Merck & Co.

PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2022 Financial Results

Retrieved on: 
Tuesday, March 28, 2023

Fourth Quarter 2022 and Recent Business Highlights:

Key Points: 
  • Fourth Quarter 2022 and Recent Business Highlights:
    VERSATILE-002 Phase 2 combination trial with Merck & Co. Inc.’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer.
  • National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers.
  • “We received FDA guidance on the regulatory pathway for the VERSATILE-002 Phase 2 trial and, most recently, the triple combination Phase 2 trial.
  • The event will be archived in the investor relations section of PDS Biotech’s website for six months.

Michael J. Fox Foundation for Parkinson's Research Announces Promising Results, Next Steps for "Ken Griffin Alpha-synuclein Imaging Competition"

Retrieved on: 
Tuesday, March 28, 2023

The Ken Griffin Alpha-synuclein Imaging Competition has brought the field closer than ever to this level of imaging.

Key Points: 
  • The Ken Griffin Alpha-synuclein Imaging Competition has brought the field closer than ever to this level of imaging.
  • The Ken Griffin Alpha-synuclein Imaging Competition was a turning point in MJFF's decades-long pursuit of this elusive tracer.
  • At its launch in 2019, the Ken Griffin Alpha-synuclein Imaging Competition was a new venture for Ken Griffin, who had never before funded Parkinson's research.
  • Remarkably, all Ken Griffin Alpha-synuclein Imaging Competition teams made tremendous advancements in the development of different alpha-synuclein tracer methods.

BJ Bioscience Announces Clinical Collaboration with MSD to Evaluate BJ-001 in Combination with KEYTRUDA® (pembrolizumab)

Retrieved on: 
Tuesday, March 28, 2023

The collaboration will allow for the evaluation of safety and efficacy of BJ-001, a tumor-targeting IL-15 fusion protein, in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in an ongoing Phase 1 clinical trial.

Key Points: 
  • The collaboration will allow for the evaluation of safety and efficacy of BJ-001, a tumor-targeting IL-15 fusion protein, in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in an ongoing Phase 1 clinical trial.
  • BJ Bioscience will evaluate BJ-001 plus KEYTRUDA as part of the company's ongoing trial in patients with locally advanced/metastatic solid tumors.
  • In this trial, BJ-001 is studied as monotherapy or in combination with KEYTRUDA, for safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.
  • "BJ Bioscience is excited to collaborate with MSD, one of the world's leading multinational pharmaceutical companies," said Joe Zhang, MD, PhD, cofounder and CEO of BJ Bioscience.

Aadi Bioscience Appoints Mohammad Hirmand, M.D. to Board of Directors

Retrieved on: 
Monday, March 27, 2023

"We welcome Mohammad to our Board at an exciting time for Aadi, as we advance the development of FYARRO for unmet clinical needs beyond our approved indication of PEComa.

Key Points: 
  • "We welcome Mohammad to our Board at an exciting time for Aadi, as we advance the development of FYARRO for unmet clinical needs beyond our approved indication of PEComa.
  • Mohammad is a world-class clinical development leader in oncology and will be a great complement to our board and partner with our highly experienced team," said Caley Castelein, M.D., Aadi Board Chairman.
  • "Mohammad has been instrumental in the development of Medivation's Xtandi and Welireg (belzutifan), when at Peloton Therapeutics.
  • "I am excited to join Aadi's Board of Directors in their mission to unlock the potential of nab-sirolimus in addressing mTOR-driven diseases," said Dr. Hirmand.

Eisai to Present Research from Oncology Portfolio at The Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women's Cancer

Retrieved on: 
Friday, March 24, 2023

As a human health care company, we remain steadfast in our commitment to advance the science of cancer medicine through the generation of real-world evidence."

Key Points: 
  • As a human health care company, we remain steadfast in our commitment to advance the science of cancer medicine through the generation of real-world evidence."
  • To date, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.
  • This release discusses investigational compounds and investigational uses for FDA-approved products.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Jacobio announces clinical collaboration to evaluate CD73 monoclonal antibody JAB-BX102 in combination with KEYTRUDA® (pembrolizumab) for patients with cancer

Retrieved on: 
Wednesday, March 22, 2023

BEIJING, SHANGHAI and BOSTON, March 22, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK) announced it has entered into a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA to evaluate the combination of Jacobio's CD73 monoclonal antibody JAB-BX102 in combination with Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

Key Points: 
  • BEIJING, SHANGHAI and BOSTON, March 22, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK) announced it has entered into a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA to evaluate the combination of Jacobio's CD73 monoclonal antibody JAB-BX102 in combination with Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
  • The clinical study will evaluate the clinical effect of JAB-BX102 in combination with KEYTRUDA for the treatment of advanced solid tumors.
  • "The CD73 monoclonal antibody is Jacobio's first large molecule project to enter the clinic.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Cytovation appoints Iman Barilero as Chief Development Officer

Retrieved on: 
Tuesday, March 21, 2023

Bergen, Norway, 21 March 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, announces that Dr. Iman Barilero has joined the company as Chief Development Officer.

Key Points: 
  • Bergen, Norway, 21 March 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, announces that Dr. Iman Barilero has joined the company as Chief Development Officer.
  • Dr. Barilero brings three decades of experience as a strategic executive in the global healthcare industry, successfully designing innovative and integrated patient-centric and value-based regulatory development pathways, in all phases of drug development and across all major global pharmaceutical markets.
  • Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We’re delighted to have someone with Iman’s wealth of experience join Cytovation as we progress CyPep-1 through clinical development.
  • Iman has worked across Big Pharma and biotech, and her support will be invaluable as the company enters its important next stages of development and growth.”
    Iman Barilero, PharmD, PhD, Cytovation’s Chief Development Officer, added: “CyPep-1 represents an exciting new approach to cancer immunotherapy, and it’s great to be joining Cytovation at a time when the asset has such strong clinical momentum backed by promising early data.

SELLAS Life Sciences Reports Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 16, 2023

NEW YORK, March 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the full year ended December 31, 2022 and provided a business update.

Key Points: 
  • This participation will trigger milestone payments totaling $13 million to SELLAS, which are expected during the first half of 2023.
  • Patient enrollment was completed at the end of 2022 and SELLAS expects to report topline data during the first half of 2023.
  • Opdivo® is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA and is not a trademark of SELLAS.
  • The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

Merck Provides Update from Open-Label Arm of Phase 2 KeyVibe-002 Trial Evaluating MK-7684A, a Coformulation of Vibostolimab and Pembrolizumab, in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, March 16, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial.
  • The safety profile of MK-7684A was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed.
  • Merck has an extensive clinical development program evaluating the safety and efficacy of MK-7684A alone and in combination with other agents in over 4,000 patients.
  • Ongoing Phase 3 studies in lung cancer include KeyVibe-003 , KeyVibe-006 , KeyVibe-007 and KeyVibe-008 , as well as KeyVibe-010 in melanoma.

Transgene: 2022 Full-year Results and Business Update

Retrieved on: 
Thursday, March 16, 2023

Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today publishes its financial results for 2022 and provides an update on its product pipeline.

Key Points: 
  • Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today publishes its financial results for 2022 and provides an update on its product pipeline.
  • I am confident that Transgene is at the forefront of helping to realize the potential of these exciting treatment modalities.
  • Transgene anticipates the last patient to be randomized in the trial in the first half of 2024, and final results to be communicated in 2024.
  • A clinical collaboration and supply agreement for KEYTRUDA® (pembrolizumab) was signed with MSD (Merck & Co) at the end of June 2022.