Avelumab

New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma

Retrieved on: 
Monday, February 13, 2023

These analyses reinforce the proven survival benefits of BAVENCIO® (avelumab) in the first-line maintenance setting for patients with locally advanced or metastatic urothelial carcinoma (UC).

Key Points: 
  • These analyses reinforce the proven survival benefits of BAVENCIO® (avelumab) in the first-line maintenance setting for patients with locally advanced or metastatic urothelial carcinoma (UC).
  • The findings presented today reinforce that all patients eligible for platinum-based chemotherapy, either cisplatin or carboplatin, can benefit from avelumab maintenance therapy.
  • The analysis also confirmed that the overall survival of BAVENCIO first-line maintenance were similar regardless of whether patients received cisplatin- or carboplatin-based chemotherapy.
  • “BAVENCIO remains the only immunotherapy to show improved overall survival in advanced UC patients in the first-line maintenance setting in a Phase III trial.

G1 Therapeutics Announces Upcoming 2023 Readouts from its Phase 2 and Pivotal Phase 3 Clinical Trials of Trilaciclib

Retrieved on: 
Monday, January 9, 2023

RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the 2023 data readouts that are expected to drive its near-term and long-term indications and potential future treatment paradigms for some of the most aggressive and refractory cancers, including metastatic colorectal (mCRC), bladder or urothelial cancer (mUC), and triple negative breast cancer (TNBC).

Key Points: 
  • “But the high toxicity of these cytotoxic agents poses a risk of serious adverse events that can compromise patient well-being and patient outcomes.
  • Depending on the tumor type and the chemotherapy backbone, this mechanistic profile can drive patient benefits of myeloprotection and/or anti-tumor efficacy.
  • Initial results provided in January 2023 indicate that the confirmed objective response rate as of the cutoff date was comparable between arms.
  • G1 expects to release initial PFS data from PRESERVE 1 on the combination of trilaciclib administered prior to FOLFOXIRI and bevacizumab in 4Q23.

G1 Therapeutics Provides Initial Update on Phase 2 Bladder Cancer Trial; Progression Free Survival (PFS) Data Expected in Mid-2023

Retrieved on: 
Wednesday, January 4, 2023

Additional safety and efficacy data, including the primary endpoint of progression free survival (PFS), are anticipated in the middle of 2023.

Key Points: 
  • Additional safety and efficacy data, including the primary endpoint of progression free survival (PFS), are anticipated in the middle of 2023.
  • Safety is reviewed by the data monitoring committee (DMC) on an ongoing basis, and it has recommended that the study continue as planned.
  • Depending on the tumor type and the chemotherapy backbone, this mechanistic profile can drive patient benefits of myeloprotection and/or anti-tumor efficacy.
  • Its mechanism of action of improving overall immune response by improving long term immune surveillance lends itself to longer term endpoints, such as progression free survival.

Promontory Therapeutics to Present Research on PT-112 in Advanced Non-Small Cell Lung Cancer at the ESMO Immuno-Oncology Congress 2022

Retrieved on: 
Wednesday, November 30, 2022

Abstracts will be published online on the ESMO website at 12:05 a.m. CET on Thursday, Dec. 1, 2022.

Key Points: 
  • Abstracts will be published online on the ESMO website at 12:05 a.m. CET on Thursday, Dec. 1, 2022.
  • Abstracts will also be published online in the ESMO-IO Congress 2022 Abstract Book, a supplement to the official ESMO journal, Immuno-Oncology and Technology (IOTECH).
  • PT-112 represents a highly potent inducer of this immunological form of cancer cell death.
  • Promontory Therapeutics Inc. is a privately held, clinical stage pharmaceutical company focused on small molecule immunotherapy.

Immutep Enters into Second Clinical Trial Collaboration Agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for New Combination Study of its First-in-Class LAG-3 Candidate, Eftilagimod Alpha, and Avelumab to Treat Urothelial Cancer

Retrieved on: 
Tuesday, November 29, 2022

The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.

Key Points: 
  • The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.
  • Urothelial cancer is a type of cancer in the bladder or urinary tract.
  • Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study.
  • Additional LAG-3 product candidates, including antibodies for immune response modulation, are licensed to and being developed by Immuteps large pharmaceutical partners.

Promontory Therapeutics Appoints Stan Musial as Chief Financial Officer

Retrieved on: 
Monday, November 28, 2022

NEW YORK, Nov. 28, 2022 /PRNewswire/ -- Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, today announced the appointment of Stanley J. Musial, CPA, MBA, as Chief Financial Officer. Musial brings over 25 years of financial, strategic and managerial experience with public and private biotechnology companies, with a demonstrated history in capital raising, IPO execution, mergers and acquisitions, corporate development and investor relations.

Key Points: 
  • NEW YORK, Nov. 28, 2022 /PRNewswire/ -- Promontory Therapeutics Inc. , a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, todayannounced the appointment ofStanley J. Musial, CPA, MBA, as Chief Financial Officer.
  • "We welcome Stan to the Promontory team at an exciting and pivotal time in our corporate development.
  • Promontory Therapeutics Inc. is a privately held, clinical stage pharmaceutical company focused on small molecule immunotherapy.
  • To learn more about Promontory Therapeutics, visit the company's website here .

Nektar Therapeutics Presents Preclinical Data from Novel PEGylated Interferon Gamma Program, NKTR-288, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Thursday, November 10, 2022

SAN FRANCISCO, Nov. 10, 2022 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the first presentation of preclinical data for NKTR-288 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting.

Key Points: 
  • NKTR-288 is a novel polyethylene glycol (PEG)-conjugate of interferon gamma (IFN-), designed to modify binding of IFN- to its substrates and optimize the duration of IFN- signaling.
  • These data support further evaluation of NKTR-288 as a monotherapy or in combination with checkpoint inhibitors in the clinical setting.
  • It highlights the potential of NKTR-288 to augment currently available PD-1 or PD-L1 treatment strategies and possibly broaden the responsive patient population."
  • Key details and takeaways from the presentation are as follows:
    Abstract 1086: "NKTR-288, a PEGylated Interferon Gamma Drug Candidate for the Treatment of Cancer", Hamel, D., et al.

Transgene Reports Business Update And Q3 2022 Financial Position

Retrieved on: 
Monday, November 7, 2022

Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update and its financial position for the quarter ending September 30, 2022.

Key Points: 
  • Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update and its financial position for the quarter ending September 30, 2022.
  • In a previous single-arm Phase Ib/II, Transgene generated strong clinical data in advanced HPV16-positive cancer patients who received TG4001 + avelumab.
  • Transgene plans to communicate an update on these potentially landscape changing trials at a scientific conference in the first half of 2023.
  • AstraZeneca will present a poster at SITC 2022 (November 812, 2022), on a construct that was designed within the frame of its collaboration with Transgene.

Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers

Retrieved on: 
Wednesday, November 2, 2022

The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE), which are providing avelumab for the trial.

Key Points: 
  • The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE), which are providing avelumab for the trial.
  • Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. Transgene will continue to be the sponsor of the trial and conduct the trial.
  • Avelumab is not approved alone or in combination for the treatment of HPV16-positive anogenital tumors in any region.
  • The combination of TG4001 and avelumab demonstrated anti-tumor activity (22% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers (including patients with oropharyngeal cancers and anogenital cancers).

Fate Therapeutics to Present Clinical and Preclinical Data for iPSC Product Platform at the Society for Immunotherapy of Cancer 37th Annual Meeting

Retrieved on: 
Wednesday, October 5, 2022

Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body.

Key Points: 
  • Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body.
  • The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line.
  • Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.
  • Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer.