Lyell Immunopharma Inks Agreement to Buy ImmPACT Bio USA

Lyell Immunopharma Inks Agreement to Buy ImmPACT Bio USA

By, Admin 28 October 2024

Lyell Immunopharma inks agreement to buy ImmPACT Bio USA, prioritizes its pipeline to focus on next-generation CAR T-cell therapies

Overview

South San Francisco-based Lyell Immunopharma, Inc, a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, announced that it has entered into a definitive agreement to acquire ImmPACT Bio USA Inc, a privately-owned clinical-stage biotechnology company.

IMPT-314: ImmPACT’s lead Programme

  • ImmPACT’s lead programme, IMPT-314, is a CD19/20-targeting chimeric antigen receptor (CAR) T-cell product candidate that Lyell will continue to develop for hematologic malignancies, including large B-cell lymphoma. 
  • IMPT-314 was designed to outperform the efficacy of approved CD19 CAR T-cell therapies via a dual-targeting CAR T-cell design and to improve CAR T-cell persistence by enriching for naïve and central memory T cells during manufacturing.

The Acquisition

The acquisition of ImmPACT is expected to significantly strengthen Lyell’s clinical-stage pipeline of next- generation CAR T-cell therapies and complement its suite of proprietary technologies designed to generate longer-lasting, functional T cells to achieve more durable outcomes for patients with solid tumors and hematologic malignancies.

From the CEO: Lyell

  • Lyell’s vision is to bring meaningful and durable clinical benefit to patients suffering from cancer with our next-generation cell therapies,” stated Lynn Seely, Lyell’s president and CEO. 
  • The emerging data from ImmPACT’s ongoing phase 1-2 trial and the phase 1 clinical data from a published UCLA-sponsored trial suggest the potential of IMPT-314 to have improved complete response rates and duration of response compared to the approved CD19 CAR T-cell therapies in CAR-naïve patients with aggressive B-cell lymphoma.
  • Since licensing this product candidate from UCLA, the team at ImmPACT has made impressive progress in the multi-center IMPT-314 phase 1-2 clinical programme. We look forward to presenting initial data from this program at a major medical conference later this year and initiating a pivotal trial for IMPT-314 in 2025.

Words from the CEO: ImmPACT

  • I am incredibly proud of the ImmPACT team and all of their accomplishments in developing next-generation CAR T-cell therapies,” stated Sumant Ramachandra, M.D., Ph.D., chief executive officer of ImmPACT. 
  • This transaction validates our novel science and enhances the potential for this therapy to make a meaningful impact on patients’ lives. I am confident that in Lyell, we have found a team that shares our passion for advancing novel science to benefit patients.

CAR T-cell Candidate’s Licensing

  • ImmPACT licensed its dual-targeting CD19/CD20 CAR T-cell product candidate from the University of California, Los Angeles (UCLA). 
  • Phase 1 data in 13 patients with relapsed/refractory (R/R) aggressive non-Hodgkin lymphoma treated in a UCLA-sponsored clinical trial were presented at the 2024 AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy. 
  • CAR T-cell naïve patients with R/R diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma after at least two lines of therapy or mantle cell lymphoma, follicular lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma after at least three lines of therapy were evaluated. 
  • Autologous T cells were obtained and enriched for CD14-/CD25-/CD62L+ naïve or memory T cells. 
  • Twelve out of 13 patients achieved a complete or partial response (92% objective response rate), with ten achieving a confirmed complete response (CR) (77% CR rate). 
  • The median progression-free survival was 50.1 months, and median overall survival was not reached with a median follow up of 32 months (range: 5.7 – not estimable). A favorable safety profile was observed.

Current Phase 1-2 trial by ImmPACT

  • The ongoing phase 1-2 clinical trial initiated by ImmPACT is a multi-center, open-label clinical trial designed to evaluate the tolerability and clinical benefit of IMPT-314 in patients with R/R aggressive B-cell lymphoma and determine a recommended phase 2 dose. 
  •  Initial phase 1-2 clinical data evaluating IMPT-314 primarily in patients who have received at least two prior lines of therapy for large B-cell lymphoma will be presented at a major medical conference this year. 
  • IMPT-314 has received Fast Track Designation from the US Food and Drug Administration for the treatment of R/R aggressive B-cell lymphoma.

Beginning Pivotal Trial in 2025

Lyell expects to initiate a pivotal trial in 2025 for IMPT-314 in patients in the 3rd line setting who have not yet been exposed to CAR T-cell therapy.

Lyell’s pipeline for CAR T-cell clinical programs

  • In connection with the acquisition, Lyell has prioritized its pipeline to focus resources on its most differentiated CAR T-cell clinical programs, including IMPT-314 following the close of the acquisition and LYL119. 
  • The enhanced anti-exhaustion technology incorporated into LYL119, including c-Jun overexpression, NR4A3 knockout, Epi-R and Stim R, has the potential to achieve improved efficacy at lower cell doses with an acceptable safety profile. 
  • In a validated in vivo preclinical model of non-small cell lung cancer, LYL119 achieved tumor control at a 10-fold lower cell dose than LYL797 with more gradual cell expansion to peak, and a substantial increase in the duration of cell killing demonstrated by a repetitive tumor cell killing assay in vitro.

Discontinuation of LYL797

Lyell is discontinuing development of LYL797, its ROR1-targeted CAR T-cell product candidate to focus on the Phase 1 clinical trial of its next-generation ROR1-targeted CAR T-cell product candidate LYL119, which is expected to initiate enrollment of patients with platinum-resistant ovarian cancer or relapsed/refractory endometrial cancer this year or early next year.

LYL845: The TIL Program

  • The LYL845 tumor-infiltrating lymphocyte (TIL) program is also being discontinued as the clinical data in patients with advanced melanoma did not meet our rigorous pre-determined criteria for continued development. 
  • Its next-generation TIL and rejuvenation programs that are in preclinical development will also be discontinued.

Lyell Post Transaction

Following the close of the transaction, Lyell expects its cash balance will fund operations into 2027, through important clinical milestones for each pipeline programme, including initiation of a pivotal trial for IMPT-314, which is expected to start in 2025.

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