Clusters of differentiation

France: OSE Immunotherapeutics enters a loan agreement of up to €25 million with the EIB

Retrieved on: 
Monday, February 15, 2021

Vaccine platformTedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination. Due to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021.CoVepiT: a prophylactic second generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results in August 2020, clinical trial expected to start in Q1 2021.Immuno-oncology platformBI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors.CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.Auto-immunity and inflammation platformFR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; ongoing Phase 1/2 in renal transplant, Phase 2-ready asset in a niche indication in autoimmune diseases.OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2 planned in Sjögren’s syndrome (Servier sponsor).OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Key Points: 
  • Vaccine platform
    • Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination. Due to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021.
    • CoVepiT: a prophylactic second generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results in August 2020, clinical trial expected to start in Q1 2021.
  • Immuno-oncology platform
    • BI 765063 (OSE-172, anti-SIRPα mAb on SIRPα/CD47 pathway): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors.
    • CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.
    • BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.
  • Auto-immunity and inflammation platform
    • FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; ongoing Phase 1/2 in renal transplant, Phase 2-ready asset in a niche indication in autoimmune diseases.
    • OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2 planned in Sjögren’s syndrome (Servier sponsor).
    • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
  • Elicio Therapeutics to discuss success of Amphiphiles enabled T cell therapies at CAR-TCR Digital Summit Europe

    Retrieved on: 
    Monday, February 15, 2021

    Activation of CAR-T cells with Amphiphiles delivered to the lymph nodes to induce massive CAR-T expansion.

    Key Points: 
    • Activation of CAR-T cells with Amphiphiles delivered to the lymph nodes to induce massive CAR-T expansion.
    • Elicio is developing the AMP-CAR-T platform for combination with CAR-T cell therapies in a variety of settings including those targeting CD19, BCMA, and several solid tumor indications.
    • Elicio Therapeutics is advancing the Amphiphile technology across immunotherapy platforms to defeat cancers and infectious diseases.
    • Elicio is engineering lymph node targeted cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases.

    Basilea reports derazantinib/PD-L1 checkpoint inhibitor combination results from dose-finding part of FIDES-02 study in patients with solid tumors at ASCO GU symposium

    Retrieved on: 
    Friday, February 12, 2021

    The combination of derazantinib and atezolizumab is supported by preclinical data demonstrating derazantinibs strong inhibition of colony-stimulating-factor-1-receptor kinase (CSF1R).

    Key Points: 
    • The combination of derazantinib and atezolizumab is supported by preclinical data demonstrating derazantinibs strong inhibition of colony-stimulating-factor-1-receptor kinase (CSF1R).
    • CSF1R inhibition may revert tumor-induced immunosuppression and thereby enhance the response to immune-checkpoint inhibition.
    • The following e-poster was presented at ASCO GU 2021:
      Derazantinib (DZB) in combination with atezolizumab (AZB) in patients with solid tumors: Results from the dose-finding phase Ib substudy of FIDES-02.
    • The first study, FIDES-01, is a registrational phase 2 study in patients with inoperable or advanced iCCA.

    Infinity Pharmaceuticals Presents Data from Randomized, Placebo-Controlled, Phase 2 MARIO-275 Trial of Eganelisib and Nivolumab in Advanced Urothelial Cancer at ASCO Genitourinary Cancers Symposium

    Retrieved on: 
    Thursday, February 11, 2021

    The objective of MARIO-275 was to address the need for better treatments for second line (2L) advanced UC patients.

    Key Points: 
    • The objective of MARIO-275 was to address the need for better treatments for second line (2L) advanced UC patients.
    • This is a promising advancement that has the potential to address the significant needs of PD-L1 low patients, which represent the majority of metastatic urothelial cancer population.
    • Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies.
    • MARIO-275 is a global, randomized, placebo-controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.

    Basilea reports positive topline results from phase 2 study FIDES-01 for derazantinib in FGFR2 gene fusion-positive patients with bile duct cancer (iCCA)

    Retrieved on: 
    Wednesday, February 10, 2021

    Enrolment into cohort 2 of FIDES-01 is ongoing, assessing the activity of derazantinib in iCCA patients with FGFR2 gene mutations or amplifications.

