Pembrolizumab

Galecto’s Galectin-3 Inhibitor GB1211 to be Studied in Combination with Pembrolizumab in Patients with Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma by Providence Cancer Institute

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Wednesday, October 19, 2022
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Galectin-3 is overexpressed in many cancers, including melanoma and head and neck squamous cell carcinoma (HNSCC).

Key Points: 
  • Galectin-3 is overexpressed in many cancers, including melanoma and head and neck squamous cell carcinoma (HNSCC).
  • Preclinical data has shown that GB1211 has the ability to reduce galectin-3-induced checkpoint inhibitor blockages, thus preventing galectin-3 from inducing checkpoint inhibitor resistance.
  • We are excited to start this study in melanoma and HNSCC patients to potentially counteract checkpoint inhibitor resistance by combining pembrolizumab and GB1211.
  • The randomized, double-blind placebo controlled, investigator-initiated Phase 2 trial will evaluate whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients.

Ultimovacs Announces New UV1 Data Showing Enhanced Efficacy Including in Hard-to-Treat Cancer Patients, Supporting Broad Utility

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Tuesday, October 18, 2022
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The analyses showed robust responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients PD-L1 status.

Key Points: 
  • The analyses showed robust responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients PD-L1 status.
  • This indicates a potential broad applicability for UV1 as a combination therapy to anti-PD1 checkpoint inhibitors in the real-world setting, said Jens Bjrheim, Chief Medical Officer at Ultimovacs.
  • These results provide a solid foundation for Ultimovacs extensive program of five randomized phase II trials of UV1 in different cancer indications, including malignant melanoma.
  • Ultimovacs lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in 85-90% of cancers in all stages of tumor growth.

Akeso's Ivonescimab (PD-1/VEGF BsAbs) Granted Breakthrough Therapy Designation by China NMPA for the Treatment of Advanced NSCLC

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Friday, October 21, 2022
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It is Ivonescimab's second breakthrough therapy designation for lung cancer treatment, and NMPA granted the first one in September 2022 for the first-line treatment of NSCLC patients with positive PD-L1 expression.

Key Points: 
  • It is Ivonescimab's second breakthrough therapy designation for lung cancer treatment, and NMPA granted the first one in September 2022 for the first-line treatment of NSCLC patients with positive PD-L1 expression.
  • Breakthrough Therapy Designation procedure in China is designed to expedite the development and review of innovative drugs with apparent clinical benefits.
  • Receiving the Breakthrough Therapy Designation will accelerate the clinical development and product launch process of Ivonescimab, also further demonstrating the clinical value-oriented drug development concept and innovation capability of Akeso.
  • Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by Akeso.

Kineta Announces Clinical Collaboration with Merck to Evaluate KVA12123 in Combination with KEYTRUDA® (pembrolizumab) in Cancer Patients with Advanced Solid Tumors

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Monday, October 17, 2022
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Under this collaboration, Kineta will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KVA12123 (formerly KVA12.1), its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy, in patients with advanced solid tumors.

Key Points: 
  • Under this collaboration, Kineta will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KVA12123 (formerly KVA12.1), its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy, in patients with advanced solid tumors.
  • In preclinical studies, KVA12123 demonstrated promising anti-tumor activity both as a single agent and in combination with PD-1 checkpoint inhibitor therapy.
  • "We are excited to enter into this collaboration with Merck to evaluate KVA12123 in combination with KEYTRUDA in cancer patients later this year."
  • Kineta is planning to conduct a Phase 1/2 clinical study evaluating KVA12123 as a single agent and in combination with KEYTRUDA in patients with advanced solid tumors.

Global Oncolytic Virus Therapy Market Report 2022: Side Effects Associated With Conventional Cancer Therapies Driving Adoption & Growth - ResearchAndMarkets.com

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Wednesday, October 19, 2022
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The global oncolytic virus therapy market is anticipated to grow at a considerable CAGR of over 15% during the forecast period.

Key Points: 
  • The global oncolytic virus therapy market is anticipated to grow at a considerable CAGR of over 15% during the forecast period.
  • Further, the side effects associated with conventional cancer therapies will also drive the growth of the market.
  • Negative effects associated with conventional treatments such as chemotherapy are also shifting the market towards oncolytic virus therapy.
  • A large number of oncolytic virus drugs in the pipeline is expected to create growth opportunities for the oncolytic virus therapy market across the globe.

Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron

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Monday, October 17, 2022
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The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) (Regeneron) to evaluate IO-108 in combination with Regenerons anti-PD-1 therapy, Libtayo (cemiplimab), as part of its ongoing clinical development program.

Key Points: 
  • The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) (Regeneron) to evaluate IO-108 in combination with Regenerons anti-PD-1 therapy, Libtayo (cemiplimab), as part of its ongoing clinical development program.
  • We are incredibly excited to have enrolled the first patient in an expansion cohort of the IO-108 study.
  • The Phase 1 expansion phase includes IO-108 monotherapy cohorts and IO-108 combination cohorts with anti-PD-1 antibodies (pembrolizumab or cemiplimab, depending on tumor types).
  • Under the terms of the agreement, Immune-Onc will sponsor and fund the planned clinical trials and Regeneron will provide cemiplimab (Libtayo).

Lack of global regulatory coordination for cancer clinical trials costs 1.5 million lives a year despite therapies being available

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Tuesday, October 18, 2022
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NEW YORK, Oct. 18, 2022 /PRNewswire/ -- A new study by members of the Bloomberg New Economy International Cancer Coalition (the Coalition) says that at least 1.5 million deaths (representing 20 percent of global cancer deaths) from cancer could be avoided each year if international regulations around patient trials were more standardized and people placed on live saving treatment such as Pembrolizumab and Enzalutamide.

Key Points: 
  • It analyzed how the simultaneous international regulatory approvals of these two specific drugs would have benefited patients around the world.
  • "This would allow for clinical trials in all participating nations to follow the same criteria, significantly increasing available datasets and expediting the clinical trials as a result.
  • The Coalition was launched last year at the Bloomberg New Economy Forum with the aim of promoting discussion around a reimagining of patient-centric cancer clinical trials on global health agendas.
  • Its members include representatives from regulatory bodies, patient advocacy groups, industry, and researchers and academics from major cancer centers and universities worldwide.

Galectin Therapeutics Receives FDA Approval to Proceed with Combination Immunotherapy Trial in Head and Neck Cancer

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Wednesday, October 12, 2022
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Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, stated that: The prior investigator-initiated study in advanced metastatic melanoma and head and neck cancer using belapectin and Keytruda provided a strong rationale for proceeding with this Phase 2 trial.

Key Points: 
  • Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, stated that: The prior investigator-initiated study in advanced metastatic melanoma and head and neck cancer using belapectin and Keytruda provided a strong rationale for proceeding with this Phase 2 trial.
  • To ensure the most appropriate design of our trial, we engaged in extensive consultations with expert oncologists in melanoma and head and neck cancer, which was crucial in ensuring we had the optimal clinical trial design.
  • We are also thankful for the collaborative comments we received from the FDA during the submission process.
  • Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer.

TILT Biotherapeutics Announces First US Patient Dosed in Immunotherapy Clinical Trial in Ovarian Cancer

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Tuesday, October 11, 2022
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TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, announces that the first US patient has been dosed in its ovarian cancer trial ( NCT05271318 ), using its oncolytic adenovirus, TILT-123, that has the potential to be first-in-class for this indication.

Key Points: 
  • TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, announces that the first US patient has been dosed in its ovarian cancer trial ( NCT05271318 ), using its oncolytic adenovirus, TILT-123, that has the potential to be first-in-class for this indication.
  • The companys European and US open phase I clinical programs now cover several cancer types including ovarian cancer, head and neck cancer, and melanoma.
  • TILT Biotherapeutics CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with earlier versions of oncolytic viruses, said, Ovarian cancer is a killer disease with a pressing need for better therapies.
  • TILT-123 has demonstrated a 100% response rate in pre-clinical cancer models in vivo, and it is currently in Phase I clinical trials.

BerGenBio Announces Initiation of Phase 1b/2a Trial Evaluating Bemcentinib in 1st line Non-Small Cell Lung Cancer Patients Harboring STK11 Mutations

Retrieved on: 
Tuesday, October 11, 2022
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BERGEN, Norway, Oct. 11, 2022 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m).

Key Points: 
  • STK11 mutations are detected in approximately 20% of non-squamous NSCLC patients and are known to create a more immunosuppressive tumor microenvironment limiting the response to checkpoint inhibition.
  • Early clinical data also point to the activity of bemcentinib in NSCLC patients, including those harboring STK11m.
  • The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations.
  • The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.