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New medicines #48 - April 10, 2021 - April 16, 2021
A weekly overview of the development of new medicines.
- Affimed announced initial clinical data from a phase 1 trial evaluating cord blood-derived natural killer (cbNK) cells with its innate cell engager (ICE) AFM13 (CD16A/CD30) in adult patients with recurrent/refractory CD30-positive lymphomas:
All four patients experienced significant disease reduction, with two complete responses and two partial responses, rendering an objective response rate of 100%
- Celcuity reported data from its phase 1b open label trial evaluating gedatolisib and Ibrance (Palbociclib) together with Letrozole or Fulvestrant, in ER+/HER2- advanced or metastatic breast cancer patients:
In the trial, 53 of the 88 evaluable patients (60%) exhibited an objective response
- Panbela Therapeutics announced the FDA has lifted the partial clinical hold on its phase 1 first-line study of SBP-101 in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA).
- Sage Therapeutics with Biogen announced that top-line data from their phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET) met the primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale upper limb tremor score (P=0.049):
A 36% reduction from baseline was exhibited compared to a 21% reduction in patients receiving placebo
The high dose was not well tolerated, however, with 62% of patients down-titrated from 60mg to 45 mg or 30 mg
Source: BPC (reformatted), SY, Bioworld