Amphera Announces MesoPher Cell Therapy Clinical Updates

  • In the reactive phase II study in patients with resected pancreatic cancer, MesoPher demonstrated a statistically significant 2-year recurrence-free survival rate of 60% and an excellent safety profile
  • The observed safety and statistically significant efficacy are the basis for others randomized clinical research with MesoPher in pancreatic cancer
  • The randomized phase II/III DENIM study in mesothelioma patients was completed but failed to meet its primary endpoint, although MesoPher elicited a robust T-cell response

‘S-HERTOGENBOSCH, The Netherlands–(BUSINESS WIRE)–Amphera BV, a late-stage biotechnology company developing MesoPher cell therapy for the treatment of cancer, today reports top-line results from the Phase II Reactive study and Phase -II/III DENIM study known .

In the reactive phase II study, patients with resected pancreatic cancer who had completed standard chemotherapy received 3 biweekly injections of Amphera’s MesoPher dendritic cell therapy and booster injections at 4 and 7 months.

The Reactive study met its primary endpoint with top-line safety and efficacy data from two cohorts totaling 38 patients demonstrating a statistically significant recurrence-free survival of 60% at 2 years. The results of the first cohort of 10 patients were published in the European Journal of Cancer1. Based on these results, a 2nd cohort of 28 patients was fully enrolled. As noted in all MesoPher studies, the safety profile is excellent.

Prof. Casper van Eijck, principal investigator of the reactive study:

We are excited about the promising results of the Reactive study. These results exceed expectations for this patient group compared to the best current treatments. A 60% recurrence-free 2-year survival after surgical resection is truly an exceptional result. Further randomized clinical research with MesoPher in pancreatic cancer is a likely next step. In addition, we have seen that MesoPher induces a T-cell response against the patient’s tumor, which might explain its efficacy, even though pancreatic cancer is known as a cold tumor.

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In the DENIM study, mesothelioma patients with stable disease or better after platinum-pemetrexed chemotherapy received either MesoPher maintenance therapy or Best Supportive Care (BSC). The dosing regimen was identical to the reactive study. The DENIM study confirmed MesoPher’s excellent safety profile and MesoPher induced a robust T-cell response. The immune response did not translate into clinical benefit and consequently the primary endpoint of improvement in overall survival (OS) was not met.

The unexpected result of the DENIM study can be attributed to two main factors. The majority of patients had already progressed before or during the first 3 biweekly injections as evidenced by the CT scan performed after the third injection. Therefore, the first injections were given too late, since MesoPher cannot unfold its effect in progressive patients. Only a small proportion of patients received the full MesoPher treatment. In addition, both arms performed well with a median OS approximately 18 months after randomization, possibly due to second-line checkpoint inhibitor therapy.

Notes for editors

About Amphera – www.amphera.nl

Amphera is a late-stage biotechnology company developing cell therapies to treat cancer. MesoPher consists of autologous dendritic cells loaded with PheraLys, a lysate of tumor cell lines. PheraLys contains a broad repertoire of tumor-associated antigens, many of which are found in pancreatic and other cancers.

References:

European Journal of Cancer https://www.ejcancer.com/article/S0959-8049(22)00159-9/fulltext

contacts

Amphera BV
Rob Meijer (Managing Director) [email protected]
Ilona Enninga (COO) [email protected]

Amphera Media Contact:
AdamMichael

80. Atom

+44 777 588 1813

[email protected]

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