Tags : IND

Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with

Shots: Sorrento has filed an IND for STI-1499 in patients hospitalized with COVID-19. In preclinical studies, STI-1499 has demonstrated 100% neutralizing effect (in vitro) against the highly contagious D614G mutant strain at a low dose Additionally, animal model data confirms the neutralizing profile and high potency of Ab, expected effective dose in human to be […]Read More

Algernon Reports Submission of IND to the US FDA for

Shots: The company has submitted the IND to the US FDA for evaluating its re-purposed drug NP-120 (Ifenprodil) in P-IIb/III study as a potential therapeutic treatment against COVID-19. The study will begin as a P-IIb study in 100 patients and with positive preliminary data, the clinical trial will move directly from a P-IIb into P-III […]Read More

Henlius Receives NMPA’s IND Approval for its HLX13 (biosimilar, ipilimumab)

Shots: The approval follows the trials which involves assessing of HLX13 vs originator ipilimumab to evaluate its pharmacology, pharmacokinetics and toxicokinetics profiles, immunogenicity, and toxicity The study resulted in biosimilarity data in terms of in vivo and in vitro pharmacology, PK, toxicokinetics, immunogenicity and toxicity characteristics HLX13 is a recombinant anti-CTLA-4 fully human mAb injection […]Read More

Celularity’s New Cell Therapy Receives the US FDA’s IND Approval

Shots: Following the IND approval, Celularity will initiate P-I/II study assessing CYNK-001 in 86 patients with COVID-19. The company deems CYNK-001 is the first FDA’s IND cleared immunotherapy to treat COVID-19 infected adults Cell therapy works by boosting the body’s early immune response in a way it could target the coronavirus. CYNK-001 limits the SARS-CoV-2 […]Read More

Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar,

Shots: The NMPA has accepted the IND for HLX14, a biosimilar referencing Prolia, indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture HLX14 is developed in harmony with biosimilar guidelines and was highly similar to the reference product in preclinical pharmacology, toxicology and PK studies Henlius has a robust biosimilar […]Read More

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar

Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe […]Read More

Mannin Research Signs a Collaboration with Mcmaster University for MAN-01

Shots: Mannin Research (a technology partner of Q Biomed) and Mcmaster University collaborated to research and develop drug delivery and formulation of MAN-01, to treat Glaucoma The focus of the agreement is to explore therapies for Mannin’s MAN-01 deleviry in the eye for lowering intra-ocular pressure in patients with Glaucoma including treatments for vascular related […]Read More