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Home » Topics » Clinical

Clinical
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Skin exam

No LAG for Iovance in melanoma race; verdict pending TIL more data

June 9, 2021
By Randy Osborne
Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy.
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BioKorea 2021: Pharmabcine makes plans to test anti-angiogenic antibody against pediatric brain cancer

June 9, 2021
By Gina Lee
With Pharmabcine Inc.’s anti-angiogenic antibody TTAC-0001 (olinvacimab) already in testing against recurrent glioblastoma multiforme (GBM) and metastatic triple negative breast cancer, CEO Jin-San Yoo is now giving serious thought to starting trials to test it in children with brain tumors. Plans to begin four additional trials between the end of 2021 and the beginning of 2022 are also underway.
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Marc Timmers, CEO, Byondis

Byondis eyes U.S. filing for HER2-targeting ADC in advanced breast cancer

June 9, 2021
By Richard Staines
Byondis BV is gearing up for a U.S. filing of an antibody-drug conjugate (ADCs) in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases.
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In the clinic for June 9, 2021

June 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ananda, Asklepios, Avadel, Bluerock, Chinook, Effector, Icosavax, Incarda, India Globalization, Nanology, Nascent, Noveome, Noxxon, Synaptogenix, Virios.
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Hookipa’s phase I/II HPV study data fail to impress the market

June 8, 2021
By Lee Landenberger
Data presented to the American Society of Clinical Oncology and taken from Hookipa Pharma Inc.’s ongoing phase I/II study for treating advanced human papillomavirus 16-positive (HPV16+) cancers underwhelmed investors as the stock (NASDAQ:HOOK) sagged 19.25% on June 8.
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In the clinic for June 8, 2021

June 8, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Aivita, Alnylam, Ardelyx, Arena, Astrazeneca, Atara, Aurinia, Azurrx, Beyondspring, Bio-Thera, Cardiff, Chemocentryx, Citius, Crestone, Glenmark, In8bio, Inflarx, Innovent, Kazia, Mei, Neurana, Novartis, Noxxon, Oramed, Outlook, Oxurion, Redhill, Takeda, Vaccinex.
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Red blood cells, DNA

Holds on four Bluebird gene therapy studies are released by the FDA

June 7, 2021
By Lee Landenberger
The FDA has lifted clinical holds on four studies from Bluebird Bio Inc., following recent similar actions with other gene therapy programs. Two of the studies concern phase I/II and phase III clinical trials of the gene therapy Lentiglobin (BB-1111) in treating sickle cell disease. The remaining two studies are phase III clinical trials of betibeglogene autotemcel gene therapy, which share a vector with Lentiglobin, for treating transfusion-dependent beta-thalassemia.
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DNA illustration
ASCO 2021

Grail reports positive study results on early detection of 50 cancers assay

June 4, 2021
By Ana Mulero
Grail Inc. reported on June 4 the first results of its Pathfinder study evaluating its assay for the early detection of 50 cancers, showing a positive predictive value of 44.6%. With a total of 6,629 study participants across more than 140 clinical study sites, the blood test is supported by what the health care company believes to be the “largest clinical study program in genomic medicine.”
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Stop sign

FDA issues clinical hold on Ortho's IND application for Ortho-R clinical trial

June 4, 2021
By Annette Boyle
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
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Smartphone app shows temperature readings from injected chip

Swedish startup’s injectable chips accurately track body temperature

June 4, 2021
By Meg Bryant
Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.
Read More
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