    Key Points: 
    • Enrolment into cohort 2 of FIDES-01 is ongoing, assessing the activity of derazantinib in iCCA patients with FGFR2 gene mutations or amplifications.
    • The disease control rate (DCR), reflecting the proportion of patients with a partial response or with stable disease, was 72.8%.
    • The results are not yet fully mature, as 12 patients are still ongoing, including 3 patients with a partial response.
    • The first study, FIDES-01, is a phase 2 study in patients with inoperable or advanced iCCA.

    FDA Approves Libtayo® (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma

    Retrieved on: 
    Tuesday, February 9, 2021

    By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

    Key Points: 
    • By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
    • No PD-L1 or tumor mutational burden (TMB) testing is required before starting treatment with Libtayo for advanced BCC.
    • Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.
    • Libtayo was invented using Regeneron's VelocImmune technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies.

    Agenus Announces New Responses for AGEN1181

    Retrieved on: 
    Tuesday, February 9, 2021

    These are very exciting results which demonstrate the potential of AGEN1181 as an efficacious next-generation CTLA-4 antibody.

    Key Points: 
    • These are very exciting results which demonstrate the potential of AGEN1181 as an efficacious next-generation CTLA-4 antibody.
    • AGEN1181 is showing activity in difficult-to-treat tumors without the neuroendocrine or significant liver toxicities commonly observed with the currently-approved CTLA-4 antibody ipilimumab, said Dr. Steven ODay, Chief Medical Officer at Agenus.
    • The responses seen in patients with ovarian and MSS colorectal cancer are particularly encouraging given the generally low activity seen with immunotherapy in these indications.
    • Agenus also presented on the first-ever report of intratumoral Treg depletion with a CTLA-4 antibody in clinical trials at SITC 2020.

    Arch Oncology to Collaborate with Merck on Phase 1/2 Clinical Trial of Anti-CD47 Antibody AO-176 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Select Solid Tumors

    Retrieved on: 
    Tuesday, February 9, 2021

    Under this collaboration, Arch Oncology is expanding its ongoing Phase 1/2 clinical trial to evaluate AO-176, the Companys novel anti-CD47 antibody, in combination with KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy, for the treatment of patients with select solid tumors.

    Key Points: 
    • Under this collaboration, Arch Oncology is expanding its ongoing Phase 1/2 clinical trial to evaluate AO-176, the Companys novel anti-CD47 antibody, in combination with KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy, for the treatment of patients with select solid tumors.
    • As a monotherapy, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity in patients with select solid tumors.
    • AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies.
    • In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent.

    Monopar Announces Issuance of Patent Covering Composition of Matter for MNPR-101 in Canada

    Retrieved on: 
    Tuesday, February 9, 2021

    This is an important advancement in our efforts to broaden our global patent estate for MNPR-101, said Chandler Robinson, MD, Chief Executive Officer of Monopar.

    Key Points: 
    • This is an important advancement in our efforts to broaden our global patent estate for MNPR-101, said Chandler Robinson, MD, Chief Executive Officer of Monopar.
    • MNPR-101 is a novel, first-in-class humanized monoclonal antibody to the urokinase Plasminogen Activator Receptor (uPAR).
    • We are excited about the approval of this composition of matter patent in Canada as it further enables us to explore the potential of MNPR-101 on a global scale, said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.
    • Monopar Therapeutics is a clinical-stage biopharmaceutical companyprimarilyfocused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients.

    I-Mab Announces Multiple Clinical Advancements of Its Differentiated CD73 Antibody Uliledlimab in China and the U.S.

    Retrieved on: 
    Friday, February 5, 2021

    Uliledlimab is a humanized CD73 antibody and works effectively on modulating tumor microenvironment through inhibition of the adenosine pathway.

    Key Points: 
    • Uliledlimab is a humanized CD73 antibody and works effectively on modulating tumor microenvironment through inhibition of the adenosine pathway.
    • Uliledlimab is shown to strongly suppress tumor growth especially when combined with a PD-(L)1 inhibitor in pre-clinical studies.
    • As a differentiated CD73 antibody, uliledlimab interacts with a unique epitope to function through a novel intra-dimer binding mode, thus enabling differentiated and favorable functional properties.
    • Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine.