Clusters of differentiation

Amunix Raises $117 Million Series B Financing to Fund its Oncology Pipeline

Thursday, March 4, 2021 - 1:00pm

Also participating in the round were existing investors Redmile Group, Venrock, Casdin Capital, Omega Funds, Frazier Healthcare Partners, Longitude Capital, and Polaris Partners.

Key Points: 
  • Also participating in the round were existing investors Redmile Group, Venrock, Casdin Capital, Omega Funds, Frazier Healthcare Partners, Longitude Capital, and Polaris Partners.
  • Proceeds from the financing will fund the advancement into the clinic of AMX-818, a masked, protease-activated T cell engager (XPAT) targeting HER2-expressing solid tumors, as well as support Amunixs robust pipeline of earlier stage XPATs and masked, protease-activated cytokines (XPACs).
  • We are building on the promise of these potent drugs to target and attack solid tumors, while potentially reducing their toxicity.
  • The companys pipeline includes AMX-818, an XPAT T cell engager targeting a variety of HER2-expressing solid tumors, which is currently in IND-enabling studies.

Tempest Therapeutics Announces Clinical Collaboration with Roche to Advance TPST-1120 into a Randomized Combination Study in First-line Hepatocellular Carcinoma

Wednesday, March 3, 2021 - 1:00pm

The collaboration will evaluate TPST-1120, Tempests small molecule PPAR antagonist, in combination with atezolizumab (Tecentriq) and bevacizumab (Avastin) in previously untreated patients with advanced hepatocellular carcinoma (HCC).

Key Points: 
  • The collaboration will evaluate TPST-1120, Tempests small molecule PPAR antagonist, in combination with atezolizumab (Tecentriq) and bevacizumab (Avastin) in previously untreated patients with advanced hepatocellular carcinoma (HCC).
  • TPST-1120s mechanism of action makes it specifically well-suited to combine with both PD-1/PD-L1 checkpoint inhibitors and anti-angiogenesis agents.
  • Under the terms of the collaboration agreement, Roche will manage the study operations for this global multicenter trial.
  • Tempest is headquartered in South San Francisco and supported by notable healthcare investors.More information about Tempest can be found on the companys website at www.tempesttx.com .

OncoSec Announces Publication in Clinical Cancer Research of Data Supporting the Therapeutic Potential of Lead Product Candidate, TAVO™, in Triple Negative Breast Cancer

Monday, March 1, 2021 - 2:00pm

One patient who was previously unresponsive to anti-PD-L1 therapy exhibited an increased CXCR3-GS after TAVO treatment, and subsequently demonstrated a significant clinical response after receiving additional anti-PD-1 therapy.

Key Points: 
  • One patient who was previously unresponsive to anti-PD-L1 therapy exhibited an increased CXCR3-GS after TAVO treatment, and subsequently demonstrated a significant clinical response after receiving additional anti-PD-1 therapy.
  • "The published results demonstrate TAVO's potential to positively impact immunogenicity, providing mechanistic insights as well as a strong rationale to combine with chemokines and checkpoint inhibitors."
  • TAVOhas received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.
  • OncoSec's lead immunotherapy investigational product candidate TAVO(tavokinogene telseplasmid) enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions.

TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2020 Financial Results and Provides Corporate Update

Thursday, February 25, 2021 - 9:03pm

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials.

Key Points: 
  • Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials.
  • TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.
  • Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forwardlooking statements.
  • TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC)

Monday, February 22, 2021 - 6:46pm

Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the companys PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC).

Key Points: 
  • Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the companys PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC).
  • PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) 50% for treatment with Libtayo (cemiplimab-rwlc).
  • This announcement underscores Agilent's continuing commitment to the development of IHC-based diagnostics for cancer therapy.
  • Currently, PD-L1 IHC 22C3 pharmDx is the only companion diagnostic with FDA approval for this use.

Pandion Therapeutics Presents Preclinical Data Highlighting Potential of Tissue-Tethered PD-1 Agonist to Locally Target Autoimmune Disease at the nPOD 13th Annual Scientific Meeting

Monday, February 22, 2021 - 1:30pm

PD-1 is an inhibitory receptor located on conventional T cells, which, when activated, promotes the attenuation of an immune attack.

Key Points: 
  • PD-1 is an inhibitory receptor located on conventional T cells, which, when activated, promotes the attenuation of an immune attack.
  • With tissue-tethered immunomodulation, were able to increase locally the concentration of our therapeutic candidates, driving robust responses in animal models that are not possible with their untethered counterparts.
  • The data presented at nPOD give us confidence in pursuing a tissue-tethered approach for T1D and other autoimmune diseases of the pancreas in collaboration with JDRF and Astellas.
  • Pandion Therapeuticsis developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases.

Eisai: MHLW Grants Orphan Drug Designation in Japan to Novel FGF Receptor Selective Tyrosine Kinase Inhibitor E7090

Monday, February 22, 2021 - 6:40am

In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer.

Key Points: 
  • In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer.
  • Discovered in-house by Eisai's Tsukuba Research Laboratories, E7090 is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3.
  • et al., "Biliary tract cancer registry in Japan from 2008 to 2013", J Hepatobiliary Pancreat Sci., 2016, 23, 149-157.
  • (6) Arai Y. et al., "Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma", Hepatology, 2014, 59, 1427-1434.

Boston Immune Technologies and Therapeutics and BeiGene Enter into an Exclusive Option and License Agreement to Develop Novel TNFR2 Antagonists

Wednesday, February 17, 2021 - 10:00pm

BeiGene has secured an option to an exclusive license to develop, manufacture, and commercialize BITTs proprietary TNFR2 antagonist antibodies in Asia (excluding Japan), Australia, and New Zealand.

Key Points: 
  • BeiGene has secured an option to an exclusive license to develop, manufacture, and commercialize BITTs proprietary TNFR2 antagonist antibodies in Asia (excluding Japan), Australia, and New Zealand.
  • In connection with the exclusive option and license agreement, BeiGene also invested $4 million in BITTs Series A preferred stock financing.
  • Boston Immune Technologies and Therapeutics (BITT) is a Boston, MA based company developing a novel class of antagonist antibodies targeting the TNF superfamily receptors for applications in oncology, inflammation, autoimmunity, and infectious disease.
  • BITT is also developing additional TNF superfamily antibodies including CD40 antagonists for inflammation and CD30 antagonists for oncology.

Immunitas Therapeutics Announces Cell Publication of Tumor Single Cell Analysis Identifying CD161 as a Therapeutic T and NK Cell Target in Immuno-Oncology

Wednesday, February 17, 2021 - 12:30pm

Immunitas Therapeutics (Immunitas), a single cell genomics-based drug discovery company, today announced the publication of Inhibitory CD161 Receptor Identified in Glioma-infiltrating T cells by Single Cell Analysis in the journal Cell .

Key Points: 
  • Immunitas Therapeutics (Immunitas), a single cell genomics-based drug discovery company, today announced the publication of Inhibitory CD161 Receptor Identified in Glioma-infiltrating T cells by Single Cell Analysis in the journal Cell .
  • Our analysis of tumor infiltrating T cells identified the NK gene KLRB1, which encodes the protein CD161, as a candidate inhibitory receptor on both NK and T cells with applicability as a target in cancer immunotherapy.
  • The results presented in Cell demonstrate that KLRB1 is expressed by both T and NK cells.
  • IMT-009, a first-in-class T & NK cell modulator targeting CD161, is being developed for the treatment of solid tumors and hematological malignancies.

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

Monday, February 15, 2021 - 4:02pm

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.