RedHill Biopharma’s Phase II/III COVID-19 Study Approved in Mexico

RedHill Biopharma Ltd. announced approval from the Mexican Federal Committee for the Protection against Sanitary Risks for the company’s Clinical Trial Authorization application for the Phase II/III study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia.
[RedHill Biopharma Ltd.]
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PharmaCyte Biotech Ready to Submit Investigational New Drug Application to FDA for Clinical Trial in Pancreatic Cancer

PharmaCyte Biotech has reached what can only be described as a momentous milestone in its history and what should be considered a remarkable moment for any small biotech—the submission of an Investigational New Drug Application to the US FDA. This upcoming interaction with the FDA to request a planned Phase IIb clinical trial in locally advanced, inoperable pancreatic cancer is the product of years of meticulous work and dedication to the development of a treatment for the third leading cause of cancer-related deaths in the US.
[Pharmacyte Biotech]
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AnaptysBio Reports Top-Line Data from Interim Analysis of ECLIPSE Phase II Clinical Trial of Etokimab in Chronic Rhinosinusitis with Nasal Polyps

AnaptysBio, Inc. reported top-line data from a week eight interim analysis of the company’s ongoing ECLIPSE Phase II clinical trial of etokimab, an anti-interleukin-33 monoclonal antibody, in patients with chronic rhinosinusitis with nasal polyps.
[AnaptysBio, Inc.]
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A Peripheral Immune Signature of Responsiveness to PD-1 Blockade in Patients with Classical Hodgkin Lymphoma

Investigators utilized the complementary approaches of T cell receptor sequencing and cytometry by time-of-flight analysis to obtain a peripheral immune signature of responsiveness to PD-1 blockade in 56 patients treated in the CheckMate 205 Phase II clinical trial
[Nature Medicine]
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Aerpio Pharmaceuticals, Inc. Announces a Second Clinical Trial with Funding from MTEC to Evaluate Razuprotafib for the Prevention and Treatment of ARDS in Patients with Moderate to Severe COVID-19

Aerpio Pharmaceuticals, Inc. and the US Government operating through the Medical Technology Enterprise Consortium announced that an agreement has been reached to evaluate razuprotafib in a new randomized, investigational trial for the prevention and treatment of Acute Respiratory Distress Syndrome (ARDS) in adult patients with moderate to severe COVID-19.
[Aerpio Pharmaceuticals, Inc. ]
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NIH Grants $1.44M to Cancer Targeted Technology to Support the Ongoing Prostate Cancer Clinical Trial of a Promising New Radiotherapeutic, CTT1403

Cancer Targeted Technology announced that the NIH awarded CTT $1.44M on the second year of a competitive Small Business Innovation Research Phase IIB grant.
[Cancer Targeted Technology (Business Wire, Inc.)]
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BryoLogyx Announces Cooperative Research and Development Agreement for Bryostatin-1 with National Cancer Institute

BryoLogyx, Inc. announced that it has entered into a Cooperative Research and Development Agreement with the National Cancer Institute, to conduct a Phase I clinical trial with bryostatin-1 in pediatric and young adult patients with relapsing or refractory CD22 expressing acute lymphoblastic leukemia and lymphoma.
[BryoLogyx, Inc.]
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Daiichi Sankyo Announces Clinical Trial Collaboration with AstraZeneca to Evaluate Patritumab Deruxtecan (U3-1402) in Combination with TAGRISSO in EGFR-Mutated Non-Small Cell Lung Cancer

Daiichi Sankyo Company, Limited announced that it has entered into a clinical trial collaboration with AstraZeneca to evaluate the combination of patritumab deruxtecan, a HER3 directed DXd antibody drug conjugate, and TAGRISSO, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer.
[Daiichi Sankyo Company, Limited]
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MODAG Successfully Completes Phase 1 Study of their Lead Candidate Anle138b and Receives Additional USD 1.4 Million from Michael J. Fox Foundation

MODAG announced the successful completion of its first clinical trial of anle138b (NCT04208152) in healthy volunteers. Based on the positive Phase I study results, MODAG was also able to obtain additional funding of USD 1.4 million from The Michael J. Fox Foundation for parkinson’s research.
[MODAG]
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Cynata Completes Phase I GvHD Clinical Trial Follow-up with Positive Results

Cynata Therapeutics Ltd. has announced positive results from the two-year follow-up of patients enrolled in the Phase I clinical trial of CYP-001, Cynata’s lead iPSC-derived Cymerus™ mesenchymal stem cell product.
[Cynata Therapeutics Inc.]
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Heart Regeneration using Pluripotent Stem Cells

In this review, the authors summarize the updated knowledge, perspectives, and limitations of PSC-derived cardiomyocytes for heart regeneration.
[Journal of Cardiology]
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