Onco-Summaries: Daily Oncology Updates at a Glance

05/08/2025

Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN (Ref)

Immutep received positive and constructive feedback from the US FDA regarding future clinical development of eftilagimod alpha (soluble LAG-3 protein) as a first-line Tx of R/M SCCHN with PD-L1 CPS <1. 

• Based on available data from cohort B of the Ph2b TACTI-003 trial of efti + pembro in R/M SCCHN with CPS <1, the FDA agreed on the potential of the combo to address the high unmet need in this population and was supportive of further development

• Paths for future development and potential accelerated approval based on the FDA’s Project FrontRunner include a randomized registrational trial of efti + pembro vs SOC, or a smaller single-arm study (N=70-90 pts; safety, ORR and DOR as key endpoints) followed by a confirmatory randomized study

SERB Pharmaceuticals announced an agreement to acquire Y-mAbs Therapeutics (Ref)

SERB Pharmaceuticals and Y-mAbs Therapeutics have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead commercial oncology asset, DANYELZA® (naxitamab-gqgk).

• The deal will be an all-cash transaction, representing an equity value for Y-mAbs of approximately $412 million.

  
  

• Under the terms of the agreement, SERB will commence an all-cash tender offer to purchase all outstanding shares of Y-mAbs common stock

  
  

• Holders of Y-mAbs common stock would receive $8.60 per share in cash, representing a premium of approximately 105% to Y-mAbs’ closing share price on August 4, 2025, the last full trading day prior to the transaction announcement