Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

Amphivena Presents at ASH First-in-Human Phase 1 Clinical Data on AMV564

Amphivena Therapeutics,Inc.
Posted on: 03 Dec 18

Amphivena Therapeutics, Inc., a privately held biotechnology company developing AMV564, a CD33/CD3 T cell engager for the treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), presented Saturday night in a poster presentation at the 60th Annual Meeting of the American Society of Hematology first-in-human Phase 1 clinical data that demonstrate that in patients with relapsed/refractory AML, AMV564 is well-tolerated and has anti-leukemic activity through T-cell engagement. The data from this ongoing dose escalation trial further show that AMV564 has a unique PK profile with a gradual increase in drug exposures that mitigates cytokine release syndrome (CRS).

“The ASH data reports continued evidence of single-agent clinical activity in heavily pre-treated patients with refractory/relapsed AML. AMV564 has been well-tolerated and has the potential to be safely combined with other agents. Importantly, its 2-day half-life supports intermittent dosing which differentiates AMV564 from other T cell engagers in development for myeloid malignancies,” said Eric J. Feldman, M.D., Amphivena’s Chief Medical Officer.

The poster highlights the safety and efficacy data on 26 evaluable patients, as follows:

  • Complete and partial responses (CRi, PR) observed in patients dosed at 100 mcg with a 14-day dosing regimen
  • No dose-limiting toxicity through the 150 mcg cohort, with a 0% 30-day mortality rate
  • No Grade 2+ CRS with a lead-in dose and no Grade 3+ CRS
  • Novel pharmacokinetic profile with a 2-day terminal half-life

A seamless Phase 1/2 study is ongoing at six centers in the U.S.

About Amphivena Therapeutics, Inc.

Amphivena Therapeutics, Inc. is a private biotechnology company developing AMV564, a bivalent, bispecific (2:2) CD33/CD3 T cell engaging antibody for the treatment of myeloid malignancies and solid tumors, with ongoing seamless Phase 1/2 studies in AML and MDS. Amphivena has raised $26.5 M to date in Series A and B venture financings led by MPM Capital and funds managed by Tekla Capital Management LLC. For more information, please visit www.amphivena.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181203005302/en/

Business Wire
www.businesswire.com

Last updated on: 03/12/2018

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.