Immutep quarterly activity report

Immutep Limited

  • New provisional TACTI-002 data from 2n/a patients with metastatic non-small cell lung cancer (NSCLC) show an encouraging early overall survival rate of 73.7% at the six-month benchmark

  • Constructive feedback from the US FDA regarding the clinical development program of efti in metastatic breast cancer (MSC)

  • New intermediate data for 1st TACTI-002 NSCLC line patients will be reported in a prestigious oral presentation at ASCO in June 2022

  • Recruitment of Phase IIb TACTI-003 patients is progressing

  • Strong cash and cash equivalents balance as of March 31, 2022: $87.2 million

  • Prominent Australian businesswoman, Lucy Turnbull AO, joins the Board as Non-Executive Director (NED), following the death of NED Grant Chamberlain

SYDNEY, AUSTRALIA, April 29, 2022 (GLOBE NEWSWIRE) — Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha (“efti”) and IMP761 for the quarter ended March 31, 2022 (Q3 FY22).

Effi Cancer Development Program

AIPAC – Phase IIb clinical trial
Immutep will present new biomarker data and multivariate analysis from the AIPAC Phase IIb trial in a poster presentation at the ESMO Breast Cancer Congress in May 2022. The trial evaluated efti in combination with paclitaxel chemotherapy in 227 patients with HER2-negative/HR-positive (RH+MBC) metastatic breast cancer. Final overall survival results were reported in November 2021, showing a statistically significant survival advantage in multiple patient subgroups.

AIPAC-003 – planned recording trial
In March 2022, Immutep received constructive feedback from the United States Food and Drug Administration (FDA) regarding its clinical development program for efti in MBC. The FDA supported Immutep’s view to continue to explore efti in MBC in a new registration trial, based on previously reported clinical data, including final overall survival data from the AIPAC trial. phase IIb. The planned new registration trial, AIPAC-003, will be based on Immutep’s completed Phase IIb AIPAC trial, but with an optimized design and for patients likely to benefit most from the treatment.

The FDA notice follows comments from the European Medicines Agency (EMA) regarding the efti program received in the second quarter of FY22. Other regulatory interactions are ongoing, including with the FDA and the EMA.

TACTI-003 – Phase IIb clinical trial
Recruitment of 1st patients with head and neck squamous cell carcinoma (HNSCC) in the TACTI-003 trial continued into the third quarter of FY22. 21 of approximately 154 patients were enrolled in the trial. To date, 21 sites have been activated out of 30 sites. TACTI-003 is a phase IIb multicenter, open-label, randomized and controlled trial. He earned fast-track designation for 1st HNSCC line by the US FDA in 2021.

TACTI-002 (also designated KEYNOTE-PN798) – Phase II clinical trial
Immutep has reported new interim data from patients with 2n/a metastatic NSCLC line from the phase II trial TACTI-002 in a poster presentation at the ESMO European Lung Cancer Congress (ELCC) in March 2022. Efti, in combination with pembrolizumab, shows an overall survival rate Encouraging early of 73.7% at the month-to-month milestone, as well as promising intermediate disease control and tumor growth kinetics. These early signs confirm that efti can stimulate the body’s immune system to allow pembrolizumab to work more effectively in patients with NSCLC who have progressive disease after 1st online treatment with anti-PD-1 or anti-PD-1 plus chemotherapy.

As announced yesterday, new interim data for 1st TACTI-002 NSCLC patients have been selected for a prestigious oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

In addition, the TACTI-003 phase IIb trial design will be featured in a poster presentation of the ongoing trial.
The 2022 ASCO Annual Meeting will take place in person and online June 3-7, 2022 in Chicago, USA.

PREVIEW-003 triple combination
Patient recruitment is ongoing for INSIGHT-003, an investigator-initiated Phase I trial taking place at the Institute for Clinical Cancer Research, Krankenhaus Nordwest (IKF), Germany. Already 10 out of a total of 20 patients with various solid tumors are now taking part in the trial. The study is evaluating a triple combination therapy consisting of efti and an existing approved standard of care combination of chemotherapy (carboplatin) and anti-PD-1 therapy. Interim results of the study are expected to be published in 2022.

