WHO to review AZ Covid Vax; plus virtual conference palooza—Cardiology, Hematology, Oncology, and more!

Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Here is the medical news to watch for Feb. 18-14, 2021. There are seven medical conferences this week plus a lot of other non-Covid-19 news, so it will be a busy period.

Cardiology

  • The Joint Interventional Meeting (JIM) will take place virtually Feb. 11-12. This is an interactive meeting focusing on what’s hot in interventional cardiology in 2021. There will be live cases with tips and tricks and global experts demonstrating the newest technology.
  • The Cardiovascular Research Technologies (CRT) virtual meeting starts on Feb. 13 and will continue every Friday and Saturday through April 24. (Yes, it is spread over 2 months.)
  • The FDA is expected to make a decision by February 11 on Regeneron Pharmaceuticals’ evinacumab, an ANGPTL3 inhibitor, for severe homozygous familial hypercholesterolemia (HoFH).

Covid-19: The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) is tentatively scheduled to review AstraZeneca’s AZD-1222 vaccine on February 8.

Hematology: The American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR)’s 2021 Transplantation and Related Cellular Therapies (TCT) Meetings Digital Experience will be held virtually February 8-12. Stay on top of the latest scientific updates, innovative ideas, and timely issues in cellular therapy at this meeting. Among the data to watch are:

  • Interim results of the phase Ib/II EQUATE trial of an anti-CD6 (Equillium’s itolizumab) in acute graft-versus-host disease.
  • The details of the phase III trial of omidubicel (Gamida Cell’s NiCord) in hematologic malignancies.
  • The details of the phase III trial of an antiviral (Takeda’s maribavir, TAK-620) for cytomegalovirus (CMV).

Oncology

  • On Feb. 9 the FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet virtually to consider expanded approval of pembrolizumab (Merck MSD’s Keytruda) to include treatment of high-risk, early-stage triple-negative breast cancer (TNBC).
  • The American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO-GU) will take place February 11-13. Among the data to watch are:
    • Overall survival and safety data from the ARAMIS trial of crossover from placebo to darolutamide (Bayer’s Nubeqa) in non-metastatic castration-resistant prostate cancer (nmCRPC).
    • Phase Ib data on the combination of rucaparib (Clovis Oncology’s Rubraca) with enzalutamide (Pfizer and Astellas’ Xtandi) – called RAMP – in CRPC.
    • The results of the phase II MARIO-275 trial of a PI3K-gamma inhibitor (Infinity Pharmaceuticals’ eganelisib, IPI-549) + a PD-1 inhibitor (nivolumab, Bristol-Myers Squibb’s Opdivo) in urothelial cancer.
    • An update on the phase Ib/II trial of pembrolizumab + an oral innate immunity activator (BioXcel Therapeutics’ BXCL-701) in metastatic CRPC.

Ophthalmology: The Bascom Palmer: Angiogenesis, Exudation, and Degeneration conference will take place virtually February 12-13. Among the data to watch are: the 52-week results of a phase Ib trial of an anti-VEBG (Kodiak Sciences’ KSI-301) in diabetic macular edema, age-related macular degeneration, and retinal vein occlusion.

Rare diseases: The virtual WorldSymposium on Lysosomal Diseases will take place February 8-12. This interdisciplinary forum will explore basic science, translational research, and clinical trials for lysosomal diseases. There will be data to watch in:

  • Cystinosis – Updated data from a phase I/II trial of a gene therapy (AVROBIO’s AVR-RD-04).
  • Fabry disease – phase III results with a pegylated enzyme replacement therapy (pegunigalsidase alfa, Protalix BioTherapeutics’ PRX-102), and phase I/II data on a gene therapy (AVROBIO’s AVR-RD-01, FAB-201).
  • Gaucher disease – Updated phase I/II data on a gene therapy (AVROBIO’s AVR-RD-02).
  • Hurler syndrome (mucopolysaccharidosis type I) – phase I/II data on an ex vivo autologous gene therapy (Orchard Therapeutics’ OTL-203).
  • MPS-II (Hunter syndrome) – New data from a phase I/II trial of a gene therapy (Regenxbio’s RGX-121), and 12-week data from Cohort A of a phase I/II trial of a fusion protein (Denali Therapeutics’ DNL-310).
  • MPS-IIIA and B (Sanfilippo syndrome) – phase I/II data on a gene therapy (Abeona Therapeutics’ ABO-102) in MPS-IIIA and ABO-101 in MPS-IIIB.
  • Pompe disease – New results from the phase III COMET trial of Sanofi’s avalglucosidase alfa, an investigational enzyme replacement therapy for patients with late-onset Pompe disease (LOPD) and infantile-onset Pompe disease (IOPD).

Regulatory

  • The FDA, AdvaMed, the Critical Path Institute, and the American Academy of Pediatrics will hold a three-day joint virtual public meeting February 9-11 on development of pediatric medical devices.
  • On February 10, the FDA’s Office of Minority Health and Health Equity, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, will host a virtual public workshop on “Collaborating to Advance Health Equity for Diabetes and Chronic Kidney Disease.”
  • Also on February 10, the FDA will hold another in its series of virtual town halls on coronavirus test development and validation.

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 914

Topic ID: 74,914,730,914,118,935,192,150,725,925,240