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“The new study findings presented at
In addition to the late-breaking poster, a poster will be presented on the new Gen 2 manufacturing protocol, highlighting key improvements around the current high throughput commercial manufacturing method (Poster #203). A third poster will demonstrate utility of a new reagent used for TIL expansion and effector function (Poster #357), and a fourth poster will provide data regarding investigation of key quality attributes of TIL product (Poster #194). The company will also present two posters in the Clinical Trials in
Cellular Therapy Approaches Late-Breaking Abstract
Title: Novel Cryopreserved Tumor Infiltrating Lymphocytes (LN-144) Administered to Patients with Metastatic Melanoma Demonstrates Efficacy and Tolerability in a Multicenter Phase 2 Clinical Trial
Authors: Sarnaik, et al.
Poster #: 515
- Preliminary efficacy data from nine patients in Cohort 2 shows a DCR of 78% including three partial responses and a fourth awaiting confirmation.
- Preliminary data to date show that the safety profile of Gen 2 LN-144 therapy is similar to Gen 1 LN-144 therapy previously presented at
ASCO2017. The most common adverse events reported were pyrexia, anaemia and nausea.
Cellular Therapy Approaches Abstracts
Title: A Cryopreserved TIL Product, LN-144, Generated with an Abbreviated Method Suitable for High Throughput Commercial Manufacturing Exhibits Favorable Quality Attributes for Adoptive Cell Transfer
Authors: Wardell, et al.
Poster #: 203
- The Iovance Generation 2 manufacturing process produces a potentially potent TIL product with comparable quality attributes to the Generation 1 manufacturing process.
- The abbreviated 22-day expansion platform allows for the rapid generation of TIL product for patients in urgent need of therapy. The cryopreserved product also offers flexibility of patient dosing.
- The cryopreserved drug product introduces critical logistical efficiencies allowing flexibility in distribution, and overcomes traditional barriers to the wider application of TIL therapy.
Title: Studies of Key Quality Attributes for TIL Product, LN-144
Authors: Ritthipichai, et al.
Poster #: 194
- Commercial manufacturing of TIL products will require a robust analytical platform to ensure consistent delivery of products meeting the critical quality attributes of cellular therapeutics.
- Study shows TIL products manufactured by Iovance are composed of greater than 99% CD45+CD3+ T cells.
- Residual melanoma cells in TIL products were below the limit of detection using a specialized assay developed for this assessment.
Immune Modulation, Cytokines, and Antibodies Abstract
Title: The T-cell Growth Factor Cocktail IL-2/IL-15/IL-21 Enhances Expansion and Effector Function of
Tumor-Infiltrating T cells in a Novel Process Developed by Iovance
Authors: Simpson-Abelson, et al.
Poster #: 357
- This study demonstrates the positive effects of adding IL-15 and IL-21 to the standard IL-2-containing cell culture in an ex vivo TIL generation protocol.
Clinical Trials (In Progress) Abstracts
Title: A Phase 2 Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Authors: Leidner, et al.
Poster #: 221
Title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma
Authors: Jazaeri, et al.
Poster #: 220
Additional information including the presentation schedule and full abstracts can be found on the conference website: http://www.sitcancer.org/2017/attendees/annual-meeting/schedule.
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the efficacy, safety, tolerability and cost of the Gen 2 manufacturing process, the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for its current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and its ability to obtain and maintain