Pembrolizumab

Cantargia: FDA grants Orphan Drug Designation to nadunolimab for treatment of pancreatic cancer

Wednesday, September 22, 2021 - 4:56pm

STOCKHOLM, Sept. 22, 2021 /PRNewswire/ -- Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer.

Key Points: 
  • STOCKHOLM, Sept. 22, 2021 /PRNewswire/ -- Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer.
  • More information about rare diseases and the Orphan Drug Designation Program is available on www.fda.gov .
  • "The Orphan Drug Designation by FDA provides several strategic advantages and is a valuable step forward in the development of nadunolimab.
  • The designation also confirms Cantargia's strong commitment to provide new effective treatment options to patients with pancreatic cancer."

CG Oncology and Roche to Collaborate on Clinical Trial of Oncolytic Immunotherapy CG0070 as Part of Novel Combination for Various Solid Tumor Indications

Wednesday, September 22, 2021 - 1:00pm

CG Oncology, Inc. announced today that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncologys investigational oncolytic immunotherapy CG0070, with Roches atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy.

Key Points: 
  • CG Oncology, Inc. announced today that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncologys investigational oncolytic immunotherapy CG0070, with Roches atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy.
  • The Phase 1/2 clinical trial will evaluate the safety and efficacy of this novel immunotherapy combination in patients with various advanced solid tumors yet to be disclosed.
  • We are pleased to enter into this collaboration agreement with Roche, said Arthur Kuan, CEO of CG Oncology.
  • CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer.

Cue Biopharma Granted U.S. Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101

Tuesday, September 21, 2021 - 1:00pm

11,117,945 covers Cue Biopharmas first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers.

Key Points: 
  • 11,117,945 covers Cue Biopharmas first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers.
  • CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC.
  • The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp.
  • Cue Biopharmas IP portfolio includes approximately 300 pending applications and issued patents that are either owned by Cue Biopharma or exclusively licensed from the Albert Einstein College of Medicine.

NOXXON Enrolls Last Brain Cancer Patient in Dose Escalation Portion of GLORIA Study and Confirms Phase 1/2 Read-Out in Q1 2022

Wednesday, September 22, 2021 - 7:00am

An expansion phase will be the next step in this trial to obtain clinical data in additional patients with brain cancer.

Key Points: 
  • An expansion phase will be the next step in this trial to obtain clinical data in additional patients with brain cancer.
  • The GLORIA study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy in newly diagnosed brain cancer patients.
  • Dr. Jarl Ulf Jungnelius, Senior Medical Advisor at NOXXON, commented: We are pleased to announce the enrollment of the dose escalation portion of this study is complete.
  • We expect data from the third and last dose escalation cohort of patients to be available in Q1 2022.

Fusion Pharmaceuticals Appoints Eric S. Hoffman, Ph.D. as Senior Vice President, Business Development

Tuesday, September 21, 2021 - 1:35pm

HAMILTON, ONandBOSTON, Sept. 21, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Eric S. Hoffman, Ph.D. as senior vice president, business development.

Key Points: 
  • HAMILTON, ONandBOSTON, Sept. 21, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Eric S. Hoffman, Ph.D. as senior vice president, business development.
  • To that end, Eric brings to our team deep business development and corporate strategy experience, combined with a scientific and finance background."
  • Prior to Vicarius, he was chief business officer of Genocea Biosciences where he led business development, alliance management and commercial operations.
  • Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines.

Aprea Therapeutics Presents Data From Phase 1/2 Trial of Eprenetapopt (APR-246) in Advanced Solid Tumors at ESMO Congress 2021

Monday, September 20, 2021 - 9:15pm

As of the July 31, 2021 data cutoff, 33 patients were enrolled on study and 31 had initiated treatment.

Key Points: 
  • As of the July 31, 2021 data cutoff, 33 patients were enrolled on study and 31 had initiated treatment.
  • Patients in the NSCLC Phase II cohort were required to have prior exposure to a PD-1 or PD-L1 inhibitor.
  • The trial continues to enroll and treat patients and exploratory studies involving analyses of patient-derived immune cell populations are ongoing.
  • The Companys lead product candidate is eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies and solid tumors.

New Cancer Therapies Continue to Develop and Give Hope in Rapidly Improving Oncology Space

Monday, September 20, 2021 - 5:53pm

VANCOUVER, BC, Sept. 20, 2021 /PRNewswire/ -- USA News Group - Oncology data leader COTA recently released a recent survey where half of the respondents pointed to "Operation Warp Speed" as evidence that cancer treatments can and should be moving forward faster. However, in many ways, 2021 has witnessed several major developments that continue to provide optimism within the oncology field, including those from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),Roche Holding AG (OTC: RHHBY), Merck &. Co., Inc. (NYSE: MRK), Bristol-Myers Squibb Company (NYSE: BMY), and Pfizer Inc. (NYSE: PFE).

Key Points: 
  • In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells.
  • In terms of significance, this effect was not seen with single-agent radiotherapy in either the primary or the abscopal tumors.
  • "This is a compelling finding that has the potential to be broadly applicable across multiple cancer indications and warrants further study.
  • As new Keytruda combinations from Merck emerge, Bristol-Myers Squibb has begun to tout 5-year kidney cancer data for Opdivo-Yervoy.

New Cancer Therapies Continue to Develop and Give Hope in Rapidly Improving Oncology Space

Monday, September 20, 2021 - 5:51pm

In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells.

Key Points: 
  • In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells.
  • In terms of significance, this effect was not seen with single-agent radiotherapy in either the primary or the abscopal tumors.
  • "This is a compelling finding that has the potential to be broadly applicable across multiple cancer indications and warrants further study.
  • As new Keytruda combinations from Merck emerge, Bristol-Myers Squibb has begun to tout 5-year kidney cancer data for Opdivo-Yervoy.

PDS Biotech Achieves Safety Requirement Milestone For the First 12 Patients in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Advanced Head and Neck Cancer

Monday, September 20, 2021 - 1:30pm

The trial is being conducted in collaboration with Merck & Co.

Key Points: 
  • The trial is being conducted in collaboration with Merck & Co.
    VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread.
  • The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence regarding the safety of PDS0101.
  • There is an enormous unmet medical need for more effective treatment of advanced head and neck cancer.
  • That trial has enrolled patients with anal, cervical, head and neck, vaginal and vulvar cancer, who have failed prior treatment.

TG Therapeutics Announces Combination Data Presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

Monday, September 20, 2021 - 12:30pm

NEW YORK, Sept. 20, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

Key Points: 
  • NEW YORK, Sept. 20, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
  • Patients with CLL received2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance.
  • The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone.
  • Following the live event, an archive file will be available for replay, for a period of 30 days after the call.