IMP761 development program for autoimmune diseases
Immutep is continuing the required preclinical development evaluations of IMP761 before entering clinical trials. In addition, Northway Biotech, the company’s contract development partner and manufacturing organization, is continuing to develop a GMP-compliant manufacturing process for IMP761 to prepare materials for clinical trials.

Intellectual property
In February 2022, Immutep obtained a new Australian patent protecting its intellectual property for therapeutic preparations comprising efti and an anti-PD-1 or anti-PD-L1 antibody, such as pembrolizumab, nivolumab, avelumab, durvalumab or atezolizumab.

The Company and its IMP701 licensing partner, Novartis, have been granted a new patent from the Japanese Patent Office for LAG525 (IMP701) for the treatment of cancer. The new patent protects pharmaceutical compositions comprising LAG525 at a specific dose and for use in a defined treatment regimen. The compositions can also be administered in combination with a second agent such as an anti-PD-1 antibody, an anti-PD-L1 antibody or a chemotherapeutic agent. LAG525 (INN: ieramilimab) is a humanized form of Immutep’s IMP701 antibody.

During the quarter, Immutep was also granted a new patent for its preclinical autoimmune candidate, IMP761, by the Russian Federal Intellectual Property Service, known as Rospatent. The patent protects IMP761 and associated methods of use in inflammatory and autoimmune diseases for the territory of the Russian Federation.

Business Update

Board changes
Immutep was deeply saddened by the sudden and unexpected passing of Non-Executive Director Grant Chamberlain in January 2022. Mr. Chamberlain was a highly respected and valued member of the Immutep team. Immutep’s Board of Directors and staff send their sincere condolences to his family and friends.

The company welcomed prominent Australian businesswoman, philanthropist and former local government politician, Lucy Turnbull AO as Non-Executive Director of Immutep in February 2022. Ms. Turnbull joined Immutep’s Board of Directors after having served as President from October 2010 to November 2017, from the role due to professional and personal commitments at the time.

Financial summary
Customer collections for the quarter were $8,000 compared to $14,000 in Q2 FY22 (i.e. the quarter ended December 31, 2021).

Net cash used in G&A activities during the quarter was $1.6 million, compared to $0.2 million in Q2 FY22. The difference compared to the last quarter is mainly explained by the prepayment of certain annual charges. Payments to related parties for the quarter include $127,000 in payment of non-executive director attendance fees and executive director compensation.

Net cash used in research and development activities during the quarter was $8.13 million, compared to $4.67 million in the second quarter of FY22. Q3 FY22 was primarily due to increased efti and IMP761 contract manufacturing activities. Total net cash used in operating activities during the quarter was $10.95 million. By comparison, total net cash used in operating activities in Q2 FY22 was $6.06 million.

The Company’s cash and cash equivalents balance as of March 31, 2022 was $87.20 million, compared to a balance of $99.66 million as of December 31, 2021. The higher than expected cash balance of ‘Immutep places the company in a strong financial position with expected cash flow based on early 2024 estimates.

About Immutep
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3-related immunotherapeutics for the treatment of cancer and autoimmune diseases. Immutep is committed to leveraging its technology and expertise to bring innovative treatment options to market for patients and maximize shareholder value. Immutep is listed on the Australian Securities Exchange (IMM) and NASDAQ (IMMP) in the United States.

Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is an antigen-presenting cell (APC) activator first in class explored in cancer and infectious diseases. Immutep is also developing a LAG-3 agonist (IMP761) for autoimmune diseases. Other LAG-3 products, including antibodies for modulating the immune response, are being developed by Immutep’s large pharma partners.

Further information can be found on the company’s website or by contacting:

Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268; [email protected]

American media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; [email protected]

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