Immutep (ASX: IMM) and (FRA: YP1B) are the global leaders in understanding and development of therapeutics that modulate Lymphocyte Activation Gene-3 or "LAG-3” which is a cell surface molecule which plays a vital role in regulating T cells.
LAG-3 was discovered by the company’s Chief Scientific Officer and Chief Medical Officer Dr. Frederic Triebel, placing Immutep at the forefront of immunotherapy drugs for cancer and autoimmune diseases.
The company’s objective is to harness and strengthen the power of the body’s own immune systems through therapeutic intervention for the benefit of patients’ health. This is how immunotherapy fights cancer and autoimmune disease.
Immutep at November 2020 is running a Phase IIb study for its lead drug candidate, eftilagimod alpha (efti), as an immunotherapy solution for patients with late-stage breast cancer.
Immutep announced in early December 2020 that the drug appeared to extend patients’ lifespan by 2.7 months when taken in combination with chemotherapy compared to patients treated with chemotherapy alone. The treatment was used for patients “known to be insensitive to immune checkpoint inhibitor therapy”, the company said.
The 76 patients who had the Immutep breast cancer treatment survived on average 20.2 months, compared with 17.5 months for the 71 patients who hadn’t used the Immutep drug in conjunction with chemotherapy, the company said. The increased survival rates correlated with a statistically significant increase in a certain type of T-cells involved in fighting cancer – an important proof of concept showing that efti is working.
The survival benefit was significantly improved for younger patients. Patients under 65 on the Immutep drug plus chemotherapy lived an average of 21.9 months, 7.1 months longer than those who received chemotherapy plus placebo.
The survival rate “data in subgroups such as those below age 65 years are highly encouraging and may lead to more effective treatment options for metastatic breast cancer patients,” said principal investigator of the study, Hans Wildiers.
According to the company’s chief medical officer Dr Frederic Triebel the result supports the company’s belief that efti can be an effective activator of the body’s own immune system in fighting late-stage cancer. “Metastatic breast cancer is typically a non-immunogenic cancer and is therefore significantly less responsive to modern immune checkpoint inhibitor (ICI) therapies,” he said.
“As such, chemotherapy continues to be the standard of care in many instances and there continues to be a large unmet medical need.” Together with these results, the dual-listed Immutep (NASDAQ: IMMP) announced a new Phase II clinical trial in China.
The company’s Chinese partner, EOC Pharma, will commence the trial in the first quarter of next year. Very similar to the AIPAC study, the trial will be a “randomised, double-blind, placebo-controlled phase II clinical study”, IMM said. EOC Pharma will run the test for up to 152 metastatic breast cancer patients in China to evaluate the efti treatment. The trial will run over a period of 24 months and is expected to take place at 20 clinical trial sites across China.
EOC Pharma CEO Xiaoming Zou said breast cancer is now the most common form of cancer in Chinese women and kills around 1.2m people each year.
The trial has received approval from the Chinese National Medical Products Administration ahead of its Q1 launch, the company said.
Combined with the AIPAC study, Immutep CEO Marc Voigt said excitement is now building about the potential for efti to be a game-changing treatment, when combined with paclitaxel chemotherapy in the battle against metastatic breast cancer.
IMM have one pre-clinical and three clinical LAG-3 product candidates under development, including two antibodies for modulating immune responses in autoimmunity and cancer, through pharmaceutical partnerships, with Novartis and GlaxoSmithKline.
The company’s lead product candidate is eftilagimod alpha (LAG-3Ig or IMP321), a first-in-class antigen presenting cell (APC) activator currently being investigated in clinical trials as a treatment (in combination with chemotherapy or immune therapy) for breast cancer and melanoma. The company's other products are
1. IMP321, known as eftilagimod alpha - immunotherapy for cancer
2. IMP761 - preclinical immunotherapy for autoimmune disease
3. IMP701, known as LAG525 - immunotherapy for solid tumours, blood cancer and breast cancer (partnered with Novartis)
4. IMP731, known as GSK ‘781 - immunotherapy in ulcerative colitis (partnered with GSK)
Insight – 004 – Phase 1 Clinical Trial
Of interest for our readers in Europe, IMM has been conducting a Phase 1 Clinical Trial in Frankfurt, Germany in collaboration with Merck KGaA and Pfizer Inc. These trials are expected to deliver final data in 2021. First data from the study was presented at ASCO and ESMO in 2020.
If trials are successful the result will be co-development and co-commercialisation avelumab under the brand name Bavencio, which is a fully human monoclonal antibody.
Immutep’s INSIGHT-004 drug serves as the fourth arm of the investigator-initiated INSIGHT trial. The trial is designed to evaluate the combination of efti with avelumab in 12 patients with different solid tumours, primarily gastrointestinal. In September 2020, Immutep announced 41.7% of patients showed a partial response to the therapy, compared to 33% recorded previously. Moreover, the trial indicated a disease control rate of 50%.
In a presentation at the ESMO Virtual Congress yesterday, INSIGHT-004 trial investigator and IKF director Professor Salah-Eddin Al-Batran said: “It is encouraging to see the range of patients with different solid cancers that are responding to the combination of efti and avelumab, including PD-L1-negative cervical cancer, squamous anal cell carcinoma and mesothelioma. These tumours are not typically responsive to immune checkpoint therapy and warrant further investigation.
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September 2020 Video IMM presentation