|
Allogene Therapeutics, Inc, a clinical-stage biotech company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, has announced an expanded strategic collaboration with Foresight Diagnostics, to include the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) for treatment with cemacabtagene ansegedleucel (cema-cel).
Under the amended and restated strategic collaboration agreement, Allogene and Foresight will work together to support the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel. Cema-cel is being studied in the groundbreaking randomized controlled pivotal ALPHA3 clinical trial as part of a first-line (1L) treatment to potentially improve the cure rate in patients with LBCL. In the ALPHA 3 clinical trial, patients who achieve remission following initial treatment but remain positive for MRD will be identified by using Foresight Diagnostics’ ultra-sensitive ctDNA-based Foresight CLARITY investigational use only (IUO) assay, powered by PhasED-Seq. Patients who remain minimal residual disease positive may be at high-risk of relapse, and therefore will have an opportunity to receive cema-cel as a one-time consolidation dose to prevent disease recurrence.
“The continued collaboration with Foresight Diagnostics strengthens our commitment to advancing next-generation cancer therapies by integrating minimal residual disease detection as a powerful tool in patient care,” said David Chang, president, CEO and co-founder of Allogene. “We believe that this strategic expansion will help accelerate the development and potential approval of cema-cel as we continue our mission to transform the LBCL treatment landscape for patients beyond the United States.”
As part of this agreement, Allogene Therapeutics will invest approximately $37.3 million for minimal residual disease assay development, milestone payments for US, and certain international regulatory submissions and clinical sample testing. Both companies have committed to use commercially reasonable efforts to obtain regulatory approvals of their respective products and execute the agreed-upon work plan to support and enable the joint development activities.
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B-cell lymphoma (LBCL). In June 2022, the US Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to cema-cel in r/r LBCL. The ALPHA3 pivotal phase 2 trial in first-line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.
In ALPHA3 clinical trial, over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first-line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30 per cent will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, “off-the-shelf” treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD.
|