Immutep Limited (IMMP) saw a push of 8.87% in the premarket today. However, the last trading session closed at $3.72 with a decrease of 21.68%.
Final Phase IIb AIPAC Study Results – Were they satisfactory?
IMMP announced AIPAC study results on 10th November 2021. The placebo-controlled, double-blind AIPAC trial randomly assigned 227 patients with HER2-negative/HR-positive metastatic breast cancer. These encouraging final findings gave the company even more faith in efti’s ability to provide substantial therapeutic benefit for a wide range of cancer patients.
Because metastatic breast cancer patients in the chemotherapy environment are difficult to treat and big patient groups, the results of the AIPAC study are extremely encouraging. Immunotherapies generally fail to give an extra benefit. These encouraging findings come at an important moment as IMMP finalizes the trial design for the planned Phase III investigation in metastatic breast cancer, which is still subject to regulatory body approval.
Patent for Eftilagimod Alpha – What is it?
On 2nd November 2021, IMMP announced that the Chinese Invention Office has granted a new patent (number ZL 201610221687) entitled “Use of recombinant LAG-3 or derivatives thereof for generating a monocyte immunological response.” The patent is part of a developing patent portfolio for the Company’s flagship product candidate eftilagimod alpha across important worldwide markets, including China.
Company Reviews on Patent
The company is making significant achievements in expanding the worldwide patent portfolio around the LAG-3 research pipeline, which includes lead candidate efti. IMMP will continue to make these critical investments, and they are particularly thrilled to be collaborating so closely with the Chinese partner, EOC Pharma, as they increase their clinical development of efti for the Chinese market.
Positive EMA Scientific Advice – Is it fair?
IMMP announced on 29th October 2021 that the European Medicines Agency (EMA) has given its approval to its clinical development program for the main pharmaceutical candidate, eftilagimod alpha (efti), which includes the planned Phase III trial in MBC.
Based on clinical results presented in December 2020 at SABCS, the EMA has endorsed the Company’s decision to continue the development of efti in MBC in a Phase III clinical study. Moreover, the study will be based on the company’s existing Phase IIb AIPAC trial, which has shown promising preliminary findings in key patient subgroups. Final overall survival results from the Phase IIb AIPAC study will be presented as a late-breaker poster session at SITC 2021 in mid-November.
Is the scientific advice worth it?
According to the company, receiving favorable and constructive feedback from the European Medicines Agency (EMA) on our efti clinical development program is a significant accomplishment for IMMP. The company now looks forward to working with the EMA and other agencies, including the US Food and Drug Administration, to finalize the trial preparations.