidara.
  • The company plans to file an investigational new drug (IND) application in mid-2024 for CBO421.

Coherus Presents Phase 1/2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2023 ESMO Immuno-Oncology Congress

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Wednesday, December 6, 2023

REDWOOD CITY, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced data from the ongoing Phase 1b/2 clinical trial of casdozokitug (casdozo), a first-in-class IL-27-targeting antibody, being presented at the 2023 ESMO Immuno-Oncology Congress taking place December 6 – 8, 2023 at Palexpo Exhibition Centre in Geneva, Switzerland. The presentation includes updated data for casdozo monotherapy dose escalation and expansion cohorts and a cohort evaluating treatment with casdozo in combination with the anti-PD-1 antibody pembrolizumab (pembro) in patients with non-small cell lung cancer (NSCLC) who have progressed after 2-4 prior lines of therapy, including chemotherapy and anti-PD-1 agents. Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment. Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.

Key Points: 
  • Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment.
  • Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.
  • The overall response rate (ORR) in the subset of patients with squamous NSCLC (n=2/9) was 22% in this data cut.
  • Casdozo continues to demonstrate an acceptable safety profile as monotherapy or in combination with a PD-1 inhibitor (pembro).

Viracta Therapeutics Announces Interim Data from Phase 1b/2 Clinical Trial of Nana-val in Patients with Epstein-Barr Virus-Positive Solid Tumors that Show Confirmed Tumor Responses at Higher Dose Levels

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Monday, December 4, 2023

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that additional data from the Phase 1b/2 clinical trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC) showed two ongoing confirmed partial responses (PRs) at higher dose levels. These data were featured in an oral presentation made by A. Dimitrios Colevas, M.D., Professor of Medicine (Oncology) at the Stanford Cancer Institute, during the European Society for Medical Oncology (ESMO) Asia Congress being held in Singapore. Nana-val is the company’s all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers.

Key Points: 
  • Nana-val is the company’s all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers.
  • “The initial efficacy, safety, and pharmacokinetic data from the first five dose cohorts of the Phase 1b trial in patients with recurrent or metastatic EBV-positive NPC are very encouraging,” said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta.
  • Confirmed PR at the third dose level demonstrated >50% reduction in tumor size through 50 weeks and confirmed PR at the fifth dose level demonstrated ~30-40% reduction in tumor size through 14 weeks.
  • Investigative sites are now open for enrollment into the sixth dose cohort of the Phase 1b dose escalation portion of the study, which incorporates Nana-val’s novel SDD regimen.

Merus Presents Interim Data on MCLA-129 at ESMO Asia Congress 2023

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Sunday, December 3, 2023

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 02, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced updated interim clinical data on MCLA-129 from ongoing expansion cohorts in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) were presented at the European Society for Medical Oncology (ESMO) Asia Congress 2023.

Key Points: 
  • UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 02, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced updated interim clinical data on MCLA-129 from ongoing expansion cohorts in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) were presented at the European Society for Medical Oncology (ESMO) Asia Congress 2023.
  • “MCLA-129 is a very active drug in EGFRm NSCLC and we’re planning a focused investment to evaluate MCLA-129 in combination with chemotherapy, which we expect to start early in 2024,” said Bill Lundberg M.D., President, Chief Executive Officer of Merus.
  • “We are in a fortunate position to have a strong balance sheet.
  • per investigator assessment
    The full presentations are available on the Publications page of our website.

Cidara Therapeutics to Present New Preclinical Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress

Retrieved on: 
Thursday, November 30, 2023

SAN DIEGO, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company will present new preclinical data on its novel, dual-acting CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress.

Key Points: 
  • SAN DIEGO, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company will present new preclinical data on its novel, dual-acting CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress.
  • Cidara will also present new preclinical data on CBO421, its first-in-class CD73 targeting DFC.
  • The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.
  • Presentation details are summarized below:

Ambrx Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalation Study Evaluating ARX517, a Proprietary PSMA-Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer

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Tuesday, November 28, 2023

SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx (NASDAQ: AMAM), today announced a clinical update regarding its proprietary anti-PSMA antibody drug conjugate (ADC) ARX517 in the ongoing APEX-01 Phase 1 / 2 dose escalation and dose expansion clinical trial in metastatic castration-resistant prostate cancer (mCRPC).

Key Points: 
  • Following the completion of the 21-day DLT observation period from APEX-01 dose escalation Cohort 9 (3.4 mg/kg), no DLTs or SAEs were observed.
  • A PSA decrease was not reported in the third patient because the patient had non-PSA secreting mCRPC.
  • On Monday November 27, the safety monitoring committee (SMC) voted to dose escalate to 4.5 mg/kg (Cohort 10) as well as expand patients at the 3.4 mg/kg dose (Cohort 9).
  • We believe this is a direct result of the stability of conjugation supported by PK data presented at ESMO last month.